Clinical pharmacology

Anavex Life Sciences Announces Expansion of Leadership Team

Retrieved on: 
Mercoledì, Maggio 22, 2024

“The most important part of building a long-term, commercially sustainable, growing business is putting the right players on the field,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex.

Key Points: 
  • “The most important part of building a long-term, commercially sustainable, growing business is putting the right players on the field,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex.
  • Prior to Anavex Dr. Lopez-Talavera held key leadership positions at Fractyl Health, Intercept Pharmaceuticals, AbbVie, Bristol Myers Squibb and Roche.
  • Dr. Edwards brings to Anavex 18 years of experience in various aspects of drug development including DMPK (drug metabolism and pharmacokinetics), Clinical Pharmacology, and Clinical Science.
  • Before joining Anavex, Dr. Edwards served as Vice President of Clinical Science at Acer Therapeutics, and positions of increasing responsibility at Madrigal Pharmaceuticals, Intercept Pharmaceuticals, Amylin Pharmaceuticals, and Arena Pharmaceuticals.

Get Your Study Enrolled - Designing Your Impairment Protocol to Prevent Challenges, Upcoming Webinar Hosted by Xtalks

Retrieved on: 
Lunedì, Aprile 22, 2024

TORONTO, April 22, 2024 /PRNewswire-PRWeb/ -- As drug development progresses, regulators require clarity on how products are metabolized in the human body, and the risks associated with compounds that may linger in critical organs.

Key Points: 
  • In this free webinar, learn how renal impairment study protocols can be improved to maximize patient enrollment.
  • Making informed decisions about the design of a study protocol is important, as overly complex protocols can quickly narrow the patient population.
  • Therefore, making informed decisions about the design of a study protocol is important, as overly complex protocols can quickly narrow the patient population.
  • Register for this webinar to understand how impairment study protocols can be improved to maximize patient enrollment.

Critical Path Institute Appoints Dr. Klaus Romero as New CEO and Promotes Cécile Ollivier to Vice President of Global Affairs

Retrieved on: 
Giovedì, Gennaio 25, 2024

AMSTERDAM, Jan. 25, 2024 /PRNewswire/ -- Critical Path Institute (C-Path) has named Klaus Romero, M.D., M.S., FCP, as its new Chief Executive Officer and promoted Cécile Ollivier, M.S., from Managing Director, Europe to Vice President of Global Affairs.

Key Points: 
  • AMSTERDAM, Jan. 25, 2024 /PRNewswire/ -- Critical Path Institute (C-Path) has named Klaus Romero, M.D., M.S., FCP, as its new Chief Executive Officer and promoted Cécile Ollivier, M.S., from Managing Director, Europe to Vice President of Global Affairs.
  • We are confident in his capacity to propel the organization forward in its next phase of global impact and pioneering innovation."
  • "Assuming the position of CEO at C-Path represents a profound honor, coupled with a tremendous sense of responsibility," said Romero.
  • "We are thrilled to announce the promotion of Cécile Ollivier to Vice President of Global Affairs," said C-Path Board member Tomas Salmonson Ph.D., M.S.

C-Path Appoints Dr. Klaus Romero as New CEO

Retrieved on: 
Martedì, Gennaio 9, 2024

TUCSON, Ariz., Jan. 9, 2024 /PRNewswire/ -- Critical Path Institute (C-Path) today announced that Klaus Romero, M.D., M.S., FCP, has been named its new Chief Executive Officer. Romero, a seasoned clinician scientist, has been vital in positioning C-Path as an essential partner in accelerating drug development worldwide, significantly shaping scientific and regulatory pathways to expedite the delivery of therapies for people in urgent need.

Key Points: 
  • TUCSON, Ariz., Jan. 9, 2024 /PRNewswire/ -- Critical Path Institute (C-Path) today announced that Klaus Romero, M.D., M.S., FCP, has been named its new Chief Executive Officer.
  • "Assuming the position of CEO at C-Path represents a profound honor, coupled with a tremendous sense of responsibility," said Romero.
  • His ascension to CEO is a significant milestone in our mission to bring transformative therapies to patients who desperately need them."
  • Romero will continue to serve a dual role as CEO and CSO until the CSO position is filled.

Hepion Pharmaceuticals Schedules Conference Call to Review Additional Efficacy Data from Phase 2 ‘ALTITUDE-NASH’ Liver Function Trial of Rencofilstat

Retrieved on: 
Venerdì, Novembre 10, 2023

Hepion is pleased to invite all interested parties to participate in a conference call at 4:30 p.m.

Key Points: 
  • Hepion is pleased to invite all interested parties to participate in a conference call at 4:30 p.m.
  • ET on November 13, 2023, during which the additional ALTITUDE-NASH efficacy data will be discussed.
  • To participate in this conference call, please dial (800) 715-9871 (U.S.) or (646) 307-1963 (international), conference ID 8619177, approximately 10 minutes prior to the start time.
  • The call will also be broadcast live and archived on the Company’s website at www.hepionpharma.com under “Events” in the Investors section.

