Events

Nonclinical Safety for Novel Modalities

Venue:
Genentech, Building 85 Conference Room D&E, 601 Gateway Blvd, South San Francisco, CA 94080

In addition to insightful symposium topic presentations, the event will also feature talks from our exceptional 2025 NorCal SOT Award winners. Attendees will have the opportunity to engage with student research showcased during a poster session and connect with peers in a networking reception.

We look forward to your participation!

Materials:
Agenda

Register Now

Venue:
Tin Roof, 8371 International Dr, Orlando, Florida

Please join us for our annual reception at the 64th Annual SOT Meeting! We will have a delightful selection of hors d’oeuvres and drinks and will announce the winners of our Graduate Student and Postdoctoral Achievement Awards, as well as our new Executive Committee members.

We look forward to seeing you there and celebrating another successful year with the NorCal SOT community.

Venue:
UC Berkeley, Martin Luther King Jr. Building, BNorth level, room 82D

Come join us at the University of California, Berkeley for an inspiring evening to learn about careers in toxicology and STEM

• Connect with professionals from government, industry, and academia
• Learn and explore career opportunities in toxicology and related fields
• Socialize and network with trainees and professionals

Mentors and Mentees needed.

Hosted by: The SOT Northern California and Pacific Northwest Regional Chapters

This will be a virtual panel discussion featuring mentors from government, industry, and national labs. Each mentor will introduce their role as a toxicologist in their respective fields. Following introductions, mentees will be split into breakout rooms, where they will have the chance to engage directly with the mentors. Each breakout session will last about 20 minutes, after which the mentees will be rotated to another group, ensuring that by the end of the event, all participants will have interacted with mentors from different sectors.

National Laboratory Scientists:
Panshak Dakup, PhD, Biomedical Scientist, Pacific Northwest National Lab
Dorothy You, PhD, Postdoc Researcher, Lawrence Livermore National Lab

Government Toxicologists:
Katerine Saili, PhD, Associate National Program Director, US EPA
Nathalie Pham, PhD, DABT, Senior Toxicologist, DTSC CalEPA
Michelle Hu, PhD, Associate Toxicologist, DTSC CalEPA

Industry Toxicologists:
Sunjay Sethi, PhD, DABT, Project Toxicologist, IDEAYA Biosciences
Sarah Carratt, PhD, DABT, Principal Scientist, Pfizer
Leslie Valencia, PhD, Senior Scientist, Genentech

Bridging the Gap: Translating Toxicology from Bench to Bedside

Venue:
Crowne Plaza Hotel

Materials:
Agenda

Venue:
Crowne Plaza Hotel

Beyond the Norm: Spotlight on Alternative Species for Toxicity Testing

Venue:
Genentech, South San Francisco, CA

Materials:
Agenda

The evening included announcing our student and postdoctoral achievement award winners, as well as our new board members.

Venue:
Squatters Pub Brewery, Salt Lake City, UT

Join us for an enlightening evening to explore and learn more about careers in Toxicology and STEM!

• CONNECT with professionals from government, industry, and academia
• LEARN about diverse opportunities in toxicology and related fields during a 30-minute panel discussion
• NETWORK with other trainees and professionals during the social hour that follows

Venue:
UC Davis

Tox Hack: Unleashing the Power of AI and Machine Learning

Venue:
Foster City Crowne Plaza

RRRevving It Up With the 3R’s

Venue:
Merck Research Laboratories, South San Francisco, CA

Materials:
Agenda

The evening included announcing our graduate student and postdoctoral achievement award winners, as well as our new board members.

Venue:
Tin Roof, Nashville, Tennessee

Aiming for Success in DART: Current Status, Case Studies, and Future Directions

Venue:
Foster City Crowne Plaza, Foster City, California

Materials:
Agenda

Rise to the Next Normal—Toxicology Hot Topics, Career Development, and Networking

Venue:
Foster City Crowne Plaza, Foster City, California

Materials:
Agenda

The evening included announcing our graduate student and postdoctoral achievement award winners, as well as our new board members.

