The Pharma & Biopharma Outsourcing Association (PBOA) held its first Meeting & Conference October 3-4 at the Bethesda North Marriott in Rockville, MD. The event drew participants from 20 PBOA member companies, as well as three affiliate members.

The event was targeted to executive, quality, regulatory and operations personnel at PBOA member companies. The roster of speakers included five high-level FDA personnel, discussing such topics as quality metrics, FDA/EMA mutual recognition of inspections, DSCSA implementation, warning letter trends, and the overhaul of the agency’s inspectorate.

Other presenters spoke about outsourcing business trends, M&A activity, facility expansions, developments in continuous manufacturing, safe handling of potent ingredients, employee engagement, and legislative and regulatory trends and PBOA priorities. Non-FDA speakers represented such organizations as Rutgers University, PharmSource, RBC, Boston Consulting Group, BioPlan Associates, IPS, SafeBridge Consultants, ISR, BGR Government Affairs, and Guiding Change.

PBOA’s president Gil Roth, said, “I couldn’t be happier with the event. The combination of strong, CMO/CDMO-specific content with networking opportunities for our members and speakers resulted in a fantastic first meeting and conference for PBOA.”

“The chance to meet with our industry peers, and interact with so many good speakers, made the conference very worthwhile to attend,” said Andy Rensink, president of Tapemark.

“We were honored to have significant engagement with many FDA leaders, as well as a well-curated agenda filled with recognized experts, enabling CDMOs of all sizes to learn and grow,” said Cornell Stamoran, vice president of strategy, Catalent Pharma Solutions.

“Our first-ever PBOA membership conference was a huge success. The networking events were great, the agenda brought forth very critical topics, and the ability to have candid sessions with FDA staff was invaluable,” said Peter Bigelow, chairman of PBOA and president of xCell Strategic Consulting.

The event included a cocktail reception at the end of the first day, followed by an informal networking dinner at Rock Bottom Brewery and Restaurant in Bethesda, MD, both sponsored by TraceLink. The conference was co-sponsored by TraceLink, Masy BioServices, and Vantage Consulting Group.

Mr. Roth added, “We’re looking forward to bringing our members together again in 2018. The CMO/CDMO sector deserves events like this one, where providers can talk and learn about the issues that matter to them, and I’m glad that the PBOA has made this a reality.”

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