Thursday, June 15, 2017 7:30:14 AM
- Dr. Nitya Ray joins Actinium Executive Team with 30 years of radiopharmaceutical and biologics product development, manufacturing and strategic planning experience
- Also announced is the recent hiring of Dr. Ramesh Kashi and Mr. Vimal Patel who bring deep expertise in product development and manufacturing to enable expansion of operations
Sandesh Seth, Actinium’s Chairman and CEO said, “We are pleased to welcome Dr. Ray to the Actinium Executive Team. Dr. Ray is a leader with decades of relevant experience which includes development of antibodies, antibody drug conjugates, radiopharmaceuticals and small-molecule drugs. His proven track record with drug development, clinical and commercial manufacturing, supply chain management, and strategic planning expertise provides Actinium with the right blend of skills and experience that will not only enable the success of our current clinical trials but also help set the stage for our commercial operations. In this endeavor, he will be ably supported by his entire team which also includes recent hires Dr. Ramesh Kashi and Mr. Vimal Patel. We have added decades of invaluable knowledge and experience to Actinium’s product development capabilities. Given the late stage of development of Iomab-B and the ambitious plans we have for our Actimab drug candidates and alpha particle technology platform, we could not be more excited to welcome these new team members. I am delighted in our ability to recruit such strong talent as evidenced by these most recent additions and look forward to the contributions they will make to Actinium.”
Dr. Nitya Ray said, “I have spent virtually all of my career in radiopharmaceutical and antibody therapeutics drug development. Actinium’s radioimmunotherapies represent significant progression for the field and have the potential to dramatically improve outcomes for patients, especially in patients with hematologic malignancies, which are known to be radiosensitive. I could not think of a better time to join Actinium as my experience and knowledge can be applied to product development, manufacturing, and supply chain efforts to support Actinium’s late stage clinical development and to prepare for commercial manufacturing. Actinium has assembled a strong team that is growing rapidly and I look forward to working with my colleagues to build a leading radioimmunotherapy company.”
Dr. Ray joins Actinium from CytoDyn, Inc. where he was Sr. Vice President of Manufacturing and CMC Team Leader. At CytoDyn Dr. Ray developed robust and cost effective manufacturing processes for an antibody therapeutic drug candidate, currently in two Phase 3 clinical studies intended to treat and prevent HIV infection. Dr. Ray led a successful regulatory meetings with the FDA while simultaneously developing strategies for process development, scale-up, validation, commercial manufacturing, and supply chain to support potential commercialization of the CytoDyn’s HIV therapeutic drug candidate. Prior to CytoDyn, Dr. Ray spent 15 years at Progenics Pharmaceuticals, Inc., a radiopharmaceutical therapeutic and diagnostic company, most recently as Senior Vice President, Manufacturing. At Progenics, Dr. Ray led the development of scalable manufacturing processes and achieved order-of-magnitude cost reduction through improved productivity and scale. In addition, Dr. Ray built process and product development teams for Progenics’ small molecule, biologics, and radiopharmaceuticals that developed innovative processes for various phases of clinical development and commercial manufacturing. Dr. Ray supported in-house cGMP biologics manufacturing for Phase 1–3 clinical development and managed relationships with Contract Development and manufacturing Organizations (CDMO’s) on a global basis. Dr. Ray also worked at Hoffman-La Roche with a focus on biopharmaceuticals and Verax Corporation in roles of increasing responsibility. Dr. Ray has a Ph.D. in Biochemical Engineering and an M.S. in Chemical and Biochemical Engineering from Rutgers University and a B.S. in Chemical Engineering from Jadavpur University.
Dr. Ramesh Kashi joins Actinium from Merck & Co. where he led a functional group that performed formulation development, scale-up and technology transfer to enable good manufacturing practices (GMP) of clinical supplies for two antibody therapeutics. He also supported formulation development of Keytruda, a PD-1 inhibitor, other checkpoint inhibitors and therapeutic proteins. In addition, Dr. Kashi supported initiation of Phase 1 to 3 global clinical trials and provided chemistry, manufacturing and controls (CMC) related support on regulatory matters. Prior to Merck, Dr. Kashi worked at Agenus, Inc. in the Protein Support and Formulation Department where he worked on protein based therapeutics at R&D and manufacturing scales and supported biologic license application (BLA) efforts. In addition, Dr. Kashi has worked at Baxter Bioscience/Healthcare Corp., Diagnostics Products Corporation (acquired by Siemens) and Biogen, Inc. Dr. Kashi has a Ph.D. in Biochemistry from the Indian Institute of Science and completed Post-Doctoral research at Massachusetts General Hospital, Harvard Medical School and the New England Medical Center, Tufts Medical School. Dr. Kashi is also the author of several issued patents, pending patents and research publications.
Mr. Patel comes to Actinium from Pfizer where he was most recently a Senior Scientist focused on clinical and commercial processes for antibody drug conjugates (ADCs) and payloads. Mr. Patel supported processes for six ADCs and supported in-house manufacturing as well as outsourced manufacturing through CMOs. Prior to Pfizer, Mr. Patel was a Senior Scientist at Progenics Pharmaceuticals, Inc. where supported cGMP manufacturing of biologics for Phase 1 – 3 clinical development and optimized processes for antibody drug conjugation. Previously, Mr. Patel worked at SibTech as a Research Scientist where he worked on radiopharmaceuticals. Mr. Patel has a M.S. in Biotechnology from the University of Connecticut and a B.S. in Chemical Engineering from Sardar Patel University.
About Actinium Pharmaceuticals, Inc.
Actinium Pharmaceuticals, Inc. is a biopharmaceutical company developing innovative targeted therapies for patients with cancers lacking effective treatment options. Actinium's proprietary platform utilizes monoclonal antibodies to deliver radioisotopes directly to cells of interest in order to kill those cells safely and effectively. The Company's lead product candidate Iomab-B is designed to be used, upon approval, in preparing patients for a hematopoietic stem cell transplant, commonly referred to as bone marrow transplant. A bone marrow transplant is often the only potential cure for patients with blood-borne cancers but the current standard preparation for a transplant requires chemotherapy and/or total body irradiation that result in significant toxicities. Actinium believes Iomab-B will enable a faster and less toxic preparation of patients seeking a bone marrow transplant, leading to increased transplant success and survival rates. The Company is currently conducting a single pivotal 150-patient, multicenter Phase 3 clinical study of Iomab-B in patients with relapsed or refractory acute myeloid leukemia (AML) age 55 and older. The Company's second product candidate, Actimab-A, is currently in a multicenter open-label, 53-patient Phase 2 trial for patients newly diagnosed with AML age 60 and over. Actimab-A is being developed to induce remissions in elderly patients with AML who lack effective treatment options and often cannot tolerate the toxicities of standard frontline therapies. In addition, Actinium is developing Actimab-M, which is being studied in patients with relapsed or refractory multiple myeloma in a Phase 1 clinical trial. Actinium is also utilizing its alpha-particle immunotherapy (APIT) technology platform to generate new drug candidates based on antibodies linked to the element Actinium-225 that are directed at various cancers that are blood-borne or form solid tumors. Actinium Pharmaceuticals is based in New York, NY. To learn more about Actinium Pharmaceuticals, please visit http://www.actiniumpharma.com and to follow @ActiniumPharma on Twitter please visit, http://www.twitter.com/actiniumpharma.
Forward-Looking Statements for Actinium Pharmaceuticals, Inc.
This news release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause actual results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential, or financial performance. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Actinium Pharmaceuticals undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.
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