Navigation Links
Matthew Lehman of SPRI Clinical Trials Speaks On Designing Trials For Success At The Trout Group Investor Relations Seminar
Date:6/18/2009

NEW YORK, June 18 /PRNewswire/ -- In designing and conducting clinical trials, it is critical to meet FDA objectives while preventing program "drift," according to Matthew Lehman, chief operating officer of SPRI Clinical Trials-Global, LLC in his remarks at a recent seminar for biotechnology companies.

Lehman spoke on "Designing Trials for Success: Balancing FDA Expectations and Operational Reality," at the Trout Group Investor Relations Seminar: Management's Guide to Wall Street, held recently in Munich, Germany. He addressed CEOs and CFOs from private and small and mid-cap life science companies.

The FDA and other regulators are the gatekeepers to realizing shareholder value and future profits, Lehman said. FDA goals of drug safety, efficacy and economic cost/benefit are consistent with those of the other key stakeholders in the drug development process: patients, clinicians and payors. To maximize long term shareholder value, companies must conduct research that is scientifically and statistically valid, clinically meaningful, and that optimizes the use of capital from a time and effectiveness standpoint, he said.

To meet FDA objectives for clinical trials, companies must assure patient safety and evaluate efficacy with validated, clinically meaningful endpoints and statistical significance for the study, Lehman said.

"The FDA expects good science and good medicine. Meetings are serious, specific and formal and should have a defined purpose," he said. "Reviewers want to speak scientist to scientist. Companies should deliver reasoned proposals and obtain yes/no answers."

Although it should be simple to secure agreement with the FDA and then follow through on a development plan, competing interests and operational realities can take programs off track. Management and shareholders need to be aware of this "program drift" and plan accordingly, Lehman said.

'/>"/>
SOURCE SPRI Clinical Trials
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2

Related biology technology :

