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Where Hope IS the Strategy: Customizing Alliance Management to Fight Deadly Disease

Posted By Michael J. Burke, Monday, September 30, 2019
Updated: Friday, September 27, 2019

      Andre Turenne began his Wednesday keynote address at the 2019 ASAP BioPharma Conference , held Sept. 23­–25 in Boston, by reminding everyone why biopharma companies form partnerships in the first place: to more effectively find and create new medicines and treatments that will improve patient health outcomes—and in some cases, with the fervent hope of one day preventing or arresting the progress of currently untreatable diseases.

      Turenne, since July 2018 the president and CEO of Voyager Therapeutics, started off his keynote presentation, “Fit for Purpose Alliance Management: Why Customization Matters,” by telling the story of Kyle Bryant, an inspirational and determined young man who was diagnosed at age 17 with Friedreich’s ataxia (FA). The diagnosis of FA, a progressive and eventually fatal disease, means that Bryant will gradually lose motor function and speech. But he has been making the most of his life in the meantime, among other things founding and directing a cross-US bike ride called rideATAXIA—billed as “the world’s toughest bike race”—to benefit the Friedreich’s Ataxia Research Alliance (FARA), and with his friend Sean Baumstark cohosting a podcast, Two Disabled Dudes.

      Bryant is also the subject of an award-winning 2015 documentary, The Ataxian, which shows how he participated in and ultimately completed the grueling cross-country bike ride. Turenne showed the audience the trailer for the film, in which Bryant said of the debilitating disease, “There’s a way to fight it. And there’s always hope.”

      Turenne and his company are trying to translate that inspiring attitude into a forward-thinking strategic vision. Through their commercial collaboration with Neurocrine Biosciences, Voyager Therapeutics is working on treatments in the areas of Friedreich’s ataxia and Parkinson’s disease (PD). In addition, the Voyager pipeline includes a partnership with Abbvie around treatments for Alzheimer’s disease and related conditions.

      Around 6000 people in the US have FA, which is being targeted by gene replacement therapy. About a million Americans have PD; they lose the ability to produce dopamine, which controls motor function, so the goal is to mitigate that loss to help restore motor activity.

      Especially for a small company like Voyager, “collaboration is of the utmost importance,” Turenne acknowledged. “Who we choose to work with and how…has a huge bearing on what we do. And no two collaborations are alike, so we need a customized approach to alliance management.”

      Turenne may be the rare example of a CEO who came up through the ranks of alliance management and business development, but as ASAP president and CEO Mike Leonetti said, he’s “living proof” that it is possible. Or as Turenne explained, “The phenotype of a CEO is changing as the industry is changing. If you talk with VCs, there is no fixed stereotype of what a CEO should be.”

      Perhaps Turenne’s AM/BD experience also contributes to his keen interest in partnering with companies that “punch above their weight in the execution of this function.”

      In Turenne’s thinking, the key factors when considering forming an alliance are:

  • Each company’s size, strategy, and areas of focus
  • The partnered program’s relative importance to each company
  • The other company’s (your potential partner’s) alliance management experience and organizational setup
  • The evolution of any of the above factors for either company over time

      As Turenne put it, “We’re only as good as the way we can work together.” And while he said he doesn’t like to talk about companies with less alliance management expertise as the “weak link,” the success or failure of a given alliance often boils down to the level of the least experienced player. How to bridge that gap to “customize and calibrate the relationship” then becomes the big challenge.

      Add to that a burgeoning biopharma industry that is far from static, and change must be assumed—and anticipated and planned for in advance. The original setup of the alliance, however well structured, may no longer apply given changing market conditions, turnover in either organization, or companies’ shifting strategies, so alliance managers must be agile enough to pivot and adapt to these altered states.

      Among the trends Turenne has seen that have significant implications for biopharma alliance management are:

  • Well-capitalized biotechs seeking to collaborate with smaller companies
  • Big pharma companies trying to “act smaller” and be more nimble and flexible
  • The massive movement of talent across the industry, which means a greater cross-fertilization of alliance management approaches throughout biopharma

      After a dozen years at Genzyme—where he established the alliance management function—and later its eventual acquirer Sanofi, Turenne came on board at Voyager in 2018 already convinced of the importance of alliance management and the need to tailor and customize its application to the partnerships at hand. And having been in senior positions in companies large and small, he has some thoughts on how big and small companies can partner effectively.

