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The Benefits of Sponsor and CRO Collaboration—from Leveraging Innovation to Sharing Patient Information

Posted By Cynthia B. Hanson, Saturday, October 17, 2015

For many years, Contract Research Organizations (CROs) have sought to move beyond their role as fee-for-service providers and branch out into strategic alliances with pharmaceutical companies. These emerging services alliances pattern to some degree the partnerships that pharmaceutical companies form with biotech firms and with each other—but there are differences too. This CRO/Sponsor evolution became a talking point on Thursday, Sept. 10 at the 2015 ASAP BioPharma Conference in the session “Enabling Innovation and Value Creation in Sponsor/CRO Collaborations.” Moderated by Doug Williams, business development consultant at BioDigital, the discussion addressed the benefits in two partnering mini-presentations: Covance/Eli Lilly and Company and EMD Serono/Quintiles.

 

In 2008, Lilly and Covance created a groundbreaking 10-year strategic agreement that spans the drug development process, explained Andrew Eibling, CSAP, global vice president and alliance manager at Covance, about the history of the partnership.  “It involved working across the spectrum and various silos of drug development.”

 

Today, Covance has a highly successful cardio vascular partnership with Lilly. At the beginning, it required lots of fine-tuning, because in the rush to get started, they missed out on some crucial steps, recalls Jay Turpen, senior director of clinical laboratory operations at Lilly.

 

“First, we got the right people together to frame out how we were going to work together. It’s so crucial to invest in defining the process: how to communicate, what hand-offs look like, handling escalation. There were skeptics from both companies, so we took time and invested in kaizan events to determine the likely areas where there was the most friction in the program, and invested proactively in those areas,” he added. “Creating a culture of one team with one approach and applying alliance management was successful, and we were able to enroll the study in less than … the scheduled 24 months, and it was 98-99 percent clean through the process.”

 

Then there was a second added valuepartnering on laboratory research. “What’s in the best interest of both Lilly and Covance as we build this new lab system? What information is in our mutual interest?” they asked. “We got literally thousands of people working on these alliances. There needed to be common linkages across those silos,” Turpen added. The central labs group started a unique rewards recognition program. And they reached the point where they now pass patient information back and forth.

 

The final results? “Lilly’s CEO said that it was the best study the company has ever done. It was a high five, a best practice, a solid metric for what a great job that team did,” said Eibling.

 

In the case of EMD Serono/Quintiles, Quintiles’ clinical development division wanted a CRO who got involved early in clinical stages sitting at the development table. The companies also were looking for processing standards, high benchmarks, and most of all, innovative minds at the boardroom table. They signed a partnership with EMD Serono in 2013, and the CRO became a partner in drug/biosimilar development.

 

“Clinical development is challenging because how do you persuade patients and physicians to join a trial? Or are you going to fall back on biosimilar drug development?” Those were some of the key questions raised by Raymond Huml, DVM, executive director of strategic drug development and head of global biosimilars strategic planning at Quintiles Biosimilars Center of Excellence, and Louk Pechtold, CA-AM, directoralliance management biosimilars, in the biosimilars unit at Merck Serono SA. 

 

Biosimilars are follow-on copies of originator medicines made from living tissues (e.g., monoclonal antibodies). The question of biosimilar drug development is increasingly important because by 2020, some $100 billion of original biological medicines will lose intellectual property protection.

 

They also addressed the question of how alliance managers factor into drug/biosimilar development. “We have upper management, middle level, and closer-to-the-ground alliance management. There are alliance managers that look over entire portfolios, but at the end of the day, you need someone who understands the differences or subtleties. And there are differences with biosimilars,” explained Pechtold.

 

“The main value in collaboration is leveraging innovation from one partner to another,” Huml added. Regulatory experience is a plus, and having a global reach can be an advantage. “Those with experience working with multiple companies also have an advantage over one-on-one,” he concluded.