Venue:
Joe’s Crab Shack, San Diego, CA

Four-Part Virtual Series In Lieu Of Face-To-Face Meetings Due To The Coronavirus Pandemic

Thank you to the generous sponsors of the Fall 2021 webinar series:

Silver: Aligos Therapeutics, Biomere, Experimur, Inotiv, ITR Canada, LabCorp Drug Development, Leadscope—An Instem Company

Bronze: Charles River Laboratories, Frontage Laboratories, Genentech, Gilead Sciences, InSphero Inc, NeuCyte Inc, Sinclair Research, Theravance Biopharma, WuXi AppTec

Webinar 4: Many Faces of Microglial Cells in Health and Diseases

Speaker:
Fen Huang, PhD, Associate Director in Translational Science, Denali Therapeutics

Sponsor Short Talk:
Establishing an In Vitro Assay for Predicting Neurotoxicity Risks Using Functional Human iPSC-Derived Neurons (Dr. Wayne Poon, NeuCyte)

Webinar 3: Preclinical Models of Dementia: Recent Advances and Remaining Challenges

Speaker:
Amy Easton PhD, Principal Scientific Manager, Neuroscience, Genentech

Sponsor Short Talk:
Beyond the FOB: Development Strategies for Neurologic Drugs (Dr. G. Alex Wakefield, Sinclair Research)

Materials:
introduction and Dr. Wakefield’s presentation
Q&A panel with Dr. Easton and Dr. Wakefield

Webinar 2: Designing a Nonclinical Toxicology Plan for the Development of CNS-Penetrant Therapeutics: Approaches and Lessons Learned

Speaker:
Mark Canet, PhD, Senior Scientist, Toxicology, Denali Therapeutics

Sponsor Short Talk:
Prediction of Abuse Liability (Dr. Glenn Myatt, Leadscope)

Webinar 1: Will CMS Find Aducanumab Reasonable and Necessary for Alzheimer Disease?

Speaker:
Kevin Schulman, MD, Professor of Medicine, Clinical Excellence Research Center, Stanford University

Materials:
Recording

Hosted by the Midwest and Northern California Regional Chapters (endorsed by SOT Education and Career Development Committee)

Panelists:
Kristen Ryan, PhD (NTP); Courtney Carignan, PhD (Michigan State University); Doris Zane, PhD, DABT (Gilead); Andy Vick, PhD (CRL); Worlanyo Eric Gato, PhD (Georgia Southern University); Tracy Costello, PhD (career coach and Board of Directors, National Postdoctoral Association)

Overview:
Four speakers with diverse backgrounds and expertise from varied fields of toxicology (academic, government, industry, contract research organizations) shared their personal journeys with workshop attendees. Speakers shared how to approach jobs in their respective fields, build necessary skill sets, and highlight the challenges and opportunities about each career path, followed by a panel discussion where attendees can interact with each speaker and ask questions.

Following the panel, exclusive talks were given by a ToxMSDT mentor (on scholarship opportunities in toxicology), an SOT CDI committee speaker (about diversity and inclusion in toxicology, focusing on opportunities for underrepresented populations), and a career coach (about building skill sets for career exploration challenges).

Materials:
Recording

NorCal SOT 2021 Spring Webinar Series #3 Nonclinical Safety Development of a mRNA-Based COVID-19 Vaccine, BNT162b2, during the Pandemic

Speaker:
Jason Pinkstaff, PhD, DABT, Biologics Expert, Regulatory Toxicology, Drug Safety Research and Development, Pfizer Inc.

Overview:
After its identification in 2019, there was an urgent need for a prophylactic vaccine to address the increasing number of outbreaks worldwide of Severe Acute Respiratory Syndrome (SARS)-CoV-2 infections and its associated disease, Coronavirus Disease 2019 (COVID-19). BNT162b2 is a lipid nanoparticle (LNP)–encapsulated nucleoside-modified mRNA vaccine, which encodes the full-length SARS-CoV-2 Spike protein, developed to prevent COVID-19. BNT162b2 nonclinical safety was evaluated in three GLP-compliant studies, two repeat-dose toxicity studies, and a developmental and reproductive toxicity (DART) study, which were submitted to health authorities in a rolling fashion to allow for rapid clinical trial initiation and ultimately emergency use authorization or conditional approval.

