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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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Academia and Industry—Creating a Seamless Fit (Part Two)

Posted By Genevieve Fraser, Wednesday, June 7, 2017

In the session “Making the Most of Industry-Academia Collaborations,” Mark Coflin, CSAP, head of alliance management at Shire Pharmaceuticals was joined by his colleague, Joe Sypek, PhD, director and external science lead at Shire, as they explored cultural differences between partners in academia and industry working together to find a cure for a disease (see Part I of this blog post) http://www.strategic-alliances.org/blogpost/1143942/277595/Academia-and-Industry-Partnerships-Creating-a-Seamless-Fit--Part-I. Joining them at the 2017 ASAP Global Alliance Summit, “Profit, Innovation, and Value for the Part­nering Enterprise,” were Sanford Burnham Prebys Medical Discovery Institute’s (SBP’s) Paula Norris, PhD, laboratory director and project manager, and Sarah Hudson, PhD, R&D project and operations associate director. The 2017 Summit was held Feb. 28-March 2 in San Diego, Calif.

 

Norris works with principal investigators (PIs) to develop strategic plans for lab operations and policies. On any given project, she might work with four or five partners at a time. Some are smaller start-up companies; others are larger pharmaceutical companies. “In the past, we were grant-centric, but now less so as we work with industries,” she explained. “We explore a partner’s expectations, then go back to our group and discuss what we need to do to make it work. But there’s a language gap with industry. The language in industry is not necessarily the same as ours. So at times, there’s miscommunication. But we’ve gotten better at asking questions about what they mean, especially when we’re not sure [of] what they want or their end goal.”

 

“We’ve spent time working on culture and skill seton education across the institute. For example, what is a hit or lead?” she asked rhetorically. “We need to educate in terms of the basic terms of an alliance partner’s language.”

 

“It’s also important to hone in on expectations. If partners have different expectations, it can cause problems,” Norris stated. “Instead of going off on a tangent, we need to understand the scope and what the goals are and stay focused. Otherwise, we will fail to line up with the milestones. The criteria are only met when the milestone is achieved. “

 

“It can be a challenge if a partner says it’s a ‘no go,’ and we think there is an avenue. We need to remember that the money comes from a partner. If there’s scope creep, we need to draw them back to achieve the milestone. To do that you must have the right people involved and have communicated broadly. You need to define the statement of workmake sure the language is conciseso both parties are clear about what they need to do for the project.”

 

Hudson acknowledged that she and Norris are proud of the innovation and knowledge base of PIs, but to retain the culture, academia must adapt to make industry-academia projects run more smoothly. This only happens if someone is designated as the point person: “It’s quite important for long-term capabilities. A manager makes sure deadlines are met for milestones.”

As the leader of the project manager group at SBP, Hudson’s role is to partner with scientific project leaders in collaborations and initiatives. “These pharmaceutical and biotech companies, as well as alliances with other academic institutions, all have the same flavor but run differently,” Hudson conceded. “So, we do what we must to adapt with projects run by a joint steering committee.”

It’s important not to assume everything is going well, Coflin added.  As in every kind of relationship, the person talking needs to be truthful so that members of the team come to you with issues.  Being a good partner involves communicationsmonthly meetings. “Scientists tend to be reserved so they won’t get scooped. You need to create trust. Labs operate in a silo working by themselves, but to have an effective partnership, you need to work in a collaborative environment,” he said.

 

Scientists need to develop basic alliance management skills, Hudson stressed. “Because we don’t have large infrastructure, it’s important that we impart these skills to scientists so we can be proactive, instead of merely responsive.”

 

Since their groups have been working on alliance skills, both Hudson and Norris have personally seen a difference in greater productivity and efficiency through collaboration as their projects progress.

 

Sypek agrees that things break down when there is a lack of communication. If you are to reach the next level, you need to feel comfortable about talking with partners, he said. “The more you communicate, the better you get. But each project must be treated as individual, as unique, especially if the PI and/or goals are different.”

 

“What you are doing is transformative to an institution, Coflin stated. “Just as we do at Shire, you must prepare your institution to partner. Despite the fact they might be uncomfortable, it’s important to give them tools to be ready to partner. That sort of preparation is how you build capability.”

 

The entire panel then agreed on one axiom: A common goal helps make it work!

Part I of this blog post focuses on Shire Pharmaceutical’s perspective on academic-industry partnerships. http://www.strategic-alliances.org/blogpost/1143942/277595/Academia-and-Industry-Partnerships-Creating-a-Seamless-Fit--Part-I

Tags:  alliance partners  alliance skills  biotech  collaboration  communication  Joe Sypek  Mark Coflin  partner  partner language  partners  Paula Norris  principal investigators  Sanford Burnham Prebys Medical Discovery Institute  Sarah Hudson  Shire Pharmaceuticals  transformation 

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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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