Managing Clinical Trials

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.

Mouse Hematology: A Laboratory Manual

Mike McGarry, Ph.D., our Vice President of Preclinical Studies, along with his Arizona Mayo Clinic colleagues Cheryl A. Protheroe and James J. Lee, has just authored a new book, Mouse Hematology: A Laboratory Manual, now available for pre-order from Cold Spring Harbor Laboratory Press (ships in December):

http://tinyurl.com/mousehematology

Dr. McGarry, a preclinical research scientist with over 35 years of experience generating animal-based data, leads preclinical program design, management and execution on behalf of Medelis’ biotech clients around the world.

Here’s the description from CSH Press:  

The mouse has become a standard laboratory model organism, particularly for the study of hematopoiesis, the immune system, and inflammation. Although laboratories studying stem cells, blood, and blood-forming tissues have assimilated many new molecular diagnostic methods, the identification of cell lineages through classical light microscopic techniques is often poorly understood and practiced. Mouse Hematology presents a concise review of conventional methods for the preparation, enumeration, and microscopic examination of blood and blood-forming tissues of the laboratory mouse. Along with a short laboratory manual featuring detailed protocols, Mouse Hematology includes a DVD of short video demonstrations of the techniques and a poster of blood cell types for easy identification at the microscope. These rapid, inexpensive assessments can save valuable time and resources essential to the design, development, and interpretation of experiments.     

Contents include:

1. Collection of Peripheral Blood
2. Counting Red Blood Cells, Platelets, and Viable Nucleated White Blood Cells
3. Peripheral Blood Films and Cytospin Preparations
4. Cell Differential Assessments of Peripheral Blood Films
5. Preparation of Bone Marrow for Microscopic Examination
6. Cell Differential Assessments of Bone Marrow

The book also includes 8 videos on an accompanying DVD:

1. Venous Access for Blood Film Using Lateral Tail Vein
2. Venous Access for Blood Film Using Tip of Tail
3. Blood Film
4. Staining with Coplin Jar or Carriages
5. Coverslip
6. Cytocentrifuge Procedures
7. Surgical Exposure of Femur
8. Brush Smear of Marrow

To preorder, visit the CSH Press website: http://tinyurl.com/mousehematology.

The "Lost Opportunity” in Phase I Oncology Trials

Cancer drug developers traditionally use the phase I trial solely to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of a drug.  Today, we’ve published a free new downloadable abstract, "The Lost Opportunity in Phase I Oncology Trials," an interview with renowned oncology investigator Daniel D. Von Hoff, M.D.  In the interview, Dr. Von Hoff advocates for a phase I approach that looks beyond toxicity and gleans meaningful efficacy data, creating a more compelling rationale for further investment and improved patient care.

“A Chief Medical Officer looking at the phase I typically sees it as a toxicity trial, not a therapeutic trial, because of course it is not randomized,” Dr. Von Hoff explains. “But we - doctors at the bedside and the patients themselves - do not see it that way. We are looking for improvement and survival. [The phase I] is an opportunity to look for therapeutic effect as well because it might just be there.”

Dr. Von Hoff supports an additional analysis that uses a cancer patient as his or her own control.  Rather than solely relying on the traditional data captured in normal phase I protocols, he recommends measuring the tumor’s “time to progression” on the current drug versus the tumor’s “time to progression” on the patient’s previous treatment.  This data — time to progression on each drug — should be systematically tracked in the protocol so it becomes part of each patient’s data bank.

“I have never seen a CMO plot time on a new drug versus the time on a just-prior therapy to build a story for raising money,” Dr. Von Hoff continues. “This idea of using the patient as his or her own control is a lost concept in drug development. Dr. Bob Temple at the FDA, an icon in clinical trial design, calls it a lost art. He’s referring to the ability to document changes in the natural history of a patient’s tumor, and how this information can give you a sense of whether the drug will work.”

“If you treat 30 patients and 30% stay on a new therapy for a longer time than the just-prior drug they had progressed on, then that would justify a deeper investment,” he explains.  “Patients’ tumors grow at an inexorable, ever-quickening rate. If you find an agent that can taper that growth, then it is probably doing something and should be pursued.”