This presentation will review the nonclinical safety profile that supported two IM administrations of 30 μg RNA/dose BNT162b2 in the clinic and ultimately to the general public under emergency use authorization or conditional approval.

NorCal SOT 2021 Spring Webinar Series #2
Inhalation Toxicology: Wildfire Exposure, Risk, Mitigation, and Impact

Human Health Risk Due to Wildfire Smoke Exposure

Speaker:
Keita Ebisu, PhD, Research Scientist, Office of Environmental Health Hazard Assessment, California Environmental Protection Agency

Overview:
Wildfire smoke can impose a direct impact on human health. Fine particulate matter (PM2.5) is one of the toxic pollutants emitted from wildfire. Under the future climate change scenario, people will be exposed to wildfire smoke more frequently and intensely in California, and it is critical to reveal potential health impacts from exposure to PM2.5 from wildfire. We investigated the relationship between PM2.5 and morbidity during the October 2017 Northern California wildfires. We found that PM2.5 during the fire was more strongly associated with emergency department visits for asthma compared with the non-fire period. We also found some associations between PM2.5 exposure during the wildfire and other respiratory-related health outcomes.

Wildfire Smoke Exposure Mitigation: The Science Behind Strategies to Protect You and Your Kids

Speaker:
Stephanie Holm, MD, MPH, Public Health Medical Officer, Children’s Environmental Health Center, Office of Environmental Health Hazard Assessment, California Environmental Protection Agency, and Co-Director, Western States Pediatric Environmental Health Specialty Unit

Overview:
Children are particularly vulnerable to wildfire smoke, and as a result, toxicologists and anyone who does clinical, research, or public health work relevant to children should consider the issues around how to mitigate exposures. Low-cost tools for assessing particulate matter exposure are available, but understanding their limitations is critical. Improving indoor air quality is key to decreasing exposure, and there are known health benefits to improving indoor air quality. This talk will review some of the data on low-cost tools as well as on indoor air quality interventions for protection from wildfire smoke exposure.

Impact of Wildfire Smoke Exposure across the Life Span: Lessons Learned from a Nonhuman Primate Cohort

Speaker:
Lisa Miller, PhD, Professor, University of California Davis

Overview:
The objectives of our study were to determine the long-term health impact of neonatal wildfire smoke exposure and assess whether adverse health effects from wildfire smoke exposure may be transmitted to offspring. To complete our objectives, we investigated a cohort of California National Primate Research Center (CNPRC) outdoor-housed female rhesus monkeys that were born within three months prior to the Trinity and Humboldt County wildfires of June/July 2008. We conducted a nonterminal and minimally invasive study in eight-year-old adult female monkeys born in the spring of 2008 and exposed to wildfire smoke PM2.5 as infants. As an experimental control for the effects of wildfire smoke PM2.5, we compared our findings in eight-year-old adult female monkeys that were born in the spring of 2009 and not exposed to wildfire smoke PM2.5 as infants. Our primary assessments for long-term health impacts of early-life wildfire smoke PM2.5 included (1) evaluation of the peripheral blood response to microbial ligands (n=30 per group) and (2) conduction of high-resolution computerized tomography (CT) (n=14 per group). We also determined if offspring from wildfire smoke PM2.5–exposed female monkeys showed evidence of immune dysregulation relative to offspring from control female monkeys. When compared with control adult monkeys, peripheral blood cells from wildfire smoke PM2.5–exposed adult monkeys showed altered cytokine synthesis when cultured with microbial ligands, as well as evidence of lung remodeling in CT scans. Offspring of wildfire smoke PM2.5–exposed adult monkeys displayed significant differences in immune profiles relative to offspring of control adult monkeys. We conclude that early-life exposure to wildfire smoke PM2.5 can result in immune and lung function decrements that persist with maturity and show evidence of multigenerational transmission of immune dysregulation as a result of maternal exposure.

