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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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Playing with Blocks—and Teams: How to Build Together for Alliance Success

Posted By John M. DeWitt, Monday, April 1, 2019

Lynda McDermott, CA-AM, president of EquiPro International, kicked off her preconference session at the 2019 ASAP Global Alliance Summit in Fort Lauderdale, Florida, by dividing the attendees into teams of two and three per table, instructing them to do something that you usually won’t find people doing in a professional setting: play with blocks. Her instructions were simple: Build the tallest tower, with the smallest number of blocks. With that said, McDermott set them to work.

Given that this occurred at a conference dedicated to business collaboration, one might think that a fair number of the teams would begin to work together to win the challenge at hand. However, nobody decided to collaborate. Several groups did discuss the possibility of collaboration, but all ultimately decided against it, for various reasons. Fifteen minutes later, two teams stood at the top of the leaderboard, tied for first. That is unimportant, though, because the key here is in the lesson learned.

McDermott specifically asked, once the toys were put away, if any groups had elected to collaborate. When everyone answered no, she revealed that she was not surprised in the slightest by that answer. In fact, she explained, she has done this same exercise with the blocks all around the world, and just about every group refused to collaborate. This, she continued, was no fault of ours. “Collaboration,” she said, “is not a natural instinct.” This, then, makes the work of alliance management even more meritorious than one might ordinarily think. The simple fact that forcing people to work together goes against our natural instincts makes the work that alliance managers accomplish all the more noteworthy. And it helps to underscore the non-collaborative behaviors faced by collaboration leaders and teams every day.

McDermott then went on to describe three categories, or “buckets,” as she called them, of alliance performance. These are the framework of the alliance, the team dynamics within the alliance, and how lean and agile the alliance is. She then asked the attendees to fill out a survey, with several questions relating to each of the three buckets. These questions were meant to assess areas such as communication, commitment, conflict resolution, and company culture. The idea behind surveys like this, she explained, is to gauge how an alliance is doing and identify how their performance can be improved. Once everybody had filled out the survey, she asked them to share their answers and wrote them down. While all of the questions yielded more positive answers than negative ones, the lowest numbers of positive answers (it was a simple yes or no survey) were all in the “framework” category.

She closed out the session by stressing that an alliance manager is more than just a mere manager. An alliance manager is “a teacher and a coach.” She explained that it cannot be assumed that everybody engaged in an alliance knows how to live productively in an alliance team. Therefore, one must incorporate training and learning into the alliance lifestyle, and encourage people to learn by doing.

See more of the ASAP Media team’s comprehensive coverage of the 2019 ASAP Global Alliance Summit on the ASAP blog and in Strategic Alliance publications.

Tags:  alliance management  alliance manager  collaboration  communication  company culture  conflict resolution  EquiPro International  framework  Lynda McDermott  team dynamics 

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Partnering the Future: Our Community’s Ahead-of-the-Curve Thinkers Pave the Path Forward

Posted By Michael Leonetti, CSAP, Monday, March 11, 2019
Updated: Saturday, March 9, 2019

Want to know what the future holds for your organization? Go to an ASAP conference or read ASAP Media publications. It’s been that way since the first ASAP Global Alliance Summit in 1999—but two decades later, at the 2019 Summit in Fort Lauderdale, Florida, it feels different. As the future of business rapidly unfolds before us in this partnering everywhere world, it seems our thought leaders are on the cusp of just about everything.

Last fall, I kicked off three conferences in three months on two continents, each time ticking off essentially the same list of trends that now are accelerating alliances and transforming how we partner. On Tuesday, March 12, I welcome alliance management’s best and brightest at the Summit’s opening and my list of game-changing topics remains pretty much the same:

  • Artificial intelligence (AI) software learns to learn
  • Internet of Things (IoT) on the edge
  • Public cloud innovation
  • Cyber security, distributed trust, blockchain, data protection and privacy (in particular, Europe’s General Data Protection Regulation, or GDPR)
  • Med tech, organ on a chip, and bio printing
  • Agile partnering and agile technologies
  • Consumers and their tools (social media) and immersive customer experience (CX)
  • Amazon and Alibaba

For alliance managers in biopharma, I also added the volatility of the Affordable Care Act (ACA) in the US—and healthcare costs everywhere; the co-pay accumulator and the consolidation of patient access; the inevitable convergence of e-services; the role of gene therapy as an economic change maker; digital therapeutics; and new antibiotic discoveries.  

