”21st Century Trends in Drug Development: Probing New Regulatory Angles”
CiToxLAB team is pleased to invite you to its 2017 Symposium!
As conventional drug development paradigms have shown their limits with falling approval rates, a rich variety of innovative strategies has emerged over the last decade, addressing a call for change across the full drug development continuum. From next generation therapeutic products to advanced regulatory strategies or high translational value experimental models, this symposium will showcase new angles that were applied to progress remarkable therapeutic portfolios. Beyond strategies and products, the real success factor in today’s drug development landscape is the people that lead these novel programs. We are proud to present an agenda with exceptional leaders in action, sharing their inspiring perspectives and advice on tomorrow’s path to drug approval.
When : September 13, 2017
Where : DoubleTree Suites by Hilton Boston Hotel in Cambridge, MA.
Registration: Response is due by e-mail (email@example.com) to CiToxLAB before August 31.
Preliminary agenda and speakers:
- Michael R. Bleavins, PhD, DABT, White Crow Innovation, LLC: ”Integrating Biomarkers into GLP Studies: Advantages, Challenges, and Considerations”.
Dr Michael Bleavins is the founder of White Crow Innovation, LLC, a Michigan-based drug development consulting company. He provides options, strategy, and GLP/GCP support to biotechnology companies. Mike has extensive experience in nonclinical and clinical testing to support non-traditional regulatory filings, and the bridging of mechanistic findings from animals to humans. Mike is a Diplomat of the American Board of Toxicology. He is also a member of the Society of Toxicology, American College of Toxicology, and Roundtable of Toxicology Consultants. Mike is Adjunct Professor in Environmental Health Sciences (University of Michigan School of Public Health) and lectures in the University’s Toxicology program and Translational Pharmacology series. He also serves as Adjunct Professor in Pharmaceutical Sciences at Wayne State University (Detroit). Mike joined Warner-Lambert/Parke-Davis in 1987 as Research Scientist and retired from Pfizer in 2006 as Executive Director in World Wide Safety Sciences. Mike was responsible for nonclinical and clinical laboratory operations including biomarkers, clinical pathology, cell biology, molecular biology, immunotoxicology, translational medicine, live-cell imaging, genetic toxicology, investigative pathology, histology, pharmacogenomics, metabonomics, and biochemistry, where he has more than 65 publications in these areas. Following his retirement from Pfizer, Mike founded Michigan Technology and Research Institute with Drs Felix de la Iglesia and Elizabeth Garofalo. Upon the return of Dr. Garofalo to large pharma, and retirement of Dr. de la Iglesia, in April 2012, Mike developed White Crow Innovation into a full-time consulting company. He now consults for a number of Boston area biotechnology companies on drug development and integration of biomarkers into clinical trials. Mike holds a dual PhD in Environmental Toxicology and Animal Science from Michigan State University, with postdoctoral fellowships at the University of Wisconsin-Madison and General Motors Biomedical Sciences Laboratories.
- Nicholas Clayton, MSc, Sanofi Genzyme : ”Development of Sargramostim under the FDA Animal Rule”.
Nicholas Clayton is a Program Leader for Rare Diseases at Sanofi Genzyme, and a member of the Radiation Research Society. Nick joined Genzyme in 2003, and in 2015, he became the R&D Program Lead for the development of Leukine for H-ARS. Nick has had many roles at Sanofi Genzyme, including managing early stage R&D programs focused on Rare Diseases and Transplant Immunology, and was Chair of the Sanofi North America IACUC. Before joining Genzyme, Nick was a scientist at Millennium Pharmaceuticals. He received his MSc in Pharmacology from the Massachusetts College of Pharmacy and his BS from the University of New England.
- William Fodor, PhD, Cell Therapy Group : ”The Importance of Appropriate Nonclinical Animal Modeling for Developing Cell and Tissue based Therapies”
Dr William (Bill) Fodor has over 25 years of research, management, training and consulting experience in academia and the biotechnology industry and was a founding scientist at Alexion Pharmaceuticals. His experience spans many biologic systems with an emphasis on novel Advance Tissue Medical Product development for the healthcare industry. Bill received his PhD in Molecular genetics from the Ohio State University, and received post-doctoral training in the Laboratory of Dr Richard Flavell, first at Biogen and then at the Yale University School of Medicine.
- Jennifer Lockridge, PhD, Dicerna Pharmaceuticals : ”Nonclinical Strategies for Oligonucleotide Development Programs”.
Dr Jennifer Lockridge is VP of Program Development at Dicerna Pharmaceuticals and has twenty years of experience in the development of oligonucleotide therapeutics. She currently oversees development programs at Dicerna including nonclinical studies. Prior to joining Dicerna, Jennifer spent nine years consulting with multiple biotech and large pharmaceutical companies providing direction and support for early development stage oligonucleotide programs as well as pharmacology and pharmacokinetics expertise. From 1996 to 2007, she was employed at Sirna Therapeutics, Inc. (formerly Ribozyme Pharmaceuticals, Inc.) as Director of Project Management at Sirna, where she managed and was involved with all aspects of siRNA and ribozyme development programs. Jennifer received her PhD in pharmacology at the Oregon Health Sciences University, Portland, Oregon and pursued post-doctoral training at the FDA’s National Center for Toxicological Research, Jefferson, Arkansas.
- Dana Minnick, PhD, DABT, RAC, RHO, INC : ”Preparing for Your Pre-IND meeting and IND: Regulatory Pathways for a Successful Drug Development”.
