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Lilly, Covance Ilustrate How They Outlined Their Partnership’s “Strategic Future”

Posted By Administration, Friday, June 20, 2014
Originally posted on 11/21/2013

How does a long-term biopharma partnership maintain strategic, operational, and cultural alignment when the rapid pace of change in the industry often necessitates changes in strategy for the respective partners? That’s a question the 2013 ASAP BioPharma Conference opening plenary session “Smooth Sailing in Stormy Seas: Maintaining Long-Term Alignment in the Midst of Change”—a profile of the alliance between pharmaceutical giant Eli Lilly and Company and contract research organization (CRO) Covance, Inc.—sought to answer.

In 2012, the key stakeholders in this five-year-old alliance decided to reevaluate what had up until that point had been a highly successful relationship. Kenneth Carlson, CA-AM, manager of clinical pharmacology study delivery solutions at Eli Lilly and Company, began the presentation by providing a brief overview of the partnership’s history.

Covance wanted to validate its partnering model and perfect its long-term partnership creation model, all the while growing its discovery capabilities. Lilly wanted to transform its R&D model (reduce infrastructure, focus on core activities), grow opportunities in Greenfield and the state of Indiana as a whole, and drive key initiatives, such as shorter timelines to obtaining patents, and enrolling clinical trial patients earlier and faster.

The alliance was harmonious and successful its first four years, hitting its key performance indicators (KPIs). However, dynamics related to the alliance’s portfolio were changing—in a nutshell, conducting clinical trials was coming with more and more complexities as time grew on.

Steven Twait, CSAP, senior director of alliance management and M&A integration at Eli Lilly and Company, talked about an alliance tool that helped the two companies reevaluate their partnership: the “Strategic Futures” Exercise. Twait set the scene by mentioning that two of what Lilly calls the “five C’s”— 1) common purpose, 2) clear purpose, 3) complementary roles, 4) compatible processes, and 5) collaborative relations—were slipping a bit in the partnership, specifically the common and clear purpose elements.

As part of the Strategic Futures process, Twait asked the members of the alliance’s “ClinPharm” (Clinical Pharmacology) Committee to provide their view of the alliance’s three- to five-year objectives, and the obstacles and barriers to achieving those objectives. Carlson and Andrew Eibling, CSAP, global vice president of alliance management at Covance, Inc., spent six weeks synthesizing the answers provided by committee members. The committee dedicated the next one of its quarterly full-day meetings to create a dialogue about these objectives and barriers with the goal of leaving with alignment for a three-year vision, key priorities, and a few guiding principles, which in this case turned out to be flexibility, transparency, not making assumptions, and putting an immediate halt to activities that were not creating value.

Eibling then spoke about the key lessons gleaned from the exercise:
  • Choose the right executive level to work through your issues – In this case, the ClinPharm Steering Committee was the right place to address the growing misalignment in the Lilly-Covance partnership, but Eibling noted that it may be appropriate to implement Strategic Futures higher or lower in the chain when applying it to other alliances.
  • Manage perceptions up front – In this partnership, the perceptions were almost too positive; the two organizations worked together so well it was hard to discern who was from Lilly and who represented Covance, according to Eibling. There is always a need to step back and prepare for the future—even when things are going well.
  • Candid feedback – Setting up a forum that allows individuals working on the alliance to provide unvarnished opinions on topics such as the perceptions of the partner, the alliance, and how the current operational principles could hinder the alliance in the future was essential in the reevaluation process.
  • Get people out of the “day-to-day” and focus on strategy – Set aside a day to focus on the long-term—you can “talk about deliverables tomorrow,” said Eibling.
  • Consideration of progress needs a “steward” – Carlson was appointed the owner of the recommended actions that resulted from the governance committee meeting and making sure there was appropriate follow-up.
  • Not a one-time exercise – This process has to be iterative and must be conducted periodically.