“There is no question in my mind that, if a CMO started comparing time on new drug versus time on just-prior therapy, the rewards are there – both for the patients and for the progression of the drug. All it takes is a more proactive approach to the phase I. It is so simple yet I have never seen a CMO adopt this.”

In the abstract, Dr. Von Hoff answers many questions about this “lost art” in the phase I trial.  Download the full issue here; you’ll also gain access to the other issues in the series, and we’ll notify you of future publications as well.  

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.

Insight: Preventing a Preclinical Dead End

Oncology preclinical studies are commonly viewed as straightforward investigations run exclusively by researchers.  Tasked with finding molecules that stop cell growth, researchers often operate independently without true integration with the preclinical, regulatory and clinical teams.

Dr. Mike McGarry, a preclinical research scientist with 35 years of experience generating high quality animal-based data, advocates for a more synergistic approach.  In an upcoming issue of "Peer Perspectives in Oncology," he weighs in on the typical preclinical process and shares insight that can help CMOs extract more useful information that aids drug development and speeds overall progress to phase I.

One of the big issues Dr. McGarry commonly sees is a chasm between a sponsor’s preclinical and clinical teams.

"Preclinical researchers are extremely technical and scientific; they’re focused on microscopic details of various tissue or organ side effects," he explains.  "On the other side, the CMO is pushing to move a drug forward while managing costs to meet the company’s targets.  That forward momentum can create friction with the conservative, tentative nature of the research scientist who is watching the nuances unfold and has perhaps a very different perspective on the trial."

Without close communication and integration, preclinical experimentation can lead to a regulatory brick wall, a scenario no CMO wants to experience.

"I’ve spent most of my career in preclinical experimentation, and it's an expensive funneling process," he continues.  "You start with thousands of compounds and eventually narrow it down to the one that warrants close scrutiny, hopefully making it into clinical study and application. As you’re narrowing the field, the preclinical team also has to focus on the end goal or you can easily end up in a place that has no utility."

For a CMO, the answer is to get more involved in the preclinical process to gain insight, lead the study direction and prevent the silo effect from derailing a promising drug.

"There needs to be ongoing, seamless communication and integration among the clinical, regulatory and pre-clinical teams," he adds. "Communication affects the quality of results to be reported and thus the usefulness of the data.  Each team should be actively involved in feasibility dialogue at each step in the study."

The complete interview is one of several slated to be published this summer.  You can sign up to be notified via email here.   

Dan Von Hoff discusses "The Complete Phase Ib"

Medelis has published a free new downloadable abstract, "The Complete Phase Ib: An Approach to Getting to Phase II Faster," an interview with renowned oncology investigator Daniel D. Von Hoff, M.D. 

"The typical phase I approach is essentially serial drug development, which involves running multiple separate trials,” Dr. Von Hoff explains at the beginning of the interview.  "Each site at each trial adds a layer of time, cost, and management oversight. What I call 'the complete phase Ib' is a simple solution that essentially tests the various drug combinations in one phase Ib with multiple arms run in parallel.

"For example, assume you have good preclinical data on a single agent that may be more effective in combination with another agent—for example, a monoclonal antibody plus gemcitabine (GEMZAR®)," he explains. "Most Chief Medical Officers anticipate that the pivotal clinical trials will be standard therapy with or without the new drug, and they prepare for that eventuality by conducting a phase I trial of the combination. Typically, this involves launching five, six, or sometimes more combination phase I trials. Each trial has to be negotiated and managed separately, and each must have its own protocol, adding layer upon layer of cost and effort.

"The strategy I'm suggesting eliminates all these separate serial trials because it puts the combinations into one phase Ib trial."

Dr. Von Hoff offers a detailed look at this approach and the many benefits to sponsors, patients, and investigators, including:

• Patient accrual and treatment benefits
• How the approach can "rescue" patients
• Dosing strategies
• Logistical considerations
• Cost and timing considerations
• Effects on phase II studies
• Reactions from the FDA investigators, sponsors and patients

The abstract is the second in Medelis' "Peer Perspectives in Oncology" series.  In the first issue, "Patient Safety in Clinical Trials," Dr. James Gourzis discusses recent issues in patient safety and the role of sponsors, CROs, IRBs, DMCs and the FDA in ensuring patient safety in future clinical trials.

You can download each of the interviews here.  You’ll receive email notices when future issues are published as well.