PCI Pharma Services is an integrated full service contract manufacturing organization (CMO) capable of taking compounds from the earliest stages of development through to commercialization. Its core services support each stage of the product lifecycle, including drug development, clinical trial supply, commercial launch and ongoing commercial supply.

Over the past decade, the Philadelphia-based CMO has undergone rapid growth of its services portfolio while expanding its global reach through acquisitions. In 2018, PCI bought Pharmaceutical Packaging Professionals (PPP) in Melbourne in March, providing new access to Australia and the wider Asia-Pacific region. Then in September it struck a deal for Sherpa Clinical Packaging in San Diego, CA, extending its presence across the U.S. to the West Coast and bolstering its presence in the biopharmaceutical development space.

During the year, PCI also underwent some internal change when it announced in July that Salim Haffar would join the company as its new chief executive officer. He brings to the chief executive role more than 20 years of experience in the pharmaceutical industry. At the time of the announcement, he was serving as president of Aptar Pharma, where he oversaw the company’s growth strategy and journey to become a leading global provider of drug delivery systems across three end markets—prescription, consumer healthcare and injectables.

He officially took hold of PCI’s reins in September, just as the Sherpa deal was going down. Contract Pharma had the chance to talk with Salim recently about the acquisition, PCI’s plans for the future and industry trends and challenges in general. 

Contract Pharma (CP): You joined PCI just ahead of the Sherpa acquisition. Can you give some insight into that deal and how it expands PCI’s capabilities?

Salim Haffar (SH): It started with a strategic goal to continue to grow and expand our clinical business on the West Coast where a lot of biopharma research and development activity is taking place. It really allows us to expand further into the early phases of drug development and expand our pipeline and better partner with our biopharma customers. The acquisition was the next logical step in our clinical services expansion strategy, further enhancing our development-stage capabilities and geographic presence. The addition of the San Diego business complements an amazing early phase business in Australia, bolstering a comprehensive offering for speed in initiating early phase studies for our clients. It broadens PCI’s strengths and provides a real depth of continuity for clients in a molecule-to-market portfolio of services.

CP: When did PCI choose to focus more efforts on expanding the clinical side of its business?

SH: PCI has really been focusing on expanding its clinical business for close to a decade now. First, by building the capability internally through our talent base and expanding our Rockford, IL facility. PCI’s also been on the acquisition trail for some time, buying companies like Biotec, which goes back to 2014. More recently, we acquired Dublin-based Millmount Healthcare, expanding PCI’s packaging capabilities in the EU. We then established an Asia-Pacific HQ and strengthened our position in the market with the acquisition of Melbourne, Australia-based Pharmaceutical Packaging Professionals (PPP). And, of course, Sherpa was the most recent piece of the puzzle to build our clinical business, enabling our expansion to the U.S. West Coast.

CP: Earlier this year PCI unveiled a $20 million investment to expand its biotech technologies including advanced injectable delivery forms. What does this investment entail?

SH: For years PCI has been at the forefront of packaging, testing and releasing branded biologic drug product. We now must also cater to a large customer base of biosimilars. The $20 million investment we are making is going to add expanded biotech clinical and commercial packaging and release testing capability at our Center of Excellence in Philadelphia. We will also expand cold chain capacity at numerous global sites to support our biotech infrastructure, both refrigerated as well as expand frozen and cryogenic temperatures. This latest investment will also include capacity expansion for cutting edge technologies for the labeling and assembly of state-of-the-art safety syringes, autoinjectors and pen devices with integrated high speed cartoning, and in-line serialization. This investment will help customers both in the clinical stage as well as the commercial stage. Leveraging this clinical-to-commercial expertise is a huge advantage for our clients, allowing us to best position them for success in development and commercialization.

CP: What about investment in PCI’s legacy business?

SH: In addition to the acquisitions we’ve discussed, PCI has undergone a lot of expansion in its existing legacy business. We are building a brand new dedicated and expanded clinical center in what I call our Mother Ship—the Rockford, IL site. We’re making this one of our largest clinical centers to serve a large customer base by adding 30,000 additional square feet of space in support of primary and secondary packaging and labeling operations for investigational medicinal products at the Clinical Services Center of Excellence.

The expanded building, which is expected to open for business in late 2019 following internal fit-out and a period of validation and licensing, will provide increased flexibility to meet customer needs. Purpose-built for scalable primary and secondary packaging and labeling, the new packaging suites offer maximum flexibility, with the ability to operate on either a stand-alone or integrated basis across suites. The build will feature a state-of-the-art 2-8°C packaging room for cold chain products. Additionally, the expansion will include a reception area and will double the current office space to meet staff growth plans, demonstrating our commitment to investment in a leading position to support clients’ global clinical trial supply needs.

The Rockford site is also undergoing a bottling line capacity expansion for commercial packaging. Construction of the additional packaging suites began in March 2018 to add considerable footprint for primary and secondary packaging operations equipped with high speed tablet filling, cartoning, as well as in-line serialization and aggregation. The new expansion will grow the bottling operation in Rockford by producing an extra 100 million bottles per year. Also worth noting, PCI is undertaking an significant expansion of the Rockford segregated potent compound packaging site, a stand-alone facility that supports these unique molecules, often in oncology, that require specialized high containment infrastructure and processes. This expansion furthers investment we have made in a complementary site in Dublin.

