Sanofi S.A. is a French multinational pharmaceutical and healthcare company headquartered in Paris,France. The corporation was established in 1973 and merged with Synthélabo in 1999 to form Sanofi-Synthélabo. In 2004,Sanofi-Synthélabo merged with Aventis and renamed to Sanofi-Aventis,which were each the product of several previous mergers. It changed its name back to Sanofi in May 2011. The company is a component of the Euro Stoxx 50 stock market index. In 2023,the company’s seat in Forbes Global 2000 was 89.
The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the U.S. Food and Drug Administration (FDA),which is a part of the U.S. Department of Health and Human Services. The current Director of CBER is Peter Marks,M.D.,PhD. CBER is responsible for assuring the safety,purity,potency,and effectiveness of biologics and related products. Not all biologics are regulated by CBER. Monoclonal antibodies and other therapeutic proteins are regulated by the FDA Center for Drug Evaluation and Research (CDER).
Regeneron Pharmaceuticals,Inc. is an American biotechnology company headquartered in Westchester County,New York. The company was founded in 1988. Originally focused on neurotrophic factors and their regenerative capabilities,giving rise to its name,the company then branched out into the study of both cytokine and tyrosine kinase receptors,which gave rise to their first product,which is a VEGF-trap.
Stephen Michael Hahn is an American physician who served as the commissioner of food and drugs from 2019 to 2021. Before becoming commissioner,he was an oncologist serving as chief medical executive of the MD Anderson Cancer Center. In 2021,he became chief medical officer at Flagship Pioneering,the venture capital firm that launched Moderna.
ARIAD Pharmaceuticals,Inc. was an American oncology company,now part of Takeda Oncology,which was founded in 1991 by Harvey J. Berger,M.D. and headquartered in Cambridge,Massachusetts. ARIAD engaged in the discovery,development,and commercialization of medicines for cancer patients.
Jonathan W. Simons is an American physician-scientist,medical oncologist,and leader in prostate cancer research. In August 2021,Simons was appointed the medical director and Chief Science Officer of the Marcus Foundation. Prior to joining the Marcus Foundation,he served a 14-year tenure as the President and chief executive officer of the Prostate Cancer Foundation. Simons’laboratories,partly funded by the Prostate Cancer Foundation,at Johns Hopkins University and Emory University made original contributions to understanding the molecular biology of prostate cancer metastasis and principles of “broken immune tolerance”via T cell based immunotherapy for prostate cancer. The Simons lab invented GM-CSF genetically engineered vaccines for prostate cancer in rodents and humans for these studies,and subsequently Simons’clinical team took the biotechnology into the world’s first human gene therapy clinical trials for advanced prostate cancer at Johns Hopkins.
Spectrum Pharmaceuticals,Inc. is an American biopharmaceutical company located in Boston,MA. It develops and markets drugs for treatments in hematology and oncology.
Brett P. Giroir is an American pediatrician. He was formerly the U.S. assistant secretary for health,a four-star admiral in the U.S. Public Health Service Commissioned Corps and an acting Food and Drug Administration commissioner.
Novavax,Inc. is an American biotechnology company based in Gaithersburg,Maryland,that develops vaccines to counter serious infectious diseases. Prior to 2020,company scientists developed experimental vaccines for influenza and respiratory syncytial virus (RSV),as well as Ebola and other emerging infectious diseases. During 2020,the company redirected its efforts to focus on development and approval of its NVX-CoV2373 vaccine for COVID-19.
Edith A. Pérez is a Puerto Rican hematologist-oncologist. She is the Serene M. and Frances C. Durling Professor of Medicine at the Mayo Clinic Alix School of Medicine.
Thomas P. Stossel was an American hematologist,inventor,medical researcher,and writer who discovered gelsolin and invented the BioAegis technology estate. He was also a professor emeritus of medicine at Harvard Medical School and a professor emeritus of clinical research at the American Cancer Society. He was Chief Scientific Advisor to BioAegis Therapeutics Inc.,a clinical-stage biotech company developing a non-immunosuppressive anti-inflammatory with the potential to address a wide range of infectious,inflammatory,and degenerative diseases.