      One key is to understand and acknowledge each company’s experience with partnering and how each one works. Ideally then each company can stretch toward the other and meet in the middle in terms of establishing their joint partnering capability.

      “Any effort in a humble way [for a bigger company] to share experience with the smaller partner can have a big impact,” Turenne explained. The larger partner can try to flex to meet the needs of the smaller partner so the gap between them is lessened. At a conference whose theme was “Bridging the Many Divides,” Turenne’s words certainly resonated.

      When he looks into the future, Turenne hopes that the partnership with Neurocrine around FA and PD will still be active in five years. But will they succeed in helping patients with these serious conditions? Turenne feels that Voyager’s continuing efforts to enhance and customize its alliance management capabilities will “improve our chances of making a big impact for patients.” 

Tags:  Alliance Management  André Turenne  biopharma  capabilities  collaboration  Friedreich’s ataxia (FA)  Kyle Bryant  partnerships  patient health outcomes  rideATAXIA  strategy  Voyager Therapeutics 

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An Inside Job: Building Alliance Management Culture

Posted By Michael J. Burke , Friday, September 27, 2019

      “We see at the highest levels of business and government what happens when we don’t maintain and preserve alliances.” Such was the plain, blunt statement of Rob Bazemore, president and CEO of Epizyme, Inc., Tuesday’s keynote speaker at the 2019 ASAP BioPharma Conference, going on Sept. 23–25 in Boston. While many biopharma alliance professionals might almost reflexively agree with that statement, it’s still surprising how recent—and how limited—many alliance management practices are—even in biopharma.

       But the thrust of Bazemore’s talk was the burning need for more than simply the establishment of an alliance management function—rather, the title of his keynote address was “Building an Alliance Management Culture, Not an Alliance Management Function.”

       While Bazemore acknowledged that he is not himself an alliance manager, his conviction that an alliance management culture is indispensable comes from both personal and professional experience. Several years ago, Bazemore was diagnosed with stage 4 non-Hodgkin’s lymphoma. The news was “life-changing,” as he put it. “Cancer is a fight you don’t want to have alone.” He went through chemotherapy and other treatments at the University of Pennsylvania Medical Center, and also benefited from support by family, friends, prayer chains, and even support from strangers. A whole network of alliances, you might say.

       Accordingly, the mission of his company, Epizyme, is “rewriting the treatments for people with cancer,” particularly in terms of alternatives to chemotherapy. Its drug Tazemetostat, an EZH2 inhibitor, is nearing the commercialization stage, and is currently targeted at epithelioid sarcoma and follicular lymphoma.

       Another source of Bazemore’s vital interest in alliance management culture stems from his past experiences at other companies, where sometimes “we didn’t trust alliance managers enough to deal with problems.” This led, for example to regularly scheduled mandatory escalation meetings with senior leadership—“not a best practice,” he confirmed.

       When he took the reins at Epizyme a few years ago, he inherited a “challenging collaboration” and decided to meet with the partner’s alliance manager, rather than its CEO. He found that the contract hadn’t been set up for success so the intended goals couldn’t be achieved. “There’s no magic wand for that,” he admitted.

       As a small company, Epizyme needed to partner, and needed to form new partnerships, so Bazemore knew that they had to change their approach. As part of Vision 2020, the company’s five-year strategic plan launched in 2015, alliance management had to become central to the company, its operations, and its strategic vision.

      To get where it wanted to go, Epizyme decided on the overarching goal of becoming a partner of choice. That was simply on one level a “pragmatic” decision, according to Bazemore, given its need to partner. But it had a poor track record of collaborating in the past and clearly had to approach deals differently—not just focusing on the financial aspects, but working on becoming the company others wanted to partner with.

       Now Bazemore feels that alliance management has become one of the most important functions within Epizyme—though not just a function, but a culture, which has to start with signals and actions from the top. Both senior leadership and organization structure have to encourage, nurture, and support this culture, and it must be done internally. “Alliance management is an inside job,” Bazemore said.

       Alliance managers must be allowed and encouraged to have appropriate and necessary conversations and to challenge both sides, getting the CEO involved as needed. This also means that sometimes they’ll stand up to a partner, and sometimes stand up for a partner—even at the risk of drawing the ire of their senior leadership from time to time, according to Bazemore. Making alliance culture important and central is not just paying lip service to an ideal, either, he said. It has to be real, and not just the theme for this year or a policy dependent on the presence of one alliance manager—who might move on to another company at any time.

