Biopharma Trends That Will Impact You In 2016

By Trisha Gladd, Editor, Life Science Connect

December is coming to a close, which means a new year is right around the corner, bringing new challenges and new opportunities. I recently spoke to industry experts who offered some insight on the key trends in 2016 that are expected to shape the year ahead and have a significant impact on the future of biopharma.

Flexible Manufacturing Solutions

There are a number of factors driving the need for more flexibility in manufacturing. Some of these include the desire to make facilities more adaptable to change, the need to meet increased demands for localization of manufacturing into emerging markets, and of course, increasing efficiencies in order to lower the cost of drug development. According to Parimal Desai, VP of global vaccines and biologics commercialization at Merck, meeting these goals will require the continued development of flexible manufacturing solutions. “2016 will bring more focus on developing flexible-manufacturing solutions to meet a wide range [high-volume to niche products] of capacity needs,” he explains. “This shift will require companies to implement more continuous manufacturing and invest in single-use technologies and flexible manufacturing plants with rapid changeover procedures as well as use of in-line process analytical technologies.”

Industry And Regulators Partnerships

In order to get life-saving medicines to patients quicker, the industry and regulatory agencies in the United States and across the globe will need to engage in closer dialogues in order to strengthen those partnerships. Chuck Hart, director of manufacturing at Prolong Pharmaceuticals, believes this is something that’s already been demonstrated so far and will begin to take shape even more in the next year. “The regulatory harmonization I’m seeing is very exciting,” he says. “As companies prepare for pre-approval inspection, they prepare based on the regulatory agency. For example, in the past, the EU was more interested in area cleanliness and autoclave data while the FDA concentrated on processing. Having a single standard would simplify things significantly and would make the market even stronger.” He adds that he also sees a trend with the FDA acting more as a partner, rather than a big brother. “Instead of being perceived as a bully, the FDA seems to now be working toward up-front meetings and collaborative discussions about the path forward. In my opinion, the auditors are being trained better to really work with a company, and unless its GMP violations are egregious, the FDA works more as a partner to resolve any gaps.”

New And Incoming Talent

As the industry prepares for the biologics boom experts are predicting, there will need to be an increased focus on training for new as well as existing talent. The rapid growth in biopharma seen over the past several years will result in increased competition for a finite pool of experienced and skilled talent who are able to create and execute strategies and tactics needed to succeed in the marketplace. Companies will need to commit to developing and permanently embedding these capabilities into the organization. Even as new graduates enter the marketplace, manufacturers will need to be prepared to invest in additional training for specific skillsets. “We are finding that fresh graduates do not have a good understanding of the drug development process and need significant amount of on-the-job training,” says Desai. A recent report by Eric Langer, president and managing partner of BioPlan Associates, states this cycle can be broken by stronger relationships between employers and universities.

Growing Business Partnerships

As more companies enter the biologics market, the need to seek out talent and expertise in not just recent graduates but also partners is expected to increase. According to Nice Insight’s report on 2015 outsourcing trends, 62 percent of those surveyed spent $10 million to $50 million USD (2014-2015) for outsourcing, which is a 24 percent increase from the year before. In an article published in Life Science Leader, Nigel Walker, managing director of That’s Nice, states, “The demands from industry service providers have never been greater. Some key trends driving the continuously rising outsourcing budgets include a growing pipeline of biologics, complex therapies and delivery systems, and precision-based medicines, as well as larger, more complex clinical trials, real-world evidence studies, and the need for sophisticated new technologies, all of which require advanced, integrated expertise.” Outsourcing is an efficient, cost-effective way to meet these rapidly changing industry needs.” Scott Lorimer, global VP of biologics at Patheon, says partnerships are exciting for the entire biopharmaceutical sector, not just CMOs. “These partnerships are mutually beneficial and result in drugs getting fast tracked to the clinic, reaching the market in optimal time. By partnering with biopharmaceutical services organizations, the biopharmaceutical industry is effecting accelerated development and launch of exciting new originator medicines, biosimilars, and biobetters alike.” Partnerships between traditional pharma and small biotechs are another area we may see growth. Desai says the increased need for innovative technologies and the next generation of therapies will result higher valuations for new and, as yet, unproven technologies. He explains, “This, in turn, will result in higher prices being paid by the traditional pharmaceutical companies for rights to these assets.”

Drug Pricing A Hot Topic In 2016 Election

The cost of pharmaceuticals is becoming more and more prevalent in today’s news coverage, and according to Hart, there should be no expectations for it to go away any time soon. “Unfortunately, with 2016 being an election year, we will continue to see a heavy push toward reduced drug costs,” he says. “Candidates will have a field day with headlines like the 5,000% mark-up of Daraprim. This is concerning because, based on my experience, I have a very good sense of both the up-front and sustainable costs to produce biologics, and it just cannot be done inexpensively without sacrificing quality.” It is no secret that some drugs do come at a high price tag. However, when you look at the recent report from the Tufts Center for the Study of Drug Development citing the current cost of bringing a drug to market at 2.6 billion, the solution becomes clearer — lower the cost of making the drug, and you can lower the final price tag. So while the presidential candidates continue to battle into the primaries, pharma can only continue to look at ways to reduce R&D and development costs, just as Desai says Merck will be doing in the next year.