A new non-profit trade association—The Pharma & Biopharma Outsourcing Association, or PBOA, has been formed to advocate industry causes.

The association was conceived and launched by former Contract Pharma editor Gil Roth because, he 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.”

So far fifteen CMOs/CDMOs have climbed aboard, representing large and small molecule manufacturers, from APIs to finished dosage forms, with members covering the gamut from single-site to globally networked companies.

In addition to advocating and representing its industry before regulatory, governmental, and legislative bodies, PBOA hopes to 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.

Contract Pharma talked to Gil about the association’s beginnings and what the plans are moving forward. For more information about the PBOA, visit www.pharma-bio.org, or contact Gil at gil.roth@pharma-bio.org.

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Contract Pharma: Tell me about the PBOA. What is it, how will it work and who can benefit from it?
Gil Roth: The Pharma & Biopharma Outsourcing Association is a non-profit trade association that represents contract manufacturing organizations and contract development and manufacturing organizations (CMO/CDMOs). As we start out, we’re focused on companies that operate in or sell into the U.S. If you’re a CMO or CDMO that interacts with FDA, we want to be your go-to trade group.

We’ll work to bring our members into the conversation with FDA, Congress, and other trade groups that affect the industry. We’ve partnered with a Washington, DC-area law firm that will provide both regulatory and legislative monitoring and help us reach the offices we need to reach, in order to get our message heard.

CP: Since the launch how are things going so far? What kind of response/feedback have you had from the industry?
GR: I’ve been very gratified by the response from industry. I began recruiting member companies in March of this year, and we quickly built a core of 15 members that were enthusiastic about giving this industry a voice. The founding members include Afton Scientific, Coldstream Laboatories, Cook Pharmica, Gallus Biopharmaceuticals, Halo Pharma, Hospira One 2 One, Jubilant HollisterStier, Metrics Contract Services, Patheon, Therapure Biomanufacturing, and WellSpring Pharma Services. We also added “Day One” general members in AAIPharma Services/Cambridge Major Labs, Coating Place, Confab Labs and DPT.

Those founding members each nominated a member to our board of trustees, and the board has done a great job of getting the PBOA off the ground. As you can see from the list of companies, the PBOA is bigger than any one sector of the CMO/CDMO market, covering dosage form and drug substance, biologics and small molecules, sterile injectables and oral solid dosages, and development through commercial. Our trustees help guide the agenda for the PBOA, while also providing me with management expertise, recruitment heft, and a lot of other capabilities. The board members are willing to be active participants and have helped me reach out to more potential members.

We’re also in the process of building a strong advisory committee, chaired by PharmSource president Jim Miller and including industry veterans from both the client and provider sides.

CP: What were the key drivers behind the establishment of the association?
GR: The idea for a trade association came about when I was reporting on an article for Contract Pharma early in 2013. It was on the topic of the Generic Drug User Fee Amendments (GDUFA), and a number of CMOs I spoke to felt that the allocation of facility fees was unfair. The more I researched and reported, the clearer it became that there was no one advocating for the CMOs’ interests during the GDUFA negotiating sessions, when those fees were being structured.

I began asking around the industry whether a trade association would be a good idea. Even the companies that weren’t complaining about GDUFA—either because they’re not in the generics space or their companies also have their own generic lines—understood that it’s important that our industry has representation and that we need to have a coordinated message.

So, the consensus was that a trade association would be a great idea, but no one was in a position to launch and run one.
Shortly after that, a group of biologics-oriented CMOs approached me at BIO 2013 and wanted to get my thoughts about assembling a trade association for CMO/CDMOs. None of that group had been part of my informal poll, but they’d developed the same idea on their own.

With their support, I organized a symposium with around 30 CMO/CDMOs, in September 2013, the night before Contract Pharma’s annual conference and exhibition, and received great response and feedback from the assembled group. It seemed like the time was right to build an association to represent this industry in Washington and beyond. It took a few months for me to realize that I wasn’t going to be able to get it rolling while I was still at Contract Pharma.

CP: What opportunity does this represent for contract manufacturers? How will inclusion help benefit business?
GR: The PBOA represents the first real opportunity for CMO/CDMOs to have their voices heard as an industry. In addition to our goals of outreach to regulatory and legislative bodies—that is, FDA and Congress—we’re also intent on working with the customer side of the industry. The PBOA can help disseminate best practices and get clients and providers to work together more effectively. More than that, we can get member companies talking to each other, through networking events, workshops and the like.

