Dr Kevin Robinson held a virtual roundtable with representatives from a number of top-tier contract (development and) manufacturing organisations (CMOs/CDMOs), including Pfizer CentreOne, Samsung Biologics, MedPharm, Metrics Contract Services, Vibalogics and Sterling Pharma Solutions, to discuss the pressing issues in the pharmaceutical outsourcing sector
Having addressed demands for flexibility and operational excellence in part I, I ask the panellists about speed-to-market within the pharmaceutical industry and how outsourcing partners can accelerate the process for their customers.
Discussing what tips and techniques are proving to be effective, Tom Wilson, Contract Manufacturing Lead at Pfizer CentreOne, tells me that “as a CDMO, patient need is key to everything we do.”
“If there are patients who need a medication, they can’t wait. To accelerate the go-to-market process, the partner company must pick a CDMO that they can both collaborate with and trust. There needs to be cultural alignment between the partner and the CDMO so that they feel comfortable sharing their intellectual property and having open conversations.”
“Although speed of development and delivery timelines have always played a prominent role in the outsourcing selection criteria, we’re seeing our clients come under even more pressure to deliver products to market quickly and efficiently,” says James Choi, Senior VP, Chief Information and Marketing Officer, Head of Investor Relations, Samsung Biologics.
“One of the key ways that contract service providers can support customers is through the adoption of automation strategies that accelerate the pace of process development. Successful implementation can present good opportunities to improve the lead times for rapid cycle development, upstream capacity availability and quality.”
“At Samsung Biologics, we’ve worked hard to adapt and automate our processes, which then allows our customers to benefit from these improved efficiencies. Some key examples include introducing automation throughout our production lines, as well as implementing ultra-scale (Ambr), in-silico and predictive modelling."
"We’ve also replaced a lot of paper records with mobile applications to deliver the most up-to-date content directly to the manufacturing floor and quality control (QC) labs, which not only reduces compliance risks but also offers improved visibility across the company to keep our teams better aligned.”
“To date,” he summarises, “we’ve seen some huge successes. By leveraging these technological improvements, we’ve been able to reduce the client tech transfer process to just 3 months — a huge decrease when compared with the industry standard — while maintaining high levels of quality.”
“MedPharm has found that the most time- and cost-effective programmes are those based on a solid foundation of trust and a genuine sponsor– CDMO partnership,” observes Vice President of Business Development, Lynn Allen.
“When the time is taken to develop communication plans, robust contracts are negotiated and effective project management systems are established, sponsors are able to accelerate timelines — from project initiation to commercialisation — without getting slowed down by the start-up pains of a new relationship.”
“Innovation is also key to acceleration, she adds: “Rather than repeat the development steps using the same processes, when CDMOs find new ways to get to the same answer more quickly or with more reliable data, the savings in time and money for the sponsor are crucial.”
“When you start looking at a novel oral solid dosage form development project, much of the timeline is linked to planning and, more specifically, the development strategy rather than the actual time for production,” comments Britton Jimenez, VP Business Development, Metrics Contract Services.
“Some things, such as stability, cannot be expedited; but, occasionally, some elements of the timeline can be delivered more quickly if the right resources are there to support that activity.”
“A great example was the development of COVID-19 vaccines. These projects were no different than any other development programme; but, the industry was able to develop commercially EUA-approved product in less than 12 months. Many people will ask how this was done because most projects take 7–10 years."
"The answer is quite straightforward: the necessary financial backing and focus on these compounds was in place. Typically, innovators, sponsors and service providers do not have an abundance of resources and/or capital to address the series of checks and balances that influence how quickly a product can get to market.”
“Those organisations with the most transparency and a culture focused on genuine partnership are more successful when it comes to delivering a quality product quickly. Built on communication and common goals and values, these kinds of relationships build trust and ownership on both sides, which inevitably makes everyone want to work smarter and harder to meet deadlines,” he adds.
“As mentioned previously,” says James Rogers, Head of Manufacturing and Supply at Sterling Pharma Solutions, “data is an extremely useful tool in terms of accelerating time-to-market for customers."
"It can identify areas of the production process that are less efficient than they should be or equipment that needs investment to increase its availability and performance. With this insight, CDMOs can take the necessary steps to enhance efficiency, minimise delays and bring products to market faster.
“Another vital criterion, and perhaps the most important, is to ensure that enough time is spent during the development stages of the molecule lifecycle to establish properly defined processes with robust analytical methods. Time spent at this stage will be repaid with a smoother transition to manufacturing and, ultimately, avoid delays and reduce waste.”
“In addition, CDMOs are working on ways to make better use of the data they have internally, particularly historical records. Digitising old records can allow knowledge to be harnessed to identify potential solutions to process issues that have been discovered in the past."
"This is something Sterling is addressing right now; the business has some 50 years of experience and is working in collaboration with a digital specialist to digitise and categorise lab notebooks to make them easier to search through in the future.”
“Making accurate and appropriate regulatory filings can also improve speed-to-market — ensuring that incremental changes for continuous improvement can be made more easily. Understanding the compliance landscape and how it affects the whole process plays a huge part in a project’s success.”
Bringing round two to a close, Stefan Beyer, President and Managing Director, Vibalogics, reminds me that, if selected with care, outsourcing partners can offer the infrastructure and skilled personnel required to accelerate processes for customers.
“They will have the platforms and the analytical assays in place to optimise, expedite and, when needed, also offer contingency solutions. There are many examples of ways that CDMOs are seeking to accelerate speed-to-market by making the most of existing capacity.”
“One solution that is becoming widely used in the viral vector space is the parallelisation of experiments using robotic systems to speed up the identification of the right virus cell clone combination, streamline media optimisation, etc. This allows development processes to be performed effectively at a faster rate, helping to free up significant resources and reducing overall timelines.”
“Implementing production platforms that are widely usable also has a crucial part to play,” he continues: “Such platforms need very little, if any, process development (a single cell line is required for many products); as such, harnessing these benefits can eliminate the need to customise processes to the unique needs of the product and further reduce time-to-market."
"In addition, scaled-down models that increase the predictability of large-scale systems, and using a Quality by Design (QbD) approach during early stage development are helping to minimise the risk of inefficiencies and downtime.”
“The one factor currently limiting the pace of change, though, is talent availability. More expertise is needed across the industry to help companies identify new ways to further improve process development and make better use of existing capacity throughout the entire production process.”