Managing Clinical Trials

Dr. Dan Von Hoff honored at Governor’s Celebration

Our colleague Dan Von Hoff, M.D., a founder and shareholder of Medelis and the chairman of our medical advisory board, was recently named Arizona’s ‘Community Service Leader of the Year’ at the 2008 Governor’s Celebration of Innovation in Phoenix. 

A member of the NIH’s National Cancer Advisory Board, Dr. Von Hoff is a world-renowned cancer researcher who has devoted more than 35 years to two primary goals: identifying the best new anti-cancer agents to treat patients and curing pancreatic cancer. He has published more than 540 scientific papers, more than 130 book chapters, and nearly 950 scientific abstracts. He also holds a dozen patents for new anti-cancer agents and medical devices.  (Full bio here.)

The annual award honors an organization or individual who contributes to Arizona's technology industry through relentless community involvement, leadership, visibility and excellence in economic development activity.

Medelis will soon publish a new issue of “Peer Perspectives in Oncology” featuring an in-depth interview with Dan about oncology phase I trials.  He describes how Chief Medical Officers can design better phase I trials to glean meaningful efficacy data by using the patient as his or her own control. He further explains how a CMO can gather evidence showing a drug changes the natural history of a patient’s disease, demonstrating improved care and a stronger case for moving a drug into phase II. 

In our summer 2008 issue, Dan offers a detailed look at “The Complete Phase Ib,” a clinical trial structure that creates rapid accrual rates, substantial economies of scale and significant time savings for sponsors versus the traditional sequential approach.

You can download past issues and sign up to be notified of future publications here.

Medelis expands CRO services into Europe, appoints Dr. Deirdre Tessman to run the operation

We’re very pleased to announce that our colleague Deirdre Tessman, Ph.D., has officially joined our organization to lead our new Medelis Europe division as its Managing Director.  She’ll also be re-joining her longstanding former colleagues Dr. Daniel Von Hoff, Dr. Skip Burris, and Dr. Mace Rothenberg, all members of Medelis' Medical Advisory Board.

Deirdre brings ten years of experience managing European studies, an extensive understanding of European regulatory requirements and a deep familiarity with all phases of clinical development to Medelis clients who wish to complete the regulatory requirements of the European Community for their therapies and devices.

Beyond her European expertise, Deirdre brings more than 30 years of worldwide drug development and regulatory experience to our organization. She’s directed all phases of pharmaceutical development from research through drug approval and marketing with additional expertise in the startup and turnaround of pharmaceutical companies.

Medelis Europe delivers complete oncology drug development services from preclinical through phase III. European, U.S., and Asian sponsors looking to bring drugs to the U.S. & European markets can now take advantage of Medelis’ full service offering, which now includes EDC for phase I studies; internet-based patient recruitment; and integrated preclinical studies aligning the preclinical, regulatory and clinical teams.

Please join us in welcoming Deirdre – here is her contact information. You can also find a formal announcement about her appointment and background here.

Meet us at BioPartnering Europe

We’re gearing up to attend the BioPartnering Europe conference in London, UK (Oct. 12-14, 2008) to talk about our new Medelis Europe division and the CRO services we’re offering to European, U.S. and Asian sponsors looking to bring drugs to the U.S. and European markets.

If you’re attending the conference, we invite you to join us for our open house:

Monday, 13 October from 10.00-12.00, Group 1, Booth 11
Queen Elizabeth II Conference Centre
Westminster, 4th Floor
Broad Sanctuary, Westminster
London SW1P 3EE
United Kingdom

For more details, log into your BioPartnering.com account and visit our exhibitor profile.  You can also email Dr. Deirdre Tessman to learn more.  (You'll find her complete contact information here.)