Outsourcing Association Elects Chairman

The Pharma & Biopharma Outsourcing Association (PBOA), a non-profit trade association established to advance the interests of contract manufacturing organizations (CMOs), contract development manufacturing organizations (CDMOs), and other service providers, has elected Peter Bigelow to serve as chairman of the board of trustees.

Bigelow will work with the board and with PBOA President Gil Roth to develop the PBOA's agenda, represent the association in its regulatory, legislative, and business mission, and serve as liaison between the Board and the member companies. He will serve an initial term of two years, effective immediately.

PBOA was formed in 2014 by CMOs/CDMOs to advance their regulatory, legislative and business interests.

"CMOs and CDMOs are the companies that help the pharma and biopharma industry develop and manufacture drugs and other treatments safely and cost effectively. Until now, they haven't had a trade association to represent their needs and interests. The PBOA will ensure that their voice is heard, that they have a seat at the table, and that the industry can move forward and mature," said Roth.

Peter commented, "The strategic importance of outsourcing partnerships has grown immensely in the pharmaceutical development and manufacturing industry. The PBOA represents a great opportunity for the industry to make progress on key issues. I am very pleased to be a part of this new and exciting organization."

Bigelow is the president of xCell Strategic Consulting, a consulting firm to the pharmaceutical industry. He recently served as interim president of the Qualitest Pharma division of Endo Health Solutions, Inc. Prior to founding xCell, he served as the resident of North America commercial operations at Patheon and also held the role of CEO.

He previously spent 14 years with Wyeth, where he was responsible for global supply of Wyeth’s Consumer Healthcare products and held a variety of senior engineering and operations roles for the prescription drug business. In addition, Bigelow spent 14 years at SmithKline Beecham (now GlaxoSmithKline) doing international project work in Europe and the Far East and operations experience with injectable product manufacturing.

PBOA members represent large and small molecules, APIs, and finished dosage forms, and incudes single-site and multi-national companies. The association's founding members are Afton Scientific, Coldstream Laboratories, Cook Pharmica, Gallus BioPharmaceuticals, Halo Pharma, Hospira One 2 One, Jubilant HollisterStier, Metrics Contract Services, Patheon, Inc., Therapure Biomanufacturing, and WellSpring Pharma Services. Initial general members are AAIPharma Services/Cambridge Major Laboratories, Coating Place, Confab and DPT Labs. The advisory committee is chaired by Jim Miller, president of PharmSource.

In a statement, the PBOA will work to advocate and represent its industry before regulatory, governmental, and legislative bodies, keeping members informed of relevant developments; educate pharmaceutical and biopharmaceutical companies, the general public and other stakeholders on the value that CMOs/CDMOs bring to the development and manufacture of therapeutics; and advance common industry goals and interests and support members through industry research, analysis and knowledge sharing.

Activities will include outreach with FDA, Congress and industry associations, holding workshops and webinars for member companies and other CMOs/CDMOs, establishing special interest groups to pursue focused goals, building Business Solutions partnerships with vendors that serve the industry, and developing baseline standards to streamline the client auditing process.

The PBOA's Board of Trustees includes Roth and representatives from the founding members:

• Karen Blair, vice-president, Hospira One 2 One
• David Flowers, director, business development, Jubilant HollisterStier
• Nick Green, president, chief executive officer, Therapure Biomanufacturing
• Tedd Green, president, Cook Pharmica
• Sally Langa, vice-president, sales and marketing, Halo Pharma
• Laura Parks, senior vice-president, corporate operations and strategic initiatives, Patheon, Inc.
• Sam Ricchezza, vice-president, business development , WellSpring Pharma Services
• John Ross, executive vice-president, Metrics Contract Services
• Tom Thorpe, president, Afton Scientific
• Mike Ultee, chief scientific officer, Gallus BioPharmaceuticals
• Chris Verbicky, director of business development and marketing, Coldstream Laboratories

Source: Pharma & Biopharma Outsourcing Association (PBOA)