Calendar of Events

Single Cell Applications in Mechanistic Toxicology

Thursday, April 2
12:00 Noon to 1:30 PM (ET)

Chairs: Cody Smith, Rutgers, The State University of New Jersey; and Michael Aschner, Albert Einstein College of Medicine.
Primary Endorser: Mechanisms Specialty Section
Other Endorsers: Comparative Toxicology, Pathology, and Veterinary Specialty Section; Molecular and Systems Biology Specialty Section

This free webinar is being presented as part of the 2020 SOT Virtual Annual Meeting.

Description:
Investigations into the mechanism of action of chemicals, pharmaceuticals, and contaminants typically rely on measurements of gene and protein expression. A change in expression of a gene, protein, or functionally related groups would indicate perturbation of suspect signaling pathways. These measurements are typically performed in whole tissues or homogenous populations of cells in culture. These “bulk” analyses do not consider the heterogeneity of cell types within a given tissue and thus provide a nonspecific average across cell populations, which reduces the specificity and sensitivity of the measurement. Different cell types exhibit variable responses to toxicant exposures that may be missed when analyzing bulk samples. For example, traditional bulk analyses cannot decipher responses in low abundant cells, which can be diluted by changes in more abundant cell types, and do not capture opposing signals in multiple cell types. To address these issues, single cell analytical tools have been developed that probe alterations in the genome, transcriptome, proteome, and metabolome of individual cells. While these methods are gaining popularity in the fields of immunology and cancer biology, among others, they have been minimally used to characterize target organ toxicities or to understand the mechanisms of action of toxicants. The purpose of this Workshop is to provide the audience an overview of the field of single cell biology through case studies of mechanistic investigations into toxicological responses in multiple systems using various single cell analytical methods. The first presentation will focus on antibody-based methods used to measure protein expression in single cells, including flow cytometry and single cell western blotting. The next presentation will focus on the use of single cell RNA sequencing (scRNA-seq) data to train a deconvolution algorithm, CIBERSORT, to estimate population size shifts from bulk RNA-seq data. The last presentation will introduce the single-cell amalgamation via latent semantic analysis (SALSA) workflow for cross-specimen integration of scRNA-seq data that is used to extract reliable exposure-induced gene expression changes from scRNA-seq data by reducing noise and addressing issues related to the sparsity of single cell data. This presentation also will complement scRNA-seq data with single cell proteomic analysis of cell surface proteins using single cell mass cytometry. Overall, this Workshop will introduce attendees to multiple single cell analytical techniques that provide a deeper view of the underlying biology driving adverse toxicological responses in diverse systems and will allow ample interaction between participants.

Introduction. Michael Aschner, Albert Einstein College of Medicine, Bronx, NY.

Application of Single Cell Proteomic Analyses to Identify Pharmacological Mechanism of Action of a Novel Nitrated Fatty Acid in Acute Lung Injury. Cody Smith, Rutgers, The State University of New Jersey, Piscataway, NJ.

Deconvolution of Bulk RNA-Seq Data Using Archived Single Cell RNA-Seq Data to Determine the Effects of Toxicants on Cell Population Sizes. Douglas Ruden, Wayne State University, Detroit, MI.

Peripheral Blood Monocytes of Human Smokers Exhibit Differences in M1 Macrophage-Associated Transcriptional Signatures Resolved by Single Cell RNA Sequencing. Oswaldo Lozoya, NIEHS, Research Triangle Park, NC.

Continuing Education Course AM04: Introduction to Open-Access Computational Toxicology Tools

Friday, April 3
12:00 Noon to 3:30 PM (ET)

Chairs: Agnes Karmaus, Integrated Laboratory Systems Inc; and Nicole Kleinstreuer, NIEHS/NICEATM.
Primary Endorser: In Vitro and Alternative Methods Specialty Section
Other Endorsers: Mechanisms Specialty Section; Regulatory and Safety Evaluation Specialty Section

This webinar is being presented as part of the 2020 SOT Virtual Annual Meeting. Continuing Education (CE) courses require a paid registration. Those who registered to attend the CE course in Anaheim are registered for the course. If you were not previously registered, you may register to attend.

Description:
Computational toxicology is rapidly accelerating our ability to develop methods for predicting chemical properties and chemical-mediated effects, both in the environmental chemical space and in the area of drug development. With frequently updated tools and approaches, overwhelming feedback suggests that more training is needed to help all toxicologists understand the fundamental approaches, use available tools and databases, and interpret outputs. This CE course is designed to offer an introductory-level foundation for leveraging some widely accepted approaches and demonstrate how to use open-source tools and resources to make use of these methods. Course participants across all sectors, ranging from students to career toxicologists, should walk away with the confidence to use the resources presented for computationally characterizing and predicting chemical-elicited toxicity. In addition to gaining familiarity with basic computational toxicology concepts, participants will gain insight into what makes an approach useful for research projects versus which are ready for potential regulatory applications. The first speaker will help lay a foundation for how chemicals are “interpreted” computationally, explaining how chemical structures are leveraged for subsequent analyses (i.e., fingerprinting and its use for read-across). Building on these concepts, the second speaker will provide a thorough example of how to use the US Environmental Protection Agency (US EPA) CompTox Chemicals Dashboard, which provides data for nearly 900,000 chemicals and drugs. Attendees will learn how to assess the confidence in available data, as well as learn how to use the tools available in the dashboard for predicting chemical toxicity and download pertinent data, including mechanistic information, exposure data, animal toxicity doses, and much more. The third presentation will provide a demonstration to empower course attendees in using the Integrated Chemical Environment (ICE), an interactive tool that contains in vitro to in vivo extrapolation workflows that users can leverage to conduct analyses themselves, as well as provides curated in vivo and in vitro datasets that can be used to evaluate predicted toxicology outcomes. The fourth presentation will steer the course further into the realm of biological interpretation, describing how toxicogenomics data and literature mining underlying the Comparative Toxicogenomics Database (CTD) can be utilized to computationally characterize chemical mode of action and provide insight into toxicity mechanisms. The last speaker will introduce Sysrev, a collaborative computational systematic review tool to extract pertinent data from literature, incorporating approaches such as machine learning and metadata tagging. Overall, course attendees will gain a fundamental understanding of approaches underlying the most widely used computational toxicology methods, as well as learn to use publicly available, open-source tools that apply these methods.

Course Introduction: What Do Computational Toxicology Tools Offer? Nicole Kleinstreuer, NIEHS/NICEATM, Durham, NC.

Cheminformatics 101: Fingerprinting and Read-Across. Mark Cronin, Liverpool John Moores University, Liverpool, United Kingdom.

The US EPA CompTox Chemicals Dashboard. Antony Williams, US EPA/NCCT, Research Triangle Park, NC.

Integrated Chemical Environment (ICE). Shannon Bell, Integrated Laboratory Systems, Inc., Durham, NC.

Comparative Toxicogenomics Database (CTD). Carolyn Mattingly, North Carolina State University, Raleigh, NC.

Sysrev: Collaborative Literature Extraction. Tom Luechtefeld, Insilica, Baltimore, MD.

Continuing Education Course AM07: The Basics of In Vitro Xenobiotic Metabolism and Drug-Drug Interaction Investigations: Applicability to All Xenobiotics

Friday, April 3
12:00 Noon to 3:30 PM (ET)

Chairs: Andrew Parkinson, XPD Consulting; and Brian W. Ogilvie, Sekisui XenoTech LLC.
Primary Endorser: In Vitro and Alternative Methods Specialty Section
Other Endorsers: Drug Discovery Toxicology Specialty Section; Exposure Specialty Section

This webinar is being presented as part of the 2020 SOT Virtual Annual Meeting. Continuing Education (CE) courses require a paid registration. Those who registered to attend the CE course in Anaheim are registered for the course. If you were not previously registered, you may register to attend.

Description:
In the current landscape of drug development and investigation of environmental chemicals, many personnel with toxicology backgrounds find themselves overseeing not only preclinical safety assessments but also in vitro xenobiotic metabolism and interaction studies. Therefore, the goal of this course is to provide attendees with practical perspectives from experts in the field on the approaches and techniques that are available to address the important aspects of xenobiotic metabolism. The first presentation will focus on the experimental design and interpretation of data obtained from studies of in vitro inhibition of cytochrome P450 (CYP) and other xenobiotic-metabolizing enzymes. In contrast, the second presentation will focus on the experimental design and interpretation of data obtained from studies of in vitro induction of CYP and other xenobiotic-metabolizing enzymes. The third talk will broaden considerations of xenobiotic metabolism, including assessment of the toxicological burden of reactive metabolites, and the experimental design and interpretation of data obtained from studies of in vitro reaction phenotyping techniques in human liver microsomes and other test systems derived from humans or toxicologically relevant species. The fourth presentation will discuss in vitro approaches for determining the potential for xenobiotics to be substrates or inhibitors of major transporters that are of regulatory interest and interpretation of the data obtained from these studies. The final presentation will discuss the practical implications of the in vitro approaches discussed and the current regulatory thinking on their applicability to all xenobiotics to which humans are exposed. The overarching objective of this course is to provide attendees with a solid foundation in commonly used methods to enable the design, execution, and interpretation of rigorous and reproducible in vitro xenobiotic metabolism and interaction studies that will withstand regulatory scrutiny and avoid common pitfalls. This course will benefit those whose toxicological interests are expanding to include in vitro xenobiotic metabolism, as well as professionals responsible for appraising or evaluating in vitro xenobiotic metabolism, interaction studies, and other ADME data for internal decision-making, risk assessment, or submission to various regulatory agencies.

Introductory Remarks on Xenobiotic Metabolism and Course Overview. Andrew Parkinson, XPD Consulting, Shawnee, KS.

The Basics of In Vitro CYP Inhibition Studies for Regulatory Submission and Risk Assessment. Brian Ogilvie, Sekisui XenoTech LLC, Kansas City, KS.

The Basics of In Vitro CYP Induction Studies for Regulatory Submission. Diane Ramsden, Alnylam Pharmaceuticals Inc., Cambridge, MA.

In Vitro Reaction Phenotyping and the Toxicological Burden of Reactive Metabolites. Jed Lampe, University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, Aurora, CO.

Xenobiotic Transporter Studies for Regulatory Submission. Caroline Lee, Arena Pharmaceuticals Inc., San Francisco, CA.

The Science of Drug Interactions Is Applicable to All Xenobiotics. Andrew Parkinson, XPD Consulting, Shawnee, KS.

The Health Effects Institute (https://www.healtheffects.org/) is pleased to announce:

Annual Conference 2020

The conference will be held April 5–7, 2020 at the Renaissance Boston Waterfront Hotel in Boston, Massachusetts. Details can be found at https://www.healtheffects.org/annual-conference.

Continuing Education Course AM03: Developing Therapeutics for Ocular Indications: A 20/20 View

Friday, April 10
12:00 Noon to 3:30 PM (ET)

Chairs: Kathleen Krenzer, Iuvo BioScience; and Hiromi Hosako, Alcon.
Primary Endorser: Ocular Toxicology Specialty Section
Other Endorsers: Biotechnology Specialty Section; Comparative Toxicology, Pathology, and Veterinary Specialty Section

This webinar is being presented as part of the 2020 SOT Virtual Annual Meeting. Continuing Education (CE) courses require a paid registration. Those who registered to attend the CE course in Anaheim are registered for the course. If you were not previously registered, you may register to attend.

Description:
No longer are eye drops the only way to treat the eye; the emergence of novel therapeutic and development approaches for ocular indications has impacted how we design toxicology assessments, select species, and perform toxicity evaluations. Additionally, the structural complexity of the eye as well as the unique aspects of ocular dose-administration routes require continued refinements of ocular evaluation techniques and assessment strategies. The goal of this course is to provide toxicologists with a broad overview of highly specialized ocular anatomy, current ophthalmic diagnostic techniques, evolving histopathological assessment strategies, and thought-provoking ocular drug development strategies, including case studies. The first speaker will open the session with an detailed overview of ocular anatomy complexity, focusing on unique features of the eye and critical anatomical and physiological features that may influence or impede a drug’s efficacy and safety in human patients. The speaker also will discuss novel routes of drug administration in ocular drug development. The second presentation will tune in to gold-standard, in-life ophthalmic diagnostic techniques with selected case examples showing how modern ocular diagnostic equipment can be used to prove multifactorial questions. This presentation also will touch upon recent efforts at harmonization of ocular finding nomenclature and clinical record-keeping lexicon in preparation for SEND (Standard for Exchange of Nonclinical Data) requirements dictating reporting of ocular toxicology studies. The third talk will focus on evolving strategies for histopathological assessment of ocular tissues, which will include key points to consider when processing the eye to ensure a thorough examination of key structures of the globe as well as the effect of factors such as the route of administration and the formulation or character of the therapeutic candidate on effective examination of the eye. The last presentation will highlight unique nonclinical safety challenges and considerations during ocular drug development using case studies to push our assumptions of what is the best way to evaluate the safety of ophthalmic therapeutics.

Do Animals See 20/20? The Spectrum of Ocular Anatomy and Physiology in Animals. Seth Eaton, University of Wisconsin–Madison, Madison, WI.

Getting the 20/20 Read: Clinical Evaluation Techniques for Ophthalmic Toxicology. Joshua T. Bartoe, Northern Biomedical Research Inc., Norton Shores, MI.

20/20 under the Scope: Evolving Strategies for Histopathological Assessment of Ocular Tissues. Helen Booler, Genentech Inc., South San Francisco, CA.

Using 20/20 Hindsight to Set the Course for Considerations in the Preclinical Development of Ocular Therapeutics in the Future. Brenda Smith, Allergan, Irvine, CA.

Focused on neurodegenerative diseases such as Parkinson's, Alzheimer's and ALS, and with over 23 speakers from leading drug developers including Biogen, Alector, andJanssen, the 2nd Annual Neuroimmunology Drug Development Summit will enable you to:
- Discover the latest advances in recapitulating human microglia in preclinical models to reduce the translational gap
- Hear about the successful investment strategies helping small biotechs to pursue novel targets
- Discuss how to approach neuroimmunological targets to improve the efficacy of neurodegenerative therapeutics
- Review the latest clinical data with neuroimmunological candidates to inform future research
- Network with the leading organizations on the cutting-edge of this exciting and fast-moving space to create opportunities for future collaborations

Toxicology 2020 aims to gather global leading educational scientists, researchers, and research students, to exchange and share their experiences and research results about all the aspects of Toxicology. The conference proceedings include Keynote speeches, The exhibition, Plenary talks, Workshops, Symposiums, Poster sessions, B2B networking, and Panel discussions on the latest research developments.

Speaker:
Jamie Zhu, PhD
US FDA, Staff fellow/Consumer Safety Officer

Known Unknowns: Challenges and Approaches for Handling Chemical, Hazard, and Regulatory Uncertainty in Medical Device Safety Assessments

Thursday, April 16
1:00 PM to 3:45 PM (ET)

Chairs: Tom Lewandowski, Gradient; and Alan Hood, US FDA/CDRH.
Primary Endorser: Medical Device and Combination Product Specialty Section
Other Endorsers: Computational Toxicology Specialty Section; Regulatory and Safety Evaluation Specialty Section

This free webinar is being presented as part of the 2020 SOT Virtual Annual Meeting.

