SOURCE: Conformia

July 01, 2008 08:00 ET

FDA Expands Cooperative Research and Development Study (CRADA) With Conformia

Conformia and FDA Expand Landmark CRADA Focusing on Factors Influencing Pharmaceutical Development Success

SUNNYVALE, CA--(Marketwire - July 1, 2008) - Conformia, the market leader of product and process lifecycle management (PPLM) solutions for life sciences, today announced the U.S. Food and Drug Administration's (FDA) Office of Pharmaceutical Sciences (OPS) has asked the Company to expand its Cooperative Research and Development Study (CRADA) focusing on process and product development to 25 companies. The CRADA Research Study is helping to uncover the challenges facing pharmaceutical, biotechnology, and generics process/product development organizations as they attempt to implement the ICH Quality Vision (ICH Q8, Q9, Q10) across the product and process lifecycle.

"We at the FDA have gained a lot of value from the pilot phase of the CRADA with Conformia and we are truly excited to not only continue working with Conformia but to expand the scope of our work," said Helen Winkle, Director for the Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Science. "We are particularly interested in the CRADA because it is a blinded study and we do not know the names of the companies participating. This allows us to get at the heart of the issues in a novel way and provides value for the entire set of reviewers and inspectors."

"As we've been working with companies, we've seen that the CRADA Research Study has been creating a new learning environment to help companies improve manufacturing approaches, increase efficiency, lower drug development costs and succeed with the new ICH Q8, Q9 and Q10 standards," said Anjali Kataria, Chief Marketing Officer of Conformia and Principal Investigator of the CRADA with the FDA. "These new guidelines are gaining international attention from multiple groups including global regulators such as the European Medicines Agency (EMEA) and the Pharmaceuticals and Medical Devices Agency (PMDA) as well as international industry associations. We are proud to be providing one set of inputs into the larger discussion on implementation."

"The research Conformia is conducting with industry partners has been helping us understand the critical challenges the industry is facing as it works to implement the concepts outlined in ICH Q8, Q9 and Q10," according to Jon Clark, Associate Director, Policy, FDA. "In turn, the study has helped us at the FDA get a better understanding of what we need to do to ensure the industry can achieve the goals and objectives outlined in the ICH initiatives."

Since 2006, Conformia has worked with the FDA on CRADA activities and is dedicated to gathering industry information to help develop the tools, processes and initiatives life science companies need to overcome the Quality by Design challenges they face. CRADAs are commonly used in the United States to support public - private collaboration that results in innovative research and development at institutions like the U.S. National Institutes of Health (NIH), the U.S. Departments of Defense, Security, Transportation, Energy and so on. The FDA has a number of CRADAs currently focusing on different aspects of food and drug commercialization.

Sam Venugopal, lead for the CRADA Research Study Part II, noted, "Through this expanded CRADA research study, Conformia will gather information from the participating pharmaceutical, biotechnology and generics companies to better understand and determine the factors that are currently influencing pharmaceutical development."

The factors that will be assessed will include development information bottlenecks, pilot plant information management, manufacturing science, information retrieval, quality systems and preclinical development challenges. Venugopal continued, "The research will provide essential insight and sharing those insights across the study group to help organizations overcome these challenges and more effectively implement industry guidelines ICH Q8, Q9 and Q10."

Venugopal also noted that there is no cost to companies to participate. Conformia is interested in hearing from companies that would like to participate in the landmark study and help shape the future for drug development and risk management processes.

In addition to the "blinded" research study expansion, other aspects of the Conformia CRADA include industry workshops on progress and implementation of ICH Q8, Q9 and Q10 as well as content development such as case study development and teaching materials. To date the Company has focused on large pharma companies / small molecule development and will be now expanding these programs to also include greater focus on large complex molecule case study development and workshops.

About Conformia

Conformia Software is the leading provider of product/process lifecycle management (PPLM) software solutions to regulated process industries including life sciences. Conformia solutions enable faster time to market, reduced costs, and decreased risk. As a company, Conformia remains a thought leader in addressing the most pressing issues facing pharmaceutical development teams across the globe such as implementation of ICH Quality vision. For more information please visit www.conformia.com or email Anjali Kataria (AKataria@conformia.com) or Sam Venugopal (SVenugopal@conformia.com).

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