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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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A Swim in ‘The Aquarium:’ Your Chance to Collectively Shift the Thought Currents of Alliance Management

Posted By Cynthia B. Hanson, Wednesday, September 7, 2016

ASAP Summit and Conference participants spend a lot of time sitting, listening, and absorbing the most cutting-edge information in the industry. Now it’s your turn to be a speaker, guide, and thought provoker in a new session format at this year’s ASAP BioPharma Conference Sept. 7-9, “New Faces, Unexpected Places in Partnering: The Foresight to Lead, the Foundation to Succeed,” at the Revere Hotel Boston Common, Boston. The Aquarium session encourages attendees to dive in and wrestle with the hot topics of the day in a creative, ASAP-designed version of the “fishbowl” learning activity. Moderated by Jan Twombly, CSAP, president of The Rhythm of Business, the session will start with a lively exchange on key topics from several experts in the field of alliance management as the audience peers into the tank. There will be three 25-minute rounds during the session, each with a separate topic. Participants will be allowed to “tap in” and move the conversation in new directions. When someone comes onto the stage, one person must exit. 

“We’re not sticking to a script; each of these topic discussion could branch off,” explains Ann Johnson, ASAP’s content manager, who has developed the concept as an innovation ASAP programming.  “That’s the beauty of nontraditional session structure like this: It allows for free-space that often results in exploring topics in real and meaningful ways … through many different lenses. It encourages engagement, peer-to-peer sharing, and participation, which is what our members want. There are no right answers to these topics, and in fact we want to hear diverse viewpoints,” Johnson adds. “This is a way to hear from the voices we often don’t hear from.” 

It’s an opportunity to become a member of the “school” in a fast-paced, collective swim that is geared to leave participants with a more creative and innovative perspective on the potential for change in alliance management. The following preselected topics are designed to jumpstart the conversation:

Topic #1: Lead, Follow, or Get Out of the Way

True or False: The alliance management profession in biopharma has the respect, skills, and ability to lead companies into partnering with different types of partners, across industries, and in new models.

Topic #2: Handle with Care: Managing the C-Suite

How do you ensure executive leadership (C-Suite) is appropriately involved in an alliance, without giving them a seat at the table, especially when the alliance is between a small, innovative company and big pharma?

Topic #3: Breadth or Depth – What Does it Take to Succeed?

Which qualities will be more highly valued in alliance managers as the industry adapts to digitization, outcomes based pricing, and an increasing number and variety of partnerships: broad business and technical skills and experience or deep pharmaceutical industry knowledge and experience?

As the conversation evolves, participants will then get a chance to bump the following thought leaders and senior-level partnering executives off the stage: 

  • Jeremy Ahouse, CSAP, PhD, Executive Director Alliance Management, Celgene
  • Harm-Jan Borgeld, CSAP, PhD, Head Alliance Management, Merck Serono 
  • David Burnham, Senior Vice President Strategic Alliance Management, INC Research
  • Mark Coflin, CSAP, Senior Director Alliance Management Global BD&L, Baxalta US Inc.  
  • Cathy Connelly, CA-AM, Head, Alliance Management, Sanofi Genzyme
  • Andy Hull, CA-AM, Vice President, Global Alliances, Takeda Pharmaceuticals
  • Katherine Kendrick, CA-AM; Director of Alliance Management, Elanco, Eli Lilly and Company
  • Brooke A. Paige, CSAP, Staff Vice President, Strategic Initiatives, HealthCore, Inc.
  • Petra Sansom, Sr. Director, Alliance Management, Vertex Pharmaceuticals
  • Mary Jo Struttmann, CA-AM; Executive Director, Global Alliance Management, Astellas Pharma Inc.
  • Michael Sumpter, Head of Alliance Management, Servier Monde
  • David S. Thompson, CA-AM, Chief Alliance Officer, Eli Lilly and Company
  • Steve Twait, CSAP, VP, Alliance and Integration Management, AstraZeneca

 Photo credit:  MB Photo Credit: W. Chappell

Tags:  alliance management  alliance managers  Ann Johnson  Astellas  AstraZeneca  biopharma  c-suite  David Thompson  Eli Lilly and Company  Jan Twombly  Mary Jo Struttmann  Michael Sumpter  partnerships  Petra Sansom  pharma  Servier Monde  Steve Twait  The Rhythm of Business  Vertex Pharmaceuticals 

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