4 Questions From The PDA Annual Meeting

By Ed Hess, Editor, BioProcess Online

At the 2016 PDA Annual Meeting, several themes emerged about the direction of the pharmaceutical industry. What was less clear, however, was how each drug manufacturer would respond.

A few weeks back I attended the 2016 PDA Annual Meeting held in San Antonio. In general, the main thrust of the conference focused on the technologies and approaches being applied by biopharma manufacturers as they move their therapies from development through commercialization. Following the daily keynote, the conference broke into three tracks that included bioprocessing advancements, manufacturing innovations, and continuous improvement. After a few days in the Lone Star State, it wasn’t hard to notice a host of consistent themes and topics that seemed to show up throughout keynotes, presentations, and conversations in the hallway.

Since I’ve returned to the office, I’ve had the opportunity to speak with people in the industry and travel to a customer site. And, the themes from the PDA Annual Meeting continue to be reinforced with seemingly every interaction. The words might be slightly different. Each company’s response will be unique. But, the issues highlighted at the PDA event need to be addressed by every biopharma company, whether it was in attendance or not.

How Flexible Are You?

There is no disagreement that the global biologics market will continue to blossom. By all forecasts, these therapies will have strong growth with the only debate being measured in degrees. One estimate, for example, says biologics will represent at least 30% of all pharmaceutical sales in the next 10 years. Right now, these biologic therapies account for just under 20% of the market. Of course, there’s a rub. The need for biologics will be increasing over time. But, the volumes required for each specific therapy will be less than therapies of the past. There will be blockbuster biologics. But, the vast majority of biologics will be for smaller patient populations. This dynamic will test manufacturers’ ability to be flexible and challenge their current technologies and processes. While the focus for many of today’s manufacturers is speed. Tomorrow, the focus will be on flexibility: How fast can you changeover?

Is This Technology New To You?

Are some technologies and processes proprietary? Sure. Are your people your company’s most important asset? Of course. That said, the road to biomanufacturing’s future is paved with fairly well-understood concepts and equipment. For instance, Matt Shields, executive director at Amgen Singapore, spent an entire session at the PDA Annual Meeting discussing the company’s next-generation facility in Singapore. There was plenty to take away from the session (e.g. the company reduced its facility footprint by 80% compared to a traditional facility with similar throughput). But, what struck me was that Shields said most of Amgen’s innovations could fit neatly into three categories: Modular Design with Connected Processing, Single-Use Technologies, and Real-Time Monitoring. “There’s nothing really exotic about these technologies,” Shields relayed to the audience. While other companies get some benefit by using these technologies individually, Amgen’s real breakthrough came by integrating them.

Can You Make It?

Cell and gene therapies continue to be very effective, but finding a path to commercialization is proving to be difficult in the extreme. This is especially the case for autologous therapies (where I recall an industry vet remarking earlier this year that autologous therapies “represent an unprecedented manufacturing challenge”). The words used at PDA were different, but the thought was the same. At the conference, one speaker relayed how this reality changes the conversation within pharma companies and places the spotlight on different functional roles during the discussion. “Typically, the big question within pharma is, ‘Does it [the drug] work?’ The smaller question is, ‘Can we make it?’ If the drug works, we have high confidence we can make the product,” relayed the pharma exec. “Cell therapy flips that discussion on its head. The smaller question is, ‘Does it work?’ And, the larger question becomes, ‘Can we make it?’ It’s not always clear that we can. It’s a huge challenge.”

Are You Ready To Move?

Here are two seemingly incongruous sentiments I heard multiple times at the PDA Annual Meeting: The FDA sincerely wants pharma companies to invest in newer, more advanced technologies. And, “I work for [insert big pharma name here], and there’s no way my company has the stomach to make the changes to manufacturing that you are discussing.”

Several presenters went into detail about the encouragement their companies received from the FDA as they upgraded or built facilities. The description of the FDA was that of a partner in the process. Ultimately, new technology and innovation is the only way for the FDA to realize its vision of “A maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high quality drugs without extensive regulatory oversight.” And, yet, pharma companies remain resistant to this type of change. Even when faced with aging and inefficient facilities, pharma companies maintain the status quo. Added one speaker, “When there is a regulatory burden, companies will move fast. Without that regulatory burden, companies aren’t even scouting new equipment or technology.” Pharma companies are risk averse, and few want to be first movers. But, the industry is starting to see companies implement these next-generation technologies. The balance of the companies must be ready to act as the industry moves past the early adopter stage.