      Epizyme is growing, with many new people coming in and alliance management expanding. Moving forward into the next decade will require being selective about which alliances the company enters into—they don’t want to get into alliances that sap the organization’s energy or end up wasting time and not delivering the desired results, Bazemore said. And he emphasized that these alliances will be about “relationships, not just deals.”

      And more important than simply measuring alliance management as a function at the company is figuring out how Epizyme’s “partner of choice imperative” is actually working. So far so good, it seems, but the company’s next five-year plan is already being envisioned: Epizyme 2.0. Whatever shape that takes, it’s sure to build in a leadership-enabled and -supported alliance management culture.

Tags:  alliance alliance management practices  alliance manager  biopharma  culture  Epizyme  partner  partner of choice  Rob Bazemore  strategic vision 

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Where’s the Love? Alliance Managers Show Some…to Medical Affairs

Posted By Michael J. Burke, Wednesday, September 25, 2019

Perhaps one of the less appreciated and less understood roles in biopharma alliances—particularly codevelopment, cocommercial alliances—is that of the medical affairs team, specifically medical science liaisons (MSLs). These field-level folks implement a medical affairs plan and communicate and translate the scientific data from a drug or treatment to health care providers. They own relationships with key opinion leaders (KOLs) and according to surveys are pretty important—the most “clinically useful” people many health care providers deal with.

            “They are translators of the data. They give you the scientific story,” said Mary Jo Struttmann, CA-AM, executive director of alliance management at Astellas. Struttmann participated in a session titled “A Winning Strategy: Show a Little Alliance Management Love for Medical Affairs,” along with Judy Baselice, CA-AM, director of alliance management at Pfizer, and Jan Twombly, CSAP, president of The Rhythm of Business, who moderated the session.

            In addition to being keepers of the scientific narrative, medical affairs people own important relationships with key opinion leaders (KOLs), do professional education, facilitate the creation of publications and presentations at congresses and conferences, get involved in grants and investigator-initiated trials, and at some companies perform other functions as well. They can do what others in a biopharma alliance often can’t: explain the science, interpret the data, describe the mechanism of action of a drug, delve into potential side effects and other questions—all with a primary focus on patient outcomes.

Thus the role of medical affairs is important enough in biopharma that it should be written into the alliance contract, with its own separate budget and work plan, and joint medical affairs committees should be part of that contract and integrated into the governance and work stream teams, according to all three presenters. A number of industry developments, meanwhile, have combined to raise the profile of medical affairs as well, including more payer influence, greater focus on the customer experience, an increased focus on patient outcomes, new medical technologies, and the accelerated pace of scientific discovery.

            Struttmann went so far as to say that in biopharma alliances, there are “three legs of a stool”: commercial, development, and medical affairs. Compliance requirements should keep the scientific areas—including medical affairs—separate from the commercial people, but at the same time there needs to be collaboration and coordination among medical affairs, development, and commercial—a value-added and value-creating role for alliance professionals that ultimately leads to greater value for patients and partners.

            Without adequately acknowledging the role of medical affairs in contracts, there can be significant compliance risk; such agreements may lack definition, enabling either party to overstep boundaries on roles and responsibilities. This includes delineating which activities in the alliance are global and which are territorial or regional, and dividing up who owns each activity accordingly.

In terms of governance, if there is a joint commercial committee, there should also be a joint medical affairs committee, reporting directly to the joint steering committee (JSC). Another best practice is the establishment of a “collaborative leadership team.” This team would be cross-functional and meet perhaps monthly, looking at the alliance as a whole. Representatives from commercial, development, medical affairs, and other areas would be at the table, and in such a model medical affairs can address commercial challenges by acting as a conduit for feedback from health care providers.

By setting up such mechanisms to drive cross-functional work and communication, alliance managers can bring about some positive outcomes in the alliance, including:

  • Creating a single version of “the truth” for ongoing cross-functional work
  • Eliminating the inefficiencies of having one-off conversations or meetings
  • Minimizing the risk of delays due to miscommunication
  • Improving accountability through positive peer pressure

In addition, medical affairs will benefit from these more integrated collaborative structures by:

  • Becoming more aware of commercial challenges
  • Aligning with development on the scientific challenges
  • Acting as a conduit to give insights from health care providers to both development and commercial
  • Facilitating life cycle management planning
  • Creating coordinated engagement plans for KOLs, and…
  • In the end, gaining greater recognition for the importance of medical affairs.

