Strategic Development Partnerships: Preparing for Inevitable Challenges

It’s hardly news that biopharmaceutical companies today face increasing pressure to innovate, produce, improve efficiency and quality, and reduce costs – all while keeping up with an evolving regulatory environment and getting patients better treatments and outcomes.

Bringing a product to market demands a staggering financial investment that is beyond the reach of many companies, which is why roughly half of all therapeutic drugs approved since 2000 involved some kind of risk-sharing approach to clinical development. The Tufts Center for the Study of Drug Development last week noted that such risk-sharing arrangements can lengthen the drug development timeline, but without partnerships, fewer medicines would make it to market.

What we at inVentiv Health have learned through our creation of strategic partnerships with a variety of innovative biotech and mid-size pharmaceutical companies is that operational and strategic challenges are inevitable. But by addressing them early-on and choosing partners wisely, it is possible to mitigate delays and lay the ground work for a powerful, mutually beneficial relationship.

While there are countless ways to structure strategic partnerships, several considerations are consistent across all business models as you think through future challenges.

Strategic challenges can be more easily overcome if the two partners are a good cultural fit, aligned in their strategies, clear on the ultimate desired results at an asset level and matched on an operational footprint at the project level, whether the project is domestic or global.

Operational challenges can be varied and unpredictable, so establishing a foundation for resolution is essential at the outset.  It begins with establishing good communications at the executive level, which may seem obvious but the importance is often overlooked.  At the working level, new people, processes and priorities should be introduced early to build understanding and trust.  Clarity is required around processes for decision-making, who is empowered to make certain decisions and how much flexibility is allowed.  As a general rule, greater flexibility enables greater speed and success.

At a minimum, the alliance needs strong executive sponsorship, long-term focus by both parties, transparent communication and a collaborative approach.

In the end, the key to success is full alignment on goals and a structure that incentivizes both parties to work as one team toward that goal – whether the end result is asset development or commercialization of a product.

An atmosphere of transparency, open communication and trust between parties at all levels facilitates:

• Leveraging strengths from each partner for the good of the relationship

• Effective planning and resource allocation

• Application of innovations and process improvements across the portfolio of assets

• Efficient decision-making at appropriate working levels.

Meanwhile, an organizational structure to support the partnership includes:

• The creation of strategic partnership charter

• A clearly defined governance, structure & remit

• Processes to ensure active engagement and flexibility during engagement

• Clearly defined roles and tasks for each organization and key individuals.

Forging a partnership that will benefit both the product developer and the sponsor is not a simple task.  It takes experience and flexibility in designing the right business model, as well as a wide variety of specific functional skills and expertise – tailored to whether the project is broad clinical development, full commercialization or narrower, functional support.

inVentiv Health has directly supported the development and/or commercialization of 60 percent of the drugs approved by the FDA in the past five years, some of these in strategic partnerships and the number of such partnerships is growing.  For one functional partnership – as a functional service provider to clinical development – we offered a range of critical services for a share in the project. It is a typical model, but not the only one.

In this example, both parties contributed key capabilities from their core areas of expertise, and the drug developer saved by not having to build up an expensive infrastructure for every function in a trial.  Employees from the developer company joined inVentiv Health to ensure the flow of knowledge relevant to the project and to help ensure that the interests and goals of the project were shared.

Both organizations took advantage of flexible, scalable staffing.  The developer reduced costs and focused on quality and innovation rather than the mechanics of bringing the drug to market. The result was a truly symbiotic relationship.  inVentiv received a share of the profits after the drug was launched and the drug developer conserved capital, retained control of an asset and focused on increasing the company’s valuation.

A successful partnership continually evolves, based on learning and success. When both partners have the right attributes and a solid foundation is in place for overcoming challenges, the result is a high performance team and a win-win for both partners.

Sydney Rubin, a former correspondent with The Associated Press, is chief communications officer of inVentiv Health. She can be reached at Sydney.Rubin@inVentivHealth.com.