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Accelerating Medicines and Jump-Starting Treatments: Public-Private Partnerships Enlist Takeda and Other Biopharma Companies in the Fight Against Serious Diseases

Posted By Hugh Rauscher, Friday, January 31, 2020

As the healthcare and biopharma ecosystem expands and diversifies, the public-private partnership model offers an important sphere of collaboration between biopharma companies, medical institutions, patient advocacy foundations, and governmental entities. Biopharma companies—many ASAP members among them—are increasingly getting involved with nonprofits, foundations, and other organizations to tackle the toughest diseases, and that includes ASAP global member Takeda Pharmaceuticals.

Takeda is a participant in approximately 80 large-scale collaborations between public and private entities designed to address significant health issues. The majority of these collaborations are around researching and developing new treatments. “We look to get involved where we can add value and where there is value to Takeda,” said Sean Breen, head of global science advocacy and public-private partnerships at Takeda. “In particular, we look for partnerships where patients and patient organizations have a voice in development and can help all the stakeholders understand what patients need.”

Two of the most significant public-private partnership models are the EU-sponsored Innovative Medicines Initiative (IMI) and the US-centered Accelerating Medicines Partnership (AMP).

Launched in 2008, the IMI is sponsored by the Directorate General for Research and Innovation of the European Commission. The IMI brings together medical institutions, academia, foundations, and industry with the aim of removing research bottlenecks in drug development. According to the IMI website, its €5 billion budget makes it the largest biomedical public-private partnership in the world. 

The AMP is a public-private partnership between the National Institutes of Health, the US Food and Drug Administration, and multiple biopharmaceutical and life science companies and nonprofit organizations. The AMP was launched in February 2014, with projects in three disease areas: Alzheimer’s, type 2 diabetes, and the autoimmune disorders of rheumatoid arthritis and lupus. In January 2018, an AMP project on Parkinson’s disease was also launched with nine partners. The partnership seeks to identify and validate promising biological targets for therapeutics and ultimately increase the number of new diagnostics and therapies for patients while reducing the time and cost of developing them.

“Increasingly, we are seeing regulatory and governmental authorities keen to foster collaboration in areas such as identifying biomarkers and translational research, especially around rare diseases,” said Breen. “Our people learn a lot from being involved in an effort with other world experts.”

There are important differences in the approach and mindset required when working alongside, in many cases, dozens of other biopharma companies that have been brought in to lend expertise. In such cases, Takeda does not have direct control over the objective, the data, or the intellectual property. “Sometimes we have a financial investment, but more often our ability to exercise influence depends on what we are contributing, whether that be know-how or data,” said Breen.

“As participants in these public-private partnerships, we need to understand the problem from the perspective of other stakeholders and work together for mutual benefit. This requires a flexible, adaptive mindset and not everybody can be successful.”

Takeda is not alone in these public-private partnerships. Other ASAP members that are part of AMP include global members Janssen, Lilly, and Merck, and corporate members Celgene, GlaxoSmithKline, Pfizer, and Sanofi. This promises to be an important area of expanding cooperation and collaboration between multiple entities, public and private, so expect to hear more about these disease-fighting efforts.

Tags:  Accelerating Medicines  Accelerating Medicines Partnership (AMP)  and Merck  Celgene  collaborations  GlaxoSmithKline  Innovative Medicines Initiative (IMI)  Janssen  Lilly  Pfizer  Public-Private Partnerships  Sanofi 

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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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How Merck and Pfizer Build Alignment and Navigate Complexity: A Transformative Alliance on a Journey of Oncological Discovery

Posted By Genevieve Fraser, Friday, September 21, 2018
Updated: Monday, September 17, 2018

There were some cultural differences to overcome when in 2014 pharmaceutical company Pfizer joined forces with biopharma company Merck, selling its sharing rights to develop an experimental immunotherapy drug to accelerate progress against some of the most difficult-to-treat cancers. The alliance paired an American behemoth, Pfizer, founded in 1849 in Brooklyn, New York, with Merck, a German-based multinational corporation, founded in 1668 (no typo).

 

 To drive alignment in their complex partnership, Pfizer and Merck utilize a “divide-and-conquer” approach, as explained by two of the companies’ alliance leaders during a session at the March 2018 ASAP Global Alliance Summit in Fort Lauderdale, Florida, USA. Discussing their experiences “Navigating and Effectively Managing Complex Alliances between Large Biotech/Pharma Organizations,” Judy Baselice, Pfizer’s director alliance management, and Brian N. Stewart, CA-AM, director alliance management at Merck KGaA, Darmstadt, Germany, described how the Merck-Pfizer partnership uses five main tools for keeping the alliance on the same page.

  • Divide and conquer – Six alliance managers with divide and conquer responsibilities with different alliance committees, working groups, and other activities.
  • Distribute monthly dashboards – Capture everything from development and commercial activities to changes in manufacturing, medical affairs, and a snapshot of competitors; distributed to everyone from senior leadership to project management, so everyone knows what’s going on.
  • Invest in coordination and jointly chair meetings – What are the issues and activities and what’s coming up next? Discuss what was agreed to coming out of the gate.
  • Use available technologies – Exchange information from a review of clinical development to the use of federated calendars (meaning you type in a name and availability shows up).
  • Refer to guidance included in the contract – these are your guidelines for final decisions.

The matrix of what the alliance looks like includes co-administrated studies, co-promotion and co-commercialization agreements, a dedicated alliance management team, reports and global marketing with the alliance general manager, as well as target goals for external partnering. Management tools include a SharePoint site, calendars with a pull-out archive section, and regional groups, all of which added to the complexity of the alliance. Of course, what they needed when they launched was to recruit patients, to get the study readouts, and to receive notifications when there were significant changes.

 

External alliances that were outside of the core alliance involved collaboration agreements. Each involved incremental complexity—three- to four-way agreements, extended research and collaboration agreements within the compound, as well as assets that the teams did due diligence on. There were also alliance and third-party signed agreements to move forward, along with standalone agreements not part of other overall agreements.

 

“These separate agreements add additional layers of complexity with each deal we do,” Baselice stated. “Not every one of these partnerships will look alike. We also declined opportunities and had to determine which molecules were not ready based on a need for additional data.”

 

“We co-funded funded fifty percent of each trial as well as each organization’s legal team review of IP clauses. It can take six to 12 months per project,” Stewart added. “Also, we needed to educate both companies on what to do and what’s at risk which involved the future of our alliance in some respects. Effectively managing the alliance matrix is a matter of life or death for some.”

 

“The important thing is to keep everyone updated,” Baselice said. “It was important to be consistent and to avoid confusion. We needed teams to feel there was no need to horde data. We stressed openness and transparency. We have nothing to hide and the goal is to move it forward, share info and foster the attitude that everyone is there for the project. Of course, there are some things Pfizer can do that Merck can’t and vice versa. For example, Merck can go into countries Pfizer can’t, like Iran.”

 

Read more about the Merck-Pfizer partnership and insights into how the two companies’ partnering leaders manage their complex alliance in the August 2018 issue of eSAM Plus.  

Tags:  agreements  alliance  Brian N. Stewart  co-commercialization agreements  collaboration agreements  Complex Alliances  dashboards  due dillegence  External alliances  Judy Baselice  Large Biotech/Pharma Organizations  Merck KGaA  Pfizer  third-party signed agreements 

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