Managing Clinical Trials

Medelis co-founder Daniel Von Hoff receives prestigious ASCO scientific honor

We are pleased to share the news that Medelis co-founder and Medical Advisory Board member Daniel D. Von Hoff, M.D. was recently awarded the 2010 David A. Karnofsky Memorial Award by the American Society of Clinical Oncologists during their 26th annual meeting in Chicago. One of ASCO’s highest scientific honors, the award honors pioneering oncologists who, through clinical research, have changed the way oncologists think about the practice of oncology. 

In his award lecture, “The Last 12 Weeks,” Dr. Von Hoff discussed a model for helping patients whose solid tumors are refractory to standard therapies and are searching for help in their last 12 weeks. The key is, as described by ASCO, “to look deep into the tumor genome in search of its Achilles’ heel, a mutation that defines the tumor’s vulnerability and provides a therapeutic target.” 

“Rather than reach for the next agent to come along,” select one that is thought to have selectivity for the target on the basis of either preclinical studies or activity in other cancers containing the same vulnerability, Dr. Von Hoff said. The result is an initial phase I trial with one patient. “I believe that if we can work smarter, phase I trials can be more therapeutic,” he explained. 

Dr. Von Hoff also discussed his preference for the term “precision medicine” rather than “personalized medicine.” He told ASCO, “I don’t like the term ‘personalized medicine.’ Most nurses and doctors already try to deliver personalized medicine. We don’t always achieve it, but that’s why we got into medicine in the first place — to listen and engage with the patient,” he said. Instead, Dr. Von Hoff prefers the phrase “precision medicine” to describe the ongoing efforts to characterize individual patients and the tumors they have, to discover new genetic markers, and to develop targeted therapies with the maximum potential for disease response. “My primary goal is to optimize the care of the patient sitting in front of me.”

Congratulations, Dan, on this prestigious honor and your deep dedication to your patients and our field.

Links:  ASCO article about the Karnofsky award  |  Highlights from Dan’s lecture, “The Last 12 Weeks” |  Full list of 2010 ASCO awards

ASU launches new Master of Science, Clinical Research Management program

Innovative online program provides convenient specialty training for nurses, physicians & health care professionals

Medelis President and CEO Bob Bosserman serves on the advisory board for Arizona State University's Center for Healthcare Innovation & Clinical Trials, and we're pleased to share this information about their Master of Science in Clinical Research Management, a new online 33-credit degree program for working professionals around the globe.

The field of clinical research is changing dramatically, and this program prepares students to be innovative industry leaders in specialized positions including regulatory affairs, clinical research operations, auditing, and monitoring. The curriculum includes

• Emerging technologies and methodologies
• Clinical research project management
• Study design
• Trends in global trial operations
• Regulatory requirements for healthcare-related product development
• Clinical research process improvement techniques

Students can complete the degree online in 17, 24, or 42 months, and the program culminates in a 6-credit capstone project designed to advance the field of clinical research.

ASU is currently accepting applications for Fall 2010. To learn more and apply, please visit the ASU College of Nursing & Health Innovation web site.

Dr. Alan Sandler, Dr. James Cassidy Join Medelis' Medical Advisory Board

We’re pleased to announce more company news today:  Two leading oncology researchers, Dr. Alan Sandler of Portland, Oregon and Dr. James Cassidy of Glasgow, Scotland, have joined our Medical Advisory Board.  

Alan Sandler, M.D. is a Professor of Medicine in the Division of Hematology & Medical Oncology, Department of Medicine, at Oregon Health & Science University in Portland, Oregon. Board-certified in Medical Oncology and Internal Medicine, he serves as the Division Chief of the Hematology & Medical Oncology Division and holds the DeArmond Chair for Clinical Cancer Research. He specializes in cancer and blood disorders with a special interest in lung cancer, and he is widely considered a key opinion leader in the development of targeted therapies in the treatment of thoracic malignancies.

Dr. Sandler is a member of the American Society of Clinical Oncology and the Eastern Cooperative Oncology Group, where he serves as the Co-Chair of the Thoracic Committee. 

James Cassidy, MBChB, MD, MSc, FRCP is a leading researcher in anti-sickness compounds and innovative approaches to drug-resistant tumors. Dr. Cassidy is a Professor of Oncology and heads the Medical Oncology Department and the Division of Cancer Sciences & Molecular Pathology at the University of Glasgow, Scotland. He heads the Centre for Oncology and Applied Pharmacology (COAP) and has his own Cancer Research UK (CRUK) lab based program exploring methods for gene and drug delivery. He also heads the Glasgow Experimental Cancer Medicine Centre (ECMC) which is focused on Good Laboratory Practice (GLP) quality assured assessments of molecular markers, pharmacodynamics and pharmacokinetics of novel agents at the clinical/lab translational interface.

On the clinical side, Dr. Cassidy runs a service for colorectal cancer patients and has a major commitment to early phase clinical studies of innovative therapies. 

