ClearView: Should you partner or go it alone?

Aug 17, 2017 Tags: Biotech Business development Pharma Drug development business developemnt

Partnering isn’t an all-or-nothing, one-size-fits all commercialization plan. There are a multitude of options and strategies, including the option of choosing not to partner. To decide which is best for your company and your assets, evaluate your options early and in detail.

“The biggest mistakes companies make are in not thinking about partnering early enough and not planning for it relative to commercialization,” says Debbi Amanti Belanger, Principal at ClearView Healthcare Partners, a global life science consulting firm. She advises companies to begin considering their commercialization goals and options at about the time their lead program enters Phase I clinical trials.

Debbi Amanti Belanger, principal at ClearView Healthcare Partners

Debbi Amanti Belanger, Principal at ClearView Healthcare Partners

Postponing partnering decisions until Phase II can trigger delays and the need for additional studies. As Belanger explains, “When companies first assess their partnering options for commercialization during Phase II trials, they often realize they should have included additional endpoints or looked at additional indications in earlier studies.” Although initial studies may have included the endpoints and indications that are most attractive to the market and to payers, they may not be the endpoints or indications that are most attractive to potential partners seeking to advance their own programs. Such an oversight could cause the company and the asset to be undervalued.

“Sometimes small companies move too fast. They’re nimble…at the risk of not thinking about the best way to optimize the asset,” Belanger says.

A myriad of options

Companies have a myriad of options to consider. “The fundraising environment is more favorable now than it’s been for the past five to seven years, so companies are able to raise funds and retain more of their equity. At the same time, the market is consolidating so there’s a significant benefit to partnering.”

Big pharma and big biotech are major players, but so are hospitals, foundations and academic institutions through their tech transfer departments. These departments have always looked toward tech transfer as a means to garner a return from their scientific discovery. In the recent past, the thought process around partnering has changed in these organizations. They have become more cognizant of commercial issues and viability in early stages.

Venture philanthropy undertaken by patient advocacy foundations offers a wide range of programs, too. The partnership between Vertex Pharmaceuticals and the Cystic Fibrosis Foundation, for example, informed the company’s development program for years and also provided a significant return on investment for the foundation. It was a major win-win for both partners.

Begin planning upon entering the clinic

“A small biotech developing its first asset should begin thinking about its commercialization strategy as its asset first enters the clinic. The objective at this point is not to out-license the asset or seek a partner, but to plan for Phase II and III studies that generate commercially viable data,” Belanger says.

By considering partnership options early, biotechs can design their trials to attract the interest of potential partners, thereby enhancing their development and commercialization options. Specifically, they can determine what potential partners need and which endpoints they value and thus design studies that meet those goals. Then, when they talk with potential partners, the biotech either already will have, or will have designed studies to gather the data that is most attractive to selected potential partners. “Already having that data will help you negotiate the best terms,” she points out.

Partnering isn’t the default position, of course. In determining whether to partner or go it alone, companies should first assess a range of conditions and the likelihood of pursuing them on their own.

Factors to consider include access to expertise, costs, key competitors, potential partners and all indications. Also think about licensing strategies. For example, you may choose to out-license a therapeutic for a broad indication but retain all rights for niche indications, or out-license the asset to certain geographic areas while retaining rights in those you can service yourself.

“The fundamental question,” Belanger says, “is whether you can access the same level of talent needed to get to market if you develop an asset yourself that you could access by partnering.

“Most companies are very self-aware,” she continues. “They know their skill sets and their gaps.” Nonetheless, a formal assessment can help. Consider internal skills, clinical development and relations with the community – including key opinion leaders, physicians, patients and advocacy groups and commercialization expertise, among other factors.

For example, in terms of commercialization, if a company hasn’t built its sales force, “look for partners whose sales forces are underutilized or that have drugs that are coming off patent. Ask yourself whether you can hire and train a sales force in time for an effective launch and whether it can compete with existing forces. In markets that are unentrenched, where no one has won physicians’ (or payers’) loyalty, developing your own sales force may be feasible,” she says. When sales forces have deep relationships with physicians and have been talking with them for years, however, a new force will have a hard time competing. In that case, if they’re not direct competitors, work with them.

The analysis requires thinking from both a clinical and a commercial perspective, Belanger says. “Identify the commercial opportunities and whether you can support them, and determine how the program would differ if you partnered with a leading player in the space. If the difference is large and positive, consider partnering.”

In deciding whether to partner or go it alone, remember, Belanger emphasizes, “There isn’t just one way to partner. It isn’t all or nothing. There are lot of options. Which option is best depends upon what you want the company to become.”

Download ClearView Healthcare Partners’ new whitepaper, To Partner or Not to Partner: Determining Your Commercialization Plan for an in-depth discussion of the key decision-points when determining your commercialization plan.