Then, each time after I ticked off this list—at the ASAP BioPharma Conference in September, at the October ASAP Tech Partner Forum, and in November at the ASAP European Alliance Summit—I found myself sitting back in wonder, listening as speaker after speaker boggled my mind. Heading into spring at this month’s Summit—and heading into summer at the June 19, 2019 ASAP Tech Partner Forum in Santa Clara, California, hosted by Citrix Systems—the ride gets even wilder, and more relevant, current, and provocative.

We’ve had CEOs onstage talking about combining Cambridge, Massachusetts, life sciences and Silicon Valley technologies into software-based, FDA-approved therapeutics that replace pills. A global alliance manager who manages a $5 billion public-private partnership dedicated to accelerating the innovative medicines pipeline. Chief alliance officers from software, artificial intelligence, and robotics companies that are partnering at light speeds to automate everything they can, from clerical work and automobile driving to marketing, sales, and even alliance management itself.  

I was amazed to hear in an IoT session the back-and-forth between speakers and audience about regulatory efforts, like GDPR, to stick the data privacy genie back into the bottle. “What about privacy?” ChromaWay’s Todd Miller asked the panelists.  Scott Smith, founder of Fathym, surprisingly replied:

I think people will eventually give up privacy. Go back 100 years, when we all lived in small villages. We lived with no privacy whatsoever. I think that today's privacy issue grows out of [Orwell’s] 1984 and the ‘70s when we were concerned about Big Brother and the CIA, but I think in comparison with human history, today's concern over privacy is an anomaly. I think we’d be shocked at what they already know. … I was sitting next to a 20 year old when Snowden came out. She said, "I thought everyone already knew this.”

There’s a reason we’re so on top of things in the ASAP community: We’re in the middle of it. We didn’t have to do a dissertation on it (though we do have a plethora of PhDs in our ranks). We’re seeing, hearing it, living it every day. That’s why we build our leadership muscle—the topic of the Q4 2018 Strategic Alliance Quarterly cover story. We’ve got to be strong and flexible to pave the road to the future through our partnerships.

Ready for our next mind-blowing workout? Join me and attend at least one of the next three events already on the calendar in this year—the March 11-13, 2019 ASAP Global Alliance Summit, the June 19, 2019 ASAP Tech Partner Forum, and the September 23-25, 2019 ASAP BioPharma Conference. You’ll return to your daily tasks with profound new insights—and a brain that’s just bulging with newfound leadership muscle.

Visit http://asapsummit.org for the most up-to-date agenda for March 11-13, 2019 ASAP Global Alliance Summit, and register for the event, at. See the ASAP Media team’s comprehensive before, during, and after coverage of the 2019 Summit in Strategic Alliance publications and on the ASAP blog.

Michael Leonetti, CSAP, is president and CEO of ASAP and executive publisher of ASAP Media and Strategic Alliance publications. A previous version of this article appeared in Q4 2018 Strategic Alliance Quarterly.

Tags:  Agile partnering  Alibaba  alliance management  alliance managers  Amazon  Artificial intelligence (AI)  bio printing  blockchain  customer experience  Cyber security  distributed trust  GDPR  healthcare  Internet of Things (IoT)  Med tech  organ on a chip  Public cloud 

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Covey Got It Just Right: ‘Sharpen Your Saw’ in 2019—Because the Faster Partnering Moves, the More Learning and Professional Development Matters

Posted By Michael Leonetti, CSAP, Saturday, March 9, 2019

We recently did some research into ASAP’s Certified Strategic Alliance Professionals. Going back to 2010, we found that fully 90 percent of CSAPs—nine out of every 10 recipients—remain active members in the association. That tells me that that CSAPs are leaders who think seriously about our profession, who want to ensure this is an enduring profession, and who can do the hard, heavy lifting it takes to be at the top of their game.

