Chief Medical Officer (Ireland)

Target RWE Releases Important Updates on the Cirrhosis Quality Collaborative/TARGET-Liver Disease Partnership with the American Association for the Study of Liver Diseases

Retrieved on: 
Friday, November 10, 2023

DURHAM, N.C., Nov. 10, 2023 /PRNewswire/ -- Real-world evidence (RWE) leader Target RWE announced today that the CQC and TARGET-Liver Disease (LD) partnership with the American Association for the Study of Liver Diseases (AASLD) has enrolled approximately 75,000 patients.

Key Points: 
  • DURHAM, N.C., Nov. 10, 2023 /PRNewswire/ -- Real-world evidence (RWE) leader Target RWE announced today that the CQC and TARGET-Liver Disease (LD) partnership with the American Association for the Study of Liver Diseases (AASLD) has enrolled approximately 75,000 patients.
  • Target RWE has enrolled approximately 75,000+ patients under the TARGET-LD protocol to support AASLD/CQC.
  • The strategic partnership between Target RWE and AASLD is designed to fulfill the unmet need for a large, real-world registry of patients with chronic liver diseases.
  • "These liver diseases are growing in prevalence and are placing a tremendous burden on healthcare systems around the world.

Ayala Pharmaceuticals Presents Updated AL102 Results from Phase 2 Clinical Trial in Desmoid Tumors at ESMO Congress 2023

Retrieved on: 
Monday, October 23, 2023

REHOVOT, Israel and MONMOUTH JUNCTION, N.J., Oct. 23, 2023 (GLOBE NEWSWIRE) -- Ayala Pharmaceuticals, Inc. (OTCQX: ADXS), a clinical-stage oncology company, today announced that new data from the RINGSIDE study evaluating its lead investigational candidate AL102 for the treatment of desmoid tumors (DT) are being presented today at the European Society for Molecular Oncology (ESMO) Congress 2023, taking place October 20th to 24th in Madrid, Spain. The data are from Phase 2 (Part A) of the study and from the Open Label Extension (OLE). The results are featured in a poster being presented by Professor Robin Jones, Team Leader in Sarcoma Clinical Trials at The Institute of Cancer Research and Consultant Medical Oncologist at The Royal Marsden, UK.

Key Points: 
  • The data are from Phase 2 (Part A) of the study and from the Open Label Extension (OLE).
  • The results are featured in a poster being presented by Professor Robin Jones, Team Leader in Sarcoma Clinical Trials at The Institute of Cancer Research and Consultant Medical Oncologist at The Royal Marsden, UK.
  • “The RINGSIDE results continue to improve over time, with more patients in this latest Phase 2 and OLE data cut demonstrating responses to treatment with AL102,” said Kenneth Berlin, President and CEO of Ayala.
  • The safety results appear consistent with the GSI class.”
    The ongoing Phase 2/3 RINGSIDE clinical trial is a randomized, global multi-center study evaluating AL102 in patients with progressing desmoid tumors.

HerMD Expands Healthcare Team with New Chief Medical Officer Dr. Michael Krychman

Retrieved on: 
Tuesday, October 3, 2023

CINCINNATI, Oct. 3, 2023 /PRNewswire-PRWeb/ -- HerMD, the female-founded physician-led women's health provider committed to revolutionizing women's healthcare strengthens their leadership team with the advancement of Dr. Michael Krychman from Vice President of Medical Affairs and Mental Health Services to Chief Medical Officer.

Key Points: 
  • With this transition as Chief Medical Officer, Dr. Krychman will leverage his expert knowledge and experience to drive HerMD's mission of delivering accessible, comprehensive women's healthcare.
  • "Dr. Krychman has been a trailblazer in women's menopausal and sexual health with a key understanding of both patient and provider experience," says Dr. Somi Javaid, Founder and Lead Chief Medical Officer of HerMD.
  • As Dr. Krychman assumes the role of Chief Medical Officer at HerMD, he will deepen his pivotal role in shaping the organization's strategic direction to bring menopause and sexual healthcare to women through evidence-based treatment options.
  • Founder Dr. Somi Javaid will transition to the role of Lead Chief Medical Officer, continuing to shape the many ways in which HerMD revolutionizes women's health care.

Intra-Cellular Therapies Announces Presentations at Psych Congress 2023 Including Positive Results from Study 403 in Mixed Features

Retrieved on: 
Monday, September 11, 2023

“We are very excited to share additional lumateperone data including the positive results from Study 403.

Key Points: 
  • “We are very excited to share additional lumateperone data including the positive results from Study 403.
  • Study 403 is the first prospective double-blind placebo-controlled study in patients with either MDD or bipolar depression exhibiting mixed features based on DSM-5 criteria,” said Dr. Suresh Durgam, Executive Vice President and Chief Medical Officer of Intra-Cellular Therapies.
  • “Patients with mixed features have greater severity of illness, respond poorly to antidepressants and present a high cost to the healthcare system.
  • There were no notable changes in weight, body mass index, or waist circumference and no clinically relevant changes in metabolic parameters.

Curium Announces Publication of [18F]DCFPyL Versus [18F]Fluoromethylcholine Results From European Phase III Study (PYTHON Trial)

Retrieved on: 
Friday, July 21, 2023

PARIS, July 21, 2023 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, announced today the publication of the results of its European, multicenter, prospective cross-over clinical trial which compared [18F] piflufolastat ([18F]DCFPyL) versus [18F]fluoromethylcholine PET/CT in patients with first biochemical recurrence of prostate cancer.

