The complexity of cell and gene therapies, combined with limited regulatory precedent, makes these treatments especially challenging to develop. With the right partner, there’s no need to reinvent the wheel.
At our complimentary 2-day seminar, you’ll learn from cell and gene therapy experts from discovery through efficacy and safety studies as they discuss specialized delivery, testing and considerations for building a program tailored to your therapy. Meet our multidisciplinary team of early discovery through preclinical scientific, regulatory, and therapeutic area specialists, and discover how we can help you design and execute a robust, efficient program that delivers the data authorities require.
Tuesday February 9, 2021 | Cell Therapy Focused
Moderated by Carina Peritore
|14:00 – 14:15 GMT||Considerations for Program Development | Shawna Jackman|
|14:15 – 14:45||Biologics Testing for Cellular Therapy (Starting material to product pre-manufacturing) | Steve Miklasz & Dominic Clarke|
|14:45 – 15:15||In Vitro Pharmacology and Safety for CAR-T IND-Enabling Studies | Sanne Holt|
|15:15 – 15:30||Break|
|15:30 – 16:00||Diving into Cell Therapy Programs: Practical Considerations | Simon Authier|
|16:00 – 16:30||Cellular Therapy Regulatory Development | Shawna Jackman|
Wednesday February 10, 2021 | Gene Therapy Focused
Moderated by Keith Sutton
|14:00 – 14:15 GMT||Considerations for Program Development | Keith Sutton|
|14:15 – 14:45||Bioanalysis and Biodistribution for Gene Therapies | Philippe Ancian|
|14:45 – 15:15||Gene Therapy Delivery: From Rodents to NHPs | Gunnar Flik|
|15:15 – 15:30||Break|
|15:30 – 16:00||Gene Therapy and Preclinical Studies: Utility and Examples of In Situ Hybridization and Immunohistochemistry Assays | Frederic Gervais|
|16:00 – 16:30||Analytical Challenges for Preclinical and Clinical | Philippe Ancian|
|16:30 – 17:00||Challenges Associated with the Development of nAb Assays in Support of Gene Therapies Using Adenovirus Vectors; Mitigating the Impact of Pre-Existing Antibodies | Marie-Eve Poupart|
Senior Veterinary Pathologist
Frederic Gervais is a senior veterinary pathologist, ECVP diplomate and has been working at Charles River Laboratories Evreux for more than 16 years now. He started as a bench pathologist involved in the evaluation of GLP and non-GLP Tox studies with a wide range of compounds. Since 2011, Frederic has been in charge of developing and expanding molecular pathology techniques including immunohistochemistry and in situ hybridization assays. Those techniques are especially useful in the context of gene therapy studies.
Senior Principal Research Scientist, Safety
Shawna Jackman is the Senior Principal Research Scientist at our Shrewsbury, MA site. She is a subject matter expert for regulatory-enabling cell and gene therapy programs, including assessments in specialty models and immunocompromised rodents. Dr. Jackman provides scientific oversight for specialty biologics and other toxicology programs, and is involved in client and regulatory discussions regarding study design, execution and data interpretation. Dr. Jackman received her Bachelor’s degree in molecular biology from Lehigh University before earning her PhD in genetic toxicology from West Virginia University. She is also the preclinical lead for our involvement in the California Institute for Regenerative Medicine (CIRM) Translational Center. Dr. Jackman is a diplomat of the American Board of Toxicology and is an active member of the Society of Toxicology, American Society for Gene and Cell Therapy, and International Society for Stem Cell Research.
Advanced Therapy and Key Account Development Director
Steven Miklasz is the Advanced Therapy and Key Account Development Director for Charles River Biologics Testing Solutions Division. As a subject matter expert for CMC for biologics and cell and gene therapy products. Mr. Miklasz guides and supports clients with solutions from our cGMP portfolio services. Having held scientific and commercial positions in both academia and industry, he is author of several patents and publications related to monoclonal antibody technology.
Global Head of Cell Therapy, HemaCare, A Charles River Company
Dr. Dominic Clarke is currently the Global Head of Cell Therapy at HemaCare, a leading provider of source material for clinical development and commercial manufacturing of cell-based therapies. He previously worked at Charter Medical and BioLife Solutions. Dominic has a PhD in cellular and molecular biology from Binghamton University and did post-doctoral work in cell and developmental biology at State University of New York Upstate Medical University. He is the current co-chair for the International Society for Cell and Gene Therapies Process and Product Development Committee.
Dr. Sanne Holt is the Group Leader at our site in Leiden, The Netherlands. Her research focuses on efficacy and toxicity testing of novel drug therapies in human primary cell-based models. She previously worked as an investigator within the Cell and Gene Therapy Unit for GlaxoSmithKline, where she focused on the translational and safety aspects of T cell therapies. Dr. Holt holds an MRes and PhD in medical and molecular genetics from King’s College London.
Senior Director of Scientific Operations and Veterinary Science
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 assessment 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. 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 19 years working at Charles River. Dr. Authier is Associate Professor at University of Montreal, Canada where he is involved with clinical immunology and pharmacology and he has authored +100 peer reviewed articles and book chapters on preclinical models. To date, Dr. Authier has provided scientific overview for more than 1100 non-clinical studies covering a broad range of therapeutic indications and molecule classes.
Keith is a scientific advisor at our site in Edinburgh, UK. He has over 20 years of experience working in the fields of molecular biology, physiology, and immunology. Dr. Sutton also has a broad experience with cell and gene therapies and designing PK and PD assessments for cell and gene therapies, mAbs, and ASOs. He has worked in commercial and academic environments across the UK, USA, and Australia.
Dr. Ancian has spent the last 20 years in the pharma, biotech and CRO industries where he has implemented and monitored biomarker analyses at the discovery, preclinical and clinical stages with expertise in specialized genomics and proteomics platforms. He holds a PhD in molecular and cellular biology from Nice University as well as an engineering degree in chemistry from the National School of Chemistry of Montpellier, France. Philippe is passionate about advanced therapies, in particular cell and gene therapies.
Site Director, Discovery
Gunnar Flik joined Charles River in 2017 as part of the acquisition of the Brains On-Line group and is currently Site Director of the Charles River Site in Groningen. Prior to joining Charles River Gunnar worked as a pharmacist for three years, during which he also established Brains On-Line as an organization that supported universities and pharmaceutical companies with CNS research assays. As a serial entrepreneur Gunnar was involved in setting up multiple companies in the field of contract research, drug development, and diagnostics. After earning his Master of Science in neuropharmacology at University of Groningen, he went on to earn Doctor of Pharmacy from the school’s Faculty of Pharmacy. Gunnar has co-authored 23 peer reviewed articles.
Senior Research Scientist, Immunology
Marie-Eve Poupart, MSc is a senior research scientist in the immunology group at the Charles River in Senneville, Canada. She joined Charles River in 2008, where she currently works in the immunogenicity group. Her domain of expertise is the assessment of drug safety using cell- based neutralizing antibody assays. She earned her BSc in biochemistry and a Master of Science in pharmacology from the University of Montreal. She is an active member of the AAPS NAb validation testing and reporting harmonization group.