President, Chief Executive Officer and a member of the board of directors
Sanjeev Luther joined Rafael Pharmaceuticals in 2015 and is the President and CEO, bringing more than 30 years of experience to the team. Sanjeev has held positions in business development, strategic alliances, commercialization and operations with Fortune 500 corporations, including Bristol-Myers Squibb, Novartis, Bausch and Lomb, GE Healthcare and Mallinckrodt.
Leveraging his expertise in pharmaceuticals and biotech, Sanjeev has shepherded Rafael as it continues to refine its corporate strategy and elevates its business portfolio.
Robert Shorr, Ph.D., DIC
Chief Scientist and Co-founder
Dr. Shorr has a 40-year track record in drug discovery from concept through approval and market launch. As Rafael’s Chief Scientific Officer, Dr. Shorr’s primary focus is on the discovery and development of safe and effective novel drugs and delivery technology. He has previously served as VP of Science and Technology at Enzon Pharma, VP of Science and Technology and Chief Scientist at United Therapeutics, and Associate Director of Molecular Pharmacology at SmithKline Beecham. At Enzon, Dr. Shorr was responsible for co-development with Schering-Plough of the blockbuster drug, PEG INTRON A, for the treatment of hepatitis and certain forms of melanoma. Dr. Shorr has authored more than 250 technical articles, abstracts, book chapters and conference proceedings and has more than 150 inventions with more than 300 issued and pending patents worldwide. He earned his Ph.D. from the University of London, and a DIC from the University of London Imperial College of Science and Technology.
Mike Hu, Ph.D.
Chief Development Officer
Dr. Hu has 20+ years of experience in clinical and pre-clinical research and development (R&D) in pharmaceutical industry and academia. He has previously held leadership and management roles at Novartis, GlaxoSmithKline and Jazz Pharmaceuticals. Over his career, Dr. Hu has primarily focused on building pipelines for big pharma and small biotech companies in oncology and hematology. He has contributed to clinical and pre-clinical R&D, global submissions, regulatory approvals, and life cycle management of 18 drugs in various indications with multi-billion dollar franchises. Dr. Hu earned Ph.D. in Pharmaceutical Sciences from Shenyang Pharmaceutical University.
José Octávio Costa Filho, M.D.
Chief Medical Officer
Dr. Costa has 30+ years’ experience in clinical development, clinical operations, strategy and global medical affairs, with several years’ experience in clinical practice. Dr. Costa has previously worked with companies like Merck & Co., Celgene, Novartis and more recently at Servier Pharmaceuticals. Over his career, he has extensive experience in phase I-IV clinical development and regulatory experience with all major regulatory agencies. He has played important role in development and life-cycle management for several blockbuster products including Revlimid in entire Latin American region. He earned his Doctor of Medicine from The Medical College of Sorocaba, Sao Paulo.
Timothy S. Pardee, M.D., Ph.D.
Co-Chief Medical Officer
Dr. Pardee is an Associate professor and the Director of Leukemia Translational Research at the Comprehensive Cancer Center of Wake Forest Baptist Medical Center. He heads an NCI-funded research program focused on the role of cellular metabolism in cancer cell survival and resistance to therapy as well as novel therapeutics. Dr. Pardee has played a lead role in the development of the novel metabolism-targeting agent CPI-613® (devimistat). He earned his M.D. and his Ph.D. from SUNY Buffalo.
Arshad Haque, M.D., MBBS, MPH
Vice President, Head of Global Drug Safety & Pharmacovigilance
Dr. Haque provides leadership and oversight of all global safety risk management and pharmacovigilance activities for Rafael Pharmaceuticals. Previously, he held leadership roles in several pharmaceutical companies including Pfizer, Sanofi Genzyme, Abbott, AbbVie, Alexion and Baxalta/Shire (currently Takeda). Dr. Haque has extensive experience in Phases 1 through 4 clinical development, successful global approval of several pharmaceutical therapies, and fulfillment of postmarketing drug safety and regulatory commitments. He is a physician with clinical practice in cardiology and anesthesiology/critical care. He is also an epidemiologist with experience as a surveillance medical officer in poliomyelitis eradication for the World Health Organization, West Virginia Bureau for Public Health – Division of Immunization Service. He also served as a senior epidemiologist at Wyeth.
Paul Bingham, Ph.D.