Description:
The regulatory landscape for the safety evaluation, clinical testing, and commercial development of medical devices is undergoing considerable changes, including new requirements for material characterization and chemical risk assessment early on in the development process. In this dynamic environment, extractables/leachables (E/L) analysis is becoming a key tool in biocompatibility assessments to ensure patient safety and establish regulatory compliance. The first speaker will begin the discussion on medical device chemical characterization strategies, a necessary step for understanding potential chemical exposures from medical device components. The presentation will include examples of how information concerning material chemistry and the manufacturing process can reduce the cost and effort associated in resolving “unknown” extractable compounds. The next presentation will focus on predictive toxicology methods (e.g., computational toxicology programs, read-across, Threshold of Toxicological Concern) for evaluating potential risks from extractable compounds. Case studies will be presented to demonstrate the importance of expert judgment when interpreting in silico hazard predictions, as well as approaches for justifying a read-across approach for risk assessment of extractable compounds. The third speaker will then discuss the US Food and Drug Administration (US FDA) perspective on the issues raised in the preceeding talks. Agency experience with unique nontargeted analytical methods that generate data adequate for toxicological risk assessment will be presented, which include, but are not limited to, extraction method design, analytical instrument/tool selection, selecting an analytical evaluation threshold (AET), sample manipulation, system suitability, calibration, identification/semi-qualification, and data reporting. The final speaker will present a broader overview of the global regulatory landscape for medical device safety evaluation. Notable activity includes the revision of ISO 10993-1, implementation of the European Union’s revised Medical Devices Regulation, and amendments to California Proposition 65. This presentation will cover how new requirements for extractables/leachables analysis will affect the manufacturer’s ability to justify the safety of hazardous substances within devices, verify warning label exemption, evaluate biological equivalence of predicate/proposed devices, and support supply chain controls and ensure efficient change management.

Introduction. Thomas Lewandowski, Gradient, Seattle, WA.

Chemical Characterization Strategies for Medical Device Biocompatibility Assessment. Adam Kozak, Cambridge Polymer Group Inc., Boston, MA.

Predictive Toxicology Approaches for Medical Device Biocompatibility Assessment. Joel Cohen, Gradient, Cambridge, MA.

CDRH Scientific Perspective on Material Characterization and Toxicological Risk Assessment of Nontargeted Medical Device Extractables. Berk Oktem, US FDA/CDRH, Silver Spring, MD.

Extractables and Leachables Analysis of Medical Devices in a Changing Global Regulatory Environment. Whitney Christian, Medtronic, Jacksonville, FL.

Panel Discussion. Alan Hood, US FDA/CDRH, Silver Spring, MD.

Continuing Education Course AM06: Modern Modeling Strategies to Address Uncertainty and Variability in Dose-Response Assessment

Friday, April 17
12:00 Noon to 3:30 PM (ET)

Chairs: Kan Shao, Indiana University; and Weihsueh A. Chiu, Texas A&M University.
Primary Endorser: Risk Assessment Specialty Section
Other Endorsers: Biological Modeling Specialty Section; Regulatory and Safety Evaluation Specialty Section

This webinar is being presented as part of the 2020 SOT Virtual Annual Meeting. Continuing Education (CE) courses require a paid registration. Those who registered to attend the CE course in Anaheim are registered for the course. If you were not previously registered, you may register to attend.

Description:
Quantifying dose-response relationships to evaluate the toxicity of environmental chemicals is a key step in human health risk assessment and has evolved substantially in recent years. In addtion to fundamentally developing a dose-response curve and estimating a dose level that results in a predetermined critical effect, recent advances in toxicology and modeling stategies enable dose-response assessment to more comprehensively and quantitatively address uncertainty and human variability. The purpose of this course, to be delivered by a mixed group of experts from academia, government, and industry, is to provide participants an overview of the cutting-edge modeling strategies employed in dose-response assessment to quantify uncertainty and variability. The first presentation will introduce the benchmark dose (BMD) methodology and its utilities to quantify various sources of uncertainty in dose-response modeling with a demonstration of the Bayesian BMD modeling system. The second speaker will present an overview of the principles and recent applications of probabilistic dose-response assessment approaches developed under the WHO/IPCS guidance to address uncertainty and variability in quantitative risk assessment. The third presentation will provide an overview together with case examples of Diversity Outbred (DO) mouse population-based in vitro systems to demonstrate a data-driven probabilistic approach to derive a chemical-specific uncertainty factor for inter-individual variability. The last speaker will introduce how to predict population distributions of toxicokinetic-relevant physiological quantities that NHANES does not measure based on the measured counterparts using the HTTK-Pop R package that incorporates population variability in high-throughput toxicokinetic modeling. Throughout the course, use of and applications to in vitro and high-throughput testing systems will be highlighted, including their relevance to in vitro to in vivo extrapolation (IVIVE).

Benchmark Dose Modeling Strategies for Uncertainty Quantifications in Dose-Response Assessment. Kan Shao, Indiana University, Bloomington, IN.

Probablistic Dose-Response Assessment to Quantatively Address Uncertainty and Variability. Weihsueh Chiu, Texas A&M University, College Station, TX.

Modeling Dose-Response across Populations: Quantification of Inter-Individual Variability. Alison Harrill, NIEHS, Research Triangle Park, NC.

Simulation of Population Variability in High-Throughput Toxicokinetic Modeling in Support of Dose-Response Assessment. Caroline Ring, ToxStrategies Inc., Austin, TX.

Once again, the conference will bring together the leading microbiome companies working to successfully commercialize microbiome-based diagnostics, therapeutics, adjunct therapies and direct-to-consumer services and products across a range of therapeutic areas, from gut to skin and beyond. Expanding on this core focus year on year, we continue to offer informative, hands-on workshops, panels sponsored and directed by industry to focus on your concerns and tightly curated content that goes beyond the usual infomercials to provide tangible and useful insights to how your peers are addressing their commercial approach to the space.

Globally Harmonized Guidance for Dose-Response Analysis and Derivation of Health-Based Guidance Values for Chemicals in Food

Tuesday, April 21
12:00 Noon to 2:45 PM (ET)

Chairs: Virunya Bhat, ToxStrategies Inc.; and Yu (Janet) Zang, US FDA.
Primary Endorser: Food Safety Specialty Section
Other Endorsers: Regulatory and Safety Evaluation Specialty Section; Women in Toxicology Special Interest Group

This free webinar is being presented as part of the 2020 SOT Virtual Annual Meeting.

Description:
The World Health Organization recently coordinated an international effort to update its guidance document on dose-response assessment for chemicals in foods, including additives, contaminants, natural toxicants, and residues of pesticides and veterinary drugs. Although the guidance relates to food safety, it reflects the state-of-the-science on dose-response assessment and benchmark dose (BMD) modeling, including key areas of consensus among international experts and thus is broadly applicable beyond chemicals in food. Key motivators for the update were newly available modeling technology and the need for harmonization of BMD approaches used by the US Environmental Protection Agency (USEPA) and European Food Safety Authority (EFSA). The speakers were members of an international working group charged with drafting theharmonized guidance. Alan Boobis (Imperial College London) will begin with an overview of the guidance, objectives of the working group, and notable updates. Lynne Haber (University of Cincinnati) will address the need for global harmonization with case studies and present the new consensus decision tree, designed to aid in harmonizing approaches and be a practical guide to risk assessors and managers by illustrating how key decision points are affected by a variety of practical scenarios. Matt Wheeler (NIEHS) will outline important considerations in the practice of BMD modeling, explaining recommendations of modeling strategies for different types of data, and present challenges and solutions in harmonizing different methods. The remaining half of the webinar will provide nuts-and-bolts instruction on conducting BMD modeling with model averaging, beginning with a brief introduction of the different BMD platforms, followed by Jose Cortinas-Abrahantes (EFSA) and Allen Davis (US EPA) providing case study demonstrations using EFSA PROAST and US EPA BMDS software, including implications of key decisions when conducting the modeling. Matt Wheeler (NIEHS) will demonstrate more advanced topics, including Bayesian prior selection and sensitivity analysis. This second half is designed as a “hands-on” demonstration, with the intent that participants who wish will be able to follow along with the step by step on their own computers. To do so, be sure to have the latest version of BMDS downloaded, and be prepared to access the EFSA online platform. The session will conclude with a Q&A panel moderated by Jeff Gift (US EPA) and allow time for operational questions and discussion.

Introduction. Janet Yu Zang, US FDA, College Park, MD.

Bring Together Multidisciplinary Expertise: Highlights of Updates in the New Dose-Response Analysis Guidance for Chemicals in Food. Alan Boobis, Imperial College London, London, England.

Step by Step: Decision Tree for Dose-Response Analysis and Choice of the Benchmark Response. Lynne Haber, TERA Center, University of Cincinnati, Cincinnati, OH.

Bring Harmonization into Dose-Response and Benchmark Dose Modeling Guidance. Matthew Wheeler, CDC, Cincinnati, OH.

Benchmark Dose Modeling: Can We Bridge the Differences? Lynne Haber, TERA Center, University of Cincinnati, Cincinnati, OH.

Benchmark Dose Analysis Using PROAST: An Interactive Demonstration. José Cortiñas Abrahantes, European Food Safety Authority, Parma, Italy.

Benchmark Dose Analysis Using BMDS: An Interactive Demonstration. J. Allen Davis, US EPA, Cincinnati, OH.

Boundary Cases for Bayesian Benchmark Dose Analysis. Matthew Wheeler, NIOSH, Cincinnati, OH.

Panel Discussion. Jeffery Gift, US EPA, Research Triangle Park, NC.

Over 300 pharmaceutical scientists working across formulation, drug delivery and manufacturing science and technologies, representing global pharmaceutical organisations, leading biotech and internationally renowned academic institutions

PLUS interactive opportunities including:
- Roundtable discussions
- Panel discussions
- Pre-event podcasts and webinars

Co-located with the 3rd Annual Inhalation and Respiratory Drug Delivery USA Congress.

Go Social: Join our Formulation and Drug Delivery Network on LinkedIn, follow us on Twitter @FDDCongress and join the conversation at #FDDUK20

*2020 Live Webinar*

Toxicology Congress 2020 provides a global Platform to the toxicologists, pharmacologists, PhD Scholars, medical and Pharmacy Students, Academicians (professors), researchers and lab experts to share their research findings in the field of Toxicology and Pharmacology. It provides an excellent opportunity for Toxicology and Pharmacology industries and companies to display their products and services in the said field at our exhibitors’ desk to gain global recognition to their products and services offered. Join us at this prestigious event.

Applying Modern Toxicology to Dietary Supplements with Ancient Roots: Botanical Safety in the 21st Century

Thursday, April 23
1:00 PM to 3:45 PM (ET)

Chairs: Cynthia Rider, NIEHS/NTP; and Michelle Embry, HESI.
Primary Endorser: Regulatory and Safety Evaluation Specialty Section
Other Endorser: Mixtures Specialty Section

This free webinar is being presented as part of the 2020 SOT Virtual Annual Meeting.

Description:
Botanical dietary supplements are consumed by millions of people globally, with tens of thousands of products available in the US marketplace. Ensuring the safety of these products is an important public health priority. However, evaluating their safety can be challenging due to the inherent complexity and significant variability in composition and quality, including the possibility of contamination and adulteration. Furthermore, the bioactive constituents in botanicals are often unknown, necessitating toxicological evaluation of the whole mixture. While there have been significant advancements in the development of new approach methodologies (NAMs) for read-across and screening/prioritization of single chemicals, there has been much less attention focused on adapting and evaluating these Program Schedule—Wednesday | 107 methods for application to complex mixtures. Botanical dietary supplements offer a unique opportunity for exploring the extension of NAMs to complex mixtures and building confidence in their application to a risk evaluation context. Toward this goal, there are several key areas that require attention. First, it is necessary to understand the current regulatory landscape for botanicals (i.e., What is the historical context and what are the current approaches being used to ensure product safety?). Next, an overarching challenge in evaluating botanicals is their complex chemistry. Therefore, defining the level and nature of non-targeted and targeted chemical analysis necessary for complex mixture characterization is critical. In terms of hazard characterization, identifying the critical endpoints and assays to include for safety evaluation is an important first step. This effort requires identifying likely biological targets of botanical toxicity (e.g., toxicity signals in adverse event reporting and animal studies) and evaluation of fit-for-purpose NAMs. Finally, to build confidence in any NAM-based safety assessment, it is critical to build orthogonal datasets to compare NAM results with toxicity observed in animal models and humans. Research efforts in each of these key areas will be highlighted by speakers with diverse perspectives.

Introduction. Cynthia Rider, NIEHS/NTP, Research Triangle Park, NC.

Applying Modern Toxicology to Botanical Dietary Supplements. Michelle Embry, HESI, Washington, DC.

Chemical Analysis: The Foundation of Botanical Safety. Joshua Kellog, Pennsylvania State University, State College, PA.

Developing and Applying In Vitro Liver Models to Address Potential Hepatotoxicity of Botanical Dietary Supplements. Amy Roe, Procter & Gamble, Cincinnati, OH.

Systems Toxicology Approaches to Evaluate Botanical Safety. Joseph Dever, Amway Nutrilite, Grand Rapids, MI.

Challenges and Approaches for Using Animal and Human Data to Evaluate In Vitro Systems in Botanical Safety Assessment. Cynthia Rider, NIEHS/NTP, Research Triangle Park, NC.

Electronic Cigarettes and Cardiovascular Toxicity: New Friend or Old Foe?

Tuesday, April 28
12:00 Noon to 2:45 PM (ET)

Chairs: Ivan Mark Olfert, West Virginia University School of Medicine; and Daniel J. Conklin, University of Louisville.
Primary Endorser: Cardiovascular Toxicology Specialty Section
Other Endorsers: Clinical and Translational Toxicology Specialty Section; Inhalation and Respiratory Specialty Section

This free webinar is being presented as part of the 2020 SOT Virtual Annual Meeting.

Description:
Popularity of and interest in electronic cigarettes (e-cigs) have grown rapidly and in large part due to marketing e-cigs as “harm-free” or “reduced-harm” products compared with cigarettes. These claims are based largely on observations that e-cigs have fewer toxicants than cigarettes and some evidence the e-cigs induce lower lung inflammatory responses compared with traditional cigarettes. Such a narrowly defined perspective toward health fails to consider that use of e-cigs (also known as vaping) is likely to have effects on other organ systems, too. For example, the cardiovascular system is well known to have significant comorbidities associated with inhalation of xenobiotic particulate matter (e.g., air pollution, smoking). Given that e-cigs have only been around for little more than a decade, robust studies evaluating and reporting the effects of vaping on cardiovascular function are only now beginning to emerge. Despite the current marketing dogma, the emerging evidence paints a bleak picture toward the overall benefits versus risk from e-cigs and opens many intriguing questions, such as (1) What component(s) in, or produced from, the e-liquid may be responsible for inducing cardiopulmonary and vascular dysfunction? (2) Does secondhand exposure induce the same health concerns? (3) Does the type of device (JUUL versus other devices), and/or temperature settings (wattage), change its harm potential? and (4) Are the long-term effects on vascular function the same across different vascular beds? This Symposium brings together a group of established investigators that have specific expertise with vaping and aerosol research who have begun to address these questions. Specifically the presentations will bring together data from in vitro cell and in vivo animal studies—that provide harbinger toward long-term cardiovascular health in humans—as well as direct studies on humans examining health and cardiovascular function. Collectively the talks are designed to provide the audience a broad, but in depth, journey on current knowledge and potential mechanisms underpinning cardiovascular toxicity from vaping. We anticipate that this Symposium can provide a framework for stimulating both public and scientific discussion on the relative benefits versus harm conferred by inhalation of novel tobacco products to overall health. Given the current interest and need for establishing public policy and regulation toward novel tobacco products, and particularly e-cigs, the speakers will be asked to discuss relevant available data regarding the potential positive and negative outcomes being observed that may complement or assist regulatory evaluations. The panel discussion also will specifically ask the speakers (and invite the audience) to participate in a discussion on the potential of the findings presented during the Symposium toward issues for regulatory concern.

Electronic Cigarettes: Vapors’ and Flavors’ Effects on Cells. Prue Talbot, University of California Riverside, Riverside, CA.

Adverse Cardiovascular Effects of Aerosols from Leaf Vaporizers and E-cigarettes. Matthew Springer, University of California San Francisco, San Francisco, CA.

Cardiovascular Toxicity of Electronic Cigarettes: Role of Aldehydes. Daniel Conklin, University of Louisville, Louisville, KY.

Toxicological Effects of Vaping on Central and Peripheral Vascular Function: Insights from Intravital and In Vivo Studies in Animals. Mark Olfert, West Virginia University School of Medicine, Morgantown, WV.

Electronic Cigarettes versus Nicotine Replacement Therapies: Cardiovascular Implications. Christian Delles, University of Glasgow, Glasgow, Scotland.

Panel Discussion. Daniel Conklin, University of Louisville, Louisville, KY.

