Managing Clinical Trials

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.

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.

Oncology clinical research scientist recommends a nuanced preclinical study process to speed drug development

Medelis has just published the third issue of "Peer Perspectives in Oncology," our free Q&A series focused on issues that face Chief Medical Officers today: rising costs, optimum patient accrual, targeted therapeutics, patient safety, FDA regulations, efficacy, budgets, and timelines.

In "Preclinical Trials:  A Nuanced Approach to Get Into the Clinic Faster," Dr. Mike McGarry describes a nuanced preclinical process that can help a CMO get into the clinic faster.  This approach hinges on a strategic, well-defined rodent model, quality data, and ongoing integration between the pre-clinical, regulatory and clinical teams.

Dr. McGarry, VP of Preclinical Studies at Medelis, is a preclinical research scientist with 35 years of experience generating high quality animal-based data.  In the interview, he provides a detailed inside look at the issues that can speed or derail the oncology preclinical phase:

• Critical factors for a CMO to understand and evaluate during this step in the drug development process
• Regulatory assessments and how to avoid hitting a preclinical wall
• The nuances and complexities of animal models, tumor selection, and other variables
• How to keep the preclinical, regulatory and clinical teams involved in feasibility dialogue
• The typical preclinical process and the questions a CMO should be asking at each step
• Additional requirements unique to oncology preclinical trials
• What to look for in an outside preclinical team.

The abstract is free, and you can download it here.  You can also download the first two issues in the series, "The Complete Phase 1b:  A Proven Approach to Getting to Phase II Faster," an interview with Dr. Dan Von Hoff, and "Patient Safety in Clinical Trials," a discussion with Dr. James Gourzis.

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.