1. USP Names Matthew Heyman Vice President of External Affairs and Strategic Integration
2. Matthew B. Wiener, CEO of Pharmatech, Inc., Is Awarded the Cancer Leadership Award From the Colorado Cancer Coalition
3. BioSpecifics Technologies Corp. Announces Appointment of Dr. Matthew Geller to Board of Directors
4. Cord Blood America CEO Matthew Schissler Says Operations Significantly Streamlined
5. Matthew J. Pfeffer Joins MannKind as Corporate Vice President and Chief Financial Officer
6. Neurobiological Technologies Appoints Matthew M. Loar as Chief Financial Officer
7. Matthew B. Potter Joins Pressure BioSciences, Inc. as Vice President of Sales
8. Cord Blood America CEO Matthew Schissler Interviewed by BIONOVA, Greeces Leading Biotech Magazine
9. Cerimon Pharmaceuticals Names Matthew J. Meyer its General Counsel and Vice President of Business Development and Licensing
10. Genstructs Andrea Matthews Selected for Mass High Techs People to Watch Under 30
11. Caliper Life Sciences to Present at Lehman Brothers Global Healthcare Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/10/2014)... Deep Knowledge Ventures last week ... ‘Commercialising Longevity Research’ and welcomed a host of ... Bioscience Innovation Center for the event, organised by ... Ltd. The meeting highlighted the need for both ... age-related disease, as well as the crucial role ...
(Date:7/10/2014)... (PRWEB) July 10, 2014 Unraveling life’s ... together. The Archer Family purchased a DNA ... DNA, but ended up with a lifetime of memories, ... within the family members’ DNA genuinely brought the family ... to search deeper into genetic history and prior to ...
(Date:7/10/2014)... EvoDerma ’s NOOME Anti-Aging Motion has been upgraded for ... a second treatment cup to help prevent and smooth skin ... thinner on the edges for a softer contact with the ... surfaces on the face, neck and décolleté. Choose to use ... such as the cheeks and neck, or opt for the ...
(Date:7/10/2014)... July 10, 2014 On July ... Medvedev , presented Russia,s first ... . The Company is developing a unique project called ... BIOCAD develops a number of innovative drugs based on ... The ceremony took place at the International Exhibition "Innoprom ...
Breaking Biology Technology:DKV Sponsors Forum on Commercialising Longevity Research; Brings Together Scientists, Investors, Entrepreneurs and Celebrities 2DKV Sponsors Forum on Commercialising Longevity Research; Brings Together Scientists, Investors, Entrepreneurs and Celebrities 3DKV Sponsors Forum on Commercialising Longevity Research; Brings Together Scientists, Investors, Entrepreneurs and Celebrities 4DKV Sponsors Forum on Commercialising Longevity Research; Brings Together Scientists, Investors, Entrepreneurs and Celebrities 5DKV Sponsors Forum on Commercialising Longevity Research; Brings Together Scientists, Investors, Entrepreneurs and Celebrities 6Ancestry DNA Test Reveals a Controversial and Undiscovered Family History 2Ancestry DNA Test Reveals a Controversial and Undiscovered Family History 3Ancestry DNA Test Reveals a Controversial and Undiscovered Family History 4Ancestry DNA Test Reveals a Controversial and Undiscovered Family History 5Introducing a New Bonus Treatment Cup for EvoDerma’s NOOME Anti-Aging Motion 2Dmitry Medvedev Presented BIOCAD the First National "Industry" Award 2
... , , ... issue of the journal,Diabetic Hypoglycemia ( http://www.hypodiab.com ) reviews ... Professor Vincent Marks , a leading ... criminal behavior, discusses how,hypoglycemia-related neuroglycopenia can cause behavioral changes, which ...
... ... the company as a regulatory consultant after retiring from Eli Lilly & Co. ... science and human pharmaceutical products, including director of regulatory affairs and clinical research. ... US regulatory submissions. , ...
... ... ... 2010 -- Agriculture is a game-changer that addresses multiple global issues – hunger, poverty, ... CEO Ellen Kullman told attendees of the 40th World Economic Forum Annual ...
Cached Biology Technology:Hypoglycemia - A Role in Criminal Behavior and a Consideration for Custodial Care 2Hypoglycemia - A Role in Criminal Behavior and a Consideration for Custodial Care 3Michael Langley, DVM, MBA, RAC Joins the Anson Group as a Regulatory Consultant 2DuPont Chair and CEO: Agriculture is Key to Global Economic Growth, Sustainability and Security 2
(Date:7/11/2014)... 2014---A team of researchers from The Chinese University of ... gene of wild soybean linked to salt tolerance, with ... saline soil. This study published online in Nature ... genomic information for crop improvement. , Soybean is an ... human selection, cultivated soybeans have less genetic diversities than ...
(Date:7/11/2014)... animals often develop relationships with other group members to ... wild chacma baboons the strategy for grooming activities shows ... just published in the scientific journal Biology Letters ... baboons is not practiced without ulterior motives. To be ... the individual, while grooming another individual can provide access ...
(Date:7/11/2014)... two different ways that allow unprecedented experimental insights ... of oxygen molecules in photosynthesis. The two studies ... Nature Communications . , "The new knowledge will ... oxidation, which are key components for building artificial ... energy in fuels like hydrogen, ethanol or methanol," ...
Breaking Biology News(10 mins):BGI reports a novel gene for salt tolerance found in wild soybean 2Baboons groom early in the day to get benefits later 2Molecular snapshots of oxygen formation in photosynthesis 2
... at the Stanford University School of Medicine have taken ... cells that could eventually be transplanted into living organisms. ... surgical resident Oscar Abilez, MD, and colleagues have successfully ... building blocks of blood vessels, after placing them in ...
... over a decade, the technique of distraction has been ... to reduce pain associated with certain medical procedures. The ... there is an important psychological element in the perception ... the harmful stimulus affecting the perception of the pain. ...
... of York have made a huge leap forward in the ... the Department of Biology has made a significant advance in ... biological warfare. , Bacteria like E. coli frequently try to ... called colicins, which are potent toxins. , The research ...
Cached Biology News:Stanford doctors advance in bid to turn mice stem cells into blood vessels 2Stanford doctors advance in bid to turn mice stem cells into blood vessels 3Virtual realities against pain 2