Contract Pharma asked Sean Diver, the newly appointed President of the Drug, Chemical & Associated Technologies Association (DCAT), to discuss the important role the industry is playing during the COVID-19 pandemic, trends in drug manufacturing, and technology’s role in formulation and drug delivery.

Mr. Diver has been in the pharmaceutical industry for over 30 years, having served technical and commercial leadership roles for both innovator companies and contract development and manufacturing organizations (CDMOs). Currently, he is the Director of Commercial Development in the Lonza Pharma Biotech & Nutrition Segment at Lonza focused on late-stage, small-molecule drug substances. Mr. 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. Mr. Diver holds a B.S. in Chemical Engineering from Lehigh University.

Contract Pharma (CP): In these unprecedented times, the pharmaceutical industry is playing a particularly important role. How has the industry—both pharmaceutical companies and their suppliers—met the challenges thus far and what would you identify as key contributions as it relates to COVID-19 and overall?

Sean Diver (SD): COVID-19 has certainly presented significant challenges to the pharmaceutical industry. 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. 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.

CP: The industry’s rapid response and acceleration of development timelines to develop prevention, treatments, or disease mitigation for COVID-19 has been unparalleled. What lessons learned and/or experience gained will be useful for the industry not only as it relates to COVID-19, but also for future development and commercialization approaches overall?

SD: 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.

CP: Aside from the issues presented by the global novel coronavirus, what do you see as the major issues and trends impacting the pharmaceutical industry today?

SD: I see a few issues and trends for the industry today that come to mind. For one, the cost of development and affordability of medicines are still major obstacles in getting medicines to patients globally.

At the same time, technical innovation has been outstanding and will continue to be critical in the future for treatment (and cures!) of rare diseases.

In addition, capacity to manufacture everything coming out of the clinic across all of the technology platforms will continue to be a challenge.

CP: One of the ongoing important issues for the industry is looking at how the product mix—both from the industry’s pipeline and recently commercialized products—is evolving. From an industry view, what are some key trends in small molecules, biologics, and newer modalities, such as cell therapies and gene therapies? What is the associated impact on manufacturing and supply decisions?

SD: If I look at what I see in the industry pipelines, and absorb what I am reading in DCAT’s Value Chain Insights, among other sources, I see that these technology platforms are yielding very exciting drug candidates. 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. 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.

CP: Looking ahead over the next five years, what challenges and opportunities do you see in the pharmaceutical manufacturing sector overall? In small-molecule APIs? In biologics? In drug products? What factors will respectively shape those segments?
SD: 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.   

CP: In light of the pandemic, how is DCAT aligning with the business development needs of its member companies?

SD: For starters, we proactively cancelled our DCAT Week 2020 event to ensure that the health and safety of our members were considered first and foremost. We have also been monitoring the voices of the membership, and they have 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 also hosts year-round education and networking opportunities, and we have not stopped because of the pandemic. We have engaged virtual tools to bring webinars to the community. For example, in October, we offered two webinars. One webinar evaluated the market impact on the COVID-19 pandemic on companies’ pipelines, product launches, and performance and how industry fundamentals and growth prospects have been affected while the second webinar featured theater-based presentation techniques for effective, impactful presentations.

Our benchmarking studies have continued virtually, and at present, we are working with our member companies on a study pertaining to maintaining operations during the COVID-19 crisis and business continuity planning processes. 

Our committees are engaged, and meeting through virtual systems, and we will be holding our DCAT Scholarship Golf Outing on June 21, 2021 at TPC Jasna Polana Golf Club in Princeton, NJ.

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.

CP: Formulation and drug-delivery technologies play an important role in new product development, both in formulations with new active pharmaceutical ingredients (APIs) and in new routes of administration for existing APIs. From an industry view, what are some key trends in this sector?
SD: I see a big trend toward inhaled products, which certainly shapes formulation and drug-delivery technology. In addition, solving difficult bioavailability issues with new and effective delivery technologies is certainly a major trend in the market today.

CP: What do you see as the major technology trends impacting the pharmaceutical manufacturing sector overall? In active pharmaceutical ingredients? In dosage forms?

SD: The major technology trends I see in the manufacturing sector are the ability to manufacture highly potent products and the ability to do this at a scale that supports the commercial needs of the products.