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:1/15/2014)... Biotechnology Company, Limited ("TaiGen") today announced that they have ... pharmaceutical company, to develop and commercialize nemonoxacin (Taigexyn ® ... Turkey and other members of ... for the treatment of bacterial infections including those caused ...
(Date:1/14/2014)... Carahsoft and CDS Federal Services have ... at 2pm EST (11am PST), “Natural Language Processing: Converting ... how technology can turn raw, heterogeneous data into actionable ... The online webinar will last approximately one hour. , ...
(Date:1/14/2014)... Jan. 14, 2014  3D Communications, a leading provider of strategic communications ... and media events in the United States ... Virginia Cox , JD, is returning to the firm,s ... re-joins 3D after more than two years of service as ...
(Date:1/14/2014)... NY (PRWEB) January 14, 2014 EquitiesIQ, ... Alliqua, Inc. (OTCQB: ALQA). Alliqua is an emerging biomedical ... serve the wound care market. , Free report download: ... restructured with a seasoned management team and Board, which ...
Breaking Biology Technology:TaiGen Biotechnology Signed Exclusive License Agreement with R-Pharm for Nemonoxacin (Taigexyn(R)) 2TaiGen Biotechnology Signed Exclusive License Agreement with R-Pharm for Nemonoxacin (Taigexyn(R)) 3TaiGen Biotechnology Signed Exclusive License Agreement with R-Pharm for Nemonoxacin (Taigexyn(R)) 4Webcast - Natural Language Processing: Converting Raw Data into Actionable Knowledge – Hosted by Carahsoft and CDS Federal Services 2Former FDA Associate Commissioner Returns To 3D Communications 2EquitiesIQ Initiates Coverage of Alliqua, Inc. 2EquitiesIQ Initiates Coverage of Alliqua, Inc. 3
... REDWOOD CITY, Calif., March 4 Maxygen, Inc.,(Nasdaq: ... the development of,improved protein drugs, today announced changes ... president in charge of global,business development and U.S. ... business officer. In addition, the company announced the,pending ...
... new independent non-executive directors added to Board with ... ... appointed independent non-executive Chairman, BRISBANE, Australia, March 4 ... John Lee and Robert Williamson to the Company,s Board as,independent ...
... Biosciences,(Nasdaq: MATK ) announced today that life,sDHA, its ... heart health, is available in new So,Good Omega DHA ... selling soymilk brand. Available in original or vanilla flavor, ... major retailers throughout,Canada., "So Good Omega DHA Soymilk ...
Cached Biology Technology:Maxygen Announces Management Changes 2Progen Expands Board of Directors 2Progen Expands Board of Directors 3Progen Expands Board of Directors 4Canada's Best-Selling Soymilk Now Available with Martek's life'sDHA 2Canada's Best-Selling Soymilk Now Available with Martek's life'sDHA 3
(Date:4/23/2014)... conclusive evidence that the source of a unique rhythmic ... called the "bio-duck," is the Antarctic minke whale ( ... personnel in the 1960s who thought it sounded like ... various locations in the Southern Ocean, but its source ... 2013, an international team of researchers deployed acoustic tags ...
(Date:4/23/2014)... the likelihood of an accurate group decision increases with ... when a collective faces a variety of factors ... University researchers report that smaller groups actually tend to ... excessively focused on only certain pieces of information. , ... known about collective intelligence, or the "wisdom of crowds," ...
(Date:4/23/2014)... The shale gas boom has transformed the energy ... locations, it could cause conflict among the energy ... resources, say researchers. They add that degraded water ... adequate safeguards. The feature article appears in the ... , Meagan S. Mauter and colleagues point out ...
Breaking Biology News(10 mins):Scientists identify source of mysterious sound in the Southern Ocean 2Scientists identify source of mysterious sound in the Southern Ocean 3Too many chefs: Smaller groups exhibit more accurate decision-making 2Too many chefs: Smaller groups exhibit more accurate decision-making 3How to avoid water wars between 'fracking' industry and residents 2
... January 11, 2010 Why do some people like to ... hand, taking the opposite tack by buying insurance to reduce ... Hebrew University of Jerusalem and two Asian universities say the ... team set out to tackle the long-standing question in economic ...
... standards to help ensure the quality and enhance the ... and a variety of functional foods are being proposed ... internationally recognized compendium of quality standards for food ingredients. ... breast milk and commonly added to infant formula, and ...
... Ohio Blocking the function of an enzyme in the ... nerve cells from dying after a stroke, new research suggests. ... that the tocotrienol form of vitamin E, an alternative to ... acids that eventually kill neurons. The Ohio State University ...
Cached Biology News:Why do people 'play the longshot' and buy insurance? It's in our genes 2Quality and safety of infant formulas, functional foods enhanced by new standards 2Quality and safety of infant formulas, functional foods enhanced by new standards 3Study reveals how one form of natural vitamin E protects brain after stroke 2Study reveals how one form of natural vitamin E protects brain after stroke 3