By Wayne Koberstein, Executive Editor, Life Science Leader magazine
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Voices of BayBio’s “Successful Public-Private Partnerships” Survey
It’s in committee. Wound up in committee. Stuck in committee. Everyone has heard and repeated the pejoratives popularly attached to the committee model.
Forget those old saws. On a purely objective, scientific, and experiential basis, it turns out committees are the best way to manage organizations — certainly better than dictatorships, divine monarchies, and anarchies — but also simply the most effective way to get shared results out of a collaboration of disparate human beings. The committee is a basic paradigm of representation, resolution, and regard for the other’s point of view.
In parts one, two, and three of this series we have drawn on the survey, “Successful Public-Private Partnerships,” conducted by BayBio in collaboration with Merrill Datasite, BIO, and FasterCures. We have heard some of its key participants, or “voices,” explore how life sciences companies and patient foundations can form partnerships around a common vision and goals, leverage their individual and shared resources, and create a formal agreement protecting both sides and the constituents they represent. When companies and foundations become allies, however, each side will likely have a very different style of operating than the other. That is why the fourth and final part of this series deals with the daily and longterm challenge of steering the partnership they have created in a coordinated and constructive way and thereby reaching the goals they have chosen together.
Old Model To New Paradigm
For many life sciences companies, alliance management is a way of life. A standard model of partnering relations and operations exists, used mainly by large pharma companies but also by the wiser start-ups. Albeit with major exceptions, however, patient and disease foundations are not equally prepared for partnering, especially with for-profit entities, and young companies often mirror the lack. Thus, even though the “old” alliance- management model used widely by industry may be constructively applied to company/foundation partnerships, as the BayBio survey found, it takes on a new character and meaning in the process. For both sides, the model becomes a new paradigm for relationships between the quite different profit and nonprofit sectors.
Experience teaches best, especially in the creation of something new. As in the previous three parts of this series, this month, in Part Four, we hear from the voices of the BayBio survey — people who have founded, organized, run, and learned from such partnerships. Here they share their insights into the “best practices” emerging from their own and others’ real-life experiences with alliances between and among life sciences companies and patient-disease foundations.
Establish a balanced, representative committee of people from both sides to manage the partnership’s ongoing planning, operations, and progress toward set goals.
Part One of this series addressed how partners can establish a common vision and goals for their alliance, with an almost infinite variety of possibilities reflecting all the potential matches. But to progress from setting goals to reaching them, every partnership needs to organize itself in a practical, operational sense. Martha Brumfield heads the Critical Path Institute (C-Path) (http://www.lifescienceleader.com/doc/clinical-trial-upgrades-a-critical-path-to-innovative-consortia-0001), a nonprofit group that organizes, coordinates, and leads industry- government-NGO consortia in creating standard biomarkers and other tools to speed successful drug development. C-Path handles an extraordinarily diverse mix of partners in its consortia, maintaining a forum where they can all work together, not just in harmony, but to real effect.
MARTHA BRUMFIELD, President and CEO, the Critical Path Institute (C-Path): We don’t form groups of people to sit around and brainstorm. Once we have a formal agreement on goals and milestones, we provide project management expertise that drives our collaborations forward. One thing we know about pharma companies — they don’t want to make small talk for two years and see nothing happen, so we do our best to make sure we hit those milestones.
THOMAS P. SELLERS, Senior Director, Patient Advocacy and Corporate Philanthropy, Millennium: The Takeda Oncology Company: It is really important for both parties to be represented and have an equal voice, and sometimes that can be helped by some facilitation as well. Each party should select people for the steering committee who are well prepared to deal with the people on the other side. At the same time, the company people must understand that patients actually have something to contribute to the process.
The actual mix of people and functions needed for the steering committee varies according to the project. You might have a unique set of folks around the table for a patient-preference survey — a statistician, an epidemiologist, someone on the patient advocacy team, and maybe people from commercial or medical affairs. We have an approach we call Fit-for-Purpose — bringing together the right group of people who are fit for the purpose of the particular partnership or project. You have a core group, then you bring the people you need for that particular issue or decision.
Foundations now frequently match their company partners’ expertise in adapting their own organizations to the collaboration.
TIM COETZEE, Chief Advocacy, Services, and Research Officer, National MS Society: What has changed is that our venture fund, Fast Forward, has recruited individuals with the expertise and competency in this area to understand how to run and manage a company’s commercial research program. We’ve also bought IT tools to tackle the data to do professional due diligence as the venture capitalists do. We had to become more sophisticated about our finance function. We hold warrants in some of these companies, and as a nonprofit organization we never before had to worry about how to place a value on a biotechnology company. The changes have made us better because they've enhanced our capability to do more sophisticated research.
Ensure each side appoints a “point person” of equal rank with the point person on the other side, empowered as a project manager, facilitator, and committee liaison. BayBio’s survey emphasized the importance of each side having a liaison and daily manager of the company/foundation partnership. On the company side, the point person would help executives “understand the issues from the patients’ perspective” and be dedicated to knowing the foundation partner. Only people with special skills in management and communication need apply.
