"Topical Drug Development -- Evolution of Science and Regulatory Policy" will feature a selection of speakers who are nationally and internationally recognized in their areas of expertise.
Explore the speaker biographies provided below to learn more about each of the presenters.
E. Dennis Bashaw, PharmD
Dr. Bashaw is currently the senior advisor for science in the Office of Clinical Pharmacology at the U.S. Food and Drug Administration in Silver Spring, Md. Dr. Bashaw received his BS in Pharmacy and Doctor of Pharmacy from the University of Kentucky in 1986. In his 31 years at the FDA, he has been a primary reviewer, team leader, and a deputy division director across several therapeutic areas. In 2005, Dr Bashaw was selected as the division director of the Division of Clinical Pharmacology-3 and served as a subject matter expert for clinical pharmacology in the development of FDA policies related to the development of dermatologic, nanotechnology, and orphan drug products. In May 2018, Dr. Bashaw entered into his current position, where he oversees the development of regulatory policy and guidance documents in the area of over-the-counter products, nanotechnology, and dermal absorption. Most recently, he was instrumental in the publication of the “FDA Guidance for Industry on Maximal Usage Trials for Over-the-Counter Products,” the “Final Rule on the Safety and Effectiveness of Health Care Antiseptics,” and the “Draft Final Rule for Sunscreen Drug Products for Over-the-Counter Human Use.”
Audra Stinchcomb, PhD
Dr. Stinchcomb is professor of pharmaceutical sciences at the University of Maryland School of Pharmacy. She is also currently the chief scientific officer and co-founder of F6 Pharma Inc., a palliative care product company. She received her bachelor's in pharmacy from the University of Colorado, and a PhD in pharmaceutics from the University of Michigan. She completed a postdoctoral fellowship at UCSF. She was a professor at the University of Kentucky from 2001-11, and joined the faculty at the School of Pharmacy in November 2011. She is a Fellow of the American Association of Pharmaceutical Scientists. Dr. Stinchcomb’s research interests span across many disciplines, including pharmaceutics, drug delivery, medicinal chemistry, neuroscience, dermatology, bioengineering, regulatory science, and translational research models.
Sheila Fallon Friedlander, MD
Dr. Friedlander is professor of dermatology and pediatrics at the University of California, San Diego School of Medicine (UCSD). Dr. Friedlander trained at the University of Chicago, Albert Einstein College of Medicine and UCLA Medical Center, and is board certified in both pediatrics and dermatology, with sub-specialty certification in pediatric dermatology; and she also completed an infectious diseases fellowship. She is a member of the Academy of Clinician Scholars at UCSD, the Scientific Advisory Committee of the American Academy of Dermatology, past president of the Society for Pediatric Dermatology, past member of the American Academy of Dermatology Board of Directors, past director of fellowship training at Rady Children’s Hospital, San Diego and UCSD.
Research interests include the etiology of infantile vascular lesions, cutaneous infectious diseases, pediatric melanoma and its prevention, and manpower supply and training challenges in pediatric dermatology. She has been listed in Best Doctors, Top Doctors, Who’s Who in America, and 2000 Notable American Women.
Murali Matta, PhD
Dr. Matta is a bioanalytical scientist with expertise in clinical/pre-clinical bioanalysis of small and large molecules, drug metabolism, pharmacokinetics, enzyme kinetics, drug-drug interaction and metabolite identification studies. He received his BS and MS in pharmacy from Andhra University, India and his PhD in pharmaceutical sciences with focus on drug metabolism and mass spectrometry from the Jawaharlal Nehru Technological University (JNTU), India. Subsequently, he completed his post-doctoral fellowship at FDA, Silver Spring, Md.
Currently, Dr. Matta is a bioanalytical lead in the Division of Applied Regulatory Science, Office of Clinical Pharmacology (OCP). He is responsible for bioanalytical support of multiple projects of the division spanning from in vitro, preclinical, and clinical studies. Dr. Matta, also serves as a member of FDA Mass Spec. Working Group and Bioanalytical Research Special Interest Group (BAR-SIG). Prior to joining FDA, he worked with Bristol Meyers Squibb (BMS), India in the Division of Drug Metabolism and Pharmacokinetics (DMPK) and clinical bioanalysis division of Mylan Generics, India for few years.
Theresa Michel, MD
Dr. Michele is the director of the Division of Nonprescription Drug Products (DNDP) in the Office of New Drugs, Center of Drug Evaluation and Research (CDER), at the Food and Drug Administration (FDA). Prior to joining FDA, she spent 10 years in industry, with clinical research experience across a variety of therapeutic areas in both commercial and development stage companies. Dr. Michele left industry in 2007, to join the FDA in the Division of Pulmonary and Allergy Drug Products, where she served as both a clinical reviewer and team leader. She is board certified in internal medicine, pulmonary medicine, and critical care medicine, completing her training at Johns Hopkins University, where she currently serves on the faculty. She obtained her BS in integrated life sciences from Kent State University and MD from Northeastern Ohio Universities College of Medicine (now Northeast Ohio Medical University) as part of a 6-year combined program.
