Funmilayo O. Ajayi, PhD, FIST, FCP
Annesway Group, LLC
Funmi was a National Research Council Resident Research Fellow at Walter Reed Army Institute of Research prior to a 10-year tenure at the Center for Drug Evaluation and Research (CDER), FDA and 14 years with Procter & Gamble (P&G). Her areas of interest include biopharmaceutics, pharmacokinetics, pharmacodynamics and drug safety. As Clinical Pharmacology & Biopharmaceutics Team Leader for the Division of Special Pathogens and Immunologic Drug Products, Funmi led regulatory review of applications for anti-infective, special pathogens & immunologic drug products and, was heavily involved in the development of regulatory guidance documents. She was 2-term chair of FDA CDER’s Committee for Advanced Scientific Education (CASE). Funmi’s P&G career and responsibilities spanned an array of assignments as a leader in the Global Clinical & Quantitative Sciences Organization including strategic planning for clinical work for multiple business sectors in addition to leading the Global Safety Surveillance & Analysis and, the Global Clinical Governance & Compliance Organizations.
Funmi is a Fellow of the London Institute of Science Technology and a Fellow of the American College of Clinical Pharmacology where she served as chair of the Honors and Awards Committee and, Strategic Visions Committee, as well as member of the 2006 and 2012 Annual Program Committees. In addition, Funmi is a long-term reviewer for the Journal of Clinical Pharmacology. As a founding member of the Nigerian Association of Pharmacists & Pharmaceutical Scientists in the Americas, she served as Secretary for 7 years and was President of the organization for 2 years. As adjunct professor, College of Pharmacy, University of Cincinnati, Funmi teaches a graduate program in drug development. She was Secretary and past Chair of Indiana/Ohio Discussion Group of the Association of American Pharmaceutical Scientists. Funmi is a member of the FDA Alumni Association International Network and, member of the Board of Directors of the United Way of Warren County, Ohio.
Over the years, Funmi received several awards and recognition including CDER Director’s Special Citation; FDA Outstanding Service Award; Outstanding Contribution Award, FDA Alumni Association; CDER CASE 25th Anniversary Celebration Special Recognition Award; P&G Sharon Mitchell Glass Breaking Award; and P&G Community Beacon Award.
Lewis M. Fredane, MD
Clinical Vice President of Neurology,
Clinical Assistant Professor, Department of Neurology,
Drexel University College of Medicine
Lew is a neurologist with more than 30 years of clinical and research experience. He received his medical degree from the Albert Einstein College of Medicine, and later completed a clinical fellowship in transplantation/immunology at St. Luke’s-Roosevelt Hospital Center in New York and training in immunology at Yale University School of Medicine under a research fellowship from the National MS Society.
As a board certified neurologist, Lew also served as a clinical assistant professor of neurology at the Drexel University College of Medicine in Philadelphia, PA. During his years in practice, Frankford Hospital (now Aria) appointed him Chairperson of the Ethics Committee. In the pharmaceutical/biotech industry, he functioned in a series of roles in drug development and medical affairs, including roles at contract research organization Omnicare Clinical Research (now Theorem/Chiltern), Meda Pharmaceuticals, and Sanofi/Genzyme.
There are 7 now marketed products which he worked on development/launch, especially Aubagio (teriflunomide, second oral agent for multiple sclerosis). In medical affairs roles (including pharmacovigilance/safety, medical communications, medical information, and life cycle management) he supported multiple products including, but not limited to, such well-known brands as Felbatol (felbamate – epilepsy), Ambien (zolpidem – sleep) and Rilutek (riluzole – ALS). As a team leader, team member, or subject matter expert he has functioned in many therapeutic areas including general neurology, neuromuscular/neurodegenerative disease, epilepsy, sleep, pain management, immunology (allergy, immune-mediated disease, and translational medicine), and neuroimmunology (especially MS).
Deborah Lee, MD, PhD
AlaWai Neurology Consulting, LLC
Scott Treiber, PhD MBA
Executive Vice President, Biopharmaceutical Development & General Manager,
Scott is an experienced clinical development professional with over 24 years of increasing responsibility in the biopharmaceutical and device industry. His expertise includes clinical operations, medical affairs, data management/statistics, pharmacovigilance/safety and medical writing. He has a strong background in CNS development but has also worked extensively in oncology/hematology, pain, cardiovascular, renal, anti-infectives and respiratory.
Scott received his BA from the University of Iowa, his PhD from the University of California, Santa Cruz and his MBA from Ellis College (NYIT).