Georgetown University School of Medicine

Sarah McGarry, M.D., Senior FDA Official in CDER and CBER, Joins Greenleaf Health

Retrieved on: 
Wednesday, November 8, 2023
FDA, COVID-19, Public Policy, Consulting, Pharmaceutical, Professional Services, Medical Devices, Infectious Diseases, Government, Science, Biotechnology, AIDS, Other Science, Health, Research, Georgetown University School of Medicine, Bioinformatics, CBER, Center for Biologics Evaluation and Research, Policy, Food, Infection, Duke University, SARS-CoV-2, Center for Drug Evaluation and Research, OND, HIV, CDER, Ritonavir, Senior, Marketing, Internal medicine, China Biologic Products, Associate, Food and Drug Administration, Pharmaceutical industry

Greenleaf Health, Inc. (Greenleaf), a leading consulting firm for companies regulated by the Food and Drug Administration (FDA), is pleased to announce that Sarah McGarry, M.D., has joined as Senior Vice President, Drug and Biological Products.

Key Points: 
  • Greenleaf Health, Inc. (Greenleaf), a leading consulting firm for companies regulated by the Food and Drug Administration (FDA), is pleased to announce that Sarah McGarry, M.D., has joined as Senior Vice President, Drug and Biological Products.
  • Throughout her 18-year FDA service, Sarah held multiple leadership, review, and advisory positions within the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).
  • Her knowledge of the FDA review process and regulatory policy will enrich the strategic and scientific guidance that Greenleaf provides to clients.
  • from Georgetown University Medical School and completed a residency in internal medicine and a fellowship in infectious diseases at Duke University.

Teva to Present New Data Supporting Safety, Efficacy and Real-World Effectiveness of AUSTEDO® (deutetrabenazine) Tablets at the 2023 HSG Annual Meeting

Retrieved on: 
Thursday, November 2, 2023
Health, Neurology, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, FDA, VMAT2, NNH, NYSE, Georgetown University School of Medicine, Medication, HD, MD, NNT, Psychiatry, START, Doctor of Philosophy, PGIC, TEVA, Yahoo Beijing Global R&D Center, Teva, Tetrabenazine, Interim, Annual general meeting, Teva Pharmaceuticals, TASE, TMC, Education, Safety, HSG, Patient, Pharmaceutical industry

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced new HD data will be presented at the Huntington Study Group® (HSG) Annual Meeting on November 2-4 in Phoenix, AZ.

Key Points: 
  • Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced new HD data will be presented at the Huntington Study Group® (HSG) Annual Meeting on November 2-4 in Phoenix, AZ.
  • TMC scores mostly improved with AUSTEDO treatment, and the safety profile was consistent with AUSTEDO’s known safety profile.
  • NNTs for treatment success based on CGIC and PGIC ranged from 3-4 and 4-5, respectively, for the VMAT2 inhibitors.
  • Significant NNHs included:
    Together, the data provide additional insight into the real-world efficacy and safety of AUSTEDO for patients with HD chorea.

Endeavor BioMedicines Appoints Paul Frohna, M.D., Ph.D., as Chief Medical Officer

Retrieved on: 
Thursday, November 2, 2023
Oncology, Health, Other Science, Clinical Trials, Research, Science, Georgetown University School of Medicine, Infection, III, Fibrosis, Idiopathic pulmonary fibrosis, Entrepreneurship, IPF, Development, BMS, B cell, Growth, ADC, Research and development, University, Austin College, Multiple sclerosis, Genentech, Cancer, Therapy, Patient, Moses Austin, Lymphoma, Pharmaceutical industry, Pharmacy, Endeavour, Pharmacology

Endeavor BioMedicines , a clinical-stage company developing therapies for of fibrotic disease and oncology, today announced the appointment of Paul Frohna, M.D., Ph.D., as its Chief Medical Officer.

Key Points: 
  • Endeavor BioMedicines , a clinical-stage company developing therapies for of fibrotic disease and oncology, today announced the appointment of Paul Frohna, M.D., Ph.D., as its Chief Medical Officer.
  • “We’re pleased to welcome Paul as our Chief Medical Officer, and we look forward to his leadership as we progress our pipeline of therapies for patients with fibrosis and cancer,” said John Hood, Ph.D., Co-Founder, CEO and Chairman, Endeavor BioMedicines.
  • “It is a privilege to join Endeavor as the company enters its next stage of growth," said Dr. Frohna.
  • He has successfully designed and initiated translational and clinical programs for biologics, small molecules and stem cells across multiple therapeutic areas.

