PCI Pharma Services provides integrated pharmaceutical development services to the global healthcare market.
Could you update us on PCI’s latest developments over the past year?
In the past 12 months, we have acquired three companies to expand our capabilities. Our acquisition of Millmount Healthcare, a commercial packaging company based in Dublin, was an opportunity to gain more market access and a global market presence for commercial packaging, as well as clinical trial packaging. The acquisition also allowed us to retain a strong position within the EU as Brexit talks continue to leave uncertainty within the region. In February 2018, PCI acquired Pharmaceutical Packaging Professionals (PPP) located in Melbourne, Australia. PPP is a leading provider of clinical trial manufacturing, packaging, labeling, storage and distribution services. Their early-stage drug manufacturing capabilities include oral dosages and sterile and non-sterile drug manufacturing of investigative medicines. PPP benefits from a significant amount of government incentives geared towards executing early-stage/Phase 1 studies in Australia. For example, the country has an economic incentive program that bring funds back to the sponsorship companies if they execute early-stage studies within the country. For PCI, having a presence in Australia benefits our customers as we can provide a promising pathway for the fast execution of Phase 1 studies.
PCI has long desired to be geographically present in the West Coast of the United States, and Sherpa Clinical Packaging proved to be a very attractive opportunity. Sherpa is a provider of clinical trial supply services and with efforts including supporting small and emerging clients. Our relationship with Sherpa strengthens the company’s position as a leader in outsourced clinical support services and further offers our clients a rapid pathway to execute their early stage studies. PCI wants to offer support from the earliest phases of clinical development, through to commercialization and ongoing supply. As our clinical trial line of business is rapidly expanding, much of our focus is currently on early stage development.
What is PCI’s value proposition in a very competitive market, and strategy for market entry?
Our clients have a diverse range of needs, and they seek partners that can service multiple facets of their business. PCI operates on a partnership model rather than a traditional technical outsourcing model, which holds a significant amount of benefit for our clients. As a service provider, PCI is very consultative in nature and being able to support clients in various needs and stages of development, allows for a continuous pathway to bring their drug to market.
Is there a higher demand for one-stop service providers, or is the market looking for niche expertise?
There is a demand for both one-stop services providers and niche service providers. The strategy that PCI has embarked on, in terms of providing a full-service offering, was based on feedback from our clients’ demands. We have customers that will only require one particular service of our lifecycle portfolio of services, but we are definitely seeing an increase in demand for support across the product lifecycle, each phase of development and commercialization.
Given that PCI is expanding geographically and across the biotech supply chain, how is the company able to continue prioritizing quality?
We have a clearly articulated vision for our business and our model is rooted in providing industry leading experience to our customers. When acquiring companies, our aim is to enhance the quality of our services and capabilities that we can offer to the market, as we have a focus on fostering a long term partnership model with our client base. We will integrate companies that have a similar culture and execution strategy as we do, and which will compliment PCI’s vision and strategy moving forward.
We will do due diligence before acquiring a company, and we also rely on feedback from customers in this respect. The strength of their service, quality and regulatory is paramount, as those aspects really underpin any outsourcing relationship. Our focus in potent compoung development, manufacturing and packaging is a great example. PCI has invested heavily in an industry leading position for supporting potent compounds, particularly in the area of oncology development. It is of great importance to us, as well as our acquired partners, to comply to the highest standards of handling these types of molecules. We want to ensure the safety of both the drug product and the employees that interact with these products.
Could you elaborate on how PCI sets its acquisition targets?
In addition to keeping a close pulse to industry trends, PCI heavily relies on feedback from our customers and where they would require our services geographically. It is an increasingly global market. We traditionally had facilities in Europe and the United States, from which we serviced the rest of the world. The company now also has a presence in Australia and we would like to expand our presence within the Asia Pacific region.
PCI is targeting international partners with the aim of nurturing a PCI global network. The company has a significant number of international clients using PCI as a pathway to commercialize products or execute trials in the United States, but we also have U.S. and European clients who are looking to expand into emerging markets. Likewise, we see international clients looking to access the North American and European markets, particularly for biosimilar commercialization.
What key trends are you seeing in serialization and anti-counterfeiting?
Serialization and anti-counterfeiting technologies are gaining a significant amount of attention. The US Drug Supply Chain Security Act’s (DSCSA) deadline for enforcement is in November 2018, and the implementation of the E.U.’s Falsified Medicines Directive (FMD) requirements is scheduled for 2019. PCI has been 100% focused on serialization readiness and we have recently announced the installation of our latest comprehensive serialization system, located at our manufacturing center of excellence in Tredegar, UK. We have also celebrated our 80th Serialization line installation, scale that we believe leads the industry.
PCI has been involved in commercial serialization for the United States, Europe and emerging markets for approximately seven years. We have put tremendous energy and resource into preparing our clients for these deadlines. Across the entire industry, we do not see the level of serialization readiness that is required, and it will be interesting to see what the FDA and EU will do in terms of enforcing the deadlines for companies that are not ready. We have been very consultative to our clients in helping them prepare to meet serialization requirements, as well as helping them develop their global Anticounterfeiting strategies. We hope the serialization initiative is just the first step in supporting delivery of safe medicines around the world.
The FDA has seen a record year in terms of approved generic drugs. Has this had an impact on PCI’s business and operations?
Broadly speaking, PCI has seen more impact from specialty drugs and orphan indications than the increase in generic approvals. Generally, more generic and bio-similar products are entering the market, and we believe that this increase will impact the market in terms of the profile of branded drugs and the competitive environment within the market. The biosimilar medicines now being approved have the opportunity to significantly change the scope of the market for biotech products and injectable delivery, particularly as these generic equivalents are being developed with advanced deliveries such as prefilled safety syringes and increasingly autoinjectors. PCI has invested considerably in this area to support the shift.
What are PCI’s key objectives moving forward?
PCI’s strategy is to expand our global presence and network to meet all our clients’ needs. We also aim to support our clients as the dynamic within the drug industry changes relative to the molecules being developed. Currently, there is a significant focus on special medicines, rare diseases, oncology, and biologics/biosimilars. Biotech products, both branded biologics and biosimilars, are rapidly growing. We have invested significantly in supporting these delivery forms, with expanded capacity and high precision technologies. These segments of development can all present challenges through which we will support our clients. Our aim is to keep up with global trends to ensure that our clients have the right commercial platform to bring their products to market successfully.