PHILADELPHIA, July 19, 2016 (GLOBE NEWSWIRE) -- Hemispherx Biopharma (NYSE MKT:HEB) announced today that it has bolstered its manufacturing and scientific capabilities with the promotion of Carol Smith, Ph.D., as Manager of Quality, the engagement of Step Change Pharma as an advisor to strengthen manufacturing and technical infrastructure, and the retention of Joseph C. Horvath, M.D., as a scientific advisor.
Dr. Smith will be responsible for all quality control and quality assurance for the manufacturing of Ampligen® and Alferon. She has more than 32 years of experience in the process development, manufacturing, and testing of antiviral drug products such as natural human alpha interferon, monoclonal antibodies, and double-stranded nucleic acids. She served as the Director of Manufacturing for alpha interferon and Manager of Quality Control in the biotech and pharmaceutical industries prior to joining Hemispherx as the Quality Control Manager in Rockville, Maryland in 1991. Since then, Dr. Smith has held several positions at Hemispherx, including Director of Manufacturing and Process Development for Ampligen® at the Rockville facility and VP of Operations as the Company expanded to the New Brunswick, New Jersey facility. She has played a critical role in the development of the analytical release test methods and in the development of the commercial manufacturing processes for Ampligen® and intermediate raw materials for Ampligen® at Contract Manufacturers (CMOs) and at the Hemispherx facility in New Brunswick. Dr. Smith has been involved in the successful inspection by the European Union of the manufacturing and quality control operations and in the successful FDA pre-approval inspection of the Ampligen® CMO in Spokane, Washington. Dr. Smith received a Ph.D. from the University of South Florida Medical School in Tampa, Florida, and an NIH Fellowship to continue her research endeavors at Hershey Medical in Hershey, Pennsylvania.
Step Change Pharma will be advising the Company on all forms of regulatory compliance and cGMP. The firm specializes in process design, re-design, and development; process analytical technology (PAT); quality by design (QbD); regulatory innovation (CMC assessment); establishing and advising regulatory process for interaction with regulatory bodies with the goal of helping companies maintain regulatory compliance; and preparation for FDA inspections and approvals. The firm’s principle, Ali Afnan, Ph.D., was a member of the Food and Drug Administration’s Drug Product Quality Initiative. He was a senior member of the agency’s PAT policy team and co-author of PAT Guidance, and is a former member of the team responsible for drafting and finalizing Process Validation Guidance.
Dr. Horvath will be advising the Company on scientific aspects of development, manufacturing, and regulatory of the Company’s clinical-stage candidates. Before re-joining the Company as a consultant, he served Hemispherx as the Director of Research and Development from 2007 – 2015 when his responsibilities included process development, method development, analytical method validation, among other related activities. Prior to joining Hemispherx, Dr. Horvath was the Scientific Director of the Biotherapeutic Research Laboratory at St. Joseph’s Hospital Cancer Institute in Tampa, Fla. where he was responsible for drafting clinical protocols and informed consent forms for clinical trials. His research resulted in 94 scientific publications. Dr. Horvath earned an M.D. at Semmelweis University Medical School in Budapest.
“The objective of enhancing the roles of these experienced professionals to the Hemispherx team are to make their vital manufacturing and scientific skill sets maximally available to the Company as we focus on advancing our two key assets, Alferon N Injection® and Ampligen®,” said Thomas Equels, CEO of Hemispherx Biopharma. “We look forward to their collective contributions as we approach the re-initiation of manufacturing at our New Brunswick facility and the further advancement of our drug candidates.”
About Hemispherx Biopharma:
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx’s flagship products include Alferon N Injection® and the experimental therapeutics Ampligen® and Alferon® LDO. Ampligen® is an experimental RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system, including Chronic Fatigue Syndrome. Hemispherx’s platform technology includes components for potential treatment of various severely debilitating and life threatening diseases. Because both Ampligen® and Alferon® LDO are experimental in nature, they are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials. Hemispherx has patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection®), approved for sale in the U.S. and Argentina. The FDA approval of Alferon N Injection® is limited to the treatment of refractory or recurrent external genital warts in patients 18 years of age or older. The Company’s Alferon N Injection® approval in Argentina includes the use of Alferon N Injection® (under the brand name "Naturaferon”) for use in any patients who fail, or become intolerant to recombinant interferon, including patients with chronic active hepatitis C infection. The Company wholly owns and exclusively operates a GMP certified manufacturing facility in the United States for commercial products. For more information, please visit www.hemispherx.net.
