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Pharma Alliance Leaders Making Adjustments to a Virtual, Stay-at-Home World

Posted By Michael J. Burke, Tuesday, April 28, 2020

During the COVID-19 crisis, it’s been heartening to see how many pharmaceutical companies—including a representative number of ASAP members—have stepped up their efforts to work toward vaccines and medicines to treat the virus, including partnering with one another and with government to speed up the processes of research and development, all while trying to keep regular manufacturing and supply operations going so that lifesaving drugs continue to reach patients who need them.

But as is true for all of us, the coronavirus has thrown significant obstacles in pharma companies’ path as well: Almost everyone is working from home, supply chains have been interrupted, sales reps can’t see physicians, and some companies in the biopharma ecosystem are already feeling the pain of financial distress.

So how are pharma alliance management groups coping with COVID? How are their teams communicating internally, reaching out to partners, and moving projects forward in the face of these hurdles?

Different Times, Different Strategies

That was the subject of an April 21 ASAP Netcast Webinar, “Alliance Management Practices in a Virtual World for Pharmaceutical Executives.” The four panelists were among the crème de la crème of big-pharma alliance leaders: Harm-Jan Borgeld, CSAP, PhD, MBA, vice president and head of alliance management for Merck Healthcare KGaA; Mark Coflin, CSAP, MBA, vice president and head of global alliance management at Takeda; David Thompson, CSAP, chief alliance officer at Eli Lilly and Company; and Steve Twait, CSAP, vice president of alliance and integration management at AstraZeneca. The webinar was moderated by Michael Leonetti, CSAP, president and CEO of ASAP.

As Leonetti noted at the outset, “We are in very different times, and different times require different strategies.” Accordingly, the four alliance leaders shared their strategies and thinking in a number of areas, from keeping their teams humming along internally to communicating with partners to monitoring supply chain and manufacturing issues.

Thompson observed that we’re currently living through a “worldwide inflection point,” a phenomenon not seen “since probably the 1930s and ’40s, where the entire world is experiencing something at the same time.” Twait concurred: “This is my 20th year in the alliance management space and I can say I have never seen anything quite like this before. COVID-19 is providing us with challenges I don’t think any of us ever anticipated.”

Buddies, Backups, and Break Times

Borgeld said one of the first things he and his colleagues at Merck in Germany did was to look at what would happen if alliance managers could not fulfill their duties, for whatever reason. So they created “a buddy system, where every alliance manager has a backup—even me. A member of the leadership team is my backup in case I would not be able to function. Also the partners have been informed of this backup system, so they know there’s always someone to contact.”

In this new world, alliance executives and their teams have had to figure out how to hold internal meetings virtually—and how often and for how long—how to carry out alliance governance, and how to interface with partners when everyone is working remotely and none of these activities can be done in person. Some of what they’ve done has changed over time already—going from two meetings a week down to one, for example, having shorter meetings, or making the meetings last only 45 minutes instead of an hour, both to give people a much-needed break that they might have formerly used to walk down the hall and “grab a cup of coffee,” as Twait put it, but also to allow for some “unstructured chat” time, in Thompson’s words.

In addition, half-day or full-day meetings across multiple time zones around the world have in many cases been condensed down to one- or two-hour videoconferences, which allows greater focus and prevents “virtual meeting burnout” while being “respectful of time zones,” as Coflin phrased it—especially important when partners and/or team members may be spread out across the globe.

There’s good and bad in this virtual situation, according to Thompson. “The upside of course is there’s a time savings, the downside is you’re not getting that human interaction,” he said. “You have to be more cognizant of how you’re going to structure your agendas for the meeting to get the most out of it.” Another positive that Twait has observed is that videoconferences today give us a window into each other’s lives—including children, pets, decorations in home offices or other rooms—and these help to build “interpersonal trust” in a way that wasn’t necessarily done pre-COVID.

Borgeld emphasized that while some of the same problems and issues arose before the virus took hold, now it’s even more critical to anticipate and address them, whether it’s coworkers who are trying to multitask and get work done while managing children at home, or partners who may be experiencing financial distress. In the latter case, he recommended, “Seek the dialogue early—it’s not important that you open the books. Focus on the alliance itself: what do we need to do? Come early, discuss it, and try to find a solution.”

Problems, Solutions, and Opportunities

Solutions can be hard to come by, especially where coronavirus is concerned, but more than one of the panelists mentioned the resourceful, flexible cooperation and collaboration between various biopharma organizations, leading to more partnerships and, hopefully, effective treatments and vaccines down the road.

“One of the things that’s very encouraging is the number of partnerships that are springing up all over,” said Twait. “Not just between pharma and pharma—we’re all working together, and many of those interests are around COVID. I’m seeing pharma to biotech, pharma to academia, pharma and others to nonprofits—partnerships of all types.”

Coflin backed up that assessment: “In this current environment where we’re looking for solutions on an urgent basis for humanity, there’s a lot of external innovations and partnerships that are rapidly forming, amongst companies, together with regulatory authorities, NIH, you name it. Everybody’s pulling together to find some solutions.”

Twait emphasized viewing the crisis as a chance to potentially change how things are being done for the better. “I try to look for the opportunities that are coming out of this, and it feels like now is the perfect time,” he explained. “What COVID is allowing us to do is to ask the question: Can we move faster, and are there ways to accelerate? It’s a great opportunity to use this burning platform and the urgency that we have to really challenge inefficiencies and change some of those internal and external processes.”

Shining Examples

Thompson advised looking at alliances with an eye toward contractual obligations, as well as the risks that may be triggered if those are left unfulfilled. “I would really recommend to everybody,” he said, “to do a thorough read of each contract: to go back through and with the lens of the business, human, and legal uncertainties and risks, foresee what’s in the contract, identify and begin to engage with the partners in a discussion now. To me that has been one of the most helpful exercises we’ve done, and also has allowed us to engage in productive discussions, because we’re identifying early the things that the contracts are pointing to. Regardless if you’re in or out of our industry, anybody who’s got a contractual relationship with anybody, that is worth doing.”

Coflin also mentioned being aware of potential supply issues, which can be dicey at a time like this. “The supply continuity is critical to the patient,” he acknowledged. “These are lifesaving medicines in some cases. So we look very carefully at the supply chain, and have since the very beginning of COVID-19, looking not only at the current inventory but also…where it’s sourced from—in some cases China, [or] Italy, and others where we’ve run into a very challenging situation with logistics. The amount of flights is less than it used to be, including cargo, so it is something that requires constant evaluation of risk and constant discussion with our partners.”

Asked for final thoughts, Borgeld gave this exhortation: “Focus on your team. Make [it] so that they can shine in this difficult environment. It’s an environment where there are challenges, and that has to be recognized. Focus on the team, make sure that the team feels that [its] needs are addressed.”

After the four panelists had answered a number of questions, both from Leonetti and the large audience sitting in on the webinar, Leonetti thanked them for sharing their insights and experiences. “You are a shining example of our community, our willingness to collaborate with each other, and our willingness to help share best practices that ultimately make us better partners and better future partners,” he said. “I can’t thank you all enough for bringing this forward and helping to keep our ASAP community alive during these virtual times.”

Tags:  academia  Alliance Leaders  alliance manager  AstraZeneca  best practices  biotech  COVID-19  David Thompson  Eli Lilly and Company  Harm-Jan Borgeld  manufacturing  Mark Coflin  Merck Healthcare KGaA  partnerships  Pharma  Pharmaceutical Executives  Steve Twait  supply chain  Takeda  virtual 

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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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