In other words, our CSAPs are still reinvesting, following the late Stephen Covey’s advice: “We must never be too busy to take time to ‘Sharpen the Saw.’”

Covey’s seventh habit of highly effective people borrows from ancient wisdom traditions as well as modern insight into the importance of renewal. It reminds us to take regular breaks in our personal lives, and to periodically re-sharpen the skills and knowledge that keep us on the forefront of our profession. This essential saw-sharpening only happens when we engage deeply in the alliance management community and participate in its events.

Just how sharp does the learning get? Check out our Strategic Alliance publications’ coverage of the November 8-9, 2018 ASAP European Alliance Summit in Amsterdam—and join me in Fort Lauderdale, Florida, for the March 11-13, 2019 ASAP Global Alliance Summit, “Agile Partnering in Today’s Collaborative Ecosystems.”

Both of these international events exemplify how our community collectively sharpens the saw—how we continually reflect, reexamine, and renew the content of our learning. ASAP events are an eye-popping confluence of brilliant and diverse people—typically a 50/50 mix of ASAP veterans and newcomers. Our content gets richer and more nuanced with every conference as it updates tried-and-true alliance management fundamentals with the bleeding edge of practice.

The alliance lifecycle—as presented in the ASAP Handbook of Alliance Management: A Practitioner’s Guideremains very relevant “blocking and tackling.” But—as we push across industry boundaries and into ecosystem partnering, agile practices, organizational collaborative capability, and even partnering process automation—it’s obvious that so many things around the alliance lifecycle must be agile. One partnership may skip lifecycle steps two, three, and four; another alliance might start at one, continue through three, and then go to market.

We’ve talked for years about partnering going beyond alliance management. Now we’re in the “perfect storm” as the partnering everywhere model comes to life. Ecosystem partnering is everywhere—in technology, in life sciences, even in jewelry, where open innovation networks fuel innovation for Swarovski, as I learned last fall in Amsterdam. Classic channel partnerships are in decline, cloud partnerships are accelerating, and the whole field of partnering is getting much larger, much more complex.

Look at digital therapeutics—I’ve been predicting at ASAP conferences that IT companies would be the healthcare partners of the future. Now we have life science member companies partnering with big data and analytics and launching therapies approved by the US Food and Drug Administration that are primarily software based, while tech companies’ business models evolve to be able to deliver safe, reliable healthcare-related services. In telecom, 5G speeds will create new networks and mobile capabilities that we’ve never seen before—requiring partners we’ve never seen before. And artificial intelligence—what organizations and processes will become our partners in the future because of the advances of AI, and how will that again change the complexity of our alliances? 

Amidst this perfect storm, ASAP is a perfect conduit for everyone who leads collaborations to learn how to do it better and evolve “the how” every day in practice. So sharpen your saw. Invest in your community through ASAP, and invest in yourself through ASAP’s professional development events and publications.

Stephen Covey got it just right: “‘Sharpen the Saw’ means preserving and enhancing the greatest asset you have—you.”

Visit http://asapsummit.org for the most up-to-date agenda for March 11-13, 2019 ASAP Global Alliance Summit, and register for the event, at. See the ASAP Media team’s comprehensive before, during, and after coverage of the 2019 Summit in Strategic Alliance publications and on the ASAP blog. 

Michael Leonetti, CSAP, is president and CEO of ASAP and executive publisher of ASAP Media and Strategic Alliance publications. A previous version of this article appeared in Q1 2019 Strategic Alliance Quarterly

Tags:  5G  agile practices  alliance lifecycle  alliance management  artificial intelligence  ecosystem partnering  healthcare-related services  mobile  organizational collaborative  Partnering  Professional Development  telecom 

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Awards Finalists Describe Complex Joint Venture for a New Vaccine—Part 1

Posted By ASAP Media, Wednesday, February 27, 2019

Merck Vaccines and Sanofi Pasteur are finalists for a 2019 ASAP Alliance Excellence Award to be presented at the upcoming ASAP Global Alliance Summit, “Agile Partnering in Today’s Collaborative Ecosystem,” March 11-13 at the Westin Fort Lauderdale Beach Resort in Fort Lauderdale, Florida. The companies built a joint venture for a new drug utilizing a governance model inspired by small, nimble biotech companies to ensure speed and flexibility. The commercialization phase of the new drug has been very successful. ASAP Media asked Jean-Phillipe Proust and Chris Scirrotto of Sanofi Pasteur, and Eric Skjeveland of Merck Vaccines to respond to these questions to help our readers better understand the processes used to develop the very complex joint venture, and why it’s noteworthy for the alliance management community.