MICHAEL RICHMAN, President and CEO, Amplimmune: Most people in the point position do have special skills. We usually have an alliance manager in our relationships, and there is reciprocity on the other side; the foundation also has an expert who understands the science and the program. In reality, there are usually teams of people managing the alliance, because it requires a lot of expertise across the board.
SELLERS: Companies are hiring people who have been in roles in the advocacy organizations to work on patient advocacy and alliance development from within the company. And large companies have no corner on the market here. If anything, a small company may be more likely to attract someone from the nonprofit community because those people are accustomed to operating within small entrepreneurial environments.
Our partnership with the Multiple Myeloma Research Foundation and its Compass Initiative in building a thousand- patient database with tumor gene sequencing is driven by our translational research folks. But it also involves a relationship cultivated through our patient advocacy department. These partnerships generally work best when there is really a clear point of contact within the company working regularly with the patient advocacy groups across the board, shepherding the contacts among the various constituencies and stakeholders in both organizations.
Commit both sides to open, transparent, and frequent communications with each other — and with their constituents. Use the common meeting ground of the committee to integrate the cultural differences between the partners — and even turn them to advantage. Alliance management can be a powerful tool for cutting through and resolving wide differences in larger goals and priorities between the company and foundation partners.
GAIL MADERIS, President and CEO, BayBio: Make sure each side understands the other’s goals. The more even in level of management the leaders are on both sides, the better. It is important to maintain open and honest communication channels, using appropriate program management tools and a meeting process. All of the mechanics are common, whether it is an industry/industry or industry/foundation collaboration. There are some key differences, however. Industry tends to shift its priorities based on dynamic factors such as competing projects in the pipeline, whereas disease foundations tend to hold constant. Even though there may be differences in the goals of the organizations at the highest level, the alliance management process can be very similar.
SELLERS: As a matter of course for each of our top partnerships, we have regularly scheduled monthly calls that cover the whole range of the relationship and its activities. We cover the programs and participation in them, especially around patient education. If a foundation wants to drive additional thinking around possible synergies between its R&D folks and ours, the issue can be raised on the call. The patient advocacy team will then transfer the request to the appropriate stakeholder in the company.
RICHMAN: Every group does partner meetings differently. Usually, there will be quarterly meetings or conference calls to update each other, and the schedule is built into the agreement corresponding to an annual report, semiannual report, and quarterly report. But sometimes they get so excited about the science and it’s moving so fast, they will meet more frequently. Why wait for a quarterly meeting when you’ve got a great scientific update?
MADERIS: To some extent, these disease foundations can be more like the small, scrappy biotechs than pharma. Even though one is nonprofit and the other for-profit, their cultures and their drives are often very aligned. Some companies tell us disease foundations are so tremendously committed to the disease that it is actually easier to raise issues around the things that aren’t working and to deal with problems in an open way, because the foundations are less likely to give up. People said, “We had some really tough problems, and we were completely open about the issues. We worked together knowing our partner was 100 percent committed to solving whatever the problem was.” The sense of urgency in disease foundations aligns very well with the sense of urgency the small biotechs have — every day matters; every product in their pipeline matters.
Plug into the growing community of industry/ foundation collaborations — and keep learning best practices. Umbrella groups, consortia, and all kinds of hybrid partnerships involving the life sciences industry, patient/disease foundations, and many other players mean one-on-one alliances are no longer the only option.
SELLERS: There’s an emerging body of patient opinion leaders who have weighed in on what the companies are doing, as well as what the regulators are doing, causing a shift toward patient-focused drug development that has really driven the creation and nurturing of these partnerships. Companies now consult with KOLs in designing a clinical trial, but you will start seeing companies consult with POLs (patient opinion leaders) in the same way and using some of the same mechanisms. There has been a recent acceleration in attention to patient-focused drug development. We have reached a tipping point around engagement with patients to find therapies faster and get them available to patients as soon as possible.
BRUMFIELD: In addition to enhancing collaboration within our consortia, we make sure we collaborate with other groups so we do not duplicate efforts. For our Predictive Safety Testing Consortium, we have a legal agreement with the Innovative Medicines Initiative’s Safer and Faster Evidence-based Translation (SAFE-T) program in Europe, because it is doing something similar. We are now fully embedded in each other’s work plan, sharing data, attending each other’s regulatory meetings, and trying to help each other be successful. This is not about competition; in our minds it is about moving things forward.
SHARON HESTERLEE, VP, Research, Parent Project Muscular Dystrophy (PPMD): There is a novel group in Europe called Treat- NMD, originally formed with a 10-million- Euro grant from the EU to focus on drug development for neuromuscular disease. Its focus is infrastructure, and it has put together the group TACT, Treat-NMD Advisory Committee on Therapeutics, which reviews funding proposals. Now, we insist that all of our project requests undergo TACT review. TACT is a pool of expert reviewers that includes pharmacologists, statisticians, ethicists, regulatory specialists — a whole gamut of people with drug development experience — along with 50 ad hoc reviewers to consult as needed.