The latest entry in the SOT FDA Colloquium series will explore "Artificial Intelligence Applications in Food and Cosmetic Safety."

Artificial Intelligence (AI) is defined as the science and engineering of making intelligent machines. Machine learning is a subset of Artificial Intelligence in which analytical model building is automated and not explicitly programmed. It is based on the idea that systems can learn from data, identify patterns, and make decisions with minimal human intervention. As more data are generated in various scientific disciplines, AI promises to provide an analytical tool with more precision than existing standard methods. Advances in computational toxicology have benefited public health by reducing reliance on animal studies and reducing the cost of performing such experiments. Machine learning methods can extend the capacity of computational toxicology methods such as read across, QSAR, and kinetic models. In fact, natural language processing and deep learning methods are being used to develop predictive toxicology models to outperform the traditional QSAR and read across models.

These developments in science and technology show great potential in further advancing the safety of our food and cosmetic production. In the broader food production and food safety space, AI technologies are being developed to enhance the growth of foods by monitoring and modifying growth parameters, managing supply chains, cleaning processing equipment, identifying plant diseases, developing new products, and enforcing employee personal hygiene procedures during food processing. In the cosmetic space, AI technologies are being used to augment data from in vitro studies and predict dermal absorption and toxicity in the absence of animal tests. As these technologies mature, we must start thinking about how to standardize procedures for safety assessments derived from AI generated data and how to best leverage these technologies to advance food and cosmetic safety.

CHAIRED BY: Lynne Ensor,VP Technical, Parexel

Join industry experts to discuss and analyze the latest advances and challenges within the industry. Network with industry professionals, discuss the revision of Annex 1, explore data integrity considerations for conventional and rapid microbiology methods, analyze arising issues with environmental monitoring and gain insight into an industry perspective on automated endotoxin testing and process automation.

Post-Conference Workshop – May 1, 2020
The Use of Recombinant Chromogenic Assays as Alternate Methods for the Bacterial Endotoxins Test (BET)
Workshop Leader: Veronika Wills, Manager, Technical Services, Associates of Cape Cod

Prices:
Conference + 1 Workshop: USD 2498.00
Conference Only: USD 1999.00
Workshop Only: USD 499.00

Time: 8:30 am to 5:00 pm

SPONSORED BY: Associates of Cape Cod, bioMérieux, Bioscience International, C.T.L. MAT, LONZA, Microcoat, Millipore Sigma

Exploring the current approaches towards improved contamination control

The pharmaceutical microbiology industry has seen many changes during the progression into the 21st century. With advances in rapid microbiological methods, revisions being made to regulations in the industry, enhanced knowledge of the human microbiome, and novel testing methods, this industry is ever expanding.

Join industry experts to discuss and analyze the latest advances and challenges within the industry. Network with industry professionals, discuss the revision of Annex 1, explore data integrity considerations for conventional and rapid microbiology methods, analyze arising issues with environmental monitoring and gain insight into an industry perspective on automated endotoxin testing and process automation.

Event Hashtag: #SMiPharmaMicroEC

HIGHLIGHTS FOR 2020:

• Discuss ongoing complication of personnel derived contaminations from the FDA
• Gain valuable insight towards microbiological quality considerations in non-sterile manufacturing and control of BCC from Parexel
• Learn from the perspective of the US Pharmacopeia on container closure integrity evaluation
• Examine an end-to-end contamination risk assessment for autologous cell therapy from Juno Therapeutics
• Explore a back to back Genentech session covering technical considerations for microbial QC of raw materials used in biotechnology and the past, current and future state of Mycoplasma testing

View the full agenda:

Organ to Silicon Chip: Emerging In Vitro and In Silico Tools for Evaluation of Cardiotoxicity

Thursday, April 30
1:00 PM to 3:45 PM (ET)

Chairs: Anthony Bahinski, GlaxoSmithKline plc; and Megan McCain, University of Southern California.
Primary Endorser: Cardiovascular Toxicology Specialty Section
Other Endorsers: Drug Discovery Toxicology Specialty Section; In Vitro and Alternative Methods Specialty Section

This free webinar is being presented as part of the 2020 SOT Virtual Annual Meeting.

Description:
There is a crucial need for new technologies that can quickly and reliably predict cardiovascular safety in humans due to drug and environmental exposure. Development of safe and effective drugs is currently hampered by the poor predictive power of existing preclinical models that often lead to failure of drug compounds late in their development, after they enter human clinical trials. Given the tremendous cost of drug development and the long timelines involved, as well as the need for evaluation of emerging environmental pollutants, the development of new technologies such as in silico platforms and novel in vitro platforms have the potential to provide more translational and human predictive models for cardiac toxicity. This Symposium will highlight innovative approaches to developing much-needed new toxicological methods for evaluation of cardiotoxicity beyond electrophysiology and arrhythmia. This Symposium brings together key experts from the fields of machine learning and artificial intelligence, microphysiological systems/organ-on-chips, and engineered cardiac tissues/precision medicine. They will highlight and discuss the advantages and challenges inherent in new innovative tools being applied toward identification and characterization of cardiotoxicity, in healthy and disease states, in pharmaceutical development and environmental safety.

Introduction. Anthony Bahinski, GlaxoSmithKline plc, Collegeville, PA.

Novel Platforms to Interrogate Cardiac Physiology and Drug-Induced Changes in Contractility Using hiPSc-CM. Khuram Chaudhary, GlaxoSmithKline plc, Collegeville, PA.

Engineering Functional Cardiac Microtissues for Human Disease Modeling and Drug Screening. Megan McCainUniversity of Southern California, Los Angeles, CA.

Cardiac Contractility In Vitro: From Patient-Specific to Air Pollution Studies. Anna Grosberg, University of California Irvine, Irvine, CA.

Using Weighted Gene Coregulation Network Analysis (WGCNA) to Decipher Temporal Dynamics in Cardiotoxicity. Arif Rahman, NIEHS/NTP, Morrisville, NC.

Evaluation of In Vitro Structural Cardiotoxicity Using Deep Neural Networks. Mahnaz Maddah, Dana Solutions LLC, Palo Alto, CA.

Continuing Education Course PM14: The Male Reproductive Tract: Development, Toxicology, and Pathology

Friday, May 1
12:00 Noon to 3:30 PM (ET)

Chairs: Vicki Sutherland, NIEHS/NTP; and Nicole Principato, Bristol-Myers Squibb Company.
Primary Endorser: Reproductive and Developmental Toxicology Specialty Section
Other Endorsers: Comparative Toxicology, Pathology, and Veterinary Specialty Section; Regulatory and Safety Evaluation Specialty Section

This free webinar is being presented as part of the 2020 SOT Virtual Annual Meeting.

Description:
The male reproductive system develops in utero—in rats during mid-gestation and in humans during the second month of pregnancy—but does not fully mature until puberty. Exposure to xenobiotics (e.g., diethylstilbestrol and phthalate exposure) during any stage, particularly during development and maturation, can adversely affect a male’s reproductive potential and play a significant role in development of a diseased state. Understanding what normally happens at these critical stages of development can lend clues to determine when an exposure has happened, what tissues are affected, and if functional capabilities will be impacted. Defining potential effects is routinely performed with guideline reproductive and developmental experiments and in academia with focused studies; however, these assessments do not always include histopathology evaluations, and if they do, the rigor needed for select tissues may not be utilized. Inclusion of histopathology, especially during select stages, may help identify a pattern of toxicities, subtle effects of an endocrine-disrupting chemical, or lesions that can lead to future reproductive issues (e.g., infertility). This additional data can expand our capabilities in characterizing potential modes of action that result in functional changes. Thus, a field that did not routinely assess tissues in more than a functional manner is now exploring the utility of pathology evaluations at stages not previously studied (e.g., juvenile assessment of cell populations in the testes) and appreciating that these tools can assist in recognizing patterns of toxicity. Therefore, a full toxicological and histopathology assessment of the male reproductive tract may provide additional information on functional effects, assist in determining which part of the system was targeted and how to mitigate concerns, and, for select issues, provide an early read on potential problems. This course will cover development and maturation of the male reproductive tract, explaining impacts on function at different time periods (in utero, juvenile, and adult) and addressing the potential value of histopathology at both the juvenile and the adult stages. Case studies will be used to highlight the toxicological significance of the effects of xenobiotics on male reproductive system toxicity. Understanding patterns of toxicity (e.g., effects in organ weight linked with findings in other tissues or pathology findings observed in a young animal correlating to outcomes in an adult) and utilizing some of the newer techniques and protocols (e.g., fetal testis explants, biomarkers) will not only provide a better understanding of what endpoints are affected but also may provide us with the tools to design better studies and correlate findings at earlier stages with long-term functional effects. To this end, four speakers, each a world-recognized expert in male anatomy, development, reproduction, and/or pathology, will discuss functional assessments of the male reproductive tract and address the utility of pathology in male reproductive and development evaluations.

An Overview of the Male Reproductive System: Applied Anatomy and Physiology from a Pathologist’s Perspective. Justin Vidal, Charles River, Matawan, MI.

Prenatal Development of the Male Reproductive Tract in the Rat, Dog, and Human: Critical Developmental Windows and Later-Life Consequences of Exposure. Kim Boekelheide, Brown University, Providence, RI.

Postnatal Development of the Juvenile Male Reproductive Tract in Rats: Microscopic Evaluation, Interpretation, and Time Points of Toxicologic Significance. Catherine Picut, Charles River, Durham, NC.

Pathology in Reproductive Toxicology Assessments and the Role of Stage-Awareness for Testis Evaluation. Cynthia Willson, Integrated Laboratory Systems Inc., Research Triangle Park, NC.

Join over 80 speakers and 300 attendees across 4 days of unrivalled depth and breadth of discussion broken down into:
- 4 tracks hosting scientific case studies and thought leading panel analysis of discovery, translational and clinical drug development, and non-invasive biomarker application in the clinical algorithm of care
- 7 discussion driven, expert led workshops into: epigenetics, targeting the inflammasome, assessing translational models and non-invasive evaluations of NAFLD and NASH; understanding NASH associated-hepatocellular carcinoma, drug safety in NASH, and regulatory and clinical considerations for paediatric NASH
- 2 forward thinking seminars dedicated to applying relationships and lessons learned from wider anti-fibrotic drug development for pulmonary, renal and cardiac fibrosis to hepatic fibrosis, and understanding the market access challenges associated with NASH including the pricing and reimbursement considerations

The Epidemic of Chronic Kidney Disease of Unknown Etiology in Agricultural Communities

Tuesday, May 5
1:00 PM to 2:20 PM (ET)

Chairs: Alison Harrill, NIEHS/NTP; and Julia Tobacyk, University of Arkansas for Medical Sciences.
Primary Endorser: Occupational and Public Health Specialty Section
Other Endorser: Clinical and Translational Toxicology Specialty Section

This free webinar is being presented as part of the 2020 SOT Virtual Annual Meeting.

Description:
Over the last two decades, occurrence of severe renal disease has dramatically increased in socially vulnerable farming communities within Central America, Sri Lanka, and India—and most recently reported in the United States. In countries such as Nicaragua and Costa Rica, chronic kidney disease mortality is over fivefold the national rates and increasing, with an overall mortality >20,000 young and middle-aged agricultural workers in affected regions. The epidemic of chronic kidney disease of unknown origin (CKDu) is not associated with classic CKD risk factors such as diabetes and hypertension. Potentiating factors are beginning to be explored, including heat stress and dehydration resulting from strenuous work in hot climates, agrochemical and metal exposures in occupational settings, and through drinking water sources. There is some evidence indicating that repeated episodes of acute kidney injury occurring during the growing season may have a cumulative effect in precipitating chronic kidney disease. A key question is whether the cause of the disease is the same worldwide or whether different factors are leading to the same manifestation in various disease hot spots. For example, well water as a primary drinking source has been implicated as a risk factor for the disease in Asian countries, but there is not sufficient evidence linking drinking water exposures elsewhere. What is clear is a strong association with strenuous work in primarily agricultural occupations. Pathologic features of the disease indicate a possible toxic nephropathy, yet systematically collected exposure data are sparse but ongoing. In this session, the key features and underlying renal pathology will be reviewed along with early investigations toward assessing the evidence of an environmental toxic mediator. A panel discussion serves as a “call to action” to engage toxicologists to consider studies that will help to mitigate the serious human health catastrophe of CKDu in economically disadvantaged communities.

Introduction. Alison Harrill, NIEHS/NTP, Research Triangle Park, NC.

Chronic Kidney Disease of Unknown Origin: Providing Insight into CKDu by Leveraging the National Toxicology Program Pathology Archives. Susan Elmore, NIEHS, Research Triangle Park, NC.

Descriptive Analysis of Nephrotoxic Drinking Water Contaminants and Urinary Biomarkers of Exposure among Sugarcane Workers in Guatemala. Jamie Butler-Dawson, University of Colorado Denver, Denver, CO.

Developmental Nephrotoxicity of Agrochemical Mixtures Derived from Sri Lankan Water Sources. Nishad Jayasundara, University of Maine, Orono, ME.

Developmental Toxicity of Per- and Polyfluoroalkyl Substances (PFAS): Current In Vivo Approaches and Application to Human Health Risk Assessment

Thursday, May 7
1:00 PM to 3:45 PM (ET)

Chairs: Justin Conley, US EPA; and AtLee Watson, NIEHS/NTP.
Primary Endorser: Reproductive and Developmental Toxicology Specialty Section
Other Endorsers: Immunotoxicology Specialty Section; Neurotoxicology Specialty Section

This free webinar is being presented as part of the 2020 SOT Virtual Annual Meeting.

Description:
Per- and polyfluoroalkyl substances (PFAS) hazard and risk assessments are a high-priority focus of health-based agencies on a global scale due to widespread occurrence and exposure. The PFAS chemical class is diverse, in regard to physicochemical and toxicokinetic characteristics, and extensive, with hundreds to thousands of existing structures and additional novel structures introduced annually. The legacy PFAS, perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS), have been studied extensively in traditional and alternative animal models; however, little to no data regarding persistence, toxicokinetics, or toxicity are available in the peer-reviewed literature on emerging PFAS with known human exposures, such as the perfluoroalkyl ether acids (e.g., hexafluoropropylene oxide-dimer acid [GenX] or Nafion byproduct 2). Importantly, the specific molecular mechanisms and downstream events responsible for the adverse effects described in rodent studies of PFOS and PFOA, including neonatal mortality, immunomodulation, altered thyroid hormone concentrations, and impaired carbohydrate and lipid metabolism, are relatively unresolved. Further, it is unknown if exposure to emerging PFAS elicit similar developmental outcomes, and how their relative potencies compare with those of legacy PFAS. Thus, research examining critical upstream events, as well as previously unstudied adverse outcomes from early-life exposures, is needed to facilitate screening of PFAS and inform human health and environmental risk assessments. A key assumption has been that many, if not all, of the adverse effects of PFAS are mediated in large part by modulation of peroxisome proliferator activated receptors (PPARs), particularly PPAR-alpha. However, it appears that multiple molecular mechanisms may be involved in the spectrum of effects described for developmental PFAS toxicity. The first three presentations in this session will focus on in utero and early life stage exposure studies in laboratory rats and mice to emerging and legacy PFAS. Research presented will cover the current state-of-the-science for in vivo effects on neonatal viability, neurological responses to alterations in thyroid hormone concentrations, development of immune competence, and metabolic capacity. Each presentation will pay particular attention to elucidating the specific molecular mechanisms and key events associated with the adverse effects of PFAS exposure. The final two speakers of the session will present current state-level (US) and international (European Union—European Food Safety Authority) regulatory approaches for derivation of human health-based guidance levels. These presentations will include a case study of the utilization of in vivo toxicity data for generating a transgenerational exposure model to address critical life stages for PFOA, and the use of epidemiological studies and the potential for incorporating a mixtures-based approach to characterize risk of multiple PFAS in food.

Introduction. AtLee Watson, NIEHS/NTP, Research Triangle Park, NC.

PFHxS and Developmental Neurotoxicity: Does Thyroid Hormone Action Play a Role? Katie O’Shaughnessy, US EPA, Research Triangle Park, NC.

