CMO executives share their opinions on where outsourcing is going and what is driving market change in Pharma Contract Services. Justin Schroeder of PCI Pharma Services discusses the Market Outlook with Pharmtech
Q: Where do you see pharma contract services heading in the near future? What are the top issues driving change today?
A: As we ushered in a new year, there was much media coverage of both the number of new drug approvals in 2014, as well as the success rate for the industry in new drug application (NDA)/biologics license application (BLA) filings translating into approvals. In 2014, FDA approved 41 novel medicines. This is 14 more than the year prior and second most for any year, trailing only the 53 approved in 1996 (1).
This was clearly encouraging news for an industry that is often criticized for weak pipelines and poor success rates for bringing products to successful commercialization. FDA notes that 32 of the 41 approvals were first-cycle approvals (2).
Also noteworthy in evaluating 2014 approvals was the continuation of the industry trend of developing specialized medicines and products for narrow therapeutic classes. FDA’s designations for Orphan Drugs and Priority Review for drugs of unmet need helped expedite the development and approval process for products. Seventeen approvals, or 41% of the total, were for rare diseases that affect 200,000 or fewer Americans. Seventeen approvals were regarded as “first in class” therapies or 41%. Nineteen NDAs were approved utilizing the Fast Track or Breakthrough status (2).
Three examples of priority review therapies garnered significant acclaim due to their importance:
- Pharmacyclics’ Imbruvica for chronic lymphocytic (CLL) leukemia and mantle cell lymphoma (MCL)
- Roche’s Gazyva for chronic lymphocytic leukemia (CLL)
- Gilead’s Soldalvi for treatment of Hepatitis C.
It is noteworthy that oncology treatments alone garnered 8 approvals in 2014, or 18% (3).
With more success in development and commercialization of lifesaving medicines with narrow therapeutic indices and modest patient populations, the economic model for the industry is challenged. The development costs for these therapies is every bit that of traditional medicines and often more challenging for identifying patient populations for these disease states and administration of clinical trials.
Similarly, the supply chain requirements can be disproportionately burdensome, with economies of scale and specialized requirements, as well as increased cost for the API. This can also be true of specialized medicines such as those for oncology or autoimmune therapies, where manufacturing and handling may be very specialized due to the potent nature of the API, in-process or final drug product.
The growth in biologics has similarly changed the industry supply chain with demands on its manufacturing, packaging, and logistics components.
As a leading outsourced services provider for drug development and commercialization, we have experienced this changing dynamic first-hand. The industry shift from small molecule delivery forms to large molecule parenteral delivery forms has required us to adapt our technologies as well as our infrastructure for the expanding Cold Chain requirements of these products, typically requiring storage at 2–8 °C.For example, many of these products have allowable excursions for secondary packaging, so that they may be executed in a controlled ambient condition environment. However, they may vary substantially in the duration from as long as 24 hours to as little as a half hour in some instances. This creates the need for very tightly controlled procedures and work practices to ensure the integrity of the operation. In other situations, products may need to be processed completely in a Cold Chain environment, which creates its own unique challenges for logistics, equipment and personnel.
Biologic products and drugs with parenteral delivery forms are seeing a shift in how medicine is administered to patients. Syringe and vial delivery forms traditional administered at a clinic or hospital are now shifting to a patient convenience model whereby through patient education and better drug delivery, patients can self-administer at home or on the go. The net effect on the industry and its supply chain is the evolution to novel delivery forms such as autoinjector devices, transdermal patches, and infusion therapies by means of personal delivery devices. These may require very complex and precise assemblies to enable patient safety and convenience. Often this translates to precision robotic automation for manufacturers and packagers. At PCI we have actively made these investments as the industry model rapidly evolves.
In addition, more and more of the products that are being brought to market are regarded as potent, both in oral and parenteral delivery forms, with Occupational Exposure Limits (OELs) that create a need for very specialized handling and infrastructure to protect workers supporting the manufacturing, packaging, and supply chain logistics.
PCI and Penn Pharma have invested substantially in state-of-the-art contained manufacturing, recognized by ISPE in 2013 as a Facility of the Year for our site in the United Kingdom. Having both the expertise in handling potent compounds as well as the appropriate technologies to isolate these therapies allows pharmaceutical firms to bring novel therapies to commercialization more safely and effectively, thereby benefiting patient populations around the globe by virtue of reduced time for pipeline development, lowered cost, and effective delivery.
It is an exciting time to be in the pharmaceutical industry. Therapies are being brought to market that were once thought of as a pipedream. Now we are starting to see them graduate from the pipeline and giving hope to patients around the world. As the industry evolves, we are grateful for our role in helping develop and commercialize the therapies of the future.
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