Key Points: 
  • PARIS, July 21, 2023 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, announced today the publication of the results of its European, multicenter, prospective cross-over clinical trial which compared [18F] piflufolastat ([18F]DCFPyL) versus [18F]fluoromethylcholine PET/CT in patients with first biochemical recurrence of prostate cancer.
  • The results of the PYTHON trial were published online ahead of print in the European Journal of Nuclear Medicine and Molecular Imaging in June 2023.
  • The PYTHON Study (NCT04734184) was a Phase III, European, multicenter, prospective cross-over trial, to evaluate and compare the detection rates, impact on patient management and safety profiles of [18F]DCFPyL and [18F]fluoromethylcholine, in patients with first biochemical recurrence after initial definitive therapy with curative intent.
  • This study successfully met the primary endpoint.

Vera Therapeutics Appoints Kerry Cooper, M.D., as Senior Vice President of Medical Affairs

Retrieved on: 
Thursday, May 4, 2023

BRISBANE, Calif., May 04, 2023 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological disease, today announced the appointment of Kerry Cooper, M.D., to the role of Senior Vice President, Medical Affairs, where he will report to Chief Medical Officer Celia Lin and be responsible for overseeing medical affairs strategy and scientific communications.

Key Points: 
  • BRISBANE, Calif., May 04, 2023 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological disease, today announced the appointment of Kerry Cooper, M.D., to the role of Senior Vice President, Medical Affairs, where he will report to Chief Medical Officer Celia Lin and be responsible for overseeing medical affairs strategy and scientific communications.
  • He has led medical affairs strategies for drug development programs in chronic kidney disease (CKD), hyperparathyroidism, hyperkalemia and other renal conditions.
  • Over twelve years, he served in leadership roles in medical affairs at several leading pharmaceutical companies, including AstraZeneca and Amgen, where he served as Global Medical Affairs Leader for Nephrology.
  • He joins Vera from ProKidney, where he led the development of the medical affairs function.

Stimufend® (pegfilgrastim-fpgk) Now Available in the United States

Retrieved on: 
Thursday, February 16, 2023

Stimufend is available in a single-dose, pre-filled syringe that delivers 6mg/0.6mL solution for subcutaneous injection.

Key Points: 
  • Stimufend is available in a single-dose, pre-filled syringe that delivers 6mg/0.6mL solution for subcutaneous injection.
  • Additionally, more than 220 chemotherapy regimens can be supported entirely by administering Fresenius Kabi products.
  • Limitations of Use: Stimufend® is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
  • To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

11th Chief Medical Officer Summit 360° Agenda and Keynotes Announced from The Conference Forum

Retrieved on: 
Thursday, December 15, 2022

NEW YORK, Dec. 15, 2022 /PRNewswire-PRWeb/ -- The Conference Forum is pleased to announce the agenda and keynote speakers for the 11th annual Chief Medical Officer Summit 360°, the only conference dedicated to supporting the role of the Chief Medical Officer in emerging biotechs. The CMO Summit 360° will take place in Boston on April 4-5.

Key Points: 
  • The Conference Forum is pleased to announce the agenda and keynote speakers for the 11th annual Chief Medical Officer Summit 360, the only conference dedicated to supporting the role of the Chief Medical Officer in emerging biotechs.
  • NEW YORK, Dec. 15, 2022 /PRNewswire-PRWeb/ -- The Conference Forum is pleased to announce the agenda and keynote speakers for the 11th annual Chief Medical Officer Summit 360, the only conference dedicated to supporting the role of the Chief Medical Officer in emerging biotechs.
  • The CMO Summit 360 will take place in Boston on April 4-5.
  • "The two-day CMO Summit has over 60 biotech Chief Medical Officers speaking in over 40 sessions.

Vor Bio Reports Third Quarter 2022 Financial Results and Provides Company Update

Retrieved on: 
Thursday, November 10, 2022

Initiated in-house clinical manufacturing at Cambridge, MA headquarters

Key Points: 
  • Initiated in-house clinical manufacturing at Cambridge, MA headquarters
    CAMBRIDGE, Mass., Nov. 10, 2022 (GLOBE NEWSWIRE) -- Vor Bio (Nasdaq: VOR), a clinical-stage cell and genome engineering company, today reported financial results for the three-month period ended September 30, 2022 and provided a business update.
  • Research & Development (R&D) Expenses: R&D expenses for the third quarter of 2022 were $16.9 million, compared to $12.9 million for the third quarter of 2021.
  • General & Administrative (G&A) Expenses: G&A expenses for the third quarter of 2022 were $7.2 million, compared to $5.7 million for the third quarter of 2021.
  • Net Loss: Net loss for the third quarter of 2022 was $23.8 million, compared to $18.6 million for the third quarter of 2021.

Solera Appoints New Chief Financial Officer and Chief Medical Officer

Retrieved on: 
Monday, June 6, 2022

PHOENIX, June 6, 2022 /PRNewswire/ -- Solera Health, the premier platform for connecting people seamlessly and easily to health solutions that work, announces the appointment of Bill Perilli as Chief Financial Officer and Dr. Byron Crowe as Chief Medical Officer.

Key Points: 
  • Crowe currently serves as a faculty member at Harvard Medical School and practices clinically at Beth Israel Deaconess Medical Center in Boston.
  • His work in improving health systems at scale has spanned large academic medical centers, international non-profits and digital health innovators.
  • I'm very excited to join as the Chief Medical Officer at this pivotal stage and further expand access to groundbreaking, evidence-based digital programs to patients nationwide."
  • Solera strategically matches consumers to their best-fit solution and helps keep them engaged for successful health outcomes.