Robert Peter Kadlec is an American physician and career officer in the United States Air Force who served as Assistant Secretary of Health and Human Services from August 2017 until January 2021. He is responsible for the creation of the COVID-19 vaccine development program Operation Warp Speed.
COVID-19 drug development is the research process to develop preventative therapeutic prescription drugs that would alleviate the severity of coronavirus disease 2019 (COVID-19). From early 2020 through 2021,several hundred drug companies,biotechnology firms,university research groups,and health organizations were developing therapeutic candidates for COVID-19 disease in various stages of preclinical or clinical research,with 419 potential COVID-19 drugs in clinical trials,as of April 2021.
Operation Warp Speed (OWS) was a public–private partnership initiated by the United States government to facilitate and accelerate the development,manufacturing,and distribution of COVID-19 vaccines,therapeutics,and diagnostics. The first news report of Operation Warp Speed was on April 29,2020,and the program was officially announced on May 15,2020. It was headed by Moncef Slaoui from May 2020 to January 2021 and by David A. Kessler from January to February 2021. At the end of February 2021,Operation Warp Speed was transferred into the responsibilities of the White House COVID-19 Response Team.
Moncef Mohamed Slaoui is a Moroccan-born Belgian-American researcher who served as the head of Operation Warp Speed (OPWASP) under President Donald Trump from 2020 to 2021.
SARS-CoV-2,the virus that causes COVID-19,was isolated in late 2019. Its genetic sequence was published on 11 January 2020,triggering an urgent international response to prepare for an outbreak and hasten the development of a preventive COVID-19 vaccine. Since 2020,vaccine development has been expedited via unprecedented collaboration in the multinational pharmaceutical industry and between governments. By June 2020,tens of billions of dollars were invested by corporations,governments,international health organizations,and university research groups to develop dozens of vaccine candidates and prepare for global vaccination programs to immunize against COVID‑19 infection. According to the Coalition for Epidemic Preparedness Innovations (CEPI),the geographic distribution of COVID‑19 vaccine development shows North American entities to have about 40% of the activity,compared to 30% in Asia and Australia,26% in Europe,and a few projects in South America and Africa.
Michael Joseph Mina is an American epidemiologist,immunologist and physician. He was formerly an assistant professor of Epidemiology &Immunology and Infectious Diseases at Harvard T.H. Chan School of Public Health,assistant Professor of Pathology at Brigham and Women's Hospital,Harvard Medical School,and currently Chief Medical Officer at eMed.
Bob Löwenberg is a clinical hematologist/investigator. He is Professor of Hematology at Erasmus University Rotterdam.
John R. Mascola is an American physician-scientist,immunologist and infectious disease specialist. He was the director of the Vaccine Research Center (VRC),part of the National Institute of Allergy and Infectious Diseases (NIAID),National Institutes of Health (NIH). He also served as a principal advisor to Anthony Fauci,director of NIAID,on vaccines and biomedical research affairs. Mascola is the current Chief Scientific Officer for ModeX Therapeutics.
Richard B. Gaynor is an American physician specializing in hematology-oncology,educator,drug developer,and business executive. He served as an Associate Professor of Medicine at UCLA School of Medicine for nearly a decade,and subsequently as an endowed Professor of Medicine and Microbiology at the University of Texas Southwestern Medical School prior to joining the pharmaceutical industry in 2002. His research on NF-κB,IκB kinase,and other mechanisms regulating viral and cellular gene expression has been covered in leading subject reviews. He has been a top executive at several pharmaceutical companies,with respect to the development and clinical testing of novel anticancer drugs and cell therapies. For over a decade and a half,he worked at Eli Lilly and Company,where he became the Senior Vice President of Oncology Clinical Development and Medical Affairs in 2013. Gaynor was President of R&D at Neon Therapeutics from 2016 to 2020,when he became the President of BioNTech US,both pharmaceutical companies headquartered in Cambridge,MA. His honors include being elected a member of the American Society for Clinical Investigation,and the Association of American Physicians.
