Applied Clinical Trials
Industry news focusing on the people and organizations who work in the clinical trials profession.
With over 20 years experience in computer compliance, business development, and consulting within the pharmaceutical industry, Colin Goddard has been appointed General Manager at the newly opened Plexys facility in Amsterdam, The Netherlands.
Colin Goddard
INC Research (Raleigh, NC) has made several new appointments including Patrick Melvin as Executive Director of Oncology, and Bruce Wakeman as Vice President of Alliance Development. David Gill, formerly of Transenterix, has also joined the company's executive team.
Jeffrey Freitag, MD, Senior Vice President, PharmaNet Consulting, will expand his role to become Chief Medical Officer of PharmaNet Development Group (Princeton, NJ) where he will be the senior medical representative for the company and provide guidance to physicians who are involved in designing and monitoring Phase I through Phase III clinical trials.
David Gill
CTI Clinical Trial and Consulting Services (Cincinnati, OH) has promoted Catherine Close to Director, Business Development and Client Management and has promoted Meredith Boley to Regulatory Specialist I. David Flick has also joined as an Information Technology Support Specialist.
Jeffrey Freitag, MD
Bringing with him over 10 years of recruitment experience, Quanticate People (London, UK) has appointed Richard Ellis as General Manager.
The European Federation of the Pharmaceutical Industries and Associations (Brussels, Belgium) has selected Richard Bergström as its new Director General.
Bruce Wakeman
Ockham (Cary, NC) has promoted Michael Enright from Chief Financial Officer to President of its OckhamCROTM division where he will provide senior-level leadership and perspective to pharmaceutical, biotechnology, and medical device clients for the company's Phase I-IV clinical operations globally.
Dmytro Razborov has been appointed Regional Director of Synexus' (Manchester, UK) Ukraine with responsibility for operations and business development.
Kendle (Cincinnati, OH) has announced that beginning May 1, Senior Vice President and Chief Operating Officer Stephen Cutler, PhD, will become the company's next President and Chief Executive Officer. Chairman and CEO Candace Kendle, will continue to serve as Chairman. In addition, Jamie Macdonald will take on the position of Senior Vice President and Chief Operating Officer.
Accelovance (Rockville, MD) has made two additions to its senior management team including Joseph W. Angle, Jr. as Chief Financial Officer and Lisa Beth Ferstenberg, MD, as Chief Medical Officer.
Robert DiLaura, PhD, Eliot Siegel, MD, and Kiyoteru Takenouchi, PhD, have been appointed Board of Directors for CDISC (Round Rock, TX), each for a three-year term.
ClinTec International (Glasgow, UK) has promoted Stuart Grant, PhD, into the newly created role of Associate Director of Regulatory Affairs and Medical Writing.
Cytel (Cambridge, MA), a provider of clinical trial design and implementation services and software, has announced the addition of Jim Baker, formerly Senior Director at Study Standards Implementation at Millenium, as the company's Vice President, Clinical Research Services.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Oveporexton Shows Superior Efficacy in Phase II Narcolepsy Type 1 Trial Without Hepatotoxicity
May 16th 2025In the TAK-861-2001 Phase IIb study, oveporexton significantly improved wakefulness, daytime sleepiness, and cataplexy frequency in patients with narcolepsy type 1, outperforming current therapies and avoiding liver toxicity seen with earlier OX2R agonists, according to results published in The New England Journal of Medicine.