Dr Dana Minnick, DABT, RAC, Regulatory Scientist, is a toxicologist and regulatory affairs professional with 16 years’ experience supporting drug and biologics programs throughout the development lifecycle in both the pharmaceutical and CRO industry. Dana has demonstrated capabilities in identifying gaps and defining drug development strategies with specific expertise in nonclinical safety assessment and regulatory affairs to support proposed clinical trials and enable successful regulatory filings. Her experience in early phase drug development has resulted in many successful FDA pre-IND meetings and IND filings. Dana is also experienced in excipient and impurity qualification and preparation of position papers for FDA submissions. Prior to joining Rho, Dana was a Drug Development Program Manager at RTI International where she led the regulatory affairs team for the NIH NHLBI Science Moving towArds Translation and Therapy (SMARTT) program. In this role, Dana provided extensive drug development consulting and advice to over 30 investigators, leading to 8 pre-IND meetings, 3 successful IND filings and 3 Orphan Drug Designations. Dana was also an integral regulatory and nonclinical team member for the Global Alliance for Tuberculosis where she managed two nonclinical programs, participated in several FDA meetings, IND submissions, IND annual reports and Investigator Brochure updates. Dana also participated as a toxicologist, regulatory affairs member and Steering Committee member for a USAID program evaluating the use of a long-acting injectable therapeutic for HIV-1 prevention. 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 environmental health sciences/toxicology from Case Western Reserve University in 1992 and continued her genetic toxicology studies as an IRTA Fellow at NIEHS. She is a Diplomate of the American College of Toxicology and has maintained certification in Regulatory Affairs (RAPS) since 2008.
- David Nguyen, PhD, Sage: “Developing Translatable EEG/ERP Biomarkers for Proof of Mechanism in the Clinic”.
Dr David Nguyen has over fifteen years of experience developing and applying novel signal processing algorithms to electrophysiological data in the nonclinical and clinical domains. In addition, he has over ten years of hands-on experience performing detailed single neuron recordings in awake-behaving animals. After a postdoctoral fellowship at the National Institute on Aging in Baltimore, David joined Pfizer World Research and Development, Cambridge, where he applied his knowledge to PK/PD modeling and translational strategy. He is now a Principal Scientist at Sage Therapeutics, where he continues to apply signal processing and electrophysiological techniques to characterize and understand pharmacodynamics, neuromodulation, and translation into the clinic. David received his education from Boston University, Georgia Tech and MIT, with focused training in the areas of adaptive signal processing, systems neurobiology, and electrophysiology.
- Kenneth J. Olivier Jr., PhD, Torque Therapeutics : ”TGF beta and the Juvenile bone”.
Dr Ken Olivier is the Head of Nonclinical Development at Acceleron Pharmaceuticals in Cambridge, MA. He has worked for over 15 years in Biotechnology and Pharmaceutical companies, including Regeneron Pharmaceuticals, Biogen, GlaxoSmithKline and Merrimack Pharmaceuticals developing diagnostics, small molecules and biologics for indications in cardiology, neurology, immunology, infectious disease, muscular dystrophy, anemia and oncology. His publications include evaluations of toxicity related to novel therapeutics in immunology and oncology, such as interferons, bispecific antibodies and targeted liposomal nanotherapies. Most recently, he has published a book on discovery, development and commercialization of antibody-drug conjugates. Ken has chaired/co-chaired/presented symposia annually over the past 13 years, covering topics such as safety pharmacology, stem cells, computational modeling, antibody-drug conjugates, statistics and the art of clinical dose level selection. He has participated on the Editorial Board for the International Journal of Toxicology since 2013 and was elected Councilor for the American College of Toxicology (ACT) in 2014. Ken has pledged to continue his support of the program and promise for excellence in safety assessment and risk management in the improvement of the quality of life for all patients. Ken obtained a BS in Toxicology from the University of Louisiana at Monroe and a PhD in Veterinary Biomedical Sciences from Oklahoma State University.
- Graham Wood, PhD, Altasciences Clinical Research : ”First-in-Human Phase I Clinical Trials with Centrally Acting Drugs”.
Dr Graham Wood joined Altasciences Clinical Research as Executive Vice President, Phase I Clinical Development in 2015. In his role, Graham works directly with clients on their clinical development programs, and provides strategies to further enhance the array of specialty Phase I study areas offered by Altasciences. Graham also leads the global Project Management team to ensure the successful completion of studies and efficient management of multi-site Phase I to Phase IIa programs. Ken started his career at Phoenix International Life Sciences in 1999 as a Project Manager focused on Phase I studies. In 2006, Graham accepted a position at Allied Research to help build their innovator Phase I business. After the acquisition of Allied Research by Cetero Research, Graham became President of the Toronto and Miami operations (Phase I to Phase IV studies). In this role, he successfully led six FDA and a Health Canada audit. In 2012, he became the CEO of Manna Research, a late stage investigator site. Under his leadership, Manna became the largest network of primary care sites in Canada and was sold to LMC Research in 2015. Throughout his career, Graham has helped sponsors bring over 30 compounds from Phase I to IIa, as well as worked on over 400 Phase I studies. Graham has a PhD. in Neurology and Neurosurgery from McGill University.
Response is due by e-mail (firstname.lastname@example.org) to CiToxLAB before August 31.
Registration includes lunch, refreshment breaks and afternoon cocktails.
Please feel free to call us at CiToxLAB (450-973-2240 ext 2206) with any questions.