About Us

About

Leadership Team

Our Programs

Jamie Gault joined Scioderm as Vice President, Regulatory Affairs and Quality in February 2015. Ms. Gault brings more than 25 years of experience in Regulatory Affairs and Quality, having most recently served as Global Head, Regulatory Affairs at Novella Clinical. Ms. Gault has a broad regulatory background and strong knowledge of the technical aspects of new drug approval, and has designed and implemented regulatory strategies at pharma companies and behalf of clients. Ms. Gault has implemented global regulatory programs across multiple therapeutic areas, including dermatology, oncology, cardiology, neurology and antivirals. She began her career as a bench chemist and has progressed through CMC, regulatory compliance and regulatory affairs positions at pharma, biotech and service organizations. Prior to Scioderm, Ms. Gault held positions at Novella Clinical, Fulcrum Pharma, Clinsys Clinical Research, BioCryst Pharmaceuticals, Inc., Voyager Pharmaceuticals, Duke Clinical Research Institute, Glaxo Wellcome Inc. and Sphinx Pharmaceutical Corporation. She holds a B.S. in chemistry from Fairmont State College and has held a Regulatory Affairs Certified Credential from the Regulatory Affairs Certification Board (RAC) since 1996.

Our Programs

Mariam Khalil, Vice President of Finance and Operations joined Scioderm, Inc. in May 2013. Ms. Khalil has more than 20 years’ experience in the financial field serving the life sciences community. Ms. Khalil has been a key team member in the due diligence process and transition of numerous start-up companies through the successful completion of merger, acquisitions and IPO filings in the Research Triangle Park area. Ms. Khalil has held the following previous roles: Director of Finance for Lumena Pharmaceuticals Inc., Colucid Pharmaceuticals Inc. and Coserics Inc. In addition, Ms. Khalil, served as Controller of Serenex and Manager of Transition following its Acquisition by Pfizer. Mariam holds a B.S. in Accounting from Bernard Baruch College, City University of New York and is Certified Public Accountant.

Our Programs

Willistine Lenon joined Scioderm as Vice President of Clinical Operations in May 2013. Ms. Lenon has worked for more than 20 years in the field of clinical research. Prior to this position, Ms. Lenon worked at a number of major contract research organizations and pharmaceutical companies, including Quintiles, PPD, Atherogenics and Novartis. Ms. Lenon has extensive experience in a wide variety of key therapeutic areas, including pulmonary and allergy, cardiovascular, genitourinary, hematology, metabolic disorders, neurology, ophthalmology, analgesia and rheumatology. Ms. Lenon has repeatedly proven her ability to lead through diverse and challenging situations in every area of clinical research from start-up to final clinical study report. She is an excellent agent of change and has a long track record of accomplishment in leading global studies. Ms. Lenon is a graduate of Trinity University and has received numerous awards and honors for her career achievements, including awards for exceptional leadership and team collaboration in 2011 and 2012.

Our Programs

Ron Nardi, Ph.D. brings more than 35 years of experience in drug discovery, development and regulatory affairs to Scioderm, and has been instrumental in obtaining regulatory approvals for a number of medical devices and novel therapeutics. Dr. Nardi was most recently Executive Vice President of Regulatory Affairs and Quality Assurance at International Partnership for Microbicides. Previously, he was Chief Scientific Officer for Ferring Pharmaceuticals A/S and for BioValve Technologies, Inc. Dr. Nardi also has R&D operational and management experience with Wyeth Pharmaceuticals, GlaxoSmithKline and Warner-Lambert Company. Dr. Nardi received his Ph.D. in pharmacology and toxicology from Rutgers University and completed a postdoctoral fellowship at the Institute for Cancer Research at Fox Chase Cancer Center.

Scientific Advisory Board

For more than 20 years, Marlene Haffner, M.D. was the Director of the Office of Orphan Products Development at the U.S. FDA. In addition to assisting in the development of more than 300 products in the U.S. she is credited with assisting in the development of programs in Japan, the E.U. and Australia, among others. Trained as an internist and hematologist, Dr. Haffner earned her medical degree from the George Washington University School of Medicine and completed further training at the Columbia University School of Medicine and the Albert Einstein College of Medicine in New York City.

Jonathan K. Wilkin, M.D., was the Founding Director of the FDA’s Division of Dermatology and Dental Products. Prior to his tenure at the FDA, Dr. Wilkin was director of dermatology and professor of pharmacology and medicine at Ohio State University. He has more than 130 publications in dermatology and clinical pharmacology. Dr. Wilkin received his medical degree from the Ohio State University College of Medicine. Dr. Wilkin is a fellow of the American Academy of Dermatology and the American College of Physicians, and is a member of the American Dermatological Association. He is board certified by the American Board of Dermatology and the American Board of Clinical Pharmacology.

Anna Bruckner, M.D. is an EB expert and currently an Associate Professor of Dermatology and Pediatrics and Director of the Pediatric Dermatology Fellowship at the University of Colorado School of Medicine. Dr. Bruckner has been directly involved with patient care and clinical research in EB since 2004, originating at Stanford University where she organized and directed a monthly multidisciplinary EB clinic. Dr. Bruckner has authored textbook chapters about the diagnosis, clinical manifestations and treatment of EB. Dr. Bruckner received her medical degree from Northwestern University and is board certified in dermatology and pediatric dermatology.

Jeff Handler, Ph.D., has more than 20 years of experience in the pharmaceutical and medical device industries. Dr. Handler’s previous industry experience includes serving as vice president of drug development for Melior Discovery and vice president of research and development for Dermik Laboratories/Sanofi Aventis Dermatology. Dr. Handler received his Ph.D. in pharmacology from the University of North Carolina at Chapel Hill, and his MBA from Villanova University. He is a diplomat of the American Board of Toxicology, and a member of the Society of Toxicology, the Mid-Atlantic Society of Toxicology, and the American College of Toxicology.

Amy Paller, M.D., specializes in genetic disorders of the skin and inflammatory skin disorders (Epidermolysis Bullosa, atopic dermatitis, psoriasis, autoimmune disorders) in children. Dr. Paller is also the director of cutaneous clinical trials research at Children’s Memorial Hospital in Chicago. She has been involved in more than 70 clinical trials, and currently is conducting research on atopic dermatitis, psoriasis, localized scleroderma, and EB. Dr. Paller received her M.D. from Stanford University and is board certified in dermatology, pediatric dermatology and pediatrics.