Adverse Developmental Effects of Gestational Exposure to Emerging Perfluoroalkyl Ether Acids: Mechanistic Insights and Potency Comparisons with Legacy PFAS. Justin Conley, US EPA, Research Triangle Park, NC.

Developing an Understanding of the Effects of PFAS on the Immature Immune System. Jamie DeWitt, East Carolina University, Greenville, NC.

Derivation of Health-Protective Water Guidance for Bioaccumulative PFAS Chemicals Requires Incorporation of Placental and Breast Milk Exposure Pathways. Helen Goeden, Minnesota Department of Health, Minneapolis, MN.

The European Food Safety Authority Assessment of PFAS in Food: Preliminary Results and Ongoing Work. Thorhallur Haldorsson, University of Iceland, Reykjavik, Iceland.

The principle subject Pharma congress is "Novel Technologies and Future possibilities in changing the Pharma Industry" that stresses Impact of Discovering, Developing and Marketing Drugs, its enrollment and endorsement" which covers a wide scope of fundamentally significant sessions Pharmaceutical Industry at this Pharmaceutical Congress

Key Topic Areas for 2020
- Immunotherapy Drug Delivery Emerging Opportunities
- Antibody and Enzyme Transport Vehicles: Delivering Large Molecules Across the Blood Brain Barrier
- Intersections Between Drug Delivery and Regenerative Medicine
- Challenges and Opportunities to Improve CNS Delivery
- Delivery of Targeted Therapeutics and Nucleic Acids
- AI/Machine Learning And The Impact on Drug Delivery
- Advancing the Connected and Smart Drug Delivery Ecosystem
- Novel SubQ Drug Delivery Approaches for Biotherapeutics
- Improving Academic and Industry Partnerships
- Pharma Spotlights on Drug Delivery Needs
- Early Stage Technology Showcase

This year we are introducing the Pain Research Essentials theme to closely observe analgesics drug development from a preclinical point of view. Within this theme talks will address the latest biomarker discoveries, bridging the translational gap, differences of pain pathology across sexes and consequently, the need for distinct gender animal models. This will be topped with a panel discussion around novel drug targets in neuropathic pain treatment.

Join SMi’s leading Pain Therapeutics Conference which will explore the cutting-edge research of novel therapeutics in the pipeline of leading pharmaceutical companies and discuss solutions for the challenges of understanding pain as a heterogenous disease and the diverse treatment approaches it requires.

Protecting Public Health and the Environment during Wildfire Recovery

Thursday, May 14
1:00 PM to 3:45 PM (ET)

Chairs: Shelley DuTeaux, California Department of Pesticide Regulation; and Shoba Iyer, California Environmental Protection Agency.
Primary Endorser: Occupational and Public Health Specialty Section
Other Endorsers: Northern California Regional Chapter; Southern California Regional Chapter

This free webinar is being presented as part of the 2020 SOT Virtual Annual Meeting.

Description:
California is the only state that mandates cleanup activities following wildfires and assists impacted homeowners via a comprehensive remediation program. In most states, property owners deal with the destruction left in the wake of a wildfire largely on their own. These uncoordinated recovery activities have led to questionable and often hazardous ways of dealing with debris and ash, and can result in a legacy of contamination for affected communities. California emergency response and environmental protection agencies joined forces in 2007 to develop a coordinated approach to remediating properties impacted by wildfires, which includes expedited removal of immediate hazards, asbestos abatement, and fire ash and debris removal. This unique and public health-protective approach supports communities in safely rebuilding. This session will outline the principles underpinning the California model; describe the steps involved in removing contaminants and clearing properties; present results from ash, air, soil, and water sampling in the aftermath of the fires; and discuss how public health, occupational health, and the environment are protected along the way. The presentations in this session will be given by State of California employees who were deployed under the Governor’s Declaration of Emergency to work on wildfire recovery in Northern and Southern California following the November 2018 Camp and Woolsey wildfires and who will be drawing from their “boots on the ground” experience.

Introduction. Shelley DuTeaux, California Department of Pesticide Regulation, Sacramento, CA.

Overview: Why a Recovery Program after Wildfires with Urban Interface Is Critical to Protecting Public Health and the Environment. Marcus Santillano, California Environmental Protection Agency, Sacramento, CA.

Fire Ash and Debris Removal: Phases I and II of Wildfire Recovery. Lori Chumney, California Environmental Protection Agency, Sacramento, CA.

What Is in the Ash and How Do We Keep It from Getting in the Air? Shelley DuTeaux, California Department of Pesticide Regulation, Sacramento, CA.

Fire Ash and Debris Removal: Quantitation of Success via Confirmation Soil Sampling. Shoba Iyer, California Environmental Protection Agency, Oakland, CA.

Water, Water Everywhere: Efforts to Protect Drinking Water and Sensitive Aquatic Species. Beckye Stanton, California Environmental Protection Agency, Sacramento, CA.

Continuing Education Course SR01: Advances in CRISPR-Cas9 Tools and Applications for Toxicologists

Friday, May 15
12:00 Noon to 1:00 PM (ET)

Chairs: Cheryl Rockwell, Michigan State University; and Elena Demireva, Michigan State University.
Primary Endorser: Continuing Education Committee
Other Endorser: Mechanisms Specialty Section; Molecular and Systems Biology Specialty Section

This webinar is being presented as part of the 2020 SOT Virtual Annual Meeting. Continuing Education (CE) courses require a paid registration. Those who registered to attend the CE course in Anaheim are registered for the course. If you were not previously registered, you may register to attend.

Description:
CRISPR-Cas-based technologies have revolutionized science by significantly decreasing the time, money, expertise, and labor required to implement gene editing. Thus, this approach is becoming routine in many laboratories as a facile method to alter the genome. And yet, CRISPR-based methodologies continue to evolve. Recent publications demonstrate that CRISPR gene editing can be expanded in new directions to widen the utility and potential applications of this technology. The first presentation in this course will provide an overview of the latest developments in CRISPR-Cas-based techniques, with a focus on new Cas9 variants with new and expanded capabilities. The first presentation also will cover the new field of RNA targeting and the use of pooled CRISPR libraries with single cell transcriptomics to characterize complex phenotypes. The second presentation will focus on the use of CRISPR-Cas9-based screens from a toxicologist’s perspective. Specifically, this presentation will discuss how such screens can be used to gain a detailed, mechanistic understanding of a toxicant’s effect as well as the role of specific genes. Overall, this course is designed to provide an overview of the most recent advances in CRISPR-based technologies as well to provide some insight into future uses.

Latest Advances in CRISPR-Cas Technologies. Elena Demireva, Michigan State University, East Lansing, MI.

Use of CRISPR/Cas9-Based Genome-Wide Screens in Toxicology from a User’s Perspective. Christopher Vulpe, University of Florida, Gainesville, FL.

Continuing Education Course PM10: An Introduction to New Approach Methodologies (NAMs) and Understanding Their Potential to Support Regulatory Decisions

Friday, May 15
12:00 Noon to 3:30 PM (ET)

Chairs: Mansi Krishan, Danone North America; and Suzanne Fitzpatrick, US FDA/CFSAN.
Primary Endorser: Risk Assessment Specialty Section
Other Endorser: Drug Discovery Toxicology Specialty Section

This webinar is being presented as part of the 2020 SOT Virtual Annual Meeting. Continuing Education (CE) courses require a paid registration. Those who registered to attend the CE course in Anaheim are registered for the course. If you were not previously registered, you may register to attend.

Description:
Recent shifts in the global regulatory landscape to consider the use of nonanimal testing methods have led to significant advances in the development of alternative test methods to replace, reduce, and refine animal use. The term new approach methodologies (NAMs) broadly describes any nonanimal technology, methodology, approach, or combination that can be used to provide information on chemical hazard and risk assessment. With new opportunities comes new challenges, such as validation of test results, understanding their applicability in different sectors and risk assessments, and global regulatory acceptance of these methods. Despite these challenges, the development, use, and acceptance of these predictive toxicology methods is on the rise. There is a wealth of knowledge and data that is being generated with NAMs; however, there are questions on when, how, and where can we use these NAMs. This CE course will provide an overview of NAMs along with case studies where they are being used or could potentially be used for regulatory risk assessment. The speakers will present on (1) chemical-biological data and analysis tools (Tox21/ToxCast) and examples where high-throughput screening (HTS) methods have been approved for use in regulatory decision-making; (2) read-across approaches and their use in regulatory risk assessment; (3) use of evidence maps and systematic reviews and case studies with a focus on application of each to regulatory risk assessment; (4) use of the adverse outcome pathway (AOP) including most well-developed examples of AOP-supported decision processes for evaluating skin sensitizing potential and a computational model to predict the likelihood of reproductive impairment based on aromatase inhibition; and (5) concepts underpinning Integrated Approaches to Testing and Assessment (IATA) and concrete examples for assessing developmental neurotoxicity (DNT) and carcinogenicity of chemicals used in a variety of sectors. Also, updates will be provided on IATA case study projects currently running at the OECD and a set of resources being developed to support IATA development, evaluation, and regulatory uptake. This course will be useful to those interested in understanding the regulatory application of NAMs.

Chemical Bioactivity Data and Useful Analysis Tools for You to Explore. Nisha Sipes, NIEHS/NTP, Durham, NC.

Building Confidence in Read-Across Conclusions with NAMs. Craig Rowlands, Underwriters Laboratories R&D, Northbrook, IL.

Systematic Reviews: Application in Regulatory Risk Assessment. Kristina Thayer, US EPA, Research Triangle Park, NC.

The Adverse Outcome Pathway (AOP) and Its Use to Support Regulatory Risk Assessment. Catherine Willett, Humane Society International, Jamaica Plain, MA.

Overview and Case Studies to Demonstrate the Use of Integrated Approaches to Testing and Assessment (IATA) in Regulatory Risk Assessment. Maurice Whelan, European Commission Joint Research Centre, Ispra, Italy.

Continuing Education Course PM13: In Vitro Approaches to Assess the Toxicity of Inhaled Substances

Friday, May 15
12:00 Noon to 3:30 PM (ET)

Chairs: Amy J. Clippinger, PETA International Science Consortium Ltd., United Kingdom; and Emily Reinke, Army Public Health Center.
Primary Endorser: In Vitro and Alternative Methods Specialty Section
Other Endorsers: Inhalation and Respiratory Specialty Section; Regulatory and Safety Evaluation Specialty Section

This webinar is being presented as part of the 2020 SOT Virtual Annual Meeting. Continuing Education (CE) courses require a paid registration. Those who registered to attend the CE course in Anaheim are registered for the course. If you were not previously registered, you may register to attend.

Description:
Inhalation is a major route of human exposure to airborne substances, and as such, there are regulatory and nonregulatory needs to assess the potential toxicity of inhaled substances. While the standard regulatory requirement is a rat inhalation toxicity test, anatomical and physiological differences between rodents and humans have led to substantial investment in the optimization of alternative approaches. These alternative approaches can be based on human mechanisms of toxicity, thus better protecting human health while reducing animal use. In this course, speakers from government, contract research organizations, academia, and NGOs, as well as method developers, will discuss progress and challenges associated with various approaches for inhalation toxicity testing. It will include an introductory overview, setting the stage for the remaining talks by discussing the currently used rat inhalation tests and how an alternative approach can be demonstrated to be a valid replacement. Other topics to be covered will be the use of cell culture systems, 3D reconstructed human tissue models, and human precision-cut lung slices, as well as the use of in vitro exposure devices for deposition of test chemicals. The final speaker will present a regulatory perspective on processes in place that allow for acceptance of alternative approaches for inhalation toxicity testing, highlighting a successful example. These presentations will explore the value of the air-liquid interface (ALI) for testing, advantages and limitations of different approaches, and case studies of the use of different model systems in both nonregulatory and regulatory paradigms. Overall, a course attendee should learn about the state-of-the-science of in vitro approaches for respiratory toxicity testing and gain insight into determining which method is most appropriate, depending on the test substance and purpose of the study. This course is aimed at scientists at all levels from industry, government, and academia.

Regulatory Landscape and Key Considerations for Establishing Inhalation Reference Data. David Allen, Integrated Laboratory Systems Inc., Research Triangle Park, NC.

Current Status of In Vitro Models to Evaluate Pulmonary Toxicity. Arno Gutleb, Luxembourg Institute of Science and Technology, Esch-sur-Alzette, Luxembourg.

3D In Vitro and Ex Vivo Pulmonary Test Systems Provide Human-Relevant Toxicity Data. Holger Behrsing, Institute for In Vitro Sciences Inc., Gaithersburg, MD.

Regulatory Use of Nonanimal Approaches for Assessing Inhalation Toxicity of Pesticides. Monique Perron, US EPA/OPP, Washington, DC.

This joint American College of Toxicology and Society of Toxicologic Pathology course, held every other year, provides lectures given by highly respected pathologists with current, relevant experience in toxicologic pathology. Lectures will cover anatomy and physiology, spontaneous and chemically induced pathological changes, clinical pathology, and case study examples. The knowledge gained will be immediately applicable to your day-to-day practices. Different organs or systems are featured in subsequent courses.

Course Location
Gaithersburg Marriott Washingtonian Center
9751 Washingtonian Boulevard
Gaithersburg, MD 20878 United States

Successfully Validate Novel Targets, Improve Preclinical Predictability of Patient-Derived Models and Optimize Drug Pharmacology to Accelerate Translation of Robust Protein Misfolding Targeted Therapeutics into the Clinic. With numerous molecular approaches emerging that demonstrate viable efficacy of targeting protein misfolding and aggregation, join the Protein Misfolding Drug Discovery Summit – the only industry and translational focused conference dedicated to the discovery and translation of disruptive disease-modifying therapeutics with optimized pharmacology to target protein misfolding in proteopathies and cancer.

Venue Details: Revere Hotel Boston Common, 200 Stuart Street, Boston, MA, 02116, United States

- Dive into novel therapeutic approaches for PTSD with Aptinyx, Bionomics, Tonix and MAPS
- Uncover the emergence of the next generation of anti-psychotics with Karuna Therapeutics and Intra-cellular Therapeutics
- Explore industry approaches for innovative trial design and new methods to modeling the placebo response with Novartis, Otsuka and Yale University
- Hear how pioneering biotechs are spearheading drug development for substance use disorders with Cerevel Therapeutics, Opiant Pharmaceuticals and NIDA
- Learn how to advance neurophysiology and cognition translational biomarkers and be part of the drive towards precision medicine with Takeda
- Uniting 80+ drug developers from all corners of the world, Neuropsychiatric Drug Development is your opportunity to discuss in depth, how to push forward the frontiers of neuropsychiatric drug development to develop the next generation of more clinically effective therapeutics.

Application of RISK21 Framework in Regulatory-Based Decision-Making: From Business Decisions to Prioritization to Risk Assessment

Thursday, May 19
10:00 AM to 12:45 PM (ET)

Chairs: Michelle Embry, HESI; and Douglas Wolf, Syngenta.
Primary Endorser: Regulatory and Safety Evaluation Specialty Section
Other Endorsers: Exposure Specialty Section; Risk Assessment Specialty Section

Description:
A risk-based approach should be the basic operating principle for decision-making for chemical prioritization and evaluation. An exposure-driven assessment for chemicals proposes a paradigm shift in support of a harmonized risk assessment-based regulatory decision-making. The application of best available science, via integration of new and traditional data streams, will create a risk-based prioritization scheme and tailored exposure-driven risk assessments. A common framework of an integrated approach that enhances efficiency and informs business and risk management decisions that is scientific, transparent, and efficient is available and easy to incorporate into any chemical decision process. The Health and Environmental Sciences Institute (HESI) Risk Assessment in the 21st Century (RISK21; www.RISK21.org) project was initiated to develop a scientific, transparent, and efficient approach to the evolving world of risk assessment. The RISK21 team developed a framework that reconsiders the way chemical risk assessment information is obtained and used. It is a problem formulation-based, exposure driven, tiered data acquisition approach that allows an informed decision on human and environmental safety to be made when sufficient evidence is available and maximizes the ability to inform decisions and optimize resource usage. To achieve innovative solutions in risk evaluation one needs to apply a systematic approach to formulate consistent, technically robust and scientifically credible problems that need to be solved. A structured problem formulation approach enables one to keep focused on describing and evaluating the breadth and depth of the specific problem to be solved, instead of rapidly trying to create solutions. The application of the framework enables the evaluator to identify key issues and possible approaches to address the value of available information and make decisions about what, if any, additional information is needed to inform a decision. This problem formulation-based, exposure-driven, tiered data acquisition approach allows a decision on the sufficiency of available evidence of safety, business risk, or prioritization across a large group of chemicals to be made. The framework enables the assessment of the value of available information and deciding what, if any, additional evidence is needed to reach a decision.

High-Throughput Risk-Based Prioritization for Ecological Risk Assessment. Jon Arnot, ARC Arnot Research & Consulting, Toronto, Ontario, Canada.

Exposure- and Hazard-Driven Prioritization for Evaluation of Chemicals in Canadian Drinking Water. Ella Atlas, Health Canada, Ottawa, Ontario, Canada.

Using the RISK21 Framework as a Tiered Approach for Chemical Risk Assessment: A Proof of Concept. Sandrine Deglin, HESI, Washington, DC.

Use of RISK21 for Communication of Absolute and Comparative Risks: The Case of Glyphosate Use in Different Countries. Angelo Moretto, Università degli Studi di Milano, Milan, Italy.

Application of the RISK21 Framework as a Decision and Communication Support Tool to Inform Project Risk and Business Decisions in Crop Protection Active Substance Development. David Cowie, Syngenta, Bracknell, United Kingdom.

The unique scientific program of the Congress will bring you the latest updates in the field of autoimmune diseases, presented by the world's leading experts, while at the same time providing an amazing stage for young upcoming talents to present their research to a first-rate audience.

Established by Professor Yehuda Shoenfeld, the congress constitutes a network of international leaders on immunology, rheumatology and related fields, all of whom contribute their unique and diverse knowledge to the "family of autoimmunity."

TaRGET II Consortium: Elucidating Epigenetic Responses to the Environment across Target and Surrogate Tissues

Thursday, May 21
1:00 PM to 3:45 PM (ET)

Chairs: Dana C. Dolinoy, University of Michigan; and Rosonald R. Bell, Epizyme.
Primary Endorser: Molecular and Systems Biology Specialty Section
Other Endorsers: Mechanisms Specialty Section; Occupational and Public Health Specialty Section

This free webinar is being presented as part of the 2020 SOT Virtual Annual Meeting.

Description:
It is increasingly recognized that exposures to chemicals affect health and disease not only by mutating genes, but also by modifying the epigenome, alterations to DNA that are mitotically heritable and lead to disease when deregulated. Thus, the US National Institute of Environmental Health Sciences (NIEHS) established the multi-phased Toxicant Exposures and Responses by Genomic and Epigenomic Regulators of Transcription (TaRGET) Program to identify epigenetic mechanisms that drive environmentally induced disease susceptibility. The second phase of the program, the TaRGET II Consortium, was established in 2016 and utilizes mouse models to evaluate when surrogate sources of DNA can be used in epigenetic epidemiology studies of human exposures and disease risk. Target tissues are those directly affected by environmental exposures (e.g., the brain by lead), while surrogate tissues are those that are easily accessible (e.g., blood). Epidemiology studies typically generate epigenetic data using surrogate tissues, but it is unknown whether associations with environmental factors observed in these surrogates correlate with those occurring in the tissues targeted by toxicants. Using perinatal exposure models of seven representative toxicants (lead, arsenic, air pollution [PM2.5], bisphenol A, tributyltin, dioxin, and di(2-ethylhexyl)phthalate), TaRGET II is generating epigenetic signature data in target and surrogate tissues and isolated cell populations at three life stages in mice. Epigenomic data include chromatin assembly via ATAC-seq, DNA methylation via whole genome bisulfite sequencing, and transcriptomics via RNA-seq. Through a series of talks discussing both individual and multiple perinatal exposures, the purpose of this Symposium is to familiarize the toxicological community with the consortium and discuss the impacts of these integrative analyses on the field of toxicoepigenetics. TaRGET II data are made publicly available and will enable further refinement of the design and analysis of human studies where target tissues are inaccessible and provide insight into epigenetic mechanisms behind the developmental origins of health and disease.

Introduction. Dana Dolinoy, University of Michigan School of Public Health, Ann Arbor, MI.

Overview and Goals of the TaRGET II Consortium. Frederick Tyson, NIEHS, Research Triangle Park, NC.

Integrated Analysis of Consortium-Wide Chromatin Structure and Gene Expression. Bo Zhang, Washington University in St. Louis, St. Louis, MO.

Imprinted Genes: Vulnerable Targets for Multiple Environmental Exposures? Marisa Bartolomei, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.

Perinatal Exposure to Lead and Phthalates Results in Altered DNA Methylation in Adult Mouse Liver and Blood: Implications for Target versus Surrogate Tissue Use in Environmental Epigenetics. Laurie Svoboda, University of Michigan, Ann Arbor, MI.

Systemic Effects of Perinatal Air Pollution and Arsenic Exposure on Target and Surrogate Tissues. Shyam Biswal, Johns Hopkins University, Baltimore, MD.

This focused conference will put you in front of the research teams exploring the future of therapeutic cannabinoids in a host of disease areas for patients with unmet clinical needs. The comprehensive agenda will address the end to end development challenges which are holding back clinical and commercial success, and give you the insight from world-leading experts to overcome the most critical hurdles.

Join us and leading experts from Cannabics, CannRx, Emerald Biosciences, InMed Pharmaceuticals and more to discuss target biology, compound formulation, safety testing, patient engagement, trial design and commercialisation.

Early booking and group discounts apply. Academic rates also available - see the website for details.

Venue Details: Hilton London Kensington, 179-199 Holland Park Avenue, London, W11 4UL, United Kingdom

With a global rise of incidences of allergies, atopic march And childhood metabolic disorders, the infant microbiome in this first 1000 days represents a key window of opportunity to create products and solutions to target and prevent the onset of these chronic health conditions.

Early booking and group discounts apply, start-up and academic rates are available - see the website for details.

Single Cell Technologies: A Potentially Transformative Tool for Toxicology

Thursday, May 28
12:00 Noon to 2:45 PM (ET)

Chairs: Sudin Bhattacharya, Michigan State University; and Justin A. Colacino, University of Michigan.
Primary Endorser: Molecular and Systems Biology Specialty Section
Other Endorser: Association of Scientists of Indian Origin Special Interest Group; Stem Cells Specialty Section

This free webinar is being presented as part of the 2020 SOT Virtual Annual Meeting.

Description:
Single cell genomics and epigenomics have been among the breakthrough biological technologies of the last few years. These methods provide detailed views of living systems at unprecedented resolution and bypass the problems associated with averaging over heterogeneous cellular responses in bulk assays. Some spectacular successes of single cell RNA sequencing (scRNA-seq) include cell-by-cell reconstruction of transcriptomic atlases of xenopus and zebrafish embryos, along with ambitious undertakings like the Human Cell Atlas to map the transcriptomes of all cell types in the human body. This timely and topical Symposium will provide an overview of the capacities and limitations of current single cell technologies and describe cutting-edge applications of single cell methods in detecting perturbations in cellular state in health and disease, including identification of rare and altered cell types. The presenters will explore the role of single cell transcriptomic profiling in revealing phenotypic heterogeneity among breast cancer stem cells, mapping alterations in the developmental trajectory of early germ cells subject to environmental insult, discovery of a novel subpopulation of alveolar macrophages in an animal model of asbestos-induced pulmonary fibrosis, and identification of an altered effector CD8 T lymphocyte population in smokers. Overall, the presentations in this Symposium will introduce the field of single cell ’omics and provide a snapshot of the first generation of applications of these novel technologies in toxicology.

Introduction. Sudin Bhattacharya, Michigan State University, East Lansing, MI.

Dissecting Complex Systems with Multidimensional Single Cell Data. Grace Zheng, Arsenal Biosciences, South San Francisco, CA.

Single Cell Profiling to Characterize Breast Stem Cell Heterogeneity in Development and Cancer. Justin Colacino, University of Michigan, Ann Arbor, MI.

Understanding Environmental Impact on Germ Cell Differentiation Trajectories Using scRNA-Seq. Patrick Allard, University of California Los Angeles, Los Angeles, CA.

Single Cell Transcriptomics Identifies Key Cellular Players in an Animal Model of Asbestos-Induced Pulmonary Fibrosis. Nikita Joshi, Northwestern University, Chicago, IL.

Single Cell RNA Sequencing Reveals Altered Effector CD8 T Lymphocytes in Smokers. Suzanne Martos, NIEHS, Research Triangle Park, NC.

Continuing Education Course AM08: Timing Is Everything: Developmental Exposure Alters the Path of Immune Cell Maturation and Function

Chairs: Alessandro Venosa, University of Utah; and Jamie DeWitt, East Carolina University.
Primary Endorser: Immunotoxicology Specialty Section

This webinar is being presented as part of the 2020 SOT Virtual Annual Meeting. Continuing Education (CE) courses require a paid registration. Those who registered to attend the CE course in Anaheim are registered for the course. If you were not previously registered, you may register to attend.

Description:
There is compelling evidence that exposure to exogenous agents at different stages of development contributes to disease later in life (and across generations), with animal models supporting this concept in reproductive, metabolic, and neurodegenerative diseases. Two major notions link prenatal and early-life exposure to increased risk of disease later in life—namely, the Barker hypothesis and the hygiene hypothesis—while epigenetic reprogramming may extend this susceptibility across future generations. The immune system represents a unique niche of cells tightly entangled with the parenchyma in every tissue, acting as pro-homeostatic sentinels equipped to mount the appropriate response upon exogenous aggression. While the linkage between developmental immunotoxicity (DIT) and susceptibility to later-life diseases is an accepted paradigm, the mechanisms by which exogenous agents impact the developing immune system and change disease susceptibility are not well established. Clinical evidence suggests that the underlying effects of these agents may be masked until triggered by a later-life event (i.e., infectious exposure or aging itself), at which point the immune response may enact a super-responsive state, favoring disease pathogenesis. Recent evidence highlights myriad variables to take into account to accurately study DIT, including the importance of evaluating the appropriate window of vulnerability; establishing whether the toxicant exerts direct and long-lasting effects on the immunological machinery or reprograms the behavior of bystander parenchymal cells; outlining which pathway each environmental agent will be affecting; and, more recently, determining sex-based outcomes to exposure. With basic and translational researchers facing the challenge of elucidating the molecular mechanisms mediating DIT, it is pivotal that regulatory agencies and industry work in unison toward implementing safety protocols that address these factors. Therefore, this Continuing Education course proposes to (1) inform the attendees on the current advances in the design and execution of DIT studies geared at developing preclinical tools to predict risk of adult-life disease; (2) provide the most recent evidence, spanning multiple phylogenetic species (nonhuman primates, rodents, and fish), of DIT across a wide array of exogenous agents; and (3) provide insights on the impact that studying DIT could provide at the regulatory level.

Introduction to the Course and Overview of Developmental Immunotoxicity. Alessandro Venosa, University of Utah, Salt Lake City, UT.

Development of the Immune System across Phylogenetic Classes. Mark Collinge, Pfizer Inc., Groton, CT.

Design and Implementation of Studies to Detect Developmental Immunotoxicity in Young and Adult Organisms. Victor Johnson, Burleson Research Technologies Inc., Research Triangle Park, NC.

Zebrafish as a Model for Developmental Immunotoxicity. Jessica Plavicki, Brown University, Providence, RI.

Early-Life Exposure and Later-Life Disease. Jamie DeWitt, East Carolina University, Greenville, NC.

Regulatory Impacts of Developmental Immunotoxicity. Ellen Hessel, Rijksinstituut voor Volksgezondheid en Milieu (RIVM), Bilthoven, Netherlands.

Continuing Education Course SR02: Qualifying Biomarkers and Navigating the US FDA Predictive Toxicology Roadmap to Improve Decision-Making in Toxicology and Drug Safety Assessment

Friday, May 29
12:00 Noon–1:00 PM (ET)

Chairs: Robert Young, MilliporeSigma; and Vincent Reynolds, Eli Lilly and Company.
Primary Endorser: Regulatory and Safety Evaluation Specialty Section
Other Endorsers: Biotechnology Specialty Section; Carcinogenesis Specialty Section

Description:
This session will provide an educational opportunity for attendees interested in learning how information from adverse outcome pathways (AOPs) can be leveraged with two recent US Food and Drug Administration (US FDA) initiatives (i.e., the Biomarker Qualification: Evidentiary Framework and the Predictive Toxicology Roadmap) to improve decision-making for toxicology and human safety issues. The biomarker framework is aimed at identifying and qualifying biomarkers that, within a defined context of use, can be used reliably for specific interpretations and applications. The predictive roadmap is a call to action highlighting the need for a comprehensive strategy to assess new methods and technologies that can improve predictive capabilities, minimize the use of animals, and guide decision-making in regulatory reviews. Because firsthand industry knowledge with these regulatory initiatives may be limited, it is important that experience and learnings available to date be broadly communicated. This session will open with a discussion of ongoing efforts to use AOPs as tools to enhance our mechanistic understanding of various toxicities and to use networks of AOPs as the basis for biomarker development. An example of the genesis and application of biomarkers will be discussed in the context of efforts to develop comprehensive predictions of liver cancer in rodents, including their use in de-risking compounds that would cause cancer through rodent-specific mechanisms. From this initial presentation, session attendees will gain an increased appreciation of the importance of exploiting opportunities for mechanistic screens incorporating biomarkers to define the AOP through which a chemical may mediate effects. The session will then ask a crucial question: After identification of a potentially useful biomarker, what are the next steps needed to ensure regulatory acceptance? To address this point, the second presentation will summarize how the Biomarker Qualification: Evidentiary Framework can be used to define the steps needed to validate the linkage of a biomarker with a specific toxicity or mechanism and provide advice—including a list of dos and don’ts—on how to move efficiently through the process needed to ensure regulatory acceptance of the biomarker for its intended purpose(s). The value of this approach when interacting with regulatory agencies will be demonstrated by reviewing how an understanding of the AOP was used to support arguments that a carcinogenic response with a mutagenic test material could be ascribed to nongenotoxic mechanisms. Collectively, material presented in this session will instill a greater awareness of the value that can be realized with the recent US FDA Biomarker Qualification: Evidentiary Framework and Predictive Toxicology Roadmap initiatives. Although these initiatives were formulated by US FDA, their conceptual underpinnings are universal and applicable for focusing and guiding the dialogue on toxicology issues and concerns with other regulatory agencies, such as the US Environmental Protection Agency. Session attendees will recognize that energetic engagement between industry and regulatory scientists will contribute to the success of the vision of these initiatives and improve decision-making for toxicology, safety assessment, and risk management questions that directly affect human health.

Building Predictive Biomarkers from the Perspective of the Adverse Outcome Pathway. Chris Corton, US EPA/NCCT, Research Triangle Park, NC.

A Roadmap to Innovation in Drug Development—Stories about the US FDA New Biomarker Qualification Program. John Michael Sauer, Critical Path Institute, Tucson, AZ.

SLAS Europe 2020 provides a unique combination of education, access to innovative technologies and intelligent peer networking, delivering unmatched value for professionals and students looking to discover the latest life sciences technologies and how they can be applied to drive research objectives.

The Machine Learning Boot Camp is a two-day intensive boot camp of seminars combined with hands-on R sessions to provide an overview of concepts, techniques, and data analysis methods with applications in biomedical research.

TRAINING OVERVIEW

This two-day intensive training will provide a broad introduction to machine learning methodology with applications in biomedical research. Taught by a team of biostatisticians, the Boot Camp will integrate seminar lectures with hands-on R lab sessions to put concepts into practice. Emphasis will be given to supervised (e.g., penalized methods, classification and decision trees, survival forests) and unsupervised methods (e.g., clustering algorithms, principal components) with numerous case studies and biomedical applications. The workshop will conclude with a brief overview on ‘deep learning’ approaches DOs and DON’Ts.

• Penalized Regression Methods (Ridge and Lasso)
• Support Vector Machines
• Decision Trees (Random Forest)
• Predicting Survival Outcomes (Cox Regression/Lasso, Survival Forests)
• Clustering Algorithms
• Principle Component Analysis (PCA)
• Deep Learning – An Overview

Investigators at all career stages are welcome to attend, and we particularly encourage trainees and early-stage investigators to participate.

PREREQUISITES AND REQUIREMENTS
There are three prerequisites/requirements to attend:

• Each participant must have an introductory background in statistics.
• Each participant is encouraged to be familiar with R. The main software used for the workshop will be R/RStudio, therefore we strongly recommend that participants have a basic understanding of this software prior to attending the Training.
• Each participant is required to bring a personal laptop with R/RStudio installed prior to the first day of the workshop, as all lab sessions will be done on your personal laptop. R is available for free download and installation on Mac, PC, and Linux devices.

INSTRUCTORS

• Noah Simon, PhD, Department of Biostatistics, School of Public Health, University of Washington.
• Yifei Sun, PhD, Department of Biostatistics, Mailman School of Public Health, Columbia University.
• Cody Chiuzan, PhD, Department of Biostatistics, Mailman School of Public Health, Columbia University.

ADDITIONAL INFORMATION

• Full details on website:

If you are, or would like to be, a player in the microbiome arena, this is the conference you should attend to not only hear the latest pre-clinical and clinical development from organizations developing microbiome-based therapeutics, biomarkers and diagnostics, but also to make long-lasting connections that will accelerate your microbiome developments forward, and help translate this promising science into a reality for patients.

New Sessions Around 6 Key Themes:
- Potentiating Antibodies through Conjugation
- Bispecific Formats for T Cell Activation
- Cell Engagers for the Innate Immune System
- Advances in Computational and Machine Learning Approaches for Antibody Engineering
- Antibody Discovery and Developability
- Modifying Fc Interactions to Enhance Antibody Therapies

Visit: AntibodyEngEu.com

The Quantitative Genomics Training is a two-day intensive training of seminars and hands-on analytical sessions to provide an overview of concepts, methods, and tools for whole-genome and transcriptome analyses in human health studies.

TRAINING OVERVIEW

Genome-wide association studies have discovered tens of thousands of loci significantly associated with complex traits. However, the majority of these loci are located outside of protein-coding regions making it difficult to determine the causal gene or the mechanism through which the phenotype is affected. With whole-genome and RNA sequencing becoming increasingly accessible and feasible to conduct large-scale analyses, we can use different quantitative genomics methods to address these challenges in human health studies.

This two-day intensive workshop will provide a rigorous introduction to several different techniques to analyze whole-genome sequencing and transcriptome data. Led by a team of experts in statistical genomics and bioinformatics, who have developed their own methods to analyze such data, the training will integrate seminar lectures with hands-on computer lab sessions to put concepts into practice. The training will focus on reviewing existing approaches based on predicted expression association with traits, colocalization of causal variants, and Mendelian Randomization, including discussion on how they relate to each other, and their advantages and limitations. Emphasis will also be given to reviewing integrative sequence based association studies for whole-genome sequencing data, and functional annotation of variants in noncoding regions of the genome.

By the end of the workshop, participants will be familiar with the following topics:

• Sequence based association tests (Burden, SKAT and extensions)
• Functional genomic annotations
• Analysis of genomic variants in human diseases
• Transcriptome wide association tests (PrediXcan, MetaXcan, and extensions)
• Mendelian Randomization techniques
• Colocalization techniques

Investigators at all career stages are welcome to attend, and we particularly encourage trainees and early-stage investigators to participate.

PREREQUISITES AND REQUIREMENTS

There are three prerequisites to attend this workshop:

• Each participant must have an introductory background in statistics and genetics, and/or in the statistical analysis of genetic data.
• Experience using R/Linux is preferred.
• Each participant must bring a laptop.

INSTRUCTORS

• Hae Kyung Im, PhD, Department of Genetic Medicine, University of Chicago.
• Iuliana Ionita-Laza, PhD, Department of Biostatistics, Columbia University.
• Kai Wang, PhD, CHOP and University of Pennsylvania.

ADDITIONAL INFORMATION

Full details on website:

Sex, Lungs, and Air Pollution

Thursday, June 11
12:00 Noon to 2:45 PM (ET)

Chairs: Meghan E. Rebuli, University of North Carolina at Chapel Hill; and Robert M. Tighe, Duke University.
Primary Endorser: Inhalation and Respiratory Specialty Section
Other Endorsers: Clinical and Translational Toxicology Specialty Section; Women in Toxicology Special Interest Group

This free webinar is being presented as part of the 2020 SOT Virtual Annual Meeting.

Description:
The National Institutes of Health (NIH) recently mandated that sex be considered a biologic variable in animal and clinical research. Recent focus on sex-dependent biologic effects in toxicology has translated into new discoveries of sex differences in pulmonary responses to respiratory toxicant exposures, such as tobacco and wildfire smoke, ozone, and ambient air pollution. As the effects span multiple models, it suggests common mechanisms that should be highlighted and considered when evaluating respiratory toxicant exposure. This session will explore recent innovative research on sex-dependent pulmonary effects of air pollution. The first speaker will introduce the biology behind the development of respiratory sex differences and its importance for regulatory and safety considerations. Differences in susceptibility to disease, morbidity, and mortality related to respiratory sex differences will be described. For example, asthma prevalence rates are higher in boys than in girls, but this pattern reverses at the onset of puberty, and reverses again following the onset of menopause. The speaker will also review sex differences in nonclinical respiratory toxicology research models and how they contribute to regulatory decisions regarding human safety and risk assessment. The next talk will discuss the impact of in utero secondhand smoke (SHS) exposure on the development of cancers later in life and their sex dependence. Though it is well established that SHS exposure contributes to lung disease-related deaths, the onset and progression demonstrates sex specificity. This speaker will illuminate possible mechanisms, including genetic or hormonal influences, for these sex-specific responses using a rodent model of SHS exposure and urethane-induced tumorigenesis. Overall, SHS exposure in utero promotes metastasis in females through matrix remodeling, while promoting large tumors in males. The third speaker will describe sex-specific patterns of inflammation and airway hyperresponsiveness (AHR) in ozone exposure that impair lung innate immunity. The findings suggest that fluctuations of circulating hormone levels affect ozone-induced inflammatory responses. In this study, male and female mice underwent gonadectomy and hormone replacement prior to ozone exposure. After exposure, male mice displayed higher AHR than controls, while in females, AHR was reduced, both of which were ameliorated by hormone replacement. Together, these results indicate that sex hormones can modulate ozone-induced inflammation and AHR in adult mice. The fourth speaker will discuss how wood and biomass smoke impacts respiratory and immune function in primates across the life span. Wildfire events are a growing public health concern with the potential to increase cardiac and respiratory disease burden. However, little is known about the long-term effects of acute wildfire smoke inhalation. The speaker will report on recent research on the health of ambient wildfire smoke-exposed primates. Sex-specific responses in lung and immune function throughout the primate life span were observed. At infancy, females showed reduced lung compliance, which persisted into adulthood. These findings suggest that exposure age and sex enhance vulnerability to long-term health outcomes following exposure to wildfire smoke.The fifth speaker will describe how in utero exposure to ambient air pollutants in combination with prenatal stress can induce sex-specific respiratory outcomes in epidemiologic studies. Using epidemiological data, the speaker will describe how prenatal ambient pollution exposure and stress can sex-specifically modify children’s respiratory outcomes. The speaker also will identify critical windows of developmental exposure, which result in adverse respiratory outcomes. This highlights that in humans, similar to other model systems, there are sex-specific windows of vulnerability and adverse outcomes of exposure to respiratory toxicants. Finally, there will be a scheduled panel discussion on how sex-specific findings in respiratory toxicant exposures influence funding, risk and safety assessments, and standard setting. This discussion will help define best practices for inclusion of sex as a biological variable in toxicity testing from cell culture to epidemiology. Presenters and Chairs who are from industry and academia, MDs and PhDs, junior and senior investigators, diverse in sex, race, and ethnicity, from across the US and Canada, and studying a variety of model systems will provide diverse perspectives on this issue. In summary, this Workshop will provide an overview of some of the sex-specific responses to respiratory toxicants and potential mechanisms elucidated from multiple models and a variety of respiratory toxicants.

Introduction. Meghan Rebuli, University of North Carolina at Chapel Hill, Chapel Hill, NC.

Influence of Sex and Sex Hormones on Lung Function and Disease: Research, Risk, and Regulatory Insights. Jeffrey Card, Intertek Scientific & Regulatory Consultancy, Mississauga, Ontario, Canada.

Murine In Utero Secondhand Smoke Exposure Promotes Urethane-Induced Lung Tumors in Males and Metastases in Females via Extracellular Matrix-Remodeling. Alexandra Noel, Louisiana State University, Baton Rouge, LA.

The Role of Gonadal Hormones in Sex-Specific Lung Inflammatory Response to Ozone. Patricia Silveyra, University of North Carolina at Chapel Hill, Chapel Hill, NC.

Sex-Dependent Health Impacts of California Wildfire PM2.5 across the Life Span. Lisa Miller, University of California Davis School of Veterinary Medicine, Davis, CA.

Disentangling Effects of In Utero Exposure to Ambient Air Pollutants, Prenatal Stress, and Fetal Sex on Respiratory Outcomes in Epidemiologic Studies. Rosalind Wright, Icahn School of Medicine at Mount Sinai, New York, NY.

This year, the symposium will be held on the Penn State University campus in State College, PA from June 14-18, 2020. The sessions will showcase cutting edge research and highlight advancements in the study of AHR in terms of public and environmental health, toxicology, pharmacology and biology of development. The themes of the symposium will therefore address many systems / models of pathologies related to environmental toxicology.

Along with opportunities to network with colleagues from around the world and learn the latest scientific information, the Penn State campus and surrounding area offers many things to do and see. Central Pennsylvania is a beautiful part of the United States boasting scenic mountains, local culture, and a world class research institution. Come for the meeting, but make sure to take advantage of all the area has to offer.

Following on the success of the 2019 West Coast event, SMi proudly presents the 4th Annual Pharmaceutical Microbiology West Coast Conference, in San Diego, USA, on June 18th and 19th 2020 bringing microbiology experts to focus on innovations in rapid methods and contamination control strategies. Microbes such as bacteria, fungi, parasites and viruses that can contaminate current and novel pharmaceutical products or therapies may stem from various sources such as raw materials and human operators, are taken into consideration.

A significant portion of the conference will focus on contamination control strategies and facilities support/novel technologies such as a look at a sustainable global contamination control program, cleanroom pass thru best practices and a case study executing rapid transition from clinical to commercial manufacturing and more. Also see a regulatory session discussing objectionable organisms in non-sterile drug products and an all-women panel discussion: ‘culturing’ successful women microbiologists.

Get the latest regulatory guidance direct from 20+ Competent Authority and Notified Body representatives to gain clarification on the requirements and their expectations. And, benchmark your regulatory progress with leading industry case studies including strategic advice to help ensure you're on track for compliance.

Build your 2, 3, 4 or 5 day pass and secure your place today. You will gain full access to all conference tracks and training courses on the days you choose to attend so be sure to take a look at the full 5 day agenda.

The Epigenetics Boot Camp is a two-day intensive boot camp of seminars and hands-on analytical sessions to provide an overview of concepts, techniques, and data analysis methods utilized in human epigenetics studies.

TRAINING OVERVIEW

This two-day intensive boot camp integrates the principle concepts of epigenetics and the effects of risk factors on the epigenome as we step through the key components of designing and executing DNA methylation studies. Led by a team of scientists with more than 40 years of combined expertise in the field of environmental epigenetics, this epigenetics training will integrate seminar lectures with hands-on computer sessions to put concepts into practice. Emphasis will be given to leveraging existing resources from ongoing studies and initiating new investigations. The afternoon lab sessions will provide an opportunity to work hands-on with real methylation data generated by the Illumina Infinium MethylationEPIC (850k) BeadChip platform. Participants will learn and practice data handling, cleaning, and basic analysis of epigenome-wide DNA methylation data.

By the end of the epigenetics training, participants will be familiar with the following topics:

• Principles of epigenetics
• Concept ideation and study design
• Sample collection and processing
• Laboratory methods and platforms for analysis
• Data handling and cleaning
• Data analysis
• Study design advantages and pitfalls
• Emerging epigenetic topics and laboratory platforms

Investigators at all career stages are welcome to attend, and we particularly encourage trainees and early-stage investigators to participate.

PREREQUISITES

• Each participant is required to bring a personal laptop as all lab sessions will be done on your personal laptop. Tablets and ipads will not work with the platform being used.
• The Boot Camp will use data sets in R, therefore we strongly recommend that participants have a basic understanding of this platform prior to attending the Boot Camp. It is ok if you have never used this platform before because the tutorials outlined below will provide you with the basic skills needed for Boot Camp success.

KEYNOTE SPEAKER

• John Greally, DMed, PhD, Center for Epigenomics, Albert Einstein College of Medicine.

INSTRUCTORS

• Andrea Baccarelli, MD, MPH, PhD, Mailman School of Public Health, Columbia University
• Andres Cardenas, PhD, MPH, School of Public Health, University of California, Berkeley
• Elena Colicino, PhD, Icahn School of Medicine at Mount Sinai
• Jonathan Heiss, PhD, Icahn School of Medicine at Mount Sinai
• Allan Just, PhD, Icahn School of Medicine at Mount Sinai
• Allison Kupsco, PhD, Mailman School of Public Health, Columbia University

ADDITIONAL INFORMATION

• Full details on website:

The current industrial revolution signifies the huge value of protein engineering for API and chemical production. The development of enzyme-catalyzed processes offers multiple benefits to industrial chemical processes including high specificity, by-products reduction, cost effective mild reaction conditions, alternative feedstocks and higher product yields. Biocatalytic technology has the potential to carry out conventional multistage processes into efficient one-pot reactions.

Join us and leading experts from Merck, Pfizer, Takeda, GSK, BASF, DuPont Biomaterials and more to discuss new biocatalytic enzyme design, enzyme engineering, cascade pathways, biocatalyst manufacturing and scaling up.

Group discounts and early booking rates are available. Please visit the website for full pricing information.

Join us in Boston with 60+ experts alongside organisations such as National Institute of Health, Genentech, MD Anderson Cancer Institute, Bristol Myers Squibb and more and utilize industry insight behind the latest imaging modalities to monitor immune responses in a safe and non-invasive manner, enabling you to accelerate your oncology drug development with confidence.

The PREDiCT: Imaging Modalities for Oncology Drug Development Summit, June 23-25, Boston MA, will be the pioneering platform across preclinical and clinical stages to guide your application of multimodal imaging to enhance therapeutic success. Bringing together 60+ imaging experts from drug developers and leading academics across 3 days we will provide you with leading strategic applications behind targeted drug response to fast-track your clinical oncology pipeline.

With about 85% of the proteome currently undrugged, accessing these targets that are, at present, extremely difficult to drug, has prevented researchers from achieving desired clinical successes.

Join the pioneering directors, team leaders and senior scientists from the biopharmaceutical industry and academia to enhance your existing structural, chemical and computational toolbox and explore how these innovative technologies can be uniquely employed to target the entire proteome and advance your small molecule drug discovery pipeline.

Join your peers from the likes of Merck, Ipsen, Advanced Accelerator Applications, ETH Zurich, Johns Hopkins Medicine and more to explore the full potential of theragnostic radionuclide therapies within advanced oncology portfolios and gain practical insights on how to deliver meaningful clinical efficacy.

Time: 9:00 am - 6:00 pm

Across 3 days, with 100+ ADC experts, this comprehensive antibody-drug conjugate conference will enable you to propel your ADC pipeline into clinical development. Some of the highlights from the 2020 meeting include exploring targets beyond HER-2; confidently meeting Chinese NMPA regulatory requirements to successfully translate into the clinic and effectively scaling up your manufacturing processes for clinical development. World ADC Asia not only delves into general antibody-drug conjugate challenges, it also focuses on challenges and opportunities specific to development within Asia.