Chief Research Officer at US Fertility, Kate Devine, M.D., receives prestigious award from ASRM

Retrieved on: 
Wednesday, October 18, 2023
American Society for Reproductive Medicine, SART, Publishing, Ira, Fertility, Medical director, Congress, K Street, Yale Physician Associate Program, Research, SGF, Society, Letter, Reproductive medicine, LOS, Assisted reproductive technology, ASRM, Opening ceremony, NIH, Georgetown University School of Medicine, Patient, Bangladesh Technical Education Board, Birth control, Pharmaceutical industry, Medicine, Infertility

LOS ANGELES, Oct. 18, 2023 /PRNewswire-PRWeb/ -- US Fertility celebrates, Kate Devine, M.D., Medical Director and Chief Research Officer, who received the Ira and Ester Rosenwaks New Investigator Award of the American Society for Reproductive Medicine for 2023.

Key Points: 
  • , Medical Director and Chief Research Officer, who received the Ira and Ester Rosenwaks New Investigator Award of the American Society for Reproductive Medicine for 2023.
  • "I am incredibly humbled to receive such an honor and send gratitude to ASRM and my physician peers who have supported me," shares Dr. Devine.
  • The award was announced during ASRM's Opening Ceremony on Monday, October 16, 2023 and presented during the ASRM Research Symposium on Wednesday, October 18, 2023.
  • Learn more about US Fertility's Research Division , which conducts and publishes high-quality research studies to advance the field of reproductive medicine to provide better, more effective care to infertility patients.

EmVenio Research continues momentum of team growth with two new principal investigators

Retrieved on: 
Thursday, September 21, 2023
Molecular biology, Doctor of Medicine, University, Diabetes, Internal medicine, Smoking and Health: Report of the Advisory Committee to the Surgeon General of the United States, Physician, American Board of Internal Medicine, Georgetown University School of Medicine, Cardiovascular disease, Infection, University School, Physiology, DRS, Research, Georgetown University, American Board of Commissioners for Foreign Missions, Health care access among Dalits in India, Indiana University School of Medicine, Surgeon, Accreditation, Knowledge, Growth, Jan Vansina, National Board of Medical Examiners, Pharmaceutical industry, Medical device, Nursing, Science, Indiana University

DURHAM, N.C., Sept. 21, 2023 /PRNewswire/ -- Clinical research organization EmVenio Research recently announced the addition of Michelle Mallitz, M.D. and Thomas Wade, M.D. to its team to serve as principal investigators. In their roles, they will oversee and conduct objective clinical research to ensure independent, high quality and reproducible results, as well as manage oversight of compliance, financial, personnel and other related aspects of research projects. Coming from varying medical backgrounds, Drs. Mallitz and Wade bring a depth of knowledge and experience to the EmVenio team, allowing the research organization to conduct trials addressing a wider range of infectious diseases and therapeutic areas.

Key Points: 
  • DURHAM, N.C., Sept. 21, 2023 /PRNewswire/ -- Clinical research organization EmVenio Research recently announced the addition of Michelle Mallitz, M.D.
  • "The addition of these two incredible principal investigators is proof that EmVenio's growth is focused on quality and not quantity," said Thad Wolfram, EmVenio president.
  • "These individuals bring a level of expertise and skill that opens more doors for our team to conduct a multitude of research studies for pharmaceutical sponsors and clinical research organizations.
  • Dr. Thomas Wade holds nearly 23 years of medical practice and clinical research experience, serving as a principal investigator and practicing internal medicine.