The PBOA has three key areas:
1. Advocacy/Representation with regulatory and government agencies. Our goal is to serve as the guidance organization for regulatory agencies globally when legislation and policy affect the industry. We will work to ensure the development of laws and policies that promote balanced oversight and the advancement of our industry.

2. Education of members, customers, and general public. We’ll monitor legislation, regulation and media activity that impacts the CDMO industry and provide analyses to members to help them be prepared to address changes. We plan to offer excellent networking, information-sharing and educational resources designed to keep members informed of industry issues. We will educate customers and other stakeholders about the value CDMOs bring to the pharma and biopharma industries.

3. Collaboration around common industry goals. Our members will help develop our agenda regarding issues that affect our industry and can simplify or promote the efficient growth of our businesses. Some initiatives include common third-party auditors program acceptance, Business Solutions partnerships to provide discounts on goods and services that our members use, and industry research to help get a better picture of the CMO/CDMO industry.

CP: What are the obstacles to getting off the ground and what do you perceive will be the major challenges to making the association a success?
GR: I think the biggest obstacle is that no one has ever done this before for our industry. It’s a cliché, but it really is both an obstacle and an opportunity.

When I began recruiting companies to join the PBOA last spring, one person said to me, “When I joined the industry six years ago, the first thing I asked my company was, ‘What trade associations do we belong to?’ When they told me there aren’t any, I started to worry that I made the wrong career choice.’” That company joined on the spot.

Still, the CMO/CDMO industry has a lot of players that are so concerned about the day-to-day operation that they don’t have time to step back and take in a broader, longer-term perspective. So it can be a challenge to get them to take that step back, and then to make the investment in time, money and resources that the PBOA requires.

It’s amazing that we’ve come as far as we have without having any sort of collective body in place to advocate for the industry, but given the pressures that the entire healthcare ecosystem is experiencing, it’s not a state of affairs that can last much longer. I like to cite a quote that’s been attributed to a variety of Louisiana politicians, “If you’re not at the table, then you’re probably on the menu.”

CP: Describe your interaction with FDA. Have they been receptive to the PBOA?
GR: Our first meeting with FDA came about somewhat by accident, but we were well received. Along with two members of our Board, I attended a public hearing about several GDUFA guidances in September. We didn’t think the topics would be relevant to the CMO/CDMO side of things, but we wanted to get a feel for this sort of hearing, to see what the presentations were like and how the FDA panel conducted its questioning.

Lo and behold, the second presentation was from a small generic drug company and was focused completely on GDUFA’s facility fees and how the “no-waiver” policy was unfair to smaller manufacturers. Both trustees nudged me to sign up for the open comments portion at the end of the morning session, where I would get five minutes at the podium in front of the FDA panel. I did, then began scribbling notes about GDUFA, facility fees, the bill that one of our members lobbied his Representative to introduce (H.R. 3631, the Small Manufacturer Protection Act), which would permit FDA to waive those fees for companies under a certain threshold, and more.

When my turn came up, I took to the podium, adjusted my tie, and introduced the PBOA to the FDA on the public record. My presentation only took up a few minutes, and focused on the need for more interaction between FDA—not just the Office of Generic Drugs—and CMOs/CDMOs. The panel members’ questions were cordial and it really felt like they were welcoming us aboard. They seemed legitimately interested in understanding more about this business and how it differs from in-house pharma and biopharma operations.

CP: What are the PBOA’s ultimate goals, both short- and long-term?
GR: In the short term, we want to build bridges to connect the CMO/CDMO industry with FDA and Congress, educate both clients and providers about best outsourcing practices, and bring our industry into the 21st century.

In the middle term, if we can succeed with our initiative in developing baseline auditing standards between manufacturers and clients, we can not only provide savings for both parties, we may be able to demonstrate to FDA and other regulatory bodies that CMO/CDMOs are committed to quality above and beyond cGMP. Along with our regulatory/legislative advocacy activities, that could go a long way toward changing the image of our industry.

In the long term, if this model works, we could expand into other areas of outsourcing, as well as other geographic regions. But I spent enough years writing articles about the perils of “scope creep” to know that we need to stick with our initial mission.