Fortrea Completes Expansion of Clinical Pharmacology Solutions Following Targeted Investments at its Four Clinical Research Units in U.S. and U.K.

Retrieved on: 
Giovedì, Novembre 2, 2023

“Our integrated platform of services includes best-in-class infrastructure and experienced professionals who are fully dedicated to clinical pharmacology, including physicians, nurses, clinical scientists, CRAs and pharmacokineticists.

Key Points: 
  • “Our integrated platform of services includes best-in-class infrastructure and experienced professionals who are fully dedicated to clinical pharmacology, including physicians, nurses, clinical scientists, CRAs and pharmacokineticists.
  • Improvements in recreational, living and “work-from-home” spaces at Fortrea CRUs have been constructed to enhance the experience of volunteers participating in research at the sites.
  • The expansion of Fortrea’s early clinical development pharmacy services facilities includes new state-of-the-art cGMP pharmacies in the Leeds and Daytona CRUs.
  • “I believe Fortrea’s early clinical development solutions set a new standard for what the research industry should expect from its partners,” said Dr. Cohen.

Aitia Appoints Drug R&D Executive Jean-Michel Gries as President & Chief Operating Officer

Retrieved on: 
Martedì, Settembre 19, 2023

SOMERVILLE, Mass., Sept. 19, 2023 /PRNewswire/ -- Aitia, the leader in the development and application of Causal AI and Digital Twins to discover and develop new drugs, today announced the appointment of Dr. Jean-Michel Gries as President & Chief Operating Officer.

Key Points: 
  • SOMERVILLE, Mass., Sept. 19, 2023 /PRNewswire/ -- Aitia, the leader in the development and application of Causal AI and Digital Twins to discover and develop new drugs, today announced the appointment of Dr. Jean-Michel Gries as President & Chief Operating Officer.
  • Jean-Michel is an accomplished senior life science executive with a track record of innovative drug discovery, translational medicine, and clinical development, combining the science and business of drug development.
  • He comes with a wealth of unique experience in drug R&D from big pharma, CROs, and small biotechs.
  • "I look forward to bringing my expertise and working alongside Colin and the teams towards revolutionizing drug discovery and development and ultimately improving the lives of patients."

Eikon Therapeutics Builds Leading Clinical Development Organization with Appointment of Senior Team with Extensive Industry Expertise

Retrieved on: 
Giovedì, Giugno 1, 2023

Eikon Therapeutics, Inc., a clinical stage biotechnology company that is advancing breakthrough therapeutics through the purposeful integration of engineering and science, today announced its Clinical Development organization.

Key Points: 
  • Eikon Therapeutics, Inc., a clinical stage biotechnology company that is advancing breakthrough therapeutics through the purposeful integration of engineering and science, today announced its Clinical Development organization.
  • Eikon recently announced its development pipeline, which includes a number of acquired clinical and preclinical stage assets that complement its discovery-stage programs.
  • Harry Raftopoulos, M.D., Senior Vice President, Clinical Research Oncology –Raftopoulos joined from Bayer Pharmaceuticals, where he most recently served as Head of Late-Stage Oncology Clinical Development.
  • Based in the company’s New York City and Hayward locations, additional clinical development team members recently appointed include:

Hepion Pharmaceuticals to Highlight AI-POWR™ at the 2023 CSPS Annual Symposium: The Next Frontiers in Pharmaceutical Sciences

Retrieved on: 
Mercoledì, Maggio 24, 2023

Title: Simulation in drug development: Clinical Pharmacology, Quantitative Systems Pharmacology Artificial Intelligence and Beyond?

Key Points: 
  • Title: Simulation in drug development: Clinical Pharmacology, Quantitative Systems Pharmacology Artificial Intelligence and Beyond?
  • Session: 9:00 – 11:00 AM ET SESSION 6: AI and Computer Technology in the Sciences
    Dr. Mayo commented, “Artificial intelligence and machine learning are here, and are being integrated into drug development.
  • AI-POWR™ is Hepion’s proprietary AI/ML platform designed to speed up drug development by detecting a priori patients who will respond to our lead compound, rencofilstat.
  • CSPS has graciously allowed us the opportunity to describe the integration of AI-POWR™ into all aspects of our clinical pharmacological programs.”
    A copy of the presentation will be accessible on the Company’s website at www.hepionpharma.com under “Publications” in the Pipeline section.

Michele Baptista Joins CenExel

Retrieved on: 
Giovedì, Maggio 18, 2023

Michele joins CenExel from WCG IRB, where she was a Business Development Director developing and selling ethical review services for all Phase 1, biotech, medical device, diagnostics, biologics, and social and behavioral research.

Key Points: 
  • Michele joins CenExel from WCG IRB, where she was a Business Development Director developing and selling ethical review services for all Phase 1, biotech, medical device, diagnostics, biologics, and social and behavioral research.
  • Michele has also held other business development and administration positions in the clinical trial space working for Biomed IRB.
  • “We are thrilled to have Michele join our team as our new Senior Director of Business Development," said CenExel Chief Commercial Officer, Casey Orvin.
  • "Michele has been an active part of the industry for over 30 years, and we look forward to her joining our CenExel commercial team.