The Importance of Collaborative Business Models for Drug Development

Debiopharm CEO Bertrand Ducrey offers insights and examples of how collaborative efforts can lead to the development of innovative therapies that target unmet patient needs.

In an attempt to overcome challenges and reduce the risks associated with drug development, start-ups and pharmaceutical companies have become increasingly more open to the idea of collaboration to move molecules toward clinical development and eventual market approval. The development stage of a medicine can be seen as a high-stakes bridge between discovery and commercialization, with twists and turns in dosing and formulations, disease applications, patient populations, and clinical results. The complexities of today’s drug development and approval process have increased the need for companies to partner and move toward a more collaborative way of working.

The benefits of this collaboration can be seen at critical points in the drug life cycle. First, when start-ups, universities, or researchers have a promising discovery-stage molecule, they can combine forces with pharmaceutical companies that have the ideal development and disease state expertise to transform their laboratory innovation more quickly into a viable clinical program.

At Debiopharm, for example, we seek out promising new molecules worldwide, in-licenses or acquires and develops them, then out-licenses to larger commercialization partners who have the resources and global distribution networks to maximize access to the greatest number of patients. Business models working in this way can help small start-ups to get their drug off the ground by allowing another firm the ability to provide the expertise and financial resources for the development and launch process.

After a compound has surpassed critical development milestones establishing its efficacy and safety profile, then it is time to partner with large international pharmaceutical companies that can assist in the later-stage development, marketing authorization, and commercialization of the product in specific markets.

One example is triptorelin, our prostate cancer therapy, which is commercialized around the world to partners in Asia, Europe, North America, and South America. Although the complex drug manufacturing is still managed in the company’s facilities in Switzerland, worldwide partners ensure that the medicine efficiently reaches the patient population in their specific markets. This means each company type is involved in the stage where it adds the most value.

When you evaluate a drug for development, you have to understand its liability, potential, and translational medicine possibilities. In our case, we leave the discovery stage to expert basic researchers, then select molecules meeting very specific criteria before strategically navigating the development process. In this way, we are able to offer a product with a stronger preclinical or clinical foundation to larger pharmaceutical companies down the road for later-stage development and global commercialization. An example of this is our partnership with Takeda for our microbiome remodeling product. Also, the recent out-licensing of our head and neck cancer therapy to Merck KGaA, Darmstadt, Germany, allows the expanded management of our Phase III trial, TrilynX, and global commercialization. Focusing on partnerships where all parties add real value means that a broader number of patients have the opportunity to benefit more quickly.

Partnering to bring innovation to market

In-licensing can be a very competitive process as, in some instances, biotech companies and universities can choose from several offers. For new technology and promising new assets, big pharma companies can fund larger investments at an earlier stage, integrating compounds into their vast drug development portfolios. These compound libraries can sometimes include competing molecules, necessitating an elimination process at some point of development. However, when pivoting to a more specialized partnering approach, researchers and small start-ups can benefit from a narrower focus on their programs to determine the drug’s potential both in the initial stages and through the expanding phases of development, improving the chances that innovative medicines reach the market.

A good example would be radio-conjugates, a field in which there are currently very few players because they are quite complex to develop. Radio-conjugates are compounds composed of a radioactive agent linked to a pharmaceutical substance used to diagnose, treat, or monitor various cancers, known as “theranostics.” These novel compounds represent solutions that have the potential to respond to the unmet needs of various cancer types and require partners specialized in this medical technology.

Leveraging partnerships and investing in digital health to manage COVID-19

Pharma companies can work mainly across four different aspects of COVID-19: diagnosis, treatment, monitoring, and vaccination. Through various forms of partnerships, healthcare companies can multiply their efforts to provide tools to better manage this pandemic.

In order to fully understand the breath of a collaborative potential against COVID, Debiopharm formulated a task force to evaluate what efforts could be made across this spectrum through its partnerships. In terms of diagnosis, two of our digital health investment portfolio companies, Immunexpress and Biocartis, were able to provide rapid diagnosis of septicemia, helping to differentiate the causes and therefore treatment pathway for the patient. For treatment, one of our antivirals, alisporivir, was launched into clinical development in the French hospital setting. Regarding the monitoring and follow-up of patient symptoms between visits, one of our former investment portfolio companies, Kaiku, also signed agreements with hospitals for remote monitoring of cancer patients in the hospital and at home. This allows cancer patients to receive the attention they need during the pandemic while COVID-19 patients take priority during peak periods. Finally, we launched a worldwide scientific challenge with InnoCentive to determine if a pool of specialty “problem solvers” can find a way to develop a single-dose COVID-19 vaccine based on mRNA technology. We recognize this is a serious challenge and are hopeful that tapping into a large pool of worldwide innovators can identify a promising theoretical solution for further exploration.

If this pandemic has taught us anything, it’s that we can find faster solutions for patients and we need each other to find the best solutions. This is the time to strengthen collaborations so that together we can build a healthy world for the future.

Bertrand Ducrey, Ph.D., is the CEO of Debiopharm, a Swiss-based global biopharmaceutical company.