Translational Biology Considerations for Deposition of Aerosols in the Respiratory Tract: Factors Influencing Pharmaceutical and Environmental Research and Pharmaceutical R&D

Speaker:
Matthew Reed, PhD, President, CoelusBio

Overview:
Aerosols are defined as “a suspension of fine solid particles or liquid droplets in air.” (Hinds, William. Aerosol Technology: Properties, Behavior, and Measurement of Airborne Particles, 2nd Edition) And air is the conduit for the respiratory tract’s interface with environmental and pharmaceutical aerosols. As toxicologists, we base human risk assessment and risk management with hazard identification, exposure assessment, dose-response, and human observation. Therefore, by default, these tenets are applied to the air we breathe in our daily lives and in the workplace, as well as to the treatment of disease. This discussion will cover the principles used to determine aerosol “dose” in humans and the translational systems and species we use in pharmacology and toxicology. Case examples will be used to investigate the similarities and differences applied to the study of aerosols and human health across disciplines.

NorCal SOT 2021 Webinar Series: Safety Assessment in Nonhuman Primates: Does Animal Origin Matter?

Speaker:
Gerhard F. Weinbauer, Covance Preclinical Services GmbH, Muenster, Germany

Overview:
Many new medical drugs such as biotherapeutics target highly human-specific factors and pathways and, therefore, often require the use of nonhuman primate (NHP) models as relevant species. Whilst the number of NHPs used per drug development program has decreased due to scientific advances and implementation of the 3Rs principle, past years have seen an overall increase of NHP model use in drug development since current drug development moves from protein targets to nucleic acid-based targets associated with more selectivity for human targets. The far predominant NHP model is the long-tailed macaque (cynomolgus monkey, Macaca fascicularis) being provided largely from Asia mainland (e.g. Cambodia, China, Vietnam) and islands such as Mauritius. The increased demand combined with export bans and transport restriction have led to considerable shortage of animal supply raising questions whether animal origin matters for the purpose of safety assessment of new medications. This presentation provides an overview of genetic diversity in cynomolgus monkeys and compares safety parameters and endpoints in animals of different origins. In general, it appears that origin could matter for island-derived animals much less so mainland-derived animals.

Materials:
Webinar Recording

NorCal SOT 2020 Webinar Series: QSAR Approaches in Toxicology for PMIs

Speaker:
Alejandra Trejo-Martin, BSc, MBA, Gilead

Overview of Acute Toxicity, Its Use in Classification and Labelling (C&L), the 3Rs and the Objective of Project

Speaker:
Jean Lord, PhD, Genentech

Overview of In Silico Models for Acute Toxicity Prediction and Study Design

Speaker:
Glenn Myatt, PhD, Leadscope (an Instem company)

Results, the Important of Expert Review, How to Perform an Expert Review

Speaker:
Catrin Hasselgren, PhD, Genentech

How to Incorporate In Silico Assessments into the C&L Workflow and Concluding Remarks

Speaker:
Melissa Masuda-Herrera, PhD, Gilead

Utility of Digital Pathology and Image Analysis in Nonclinical Drug Development and an Introduction into Machine Learning

Speakers:
Famke Aeffner, DVM, PhD, DACVP, Principal Pathologist; Amgen Inc, Amgen Research, Translational Safety and Bioanalytical Sciences, South San Francisco, CA, USA; and Vanessa Schumacher, DVM, MS, DABT, DACVP, Head of Digital Pathology and Tissue Technologies; Pharma Research and Early Development, Roche Innovation Center Basel, Basel, Switzerland

Materials:
Webinar Recording

Using Publicly Available Resources for Identifying and Characterizing Chemicals of Potential Toxicity Concern: Proof-of-Concept with Chemicals That Affect Cancer Pathways

Speaker:
Shoba S. Iyer, PhD, Office of Environmental Health Hazard Assessment, Safer Alternatives Assessment and Biomonitoring Section

Biology Dictates Model Validity: A Case Study with Sulfuryl Fluoride

Speaker:
Daisy Dong, PhD, California Environmental Protection Agency, Department of Pesticide Regulation, Risk Assessment Section

