 |
|
Events Upcoming Events NorCal SOT 2021 Spring Webinar Series #3 June 23, 2021, 12:00 Noon–1:00 PM (PT) 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. Past Events Webinar Series NorCal SOT 2021 Spring Webinar Series #2 May 21, 2021, 12:00 Noon–2:00 PM (PT) Human Health Risk Due to Wildfire Smoke Exposure Presenter: 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 Presenter: 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 Presenter: 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 Presenter: 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. Webinar Series NorCal SOT 2021 Webinar Series April 21, 2021—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. Webinar Series 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
October 15, 2020 Utility of Digital Pathology and Image Analysis in Nonclinical Drug Development and an Introduction into Machine Learning Speakers: Webinar Series September 10, 2020 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 Northern California 2019 Fall Symposium October 24, 2019 Venue: South San Francisco Conference Center, San Francisco, California “The Hematopoietic System: Therapeutics, Toxic Responses, and Strategies for 21st Century” Preliminary Agenda Brian Cathers | John Leighton | Nancy Everds | Kathleen Meyer Northern California 2019 Spring Symposium April 25, 2019 Venue: South San Francisco Conference Center, San Francisco, California NorCal SOT Annual Reception at the 58th SOT Annual Meeting Tuesday, March 12, 2019 Venue: Tir Na Nog Irish Bar and Grill NorCal SOT Career Panel Monday, February 25, 2019 from 6:00–8:00 pm Venue: Berkeley Way West Building, Rm 5101 (Address: 2121 Berkeley Way) Northern California 2018 Fall Symposium October 25, 2018 Venue: South San Francisco Conference Center, San Francisco, California "A New Hope: Nonclinical Challenges in the Burgeoning Field of Gene Therapy" Northern California 2018 Spring Symposium April 27, 2018 Venue: South San Francisco Conference Center, San Francisco, California “Immuno-Oncology: Opportunities, Therapeutic Approaches, and Safety Considerations” Presentations NorCal SOT Annual Reception at the 57th SOT Annual Meeting Our Reception this year was held on Tuesday, March 13, 2018 Northern California 2017 Fall Symposium September 28, 2017—South San Francisco Conference Center, San Francisco, California “The 3R’s” Fall Symposium Presentations: Clive Roper | Lisa Wong | Gertrude-Emilia Costin | Shaun D. McCullough | Glenn J. Myatt Northern California 2017 Spring Symposium Tuesday, May 16, 2017—South San Francisco Conference Center “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. Spring Symposium Presentations: Joe Francisco | Jessica Hawes | Phil Gatti NorCal SOT Reception at the 56th SOT Annual Meeting Our Reception this year was held on Tuesday, March 14, 2017 Northern California 2016 Fall Symposium Tuesday, October 18, 2016—South San Francisco Convention Center, South San Francisco, California 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. Managing the Risks of Leachables from Pharmaceutical Manufacturing Equipment—A Blueprint for Success April 20, 2016—San Diego, California 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. Northern California 2016 Spring Symposium Tuesday, April 26, 2016—SRI International, Menlo Park, 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. NorCal 2015 Fall Symposium
Thursday, October 22, 2015—South San Francisco Conference Center 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. NorCal SOT Preclinical Drug Safety Networking Dinner—It’s a mAb, mAb, mAb World
September 2, 2015—Chalet Ticino, Foster City, California 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. NorCal SOT Spring Symposium April 23, 2015—South San Francisco Convention Center, South San Francisco, California Preliminary Program: “Preclinical Drug Development, Bio-Threats and Biomarkers of Toxicity”
Additional Activities:
K–12 Event April 25, 2015 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. The event will be held at the following location: LGI Room, Audubon Elementary School, 841 Gull Avenue, Foster City, California 94404 This is a fun event that has become a tradition for NorCal and we look forward to your participation. If you are interested to volunteer, please email Toufan Parman. Special Joint SJSU MBT - SOT Seminar April 2, 2015, 7:00 PM–9:00 PM Venue: SJSU Boccardo Business Complex (BBC) 0032 Conference Rm NorCal Reception at the SOT Meeting in San Diego Tuesday, March 24, 2015, 7:30 PM–9:30 PM Venue: Yard House, 1023 4th Avenue, San Diego, CA 92101 NorCal SOT Speed Mentoring Thursday, January 15, 2015, 6:00 PM–9:00 PM Venue: Sudwerk Restaurant & Brewery, 2001 2nd Street, Davis, CA 95618 NorCal SOT Preclinical Drug Safety Networking Dinner Thursday, December 4, 2014 Venue: Chalet Ticino, 1058-C Shell Boulevard, Foster City, CA 94404 (in Charter Square Center) NorCal SOT Preclinical Drug Safety Networking Dinner There’s no Formula to Formulation Where: Chalet Ticino Address: 1058-C Shell Boulevard, Foster City, CA 94404 (in Charter Square Center) Date: Thursday, December 4 Time: 6:15 PM The Bay area toxicology discussion group is looking forward to our next get-together on December 4, 2014. We will start the evening with network time with wine and appetizers. Please select one of the three menu choices below when you register for this 3-course dinner that includes: salad or soup, entry, and then choice of sorbet or ice cream:
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. Northern California Regional Chapter Fall Symposium October 21, 2014, 8:30 AM–5:00 PM Venue: Genentech Building 42, South San Francisco Symposium Agenda, Speaker Bios, and Abstract Information Northern California Regional Chapter Spring Symposium April 29, 2014, 8:30 AM–5:00 PM Venue: David Brower Center, 2150 Allston Way, Berkeley, CA Topics: In vitro safety profiling of drugs and chemicals, neurotoxicology, neuroelectrophysiology, screening for drug abuse liability, current topics in therapeutic proteins, and more! UC Davis Careers in Toxicology Event April 2, 2014, 4:00 PM–8:00 PM 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. K–12 Event April 6, 2014, 1:00 PM–6:00 PM 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. NorCal SOT Reception—2014 Annual Meeting, Phoenix, Arizonia. Date: Tuesday, March 25 NorCal SOT Preclinical Drug Safety Networking Dinner Wednesday, December 4, 2013 Sapore Italiano NorCal 2013 Fall Symposium Thursday, October 24, 2013 South San Francisco Convention Center “ADME and Its Role in Toxicology”
Speed Mentoring Tuesday, October 1, 2013 Sudwerk NorCal SOT Preclinical Drug Safety Networking Dinner—Open Forum 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. Tuesday, July 23, 2013 Sapore Italiano NorCal 2013 Spring Symposium Tuesday, April 23, 2013 South San Francisco Convention Center The NorCal Society of Toxicology Presents: Speed Mentoring Wednesday, January 30, 2013 Pyramid Alehouse
NorCal SOT Networking Dinner Title: Safety Considerations in Developing Drugs for Epigenetic Targets Agenda: 6:00 PM–6:20 PM: Arrival, networking, appetizers will be served 6:20 PM–6:50 PM: Presentation: Jatinder Singh, Sr. Scientist, Safety Assessment, Genentech, Inc. 6:50 PM–7:30 PM: Dinner with group discussion of hypothetical case study and questions 7:30 PM–8:00 PM: Open discussion, conclusion, departure NorCal Fall 2012 Symposium “New Frontiers in Oncology Drug Development” Topics: Developing Antibody Drug Conjugates (ADCs), Epigenetics, cancer and micro RNAs, and more! Date: September 27, 8:30 AM–5:00 PM Meeting Presentations
NorCal SOT ‘25th Anniversary’ Spring Symposium Topics: When: April 19 , 8:45 AM–6:00 PM (lunch provided with registration) Where: SRI International Conference Facility, Menlo Park Registration deadline: April 16 (end of day) NorCal Biopharma Preclinical Drug Safety Networking Dinner Tuesday, April 3, 2012 Location: Elan Pharmaceuticals, South San Francisco, California Speaker: Thomas Gelzleichter, Genentech NorCal SOT 2011 Fall Meeting Thursday, October 6, 2011 SRI International Conference Facilities 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. NorCal SOT Spring Symposium Wednesday, April 13, 2011 Berkeley City Club Sponsors: BASi NorCal SOT Reception—2011 Annual Meeting, Washington, D.C. All Annual Meeting attendees from Northern California are cordially invited to attend the NorCal SOT reception. Date: Monday, March 7 Career Workshop at UC Davis 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! 2010 Fall Meeting 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. Meeting Presentations
Career Social Brunch 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. More Information
Best regards, Jeff Tepper (Program Coordinator) Vice President-Elect, NorCal SOT 2010 Spring Meeting 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. View the meeting flyer containing the program, sponsors, presentation abstracts and speaker biographical sketches Spring Meeting Presentations
|