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What’s the Deal? The VC Role in Biopharma

Posted By Administration, Friday, June 20, 2014
Originally posted on 11/21/2013

As the 2013 ASAP BioPharma Conference rolled on through the morning, a panel moderated by Vipula Tailor of Jubilant Life Sciences examined the role of venture capital and deal making in biopharma alliances today. And somewhat like those legendary blind men stationed at various spots around an elephant, the animal looks different depending on where you’re standing.

In “The View from the Dealmakers: Trends in Deal Structures,” Todd Foley, partner at MPM Capital, noted that while the VCs’ role is substantial, their participation in the biopharma and life sciences industry has been shrinking of late due to lower returns, so they’re “trying to figure out how to do more with less.” During times when the IPO window has not been open, they’ve been more reliant on M&A events and getting companies bought. But increasingly, they’re more involved in building companies, signing option deals, and finding ways to share risk between alliance partners.

Still, Foley said, “We have to be very selective in which companies to invest in and how to do that. Venture capital is not patient capital! We have to return money to our investors so they’ll invest in our next fund or we’ll go out of business. So we get very impatient.” Foley added that VCs don’t want to spend another two years waiting for a stalled drug to proceed or have to go back to drawing board. So there’s pressure to “swing for the fences” and try to push a project forward, which may not be best for the asset. This tendency, Foley explained, is not necessarily “VCs behaving badly, but just doing what they need to do.”

Bavani Shankar, from AstraZeneca’s neuroscience group business development and alliance management team, provided a Big Pharma perspective.

“A large part of what we’re doing has changed,” she said. “We don’t have the ‘not invented here’ syndrome anymore. We don’t have all the expertise in-house, and that changes how the deals are structured. Today we’re more collaborative, with VCs cofounding companies, collaborative agreements, option deals as opposed to licenses, working with academia and foundations that operate like biotech companies. Pharma has changed the way we operate. It adds a complexity to the deal structure. But the deal structure is the easy part—the alliance management is the hard part.”

Like other panelists, Steven Damon, founder and CEO of 4P Therapeutics, sought to shift the focus somewhat from the funding itself to how products are developed and how alliances are managed to get the work done. “There’s more than money involved here; we need expertise,” he said.

Even as a VC himself, Foley agreed that more than money is at stake and necessary for success. He cited a need for resources and “brainpower,” which requires “a change of mindset” by both small and large companies.

“For any alliance to be successful, there obviously has to be a cultural fit,” added Shankar. “One of the things we have learned is if there isn’t synergy in the way we think a program should be run, the ‘soft touch’ is important. You can have a technical success but a true failure on the alliance side. [In addition,] you always need a champion. It could be the best project, the best deal financially, but if you don’t have a champion, it’s not succeeding. You have to have momentum internally, all the way up to executive management. You have to manage a very different animal, a third party who may have very different ways of working than you do. So it may be good for the business development person to stay on as the alliance manager until you reach a steady state.”

This continuity of personnel and a focus on alignment of objectives were also cited as key to the success of such alliances. “The old-school model of continuous handoffs really doesn’t work that well,” Foley acknowledged.

Damon added that “large-company objectives may not be aligned with the success of the asset and moving it forward,” and Tailor as moderator noted that objectives for a particular asset are needed along with the higher-level objectives the companies have. “Sometimes a party’s focus is on closing the deal, not on what happens after the deal is done,” she said.

In the end, said Damon, whether you’re a VC, a small biotech, or a Big Pharma company, “you have to understand the motivations and structure of the deal and who’s running the show.”

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View of Alliance Management from Ipsen’s Exec Suite Is Sunny

Posted By Administration, Friday, June 20, 2014
Originally posted on 11/21/2013

The 2013 ASAP BioPharma Conference’s opening plenary rolled on with the plainly but appropriately named presentation “The View from the Executive Suite: Expectations of Alliance Management in the Current Industry Environment” delivered by Christophe R. Jean, executive vice president of strategy and business development at Ipsen.

Ipsen’s alliance practice, which was profiled in the inaugural issue of Strategic Alliance Magazine in 2011, has always “baked in” alliances into its company strategy rather than “bolting them on,” as the old saying goes.

