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RRD International hires former FDA Deputy Director of Antiinfective Products Division

Apr 01, 2015

Rockville, Maryland – RRD International, a product development company that provides expert-level strategic, regulatory and operational support to biopharmaceutical companies and investors, announced today the appointment of Dr. Katie Laessig as senior vice president of regulatory affairs and medical safety. Laessig, a 16-year Food and Drug Administration (FDA) veteran, has served as deputy director of the Division of Anti-Infective Products (DAIP) since 2007 and been responsible for review of antimicrobial drug and biologic products for the treatment as well as prevention of infectious diseases. Prior to joining DAIP, she held several positions of increasing responsibility within the Division of Anti-Viral Products (DAVP).

“We are delighted to have Katie join RRD and excited about the possibilities it creates for the company, our partners and, ultimately, patients,” said Scott Tarrant, president, RRD International. “Katie’s breadth of regulatory expertise and unique patient perspective through her volunteer work at Whitman-Walker Clinic will prove invaluable to RRD and its development partners – especially as we grow our anti-infectives business given the need for innovation in this area.” In her new role, Laessig will serve as an expert advisor to RRD’s product development teams and partner companies for specific products and indications. She will also work with the senior management team to develop and implement new business initiatives in the anti-infectives area.

“Katie’s addition further expands our broad expertise and commitment to the development of products which prevent and treat infectious diseases,” said Chuck Finn, Ph.D., CEO, RRD International. In January 2014, RRD announced a partnership between its subsidiary ClearPath Development Company and Astellas Pharma, Inc, to manage a portfolio of asset-centric companies focused on the commercialization of vaccines for infectious diseases. “With Katie onboard, we can expand our business model with partners in the non-vaccine anti-infective space – an area becoming more important as resistance to antibiotics increases,” added Finn. According to a 2014 World Health Organization (WHO) global surveillance report, “the problem of antibiotic resistance is so serious that it threatens the achievements of modern medicine. A post-antibiotic era, in which common infections and minor injuries can kill, is a very real possibility for the 21st century.”

“The development of new prophylactic and therapeutic vaccines, anti-infectives and biologic products with new mechanisms of action are needed to effectively address the antibiotic resistance problem,” said Finn. Laessig earned her medical degree from the University of Maryland in Baltimore in 1992 and completed her internal medicine residency in 1995 and infectious diseases fellowship in 1997, both at George Washington University Medical Center in Washington, D.C. She graduated from Cornell University in 1988 with a Bachelor of Arts in biology and a concentration in microbiology. Laessig is board certified in infectious diseases and is a member of the Infectious Disease Society of America and the American Society for Tropical Medicine and Hygiene.

About RRD International: RRD International is a product development company that provides integrated, expert-level strategic, regulatory and operational support to biopharmaceutical companies and investors. The Company’s unique Product Development Team model (PDT) provides an effective, asset-centric alternative to traditional industry practices. While comprehensive in value, structure and function – encompassing all aspects of a development program including strategic planning, management and execution – the PDT model is also highly resource efficient with an intense focus on minimizing cost, time and risk to achieve human proof-of-concept (POC). Since 2002, RRD has worked with more than 100 organizations across all major classes and therapeutic areas. For more information, visit www.rrdintl.com.

About ClearPath Development Company ClearPath Development Company works with leading biopharmaceutical companies to expand product pipeline opportunities with complementary development and finance capabilities. ClearPath’s business model provides biopharmaceutical companies with an alternative mechanism for accelerating product development. For more information, visit www.clearpathdevco.com.