Urology Care Foundation Announces 2023 Humanitarian Grant Recipients

Retrieved on: 
Tuesday, August 1, 2023
Kidney, COSECSA, American Urological Association, Patient, Erectile dysfunction, Health, Prostate cancer, University, Research, Children, Singal, Georgetown University School of Medicine, Urinary incontinence, University of Washington School of Medicine, Obstetrics, Hospital, Woman, FRCSC, Health education, Children's Hospital of Philadelphia, Incontinence, Michael Garron Hospital, Philadelphia, Medicine, Gynaecology, Urology, International Organization (journal), Microprocessor, Detroit Black Community Food Security Network, College, Education, Exelixis, Black, Surgeon, Bladder exstrophy, Health literacy, Nursing, Pharmaceutical industry, MD

BALTIMORE, Aug. 1, 2023 /PRNewswire/ -- The Urology Care Foundation, the world's leading nonprofit urological health foundation and official foundation of the American Urological Association, is pleased to announce the 2023 Urology Care Foundation Humanitarian Grant recipients.

Key Points: 
  • BALTIMORE, Aug. 1, 2023 /PRNewswire/ -- The Urology Care Foundation, the world's leading nonprofit urological health foundation and official foundation of the American Urological Association, is pleased to announce the 2023 Urology Care Foundation Humanitarian Grant recipients.
  • As one of the world's largest urology-specific humanitarian-focused grant programs, the Urology Care Foundation Humanitarian Grants aids the efforts of urologists and projects providing patient care and education in underserved areas, either within the United States or worldwide.
  • Fox Foundation Humanitarian Endowment, the Nathirmal N. Lalchandani Humanitarian Endowment, the Endourological Society Raju and Ginny Thomas Humanitarian Endowment, the Indian American Urological Association Humanitarian Endowment and from an Exelixis grant, and other contributors.
  • Learn more about the Urology Care Foundation Humanitarian Grant Program and the work of the 2023 grant recipients: https://www.urologyhealth.org/humanitarianism/humanitarian-recognition-a...

Innoviva Specialty Therapeutics Announces FDA Approval for XACDURO® (sulbactam for injection; durlobactam for injection), Co-packaged for Intravenous Use

Retrieved on: 
Tuesday, May 23, 2023
Biotechnology, Pharmaceutical, Managed Care, Health, FDA, Infectious Diseases, Hospitals, Clinical Trials, Priority review, Ventilator-associated pneumonia, D.C, QIDP, Public, Infection, Georgetown University School of Medicine, New Drug Application, NDA, Colistin, MBA, Acinetobacter, Patient, Physician, Sulbactam, Disease, Fungal infection, Mortality, Nursing care plan, Therapy, MPH, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Safety, Pharmaceutical industry, MD

Innoviva Specialty Therapeutics is focused on delivering innovative therapies in critical care and infectious disease.

Key Points: 
  • Innoviva Specialty Therapeutics is focused on delivering innovative therapies in critical care and infectious disease.
  • “XACDURO is the first pathogen-targeted therapy approved to treat hospital-acquired and ventilator-associated pneumonias caused by Acinetobacter.
  • The FDA approval of XACDURO marks an important milestone in our aim to deliver differentiated therapies to critically ill patients who have limited treatment options,” said David Altarac, MD, Chief Medical Officer, Innoviva Specialty Therapeutics.
  • “Acinetobacter poses a significant danger to hospitalized patients, who are generally very ill and particularly susceptible to infections.

Children's Hospital of Philadelphia Appoints New Urology Division Chief

Retrieved on: 
Tuesday, May 2, 2023
University, Psychology, Georgetown University School of Medicine, Perelman School of Medicine at the University of Pennsylvania, Medicine, Endocrinology, National Association Medical Staff Services, CHOP, Genetics, Howard, Pediatric urology, Naval Medical Center San Diego, Philadelphia, Differentiable function, Associate, Ethics committee, American Board of Commissioners for Foreign Missions, Test management, Villanova University, Fertility preservation, Surgeon, Book, Independent practice association, Texas Children's Hospital, Snyder, MD, Patient, Division, Treatment, Executive Committee, Hospital, Textbook, S-1 Executive Committee, NIH, Prostate cancer, Children's Hospital of Philadelphia, Nursing, Child, Match, Urology

PHILADELPHIA, May 2, 2023 /PRNewswire/ -- Children's Hospital of Philadelphia (CHOP) has named Thomas F. Kolon, MD, as Chief of the Division of Urology. Dr. Kolon has served as the Associate Chief of CHOP's Division of Urology since 2014 and is a Professor of Urology at the Perelman School of Medicine at the University of Pennsylvania. He is an expert in the care of children with genital disorders and renal, bladder, and prostate cancer and has helped develop creative 3-D printing models for planning safe organ-sparing surgery. A talented and accomplished researcher and physician, Dr. Kolon holds the Howard M. Snyder III Endowed Chair in Pediatric Urology at CHOP.

