Navigation Links
Oncology Clinical Research Scientist Recommends a Nuanced Preclinical Study Process to Speed Drug Development
Date:9/4/2008

Medelis, an oncology contract research organization, has published a free abstract, "Preclinical Trials: A Nuanced Approach to Get Into the Clinic Faster." In the abstract, Dr. Mike McGarry, a preclinical research scientist with 35 years of experience, discusses how oncology preclinical studies are commonly viewed as straightforward investigations run exclusively by researchers who operate without true integration with preclinical, regulatory and clinical teams. He describes a nuanced preclinical study process that hinges on a well-defined rodent model, quality data, and ongoing integration between the preclinical, regulatory and clinical teams.

Phoenix, AZ (PRWEB) September 4, 2008 -- Medelis, Inc., an http://www.medelis.com [oncology contract research organization __title__ Contract research organization Medelis publishes preclinical research abstract] providing complete oncology clinical trial design, management and execution, today published a free new downloadable abstract, "http://www.medelis.com/preclinical-trial-abstract-release.html [Preclinical Trials: A Nuanced Approach to Get Into the Clinic Faster __title__ Oncology contract research organization publishes abstract for preclinical trials]," an interview with Mike McGarry, Ph.D.

Dr. McGarry, VP of http://www.medelis.com/mike-mcgarry.html [Preclinical Studies __title__ Dr. McGarry is 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 describes a nuanced preclinical study process that can help a Chief Medical Officer (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.

Topics covered include:

  • 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 rodent models, tumor selection, and other variables
  • How to keep the preclinical, regulatory and clinical teams involved in feasibility dialogue
  • The typical preclinical study 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
For 30 years, Dr. McGarry served as an investigator and Director of the Department of Laboratory Animal Resources at the Roswell Park Cancer Institute working primarily in experimental hematology and immunology with basic scientists and clinical colleagues. He chaired the Institute's Animal Care and Use Committee and served on the Scientific Review Committee of the Institute's Human Studies Review Board.

Dr. McGarry served as an IACUC member at both the Mayo Foundation and Arizona State University. While serving on the IACUC he helped numerous colleagues write and execute research protocols in a variety of species for experimental therapeutics, toxicology, pharmacokinetics, photodynamic therapy, immuno- and radiation-adjunct therapies, gene therapies, adoptive cell transfers and other leading edge technologies. He has himself worked with SCID-hu and nude immune deficient animals, many genetically altered (transgenic and knockout) and mutant mice in most common strains of mice. His experience extends to most other larger animal models routinely used in preclinical research.

The abstract is the third in Medelis' complimentary "Peer Perspectives in Oncology" Q&A series, which brings together respected researchers to discuss issues that face Chief Medical Officers today: rising costs, optimum patient accrual, targeted therapeutics, patient safety, FDA regulations, efficacy, budgets, and timelines.

"Peer Perspectives" abstracts are available for download on the http://www.medelis.com/oncology_abstracts.html [Medelis web site __title__ Oncology contract research organization providing CRO services for preclinical studies].

About Medelis, Inc.:
Medelis, Inc. is an oncology http://www.medelis.com/oncology_cro_services.html [contract research organization __title__ Oncology CRO providing preclinical research support, animal studies, selection of rodent model, and complete CRO services] providing a total solution for biotechnology and pharmaceutical companies seeking rapid drug development and approval. Medelis' medical founders, clinical trial management physicians and advisory board members, including Dan Von Hoff, James Gourzis, Howard Burris and Michael Gordon, are internationally-recognized oncology thought and opinion leaders who understand the future of personalized medicine and threshold of credibility trials. Offerings include strategic plans for regulatory approval from phase I through NDA and complete worldwide oncology clinical trial design, management and execution.

Medelis is privately-held and headquartered in Phoenix, Arizona with U.S. locations in Nashville, Phoenix and Reno.

