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22 BioPharm International May 2022 eBook www.biopharminternational.com and work directly with their client's systems and infrastructure. In other insta nces, a hy br id, more l imited scope might work best." COVID-19 IMPACT Pretor ius obser ve s t hat t he pa n- demic forced industry to reexamine how research st udies are designed and conducted, while also demanding record-breaking speed of innovation. "As a resu lt, digita l medicine was embraced in ways never seen previ- ously. Decent ra l iz ed c l in ica l t r i- als(DCTs) became embedded in the overall clinical development ecosystem and part of the new norm in how we operate," he emphasizes. "At Parexel, DCTs are now being woven into 80% of Phase II/ III trials and 10 0% of real-world evidence new trial propos- als include DCT elements." However, Pretorius cautions this movement is not w ithout obstacle. "A challenge is the lack of industry- wide data standards and how best to manage more and more data from disparate and diverse sources across mu ltiple platforms while ensuring quality," he says. M a h ler add s t h at dow nst re a m manufacturing and the supply chain w e r e a f fe c te d b y t he p a nd e m ic . "The signif icant demand in vaccine manufacture also led to signif icant demand in primar y packaging and disposables," he stresses. "This has an impact on the globally available outsourcing capacity for any kind of (ster i le) product development and manufacturing, which certainly has become sma l ler g iven t he capac- ity need for vaccine manufacturing, and the shortage in supplies of raw materials poses some specif ic chal- lenges a nd r isk s for supply cha in planning and inventory." When contemplating the pandemic, Subra ma n ia n spec i f ies t hat, on a global scale there has been an obvious impact on resources, with CDMOs required to prioritize COVID-19 tar- gets and vaccines—an aspect that will continue onto the future as new vari- ants of the virus continue to develop. "Geo-diversity has also been on the rise, and if innovators are too reli- ant on China, Europe, or India, they will look to rebalancing their spread. However, the net result is that India has been the biggest benef iciary—as there was more reliance on China pre- viously," he says. "The other interesting impact of COV ID-19 has been the develop- ment further down the chain from the messenger R NA (mR NA) vac- cines," Subramanian continues. "So, there is much greater interest now in areas like oligonucleotide discov- ery and development, and even pep- tides—areas that Aragen is investing i n due to i nc rea si ng dema nd . In terms of mRNA vaccines, we are also seeing innovators look for sma l ler aspects of its production from lipids to linkers—basica l ly they look for anything that can increase speed and deliver customer value." BEYOND THE PANDEMIC L o o k i n g b e y o n d t h e p a n d e m ic , Subramanian expects that industr y 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 cen- tral ner vous 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 several high-prof ile failures. So, innovators are looking for partners to advance several candi- dates simultaneously to increase their chances of success." For Mahler, other potential trends that will likely impact outsourcing of R&D services are the diverse therapeu- tic modalities and APIs being inves- tigated. "For example, in the category of therapeutic proteins, we see increas- ingly complex formats," he says. "We also see a huge variety of indications and administration routes, including the challenging intravitreal and subcu- taneously administered products." Additionally, the trend for self-ad- ministration is broadening out to areas such as oncology, where devices are typically required (i.e., an increasing trend towards drug/device combination products), Mahler notes. "Of course, these [trends] bring specific challenges related to the product design, manufac- ture, and testing," he adds. Pretorius returns focus to DCTs. "Given the rapid speed of adoption and the evolv ing vendor and reg- ulatory landscape, [contract research organizations] CROs are particularly 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 sig- nificant learnings and expertise." Looking toward another burgeoning area, cell and gene therapy, Pretorius lauds the availability of new technol- ogies, 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 treat- ment for oncology." Partnerships for Outsourcing Development The trend for self-administration is broadening out to areas such as oncology, where devices are typically required.