On the Molecule to Market podcast, Sharp president Kevin Orfan discusses the importance of building robust and scalable systems and processes in a fast-growing contract packaging company with host Raman Sehgal.
Kevin talks about the challenges in keeping up with the rapid, global demand created by new, large molecule drug products and the increasing complexity they bring. He also addresses the ‘direct-to-patient’ trend he has seen in the industry as pharmaceutical companies become more willing to carry out clinical trial work in patients’ homes.
The following is an excerpt of the interview, the full version is available on the Molecule to Market website.
Raman: There seems to be a huge amount of investment and activity going on at Sharp, can you share a little bit more about the reasons behind the investment and what that’s going to enable Sharp to do moving forward.
Kevin: Let me answer that in two ways. One…we have two somewhat distinct segments of our business: the clinical business and our commercial packaging business. And while there is increasing overlap, there are also a lot of distinctions between them. Even though the legacy businesses have been in place for a number of years, we essentially built or bought new facilities in both markets and re-established the clinical businesses in each of those facilities.
Last year…there was a considerable investment into our clinical sites, and they’re starting to pay off now. In the UK, it was a brand new building. In the case of the Bethlehem, Pennsylvania site, it was owned by a pharmaceutical company previously, we took it over, and ended up doing a lot of renovation. We had a grand opening and a ribbon-cutting ceremony at both those sites late last year and we’re really proud of the work that we’ve done.
When I started last year. there was an incredible demand for our services on the commercial packaging side. We set on a path to add capacity and we came across a company that was fairly similar to what we do in pharmaceutical packaging that had a facility in Macungie, Pennsylvania, only about six miles from our Allentown, Pennsylvania campus. We acquired that site on May 15, 2020, and it added a significant amount of immediate capacity to our network, due to the fact that they already had equipment in place. The site also has a lot of unused space that we will continue to put new equipment in.
All that led to a need to hire more people and mitigated the high unemployment rates and some of the issues that we’ve all been dealing with due to COVID-19. We have also undertaken an aggressive hiring campaign in particular in Pennsylvania, and we’ve succeeded in bringing in a number of skilled people to fill really important positions for us and we will continue on that campaign for the foreseeable future, to continue to help us meet the growing needs of our customers.
Raman: You mentioned something about the increased demand for your services, are you able to show what specifically or what continues to drive that demand. Are there macro factors at play here or is it a specific capability that you have?
Kevin: I would attribute it to a number of things at a macro level. The market continues to grow very quickly and we are well-positioned to take advantage of that.
More and more of the development that’s taking place within the industry is focused on biologics, gene therapy, cell therapies, and more specialty medicines and niche orphan and rare disease therapies. And because of the fact that they’re large molecule as opposed to small molecule chemically derived drugs, there’s more complexity and the majority of them are in either liquid or freeze-dried lyophilized forms in vials or prefilled syringes.
Our company has invested heavily to keep pace with that growth. By far, the fastest-growing segment of our business is working with biologics in various formats including vials, prefilled syringes, autoinjectors and pens. And our investments in this area leaves us in a good position where we have the core competence and strong heritage of small molecule packaging experience and now also with the ability to support the fast-growing more complex personalized medicine part of the market, where we can provide clients with capabilities and expertise.
Raman: What kind of big industry trends and changes are you seeing going on right now that are actually impacting your business?
Kevin: We’re in a unique time now, of course with COVID-19, and from an industry standpoint, we’re seeing intense focus on pharma and biotech companies around the world trying to develop not only vaccines, but also the antibodies for COVID-19. And so with that, there is a profound shift in the R&D focus of those companies and also the allocation of resources across the industry. While I think that’s going to pay significant dividends for us as a population, when those vaccines and antibodies start to hit the market, it’s going to take away from focus in other areas. We need to be aware and prepared for that.
Part of the challenge in that regard is the sheer number of treatments that are going to need to be available for people around the world. It’s staggering. And if you look at, for example, influenza treatments on an annual basis… There are roughly 150 million influenza vaccinations in the US each fall and about 200 million in Europe (again estimates).
The numbers that those companies developing vaccines are talking about – hundreds and hundreds of millions or billions of doses – that’s going to have a significant impact on supply. There just isn’t that much capacity in the industry. And another 2-4 billion doses for COVID-19. We’re keeping a close eye on that because there are upstream and downstream ramifications. To some degree, I’m a little concerned about it and I think it is going to be an extremely challenging time for the industry to supply all the COVID-19-related treatments and still supply all of the medically necessary products that patients need.
Additionally, the continued shift in focus to biologics and smaller batch sizes, specialized treatments for smaller patient populations is a significant trend from a contract manufacturing perspective.
A lot of the manufacturing plants and assets around the world were scaled for much larger products with significantly higher unit volumes and very large batch sizes ranging from hundreds of thousands to even millions of units. And that’s not the future. The future is specialty medications that may have batch sizes of five or 10 or 20,000 units. So that’s a trend that we all are trying to adapt to with new investments and just a new way of thinking about how we package.
Raman: Are you able to share the exciting things coming up with Sharp?
One of the things that we are starting to focus on with one of our sister divisions within UDG Healthcare, a company called Ashfield, is supporting patients being treated in their own homes. Back in the 90s, there was a shift from care being provided in an acute care setting like a hospital to more alternate site facilities like surgery centers and clinics and that shift has continued as more and more care is being provided now outside of hospital settings.
I think we’re starting to go through another shift now and I think it’s, to some degree, being accelerated by the situation that we’re in now with COVID-19. And that is a shift toward treatment in patients’ own homes. We’ve already seen one significant shift which is offering care in retail pharmacy settings so why not treat patients in their own homes? Oral solid dose is fairly easy as long as there’s compliance with established protocol. It gets more complicated when it’s an injectable product so both the nurses and caregivers need to be prepared to provide that care while also getting the medications directly to the patient’s home.
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Sharp has an established Direct-To-Patient logistics portfolio, including central pharmacy capabilities, as well as a relationship with our sister division Ashfield (Patient Solutions). This allowed us to respond quickly to the growing demand for homecare services in response to the COVID-19 pandemic.
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