Vijendra Nalamothu, PhD
Dr. Nalamothu is chief executive officer of Tergus Pharma and has been a leader in topical pharmaceutical development for more than two decades. After earning his PhD in pharmaceutics from the University of the Science’s Philadelphia College of Pharmacy, he worked 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. He holds several patents and his efforts have led to a number of successful commercial products. His passion is to develop products that speak for themselves, leading him to be a co-founder of Tergus Pharma, shepherding the company to its industry-leading position in the marketplace.
Dr. Nalamothu’s interests include novel dosage form design and development of topical drug products. His commitment to quality and excellence led him to create the first Quality by Design (QbD) program for topicals, numerous articles, and accolades.
Luke Oh, PhD
Dr. Oh is a biologist in Division of Clinical Pharmacology-3, Office of Clinical Pharmacology at the U.S. Food and Drug Administration. His work has been focused on a number of policy makings, including MUsT guidance and the sunscreen proposed rule, sunscreen clinical PK studies, and sponsor meetings for topical drug development under both OTC monograph and NDA settings. His expertise includes dermal permeation and MUsT program for dermatological diseases. Prior to joining the FDA, Dr. Oh worked in the pharmaceutical industry for more than 14 years, developing small molecules and biologics to treat disease associated with autoimmunity and inflammation. His prior work experience includes service as an associate director at Mallinckrodt and a senior scientist at Human Genome Sciences and Vertex pharmaceuticals. Dr. Oh received his BS and PhD from the McGill University, Montreal, Canada.
Vivek Purohit, PhD
Dr. Vivek Purohit is director of clinical pharmacology, global product development at Pfizer, Inc., Groton, Conn. He received his PhD in pharmaceutical sciences from the University at Buffalo, State University of New York, Buffalo in 2005. He joined the joined the Clinical Pharmacology Group at Pfizer in 2007, and has extensive experience in the areas of inflammation and immunology, with a special focus on dermatology indications. Dr. Purohit’s areas of technical expertise are in pharmacokinetics, pharmacodynamics, and biopharmaceutics. Dr. Purohit has authored/co-authored several peer-reviewed publications, book chapters, and holds four patents. His current interests are in application of quantitative approaches to decision making and answer key development questions for efficient drug development.
Sam Raney, PhD
Dr. Sam Raney is a thought leader in topical and transdermal drug products, with more than 25 years of experience producing numerous research manuscripts, review articles, book chapters, and patents in pharmaceutical product development. Dr. Raney has been a researcher and adjunct professor within academia, a principal or sub-investigator on more than 400 pharmaceutical product studies, has held senior management roles in industry, serves as an expert panel member in the U.S. Pharmacopeia, and is the lead for Topical and Transdermal Drug Products in the FDA Office of Generic Drugs. Dr. Raney holds a bachelor's in molecular biophysics and biochemistry from Yale University, and a PhD in biochemistry and molecular biology from the University of British Columbia in Canada.
Leandro L. Santos, MSc
Leandro is currently the associate director of clinical sciences at Incyte Corporation. He holds a double major in pharmaceutical sciences and biochemistry from the University of Sao Paulo (Brazil) and a Master of Science in analytical chemistry from the University of North Carolina at Chapel Hill. He spent 13 years at Stiefel/GlaxoSmithKline before joining Dermavant in 2018, and has worked in different areas of Rx and Cx dermal product development, including analytical, formulation, preformulation, DMPK, and drug delivery. He has led projects focused on various stages of development, as well as conceptualized and implemented tools used in in silico, in vitro and in vivo workflows. He has co-authored nonclinical sections of regulatory submissions, as well as patents and papers in peer-reviewed journals, and contributed to the development of several assets currently in clinical stage of development.
Soo Hyeon Shin, PhD
Dr. Soo Hyeon Shin currently serves as a clinical pharmacologist within the Office of Clinical Pharmacology at the FDA. Her specialization is in vitro and in vivo characterizations of topical and transdermal drug delivery products. In her current role, Dr. Shin is responsible for reviewing clinical pharmacology section of drug applications for dermatology, dental, and topically administered over-the-counter drug and monograph products. Prior to joining the FDA, Dr. Shin received her PharmD from Albany College of Pharmacy and Health Sciences and her PhD in pharmaceutical sciences from the University of Maryland School of Pharmacy, specializing in in vitro in vivo correlations of transdermal drug delivery systems.
