Fifteen contract manufacturing organizations and contract development and manufacturing organizations (CMOs/CDMOs) have joined the Pharma & Biopharma Outsourcing Association (PBOA), a new nonprofit trade association that aims to help advance the industry's regulatory, legislative and business interests. 

PBOA is comprised of large- and small-molecule manufacturers, from APIs to finished dosage forms, with members covering the gamut from single-site to globally networked 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, 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.

PBOA will work collaboratively to advocate and represent its industry before regulatory, governmental and legislative bodies; educate pharma and biopharma 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 through industry research, analysis and knowledge sharing.

Activities will include outreach with the FDA, Congress, industry associations, sponsors and the public; holding workshops, webinars and networking events for member companies and other CMOs/CDMOs; establishing special interest groups to pursue focused goals; building business solutions partnerships with vendors; and developing baseline standards to streamline the client auditing process.

Gil Roth, PBOA's founder and president, said, "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."

Roth, who previously was editor of Contract Pharma until leaving earlier this year to launch the PBOA, said, "The CMO/CDMO industry has grown tremendously in the past 15 years, but the absence of a group like the PBOA has kept it from reaching its full potential."