Turnover can be a challenge, as in all alliances, and keeping the medical affairs group separate enough to be elevated and not “washed out” or diluted, as Baselice recommended, but integrated enough to be effective, may be challenging.

But getting this mix of collaboration, division of roles and responsibilities, and coordination right is part of the all-important “last mile of collaborative execution,” as Twombly emphasized. 

Tags:  Alliance Management  Astellas  cross-functional  integrated collaborative structures  Jan Twombly  Judy Baselice  Mary Jo Struttmann  Medical Affairs  Pfizer  The Rhythm of Business 

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Undivided Attention: The BMS-Concerto Story

Posted By Michael J. Burke, Wednesday, September 25, 2019

Nontraditional alliances took center stage (literally) yet again today as the opening session at the ASAP BioPharma Conference 2019 got under way in Boston. Titled “Building Value in Non-Traditional Pharma/Biotech Partnerships: BMS and Concerto Health AI,” the session was moderated by Stu Kliman, Partner at Vantage Partners, and featured David Anstatt, Executive Director of the Center for Observational Research and Data Sciences at Bristol-Myers Squibb, and Jeff Elton, CEO of Concerto Health AI.

            The big pharma company and the oncology data, platform and artificial intelligence start-up have formed a unique partnership—or in Kliman’s words “a super-cool, super-impactful, super-important alliance”—that may well be a harbinger of things to come, not only in terms of linking a large pharma company with drug-related and commercial expertise to a technology company with data-crunching capabilities, but also in terms of the closeness and “intimacy” of the partnership, with its necessary higher-than-average levels of trust and transparency.

            According to Elton, Concerto’s mission is to “think about unsolved problems in oncology” and then to acquire, integrate, and engineer real-world data in order to solve those problems for the benefit of patients. Anstatt described Bristol-Myers Squibb (BMS) as “a conservative company interested in agility”—characteristics which led it to look for agile partners with unique data and platform capabilities that BMS could leverage to drive analytics and insights across R&D, and eventually Commercial and Manufacturing.

            While it wasn’t clear from the outset where the agreement would eventually land, the two companies ultimately created a tight-knit relationship and working together model built around integrated working teams, “early and often” iteration, and highly collaborative co-development. “We have plenty of relationships where you throw it over the wall and [you get] what you get,” said Anstatt. “This [isn’t] that kind of relationship.”

            Both stressed that each company has its own specific interests and objectives within and outside the partnership—and are also committed to making the partnership work for both companies. In other words, they started with a philosophy and indeed created a contractual structure where there is literally “no out.” Or as Elton said, “I don’t have exit provisions.” The implication is that when problems arise, they will quickly be put on the table for discussion and jointly addressed. This generates unusual frankness and directness in communication, and by extension a “super high degree of alignment,” according to Elton.

            It also means that when, for example, the contractual minimum has been delivered but more is needed to solve the target business objective, team members from both companies remain focused on driving things forward.

            “We want more heads looking at it, more experts,” said Anstatt. “It has challenged our organization to do things differently.”

            So what could have been merely a vendor-customer type of transactional relationship became a means by which both parties have worked to innovate, with BMS getting the “best of” Concerto’s thinking and expertise and working with this rather unique partner to build something and develop things in an exploratory way.

Additionally, as part of their dedication to making this work, both firms are supported by Vantage Partners, which serves in a “Strategic PMO” role—developing and managing a project plan with a laser focus on value, surfacing and proactively addressing key challenges, issues and risks, and enhancing collaboration at all levels.

            As Kliman noted, like all alliances, nontraditional collaborations can fail if they are not launched in the right way—with teams aligned not just on deliverables but also “what’s the business value and what will it entail to actually deliver it?” The two parties must understand each other’s sometimes differing objectives and thus what’s driving their behaviors, and must also institute a leadership model that goes beyond governance, is focused on effective change management, and allows for continual “co-creation in an iterative kind of way.”

            Finally, Elton observed that the business terms of this alliance were rigorously grounded in business objectives; with business unit leaders highly engaged in the process and Business Development, Alliance Management, and key other groups also frequently consulted. This model may quickly become more common in the life sciences space, as he noted—and that should make for more products and solutions that enhance patient health outcomes. 

