Pop-up shop for drug development
By: Rupert Dixon, PhD | April 05, 2017
How a virtual R&D model is giving small and mid-sized companies the resource to bring their assets to market.
Emerging biopharma companies have a lot of advantages in developing new drugs. They can be agile and lean, with innovative and committed teams, often focused on developing just one or a handful of assets in an area where they have strong scientific foundations. However, these small and mid-sized companies often also lack two important ingredients to successfully develop and commercialize a drug: in-depth expertise and resources
All of the innovation and commitment in the world can’t replace these key ingredients, which is why many such firms often look to sell or out-license their assets after completing the early stages of development. Whilst this means a financial return can be realized relatively quickly, it can also mean relinquishing a significant portion of the asset’s ultimate value to a buyer who does have the know-how and resources to bring it through late development and to market.
We feel these companies needs more options. We have developed a virtual research and development solution specifically designed to give small and mid-sized biotech companies the opportunity to progress their assets themselves, retaining control and opening the door to realizing more of the asset’s potential value.
Rather than giving up ownership of their asset, these companies can partner with QuintilesIMS to develop their drug through later phases of research, to a point where it can be a far more attractive – and thereby far more valuable - prospect for a potential suitor, or all the way to commercialization if they choose. Through this model, QuintilesIMS provides a virtual asset development organization that can support every aspect of the development and commercialization process, including asset strategy planning; clinical development program design and operational delivery; CMC strategy, regulatory strategy and operations, including submission management; approval, market preparation, product launch and global marketing.
Small and midsized companies that choose this model get the benefits of a bespoke project infrastructure, with global reach and expertise tailored to their needs. Throughout the partnership, they maintain full control of decision-making, whilst benefitting from QuintilesIMS support and expertise to avoid the common and sometime costly mistakes novice companies can make when developing drugs on their own.
They also benefit from being able to leverage the QuintilesIMS organizational muscle to ramp-up development activities at high speed without adding to their own headcount or infrastructure. This lowers the business hurdle to moving in to late stage development and commercialization and also opens opportunities for companies in non-traditional geographies where they may not be a wealth of experienced drug developers and marketers in the local labor market.
Finally, they benefit from the QuintilesIMS brand. We are a globally respected Fortune 500 clinical research organization that has shepherded many drugs through development to market. Our team brings global expertise, broad experience and has unrivaled access to the data, analytics and insights these companies need to inform decision-making, and understand the long term implications of their choices.
These partnerships also give smaller biotech companies an opportunity to learn as they go, building skills and experience alongside the QuintilesIMS team that they can apply to future drug development. This enables them to learn the ropes, knowing they have the safety net of QuintilesIMS to catch them if they fall.
A number of CROs have the resources to support some of the component elements of this solution, but QuintilesIMS uniquely has the ability to seamlessly support both strategy and operations across the clinical, regulatory, CMC and commercial aspects of the entire development process. Our virtual model provides a one-stop, pop-up shop for drug development, approval and commercialization, which gives our clients a distinct advantage.