February 23, 2012
Managing the Transition from Nonclinical to Early Clinical Development
Many biopharmaceutical companies are focusing on the transition from nonclinical to clinical drug development. Our February 23rd roundtable, Managing the Transition from Nonclinical to Early Clinical Development, will explore strategies behind this transition, such as risk mitigation, and will include a presentation on the results of a recently conducted Tufts CSDD study on nonclinical and early clinical activities and speed-to-clinic practices.
Roundtables are held at the Tufts CSDD offices at 75 Kneeland Street, Suite 1100, Boston, from 10 a.m. to 4 p.m. To join us at the February 23rd roundtable and for more information on membership, please visit the Tufts CSDD Executive Forum page or contact Stella Stergiopoulos.
- DOWNLOAD the roundtable Agenda.
SPEAKERS
Jan-Olav Henck, CSO, Aptuit
Presentation Topic: Managing the Transition from Non-Clinical to Clinical Development
After obtaining his PhD from the Institute of Pharmacognosy, Innsbruck University in 1996 he was an Alexander von Humboldt Foundation postdoctoral fellow (Feodor Lynen Program) with Prof. Joel Bernstein at the Ben-Gurion University of the Negev in Israel. In 1999 he joined Bayer HealthCare in Leverkusen (Germany) where he established a laboratory for the analysis of polymorphism of drug substance in pharmaceutical formulations and compatibility studies. Since 2002 he was a group leader of the services group in the product development division at Bayer HealthCare in Leverkusen dealing with solid-state properties of drug substances in pharmaceutical formulation, applied vibrational spectroscopy, and material sciences. In 2005 he moved to the United States to take over the position as a Research Director in Analytical Research with SSCI in West Lafayette. In 2006 he became a Senior Director at SSCI (now Aptuit) heading the Chemistry group. This group mainly deals with polymorphism studies, cocrystal and salt screening as well as amorphous screens and computational studies on drug substances. In 2009 Jan-Olav was appointed the Site Director for SSCI, a division of Aptuit in West Lafayette, IN. In addition he was appointed Adjunct Professor at Purdue University, Department of Industrial and Physical Pharmacy. In October 2011 Jan-Olav took on the role as Chief Science Officer for Aptuit.
Agnès Lavergne, Clinical Sciences Leader, Aptuit
Presentation Topic: Managing the Transition from Non-Clinical to Clinical Development
Dr. Agnès Lavergne is the Clinical Sciences Leader at Aptuit Verona and previously was the director of discovery Medicine at the Neurosciences Center of Excellence for Drug Discovery at GlaxoSmithKlein. Since 2007 she has specialized in designing and implementing FTIH, phase I studies where she ensure the optimal use of innovative experimental and translational medicine to maximize the drug product quality. Prior to 2007, Dr. Lavergne was employed by Servier where she contributed to three patents supporting new clinical indications along with dossier preparation for EMA registration of an NCE with a new MoA.
She received her PhD in Neuropharmacology from the Université Paris 6 Pierre et Marie Curie (UMPC), her PharmD from Université Paris 11 – Paris Sud, and has participated in numerous conferences as a speaker in addition to having published peer-reviewed articles on safety and efficacy.
Laszlo Urban, Global Head, Preclinical Safety Profiling, Novartis Institute for Biomedical Research
Presentation Topic: Early Safety Risk Assessment, Risk Mitigation and Management
Laszlo Urban is Global Head of Preclinical Safety Profiling at the Novartis Institutes for Biomedical Research (NIBR), Cambridge, Ma, and previously was the Deputy Head of the Novartis Institute for Medical Sciences in London, UK, an internationally recognized center of excellence for pain research.
He received his MD and PhD in neuropharmacology from Debrecen University, Hungary. He has published over 130 articles, book chapters and patents, edited 3 books and has served on the editorial board of several journals while also serving as President of the European Neuropeptide Club.
Since 2001, he has been leading a pharmaceutical research department developing methods and strategy for in vitro preclinical safety assessment.
Alan M. Hoberman, PhD, DABT, Fellow ATS, Executive Director, Global Scientific Advisor
Presentation Topic: Planning for Potential Reproductive, Developmental and Juvenile Toxicity When Screening Candidate Compounds
Dr. Hoberman has been employed by Charles River Laboratories, Preclinical Services, Pennsylvania (formerly Argus Research Laboratories, Inc.) since 1981, serving as Director of Reproductive Toxicology, Director of Research and currently as Executive Director, and Global Scientific Advisor. Prior to joining Argus Research, Dr. Hoberman was the Head of Reproductive Toxicology at Hazleton Laboratories in Vienna, Virginia. He received his BS in Biology from Drexel University, and was a graduate student in Anatomy at the University of Virginia before moving to Arkansas and completing a MS in Interdisciplinary Toxicology from the University of Arkansas and a Ph.D. in Toxicology from Pacific Western University. He is a Diplomat of the American Board of Toxicology and a Fellow of the Academy of Toxicological Sciences, with over 77 publications and book chapters. He is the co-editor of a book on Pediatric Toxicology to be published in January 2012.