The Hematopoietic System: Therapeutics, Toxic Responses, and Strategies for 21st Century

Venue:
South San Francisco Conference Center, San Francisco, California

Materials:
Agenda
Brian Cathers Presentation
John Leighton Presentation
Nancy Everds Presentation
Kathleen Meyer Presentation

Venue:
South San Francisco Conference Center, San Francisco, California

Venue:
Tir Na Nog Irish Bar and Grill

Venue:
Tir Na Nog Irish Bar and Grill

A New Hope: Nonclinical Challenges in the Burgeoning Field of Gene Therapy

Venue:
South San Francisco Conference Center, San Francisco, California

Materials:
Agenda

Immuno-Oncology: Opportunities, Therapeutic Approaches, and Safety Considerations

Venue:
South San Francisco Conference Center, San Francisco, California

Materials:
Agenda
Keith Bahjat Presentation
Allyson Byrd Presentation
Sanjay Sethi Presentation
Greg Bannish Presentation
Henry Li Presentation
Herve Lebrec Presentation

Venue:
Zinc Bistro & Bar

The 3R’s

Venue:
South San Francisco Conference Center, San Francisco, California

Materials:
Agenda
Clive Roper Presentation
Lisa Wong Presentation
Gertrude-Emilia Costin Presentation
Shaun D. McCullough Presentation
Glenn J. Myatt Presentation

Combination Therapy: Fundamentals, Advances, and Case Studies

Our eight speakers provided seminars on topics related to development of combination therapeutics for small and large molecules (peptides, proteins, antibodies). General topics include toxicology/regulatory considerations, pharmacokinetic/pharmacodynamic, immunogenicity, bioanalytical chemistry, manufacturing, and production. This one-day event was held on May 16, 2017 from 7:30 am to 5:30 pm at the South San Francisco Conference Center located at 255 South Airport Boulevard, South San Francisco, CA 94080.

Venue:
South San Francisco Conference Center, San Francisco, California

Materials:
Agenda
Joe Francisco Presentation
Jessica Hawes Presentation
Phil Gatti Presentation

Venue:
Tir Na Nog Irish Bar and Grill

A diverse and interesting agenda has been prepared for this meeting. The scientific themes for this meeting will be “Infectious Diseases” and “Cardiovascular Safety Pharmacology.” In addition to the scientific program there will also be a Mentoring Luncheon open to interested Mentors and Mentees as well as a poster session. Please see the meeting agenda for further details.

Venue:
South San Francisco Conference Center, San Francisco, California

Materials:
Agenda

Join NSF and PharmaEd for our seminar, “Managing the Risks of Leachables from Pharmaceutical Manufacturing Equipment—A Blueprint for Success” April 20, San Diego, California. Pharmaceutical companies understand that a leachables risk assessment of the components in their manufacturing trains must be performed; however, it is unclear as to what factors should be considered and what role the vendors of equipment should take in this assessment. This training course will describe a practical, materials-based approach to manage risk that has worked in meeting the US FDA’s expectations for equipment evaluations.

Venue:
San Diego, California

We have an exciting line up covering diverse topics including latest advances in ADCs, epigenetics, reprotox, and genetox (agenda below). In addition, we would like to introduce our graduate and postdoctoral achievement award winners who will share their research.

Venue:
SRI International, Menlo Park, California

Materials:
Agenda

A Tail of Two Fields: Reproductive & Juvenile Toxicity, and Public Health & Risk Assessment The afternoon session will be a tribute to the late Dr. George Alexeeff and his legacy at Cal/EPA. Dr. Alexeeff was the Director of OEHHA at CalEP and a Past President of NorCal SOT.

Venue:
South San Francisco Conference Center

Materials:
Agenda

The Bay area toxicology discussion group is looking forward to our next get-together on September 2, 2015. The discussion topic will focus on post translational modifications for monoclonal antibodies. Basically, what types of modification are observed during development, which have biological/DMPK ramifications, and what preclinical strategies are pragmatic in managing these CMC issues Kathila Rajapaksa from Genentech will give a short (10–15 minute) introduction and then help lead the discussion. This presentation will set the basics for a Q&A session to follow.