Key Points: 
  • PHILADELPHIA, May 2, 2023 /PRNewswire/ -- Children's Hospital of Philadelphia (CHOP) has named Thomas F. Kolon, MD, as Chief of the Division of Urology.
  • Dr. Kolon has served as the Associate Chief of CHOP's Division of Urology since 2014 and is a Professor of Urology at the Perelman School of Medicine at the University of Pennsylvania.
  • Following his pediatric urology fellowship at Texas Children's Hospital, he served as Director of Pediatric Urology at the Naval Medical Center-San Diego.
  • Dr. Kolon is currently the executive secretary for the Pediatric Urology Advisory Council to the American Board of Urology.

BPGbio Announces Oncology Drug Pipeline and Prostate Cancer Biomarker Developments at AACR

Retrieved on: 
Wednesday, April 12, 2023
Research, Technology, Infectious Diseases, Neurology, Biotechnology, Pharmaceutical, Health, Science, Oncology, Artificial Intelligence, Uniformed Services University of the Health Sciences, Nintendo Integrated Research & Development, AACR, Therapy, Molecule, Georgetown University School of Medicine, Polymerization, Autonomous university, American Association for Cancer Research, Military medicine, Henry M. Jackson Foundation for the Advancement of Military Medicine, Biochemistry, Secretaria Nacional de Ciencia y Tecnologia, Cell biology, MD, Prostate, Risk, Walter Reed National Military Medical Center, Outline of health sciences, MA, AI, Rare, PSA, National Autonomous University of Mexico, Biopsy, Pharmaceutical industry, Cancer

“BPGbio has continued to advance our research in both therapeutics and diagnostics through our Interrogative Biology platform,” said Niven R. Narain, Ph.D , President & CEO.

Key Points: 
  • “BPGbio has continued to advance our research in both therapeutics and diagnostics through our Interrogative Biology platform,” said Niven R. Narain, Ph.D , President & CEO.
  • “We are pleased to present our data on BRG-399 at AACR, which is showing promising advancements towards pan-cancer activity.
  • BRG399 is leading the new oncology drug pipeline for BPGbio including those uniquely targeting E2 enzymes.
  • BPGbio’s prostate health screening panel is a blood-based test, and it provides guidance in men with BPH/LUTS (enlarged prostate) to determine their risk of detecting aggressive prostate cancer, avoiding the need for unnecessary biopsies.

Transcarent Announces Randy K. Hawkins, M.D. as Chief Medical Officer

Retrieved on: 
Thursday, March 16, 2023
General Health, Health Technology, Health, Practice Management, Storm, Multimedia, Durrow healthcare consultancy, U.S. Navy Diving Manual, EVP, Physician, Dartmouth College, Anesthesiology, Military medicine, Patient, Gulf War, Georgetown University School of Medicine, University of Florida College of Medicine-Jacksonville, Florida College, Safety, Private practice, University, Glen Tullman, Nursing, Transcare EMS

Transcarent , a health and care experience company that makes it easy for people to access high-quality, affordable care announced today that Dr. Randy Hawkins has joined the organization as Chief Medical Officer.

Key Points: 
  • Transcarent , a health and care experience company that makes it easy for people to access high-quality, affordable care announced today that Dr. Randy Hawkins has joined the organization as Chief Medical Officer.
  • Reporting to Transcarent Chief Executive Officer, Glen Tullman, Dr. Hawkins will oversee the organization’s clinical quality initiatives and support the organization’s health analytics strategy.
  • Dr. Hawkins joins Transcarent from Carrum where he was the Chief Medical Officer.
  • Previously, he served as Chief Medical Officer and EVP, Health Analytics at ConsumerMedical and he has also served in other senior clinical roles over his career at Connance, Glytec, and PatientKeeper, where he focused on patient safety and interoperability as their Chief Medical Information Officer.