In our formal news release, Medelis president and CEO Bob Bosserman says, “Medelis is very privileged to add Dr. Cassidy and Dr. Sandler to our distinguished group of expert advisors. They strengthen our ability to provide clients with cutting-edge expertise and assistance in the development and advancement of personalized therapies, which will ultimately help improve the treatment options for clinicians.  They also further strengthen our relationship with the clinical research community that directly cares for cancer patients and closely understands their needs.”

“Both of these physician/researchers can now bring their clinical experience to bear on the unique study design and management issues that our biotechnology and pharmaceutical clients face in the oncology drug development process,” Bosserman adds.

You can find Dr. Sandler’s full bio here and Dr. Cassidy’s bio here.

Medelis expands CRO services to medical devices, welcomes Dr. Inder Makin

Today we’re pleased to announce that we're expanding our CRO services to the medical device industry under the guidance of Inder Makin, M.D., Ph.D., who is joining us as Vice President, Devices & Radiological Health. 

Dr. Makin has more than 20 years of experience developing "concept to clinic" healthcare technologies in both academia and industry.  He has developed medical ultrasound-based research programs at various institutes, taking concepts (including catheter-based devices for intravascular thrombolysis, transdermal drug delivery devices and non-invasive and intracorporeal tissue ablation devices) through feasibility and launch. 

Dr. Makin’s unique combination of medical and biomedical engineering expertise enables him to assist our clients in effectively developing and refining new device solutions for patients.  He will also provide invaluable guidance in helping obtain marketing approvals for successful commercialization. 

Medelis will support device manufacturers throughout the product life cycle including early design and prototyping, simulation, preclinical and phase I-III clinical studies, and regulatory/marketing approval. 

You can read Dr. Makin’s full bio here. If you'd like to learn more about our services for the medical device industry, please contact us today.

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. 

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.)

New VP of Preclinical Studies to lead new oncology preclinical research services

We’re pleased to officially announce that Mike McGarry, Ph.D. has joined Medelis as VP of Preclinical Studies.  Dr. McGarry will lead a new service offering to provide preclinical study design, management and execution for our biotech and pharmaceutical clients around the world.

"Adding preclinical services allows us to provide a complete offering for biotech and pharmaceutical companies developing oncology drugs," said Medelis’ Chairman and CEO Bob Bosserman.

"We can deliver a full spectrum of services that allow our client sponsors to outsource more of their technical development work, with concomitant savings in time and money, without sacrificing a clear strategic plan for their drug candidates," he continued.  "For our clients, getting to the right result, with a minimum of risk and at a reasonable cost, is the key deliverable at every stage in the development process."

"The value for Chief Medical Officers is that we can work to bridge their preclinical study design and execution with their clinical team," said Dr. McGarry. "We can help CMOs avoid regulatory obstacles and delays, but more importantly, this well-coordinated process can yield stronger drug candidates for phase I clinical trials."

Under Dr. McGarry’s leadership, Medelis will design and execute oncology preclinical studies using specialized oncology research models while handling technical writing, laboratory services, toxicology consulting and regulatory submissions.  The company will work with clients to develop precise animal-based, IACUC-approved protocols, selecting the most suitable contract lab to perform the research.  Medelis will oversee all study execution and interpretation of results.

Medelis’ preclinical research offerings include:

• Feasibility Studies – exploratory, with several tumor lines
• Proof of Principle – definitive, demonstrative experiments
• Model development
• Efficacy of therapy in a defined animal model
• Endpoints

Links to more information:  Preclinical research services, Mike McGarry bio. 

We also invite you to download our recent Insider Abstract, "Preclinical Trials:  A Nuanced Approach to Get Into the Clinic Faster," an in-depth interview with Dr. McGarry.

Can the internet fuel drug development?

What happens when some cancer patients become frustrated with their treatment options?  They search for a cure on their own. Some raise money to build awareness; others donate to further research.

Dr. Jay Tenenbaum, an e-commerce pioneer who is battling melanoma that spread to his liver, took a different approach:  he created a company to allow patients to discover new drugs with the help of the internet. 

CollabRx builds and operates "virtual biotechs" for people seeking cures on their own.  The CollabRx platform connects researchers to one another and to a network of scientific services.  Wealthy individuals, foundations and patient groups can join in to financially support specific research activities.  The system encourages researchers to share information and collaborate, going against the grain of the traditional scientific process.

While it’s unclear whether the concept will work, CollabRx highlights how the internet is starting to affect drug development.  Some of our sponsors are starting to recognize how the internet can help them recruit patients for their trials.  While pharmaceutical companies may be slow to pick up on the power of the web, patients seem to be a few steps ahead.

Amy Dockser Marcus provides a detailed look at CollabRx in yesterday’s Wall Street Journal.  She also provides excellent tips for patients who want to make a difference in the search for a cure.