Venue:
Chalet Ticino, Foster City, California

Preclinical Drug Development, Bio-Threats and Biomarkers of Toxicity

• Rebecca Abergel, PhD, Chair of Radioactive Drug Research Committee, Lawrence Berkeley National Laboratory: Development of New Therapeutics for Radionuclide Decorporations: From Discovery to IND
• Tracy Goldstein, PhD, Associate Director and Professor, UC Davis, One Health Institute: Using a One Health Approach to Reduce Pandemic Risk and Promote Global Health: PREDICT, A Project of USAID’s Emerging Threats Program
• Serguei Liachenko, MD, PhD, US FDA: Preclinical Development of Neurotoxicity Biomarkers Using MRI
• Jon Mirsalis, PhD, DABT, Managing Director of Biosciences, SRI International: Biomarkers of Cardiac Toxicity
• Gene Garrard Olinger Jr., PhD, MBA, Principal Advisor Science, MRI Global Inc: Development of Passive Immunity for Ebola Virus Infections Through Convergence of Science & Technology: Mice, Primates and Plants
• Frances Shaffo, recipient of the NorCal SOT Graduate Student Achievement Award: Effects of Organophosphorus Pesticides (OPs) on Airway Physiology
• Fenna Sillé, recipient of the NorCal SOT Postdoctoral Fellow Achievement Award: Arsenic and Innate Immunity: Macrophage Function Upon Arsenic Exposure

Venue:
South San Francisco Convention Center, South San Francisco, California

Materials:
Agenda
Speaker Flyer

NorCal SOT will be holding another Science Day event in partnership with Berkeley Undergraduate Toxicology Association (ToxSa) and Peninsula Girl Scout on Saturday April 25, 2015. We are in need of volunteers to serve as expert toxicologists addressing parents and students questions during the day and supporting the ToxSa student when needed. We need total of 4–6 volunteers.

Venue:
LGI Room, Audubon Elementary School, 841 Gull Avenue, Foster City, California 94404

Venue:
SJSU Boccardo Business Complex (BBC) 0032 Conference Rm

Venue:
Yard House, 1023 4th Avenue, San Diego, CA 92101

Venue:
Sudwerk Restaurant & Brewery, 2001 2nd Street, Davis, CA 95618

The discussion topic will focus on formulation and is primarily directed toward toxicologists in the drug development field to understand the formulation process, and to understand how it would affect preclinical safety evaluations. We will begin with a 10–15 minutes presentation from Novartis talking about the formulation support at each R&D step from lead optimization to phase I. Topics to be covered include: Once a lead molecule is identified for further development, what do the formulation folks do? How do they start? What are the important concepts? This presentation will set the basics, and then we will have a Q&A session.

Venue:
Chalet Ticino, 1058-C Shell Boulevard, Foster City, CA 94404 (in Charter Square Center)

Venue:
Genentech Building 42, South San Francisco

Materials:
Agenda

Topics:
In vitro safety profiling of drugs and chemicals, neurotoxicology, neuroelectrophysiology, screening for drug abuse liability, current topics in therapeutic proteins, and more!

Venue:
David Brower Center, 2150 Allston Way, Berkeley, CA

Materials:
Agenda

The Careers in Toxicology Event will be held at UC Davis! The chapter will host the event featuring a panel discussion with professionals with government, academic, or industry careers. Panelists discuss their jobs, their path in gaining their position with students, answering questions and concerns about careers in toxicology. There will be a networking event following the panel discussion to allow for further discussion and mentorship. If you would like to attend as a panelist, mentor or student please contact Sandra Chang.

We are planning another K–12 education event in collaboration with Berkeley Toxicology Student Association (ToxSA) and Girl Scouts. This event will be catered to 6th–8th grade students. The event will be held at Audubon Middle school in Foster City, California. We are looking for toxicology volunteers to help with various activities. This is a fun event and last year not only the students but also the volunteers enjoyed it. If you are interested in volunteering for this event please contact Toufan Parman.

