Rafael Pharmaceuticals Appoints Vice President, Manufacturing and CMC Regulatory Affairs and Vice President of Regulatory Affairs to Strengthen Development of CPI-613
Newark, NJ, Nov. 06, 2018 (GLOBE NEWSWIRE) -- Rafael Pharmaceuticals, Inc., a leader in the growing field of cancer metabolism-based therapeutics, today announced the appointment of Mike Stelmah as Vice President, Manufacturing and Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs, and Jehan Rowlands, PharmD as Vice President of Regulatory Affairs.
Stelmah has extensive pharmaceutical industry experience in CMC and regulatory strategies. He has coordinated the submission of technical documents such as IMPD, IND, DHF, MAA, and NDA to multiple health authorities including FDA, EMA, HPRA and PMDA. Stelmah has worked with innovative pharmaceutical organizations such as Alnylam Pharmaceuticals and Regeneron Pharmaceuticals, contributing to the commercialization of leading products like Praluent, Eylea, Kavzara, Dupixent, and Onpattro.
Dr. Rowlands is a seasoned regulatory strategist whose career spans 19 years at companies including Forest, Sanofi, Otsuka, NPS Pharma, InfaCare, and most recently at Actinium. Dr. Rowlands has worked closely with the FDA to develop and execute regulatory strategies for drug candidates for a wide range of innovative therapeutic indications. His work contributed to the filing and approval of Namenda, Natpara, and accelerated the development and early NDA filing of stannsoporfin for neonatal hyperbilirubinemia while at InfaCare.
Sanjeev Luther, Rafael Pharma’s President and Chief Executive Officer, said, “Rafael Pharmaceuticals recently initiated two Phase III multinational pivotal trials for pancreatic cancer and relapsed / refractory acute myeloid leukemia. The appointments of Mike Stelmah and Dr. Rowlands will strengthen the regulatory team and contribute significantly to the development of our lead drug, CPI-613 and our promising pipeline of cancer metabolism-based therapies.”
About Rafael Pharmaceuticals, Inc.
Rafael Pharmaceuticals, Inc. is a privately held clinical-stage, metabolic oncology therapeutics company committed to the development and commercialization of therapies that exploit the metabolic differences between normal cells and cancer cells. Rafael’s primary objective is to develop innovative, well tolerated and highly effective anti-cancer agents by selectively targeting altered metabolism in cancer cells. Rafael’s first-in-class clinical lead compound, CPI-613 is being evaluated in multiple Phase I, I/II, and II clinical studies. CPI-613 has been granted orphan drug designation for the treatment of Pancreatic Cancer, Acute Myeloid Leukemia (AML), Peripheral T-Cell Lymphoma (PTCL), Burkitt Lymphoma and myelodysplastic syndromes (MDS). The Company’s investors include Rafael Holdings, Inc. (NYSE American: RFL). For more information, visit http://www.rafaelpharma.com/.
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President & CEO, Rafael Pharmaceuticals, Inc.
Public Relations, Rafael Pharmaceuticals, Inc.