Chinmay Shukla, PhD
Dr. Chinmay Shukla is a clinical pharmacology team leader of the dermatology and dental team with the Office of Clinical Pharmacology at the U.S. Food and Drug Administration (FDA). He received his Bachelor of Pharmacy from Mumbai University, India, and master's and doctorate in pharmaceutical sciences from Long Island University, New York. His research interests are design of clinical pharmacology studies under maximal use conditions for topical dermatological products and dermal microdialysis and transdermal drug delivery, where he has published several research papers in peer reviewed journals. He has also co-authored a book chapter addressing the regulatory aspects of microdialysis. He serves as a reviewer for several scientific journals and is also currently serving as a scientific advisor to the editor of the Journal of Pharmaceutical Sciences. With the American Association of Pharmaceutical Sciences (AAPS), he served as the secretary and treasurer of the Pharmacokinetics Pharmacodynamics Drug Metabolism (PPDM) Section, and also served as a chair of the Microdialysis Focus Group for two years.
Jane Sohn, PhD
Dr. Sohn is the lead toxicologist in the Division of Nonprescription Drug Products (DNDP) at the Food and Drug Administration (FDA). Prior to joining FDA, she conducted research at the National Cancer Institute (NCI) as a cancer research training fellow in the Laboratory of Human Carcinogenesis under Dr. Curtis Harris, studying inflammatory bowel disease, colon cancer, and lung cancer. Dr. Sohn started her career at FDA in 2010, as a reviewer in the Division of Pulmonary, Allergy and Rheumatology Products (DPARP), where she gained experience in nonclinical development of small molecule and biologic drug products for various routes of administration and indications. Dr. Sohn received her BS in biology from the Massachusetts Institute of Technology (MIT). She obtained her PhD in applied biosciences from the Biological Engineering Division (formerly the Division of Toxicology) at MIT, studying the effects of bacterial infection and immunomodulation on carcinogenesis under Drs. David Schauer and James Fox.
Nathalie Wagner, PhD
Dr. Nathalie Wagner is a senior clinical pharmacokinetics scientist GALDERMA R&D, Fort Worth, USA, the pharmaceutical subsidiary of Nestlé Skin Health. Nathalie completed her bachelor's degree in physiology at the University of Nice, France, and a master's degree in pharmacokinetics at the University of Toulouse in France. She has more than 25 years of clinical and non-clinical pharmacokinetics experience in medical dermatology. Her areas of expertise include clinical pharmacology, MUsT studies, QT/QTc studies, pediatrics, DDI studies, PK modeling and simulations, non-clinical DMPK and in vitro metabolism and transporter models.
In her current role, Nathalie focuses on metabolism and PK clinical development activities from early exploratory PK/PD studies to late-stage development programs for small molecules and biologics. She frequently interfaces with FDA, PMDA, and European agencies on clinical pharmacology and biopharmaceutical strategies. Over the past six years, she contributed to three new drug applications in the U.S. and Europe, one RX-to-OTC switch in U.S., and one PMDA application in Japan. Nathalie also plays an active role in advancing science in pharmacology, and in 2014, she served as president of the French Metabolism and Pharmacokinetics Association (Groupe de Métabolisme et Pharmacocinétique).
Sojeong Yi, PhD
Dr. Sojeong Yi is a clinical pharmacology reviewer responsible for OTC topical antiseptics and sunscreens as well as gastroenterology drug products in the Office of Clinical Pharmacology, FDA. Since she joined FDA in 2016, she has actively been involving in publishing proposed rules and final rules of topical antiseptic monographs and providing regulatory and scientific guidance on MUsT programs of OTC topical antiseptics. She was one of the two lead clinical pharmacologists at the FDA involved in the review of public comments that shaped the Health Care Antiseptic Final Rule. Prior to joining FDA, Dr. Yi earned a doctorate degree in clinical pharmacology at Seoul National University, and she received her BS in pharmacy at Ewha Women’s University in South Korea. She also worked as a clinical fellow and a postdoc research fellow in Dong-A University Hospital and Seoul National University College of Medicine, respectively.
Da Zhang, PhD
Dr. Da Zhang obtained her PhD in pharmacokinetics/pharmacodynamics modeling and simulation from Virginia Commonwealth University, her MS in pharmacokinetics/pharmacodynamics and toxicokinetics from the University of Arizona, and completed a three-year clinical fellowship majoring in clinical pharmacology with the Medical Oncology Branch, National Cancer Institute. Before joining the FDA, she worked at Merck & Co,. for nine years as a pharmacometrician and clinical pharmacologist on model based clinical drug development for both small molecules and biologics in multiple disease areas. Dr. Zhang joined the FDA in 2016, as a senior clinical pharmacology reviewer in DCP III, and has contributed to numerous drug approvals in bone, reproductive, and urology therapeutic areas, as well as the area of regulatory special monographs.