Throughout my career at Aventis, Hoffmann-La Roche and Alcon (a Novartis company), we focused on the proof of concept (PoC) as the critical milestone when considering when to partner with or purchase a compound from a small biotech.
Your potential pharma partner is looking for answers to key development questions surrounding the mechanism of action and your compound, how your company has addressed those, the robustness of the results and the quality of the data. This drives their evaluation of the real stage of development and the valuation.
From the venture capital side, it is about how to maximize the most recent capital raised to generate the largest inflexion point. This translates into which study or studies (and design) will generate compelling data to support the next round of fund raising or business development activity.
Over the years, I have observed a shifting paradigm that is summarized in the following trend: companies are investing more in the PoC phase as a means to maximize their return. Ryan Starkes, leader of the life sciences group at BDO, reported recently that "unlike big pharma companies, who are developing new products while maintaining a consistent level of R&D spending, biotechs continue to demonstrate a desire to increase their R&D investment," and also that "the good news for the sector is that they are attracting significant capital and are clearly putting those dollars towards their intended use." Overall, smaller companies are increasing research spending by 9% in 2012 and the average spending kept increasing when compared to 2011.
What does this mean for you? Demonstrating today your compound's PoC is an even more critical developmental milestone. If you can show compelling, valid, high-quality data supporting the safety, efficacy and commercial potential of your molecule, you can:
As an innovative biotech, it has been my experience that your challenges often center on limited resources, expertise, access to patient populations, and economic data.
You need a complete view of PoC to enhance your chance of success.
A thoughtful PoC strategy starts with finding a CRO that has the expertise to help with the development of your compound's overall strategy combined with the breadth of services and resources to efficiently reach multiple project milestones faster. That's where a full service provider gives you an advantage. However, at PoC you don't need the additional cost structure of a company that conducts these smaller, scientifically challenging studies with the same resources as an expensive pivotal Phase III trial.
You need a dedicated early clinical development team that helps you translate clinical trial ROI to commercial ROI through:
Having confidence in meeting your clinical endpoints is critical. Patient stratification is an important piece of the development puzzle. Choosing and developing the right biomarkers has changed the way to approach targeting and therapeutic focus.
Our biomarker expertise provides drug development insights that can dramatically improve your ability to target patients and the most profitable therapeutic indications so you can:
Clinical trial recruitment remains the primary reason trials fail to complete on time and skyrocket beyond projected budgets. It requires exploring new regions to access investigators and developing new strategies to find the right patients.
We offer a network of patient facilities in more than 30 countries through well-established investigator relationships. We'll help you identify the right investigators and sites to facilitate rapid study startup and targeted feasibility:
The goal of any market access strategy is maximum market potential. It's the lens through which potential buyers think about payers, providers and patients. We know that the earlier you start developing your economic PoC story, the greater your reward.
We have a proven track record of helping clients develop a tailored market access strategy early in their clinical development program, which can maximize the value of your product, improve your product's acquisition price and licensing opportunities, and increase the value of your company.
Your research skills and dedicated focus have enabled you to bring a promising compound through the early stages of drug development. As your partner, we can help you cross the PoC goal line-whether you aim to sell or license your compound or bring a new drug to market yourself.
For more information, check out our interactive brochure (best when viewed in Internet Explorer).