Venue:
Arrogant Butcher, 2 E Jefferson St, Ste 150, Phoenix AZ 85004

Venue:
Sapore Italiano, 1447 Burlingame Ave, Burlingame, CA 94010

ADME and Its Role in Toxicology

• Mitochondrial Toxicity of Nucleoside Analogs: Joy Feng, PhD, Sr. Scientist, Gilead Sciences
• Role of Metabolism in Respiratory Toxicity: Alan Buckpitt PhD, Professor Molecular Biosciences, UC Davis
• Role of Ceruloplasmin in Mn Distribution and Toxicity: Donald Smith PhD, Professor Physical and Biological Sciences, UC Santa Cruz
• Chemoproteomic and Metabolomic Strategies for Drug Discovery and Toxicology: Keynote Speaker, Daniel Nomura PhD, Assistant Professor Nutritional Sciences and Toxicology, UC Berkeley
• Transporters in Metabolism and Toxicity: Joseph Ware PhD, Sr. Scientist, Genentech, Inc.
• How Drugs Get into the Brain & Assessment of Brain Levels: Carol Green PhD DABT, Senior Director, Toxicology and Pharmacokinetics, SRI International

Venue:
South San Francisco Convention Center, 225 South Airport Blvd, South San Francisco, California

Venue:
Sudwerk, 2001 2nd Street, Davis, CA 95618

After three popular events in 2012, we are organizing another dinner for those involved in pharmaceutical research and development. The idea, as before, is to get to know others in our field and to learn from each other.

Venue:
Sapore Italiano, 1447 Burlingame Ave, Burlingame, CA 94010

Venue:
South San Francisco Convention Center, 225 South Airport Blvd, South San Francisco

• Network with fellow scientists from around the Bay Area
• Learn about toxicology career opportunities and/or share what path you took to your career
• Practice your ‘elevator speech’
• Enjoy delicious drinks and appetizers

Venue:
Pyramid Alehouse, 901 Gilman St., Berkeley, California 94710

Materials:
Agenda

Safety Considerations in Developing Drugs for Epigenetic Targets

Agenda:

• Arrival, networking, appetizers will be served
• Presentation: Jatinder Singh, Sr. Scientist, Safety Assessment, Genentech, Inc.
• Dinner with group discussion of hypothetical case study and questions
• Open discussion, conclusion, departure

Venue:
Genentech, Building 83, conference room 1A

New Frontiers in Oncology Drug Development:
Developing Antibody Drug Conjugates (ADCs), Epigenetics, cancer and micro RNAs, and more!

Materials:
Dr. Safe: The Function of MicroRNAs in Cancer and Their Potential as Drug Targets
Dr. Rafael Ponce: Immunomodulation and Cancer: Different Relationships Across Diseases and Disease States?
Dr. Howard Miabach: Tox Lessons Learned—Four Decades of FDA Dermatology Drug Withdrawals
Dr. Shawver: Applications of Genomic Profiling for Real Time Decisions in Cancer Treatment (keynote speaker)
Dr. Holash: Preclinical Strategies to Help Better Identify Responder Populations in the Clinic
Dr. Schutten: Modes of Toxicity of Antibody Drug Conjugates
Dr. Gelzleichter: Evaluation of Carcinogenic Risk for Biotechnology-Derived Therapeutics

Topics:
Path Forward with the Revised ICH-S2 Genetox Guidelines
Endocrine Modulators in the Environment and Medicine
New Perspectives in Antibody Drug Development
NorCal SOT ‘25th Anniversary’ Reception

Venue:
SRI International Conference Facility, Menlo Park

Biosimilars

Speaker:
Thomas Gelzleichter, Genentech

Venue:
Elan Pharmaceuticals, South San Francisco, California

This one-day event will feature morning presentations on stem cells followed by an on-site networking lunch. The afternoon presentations will cover current topics in toxicology, and the day will conclude with a wine and reception.

Venue:
SRI International Conference Facilities, Menlo Park, California

This one-day event will feature morning presentations on stem cells followed by an on-site networking lunch. The afternoon presentations will cover current topics in toxicology, and the day will conclude with a wine and reception.

