Analytical Bio-Chemistry (ABC) Laboratories, Inc. has made a strategic organizational change aimed at supporting the drug development efforts of specialty, virtual and other small drug development companies. The company’s new Pharmaceutical Program Management unit will assist sponsors with study design and regulatory consulting services, as well as oversight of operational performance, facilitate collaboration and ensure timely delivery of its products utilizing metrics-driven performance measurement.
   
“The business of contracted pharmaceutical development has shifted in recent years,” said John Bucksath, senior vice president and general manager of ABC Laboratories’ pharmaceutical services division. “Small, entrepreneurial companies are responsible for a larger share of development, and most turn to contract laboratories like ABC for analytical support services. We’ve found those same customers often seek help understanding the types of studies and data required to support IND and NDA applications, and place a high value on direct, frequent communication. Our Program Management unit brings a new level of personalized service to the table.”
   
Patrick Noland has been named vice president of program management and will lead the unit. Mr. Noland has 30 years of pharmaceutical development, research and manufacturing experience, which includes direct responsibility for pharmaceutical product development, extractables and leachables, method validation, and technical support for product and material investigations.
   
Also supporting ABC’s Program Management initiative is Noel Premkumar, Ph.D., who was recently named the pharmaceutical division’s chief scientific officer. Dr. Premkumar has more than 20 years of industry experience conducting in-vivo and in-vitro xenobiotic metabolism studies, and has extensive knowledge of FDA, ICH, EPA, OECD, and JMAFF guidelines, as well as Phase 0 guidance for radiolabeled micro-dosing studies. Dr. Premkumar has been with ABC Laboratories since 1990, and was a key player in developing the company’s DMPK and bioanalytical programs.