About

Who We Are

Our Corporate culture nurtures and promotes innovation, quality, commitment and social responsibility.

Our Credentials include impeccable scientific research training from world-class institutions, such as the U.S. National Institutes of Health (NIH); many years of “hands-on” practical working experience from well-respected pharma-biotech, medical device and diagnostic companies in the Healthcare Industry; globally recognized professional certification, including American Society for Quality (ASQ) certified auditor and certified quality manager.

Our Management

Our Management Team is comprised of former Big Pharma and biotech professionals with impeccable scientific training, practical know-how in expert area, and extensive experience with major regulatory authorities. Our over 100 years of combined experiences with the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and other major regulatory agencies in the world, include new drug/ product development from IND through pre-NDA/BLA stages to successful NDA/BLA approvals, product market launches, and global commercialization. We have been involved with new chemical entities and new biological molecules, medical devices and diagnostic products.

Our Vision

As we grow and build our teams, our vision of the company infrastructure:

Leadership And Advisors

Irene Wei, PhD MBA

Chief Executive Officer, Co-Founder and Company Board Member, with over 20 years of experience in Global product development and commercialization of pharmaceutical and biotech products to Vice President from Big Pharma and biotech companies including Merck, Pfizer and Immunomedics. She led project teams, including SINGULAIR, EPRATUZUMAB, INTERLEUKINS, for US/Worldwide regulatory agency negotiations and product registrations, including FDA Review Centers for scientific review and marketing approvals, and FDA District Offices for pre-inspection approvals and manufacturing. Her background includes NIH research tenure, Ph.D. Massachusetts Institute of Technology, MBA Rutgers University,

Scott A. Reines, MD PhD

Chief Science Officer with over 30 years of experience in Global product development and Clinical Research. Prior to joining, he held the position of Senior Vice President, translational medicine and other therapeutic areas at Johnson & Johnson. His career includes Vice President of Clinical Research at Merck for new drug development across several therapeutic areas, including neurology, opthalmology and gastroenterology. He has been responsible for the development of many successful globally recognized products, including EMEND, REMINYL, RISPERDAL, TOPOMAX, MAXALT, TRUSOPT, COSOPT, TIMOPTIC-XE. He authored many scientific and clinical publications in widely recognized peer-reviewed journals. M.D. Albert Einstein College of Medicine, Ph.D. Columbia University.

Arthur C. Santora II, MD PhD

Chair, Scientific Advisory Committee with over 25 years of experience in Global product development and specialty focus on Women’s Health, Endocrinology and Metabolism. His career includes tenure at Merck & Co., Inc. to Associate Vice President, Scientific and Clinical drug development. Prior to joining industry, he was Medical Officer in the Division of Metabolism and Endocrine, Center for Biologics Review, U.S. Food and Drug Administration (FDA). He continues to practice at the Rutgers-Robert Wood Johnson Medical School-Medical Center. M.D. Emory University School of Medicine, Ph.D. Emory University.

Michael J. DuBois, MBA

Company Board Member and Strategic Advisor, with over 30 years of experience in Global business development and strategic alliances, from product licensing to the forming of alliances, partnerships, joint ventures. Prior to joining the Board, he was retiring from the position of senior vice president of Global Licensing & Strategic Alliances at Schering-Plough Corporation, a Global healthcare leader with prescription, consumer OTC and animal health products. His career includes tenure at Pharmacia Corporation (as senior vice president of global licensing), Novartis (as vice president of business development and licensing) and Sandoz (similar vice president position). Mr. Dubois received his MBA and both his B.S. in Chemistry and B.S. in Pharmacy from Rutgers University.

Mark I. Greene, MD PhD, FRCP

Scientific Founder, Harvard University Discovery Technology, Harvard Medical School; Professor Emeritus, Head of Immunology, Pathology & Laboratory Medicine, John Eckman Professor of Medical Science, University of Pennsylvania, Perelman School of Medicine. Immuno-oncology medical laboratory scientist with over 30 years of research in oncogene/oncoprotein receptor biology; Scientific founder in HER2/neu receptors leading to licensing of his research to Genentech for development of Herceptin and Perjeta. Newton Abraham Professor of Medical Sciences, Oxford University. M.D. and Ph.D. Manitoba University, Canada; FRCP Fellow of the Royal College of Physicians.

Mario A. Eisenberger, MD

Scientific Board Member, R. Dale Hughes Professor of Oncology and Urology, John Hopkins University School of Medicine, Sidney Kimmel Comprehensive Cancer Center, over 30 years of Clinical-Medical expertise. Ad hoc member, FDA Oncologic Drugs Advisory Committee (ODAC) since 2010; Head of Advanced Prostate Cancer Committee, Vice-Chair Genitourinary Cancer of Southwest Oncology Group; WHO International panel member for Advanced Prostate Cancer; Prostate Cancer Foundation Clinical Investigator Award. Since 1988, he has served on Advisory, Strategic, and Data Safety Monitoring Boards, including Bristol-Myers Squibb, Janssen/J&J, Merck, Sanofi, Bayer Astellas, Medivation, Tokai, Cytogen.