Senior Global Scientific Advisor
Dr. Skolnik is the Norman S. Wikler Professor of Medicine and Director of the Division of Nephrology at the New York University Langone Medical Center. His current research interests are on the regulation and function of the potassium channel KCa3.1 in lymphocyte and mast cell activation, and the role of histidine phosphorylation and dephosphorylation in regulating KCa3.1 and other biological processes. The ultimate goal of these studies are to identify new targets to inhibit lymphocyte and mast cell activation and thereby treat autoimmune disease and allergy and new targets to promote lymphocyte activation to enhance anti-tumor immunity. In addition, Dr. Skolnik’s lab studies autosomal dominant polycystic kidney disease which is the most common hereditary cause of renal failure world wide. Dr. Skolnik has received many awards for his research including election to the American Society of Clinical Investigation, American Association of Physicians, and the Interurban Clinical Club to name a few and currently serves on the executive program and award’s committees of the American Society of Nephrology.
Jorge has had an extensive career in many areas of the pharmaceutical industry since joining 25 years ago. He served most recently as President of the Asia and Canada regions for Pfizer’s oncology unit and was simultaneously the head of Oncology Clinical Development for China. Given his unique research and regulatory expertise, Jorge achieved many “firsts” including approvals of Pfizer’s key oncology agents in record time in both Japan and China, leading to a 500% increase in revenues in the region during his tenure.
Accounting / Finance
Prior to joining SFJ Pharmaceuticals®, Bruce served as a partner and the Global Biotechnology Sector Tax Leader for Ernst & Young LLP. For 32 years, he provided advice and counsel to clients and other partners on life science industry related matters including structuring transactions, collaborations, joint ventures, and license arrangements, intellectual property planning and migration, global and domestic supply chain planning, pre-IPO planning, and equity based incentive programs. In addition, Bruce was responsible for managing the audit, review, and sign-off of numerous public pharmaceutical and biotechnology clients’ annual and quarterly ASC 740 analysis, including income statement and balance sheet implications as well as footnote related presentation and disclosures. He presented at many EY sponsored client events as well as internal training events and was a frequent speaker at industry organization events sponsored by BIO and Massachusetts Biotechnology Council. Bruce served as a member of the BIO tax and finance committee.
Bruce received an MBA from Bentley University and his Bachelor of Science in Business Administration degree from Merrimack College. He is a past Chairman of the Board of a State Affiliate of the American Heart Association, past President of the Board of a local affiliate of the Big Brothers/Big Sisters Association and a current Member of the Merrimack College Leadership Council.
Ms. Dunn has over 25 years of regulatory consulting experience with particular expertise in regulatory strategy and implementation, including clinical, nonclinical, and CMC regulatory expertise from product development to post-marketing. Ms. Dunn’s product expertise includes pharmaceuticals, cosmetics, biologics, and devices.
Ms. Dunn has (i) provided strategic regulatory advice to solve some of the most complex regulatory challenges; (ii) led product development teams; (iii) successfully led and negotiated FDA and ex-US regulatory meetings; and (iv) reviewed and written over 100 INDs and CTAs, six NDAs and BLAs. She has successfully negotiated expedited regulatory packages with the FDA, including breakthrough therapy designations, and has written numerous orphan drug designation and rare pediatric disease designation packages.
Ms. Dunn currently serves as an U.S. Agent across all Divisions of CBER and CDER, and she maintains excellent working relationships with the FDA.
In addition, she is an expert in GLP implementation and interpretation, and is an author on the RAPS chapter on GLP compliance.
Prior to forming DRA, she was a founding and majority partner at Aclairo Pharmaceutical Development Group, Inc., as well as a consultant at Milestone Biomedical Associates, SRA Life Sciences, Inc., and an independent consultant. Prior to her consulting experience, Ms. Dunn worked at Covance and EPL, Inc. in project management and project coordination roles.
Ms. Dunn holds a Master’s degree in Public Health from Old Dominion University.