Vice President, Research
Prof. Bingham is a molecular biologist, an evolutionary biologist, and an Associate Professor in the Department of Biochemistry and Cell Biology at Stony Brook University. He was the co-discoverer of the first Altered Metabolism Directed (AMD) compounds. Prof. Bingham has published numerous papers, peer-reviewed articles, and book chapters on molecular and evolutionary biology. In 2008, Prof. Bingham and his colleague, Prof. Zuzana Zachar, received the Michael Maffetone Award for Cancer Research from the Carol M. Baldwin Breast Cancer Research Fund. He earned a M.S. in Microbiology from the University of Illinois, and a Ph.D. in Biochemistry and Molecular Biology from Harvard University.
Chief People Officer
Wendy brings over 25 years of experience in a variety of human resources roles. Wendy joins us from Sanofi, where she spent the past 11 years, most recently serving as Vice President, Human Resources supporting North America Specialty Care (Sanofi Genzyme), Medical, and Support Functions. Wendy has held other HR positions at Schering-Plough, Vivendi Universal and International Management Group. Throughout her career, Wendy has particularly focused on culture, people development and talent management. Wendy earned her B.A. in Communications from SUNY Plattsburgh.
Jenna brings nearly two decades of experience in finance from the pharmaceuticals industry. Prior to joining Rafael, she spent 10 years on the research and development finance team at Daiichi Sankyo. Jenna grew her role from back-office support into a true business partner, as she integrated herself as a key member of the clinical projects team. She was instrumental in transforming the finance department at Daiichi Sankyo, creating cost saving measures that supported the company’s goals and growth. Given her experience and strong technical expertise, Jenna will ensure that Rafael allocates its financial resources most efficiently and productively, allowing the company to focus on its top priority: the patients it serves.
Head, Clinical Operations
Priya brings nearly 20 years of clinical research and development experience to Rafael. Previously, Priya led the hematology clinical operations team in gene therapy trials at Spark Therapeutics. Prior to Spark, Priya worked in clinical operations roles with increasing responsibility at Jazz Pharmaceuticals and at Teva Pharmaceuticals. Priya also has experience working in the CRO environment from both PharmaNet (now Syneos) and PRA Health Sciences. Priya earned her undergraduate degree from George Washington University and completed her Master’s Degree in Molecular Biotechnology at the University of Pennsylvania.
Jehan Rowlands, Pharm.D.
Vice President, Regulatory Affairs
Dr. Rowlands is a seasoned and experienced regulatory strategist whose career spans nineteen years at companies including Forest, Sanofi, Otsuka, NPS Pharma, and InfaCare. Dr. Rowlands has worked closely with the FDA to develop and execute regulatory strategies for drug candidates for a wide range of therapeutic indications. Throughout his career, he has contributed to the development of innovative products for unmet medical needs leading to the filing and approval of Namenda, Natpara, and accelerating development and early NDA filing of stannsoporfin for neonatal hyperbilirubinemia while at InfaCare. Dr. Rowlands most recently joins us from Actinium. He has a B.S. in Pharmacy as well as a Doctor of Pharmacy (Pharm.D.) degree from Rutgers University. He also completed a post-doctoral pharmaceutical industry fellowship jointly sponsored by Rutgers University and Hoffmann-La Roche.
Deepak Tiwari, Ph.D.
Deepak Tiwari has over 25 years of CMC experience in drug substance and drug product manufacturing. Deepak joins Rafael from ZyVersa Therapeutics, where he led CMC operations and product development activities. Prior to ZyVersa, Deepak worked at Sucampo Pharmaceuticals, which was acquired by Mallinckrodt. Throughout his career, he held various roles in the CMC area, both at small and big pharmaceutical companies. Deepak earned his undergraduate degree in Pharmacy and his Master’s and Doctorate degrees in Pharmaceutical Sciences from St. John’s University.
Vice President, QA/CQA
Mike is a strong entrepreneurial leader who over the years spearheaded multiple departments at Rafael pharmaceuticals, including Quality Assurance, Manufacturing and CMC Regulatory Affairs. Now, Mike is focused on Rafael’s uncompromising commitment to quality and patient care. Over his career, he worked with innovative medicine organizations, like Alnylam Pharmaceuticals and Regeneron Pharmaceuticals, resulting in commercialization of leading products: Praluent, Eylea, Kavzara, Dupixent, Onpattro and other. Mike holds a BioMedical Engineering degree and M.B.A. from University of Illinois at Chicago. He also achieved RAC (US & Global), Six Sigma and PMP certifications.