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.

Personalized Genomics: The First Report of a Cancer Genome

As reported by the New York Times last week, Washington University recently completed a study that decoded the entire genome of a cancer patient. The patient, a woman in her 50s who died of leukemia, became the first cancer patient and the first female to have her entire genome decoded.

To protect the patient’s identity, the data will be available to scientists only.

While the finding won’t help patients right away, the controversial project, funded primarily by a private donor, could open the door to entirely new approaches to treat cancer.

A cancer expert not involved with the study, Dr. Stephen Nimer, chief of the hematology service at Memorial Sloan-Kettering Cancer Center, called the research a “tour de force” and the report “a wonderful paper.” He said the whole-genome approach seemed likely to yield important information about other types of cancer as well as leukemia.

While scientists have debated the validity of sequencing the whole cancer genome, the study was possible due to recent advances in technology that have made it easier and cheaper to analyze 100 million DNA snippets.

Dr. Richard K. Wilson, director of Washington University’s Genome Sequencing Center and the senior author of the study, sees a bright future for DNA sequencing. “That’s personalized genomics, personalized medicine in a box,” he said. “It’s holy grail sort of stuff, but I think it’s not out of the realm of possibility.”

Dr. Wilson said he hoped that in 5 to 20 years, DNA sequencing for cancer patients would consist of dropping a spot of blood onto a chip that slides into a desktop computer that produces a report suggesting which drugs will work best for each patient.

Some feel that this study signals a change in the oncology drug development landscape. If personalized medicine for oncology becomes a reality, it could signal the end of the “one-size-fits-all” oncology blockbuster drug. Patient survival rates should increase, because cancer patients and oncologists will have a greater selection of drugs and more data to predict efficacy.

The real change will be in the drug development process: Biotech and pharma will need to create more varieties of drugs that affect different genomes. Efficacy rates should improve, but each drug will treat far fewer patients. Clinical trials will be smaller and faster, as many of the drugs should receive FDA Fast Track and/or Orphan Drug status.

That puts quite a burden on oncology drug developers. Not only do they need to shoulder the additional costs of creating more drugs (that will produce lower revenues per drug), but they will also have to create more efficient trial designs to handle the larger number of smaller, quicker trials for each drug.

One way to accomplish this is to run phase I and/or phase II trials in parallel instead of running multiple separate trials. For a deeper discussion of this strategy, check out Dr. Daniel Von Hoff’s 'The Complete Phase Ib' Insider Abstract.

But the biotech and pharma industries will adapt. If the personalized genomic predictions are correct, the burden will be worth it when powerful treatments are developed to match common genomes.

Excellent cancer discussion on the Diane Rehm show

Yesterday morning’s Diane Rehm Show on NPR featured an excellent, detailed discussion about cancer and genomics research in terms that are very understandable for patients, families, and the general population.  Diane’s guest, Dr. Bernadine Healy, is the health editor of U.S. News & World Report, the former director of the National Institute of Health, the former director of the American Red Cross, and the author of “Living Time:  Faith and Facts to Transform Your Cancer Journey.”

In the opening of the “New Approaches to Treating Cancer” segment, Dr. Healy, a cardiologist, touches on her own personal journey with cancer; she was diagnosed with a malignant brain tumor on Valentine’s Day 1999.  “One of the sad things about cancer is that so often it hits in the prime of life,” she explains.  “Virtually everybody is touched by cancer, either directly themselves – about 40% of people – but also through their families.  Cancer is a family effort; it’s a family disease.”

They go on to discuss, in nontechnical terms, how the mapping of the human genome offers the possibility of a personalized approach to diagnosing and treating the disease, along with the latest developments in the war on cancer. 

If a family member or friend is learning about cancer, this segment is an excellent resource.  Here are several links you can share:

• You can listen to the broadcast via Windows Media Player or Realplayer here. 
• Download the MP3 here. 
• Subscribe to all of the shows via podcast here. 

Discover clinical trial management, biotech and pharma resources on document-sharing web sites

We’ve recently begun using two web sites that allow users to share conference presentations, seminar materials, educational tools, research data and more.  The first, SlideShare, is like YouTube for PowerPoint and PDF presentations; the second, Docstoc, allows users to share PowerPoint as well as Excel, Word and other document types.

We’ve uploaded several of our popular Insider Abstracts so that industry professionals, students and researchers around the world can discover, download and share them with colleagues.  For example, here is our “The Complete Phase 1b” interview with Dr. Dan Von Hoff; you can scroll through all of the slides below.  To download it, just click through to the SlideShare web site.

View SlideShare presentation or Upload your own. (tags: pre-clinical medelis)

Here's a second abstract that features Dr. James Gourzis discussing patient safety in clinical trials:

View SlideShare presentation or Upload your own. (tags: patientsafety clinicalresearch)

We used this presentation to promote our new Medelis Europe division during the recent BioPartnering Europe seminar in London:

View SlideShare presentation or Upload your own. (tags: cro medelis)

These services are excellent tools for conferences, seminars, researchers, companies and far-flung groups to share and discover new data and educational materials.  We’ll continue to publish our abstracts via these services and encourage you to add us to your network and share your own materials as well.

On SlideShare, you’ll find our Insider Abstracts at www.slideshare.net/medelis, and we’ve started a group at www.slideshare.net/group/biotech-pharma.  Our Docstoc account is www.docstoc.com/profile/oncologycro.