Challenges Facing Pharmaceutical Manufacturing
New DCAT President Sean Diver Discusses Industry Issues and Trends
On November 1, 2020, Sean Diver took the reins as president of DCAT. He has been in the pharmaceutical industry for over 30 years, having served technical and commercial leadership roles for both innovator companies and CDMOs. Currently, he is director of Commercial Development in the Pharma Biotech & Nutrition segment at Lonza focused on late-stage, small-molecule drug substances. Sean Diver has been an active member of DCAT for many years by participating on various committees, including serving as chair of the DCAT Technology Committee, as a member of the Advisory Council, and as a member of the Board of Directors. CHEManager asked him to discuss the pharmaceutical industry’s role during the Covid-19 pandemic, trends in drug manufacturing, and key issues for the EU pharmaceutical industry.
CHEManager: Mr. Diver, almost one year since the coronavirus SARS-CoV2 began to spread across the globe, how has the pharmaceutical industry met the challenges posed by the Covid-19 pandemic?
Sean Diver: Covid-19 has certainly presented significant challenges to pharmaceutical companies and their suppliers. Patients need medicines for treatment of serious, life-threatening symptoms, and the general population needs prevention options. The industry has demonstrated the ability to provide solutions for both, not just in the creation of the medicine, but also working with suppliers to manufacture these products to support patients. It is not sufficient to just understand the science well enough to innovate new medicines; these medicines also need to be produced at a scale large enough to support the patient population.
What would you identify as the industry’s key contributions to the battle against the pandemic?
S. Diver: The key contribution to the fight against Covid-19 from the pharmaceutical industry is that together, innovators and their suppliers, rapidly bring safe and effective medicine to those that need it. Due to the global health risks and time pressure related to the pandemic, the industry’s development timelines for Covid-19 treatments have been greatly accelerated. What new understandings and insights will be useful for the industry not only as it relates to Covid-19, but also for future development and commercialization approaches overall?
S. Diver: The world has observed that when needed, new medicines can be developed quickly and effectively. The experience of innovators, manufacturers and regulators working so closely together is likely going to shape the future expectations for speed to market of safe and effective medicines. Certainly, the focused effort by innovators and suppliers with respect to Covid-19 is extreme, but with aligned goals, we have seen that timelines to get safe and effective medicines to the market can, and likely will be, accelerated substantially.
“The world has observed that when needed, new medicines can be developed quickly and effectively.”
Aside from the coronavirus pandemic, what do you see as the major issues and trends impacting the pharmaceutical industry today?
S. Diver: I see a few issues and trends for the industry today. One observation that comes to mind is that the cost of development and the affordability of medicines are still major obstacles in getting medicines to patients globally. Another one is that technical innovation has been outstanding and will continue to be critical in the future for treatment — and cures! — of rare diseases. Also, capacity to manufacture everything coming out of the clinic across all of the technology platforms will continue to be a challenge.
The evolving pharma product mix - both from the industry’s pipeline and recently commercialized products - is always a point of interest. Which technology platforms do you identify as having particular impact in the near future?
S. Diver: If I look at what I see in the industry pipelines and absorb what I am reading in DCAT Value Chain Insights, among other sources, I see that innovative technology platforms in the fields of small molecules, biologics, and newer modalities, such as cell therapies and gene therapies, are yielding very exciting drug candidates and new potential therapies. More and more highly potent small molecules are emerging from the market, commercial biologic products are commonplace today, and not just for oncology and immunology, but across many therapeutic areas, and cell and gene therapies are bringing cures to our doorstep.
And what is the associated impact on manufacturing and supply decisions?
S. Diver: The impact of all of this is that these products are driving technical innovation and need to be produced someplace. The worldwide capacity for the manufacturing of these products will need to expand to meet technical demands, so that these products can be delivered! In addition, facility design will need to continue to improve to deliver high-quality, safe and effective drugs in a cost-effective manner.
Over the next five years, what challenges and opportunities do you see in the pharmaceutical manufacturing sector overall, as well as for small-molecule APIs, biologics, and drug products?
S. Diver: For small molecules, I see a very robust pipeline of products, but they are very complex, and often quite potent. The ability to produce these products safely will require a wide variety of specialty equipment, at a variety of scales, to meet clinical and commercial demand.
For drug products, I believe that more complex formulations will be required since APIs are increasing in complexity. Bioavailability issues will continue to push innovation on the drug-product side for products that are inhaled or that have novel delivery systems. In biologics, there are so many new products gaining approval, I believe that getting everything produced in the next five years will be the biggest challenge to overcome. Overall, I see that manufacturing over the next five years will be a challenge and that the right capacity for the particular technology will need to expand.
“Highly potent small molecules, commercial biologic products, and cell and gene therapies are yielding very exciting drug candidates.”
As a business development association, what is the DCAT organization doing to deliver value to its member companies during the pandemic?
S. Diver: We proactively cancelled our DCAT Week 2020 event to ensure that the health and safety of our members were considered first and foremost. Our membership clearly expressed that travel in 2021 will be limited until vaccines are available. Therefore, we have moved DCAT Week 2021 to July 12–15, 2021, so that we have a better opportunity to meet in person and do what we offer best—business development networking!
DCAT continues to host year-round education and networking opportunities via virtual webinar tools. Two recent offerings looked at the market impact of the Covid-19 pandemic on companies’ pipelines, product launches, and performance and another featured theater-based presentation techniques for effective, impactful presentations.
Our committees are engaged, and meeting through virtual systems. The Research & Benchmarking Committee is currently working with our member companies on a benchmarking study pertaining to maintaining operations during the Covid-19 crisis and business continuity planning processes. We are looking forward to seeing everyone in person in 2021 in NYC, but in the meantime, we are so pleased to remain engaged with our entire membership throughout the year!
The European pharmaceutical industry and fine-chemicals industry is bracing for change as the UK and the EU continue to negotiate to define the UK’s future relationship with the EU in the wake of Brexit. What issues are of particular importance for the industry in this process?
S. Diver: By far the greatest issue facing the industry will be maintaining a continuity of supply of products to patients. All eyes will be focused on ensuring that disruptions are minimal.
What would you identify as other key issues and trends arising in the European pharmaceutical industry? For pharma companies? For suppliers?
S. Diver: The key issues for the European pharmaceutical industry are: security of supply of products; capacity of suppliers to support the strong clinical and commercial demand for medicines; and delivering treatment and prevention medicines to Europe to combat Covid-19.
The Drug, Chemical & Associated Technologies Association (DCAT), based in Robbinsville, NJ, USA, is a not-for-profit, global business development association whose unique membership model integrates both innovator and generic drug manufacturers and suppliers of ingredients, development and manufacturing services, and related technologies. DCAT is well-known for the organization of DCAT Week, an annual gathering of executives and high-level experts and business managers of companies collaborating in the biopharmaceutical/pharmaceutical manufacturing value chain. DCAT Week 2021 will take place July 12 – July 15, 2021. www.dcat.org