Don’t miss your opportunity to:
* Hear the rationale for submitting INDs in different countries; how to leverage the strength of Asia and US/Europe with the NMPA, BlissBio and Shanghai Miracogen
* Form lasting connections by engaging directly with 100+ attendees from the leading companies actively developing ADCs in Asia, such as Daiichi Sankyo, Bio-Thera, Sumitomo Dainippon Pharma Co, Seattle Genetics and Mersana
* Learn from the leading Chinese biotech’s who have recently submitted INDs or entered the clinic including Shanghai Miracogen, Blissbio and Genequantum

Venue Details: Hilton Tokyo Bay, 1-8 Maihama, Urayasu, Chiba, 279-0031, Japan

The New Principal Investigator (PI) Crash Course is a two-day intensive boot camp of seminars, discussions, and hands-on activity sessions to provide exposure to fundamental leadership and management skills and tools needed for success in your lab.

TRAINING OVERVIEW

This two-day intensive crash course integrates the principle skills that future and new PIs did not develop during their post-doctoral training, but will be necessary to survive as a new Lab leader and manager. Whether you are a doctoral student, postdoc, new PI, or looking to start your own lab, as a lab leader you will immediately be confronted on daily basis by a variety of situations that you must be prepared to handle. This crash course will provide you the tools you need to start your lab on the right foot.

Led by a team of experienced leaders and scientists in the field of environmental sciences, epigenetics, genomics, epidemiology, immunology, neuroscience and bioinformatics, this workshop will integrate lectures with hands-on sessions to put eight key “survival skills” into practice: Negotiating, Staffing, Leading, Mentoring, Managing People, Managing time, Managing projects, and Networking. Emphasis will be given to leadership styles, leadership vision, self-awareness, successful delegation, responsibility, problem solving, adaptability, communication techniques, goal setting, and strategizing. The Crash Course will conclude with a panel discussion with successful PIs at different stages of their careers, ranging from Assistant Professors to Department Chairs.

By the end of the workshop, participants will be familiar with the following topics:

• Negotiation skills for a new position/promotion/collaboration/publication
• Staffing skills for job posts/candidate screening/interviews/hiring
• Leadership and mentoring skills in the Lab
• People management: day-to-day/conflict resolution/misconduct/promotions/layoffs
• Time management: balancing research, teaching, service/when & how to say No
• Project management: planning/tracking progress/meeting deadlines/introduction to management software
• Network creation and maintenance: mentors/collaborators/supporters
• Real-life lab leader success stories and best tips from early-stage and experienced investigators

Senior post-doctoral students and associate research scientists about to start their independent position search are particularly welcome to attend, and we strongly encourage new and recent PIs to participate as it is never too late to get an overview of the survival skills that you will need throughout your career.

INSTRUCTORS:

• Andrea Baccarelli, MD, MPH, PhD, Mailman School of Public Health, Columbia University ?
• Tuuli Lappalainen, PhD, New York Genome Center
• Ana Navas-Acien, MD, MPH, PhD, Mailman School of Public Health, Columbia University ?
• Diane Re, PhD, Mailman School of Public Health, Columbia University ?
• Brandon Pearson, PhD, Mailman School of Public Health, Columbia University ?
• Matthew Perzanowski, PhD, Mailman School of Public Health, Columbia University ?
• Rachel Shelton, ScD, MPH, Mailman School of Public Health, Columbia University
• Robert Wright, MD, MPH, Icahn School of Medicine at Mount Sinai

ADDITIONAL INFORMATION
Full details on website:

The conference will take place June 28–July 1, 2020, at the UCLA Meyer and Renee Luskin Conference Center on the campus of the University of California, Los Angeles (UCLA).

The course is intended to benefit those from both biotechnology and pharmaceutical companies as well as CROs working with either small or large molecules, along with those from regulatory agencies and academia who are interested in toxicology and its application in the safety assessment of drugs and medical products. Early career scientists seeking a more in-depth knowledge and understanding of the role of toxicology in safety assessment will also benefit. The course is suitable for scientists trained in ancillary disciplines (such as chemistry, biochemistry, molecular biology, medicine, etc.) looking to make a career change to work in drug safety assessment.

The course will take place from June 28th to July 3rd 2020 at the University of Cambridge. This annual course is a collaboration between the American College of Toxicology (ACT), the British Toxicology Society (BTS) and the Cambridge Alliance on Medicines Safety (CAMS); this is the seventh time we have run the course and the fifth time at the excellent Moeller Institute, part of Churchill College, Cambridge University. Approved by the Royal Society of Biology for 96 CPD credits. This course is also recognised by EUROTOX as providing 37 hours of education for continuing professional development.

The Single Cell Analysis Boot Camp is a two-day intensive training of seminars and hands-on analytical sessions to launch students on a path towards mastery of scRNASeq data analysis methods used in health studies.

TRAINING OVERVIEW

This two-day intensive boot camp starts with a fast-paced training session on single cell data collection and basic analysis in the first half-day, then continues with in-depth sessions on advanced methods for phenotyping single cell populations using systems-biology approaches. Led by a team who have invented several of the methods used in network biology and single-cell transcriptome analysis, we demonstrate how to use network models to convert gene expression profiles into protein activity profiles, and how to transfer knowledge between established bulk datasets and novel single-cell data. We expect that, during this hands-on workshop, participants will acquire enough knowledge to plan and perform scRNAseq analyses.

By the end of the workshop, participants will be familiar with the following topics:

• Gene expression analysis of scRNA data (pre-processing, quality control, filtering, normalization)
• Gene networks reconstruction
• Principle Component Analysis (PCA) and other dimensionality reduction techniques (e.g TSNE, UMAP)
• Transcription factor and protein “master regulator” analysis
• Transfer learning and machine learning between bulk and single cell datasets
• Visualization of single cell data in RStudio

Investigators at all career stages are welcome to attend, and we particularly encourage trainees and early-stage investigators to participate.

PREREQUISITES AND REQUIREMENTS
There are three prerequisites/requirements to attend this training:

• Each participant must have an introductory background in statistics
• Each participant must be familiar with R.
• Each participant must bring a laptop with R downloaded and installed prior to the first day of the workshop. R is available for free download and installation on Mac, PC, and Linux operating systems.

INSTRUCTORS

• Pasquale Laise, PhD, Director of Single Cell Systems Biology, DarwinHealth Inc. and adjunct Associate Research Scientist, Systems Biology, Columbia University.
• Aleksandar Obradovic, MD/PhD Candidate, Systems Biology, Columbia University.
• Lukas Vlahos, PhD Candidate, Systems Biology, Columbia University.
• Jeremy Worley, PhD, Systems Biology, Columbia University.

ADDITIONAL INFORMATION

• Full details on website:

The Functional Genetics Boot Camp is a two-day intensive boot camp of seminars and hands-on analytical sessions to provide an overview of concepts and data analysis methods for computational integration of genome and transcriptome data to characterize molecular effects of genetic variants.

TRAINING OVERVIEW

Genetic studies in humans have led to discovery of thousands of loci and variants that associate to diverse traits and diseases. However, especially for variants in the noncoding genome, interpretation of functional effects of these variants has been a challenge. One of the approaches to address this challenge has been large-scale analysis of functional genomics data from human samples.

This two-day intensive workshop will provide a rigorous introduction to concepts and analytical methods to map and characterize molecular effects of genetic variants by integration of large-scale genetic and transcriptome data. Led by world experts in functional genomics, human genetics, and statistical methods development, the workshop will integrate seminar lectures with hands-on computer lab sessions to put concepts into practice. The workshop will focus on genetic effects on gene regulation, and guide the participants not only in analytical methods but also the use of major resource data sets like GTEx.

By the end of the workshop, participants will be familiar with the following topics:

• Genetic association to gene expression by eQTL analysis
• Allele-specific expression analysis
• Basics of processing of population-scale RNA-seq data sets
• Integration of GWAS and eQTL data
• Genetic effects on other epigenomic and transcriptomic traits
• Functional interpretation of rare disease-associated variants

Investigators at all career stages are welcome to attend, and we particularly encourage trainees and early-stage investigators to participate.

PREREQUISITES AND REQUIREMENTS

There are three prerequisites/requirements to attend this training:

• Each participant must have an introductory background in human genetics and genomics (genetic variants, GWAS, gene expression)
• Each participant must be familiar with R.
• Each participant must bring a laptop with R downloaded and installed prior to the first day of the workshop. R is available for free download and installation on Mac, PC, and Linux devices.

If you have any specific questions about R in the context of the Functional Genetics Boot Camp, please email us.

INSTRUCTORS

• Christopher (Casey) Brown, PhD, University of Pennsylvania.
• Sarah Kim-Hellmuth, PhD, Columbia University & New York Genome Center.
• David Knowles, PhD, Columbia University & New York Genome Center.

ADDITIONAL INFORMATION

• Full details on website:

The NIH Grant Writing Boot Camp is a two-day intensive boot camp combining lectures, hands-on activities, and discussions to demystify the NIH application process. This training will prepare participants to submit an NIH grant proposal that turns reviewers into advocates, positioning the applicant for success.

TRAINING OVERVIEW

Federal grants, particularly from the NIH, provide a critical means of support for academic research programs. Despite the importance of this support in advancing both research and researchers’ careers, training in how to obtain grants is uneven at best.

This training gap leaves many researchers struggling to learn as they go, which can introduce significant stress, delay the time to a successful application, and impact their overall productivity.

The good news is that training and hands-on practice can enable you to conquer grant writing, increase your chances of receiving funding, and devote more time to moving your scientific goals forward.

The 2-day NIH Grant Writing Boot Camp: Building a Strong Foundation for Funding Success will provide comprehensive training that supplies researchers with the tools to write persuasive, effective grant proposals.
Through a combination of seminars, discussions, examples, and hands-on activities, and a particular focus on navigating between-the-lines on how to tailor your proposals to grant reviewers, this training will orient you to all aspects of the academic funding process (i.e., grant writing and grantspersonship), including:

• How to identify and apply for the right funding opportunities with the NIH (and beyond);
• How to position your research and yourself to make reviewers your research advocates;
• How to target your application to the right place at the right time; and
• How to write clearly, effectively, and persuasively when telling your scientific story.

The workshop will begin with a live online seminar 2-3 weeks before the in-person program to introduce the fundamentals of drafting the Specific Aims page—that oh-so-important project overview that can ‘make or break’ the reviewers’ perception of the application.

The in-person portion of the workshop will cover critical topics that help you package your proposal for maximum impact:

• What the Aims page captures, why it’s so important to get it right, and how to tackle it
• A comprehensive introduction to NIH funding announcements and award mechanisms: What to apply for, how to apply
• Merit review: Understanding who, what, why, and how enables you to frame your application
• Principles of good communication: How to ‘sell’ yourself and your science
• Elements of good writing: Remembering and applying the rules you learned in 7th grade
• Psychology of grant review
• Tackling resubmissions for ultimate success

Attendees will leave the boot camp with:

• A foundational understanding of the NIH granting process and how it pertains to public health research
• Hard-copy reference materials for information retention & review
• A refined Aims page
• A refined NIH Biosketch
• One round of written feedback for a Specific Aims page will be made available to all attendees for 3 months after the workshop, at no additional cost, further solidifying the workshop concepts into practical skills.

Investigators at all career stages are welcome to attend, and we particularly encourage trainees and early-stage investigators to participate.

PREREQUISITES AND REQUIREMENTS

No prior experience in preparing or submitting NIH grant applications is necessary. However, each participant should be prepared to share and work on an NIH Specific Aims page and an NIH biosketch. Participants who have not previously written an NIH-style Aims page and/or biosketch will have an opportunity to draft their page and receive initial feedback ahead of the on-site workshop. There are no other prerequisites to attend the NIH Grant Writing Boot Camp.

INSTRUCTORS

Sheila M. Cherry, PhD, Founder, Fresh Eyes Editing.

April R.S. Gocha, PhD, Senior Editor, Fresh Eyes Editing.

ADDITIONAL INFORMATION:

Full details on website:

This Euro Diabetes 2020 Conference Welcomes all the Academic Scientists, Leading Diabetologists, Endocrinologists, Surgeons, Primary Health care specialists, Pediatricians, Pharmaceutical Industrial Delegates, talented young scientists, and student communities across the globe where all the aspects of Diabetes Mechanism, Disorders, & Treatment will be discussed under single roof.

The Exposome Boot Camp is a two-day intensive boot camp of seminars and hands-on analytical sessions to provide an overview of concepts, techniques, and data analysis methods used in studies of the exposome.

TRAINING OVERVIEW

There are many challenges to capturing the complexity of exposures in an individual across the lifetime and their potential health effects. Traditionally, environmental health studies have focused on assessing risks related to a single exposure at a time, yet in reality we are constantly exposed to multiple exposures at the same time. To advance environmental health research and positively impact human health through recommendations and policy, we need to incorporate omics data that capture all chemical species detectable in human plasma over the life course. The exposome offers this framework and can be viewed as the environmental complement of the genome.

This two-day intensive boot camp integrates the principle concepts of exposomics and the untargeted approaches of measuring endogenous and exogenous chemical exposures on an omic scale as we step through the tools and techniques currently available to analyze the exposome. Led by a team of expert scientists in the rapidly growing field of exposomics, the boot camp will integrate seminar lectures with hands-on computer lab sessions to put concepts into practice. Emphasis will be given to leveraging existing resources from ongoing studies and initiating new investigations. The afternoon lab sessions will provide an opportunity to work hands-on with real data. Participants will learn and practice data handling, cleaning, and basic analysis of exposomics data.

By the end of the workshop, participants will be familiar with the following topics:

• Principles of exposomics
• Concept ideation and study design
• Laboratory methods and instrumentation platforms for analysis
• Data extraction and cleaning with emphasis on peaks and feature tables
• Pathway data analysis and identification databases
• Data visualization and network interpretation
• Study design advantages and pitfalls
• Emerging exposomic topics and laboratory platforms

Investigators at all career stages are welcome to attend, and we particularly encourage trainees and early-stage investigators to participate.

PREREQUISITES AND REQUIREMENTS
This training is designed to accommodate investigators with varying experience levels in R. Both beginner and advanced data manipulation during lab sessions will be available, with all material and additional resources available after the training.

• Each participant must have an introductory background in statistics
• Each participant is required to bring a personal laptop with R downloaded and installed prior to the first day of the workshop as all lab sessions will be done on your personal laptop. R is available for free download and installation on Mac, PC, and Linux devices.
• The Boot Camp will use data sets in R, therefore we strongly recommend that participants have a basic understanding of this platform prior to attending the Boot Camp. It is ok if you have never used this platform before because the tutorials outlined below will provide you with the basic skills needed for Boot Camp success.

R TUTORIALS
Knowing basic R platform and commands are highly recommended for the Boot Camp as noted in prerequisites above. If you are new to R or need a refresher, you can review the below tutorials to be well prepared:

The GIS Workshop is a two-day intensive workshop that will introduce participants to the fundamental concepts and hands-on techniques of health data visualization and analysis using publicly available open source GIS programs.

TRAINING OVERVIEW

This two-day intensive course aims to introduce participants to the fundamentals of data visualization using the open-source QGIS program and building towards the introduction of foundational spatially-centered approaches to identifying relationships and associations among population and environmental variables. Led by Dr. Jeremy R. Porter, one of the highest-rated teachers at the Columbia University Mailman School of Public Health and the author of many celebrated geospatial analysis publications and books, this workshop will integrate lectures with hands-on application. The workshop emphasizes the use of open-source software packages and publicly available environmental and demographic data as an example of potential applications of these data with spatially centered visualization and analytic techniques. The workshop is comprised of 4 components 1) visualization, 2) geo-processing, 3) cluster analysis, and 4) relationship identification. Within each component, a lecture is followed by an opportunity to put the methods learned into practice.

By the end of the workshop, participants will be familiar with the following topics:

• Principles of data visualization and analysis
• Sources and techniques for the acquisition and management of spatial data
• Methods and techniques for the visualization of spatial data
• Techniques for the identification of statistical spatial (and spatio-temporal) clusters
• Techniques for the incorporation of spatial information in more traditional regression methods of association and relationship identification among variables.