Tags:  alliances  Bristol-Myers Squibb  Concerto Health AI  David Anstatt  Jeff Elton  nontraditional collaborations  strategic PMO  Stu Kliman  transactional relationship  Vantage Partners  vendor-customer 

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When Worlds Converge: Digital Therapeutics Meets Biopharma Alliance Management

Posted By Michael J. Burke, Tuesday, September 24, 2019

Even a year or two ago, the idea of digital therapeutics didn’t stir up a great amount of interest among most participants at ASAP’s BioPharma Conference, according to Mike Leonetti, president and CEO of ASAP. That sort of ambivalence no longer applies, as was evident at the September 23 Leadership Forum that kicked off ASAP’s BioPharma 2019, held Sept. 23–25 in Boston.

            The invitation-only gathering of 20-some biopharma alliance leaders was treated to a glimpse into the future—and a privileged look at a rapidly changing present—by senior executives from two companies that have been fast-tracking prescription digital therapeutics in their own alliance. Alex Waldron, chief strategy officer at Pear Therapeutics, and Joris van Dam, head of digital therapeutics for the Novartis Institutes for BioMedical Research, were introduced by Leonetti and by Brooke Paige, vice president of alliance management at Pear Therapeutics and ASAP’s board chair.

            Waldron and van Dam described digital therapeutics as “software as a therapeutic,” or customer-facing software that helps clinically treat disease. It’s still relatively new, but already has become one of the five modalities of modern medical treatment (small molecule, large molecule, gene, cell, and digital). Whereas traditional biopharma alliances are asset-based partnerships formed on the basis of a molecule, in a partnership around digital therapeutics, the technology product is the asset.

            While we often think of wearable devices when we think about digital therapeutics, perhaps the most common such device is your smartphone. So far Pear and Novartis are experiencing some success around products used to treat depression that occurs with patients who have multiple sclerosis (MS) or schizophrenia, for example.

            Patients’ usage of and familiarity with their own cell phones is a big plus in such treatment, both in terms of access—a phone app is available 24/7, when patients need it, unlike a doctor or psychiatrist—and also adherence to the treatment plan, since the app can remind patients to stick to the program they’re on and help them get going with it again.  Other uses being explored include the treatment of addiction and other types of depression.

            Managing an alliance between a smaller, tech-oriented company and a large pharma company can be challenging, of course—as can any partnership between more traditional biopharma and tech. In this case, Novartis brought its commercial infrastructure, clinical trials expertise, and scientific strengths to the table; Pear brought technology, manufacturing, and ownership of the pharmacovigilance aspect, i.e., safety and data reporting.

            As part of the forum, the 20-plus alliance leaders were asked several questions and polled on their responses. Among the highlights:

  • More than 50 percent said their company had at least one or two digital/nontraditional alliances that were being operated as managed partnerships.
  • More than 50 percent said someone other than alliance management or business development managed these partnerships at their companies.
  • More than 80 percent said they expected their companies to increase the number of these digital/nontraditional partnerships in the next two years.
  • Nearly 70 percent reported the biggest challenges of such partnerships included finding a common language, the lack of alliance management skills, and cultural differences.
  • Fifty percent of respondents felt that these partnerships should be managed by the alliance management group in their organization—but nearly as many acknowledged that they don’t currently have the bandwidth to do so.

            In the roundtable discussion portion of the forum, participants came up with a number of elements or processes in traditional biopharma alliance management that would need to be revised, modified, leveraged, or speeded up to meet the needs of digital and nontraditional partnerships and to take advantage of the potential for innovation. These included:

  • Increasing the frequency of governance meetings and check-ins
  • Speeding up decision-making processes and structures and including more senior people in them
  • Educating senior management and managing stakeholders to ensure senior-level support and alignment
  • Hiring more tech-savvy alliance managers
  • Having more people on board who are well versed in IP issues and the regulatory environment
  • Needing to trust the partner in ways beyond what has been common in the past—including continuous data sharing
  • Hiring more disruptors and fewer people who are invested in protecting “the way we do things here”
  • Establishing clear roles and responsibilities from the outset of the alliance, as early as the kickoff (if not before)
  • Understanding each other better, given the different cultures of tech and biopharma companies

A window into the future indeed, and certainly there will be much more to come on this subject as the numbers of digital and nontraditional partnerships in biopharma continue to increase. And as ASAP BioPharma Conference 2019 continues, stay tuned for more of the latest coverage!

Tags:  Alex Waldron  alliance managers  ASAP BioPharma Conference  clinical trials expertise  commercial infrastructure  digital therapeutics  Joris van Dam  Novartis Institutes for BioMedical Research  Pear Therapeutics  scientific strengths  software as a therapeutic 

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