Jean himself characterized himself, and by extension his peers at Ipsen’s C-Suite, as “always a very strong supporter” of alliance management. Its practice has helped the company with its larger strategy shift from being focused on the French market in a few disease areas to one with high growth in emerging markets such as China and Russia and a significant presence in specialty care, which accounts for 75 percent of Ipsen’s sales.

Since that Strategic Alliance Magazine profile, Ipsen has changed its organization model a bit. Central to its strategy: “Produce as many relevant proof of concepts as possible,” said Jean. Alliance management is aligned across the company’s therapeutic areas—endocrinology, oncology, and primary care. As is becoming more and more common in biopharma alliance management, Ipsen has implemented a Center of Excellence to provide alliance support to the employees from the other functions of the company who may not be familiar with the discipline’s tools, practices, and thinking.

Ipsen’s finance department plays an active role in its alliance success, helping align everyone in the organization with the “same set of data and KPIs” for alliance performance, according to Jean. “Umbrella teams” help get the inevitable few executives that are not engaged in the alliance’s affairs involved and up to speed. A “business sponsor” is appointed to serve as a champion for each alliance and to eliminate the mentality that issues that arise in an alliance are “just the problem of the alliance manager” within the rest of the organization.

The Tough Act of Stabilizing an Alliance

Stability is difficult to achieve—and fleeting when you achieve it.

“Take a picture of that moment, frame it, because I’m sure it won’t last very long,” said Jean, speaking of instants in which you find relative steadiness.

Jean outlined a few principles Ipsen tries to embody in its alliance practice, including:
  • Internal alignment – the company “speaks with one voice to the partner,” said Jean. “There is nothing worse than giving [the partner] different messages.”
  • Constructive communication – don’t point to the problem. Solve the problem.
  • Help the organization understand the partnership – Jean acknowledged this can be difficult at times for alliance managers. Sometimes management interprets the representation of the partner’s point of view as negotiating on the partner’s behalf. It “makes the job [of alliance management] interesting,” said Jean.
In addition to these values, building partner intimacy and trust is also a core component of steering through the turbulence that comes with an alliance over time. To do this, your organization has to detect what Jean called “weak signals”—whether they are hard metrics, such as disappointing sales, or “soft” characteristics. Providing an example of the latter, Jean recounted how one partner viewed Ipsen’s operating style as “very French.” The alliance team had to figure out what that meant and surface the partner’s underlying assumptions implied by such a comment. Failure to nip these “weak signals” in the bud, and mistrust can fester.

“Creating trust is a long process. Destroying trust is an immediate process,” said Jean.

Growing the Professionalism of Alliance Management

Implementing the Center of Excellence to help spread alliance management principles throughout the organization is one piece of evidence of the growing professionalism of the profession. More significant, according to Jean, alliance training will be incorporated into core management education in the near future; every business manager will need a grasp of alliance concepts to achieve the organization’s daily desired results, according to Jean.

Judging from Jean’s talk, this is one of the reasons alliance management will earn more respect in the business world. The competencies of alliance management are skills that usually make people successful in “higher managerial roles,” he said. Alliance professionals have a “transversal and thorough view” of a lot of aspects of a company’s business, he added.

There is more good news for the future. The trend towards multiparty alliances, coupled with the move to integrate alliances more downstream in the organization are resulting in the dissolution of the “not-invented-here” syndrome and spurring more and more collaborative innovation.

“The Area of alliance management is a good place to be today,” Jean concluded.

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Getz Keynote on Drug Development Alliances Kicks Off ASAP BioPharma Conference

Posted By Administration, Friday, June 20, 2014
Originally posted on 11/21/2013

After ASAP chairman of the board Russ Buchanan introduced new ASAP CEO Mike Leonetti and following opening remarks by Program Committee chair Jan Twombly, the 2013 ASAP BioPharma Conference jumped out of the starting gate with a keynote address by Kenneth A. Getz, founder and chairman of CISCRP and professor and director of sponsored research programs at Tufts University School of Medicine, entitled “Changing Dynamics in Drug Development Collaborations.”

