What about vaccines?
MS: The one TB vaccine in use, BCG, is extremely old, and confers minimal protection or benefit. Thus, the need for highly effective
TB vaccines is also great. Improved immunogenicity and protection are needed, with the ultimate objective of preventing TB
either entirely or at varying stages of infection. PDPs have also played tremendous roles in the area of TB vaccines. For
example, Aeras, a PDP focusing on TB vaccines, has multiple vaccine candidates in its pipeline with two vaccine candidates
currently being tested in three Phase II (b) clinical trials.
Administering a "global alliance" must come with its share of challenges. What hurdles have you had to surmount in leading
MS: The greatest challenge I find today is mobilizing the resources that will allow us to proceed quickly to deliver on our mission.
TB is a disease of the poor and neglected. Therefore, there are precious few with any significant clout willing to advocate
for funding the innovative work that needs to be done to make TB a disease of the past. In addition, bringing together the
many disparate partners necessary for success always carries with it some unique challenges. There are always potential tensions
in any set of relationships as broad as the ones we have. Managing those tensions requires from me two things: to set a goal
for the organization that is very specific, with parameters that are non-negotiable; and the ability to understand what drives
each of our 120 partnering stakeholders, so that we can anticipate problems before they occur. This latter capability is very
important for any organization to build and maintain the trust of its partners. We may not always agree, but we have to be
open, honest, and truly understand the constraints within which our partners work. It is crucial for everyone at the Alliance
to realize that all successful partnerships work when all parties feel successful and derive benefit from the partnership—a
'win-win' proposition. Working with Big Pharma can also present challenges related to the size of the organizations and the
fact that there are not infrequently competing interests within such large organizations. Ensuring alignment with especially
large partners can be difficult, whether they are in the private or public sectors.
Is the fact that the Alliance has yet to bring any of its compounds to full registration approval a drain on morale?
MS: We have had sufficient successes that morale has not been an issue. While it would be great to have a product registered,
we are proud of what we have accomplished in a brief period of time. The size and diversity of the pipeline, the number of
drugs in clinical development, the scope and depth of our partnerships, the innovative initiatives ranging from discovery
research through our market access work—all these and other accomplishments have maintained morale. Interestingly, a common
theme we hear from so many of our partners is that the morale within their organizations is always extremely high among those
individuals who work on neglected diseases.
Based on your practical exposure to the PDP field, what are the key elements of a good partnership?
MS: Clarity, consensus, and consistency about the rationale of the partnership—and why you are in it—is paramount. We must be
aware of a potential partner's real needs and whether these needs complement our own. It's all about relationship alignments,
of a joined-up purpose and shared motivation. These attributes cannot be covered adequately in a contract; the relationship
has to be grounded in the human interest because no legal document can possibly cover all that might go wrong. So if you don't
have that primal feeling of trust going in, stay away. The other factor I would cite is that every one of our partners is
unique. You can't work to address their needs in a cookie cutter fashion—for example, some of our industry partners want to
be involved in all aspects of the value chain, from discovery research through marketing, while others want to focus on one
specific aspect and hand the baton off to us.
What's next up for the Alliance?
MS: Product registration, introduction of new regimens, and impact on the global TB epidemic. We now know it can be done and
we can be successful. How quickly we can accomplish these goals will be very dependent on our ability to generate increasing
funding and resources. Innovative funding models like advanced market commitments, unique partnerships with selected governments,
greater involvement of the private sector—all these elements will be important in defining our impact.