Dr. Hoberman has been a member of the Teratology Society since 1978. He has also been on the council of the European Teratology Society and is Past President of the Reproductive and Developmental Toxicity Specialty Section of the Society of Toxicology of the Middle Atlantic Reproductive and Teratology Association, as well as a member of the Arkansas Biotechnology Organization. He is the Editor of the Journal of Toxicology and Industrial Health and serves on the editorial board of the International Journal of Toxicology. Dr. Hoberman is also the Secretary/Treasurer and a Board Member of the Pennsylvania Society for Biomedical Research.
Vivek Kadambi, PhD
Vice President, Drug Safety Evaluation and Director, Analytical Development and Formulation Science
Millennium: The Takeda Oncology Company
Dr. Vic (Vivek) Kadambi, is the head and Vice President of Drug Safety Evaluation (DSE) within the Non-Clinical Development Sciences organization of Millennium, The Takeda Oncology Company. Dr. Kadambi has a B.S. and a M.S. in Microbiology from the University of Bombay and a Ph.D. in Cardiovascular Pharmacology and Physiology from the University of Cincinnati. Dr. Kadambi was the recipient of the American Heart Association Fellowship, Ohio Affiliate (1997-1998) as well as the Young Investigator Award from the Heart Failure Society of America (1998). In addition, he was awarded the Outstanding Contributor Award from Millennium Pharmaceuticals Inc (2001 and 2004). Dr. Kadambi has served as the Program Chair for pharmacology and toxicology related symposia and was a councilor for the New England Society of Toxicology (2004-2005). Vic is an executive member of the Preclinical Safety Leadership Group as part of the International Consortium for Innovation and Quality in Pharmaceutical Development, on the advisory board of the Predictive Safety Testing Consortium (PSTC). He is a founder and steering committee member of the Boston Area Pharm/Tox group. Vic has built strong relationships with key thought leaders and regulatory experts within oncology safety testing. He has a strong publication record and he has presented both nationally and internationally at meetings, with a clear focus on the safety testing of oncology therapeutics.
Raymond D. Skwierczynski, PhD
Senior Director of Analytical Development
Millennium: The Takeda Oncology Company
Raymond D. Skwierczynski, PhD is Senior Director of Analytical Development at Millennium: The Takeda Oncology Company, where he is responsible for analytical development of small-molecule drug substances and drug products from pre-IND to commercialization. He is also leader of the CMC team for ixazomib citrate, an oral proteasome inhibitor that is about to enter pivotal clinical trials. Previously, he led Oral Formulation Development and Preformulation at Millennium and was responsible for leading an initiative for optimizing nonclinical development from discovery transition to proof-of concept.
He has previously worked in parenterals development in Baxter Healthcare (1984-87), materials characterization at Hoffmann-LaRoche (1994-96), and the Pharmaceutics and Analytical R&D Departments at 3M Pharmaceuticals (1996-2003). Dr. Skwierczynski received B.S. degrees in chemistry and mathematics from the University of Wisconsin – Eau Claire (1984) and M.S. (1989) and Ph.D. (1992) degrees in pharmaceutics from the University of Wisconsin – Madison. He received postdoctoral training in physical organic chemistry at UW-Madison as a PhRMA Foundation Fellow. He teaches courses on preformulation and stabilization of pharmaceuticals at the University of Minnesota, where he is Adjunct Associate Professor in the Pharmaceutics Department, and through the University of Wisconsin Extension Services in Pharmacy. In addition, he serves on the USP Expert Committee General Chapters – Dosage Forms, the Steering Committee for the AAPS Nonclinical Dose Formulation Analysis Focus Group, and the Executive Board for the Yankee Clipper Council, Boy Scouts of America.
Stella Stergiopoulos, Project Manager, Tufts CSDD
Presentation Topic: Nonclinical Process Variation and Speed Practices
Ms. Stella Stergiopoulos manages multi-sponsored and grant funded research projects at Tufts CSDD. She has experience conducting research on pharmaceutical industry practices and trends affecting pharmaceutical outsourcing practices, cycle time metrics, resource management, and protocol complexity. She has also been a speaker at conferences and has published articles in trade journals. Prior to joining Tufts CSDD, Ms. Stergiopoulos was a research associate at The Brattle Group and a researcher at Massachusetts General Hospital. She holds a B.A. from Brandeis University.