Noting that “this is the 50th anniversary of modern drug development,” with the creation of the randomized controlled clinical trial, supported by the FDA, which led to the development of the period of “blockbuster R&D,” Getz argued that it’s now time to take stock of where we are in terms of drug development alliances. The movement from more transactional relationships to integrated, open innovation alliances, outsourcing of research, and a greater global footprint for drug development was accompanied by high hopes: for lower costs, faster cycle times, and greater efficiency. As Getz said, “We are at the dawn of new alliances and open innovation.”

But the reality has been something different. While the rate of drug and biologics approvals is at a peak, and pipeline activity has grown as well, “where we struggle,” according to Getz, is with legacy business models that largely have remained unchanged for half a century. The costs of supporting drug development rise by about 9 percent per year, and costs have risen 30 percent overall from five years ago. There are smaller market opportunities now as a drug enters the market, which leads to a “terribly high probability of failure in our industry,” Getz said. Only one out of five compounds tested gets to market, and of those that do make it, only one in six will recoup the costs of development.

So why has performance been so elusive? Getz put the blame on entrenched legacy processes, risk aversion, fragmented and poorly coordinated functions, insular culture and operating policies, poor communication and coordination, implementation of changes too rapid to integrate and absorb (such as after M&A activity), and rising scientific, operating, and regulatory complexity.

With a high risk profile, high costs, and long durations before drugs can recoup investment, the upshot is, according to Getz, that “the vast majority of our investment is in failed compounds.” He also acknowledged this as “the low point in my presentation!”

With the rise of alliances between pharma companies and CROs, Getz cited what he called “aspirational metrics”: many in the industry hoped for greater cost efficiencies and shorter cycle times that largely haven’t materialized. What is needed, he said, is to stop seeing alliance partners merely as commodity providers and servers, to break down cross-functional challenges to support the alliance better, and to move beyond “insular opportunities.” Under open innovation, all parties need to be aware of the challenges—and a public that surveys show is largely unaware of scientific research and distrustful of pharma companies needs to be engaged as well.

Getz acknowledged that this won’t be easy, but that it’s very necessary to bring all parties together to work on the problem and to think differently given the complexity of today’s biopharma alliances and the exigencies and risks inherent in the market. “This is a very difficult thing to do. It requires looking over the landscape collaboratively.”

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Ruben Garcia Santos, Scott Kruglewicz Earn CSAP Designation

Posted By Administration, Friday, June 20, 2014
Originally posted on 10/31/2013

In the past few weeks, a key figure in the emerging public-private partnerships (PPPs) arena and a veteran of the IT and technology consulting industry became the latest inductees into the “CSAP Club.” ASAP sends a hearty congratulations to Ruben Garcia Santos, corporate alliance and key account manager with the United Nations Children’s Fund (UNICEF), and Scott Kruglewicz, alliances specialist leader for the analytics initiative at Deloitte Consulting, for taking the steps to brand themselves as senior leaders in our community.

In addition, employees from AstraZeneca, Cisco, Dell, IBM, Lonza, Merck Serono, Mylan, National Grid, Savvis, and USAA recently obtained CA-AM certification. Please congratulate:
  • Jennifer Ames, Cisco
  • Krista Burke, Mylan
  • Geoffrey Collett, AstraZeneca
  • Sally Elshout, Lonza
  • Andrea Gossage, National Grid
  • Ike Irus, Dell
  • Arlene Johnson-Williams, USAA
  • Shane Madigan, Cisco
  • Laura Mealy, Cisco
  • Joe Midtlyng, Cisco
  • Andrea Pare, IBM
  • Maria Pere-Perez, Savvis
  • Maia Popova, Merck Serono
  • Kenneth Price, AstraZeneca
  • Steven Ritchie, AstraZeneca
  • Sara Weber, Cisco

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