Venue:
Berkeley City Club, 2315 Durant Avenue, Berkeley, CA 94704-1606

Sponsors:
BASi, Battelle, BioReliance, ChanTest, Charles River Laboratories, Covance, Genentech, MPI Research, SRI, WIL Research Laboratories

Materials:
Agenda

Venue:
District ChopHouse & Brewery

NorCal SOT hosted an outreach workshop at UC Davis January 20, 2011. The workshop, “Toxicology Related Career Options,” gave students the opportunity to learn from, and interact with, professionals in toxicology-related careers. With 79 students and 16 toxicology professionals in attendance the event was a great success!

Northern California SOT will be hosting a Fall Symposium on “Advances in Predictive and Investigative Toxicology” on November 4, 2010, at Genentech. Our guest speakers from U.S. EPA, academics, and pharm/biotech industry will share the latest information in the field of investigative toxicology. Please view the attached meeting flyer containing the program, presentation abstracts and speaker biographical sketches. Pre-registration is highly recommended for security reason. It is a one-day meeting. Like always, we will have some fun networking with our colleagues and learn something new.

Materials:
Agenda
Applying NMR- and LC/MS-Based Metabolite Profiling to Predictive and Investigative Toxicology
From Decriptive to Predictive Environmental Toxicology at the US EPA
Investivative and Predictive Approaches to Drug-Induced Steroid Hormone Perturbation
Multi-Hit Models of Neurotoxicity: Implications for Understanding Disease and Improving Risk Assessment

NorCal SOT is starting a “Career Building Social” program. This program is meant to extend our education outreach efforts, connecting students/postdocs and young scientists with veteran toxicologists.

Please join us for the first Career Building brunch on Saturday, October 30. We hope that the brunch will be filled with friendly, interesting people with which to network. The brunch will be held in an upstairs private room at Acqua Pazza in San Mateo. The food is reasonably priced and very good.

The agenda is loosely structured, providing an informal venue where students, young professionals and more seasoned toxicologists can get together to share experiences. We hope this format will facilitate relationship building that will foster more meaningful associations for both those seeking advice and those willing to share their experience.

Best regards,
Jeff Tepper (Program Coordinator) Vice President-Elect, NorCal SOT

Materials:
Information

NorCal SOT will be hosting a Spring Meeting on Drug Development: From Small Molecules to Biologics on Thursday, May 6, 2010, at SRI International (333 Ravenswood Avenue, Menlo Park, CA 94025).

Registration is $25 for NorCal SOT members, $35 for nonmembers and FREE for students/postdocs. Students are encouraged to bring posters documenting their research and will receive $50 for doing so. Students may have their posters printed by contacting Steve Dizio. All attendees will have the opportunity to participate in a Lunch with an Expert program. The meeting is generously sponsored by BioReliance, Corp., California Department of Toxic Substances Control, ChanTest Corp., Charles River Laboratories, Comparative Biosciences, Covance, Genentech, ITR Laboratories, Inc., LAB Research, Inc., MPI Research Inc., Novartis, and SRI International.

Materials:
Agenda
Introduction
Case Files of the U.S. FDA— How Not to Develop a Cancer Drug William David McGuinn Jr, MS, PhD, DABT, US FDA
Nonclinical Evaluation of Oral Antiviral Agents Grushenka H. I. Wolfgang, PhD, DABT, Gilead
Toxicological Considerations for Oligonucleotide Therapeutics Page Bouchard, DVM, DACVP, Novartis
US FDA and Nanotechnology for Medical Products Richard A. Canady, PhD, DABT, McKenna Long & Aldridge, LLP
Assessment of Genotoxic Impurities in Small Molecule Drug Candidates John A. Wisler, PhD, DABT, Amgen
Safety Evaluation of Antibody Drug Conjugates Kirsten Achilles-Poon, BS, Genentech
Incorporation of Fertility Endpoints in Non-Human Primate Chronic Toxicology Studies for Monoclonal Antibodies Anu Vaidyanathan, PhD, DABT, Genentech