Tags:  Alliance Management  Alliance Managers  alliances  biotech  Collaboration  Contract Research Organizations  Covance  CRO  drug/biosim  Eli Lilly and Company  intellectual property  Louk Pechtold  Merck Serono SA  pharmaceutical companies  Quintiles Biosimilars Center of Excellence  Raymond Huml  strategic alliances 

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Can Your Partners Dance with the ASAP Stars? Perhaps It’s Time To Consider a 2016 Alliance Excellence Award Submission

Posted By Cynthia B. Hanson, Tuesday, October 13, 2015

Submissions are being accepted through November 18, 2015 for the 2016 ASAP Alliance Excellence Awards to be presented at the ASAP Global Alliance Summit, “Partnering Everywhere: Expert Leadership for the Ecosystem,” March 1-4, at the Gaylord National Resort & Convention Center, National Harbor, Maryland, USA.  The awards are an opportunity for partners to strut their stuff, display innovative moves, and demonstrate leadership with new models and approaches. They are a way of honoring alliance programs for a range of advances—from social impact to increased revenue to advancements in the profession.

 

Corporations, mid-sized enterprises, start-ups, and public-private initiatives are welcome to submit in the following categories

 

The Individual Alliance Excellence Award is given to a company that has excelled in planning, implementation, and results for a single alliance. The alliance may be between two companies or multiple organizations in the category of small-to-midsize company alliance and/or emerging alliance. This year’s winners were National Grid and Earth Networks for their innovative alliance that brought weather monitoring stations and programs to communities and public school STEM programs in New England.

 

The Alliance for Corporate Social Responsibility Award is for partnerships that make a profound, measurable, and positive social impact. The principal objective of the alliance is social impact, not profit—although profit, especially if used to fund program expansion, is not discouraged. The Dow Chemical Company and The Nature Conservancy received the award this year for a partnership that created a sustainability model that can be used by corporations integrating the value of nature into business decisions. 

 

The Innovative Best Alliance Practice Award is presented to a company using new, individual alliance management tools or processes that have an immediate and powerful impact on the organization and/or discipline of alliance management. These tools or processes are not comprehensive alliance programs but additions to existing alliance practice that address specific elements of alliance management, such as measurement, training, conflict resolution, general communication across-the-partner ecosystem, or similar facets of the discipline. Philips won the award for an innovative two-step approach to create a joint brand identity for a partnership. Janssen—Pharmaceutical Companies of Johnson & Johnson received honorable mention.

 

The Alliance Program Excellence Award is given to organizations that exceed expectations by consistently implementing and managing alliance portfolios and demonstrating consistent success of those alliances over time. Winners build programs on creativity, efficiency, an integrated suite of processes, tools, professional development/alliance professional certification, and other elements. Takeda Pharmaceuticals received the award for creation of its progressive Center of Excellence (COE). Bayer was given honorable mention.

 

The awards submission process has been further streamlined this year. For more information on the 2016 ASAP Alliance Excellence Awards and how to submit an application, go to: www.asapweb.org/awards

Tags:  2016 ASAP Alliance Excellence Awards  alliance management  alliances  Bayer  Earth Networks  eco-systems  Janssen  National Grid  Philips  social impact  STEM  Takeda Pharmaceuticals  The Dow Chemical Company  The Nature Conservancy  tools 

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The Final Handshake: What’s an Alliance Manager To Do When the Time to Terminate Comes?

Posted By Cynthia B. Hanson, Thursday, October 8, 2015

Best practices can be just as important in the final stretches of a partnership as they are when development and trials are proceeding apace or the revenue stream is peaking. How to gracefully negotiate that last stretch before the parting handshake was the focus of “The Graceful Exit: Preserving Value and Relationship at the End of the Lifecycle” presented at the 2015 ASAP BioPharma Conference on Sept. 10 by Diana L. Brassard, CA-AM, of external partnerships at Basalta US Inc., Mark Coflin, CSAP, senior director of alliance management global business development & licensing, bioscience, at Baxalta US Inc., and Julia Gershkovich, head of US R&D alliance management at Sanofi.

 

Good preparation for terminations preserves companies’ reputations and secures future opportunities. “Preparation is critical,” said Gershkovich. “If a partner decided to terminate, the project team may not be already there. When you get to the termination point, all internal stakeholders need to be aware and agree on this point. There needs to be respect toward the partner and transparencya lot of times we are dealing with smaller companies, and it means a lot to them.”

 

“One termination that comes to mind was with a Japanese company that was well-prepared and respectful,” recalled Coflin. “We thought about how we were going to communicate with them and how to deliver the message, including whether we should be meeting with them face-to-face. It needs to be done in mutually respectful way, because there might be future business.”

