The drug development landscape has witnessed a broadening of targets and indications, the emergence of promising new classes of therapeutics, but also an evolving regulatory framework. This symposium will present current and novel drug safety testing approaches and the underlying regulatory toxicology strategies. The sessions cover the full spectrum from early discovery to late stage investigations and across a wide range of portfolios but all focused on non-clinical drug safety testing. From de-risking panels to regulatory filing and from clinical hold lifting approaches to case studies, this symposium will engage dynamic yet pragmatic discussion on real-life drug safety testing challenges!
09:30 am – 10:00 am : Welcome coffee
10:00 am – 10:15 am : Introduction by Simon Authier, Senior Director of Scientific Operations and Veterinary Science / Deputy Chief Scientific Officer at Citoxlab
10:15 am – 11:00 am : Dana Minnick, PhD, DABT, RAC, RHO, INC : ”Bench to Clinic: Preparing for a Successful Translation”
11:00 am – 11:45 am : Aron Stein, PhD, Sutro Vax : ”Regulatory Strategies: lessons learned”
12:00 pm – 01:00 pm : Lunch
01:00 pm – 01:45 pm : Denis Roy, PhD, SciLucent : ”Nonclinical Development Regulatory Strategies: Common Issues and Pitfalls with Abbreviated Programs”
01:45 pm – 02:30 pm : Yusheng Qu, PhD, Amgen: ”Action Potential Recording and Pro-arrhythmia Risk Analysis in Human Ventricular Trabeculae”
02:30 pm – 02:45 pm : Break
02:45 pm – 03:30 pm : Ron Steigerwalt, Ph.D., DABT, Takeda : ”Carcinogenicity Study Planning and Timing”
03:30 pm – 04:15 pm : Lindsay Donald, DABT, Intertek : ”Points to Consider In Developing Antibody-Drug-Conjugates (ADC’s)’
04:30 pm – 06:00 pm : Cocktails
Please note that this complimentary event is by invitation only, and includes lunch, refreshment breaks and afternoon cocktails
Dana Minnick, PhD, DABT, RAC, RHO, INC : ”Bench to Clinic: Preparing for a Successful Translation”.
Dr Dana Minnick, DABT, RAC, is a toxicologist and regulatory affairs professional with 20 years’ experience supporting drug and biologics programs throughout the development lifecycle in both the pharmaceutical and CRO industry. In her role as a regulatory affairs professional, Dana provides regulatory consulting including strategy, preparation for FDA meetings, and regulatory filings. She has led several multidisciplinary project teams through successful NDAs/BLAs to marketing authorization. Dana is particularly experienced in regulatory strategy and development of therapeutics for rare diseases. She has demonstrated capabilities in multidisciplinary product development including identifying gaps and defining drug development strategies to support clinical trials and regulatory filings. In addition to general regulatory knowledge and strategy, she has led drug development programs from concept through marketing authorization and beyond. Her early development phase support has resulted in many successful FDA pre-IND meetings and IND filings. Dana is also board certified toxicologist with specific expertise in nonclinical safety assessment. Prior to joining RHO, Dana was a Drug Development Program Manager at RTI International. In this role, she led the regulatory affairs teams for the NIH NHLBI Science Moving towArds Translation and Therapy (SMARTT) program providing extensive drug development consulting and advice to over 30 investigators, including pre-IND meetings, IND filings, Orphan Drug Designations. Dana was also an integral regulatory and nonclinical team member for the Global Alliance for Tuberculosis where she provided regulatory and nonclinical expertise. Dana has helped many clients prepare for FDA meetings including strategic formulation of questions and content for FDA input, review of preliminary comments and attendance and moderation of meetings. Prior to RTI International, Dana provided nonclinical and regulatory expertise as a consultant at Aclairo Pharmaceutical Development Group, and formerly worked as a toxicologist at Viamet Pharmaceuticals, a Project Manager at Calvert Research, and a research investigator and toxicologist at GlaxoSmithKline. Dana has worked in several therapeutic areas and has particular expertise in metabolic diseases, cardiovascular, hematology, respiratory, oncology and antimicrobials. She earned a doctorate in toxicology from Case Western Reserve University and was a postdoctoral IRTA Fellow at NIEHS. She is a Diplomate of the American College of Toxicology and has maintained certification in Regulatory Affairs (RAPS) since 2008.
Lindsay Donald, DABT, Intertek : ”Points to Consider In Developing Antibody-Drug-Conjugates (ADC’s)”.
Lindsay Donald has over 35 years of drug development experience which has included working with contract research organizations, pharmaceutical and biotechnology companies. He has been an American Board Certified Toxicologist for over 25 years and has worked in a variety of therapeutic areas including anti-inflammatory, anti-infective, oncology, gastro-intestinal disorders and numerous biological products such as thrombolytics, cytokines, and growth factors. For the last 18 years he has worked as a consultant in drug development both independently and more recently as Vice President, Pharmaceuticals & Healthcare for Intertek. Lindsay is intimately involved with the strategic planning, design and implementation of drug development programs for clients. Nonclinical and clinical safety data in support of regulatory filings are critically evaluated and he represents clients with various international regulatory agencies including the Food & Drug Administration, Health Canada and the European Medicines Agency.
Denis Roy, PhD, SciLucent : ”Nonclinical Development Regulatory Strategies: Common Issues and Pitfalls with Abbreviated Programs”.