Investigators at all career stages are welcome to attend, and we particularly encourage trainees, students, and early-stage investigators to participate.

PREREQUISITES
There are two prerequisites to attend this workshop:

• Each participant must have an introductory background in statistics.
• Each participant must bring a laptop with the software below loaded prior to the first day of the workshop. All of the packages below are available for free download and installation on Mac, PC, and Linux devices.
  • QGIS
  • saTScan
  • GeoDa
  • R
  • R-Studio

INSTRUCTORS

• Jeremy Porter, PhD, Mailman School of Public Health, Columbia University.
• Joel Capellan, PhD, Mailman School of Public Health, Columbia University.

ADDITIONAL INFORMATION

Full details on website:

The Mendelian Randomization Boot Camp is a two-day intensive combination of seminars and hands-on analytical sessions to provide an overview of the concepts, techniques, packages, data sources, and data analysis methods needed to conduct Mendelian Randomization studies.

TRAINING OVERVIEW

This two-day intensive boot camp integrates motivation for Mendelian randomization studies, statistical concepts, genetic considerations, and practical examples to design, implement and interpret a Mendelian randomization analysis. Led by a scientist with several award winning papers on Mendelian randomization combined with extensive expertise in epidemiology, the workshop will integrate seminar lectures with hands-on computer sessions to put concepts into practice. Emphasis will be given to leveraging existing publicly available resources (data, tools and packages) as well as indicating the scope for new studies. The afternoon lab sessions will provide an opportunity to work hands-on with real data. Participants will learn and practice all the steps required for a successful Mendelian randomization analysis using publicly available data, including identifying suitable data sources, data extraction, data alignment, assumption checking and sensitivity analysis.

By the end of this Mendelian Randomization training, participants will be familiar with the following topics:

• Principles of Mendelian Randomization
• Implementation options
• Suitable publicly available data sources
• Data interpretation and handling
• Data analysis
• Sensitivity analysis
• Study design advantages and pitfalls
• Emerging Mendelian randomization techniques
• use of MR-Base

Investigators at all career stages are welcome to attend, and we particularly encourage trainees and early-stage investigators to participate.

PREREQUISITES AND REQUIREMENTS

• Each participant is required to bring a personal laptop as all lab sessions will be done on your personal laptop. Your laptop must have the capability of reading a 900Mb file into R.
• The Boot Camp will use data sets in R, therefore it is required that each participant has previous experience using R. If you have any specific questions about R and R studio in the context of the Mendelian Randomization Boot Camp, please email us.
• Each participant must have the latest version of R and R studio downloaded and installed prior to attending the Boot Camp.

INSTRUCTOR

• Mary Schooling, PhD, Department of Environmental, Occupational, and Geospatial Health Sciences at CUNY School of Public Health.

ADDITIONAL INFORMATION

Full information on website:

The Microbiome Data Analytics Boot Camp is a two-day intensive training of seminars and hands-on analytical sessions to provide an overview of 16S rRNA gene sequencing surveys including planning, generating and analyzing sequencing datasets.

TRAINING OVERVIEW

Amplicon sequencing of taxonomic marker genes such as the 16S rRNA gene in bacteria has been used over the last two decades to survey the microbiota of myriad environments. From soil to aquatic to human systems, 16S rRNA amplicon sequences are widely used to characterize the diversity and composition of the gut microbiome, discover novel microbes, and define how specific microbes link to environmental or host traits of interest. As a result, 16S rRNA amplicon surveys have proven invaluable in efforts designed to uncover the potential contribution of microbiomes to critical ecological and health processes.

This two-day intensive workshop will provide a rigorous introduction to the theory and methodology underlying the design, generation, and analysis of Amplicon Sequence Variant (ASV) based investigations of microbial communities. The workshop will introduce state-of-the-art techniques using the R language and environment. A team of leading experts in microbiome data analytics and statistics will offer a hands-on experience in learning how to implement these techniques by integrating publicly available data and R packages to explore and understand some of the pitfalls and information drawn from 16S rRNA data analysis.

By the end of the workshop, participants will be familiar with the following topics:

• The theoretical basis underpinning 16S rRNA investigations
• Methodologies for generating 16S rRNA sequence data
• 16S sequence data quality control
• Amplicon sequence variant inference
• Taxonomic annotation
• Biodiversity estimation
• Principal Component Analysis and PERMANOVA
• Taxon-covariate correlation and regression modeling

Investigators at all career stages are welcome to attend, and we particularly encourage trainees and early-stage investigators to participate.

PREREQUISITES AND REQUIREMENTS
There are three prerequisites and requirements to attend this workshop:

• Each participant must have an introductory background in statistics
• Each participant must be familiar with R and a basic UNIX command line interface.
• Each participant must bring a laptop with either Chrome or Firefox installed (latest update). Additionally, participants need an SSH client (e.g., terminal for Mac or putty for Windows) installed on their machine prior to the first day of the workshop. SSH clients are available for free download and installation on Mac, PC, and Linux devices.

INSTRUCTORS

• Maude David, PhD, Assistant Professor, Department of Microbiology & Department of Pharmaceutical Sciences at Oregon State University.
• Thomas Sharpton, PhD, Associate Professor, Department of Microbiology & Department of Statistics, Oregon State University.

ADDITIONAL INFORMATION

Full details on website:

This week-long course will begin on Monday morning with registration and continental breakfast and will end on Friday with a practice exam, comprised of questions with the type and rigor found on the American Board of Toxicology exam. The registration fee includes continental breakfast, morning and afternoon breaks, and lunch. The registration fee includes continental breakfast, morning and afternoon breaks, and lunch.

Course Location
Gaithersburg Marriott Washingtonian Center
9751 Washingtonian Boulevard
Gaithersburg, MD 20878

Key topics of discussion include:
Evaluating the suitability and success of current immunosuppression agents in the context of gene therapy
Employing risk assessment tools to develop clinical bioanalytical and immunogenicity monitoring strategies
Dissecting the immunogenicity of gene therapy vectors to better understand immunology safety concerns
Better understanding the innate immune response and its implications for gene therapy transduction
Evaluating the resolution and throughput of technologies to define empty vs full capsid presence
Implementing the use of preclinical risk assessment tools to drive clinical immunogenicity strategies for gene therapy modalities
What the implications are for the safety and efficacy of gene therapies if re-dosing is to occur

URLs:

Tickets:

To explore foremost research in pharmaceutical sciences and to discuss clinical, analytical and commercial issues in pharmacology, Pages Conferences is organizing Global Conferennce on Pharmaceutics and Pharmacology, which will be held during August 06-07,2020 in San Antonio. The conference offers a seamless view of the industry today while paving way for future research.

The conference aims to empower future generations in different fields of pharmaceutics to explore exciting research outcomes that lie in tune with the objectives and theme of this exciting event. It further helps you enhance your understanding of commercial, scientific and regulatory issues that affect strategic decision making in the pharmacology sector.

Sessions Link: https://pagesconferences.com/pharmacology-pharmaceuticsconference/call-for-abstracts.php

Contact us:

Julie Andrieo
gcpp-2020@pagesconferences.com

To provide critical information and knowledge based on latest research in toxicology, Scientific Federation is organizing the Global Conference on Toxicology which is scheduled to be held during August 06-07,2020, in San Antonio, USA. The aim of this conference is to share critical toxicology information to protect public health.

For more information:

Satya | Program Manager
Toxicology-2020
gct-2020@pagesconferences.com

The Environmental Mixtures Workshop is a two-day intensive training of seminars and hands-on analytical sessions to provide an overview of environmental mixtures concepts, techniques, and data analysis methods used in health studies.

TRAINING OVERVIEW

Traditionally, environmental health studies have focused on assessing risks related to a single pollutant at a time. This, however, does not reflect reality, since we are constantly exposed to multiple pollutants at once. Recently, there has been an increased interest in methods that allow researchers to assess exposures to many pollutants at a time. These methods are able to accommodate the high dimension of the exposure matrix, as well as the usually high correlation across exposures of interest.

This two-day intensive workshop will provide a rigorous introduction to multiple different techniques to analyze exposure to mixtures in environmental health. Led by a team of world experts in environmental health, epidemiology and statistics, many of whom have developed their own methods to analyze exposure to mixtures, the workshop will integrate seminar lectures with hands-on computer lab sessions to put concepts into practice. Emphasis will be given to supervised and unsupervised methods. Since the choice of method depends on the research question at hand, the workshop will conclude with a panel discussion on when each method presented is appropriate for use and for which research questions.

• Principle Component Analysis (PCA)
• Factor Analysis (FA)
• Clustering
• Variable Selection (Lasso, elastic net)
• Bayesian Kernel (BKMR)
• Weighted Quantile Sum Regression (WQS)
• Emerging mixtures topics and novel extensions

Investigators at all career stages are welcome to attend, and we particularly encourage trainees and early-stage investigators to participate.

• Each participant must have an introductory background in statistics
• Each participant must be familiar with R.
• Each participant must bring a laptop with R downloaded and installed prior to the first day of the workshop. R is available for free download and installation on Mac, PC, and Linux devices.

INSTRUCTORS

• Brent Coull, PhD, Harvard T.H. Chan School of Public Health, Harvard University.
• Chris Gennings, PhD, Research Professor and Biostatistics Division Director, Department of Environmental Medicine and Public Health, Icahn School of Medicine at Mount Sinai.
• Jeff Goldsmith, PhD, Assistant Professor, Department of Biostatistics, Columbia University Mailman School of Public Health.
• Marianthi-Anna Kioumourtzoglou, ScD, Assistant Professor, Department of Environmental Health Sciences, Columbia University Mailman School of Public Health.

ADDITIONAL INFORMATION

Full details on website:

Abstract submission deadline: March 31, 2020

Early registration deadline: May 14, 2020

The event brings 300 expert speakers and 2,000 cell and gene professionals from biotech, pharma, payers, regulators, start-ups, investors, researchers and tech companies together. The agenda is organised around 12 tracks of exciting content, including:

- immunotherapy

- manufacturing and bioprocess

- rare diseases

- gene editing

- pitch and partner

- gene therapy

For an updated speaker list, please visit: http://www.terrapinn.com/AR2020/Evvnt/Speakers
To check the programme, please visit: http://www.terrapinn.com/AT2020/Evvnt/Prog
To book your ticket, please visit: http://www.terrapinn.com/AT2020/Evvnt/Book

Time: 9:00 am - 5:00 pm

Venue details: Business Design Centre, 52 Upper Street, N1 0QH, London, United Kingdom

Over the last few months, the 2020 Program and CE Committees have been hard at work organizing scientific programs and courses that include topics of interest to SPS Members and colleagues. The 2020 Scientific Program features a diverse range of scientific sessions organized into two concurrent themed tracks covering issues such as Novel In Vitro and In Silico Assays to Predict Human Safety, In Vivo and Ex vivo Case Studies For Safety, Debate on the "Value" of Primary Tissue and In Vivo Studies and are disease Models Relevant in Safety Pharmacology, Macro Molecules Science: Antibodies, Oligo, and Peptides, Translation Beyond FIH Exposure Response Models, Macro Molecules Science: Gene therapy, Cell Therapy, mRNA and PROTAC, Derisking and Risk Mitigation Strategies, Clinical Cardiology, and much more! This will ensure attendees can stay abreast of new content and developments in key areas of interest.

The meeting also offers a broad Continuing Education program both on an introductory level as well as advanced courses for the expert. A program outline is now available on the 2020 Meeting website. For those interested in increasing their knowledge, recognition and expertise in the field, we will also be holding the 2020 certification exam for the Diplomate in Safety Pharmacology on September 12 and invite all interested SPS members to consider sitting the exam this year.

Meeting Location
Palais des congrés de Montréal
P 1001 Place Jean-Paul-Riopelle, Montréal

Highlights of the Annual Meeting

• A dynamic forum for best practice sharing within industry, CRO’s, academics and regulators
• Scientific Sessions organized by SPS Members
• Sessions on some of the hottest topics in safety pharmacology related research
• 6 CE Courses taught by experts in the field
• Plenary Keynote Speakers by a key opinion leaders
• Exhibit hall offering access to industry vendors
• Poster sessions featuring cutting-edge research
• Networking opportunities with a global community of scientists from regulatory, industry, and academia
• Award opportunities to bring together Student and Jr. Investigators with seasoned scientists, while sharing their research
• Exhibitor Sponsored Sessions by leading technology and service providers showcasing their new offerings and research

Every year we see innovation and breakthroughs at every level of drug development.

Covering both small molecules and biologics, you'll find new technologies, concepts and case studies in areas such as...

This conference provides attendees with thoughtful insight from key industry leaders and academic researchers concerning cutting edge drug discovery science, preclinical development trends, analysis of key clinical-stage pain therapies and newly marketed products.

- Clinical Trial Study Design

- Novel Pain Drug Targets

- Emerging Pain Drug Candidates

- Pain Biomarkers

Time: 8:00 am - 3:30 pm

Key Subjects Covered at This Event:

Cutting-Edge Technologies
Artificial intelligence and other technologies are quickly reshaping drug discovery and development. This event will showcase how they are reshaping the field of drug repurposing.

Regulatory and Legal Guidance
Legal, IP and regulatory guidance will be shared with the audience, including knowlege and insight into the 505(b)(2) regulatory pathway.

Key Therapeutic Areas for Repurposing
Repurposing is beginning to make its mark in a range of therapeutic areas in need of new therapies. Rare and orphan diseases, tropical diseases and cancer will be discussed in terms of repurposing efforts currently underway.

Prices:
Industry Early Bird Rate: USD 1395.00
Academic Early Bird Rate: USD 595.00

Time: 8:00 am to 3:00 pm

Venue details: The Westin Arlington Gateway, 801 North Glebe Road, Arlington, 22203, United States

Category: Conferences / Science, Health and Medicine / Pharmaceuticals

2020 chiefly achieves the discussion in respect to latest technology and recent developments in the science of Pharmaceutical and closely related domains. Pharmacists are specialists who have been around for a long time, making them specialists in everything identified with skin, hair, and nails. This claim to fame is separated extensively into restorative and surgical fields, with clinicians in optional care rehearsing both. This Pharmaceutical Conference concentrates on Aesthetic procedures, Trichology and Alopecia, skin diseases and dermato-oncology, Clinical Pharmacology and Pharmaceutical Chemistry and research advancements and the business approach towards Pharmaceutical Analysis and developments.

Address:
47 Churchfield Road,
W3 6AY, London.
+44-203-7690-972

The event is supported by The Arab Union of Forensics and Toxicology and is held under the chairmanship of Dr Dina Shokry, Chair of Forensic Medicine, Armed Forces College of Medicine.

The Festival of Biologics is the meeting place for the life science community to bridge the gap between academia and industry.

OUR VISION
The Festival of Biologics aims to bring together senior biologics professionals across the value chain to showcase their research, collaborate on challenges, forge new connections and ultimately advance the industry to improve patient health.

WHY NOW?
Biologics have completely transformed the way that patients are treated. Biologics don't replace older medicines with newer medicines.

With three events in one, the Festival encourages conversation across the entire industry so you can inspire change, champion innovation, and address complex challenges that the biologics industry is facing.

Now in its 11th annual edition, the World Orphan Drug Congress Europe, together with the co-located Cell And Gene Therapy Congress, will continue to bring experts from the whole value chain under one roof, where you get to meet decision makers in the areas that are most applicable for your business offering.

Warm Greetings to you from Genoteq Healthcare Conferences. I am happy to share with you about "5th World Cancer Research Conference” during 10-11 March 2021, at Valencia, Spain

WCRC 2021 anticipates huge number of participants all around the globe with thought provoking Keynote lectures, Oral and Poster presentations, Symposium and workshops. This conference meet with outstanding keynote speakers and well known leading scientists and experts from around the globe will be expected to share their knowledge.
I hope this is the best opportunity to actively participate and grab the fundamentals in which is the latest trend in Academics

As we are expecting large number of participants from all around the global for this conference, we are requesting you to kindly register yourself through the above link first, and then later we will inform you regarding payment of Registration Fees etc.,