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Riding the Waves with David and Goliath: How a Venerable Big Pharma and a Plucky Little Biotech Sailed Through Storms to the End of the Rainbow

Posted By Jon Lavietes, Monday, October 5, 2020

The ASAP biopharma community is no stranger to big pharma–biotech alliances and David-Goliath partnerships. In general, the story usually centers around an entity with an intriguing molecule accompanied by promising science looking for a partner with deep expertise—and pockets—to help develop the therapeutic candidate into a viable alternative for doctors to prescribe.

Little Biotech Grows Up

But what happens if that ambitious young company eventually wants more? Does its larger ally accommodate its growth and evolution, or is it a sign that the two partners have grown apart? The answer depends on the collaboration—as the old axiom that has been bandied about in ASAP circles seemingly forever goes, “If you’ve seen one alliance, then you’ve seen one alliance.”

On demand now to attendees of the 2020 ASAP BioPharma Conference is the story of one David-Goliath collaboration that successfully navigated—and adjusted to—the little sibling growing up. The session “The Evolution Highs and Lows of a Biotech and Pharma Alliance” shares how the venerable 352-year-old Merck KGaA, Darmstadt, Germany and 13-year-old F-star Therapeutics first started working together in 2011 to explore the latter’s ability to make antibodies and ultimately evolved their collaboration into a complex M&A licensing arrangement in part due to F-star’s transformation from an R&D–focused company to one with bets on a wholly owned portfolio.

Senior Leaders Are a Couple of Blocks Short of Reaching Alliance Heights 

Margarita Wucherer-Plietker, CA-AM, director of alliance management at Merck KGaA, Darmstadt, Germany, began the story by listing six building blocks of alliances as defined by McKinsey:

  1. Strategy – Alignment of partnership objectives
  2. Culture and communication – Open and trust-based communication among all parties
  3. Operations – The establishment of a new operating model and performance metrics
  4. Governance/decision making – Adherence to key decision processes, and metrics for speed of decision making, stage gates, and timelines
  5. Economics – Defining how much value will be created by the partnership
  6. Adaptability – Proactive planning of how to tend to the relationship over time in the wake of industry and organizational shifts

She said that, according to McKinsey, executives tended to be aware of the importance of strategy, governance, and decision-making processes—parts of the organizational machine that C-suite executives are steeped in regularly—to driving alliance success. However, they also had a proclivity to undervalue intangible factors like culture and communication, as well as adaptability. Guess which of these cornerstones proved to be more valuable to Merck KGaA, Darmstadt, Germany, and F-star? (Spoiler alert: senior leaders have it all wrong!)

Data-Driven Mindset Fuels Alliance Growth 

When Sarah Batey, PhD, vice president of project and portfolio management at F-star Therapeutics, started at F-star in 2011, the collaboration was in its infancy with small teams of scientists working with a standard licensing agreement. The parties gelled quickly, finding that they were able to communicate openly and deliver consistently “against well-thought-out, achievable-but-still-demanding work plans.” The companies also found that they were simpatico in that each applied a “similar science and data-driven mindset” to their work, according to Batey.

The trust built over time ended up being a key factor down the road when the collaboration expanded in 2017 to include multiple assets, including the clinical candidate FS118. The collaboration expanded again in 2019 when F-star retained FS118, while Merck KGaA, Darmstadt, Germany, exercised the option for one discovery-stage program and retained the option for a second one. In 2020, the partnership would evolve again in the face of COVID-19 (more on that later) as Merck KGaA, Darmstadt, Germany, exercised another option on an immune-oncology collaboration and the companies added two more preclinical discovery programs. 

Even today, “the collaboration still thrives based on the joint data-driven decision making,” said Batey, who added that the team members rarely consult the contract to resolve a situation, an example of their ability to smooth out differences.  

Jiffy Lube: Seamless Execution of Governance Greases Well-Oiled Machine

How did these two organizations manage this growth? They devised a traditional model, with a Joint Steering Committee (JSC) overseeing Joint Project Teams (JPTs) for preclinical and clinical assets. It would turn out that nothing more intricate was needed because all stakeholders put in the necessary work to make the governance mechanisms function like a well-oiled machine. The senior leaders from both companies who sat on the JSC were well versed on the alliance’s mission and value propositions, and they made themselves readily available for critical discussions. The JPTs were made up of passionate scientists who deftly organized communications and project workflows. They would prepare detailed presentations at appropriate junctures for JSC meetings in order to thoroughly brief the leadership team ahead of moments when critical decisions needed to be made. (This seamless flow of communication between the JPTs and JSC stands in stark contrast to an alliance presented in another BioPharma Conference session that initially struggled to manage what information got delivered to its top committee.)

