Dr. Bhoopathy received his Bachelors in Pharmacy from Kakatiya University in 1996 and a PhD in pharmaceutical sciences from Virginia Commonwealth University in 2001. He is the Chief Operating Officer of Absorption Systems and in this capacity, directs the convergence of the commercial, technical, and scientific aspects of the company to execute its strategic and tactical growth plans.
Absorption Systems is a world leader in BCS based biowaivers for oral products and in developing bio exemption strategies for locally applied and locally acting complex drug products. The focus of this company is to maximize the translational synergies of various non-clinical models. Using this multi-platform approach, Dr. Bhoopathy has led efforts to successfully classify and bio-waive over 50 drug substances for both the branded and generic drug companies. This accrued experience with a variety of drug substances has resulted in him being an expert in several discussion groups and regulatory forums regarding the conduct and predictability of these non-clinical tools. He is currently applying this knowledge to accelerate and extend equivalence assurance to other classes of complex drug products.
Dr. Bhoopathy has held leadership positions at the AAPS and is the Chair of the Generic Pharmaceuticals Focus Group. He has been honored as an Emerging Leader by Pennsylvania Bio; in 2013, recognized as a 40 under Forty, Most Talented Young Leader by the Philadelphia Business Journal for leadership, vision and commitment to the life sciences industry; and in 2017, Dr. Bhoopathy was selected as a winner of the 2017 Executive Management Award for his creative management vision and innovative strategies.
Dr. Eric Uffman completed his Ph.D. and postdoctoral work at Washington University in St. Louis. He then joined what is now EAG Laboratories in 2005 and since then he has directed hundreds of Reverse Engineering studies and, for the last 5 years, focused exclusively on pharmaceutical systems having performed Q1/Q2 studies on over 160 RLD systems.
Dr. Mansoor A. Khan has served US FDA for over 11 years as the Director of Product Quality Research and a Senior Biomedical Research Scientist (SBRS) at CDER , He led research teams on biotech products and small molecules, chemistry and stability, drug delivery systems and bioavailability/bioequivalence, and chemistry reviews of new and generic drugs for several complicated products. In Sept of 2015, he joined Texas A&M University as Professor and Vice Dean at Texas A&M Health Science Center College of Pharmacy in their College Station Campus. He also serves as the Interim Head of the Department of Pharmaceutical Sciences. Prior to joining FDA in 2004, Dr. Khan was a Professor of Pharmaceutics and Director of Graduate Program in the School of Pharmacy at Texas Tech University Health Science. He is a registered pharmacist, and earned his Ph.D. degree in Industrial Pharmacy from the St. John’s University School of Pharmacy in 1992. He has published over 295 peer-reviewed manuscripts, five texts including “Pharmaceutical and Clinical Calculations” and “Quality by Design for Biopharmaceutical Drug Product Development,” 25 book chapters, 250 poster presentations, and more than 250 invited presentations world-wide. Dr. Khan’s research focus is primarily in the area of formulations design and development, and biopharmaceutics. He led the FDA new drug review team that approved the first 3D product on Aug 3, 2015.
Dr. Khan has held several leadership positions at the AAPS including elected chair of pharmaceutics and drug delivery (PDD) and the founding chair of formulations design and development (FDD). He serves on the editorial board of Pharmaceutical Technology, International Journal of Pharmaceutics, AAPSPharmsciTech, and the Drug Delivery and Translational Research. He has received FDA/CDER 2015 outstanding ANDA reviews award, over ten FDA/CDER Team Excellence Awards, FDA/CDER Scientific Achievement Award, and FDA/CDER Exemplary Performance Awards, outstanding alumni award from St. Johns University, College of Phamacy, Excellence Award from Texas A&M University Health Science Center. He received the 2012 AAPS Research Achievement Award in Formulations Design and Development. He is also an AAPS and AAiPS Fellow.
Dr. Sam Raney is a thought leader in topical and transdermal drug products, with over 25 years of experience as an academic researcher, an adjunct professor, and a principal or sub investigator on over 400 studies. He has authored numerous research manuscripts, review articles, book chapters and patents related to pharmaceutical product development, lectured globally, and held senior management roles in industry. He is the Lead for Topical and Transdermal Drug Products in the FDA Office of Generic Drugs, and is an expert panel member in the U.S. Pharmacopeia. Dr. Raney holds a B.A. in Molecular Biophysics & Biochemistry from Yale University, and a Ph.D. in Biochemistry & Molecular Biology from the University of British Columbia in Canada.
Dr. Priyanka Ghosh is a pharmacologist within the Office of Research and Standards, Office of Generic Drugs. In her current role, Dr. Ghosh is responsible for research and regulatory (product-specific guidances for generic drug development, controlled correspondences, citizen petitions, Pre-ANDA meeting packages) projects in the dermal drug development area.
A pioneer in topical pharmacology and development, Dr. Vijendra Nalamothu is the Chief Executive Officer of Tergus Pharma, the industry leader in topical formulation and development services located in Research Triangle Park, North Carolina. Under Dr. Nalamothu’s innovative leadership, in 2016 Tergus Pharma was named by Inc. 500 to the America’s Fastest-Growing Private Companies List. In March 2018, under his direction Tergus Pharma acquired EnDev
Laboratories, a Dermatology-centric Contract Research Organization. Tergus Pharma is now an end-to-end service provider for topical pharmaceutical research, drug development, testing, manufacturing, and has been an industry leader since its inception.