CP: What are some other business highlights from the past 12 months?

SH: We recently unveiled an investment in our infrastructure for packaging of controlled substances, complementing our capacity for blister packaging, a key tenet of recent calls for dispensing opioid prescriptions in limited quantity unit dose packaging as a tactic to combat substance misuse. We’ve extended onsite controlled substance storage at our commercial packaging locations in Philadelphia and Rockford and will undertake further expansions as demand increases for these specialized requirements. PCI supports DEA Schedule I-V controlled substances for both commercial prescription medicines, as well as those for investigational clinical trials, with approximately two million square feet of dedicated packaging infrastructure across the two locations.

We’re also investing in adding clinical stage manufacturing capabilities at our Melbourne facility for injectable dose fill-finish. We are also investing heavily in our Dublin facility to support expansion across the base of clinical operations, in addition to commercial packaging and product release. There is a need to expand our European business driven by customer demand, but also to some degree in response to the Brexit situation. However, the greatest opportunity long term, is the expansion of our European footprint outside the UK.

Moving forward PCI will continue to engage in good high levels investments, as well as modernize our facilities with the latest technological advancements. More importantly, we’re investing in talent too.

CP: Speaking of technology, what are some of PCI’s most recent technological breakthroughs?

SH: We’re introducing a lot of automation capabilities across our sites with the help of sophisticated, high-speed testing and manufacturing equipment. This includes advanced robotics, an exciting use of technology for which we see broad opportunity to pioneer new processes. We are also investing in high containment manufacturing for high potency drugs including environments for controlled substances or very high potent and/or sophisticated specialty pharma customers that require very special manufacturing environmental settings. The packaging locations we have invested in for both the U.S. (Rockford) and Europe (Dublin) are truly industry leading high containment solutions for our clients challenging molecules.

CP: What are some of the crucial issues impacting pharma/biopharma manufacturing and supply and CDMOs in particular?

SH: Pricing continues to be a major issue. For a number of years there existed a branded biologic drug base that was clearly highly differentiated, creating really great value to patients while addressing a large number of unmet medical needs, from autoimmune diseases to certain types of cancers. As the pressure on healthcare costs increases, as well as competition with the arrival of biosimilars, the challenge we face is how to reduce drug costs. Not just the manufacturing costs of the drug, but the whole ecosystem from drug development all the way through to manufacturing and commercialization. This is where the industry is facing its biggest challenge: the impact of increasing R&D and regulatory costs and the pressure that is putting on margins and prices.

This is where strong partnerships with CDMOs are invaluable for pharma and biopharma. Customers want to see a track record and a high level of expertise that can serve as the foundation for a trusted partnership that can be sustained for many years.

Customers come to us and really want us to become part of the solution to help them address problems they are facing. We are the experts in finding efficiencies, reducing costs, and also leveraging our own investments so they can invest their dollars into their own core expertise, such as research and development.

So while the current pricing model, and how it cascades down the value chain, presents one big challenge affecting the whole industry, it’s also an opportunity for CDMOs to be part of the solution.

CP: How will the product mix between small molecules and biologics unfold?

SH: For the past 5-10 years a large portion of the drugs under development are biologics and biosimilars, which requires a different set of capabilities around drug development and API manufacturing, as well as providing clinical trial support, commercial packaging and release testing and so on, all the way through to distribution. It’s a whole new supply chain requiring different capabilities, changing the market needs and expectations versus older dosage forms like tablets and capsules and blistering. The growth trend of large molecules is not going to slow down, so it’s adding complexity in the supply chain.

At the same time, small molecules are becoming more complex with the emergence of  highly potent and toxic drugs that require different manufacturing environments for specialty pharma firms. On the small molecule side we will continue to see the emergence of more complex dosage forms, particularly in oncology, a huge opportunity.

Again, this is where CDMOs are coming in and providing solutions for their customers so they can focus on research and sales and marketing and not on having to build that sort of capability and capacity in house, creating a pathway for amazing new medicines to be delivered to patients around the world.

CP: Lastly, how are partnerships in external development and manufacturing evolving, and what does the future hold?

SH: Partnerships continue to evolve, but some are still around very basic principles. Having a high level of expertise and a proven track record that stands the test of time are the two fundamentals any pharma company, small or large, continues to look for when embarking on a partnership. Because, at the end of the day, a partnership is about trusting your drug product—whether it’s in the clinical, manufacturing or commercial stage—to a partner. So it’s a huge decision to make.

A third factor important in a successful partnership is displaying pure transparency around your capabilities. A lot more pharma customers are looking to companies like PCI to partner on the basis of us providing them expanded capabilities. Whether it’s geographic presence or whether it’s particular expertise or capability or technology they would like to have. Not just for today, but for their future drug pipeline. They are depending on us and it is important for them to know we have the capabilities and will continue to add capabilities to support their efforts.

As the regulatory rigor and the quality expectations continue to impact the pharma and biopharma industry moving forward, only those service providers who can demonstrate these basic fundamental skills will survive because the complexity of the industry is only going to increase.