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Stephan B. Abramson, Ph.D., Principal

Biographical Sketch

 
Partners LLC: Biomedical Consulting

 

Stephan Abramson, Ph.D., has nearly two decades of development and management experience in the biopharmaceutical industry. His thirteen years of work in business development at Alpha Therapeutic Corporation have shown him to be a skilled and innovative consensus builder, deal architect and negotiator. A decade in clinical affairs has highlighted his effective leadership in clinical trial design and execution, his ability to work well across departments and disciplines, and his capable communication and collaboration skills.  He provides skills and a record of accomplishment in several areas.

Business and Corporate Development:  In two years Dr. Abramson crafted a drug/device partnership with annual revenue potential well over $100 million, and manufacturing agreements both with annual earning potential above $150 million.  For each, Dr. Abramson framed the deal structure and was principal negotiator.  He has performed technical, commercial and clinical assessments of several dozen product development candidates in coagulation disorders; immunotherapy; oncology; autoimmune diseases; and HIV, hepatitis and other viral diseases.  His  expertise includes strategic planning, managing product portfolios, and preparing target product profiles, income and cash flow projections, and competitive market analyses.

Clinical Development:  Dr. Abramson led a clinical research group in preparing and submitting to FDA 18 Investigational New Drug Applications (INDs), with protocols for more than 25 clinical trials from Phase I through Phase IV, and more than 20 clinical reports, leading to 5 new product approvals and 4 license amendments, including high purity Factor IX and the first intravenous IgG (IGIV) with an antiviral treatment.  A study of his provided FDA with the first evidence of viral safety for IGIV in immunocompetent patients.  He has directed the clinical development of coagulation factors, immunoglobulin products and growth factors; and played a major role in the design and execution of clinical immunotherapy trials.

Project and Alliance Management:  Dr. Abramson has successfully led product development teams, both internally and with corporate development partners.  He has coordinated the efforts of several internal departments in preparing regulatory submissions and moving product development from the preclinical stage to Biologic License Applications.  He has organized, presented and led discussions in numerous meetings and teleconferences with FDA.

Regulatory, Quality and Related Experience:  Dr. Abramsonís project management role has resulted in a range of internal consulting activities. These include quality systems development, regulatory strategy, audits for compliance with current Good Manufacturing Practices (cGMP), and the design and implementation of preclinical development programs.  He has developed method validation protocols for internal departments and corporate partners.  He also designed and implemented a quality control sample request, handling and reporting system evaluated as an industry standard.

Dr. Abramson holds a B.Sc. in Chemistry from Caltech and a Ph.D. in Biochemistry from Harvard University, and held postdoctoral fellowships at the University of California, Los Angeles (UCLA) and the University of Southern California. He is listed in American Men and Women of Science, and is a member of the Scientific Honor Society Sigma Xi, the Licensing Executives Society (USA and Canada), and other professional societies, and has reviewed for several scientific and medical journals. Dr. Abramson has an excellent working knowledge of written and conversational German, and has  professionally translated German publications. His areas of expertise include protein purification and characterization; gastrointestinal biochemistry and enzymology; biological response modifiers in antitumor therapy; hemostasis and thrombosis; oncology; and immunotherapy.

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