 

The termination process often is very long and termination activity can take two years, observed Brassard. “There is a need internally to lock in and assure that you have resources, budgets assigned, and clarity with respect to senior leadership and with respect to obligations.”

 

Go through very defined, structured procedures, followed by putting together a table for when the transactions would go throughbefore the termination is completed, she added. “This is all very important for business development and legal procedures, and eventually for resource allocations to maintain the core team.”

 

When is it appropriate to wear more of a project management hat as an alliance manager during the termination process? “There were one or two projects where I played both roles,” said Brassard. “When things started getting more negative, and the data coming in was negative, there was a decision that the alliance manager was going to take more of a key role. The alliance management best practices were not complimentary to each other, so it was very helpful to have project management tools. A lot of what I was trying to do was maintain a respectful relationship.”

 

“I was fortunate in most of my cases,” added Gershkovich. “I had project managers working with me, and they were great. We had to deliver the messages, and in one case it was clear that it was mutually understandable because the data didn’t work out. But in another case, we had to go to district resolution to stop the program, and we were still able to continue the relationship and preserve the value.”

 

A smattering from their list of dos and don’ts:  

  • Let partners know as soon as possible.
  • Map out a communication plan.
  • Meet regularly.
  • Get together with legal stakeholders, and go through the legal provisions of the contract.
  • Be aware of cultural differences, sensitivities, and time zones.
  • Negotiate in a way where value is preserved; present it in a way that they can take it right away.
  • Intellectual property is importantbe prepared that all checkpoints are done.
  • Prior to a termination notice, communicate with your partnerthe process is so much easier with good communication if the program doesn’t work out.
  • Include public and investor announcements, but if a company may go bankrupt and/or the product may be taken out of the pipeline, minimize the announcement.
  • Craft the termination carefully, and keep in mind there may be ongoing studies.
  • Don’t assume your partner is going to be as organized and experienced as you are.
  • Don’t assume they have plans for receiving the asset that you have made.

Tags:  2015 ASAP BioPharma Conference  alliance management  Basalta US Inc.  Baxalta US Inc.  Best practices  communicate  Diana L. Brassard  Julia Gershkovich  Mark Coflin  partner  partnership  project management  Sanofi  stakeholders  terminations  transparency 

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Balancing Mega-sized Collaborations Requires a Three-Legged Stool: The Broad Institute’s Take on Managing Big Partnerships

Posted By Cynthia B. Hanson, Thursday, September 17, 2015

Partnerships come in all sizes. The Eli and Edythe L. Broad Institute of Harvard and MIT, however, significantly tips the beam with its industrial-scale platforms and collaborations that seek to pioneer a new model of biomedical science.

“The Boston-Cambridge nexus makes it possible,” explained Stephanie Loranger, PhD, director of project planning and execution at the Broad Institute, during her talk “Managing the Three-Legged Stool: Science, Compliance and Alliance” on Friday, Sept. 11 at the 2015 ASAP BioPharma Conference. “The fundamental goal of the Institute is to take on high-impact, multidimensional projects that are too difficult to take on by a smaller lab. Sometimes the projects are contained in one program, but they usually stay in multiple platforms and programs.”

The mega-projects range from government collaborations (including entities such as the National Institutes of Health, Department of Defense, and National Science Foundation) to philanthropic organizations (such as the Carlso Slim Center for Health Research, Klarman Cell Observatory, and Stanley Center for Psychiatric Research) to corporate projects with companies like Norvatis Pharmaceuticals, Roche Diagnostics, Bayer Pharmaceuticals, Calico, and Googlea new collaboration.

 

The Broad Institute also has operating agreements with neighboring organizations such as Harvard University, Mass General Hospital, Brigham and Women’s Hospital, and the Dana Farber Cancer Institute. Its board of scientific counselors includes three Nobel laureates and its programs contain hundreds of researchers. Platforms range from genomics known for world-class sequencing to proteomics to genetics perturbations, where they run massive crisper screens.

 

“What is unique about these projects is that they are run by scientists who have their own grants and are pushing the boundaries of these platforms,” she explained. “They augment the creativity of scientistswhat they can’t do in their own labs can be done there.”