Denis Roy is a Director of SciLucent who leads the Nonclinical Safety and Development practice, which provides strategic scientific, outsourcing, and regulatory expertise to support international development of a wide variety of healthcare products. In addition to internal management and oversight responsibilities, he provides senior strategic consulting services in nonclinical pharmaceutical development and regulatory toxicology testing strategies for pharmaceuticals, biologics, medical devices, and specialized/combination products for a broad range of therapeutic areas. He has a track record for successfully assisting clients in the development and implementation of integrated international regulatory strategies and addressing issues encountered during product development plans including clinical holds, with both national and international agencies. He has participated in the preparation of numerous pre-meeting packages, INDs, CTAs, and premarketing and marketing submissions in multiple countries. Denis has designed and/or conducted several hundreds of nonclinical safety studies, in a wide variety of laboratory species, using common and specialized routes of administration, including inhalation, intravitreal, intrathecal, and special delivery devices/product combinations. In addition, Denis has direct experience in animal surgeries, clinical pathology, GLP compliance, and GLP laboratory management. His broad technical and scientific expertise enables him to provide real-time and hands-on support for the design, outsourcing, conduct and reporting of a wide variety of nonclinical studies including specialty in developmental and reproductive and inhalation toxicology. He has published book chapters on carcinogenicity testing, nonclinical development of oncology drugs, and biologics development strategies. Denis has a Ph.D. in Physiology-Endocrinology, an M.Sc. in Experimental Medicine, and a B.Sc. in Biology from Laval University, Québec, Canada.
Yusheng Qu, PhD, Amgen: ”Action Potential Recording and Pro-arrhythmia Risk Analysis in Human Ventricular Trabeculae”.
Dr Yusheng Qu got her Bachelor of Science in the Department of Biology of the Peking University in China. Later on Dr Qu got her Ph.D. in the Department of Pharmacology of the Duke University in North Carolina. Her postdoctoral training was in the Laboratory of William A. Catterall at University of Washington, Seattle. Dr Qu joined Amgen in 2001, her current position is Principal Scientist, Integrated Discovery and Safety Pharmacology. She is responsible for cardiovascular safety assessment using a variety of in-vitro and ex-vivo assays, including ion channel, isolated myocytes (tissues) and isolated heart assays.
Ron Steigerwalt, Ph.D., DABT, Takeda: ”Carcinogenicity Study Planning and Timing”.
Ron Steigerwalt is currently a Research Fellow in Drug Safety Evaluation at Takeda California in San Diego. He received his Ph.D. degree in Endocrinology from the University of California in San Francisco and did postdoctoral work at Columbia University in New York and at the NIEHS in North Carolina. He entered the field of Toxicology as an FDA pharmacology reviewer and Supervisory Pharmacologist for the Division of Metabolic and Endocrine Drug Products for 7 years. He then moved on to positions as an Industry toxicologist and has 17 years pharmaceutical industry experience as a toxicologist at Chiron, Genentech, Amylin, Amgen and Takeda.
Aron Stein , Ph.D., Sutro Vax : ”Regulatory Strategies: lessons learned”.
Aron has 30 years of product development experience in pharmaceutical and biotechnology having responsibility for multiple drug approvals in both large and small companies. Prior to starting at SutroVax, Dr. Stein was the Vice President of Regulatory Affairs of Bavarian Nordic, a public Danish-based vaccine company developing viral-vector vaccines for use in infectious disease and immune-oncology. While at Bavarian, Dr. Stein established the global regulatory function in the US and EU, successfully negotiation with Health Authorities on the registration requirements for IMVAMUNE, a smallpox vaccine and for PROSTVAC, an immunotherapy for prostate cancer, and the commissioning of a new manufacturing suite. Prior to Bavarian Nordic, Dr. Stein has served in Vice President roles in Regulatory Affairs and Quality Assurance at Ionis Pharmaceuticals (formerly Isis), Abbott Laboratories, and Sequus Pharmaceuticals. Prior to that, he was the director of Regulatory Affairs at Pfizer Pharmaceuticals and a manager of Regulatory Affairs with DuPont-Merck Pharmaceuticals. Aron joined DuPont as a toxicologist in 1986. Strategic FDA initiatives involved partnering with FDA to develop CDER Guidance and reintroduction of marketed products (ABBOKINASE®). Project specific regulatory strategies have led to rapid registration for multiple drug products including DOXIL®, VIAGRA®, TIKOSYN®, and supplements for DIFLUCAN®, ZOLOFT®, and ZITHROMAX®. Aron earned his B.S. and PhD at Texas A&M University and was a NIEHS postdoctoral fellow at University of Kansas Medical Center. Outside of SutroVax, Aron enjoys gardening and travel with his wife.
Simon Authier, DVM, MBA, PhD, DSP, Citoxlab
Dr. Authier obtained a doctor in veterinary medicine degree from the University of Montreal and specialized in non-clinical studies after completing a Ph.D in preclinical pharmacology. He then completed a MBA in corporate finances and management. Over the past years, Dr. Authier investigated methodologies in non-clinical regulatory safety pharmacology studies with the objective of improving study designs for optimal sensitivity and decision making in this field. Dr. Authier overviews the work of a team of scientists and veterinarians specialized preclinical research for IND, BLA and NDA filing with a focus on pharmacology. He participated in face-to-face FDA pre-IND meetings and overviewed conduct of preclinical studies for a number of small and large molecules over the last 15 years working at Citoxlab North America. He was an invited speaker at various scientific conferences including the Food and Drug Administration (FDA), NIAID, the Safety Pharmacology Society, American College of Toxicologists, Japanese Society of Safety Pharmacology and the American Association of Laboratory Animal Science to name a few. Dr. Authier is Associate Professor at University of Montreal, Canada where he is involved with clinical immunology and pharmacology and he has authored more than 70 peer reviewed articles and book chapters. To date, Dr. Authier has provided scientific overview for more than 800 preclinical studies.
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