Issue link: https://www.e-digitaleditions.com/i/1467950
20 BioPharm International May 2022 eBook www.biopharminternational.com There could also be instances where a pharma or biotech company has an asset but does not necessarily have the required technology or features, Mahler continues. For smaller compa- nies, in particular, he adds, there may not be internal knowledge or indus- try and scientif ic expertise available. "Hence, specialized providers, such as ten23 health, may provide significant advantages for [such companies], con- tributing to faster development time- lines whilst minimizing and derisking any R&D obstacles that can be antic- ipated by the Experts," Mahler states. "Finally, even in existence of internal assets and internal experts, there may be insufficient capacity in house." Focusing somewhat on interna l capacities and the fact that the outside economic environment is encourag- ing. Ramesh Subramanian, chief com- mercial officer, Aragen, believes it is a buoyant time for R&D outsourcing at the moment. He specifies that this buoyancy can be attributed primarily to three reasons, "increased fund f lowing into [the R&D outsourcing] space, a high number of targets in the pipeline, and renewed interest in pharma R&D due to the COVID-19 pandemic." "In fact, as a direct consequence of this better funding environment, we are seeing increasing number of bio- techs pursuing their research programs with renewed vigour," Subramanian adds. "In the past, those companies that were quite conservative in advanc- ing their discovery programs are now focusing on advancing their assets quickly through the development con- tinuum to reach the proof-of-concept milestone. With this shift, we see more biotechs approaching us for more end-to-end integrated solution offer- ings, from discovery through to Phase IIb—where their assets get them bet- ter valuations. Venture capitalists are also open to a longer-term view on development and willing to take risks for such potential upsides from valu- ation of successful programs. For Big Pharma, outsourcing of all but core activity is the de rigour approach to achieve fastest development timelines." Sy P r e to r iu s , M D, p r e s i d e nt , Clinical Development, and chief med- ical off icer at Parexel, points to the need to focus on and build a lasting relationship when par tnering. " To meet complex industr y cha llenges, successful outsourcing partnerships are essential," he asserts. "This is necessi- tated by increasing pressures to reduce the cost of dr ug development and to bring therapies to market sooner. Rather than purely transactional in nature, these partnerships should be truly collaborative. Strong relation- ships can foster innovation beyond contractual obligations and typically leads to higher levels of staff engage- ment and better quality. The reason for continued demand for outsourced services can be attributed to a variety of factors including a burgeoning drug pipeline, record levels of funding, lack of in-house resources or expertise, and increased operational complexities." MANY DIFFERENT SHADES "Outsourcing happens in many differ- ent shades," notes Mahler. "Outsourcing can include full technical programs including drug substance and drug product, it can include only specif ic studies. It could be only for early-stages of a program or the opposite, just for the commercialization stage. In the end, the outsourcing model needs to fit to the needs of the pharma and biotech com- pany, their own expertise and knowl- edge base and their preference on either working with the most qualified out- sourcing partners for specific studies, versus the preference on working with just one partner." Subramanian ref lects that the focus of Big Pharma has now shifted to ensure they can retain their core activ- ities in-house. "[Big Pharma's] defini- tion of core has become a lot smaller as they look to CDMOs to be their R& D engines. We are seeing these emerging trends in R& D outsourc- ing," he says. "Pharma/biotechs are looking for more integrated discovery ser vice offerings to leverage on the eff iciencies and synergies of chem- istry and biology offerings from one service provider/co-location of these capabilities. In the outsourcing of development services, pharma/biotech companies still prefer to have the final drug substance being manufactured closer to their locations in the United States/European Union. Given the greater demand for access to capaci- ties, a large number of these biotechs leverage the capacities/expertise avail- able in Asia to execute the initial steps and the final steps in US/EU." The range of relationships is large, encompassing full-service outsourcing (FSO) to functional provider (FSP) type arrangements, Pretorius states. "Likewise, these [relationships] range from tactical /per study outsourcing to more strategic programmatic out- sourcing," he notes. "Landing on the right outsourcing model requires an assessment of each individual orga- nization's needs. Functional ser vice provision continues to be a core out- sourcing model a l low ing the ven- dor to provide embedded teams that support sponsors for specific services Partnerships for Outsourcing Development Above regulations, companies also seek to reduce the complexity of their operations internally, and to reallocate internal resources most effectively.