 

The Institute has a three-legged stool of essential components for execution of large, multi-programmatic collaborations within the ecosystem, she said. It requires balancing

  • Science management and execution of world-class platforms
  • Compliance managementmeeting budgetary, IP, reporting, and legal obligations
  • Alliance management of very large institutional partners that need major coordination

This last leg of alliance management is new to the Broad Institute“a different beast that we have not dealt with before,” she pointed out. “We don’t have an alliance management team. We have people who play roles of alliance manager. It really depends on the collaboration and who is our partner.”

 

Practically, what does this mean in relation to the Broad Institute? she asked.

  • Access to large, multifaceted datasets that one organization/collaboration cannot fund alone
  • Access to unparalleled cross-functional and cross-institutional research
  • Rapid acceleration and translation of emerging knowledge and novel discoveriestherapeutics is the big in plan for next 10 years

Tags:  Alliance management  Broad Institute  collaborations  Compliance management  cross-functional  cross-institutional research  genetics perturbations  genomics  Partnerships  platforms  proteomics  Science management  Stephanie Loranger  therapeutics 

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Overcoming the Curve of Conviction: How to Increase Value by Getting from Negotiation to Collaboration

Posted By Cynthia Hanson, Friday, September 11, 2015

“To Collaborate or Not To Collaborate?” That is the question Mike Berglund, CA-AM, alliance director at Eli Lilly and Company, asked the audience at the 2015 ASAP BioPharma Conference held Sept. 9-11 at the Revere Hotel off the Boston Common.  “Are We Negotiating or Collaborating? Increasing Alliance Value through Collaborative Decision Making” was the topic on stage as Berglund prompted the audience to consider three case scenarios that presented alliance management challenges when working with partners.

 

Decision-making roles are complex, especially in alliances, and become even more complicated when the decision is intricate or embedded, Burglund emphasized. “You as individual have certain attitudes, beliefs, and values that effect how you make decisions. It is a lot easier for me to ask if you will go out and buy a loaf of bread vs. change a specific brand of car or attend a different college. You willingness to change the buying pattern will be different.”

 

How to get to collaboration in a world of culturally entrenched views, tastes, and opinions is one of the challenges alliance managers face in the decision-making process, he indicated. Its about the Conviction Curvea framework of personal buying perspective: “In the alliance world, where you are in this curve will dictate how likely you are to change. If you are going into a governance meeting, the further to the right [on the Conviction Curve] you are, the more difficult it will be to change that position and the more resources and energy it will take.”

 

It’s like a sculptor molding a lump of clay, he added. At first, he or she has the ability to mold it into whatever structure desired, but over time, the clay hardens and becomes more difficult to change. “Working across two companies, with their positions embedded in their respective organizationsit’s hard to change. And you will see that exemplified in alliance management,” he warned.

 

A critical point for alliance managers to consider is the importance of understanding your potential partner and responding appropriately to their behaviors to get to that point of collaboration. Negotiation is all about winning, while collaboration is preferable because its jointly created value that can determine the tone of the relationship, he reminded the audience. Build the alliance from within the alliance and push it outward, he advised. “When you deploy this kind of culture and process, its being organically driven within our organizations.”

 

After challenging participants to consider three very different case scenarios, he asked in one case: “What were the factors that led this alliance to result in a joint decision?” He then drove home the value of using “company pre-meetings to understand your own convictions and then using that information to design the meeting. Choose the right people for the job, make sure that whatever is going into governance meetings has been jointly agreed upon by the parties, and eliminate the opportunity for walk-ins. You really want to limit that discussion, and push it out of governance meeting,” he advised. “Even more important, sit down and talk about company differences. You don’t have to agree, but you need to agree on how you present your different sides,” he added.

 

Then evangelize these norms with the working teams. If you have this kind of behavior in teams, collaboration will be the norm, he concluded.

 

Learn more on this topic in the recently published Q3 2015 Strategic Alliance Magazine editorial supplement article “Choose Wisely: Increase Alliance Value through Collaborative Decision-Making,” sponsored by Eli Lilly and Co. and co-authored by Berglund and Lilly’s Chief Alliance Officer David Thompson, CA-AM.

Tags:  alliance management  alliance manager  alliances  collaboration  conviction curve  Eli Lilly and Company  governance  Mike Berglund  negotiation  partners  pre-meetings 

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