Dr. Nalamothu earned his PhD in Pharmaceutics from Philadelphia College of Pharmacy working under Dr. Joseph Schwartz and Dr. Rod Wigent and began his career at Sanofi-Aventis Worldwide Dermatology (Dermik) as the Head of the Early Compound Assessment and Preclinical Group. He has also served as Global Head of Dermatology R&D at Promius Pharma, a wholly-owned subsidiary of Dr. Reddy’s Laboratories, where he spearheaded the development of specialty branded dermatological products from concept to commercialization. Throughout his career, Dr, Nalamothu’s commitment to quality and excellence led him to create the first Quality by Design (QbD) program for topicals.
Dr. Nalamothu draws from his exceptional educational background that combines scientific study with pragmatic, hands-on experience to solve R&D challenges. He also serves on the board of several Pharmaceutical and Technology companies and is a member of several pharmaceutical research focus and discussion groups. Dr. Nalamothu has authored and coauthored numerous articles and holds several patents and is a renowned speaker at conferences worldwide.
Dr. Yu Chung Tsang is currently working at Apotex Inc. as Chief Scientific Officer, Biopharmaceutics and Biostatistics. His main responsibilities are to provide pharmacokinetic and statistical advices in preparing protocol and study report for pharmacokinetic/pharmacodynamic and clinical studies of biosimilar and small molecule products in the Apotex group of companies.
Diane Potvin has a Master degree in Mathematics / Statistics from Laval University, Canada. She has worked in the Pharmaceutical industry as a statistician and Director of Biometrics for 23 years. She has experience in both the generic and the new drug development fields. She worked for MDS Pharma Services, a Contract and Research
Organization, for eleven years, at Theratechnologies, a biotechnology company specialized in innovative therapeutic peptide products, for more than six years and for the last six years, she has started her own consultation business: Excelsus Statistics.
Diane has developed a vast experience in Phase 1 to 4 studies, as well as in PK/PD and bioequivalence studies. The main topics of her research included Individual bioequivalence, inclusion of carryover effects in bioequivalence study, ANCOVA in bioequivalence assessment of endogenous compounds and a PQRI (Product Quality Research Institute) initiative on adaptive sample size sequential designs for bioequivalence assessment.
Prior to joining the Pharmaceutical Industry, Diane had worked in Oncology research at Insititut Gustave Roussy in Paris, in Preventive and Social Medecine at Université de Montreal, and in epidemiology research at St-Sacrement Hospital, Quebec City. She has also given Statistics courses for undergraduate and graduate students.
Dr. Wenlei Jiang currently serves as a Senior Science Advisor in the Office of Research and Standards/Office of Generic Drugs. She has been championing regulatory research in the areas of generic nanomaterials, narrow therapeutic index drugs, and modified release products to support review standards development and ensure post-market safety and efficacy of these drug products.
Philippe Colucci is a Principal Scientist at Learn and Confirm, a consulting firm that specializes in clinical drug development. Dr. Colucci has over 25 years of experience in clinical pharmacology and pharmacometrics, having presented over 15 seminars and posters internationally and having published over 20 abstracts, manuscripts and book chapters.
Dr. Lakshmi Raghavan is a successful entrepreneur with more than 25 years of technical and business development expertise. Lakshmi Raghavan is currently the Founder and President of Solaris Pharma Corporation, leading its Research & Development, Business Development and overall corporate strategy. Prior to Solaris Pharma Corporation, Dr. Raghavan founded DermPathe Pharmaceuticals in 2010, a contract research organization providing contract research & development services in topical & transdermal product development, taking products from concept to clinical stages. Prior to DermPathe Pharmaceuticals, Dr Raghavan led the R&D at Vyteris Corporation for 6 years, where he was responsible leading all its R&D programs based on its transdermal technology.
Dr Raghavan is the Chairman of the In vitro Committee that is part of the Q3 Microstructure Steering Committee. He is also the Community Leader of the AAPS Topical & Transdermal Group.
Dr Raghavan holds a Bachelor of Science and Master of Science in Physics from the University of Madras, Chennai, India and a Doctor of Philosophy degree in Physics from Indian Institute of Technology, Chennai, India. He has more than 40 research publications and several book chapters.
Dr. Kanfer is an Emeritus Professor, Rhodes University and is currently Professor at the Leslie Dan Faculty of Pharmacy, University of Toronto, Canada. His research interests involve bioavailability and bioequivalence and in particular, topical products for local action. He has over 40 years’ experience with the FDA’s human vasoconstrictor assay (VCA) for topical corticosteroid products and is currently focusing on the development of new methods for the bioequivalence assessment of other topical dermatological dosage forms where the drug is not intended to be absorbed into the systemic circulation.
Dr. Kanfer has supervised 47 postgraduate students (MSc & PhD) and post- doctoral fellows in Pharmaceutical Sciences. He has contributed to over 200 research publications and conference presentations and is co-editor of several books in the series, Generic Drug Product Development. He is the editor of a recently published book entitled “Bioequivalence Requirements in Various Global Jurisdictions”.
Dr. Singh is a Senior Vice President at Cipla Ltd. and heads its Respiratory Center of Excellence. He directs the development, clinical evaluation and regulatory filing of respiratory drug products/devices. His Center provides end-to-end support for the Cipla Respiratory programs for a number of international markets. Before joining industry, Dr. Singh worked for many years in the Division of Bioequivalence at the US FDA. He was Team Leader and the designated Division Expert for the locally acting drug products including inhalation products.
Dr. Kimberly Witzmann is a physician, and the inhalation and combination products team leader, in the Office of Research and Standards within the Office of Generic Drugs (CDER), at FDA. She is committed to making safe and effective generic drugs available to the American public, focusing on communications with industry for complex drug products, and developing guidance documents and product-specific recommendations for OINDPs.