Navigation Links
Matthew Lehman of SPRI Clinical Trials Speaks On Designing Trials For Success At The Trout Group Investor Relations Seminar

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.

"Management must keep the program on track by getting to the meaningful proof of the concept quickly, killing losers swiftly and honestly, and investing in the planning of clinical development to ensure data quality," he said. "Investors should understand the goals of each trial vis-a-vis FDA approval, be clear about the operation and costs of clinical trials, and acknowledge and reward management that kills losing drugs."

SPRI Clinical Trials ( was founded by Dr. Ari Kiev in 1970 to provide top rate clinical trial services to the pharmaceutical and biotech industry. With nearly 40 years of experience managing studies in the New York area, SPRI expanded internationally in 2003. Today, in addition to the U.S., the company conducts studies throughout Eastern and Western Europe. SPRI Clinical Trials-Global, LLC has principal offices in Kiev, Ukraine.

SOURCE SPRI Clinical Trials
Copyright©2009 PR Newswire.
All rights reserved

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:
(Date:6/24/2016)... , June 24, 2016 Epic ... sensitively detects cancers susceptible to PARP inhibitors by ... tumor cells (CTCs). The new test has already ... therapeutics in multiple cancer types. Over ... DNA damage response pathways, including PARP, ATM, ATR, ...
(Date:6/23/2016)... ... 23, 2016 , ... UAS LifeSciences, one of the leading ... UP4™ Probiotics, into Target stores nationwide. The company, which has been manufacturing high ... its list of well-respected retailers. This list includes such fine stores as Whole ...
(Date:6/23/2016)... , June 23, 2016 Houston ... with the Cy-Fair Sports Association to serve as ... the agreement, Houston Methodist Willowbrook will provide sponsorship ... and connectivity with association coaches, volunteers, athletes and ... with the Cy-Fair Sports Association and to bring ...
(Date:6/23/2016)... , June 23, 2016   EpiBiome , ... secured $1 million in debt financing from Silicon Valley ... up automation and to advance its drug development efforts, ... new facility. "SVB has been an incredible ... the services a traditional bank would provide," said Dr. ...
Breaking Biology Technology:
(Date:4/15/2016)... April 15, 2016  A new partnership announced ... accurate underwriting decisions in a fraction of the ... priced and high-value life insurance policies to consumers ... With Force Diagnostics, rapid testing (A1C, Cotinine ... readings (blood pressure, weight, pulse, BMI, and activity ...
(Date:3/31/2016)... , March 31, 2016   ... ("LegacyXChange" or the "Company") LegacyXChange is excited ... of its soon to be launched online site for ... ) will also provide potential shareholders a ... DNA technology to an industry that is notorious for ...
(Date:3/22/2016)... 22, 2016 According ... Market for Consumer Industry by Type (Image, Motion, ... (Communication & IT, Entertainment, Home Appliances, & ... to 2022", published by MarketsandMarkets, the market ... reach USD 26.76 Billion by 2022, at ...
Breaking Biology News(10 mins):