Why did you apply for an ASAP Alliance Excellence Award?

We thought the alliance management community would be interested in our experiences bringing two large vaccine companies together, with different organizations and cultures, in order to create an agile European structure able to adjust and adapt to the new market condition in Europe (MCM Vaccine BV). At the same time, these two companies were closing a long-lasting, full-scale joint venture in the same market geographya very complex undertaking that ended up successfully.   

What drug was developed?

VAXELIS is an infant hexavalent combination vaccine that helps to protect against six diseasesdiphtheria, tetanus, pertussis (whooping cough), poliomyelitis, hepatitis B and invasive disease due to H. influenzae type b.  This complex global product has taken more than 15 years to develop and launch in the European Union market. The six antigens in this vaccine are produced and packaged using five different facilities in four countries between EU and North America.   

What best practices did you use to improve alliance management practices and enhance the outcome?

  • Aligned and clear objectives: These were established early on and used as guideposts when making decisions on how the alliance would be structured, the framework of the governance model, and dispute resolution.
  • Trust level needed to improve: We moved from a neutral level of trust following the decision to dismantle the SPMSD joint venture, through several stages of building trust rather quickly.  The MCM joint team is now truly at a partnership level, where we respect the differences in thinking and culture of both organizations. We have a shared vision for VAXELIS, conduct shared planning sessions among those that are assigned to the joint venture, and amicably resolve our differences.
  • Fairness: Partnerships need to be built on a true win-win basis. If during the negotiation one of the parties gets the impression of imbalance, the future and outcomes will be less certain; in a negotiation for a sustainable, long partnership, the goal is to find a balanced compromise.
  • Active sponsorship from senior leadership: Senior leaders are involved not only at the joint steering committee level, but routinely participate in team meetings for the joint venture, etc.  They make a concerted effort to be visible and support the joint venture.
  • Structure and governance: Established an effective and efficient governance framework, including team charters for all governance committees with clear and simplified operating principles, decision making, and escalation procedures. We made the decision to operate and build the partnership with a “biotech spirit” with a dedicated, limited team empowered to make decisions and move quickly.
  • Created a collaborative culture: The partners have shared values and behaviors such as: open, two-way communication among those that are assigned to the joint venture, agreement to disagree respectfully and address issues early, honor and respect of differences in company culture and approach, and operation in a transparent manner with respect to the joint venture.
  • MCM Annual Meeting: Merck Vaccines and Sanofi Pasteur conduct a global MCM annual meeting, which brings together the key staff supporting the joint venture to celebrate past year successes, share lessons learned, and plan for the upcoming year for VAXELIS. A good portion of the meeting time is dedicated to F2F governance meetings for the product.
  • Alliance health checks: These were conducted twice during the first 18 months, which helped us course correct. An important finding on the Merck side was that there were too many people partially involved in the JV, which was creating unnecessary complexity and communication. We streamlined the number of people involved in the alliance and asked for a higher percentage of their time.

See Part 2 of this blog post for further information on the 2019 ASAP Alliance Excellence Awards and the Merck Vaccine and Sanofi Pasteur alliance. And stay tuned for additional awards coverage on the ASAP blog and in the monthly and quarterly Strategic Alliance magazines.

Tags:  Alliance health checks  alliance management  ASAP Alliance Excellence Awards  biotech  Chris Scirrotto  collaborative culture  commercialization phase  dispute resolution  Eric Skjeveland  governance model  Jean-Phillipe Proust  joint venture  Merck Vaccines  negotiation  Sanofi Pasteur 

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