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Pharmaceutical Technology Europe BIO/PHARMA OUTSOURCING INNOVATION eBOOK 2022 27 nificant demand in vaccine manufacture also led to sig- nificant demand in primary packaging and disposables," he stresses. "This has an impact on the globally available outsourcing capacit y for any k ind of (sterile) product development and manufacturing, which certainly has become smaller given the capacity need for vaccine man- ufacturing, and the shortage in supplies of raw materials poses some specific challenges and risks for supply chain planning and inventory." When contemplating the pandemic, Subramanian speci- fies that, on a global scale there has been an obvious impact on resources, with CDMOs required to prioritize COVID- 19 targets and vaccines—an aspect that will continue onto the future as new variants of the virus continue to develop. "Geo-diversity has also been on the rise, and if innovators are too reliant on China, Europe, or India, they will look to rebalancing their spread. However, the net result is that India has been the biggest beneficiary—as there was more reliance on China previously," he says. "The other interesting impact of COVID-19 has been the development further down the chain from the messenger RNA (mRNA) vaccines," Subramanian continues. "So, there is much greater interest now in areas like oligonucleotide discovery and development, and even peptides—areas that Aragen is investing in due to increasing demand. In terms of mRNA vaccines, we are also seeing innovators look for smaller aspects of its production from lipids to linkers—ba- sically they look for anything that can increase speed and deliver customer value." Beyond the pandemic Looking beyond the pandemic, Subramanian expects that industry will see a continuation in oncology as a leading therapeutic area of interest, although he adds that there has also been a rapid uptick in demand for central nervous system (CNS) targets. "Almost all Big Pharma is involved in oncology, so on the development side, we see a similar make up in CDMOs and of course in technologies like HP," he says. "CNS is interesting, as there have been sev- eral high-profile failures. So, innovators are looking for partners to advance several candidates simultaneously to increase their chances of success." For Mahler, other potential trends that will likely impact outsourcing of R&D services are the diverse therapeutic mo- dalities and APIs being investigated. "For example, in the category of therapeutic proteins, we see increasingly com- plex formats," he says. "We also see a huge variety of indica- tions and administration routes, including the challenging intravitreal and subcutaneously administered products." Additionally, the trend for self-administration is broaden- ing out to areas such as oncology, where devices are typically required (i.e., an increasing trend towards drug/device com- bination products), Mahler notes. "Of course, these [trends] bring specific challenges related to the product design, man- ufacture, and testing," he adds. Pretorius returns focus to DCTs. "Given the rapid speed of adoption and the evolving vendor and regulatory land- scape, [contract research organizations] CROs are partic- ularly well-placed to deploy DCT strategies because of the breadth of experience obtained across multiple sponsors," he empathizes. "Some CROs have been active in the space for more than a decade enabling them to leverage significant learnings and expertise." Looking toward another burgeoning area, cell and gene therapy, Pretorius lauds the availability of new technolo- gies, which are allowing industry to see the potential of such innovative therapies. "For patients, [cell and gene therapy] provides promising options with potentially less toxicity," he says. "We are seeing significant interest and investment in this area beyond treatment for oncology." Parting thoughts As parting thoughts, Mahler expresses his belief that "outsourc- ing and the development and commercialization of medicines in general should be more a 'system thinking' approach. Com- panies or outsourcing services may be getting so specific about one given part of the product, that the interconnectivity and dependency of all the components of a drug product are being forgotten: a sterile product can only be reliably and reproduc- ibly manufactured if the formulation, primary packaging, and processing parameters are wisely chosen in its entity." Furthermore, Mahler stresses the importance of focus- ing on 'people'—patients and employees—as well as the planet. "We, at ten23 health, hence embed considerations of fairness and sustainability in all we do. There is only one Planet," he adds. Pretorius also points to the larger operating system, ob- serving that outsourcing can also prove beneficial in the area of regulatory operations through aiding with submis- sions, product registration, tracking agency interactions, and so on. "This [service] requires working in tandem with partner internal regulatory teams and carefully defining roles and responsibilities to assure alignment," he says. "At Parexel, our regulatory outsourcing teams consist of former regulators from FDA [US Food and Drug Administration], European Medicines Agency, National Medical Products Administration, among others with specialized knowledge and first-hand experiences of regulatory expectations." While there is much to weigh and evaluate, the uptick in out- sourcing appears well founded on benefits and advantages. This has led to what might be termed a 'run' on available scheduled slots within CMOs and CDMOs. Currently, not only must one place a large cash down payment but also the requesting com- pany must now face wait times of around 12 months to get their place in the que. However, in this case good things take time, and time taken pays dividends at the (pun intended) finish line. Reference 1. PWC, Current Trends and Strategic Options in the Pharma CDMO Market, PriceWaterhouseCoopers, November 2019. PTE