SELLERS: The other sort of mechanism that we use for driving these kinds of partnerships is a group that we convene one or two times a year called The Cancer Advocacy Council. It’s by invitation only, and it’s 15 to 20 of those POLs at the C-suite level in patient advocacy groups. About one-third of the groups are legacy relationships; one third, pan-tumor organizations such as the American Cancer Society and patient support groups such as Cancer Care; and one third, patient advocacy groups with whom we want to build a relationship before we have an immediate reason to engage with them. We convene them to work on a mutually interesting topic.
One of the early meetings of the Cancer Advocacy Council was focused on how to get patient input into development of patient-reported outcomes or patient-preference surveys, and out of that we formed a collaboration between our epidemiology and outcomes research people with a patient group, as well as “patient ambassadors,” who are speakers on behalf of Millennium, to develop and field a patient-preference survey for myeloma patients. No need for focus groups. We have a patient advocacy organization with ready-made access to patients.
HESTERLEE: Even in the small Duchenne space, we have some highly competitive players, but we are able to serve as a neutral territory. Our Duchenne Drug Development Roundtable has involved about a dozen companies in the discussion. We have talked about common issues, such as the potential for using a natural history control instead of a placebo arm. We have multiple rival companies talking about their strategies. That is an emerging paradigm: As a nonprofit group, if we do it right, with strong firewalls to prevent bias toward the companies we fund, we can be that neutral platform.
This ends our four-part series, “Industry Partnerships with Patient Foundations — The Best Practices.” Many thanks to the BayBio team for its help with this series. (See BayBio’s white paper on the survey at http://baybio. org/?s=public-private+partnerships.)
BIO BOOSTS PATIENT FOUNDATIONS
The avalanching advance of industry/foundation partnerships has not escaped the industry’s largest association, the Biotechnology Industry Organization (BIO). At the 2014 International Convention, BIO provided foundations with access to its partnering meeting system, sparking nearly 600 meetings in the BIO Alliance Pavilion between about 60 participating patient groups and academics and the biotech companies at the convention. BIO has also scheduled several other events this year to encourage and facilitate more industry/ foundation partnerships. On October 14 and 15, BIO will hold the third annual Patient & Health Advocacy Summit in Washington, DC, convening leaders from patient advocacy organizations, medical and professional societies, and the biotechnology industry for two days of programming and networking opportunities. Generally, BIO is also reinforcing BayBio’s message to companies that patient foundations, in addition to funding drug development, bring almost incalculable value to companies in their expertise, resources, and rapport with patients.
LEADING BY FOLLOWING — BAYBIO’S GAIL MADERIS
BayBio’s survey and white paper, “Successful Public-Private Partnerships,” was the wellspring of our four-part series on best practices for collaborations between life science companies and patient/disease foundations in drug development. Gail Maderis, BayBio’s president and CEO and head of the San Francisco Bay area biotech-industry association, offers perspectives on the survey’s origin, implementation, and results.
A strategic planning meeting in 2010[?] sparked an internal discussion at BayBio: “How can we help our member companies recognize the growing involvement of patients and patient foundations as key players in drug development and reach out for their support?” Maderis asked.
The group noted that many smaller companies lacked easy access to the disease foundations, and many disease foundations lacked access or even awareness of all the companies working in their area. BayBio thus decided to be an umbrella group, to help raise issues and bring people together so foundations would not have to reach out individually to specific companies. “Disease foundations want to remain somewhat objective, and they are sometimes sensitive to working with an individual company,” said Maderis. To get a “lay of the land,” the public-private partnerships survey was a logical option.
“One of the biggest surprises to me was when we asked the foundations whether pharma understood their full range of capabilities, and we asked the industry whether the disease foundations understood the drug development process. The majority of respondents on both of those questions said no, which is pretty scary, but people tend to compartmentalize. When you talk to companies that have had long-standing relationships with disease foundations, it’s tremendously different: Disease foundations help them with financing, with their boards, with partnering, and their very credibility. And disease foundations have become much more acutely aware of bottlenecks in drug development. There has been a tremendous amount of learning on both sides just by way of collaborating.”
Maderis saw another survey finding as especially insightful: An industry respondent wrote, “Reach out to the foundations before you need them.” She advises companies not to wait until they apply for a grant. “If you’re developing a product in a given disease area, get in touch with the relevant foundations, get to know them.” She noted pharma companies that were pioneers in alliance management have alliance-management training courses for industry and industry collaborations, and now her group is talking to the companies about setting up a similar management training course for industry and foundation partnerships, as well as educational tools and seminars for its member companies.
Maderis concluded: “We continue to see high interest among companies in working with disease foundations along with an increase in collaborations. We are going to have to work more closely together to solve these intractable healthcare problems. Even the FDA embraced patient-focused drug development in the last PDUFA, and disease foundations are becoming more vocal advocates for patient access to drugs. All of the components of the healthcare ecosystem are converging, and it makes sense to see increasing interaction between the disease foundations and the industry.”