That isn’t to say that they didn’t have to make adjustments. The smaller F-star wasn’t accustomed to working with larger bureaucratic structures, so the companies agreed to prioritize stage-gate decision-making moments and make sure that alignment was achieved on important details.

On an operational level, alliance managers served as a “central point,” to whom project managers and leads would reach out whenever there was a question about budget, messaging, timelines, or another key element of the alliance, according to Wucherer-Plietker. Alliance managers proved to be effective gatekeepers, as they were able to efficiently facilitate engagement with business development, legal, IP, and other functions whenever they needed to be consulted.

“The key learning here is that a clearly defined touchpoint—a presence in the teams—between all parties and the central touchpoint, alliance management, was very helpful for this alliance to bring projects forward,” said Wucherer-Plietker, who pointed out that the importance of this communication flow contradicted senior management’s underestimation of this building block, as detailed in McKinsey’s findings.  

Stormy Weather and a Sea Change

This streamlined operation helped the collaboration sail through what Batey called “stormy waters” over the last several years.

“Even best laid plans can’t necessarily predict every future eventuality,” she reminded viewers.

The alliance has endured waves created by the departure of key personnel, including champions of the collaboration, and F-star’s evolution from a platform company into an organization with a proprietary pipeline. When F-star was making its move, it approached its partner about obtaining increased development and commercial rights for FS118.

“Ultimately, a change in pipeline prioritization resulted in the program fully reverting back to F-star, while Merck took the rights to an alternative program,” recounted Batey. The sides were able to negotiate a mutually valuable agreement for both sides—Batey called it “the rainbow at the end of the storm.”

The alliance also experienced external turbulence, or “at-sea waves,” said Batey, continuing with the oceanic theme. Like most biopharma collaborations, it confronted changes in the competitive landscape and scientific challenges related to target validation. However, in the presentation Batey spoke mostly about the surfing competition–sized wave disrupting everyone’s sea cruise: COVID-19. The pandemic allowed the parties to take a step back and evaluate the strategy and objectives pf the partnership, as well as what was best for patients. This is when Merck took the early option on the immune-oncology collaboration and added two more.

“In both cases, we really felt that those storm waves were a key trigger to critically review the collaboration and ultimately, in the end, bask in the rainbows. This was due to the strong relationship and trust that we had built. The strong boat was able to face the waves,” said Batey.

Wucherer-Plietker boiled down how the two organizations were able to find opportunities in times of crisis to four steps:

  1. Both parties acknowledged and appreciated that changes in the landscape could potentially cause a divergence in the parties’ interests and viewpoints.
  2. They maintained open communication on common goals and diverging interests as they related to strategic and pipeline changes.
  3. They developed a joint view and aligned objectives vis-à-vis the divergence in their respective priorities that resulted from the crisis situation.
  4. This allowed the allies to put initiatives in place that would help exploit whatever points of value remained in the collaboration.

Communication, Adaptability Turn Crises into Opportunities

To conclude the panel, Wucherer-Plietker preceded a list of key takeaways with the observation that “these building blocks, communication and adaptability, should never be underestimated.” She began the list with the assertion that an alliance is unsustainable without alignment around “high-profile alliance goals.” Wucherer-Plietker added that “these goals can be built and elevated over time.” The second key to success: enthusiastic teams who collaborate closely and communicate openly, not only when times are good but also when tough conversations are necessary. Next, trust, as always, is essential in an alliance. Wucherer-Plietker listed three ways to build it in the pharma context: 1) reliably deliver targets, 2) be transparent and define communications protocols at all levels, and 3) expect and appreciate change to the business and scientific environment over time. Finally, she urged viewers to view change as “an opportunity, not a crisis,” as they represent “inflection points” that could lead to new or reconfigured deals that work better for everyone.

More ASAP BioPharma Conference sessions, both prerecorded presentations and keynotes and panels from the livestream portion of the event, are available at the event’s portal, so check them out now for the latest trends and perspectives from biopharma alliance thought leaders.

Tags:  alignment  alliances  Big Pharma  Biotech  collaboration  communication  culture  Darmstadt  F-star Therapeutics  Germany  governance  M&A licensing  Margarita Wucherer-Plietker  McKinsey  Merck KGaA  operations  partners  partnerships  portfolio  R&D  Sarah Batey  Strategy  therapeutic 

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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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