###

Read the full story at http://www.prweb.com/releases/cros/preclinicalstudies/prweb1242484.htm


'/>"/>
Source: PRWeb
Copyright©2008 Vocus, Inc.
All rights reserved  

Related medicine news :

1. Genomic Health Announces Multiple Studies on Oncotype DX(TM) Presented at 2007 American Society of Clinical Oncology (ASCO) Breast Cancer Symposium
2. ESMO, Oxford Journals and the Japanese Society of Medical Oncology announce collaboration
3. SuperGen to Highlight Oncology Pipeline Data in Multiple Presentations at the AACR-NCI-EORTC International Conference
4. U.S. Oncology Initiates Complete Phase Ib Trial of Brostallicin Combination Therapy in Advanced Solid Tumors
5. US Oncology to Report 2007 Third Quarter Earnings Results
6. VioQuest to Present Data on Oncology Compounds VQD-002 and Lenocta(TM) at AACR-NCI-EORTC International Meeting
7. Genomic Health Reports Inclusion of Oncotype DX(TM) in American Society of Clinical Oncology Guidelines
8. Varian Medical Systems Ranks First in Overall Service Performance in 2007 Survey of U.S. Radiation Oncology Professionals
9. Accuray Announces Four New Products at Nations Leading Radiation Oncology Meeting
10. Debiopharm and NanoCarrier Sign License and Supply Agreement for Dach-Platin Polymeric Micelle in Oncology
11. National Autism Association and Deirdre Imus Environmental Center for Pediatric Oncology Announce National Greening Your School Initiative
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Oncology Clinical Research Scientist Recommends a Nuanced Preclinical Study Process to Speed Drug Development 
(Date:3/22/2017)... ... March 22, 2017 , ... ... a research collaboration to translate advances in basic neuroscience at the BMRI labs ... beyond. The collaboration seeks to improve movement, vision, and cognition impaired by stroke, traumatic ...
(Date:3/22/2017)... Chesapeake, VA (PRWEB) , ... March 22, 2017 ... ... offering asset protection assistance and financial consultations to families and business owners in ... raise support for the local American Cancer Society Relay For Life event. , ...
(Date:3/22/2017)... ... March 22, 2017 , ... Schneider Insurance and Financial, a southern Montana ... the Yellowstone Valley region, is launching a charity event aimed at raising local support ... all of Montana State, and is home to a broad variety of animals from ...
(Date:3/22/2017)... ... ... College basketball surges to its peak during the March Madness NCAA tournament, ... people to be foster parents. Through a televised spot, Coach Self is inviting adults ... to abuse, neglect and other family challenges. People who respond to Self’s call to ...
(Date:3/22/2017)... ... , ... NYC Chiropractor Dr. Steven Shoshany recently helped host a seminar at ... the U.S. and focused on a new protocol for treating pain. Dr. Shoshany is ... York, and furthermore the first seminar in the country was hosted at his Integrated ...
Breaking Medicine News(10 mins):
(Date:3/22/2017)...  Applied BioMath ( www.appliedbiomath.com ), the industry-leader ... development, today announced the latest line-up of speakers ... a day full of presentations, posters, and networking ... The focus is to learn about how mechanistic ... research and development. The event will ...
(Date:3/22/2017)... ROCHESTER, N.Y. , March 22, 2017 /PRNewswire/ ... Steriliz R-D™ Rapid Disinfector™ is the proven ultraviolet-C ... that cause healthcare-associated infections (HAIs). ... American Journal of Infection Control , the peer-reviewed ... testing and experiences of Vancouver General Hospital and ...
(Date:3/22/2017)... FinancialBuzz.com News Commentary  ... According to a report by the New Frontier Data, ... 2016, and is projected to grow at a compound annual growth ... 2025. The medical cannabis market is projected to grow at 12% ... an estimated $13.3 billion in 2025. These projections do not include ...
Breaking Medicine Technology: