In recent years, drug development organizations have increasingly turned to outsourcing as a way to optimize resources, leverage expertise, de-risk investment, and accelerate drug development timelines.
This trend has been particularly prominent in the field of oncology, where the need for novel therapies and personalized medicine has led to a surge in research and development activities. With the oncology drugs market predicted to experience a compound annual growth rate (CAGR) of 12.74% from 2019 to 2027, the importance of partnering with the right CDMO can hardly be understated.
Drug Development & Delivery recently interviewed John Ross, Senior Vice President of Development and Manufacturing at PCI Pharma Services, to discuss what it means to be the partner of choice in a very dynamic industry.
Q: Why has the demand for pharma outsourcing services increased?
A: One driver is the growing complexity of drug development and manufacturing processes. A wide range of highly specialized skills, knowledge, and equipment is required to execute these processes efficiently, particularly when it comes to biologics and highly targeted solid oral medicines. The sheer number of drug product sponsors has grown significantly, and increasingly they operate a virtual business model. This dynamic has formed a more mature outsourcing market where often the greatest depth of drug product CMC expertise lies with the CDMO. It, therefore, makes sense to work with an established CDMO with readily available, recognized capabilities. Globalization is another factor — as companies expand into new markets, they need partners who understand and can help them navigate the regulatory requirements and supply chain challenges of operating in these markets.
All of this relates to one key point: speed to market. Pharmaceutical companies are driven to get critical medicines to patients quickly. They are also under pressure to monetize the financial return from development candidates. As such, they must optimize resources, and CDMOs with the right expertise, scale, and infrastructure can help to significantly reduce the overall time and complexity of drug development and manufacturing.
Q: What capabilities should a world-class CDMO have to be able to support its clients?
A: It almost goes without saying, but globally compliant facilities and deep technical expertise are vital. When teams of experienced scientists and engineers operate state-of-the-art equipment and instrumentation, sponsors can rest assured their valuable drug product is in good hands and challenges will be addressed effectively. The underlying quality system must support the GMP compliance requirements of global markets, and the support functions, such as Project Management, must be aligned to the needs and ambitions of its sponsors.
With the growth of oncology drug candidates, containment associated with handling highly potent molecules is a primary consideration, for both operator safety and product integrity. Containment strategies have evolved from using PPE to engineered solutions – being the highest possible level of containment. World-class engineered solutions include the use of isolators for the dispensing of API along with contained manufacturing and packaging equipment. Facility design must include segregated people and material flow combined with HVAC filtration systems to reduce airborne particulates. A sponsor should therefore pay close attention to how its CDMO processes highly potent products. PCI’s facility in Tredegar, Wales is a true market leader in this field, with its Contained Manufacturing Facilities enabling the safe development, clinical, and commercial supply of products with an occupational exposure limit (OEL) as low as 0.01µg/m3.
A world-class CDMO should also boast a range of “soft skills” to complement technical operational capabilities. For example, a commitment to continuous improvement enables them to leverage new technologies and best practices to improve operational processes in support of its sponsors. And everything must be underpinned by a collaborative relationship, fueled by strong communication being mindful of critical project milestones, working effectively through any challenges that may be encountered to execute projects on time and on budget.
I believe the primary way a CDMO can support sponsors is by providing them with flexible and scalable services. The CDMO market remains highly fragmented, with more than 300 in operation and the top 5 players occupying about 15% market share. This may lead to sponsor organizations partnering with a CDMO that cannot scale with the advancement of its product, forcing them to outsource to a more suitable downstream CDMO. This can be a particular issue for small- to mid-size pharmaceutical companies that may not have the resources or expertise to manage the entire drug development and manufacturing process in house or the pipeline to warrant building out embedded internal expertise that the right CDMO is able to readily provide on a fee-for-service basis.
Q: Why is scalability such an important capability for a CDMO?
A: Inherently, scalability implies growth in batch size and output; however, many drug candidates today have highly targeted patient populations so scalability should also cause one to think about ability to support the advancement of the drug product candidate into late-stage clinical and commercial requirements even if the market expectations are such that the batch volume is not materially different from its clinical requirements.
Say you’ve partnered with a CDMO that is able to develop and manufacture your product in support of early stage clinical requirements, but its current offering would not be well suited to handle global commercial requirements. The options here would be to invest heavily in facility, equipment, or systems enhancements, or tech transfer to a CDMO able to handle the commercial requirements. Both options are expensive and will add a layer of complexity, time, and risk to the program. A CDMO with the ability to scale mitigates these challenges and will leverage the deep understanding of the drug product gained through tacit knowledge, ensuring product consistency throughout its supply lifecycle.
Even post-launch, there are challenges that can be overcome by partnering with a CDMO than can respond quickly and effectively. The pharmaceutical market is constantly changing, and demand for drugs can fluctuate based on a variety of factors, including demographics, disease prevalence, and regulatory changes. When dealing with highly targeted therapies like those handled by PCI, it is essential demand is met. In-built scalability, including global compliance, therefore allows CDMOs to adjust production volumes quickly to meet changes in market demand, ensuring life-changing therapies can reach patients around the globe.
By choosing a CDMO that is able to scale alongside your product’s evolution, sponsor organizations can therefore save money, maintain a simpler supply chain, mitigate risk, and achieve commercial launch more quickly. The ideal scenario for sponsor organizations is able to identify a CDMO able to offer true end-to-end solutions from clinical supply to commercial launch and sustained in-market support.
Q: What are the benefits of using a CDMO able to deliver true end-to-end services under one roof?
A: A true CDMO offering end-to-end solutions can act as a strategic partner, helping a sponsor company take a drug product from the early clinical phases through to commercial launch and beyond. They can develop the formulation, manufacture and package clinical supplies, ensure your product is market-ready, and then scale up manufacturing and packaging processes to meet commercial demand. These core service offerings are ideally supported by a range of support services, such as analytical development and stability, clinical support services, regulatory support, logistics, package design, artwork services, and commercial launch services.
A CDMO able to provide a full suite of development to launch services boasts a wealth of experience in all key areas of the CMC life cycle. With more than 35 years of experience in the processing of potent and non-potent solid oral, liquid and semi-solid dosage forms at both clinical and commercial scale and 25 years in the sterile fill-finish and lyophilization manufacturing space, there is little that PCI hasn’t encountered. By working with PCI, sponsors can leverage this knowledge and experience to de-risk their programs, provide supply chain simplicity, and ensure regulatory compliance and reliable product supply.
Q: What mistakes do sponsors make when outsourcing pharmaceutical manufacturing programs?
A: They sometimes fail to conduct thorough due diligence before selecting a CDMO partner. This can lead to problems down the line that impact the cost and timing of critical milestones. When a partner is selected, sponsors sometimes fail to build strong partnerships with their providers. This can lead to a transactional relationship in which the CDMO is viewed solely as a vendor rather than a partner. Building a strong and communicative partnership with a CDMO whose capabilities are suitable to the program needs can lead to greater success and a more efficient program timeline.
Some sponsors may prioritize task-level cost savings over other factors, such as quality, technical capabilities, and the level of support the CDMO is able to provide. Whereas controlling overall expenditure is absolutely necessary, saving at the individual task level may result in greater expense in the long run when downstream activities are implicated by short-term decision-making earlier causing rework or time loss later. For example, selecting the lowest cost CDMO for an imminent task that does not have the expertise to support downstream delivery of high-quality products and services may result in clinical, regulatory, or commercial delay, and ultimately a tech transfer that always adds time, cost and risk.
Q: What can sponsors do to increase their chances of success with a pharmaceutical CDMO?
A: Choosing the right CDMO is paramount. It’s essential to select a CDMO with the right capabilities, experience, and expertise to meet the program’s specific needs. Sponsors should evaluate potential CDMOs based on their track record, reputation, quality management systems, regulatory compliance, and overall fit.
Ultimately, the selected CDMO should act as an extension of the sponsors team – people you want to work with through complex issue resolution who are aligned to the goals of your program. Despite the effectiveness of remote work that exists today as a fallout of Covid, it is essential sponsors visit their CDMO’s site or sites, get to know the teams that they will be working with and the systems that will underpin and support their program. Sponsors should also seek relationships with the management of their CDMO to enable feedback channels and provide a path for enlisting added support if needed.
Sponsors should also clearly define program goals and requirements, including timelines, budget, and target product profile expectations, and remain transparent with their CDMO partners in terms of their progress and challenges with the overall product goals. This helps ensure both parties establish a collaborative relationship based on strong communication, which is invaluable in terms of building trust between the two parties. It also leads to the sponsor treating the CDMO as a partner, instead of just a vendor. By aligning from the outset and maintaining the relationship, this can help prevent misunderstandings or disagreements further down the line.
Finally, it’s vital sponsors work with their CDMO partners to identify and manage risks associated with the program, including supply chain disruptions, regulatory compliance issues, and quality concerns. To us at PCI, risk mitigation is an obligation to our sponsors. We also have an ethical and moral obligation to provide life-changing therapies to patients around the globe, with as little disruption as possible.
PCI Pharma Services: The Global, Integrated CDMO Partner of Choice – Interview with John Ross Senior VP, Development & Manufacturing as seen in Drug Development & Delivery Journal | May 2023 .