ABC Laboratories' Pharmaceutical Program Management unit assists sponsors with study design and regulatory consulting services, and dedicates senior technical staff to provide oversight of operational performance, facilitate collaboration and ensure timely delivery of its products. The program is driven by rigorous metrics-driven performance measurement of quality, timeliness and service.
"The business of contracted pharmaceutical development has shifted in recent years," said John Bucksath, Sr. 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," he said.
ABC’s Pharmaceutical Program Management unit is headed by Patrick Noland, an industry veteran with 30 years of pharmaceutical research and manufacturing experience. “ABC has long been a reliable technical resource for contract laboratory services,” said Noland. “This initiative takes outsourcing relationships to the next level. It’s about partnering with our customers to develop drugs.” Noland’s experience includes direct responsibility for pharmaceutical product development, extractables and leachables, method validation, and technical support for product and material investigations. He is a contributing author to the CMC sections of four approved NDAs, two of which were inhalation products approved in the first application round.