LLC Scientific and Strategic Advisory Board
Robert S. KAUFFMAN, MD, PhD, Boston, MA.
Former Chief Medical Officer, Vertex Pharmaceuticals, Inc., Boston, MA (2009-2014) following several executive clinical/medical positions at Vertex starting in 1998.
Dr. Kauffman has contributed to filing over 20 IND applications for early stage compounds, and has extensive experience working with drug regulatory agencies US FDA and EU EMA & national agencies. He holds a record number of drug approvals including a blockbuster such as Incivek® (telaprevir), first Direct-Acting Antiviral in Hepatitis C, and Kalydeco® (ivacaftor), the first CFTR modulator and disease modifying agent for Cystic Fibrosis. R Kauffman has an extensive industry track record (Biotransplant, Serono, Syntex …). Robert S. Kauffman received his M.D. and Ph.D. (Microbiology) degrees from the University of Pennsylvania, and is Board Certified in both Internal Medicine and Infectious Diseases. Dr. Kauffman was Assistant Professor of Medicine at Harvard Medical School.
Andrew LUBER, PharmD, Voorhees, NJ.
Dr Andrew “Andy” LUBER is CEO of VIRION Therapeutics and former Vice-President of Clinical Pharmacology at Moerae Matrix Inc.
Over 20 years of experience in industry as a Key Opinion Leader, Investigator, Consultant, Steering Committee Member, Speakers’ bureau participant, independent Contractor. Companies include Abbott, Boehringer-Ingelheim, Bristol Myers Squibb, Gilead, GlaxoSmithKline, Medarex, Panacos, Pfizer, Roche, Schering-Plough, Tibotec, Vertex, ViiV Healthcare. He has been Clinical Investigator in over 70 clinical trials (Phase I-Phase IV) and specializes in phase I-II.
Andrew Luber holds a PharmD from Temple University, Philadelphia, PA. with his training and Fellowship in Pharmacy Practice & Infectious Diseases Pharmacotherapy at UCSF: University of California, San Francisco CA.
Mac MARTIROSSIAN, CPA, Atlanta, GA.
Managing Director of MThree Advisory and brings business/strategy experience based on over 40 years of diverse Executive experience.
His corporate track record includes: AMRE Inc, The Home Depot, PRG-Schultz International, PWC: Price Waterhouse Coopers … Mr Martirossian thus has senior level general management executive experience, maximizing organizational effectiveness, creating innovative marketing tools, leading mergers and acquisitions, profit/cash flow domestically and internationally, strategic sales management,. Officer and Board level experience in finance, operations, sales and marketing.
Mac Martirossian holds a BS in Public Accountancy from Long Island University and is a US CPA: Certified Public Accountant.
Yacine SALHI, PhD, Boston MA & New York NY, USA
Vice President of Biostatistics, Programming, Modeling & Simulation, SAGE Therapeutics, Boston MA, USA.
An extensive hands-on and managerial experience in diverse aspects of drug development, including advising on study design, protocol development, preparation of statistical analysis plans, management of external providers of statistical deliverables, interpretation of results and review of clinical study reports and providing statistical expertise to support clinical development programs of clinical trials (Phases I to IV). Handled different levels of responsibility (project, team) with a focus on Oncology, Infectious and Respiratory therapeutic areas. Contributed to successful regulatory submissions in EU and some others countries. Created and developed successful in-house capabilities for biostatistics and data management. Also, a significant health authority’s interactions experience, defending statistical position.