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The End of the Transactional CRO?

Posted By Jon Lavietes, Monday, October 19, 2020

Clinical trials have undergone a bit of a transformation in recent years. Much like what has happened with pharmaceutical manufacturing operations over the last decade and more, clinical trial site management is becoming less transactional and more collaborative. Rather than employing a CRO to manage an individual trial with a firm start and end date in a vacuum, pharmaceutical companies and clinical trial site operators are beginning to engage in open-ended, long-term engagements in which the latter works with Big Pharma sponsors on multiple trials over time. In other words, site sponsors and clinical trial sites now apply a shared vision, open communication, and a dedicated infrastructure to a portfolio of trials, and continually refine their methods using lessons learned from each initiative.

Dimitri Fillos and Jessica Piggee, senior alliance and partnerships leaders at Genentech, pulled back the curtain on one such initiative, their employer’s comprehensive clinical trial program, in the on-demand 2020 ASAP BioPharma Conference session “Strategic Sponsor/Site Relationship-Based Approaches to Conducting Clinical Trials in the Changing Landscape of COVID-19,” and in the process revealed what may be the shape of pharma-CRO relationships to come.

How does a large organization like Genentech manage a long-term, one-to-many engagement with multiple clinical trial sites? Through rigorous relationship management and collaboration, said Fillos. The company operated many clinical trials at once for quite some time, and in the beginning, they were being run in silos. With each trial, scientific groups and functions from all over Genentech and its parent organization Roche would give input to partner sites on a variety of aspects of their respective projects. Within the last decade, Genentech figured out that it could reap larger collective benefits from these interactions if it could establish a top-down view of the entire portfolio. To capture collective trends and insights from all of these trials, alliance managers could function as information gatekeepers of sorts by serving as a central point of contact for both clinical trial partners and the rest of the Genentech organization.

“It can be quite complicated and disjointed in some cases in terms of communication to sites from different teams,” said Fillos.

Onboarding Processes and Startup Kits Get Trials Off on the Right Foot

This new collaborative network needed other staple alliance management practices, such as an onboarding process for new CROs, in which the parties establish mutual goals around capabilities, potential improvements, and performance targets. The topics and procedures pertaining to clinical trial execution dissected in these discussions, such as study design methods, standard-of-care issues, trial designs, disease landscapes, and treatment paradigms, can get very complex. However, in a long-term partnership model, partner sites get visibility into Genentech’s pipeline and thus have more time to address these issues and ready data management protocols in advance of launch dates.

Fillos also outlined some of the broad ways the alliance team delivers core value to the clinical trial operation. It assists in actual trial planning and design by working with appropriate clinical-study personnel to map out efficient processes and communication protocols across multiple functions within Genentech and partner sites. The practice has also built out templates for master agreements, rate cards, and other aspects of clinical trials that have helped streamline operations. Fillos said Genentech now has a study startup kit for its organization and its participating CROs.

Cross-Function Junction: Forums, Scientific Exchanges Continually Improve Program 

Alliance management also plays a big role in smoothing out disagreements that arise over time between parties by serving as the point of contact for initiating disputes in the escalation process. It has also taken on reporting responsibilities by tracking performance metrics and sharing data with internal Genentech and Roche cross-functional teams. Thanks to alliance management, the quality of clinical trial data gets improved and disseminated quicker than ever, and as a result, decisions get made faster in many situations, such as “when you need to look at data as quickly as possible to make a decision to escalate the dose in a phase 1 study,” said Fillos.  

Perhaps most important, alliance management helps aggregate, apply, and share critical lessons gleaned from the organization’s entire portfolio of sites that you wouldn’t get from transactional CRO relationships. The alliance folks also foster valuable peer-to-peer collaboration by organizing “scientific exchange meetings,” in which parties from several research functions discuss key issues, such as how to write more efficient protocols or the impact a recent regulatory guidance might have on sites around the globe.

Genentech has also put together a cross-functional leadership forum, a meeting of executives who are “invested in building out long-term strategic site relationships to support the different areas within their functional groups,” explained Fillos. Forum members represent a wide swath of functions within the organization, such as regulatory, clinical science, bioanalytics, and biomarkers, among others. They examine high-level issues pertaining to risk mitigation, long-term relationship planning, qualitative and quantitative KPIs, and the portfolio’s overall capabilities and support programs. 

“What are the site capabilities for the folks that we have been talking to and working with? Do they fit the needs of our pipeline?” said Fillos. “What are the trends of those molecules? We’re looking at therapeutic areas that are new. Are we going to need to look at patient populations that we haven’t looked at before?”

ARMing Sites and Sponsors with New Ways to Use the Network

Piggee delved deeper into the inner workings of the network model, which now encompasses more than 25 clinical trial sites worldwide. The bidirectional network consists of two pillars: 1) institution-sponsored research—clinical sites designed by partners with Genentech support—and 2) Genentech-sponsored trials that are devised in consultation with partners. A Scientific Alliance Relationship Manager (sARM) works with the first group to develop innovative institution-sponsored trials, while an Alliance Relationship Manager (ARM) focuses on improving trials that originate within Genentech. The sARM and the ARM work hand in hand to coordinate the two groups’ efforts.

The network’s governance structure was created to “ensure internal acceptance and utilization of the network across our teams. The last thing we wanted to do was build out this network and then not have teams utilize it. Obviously, that’s not ideal,” said Piggee.

A cross-functional team of executives from both Roche and Genentech make up an operational committee that monitors the network’s high-level objectives, which change over time. This committee oversees the aforementioned joint clinical operations forum. 

A former sARM and ARM herself, Piggee has seen firsthand how this structure generates additional benefits through deeper engagement and collaboration that wouldn’t occur in transactional relationships.

“The direct link from site to sponsor, and vice versa, facilitates greater communication, timely transparency, rapid resolution of issues,” she said.

With both alliance managers advocating for the alliance, the sponsor and sites are in constant communication, but in a streamlined manner. The sARM and ARM serve as single points of contact for the two larger respective groups and ensure that input from third parties—CROs, vendors, other researchers, etc.—is incorporated without suffering “the downsides of having too many hands in the pot,” said Piggee. The alliance managers can also spot broader trends and issues developing across all two dozen–plus sites and make changes that will keep people utilizing the network.

Not Bad Company, More Like Cream: Supergroups Help Clinical Trial Execution Rise to the Top

The network model has spawned so much free-flowing interaction between all of the sites that the sites themselves are collaborating with one another on initiatives independent of Genentech—“an unexpected advantage” of the model, according to Piggee. This dialogue has encouraged candid feedback about the network itself. Genentech has created “supergroups” co-led by the sARM and ARM that are responsible for cultivating ideas that germinate from those discussions, creating strategies around them, and garnering organization-wide support. These supergroups have created:

  • Comprehensive site capability profiles that help reduce duplicative site selection efforts,
  • A line-of-sight tool that has increased transparency around future studies in the Genentech portfolio, and
  • A process for gathering resources from the network to support outsourced studies.

As part of the network’s relentless focus on process and execution, Genentech instituted a formal operational review board. Historically, study sponsors have often solicited feedback from scientific experts on study protocols, but it hasn’t been common practice for them to seek out similar input on the actual execution of clinical trials. According to Piggee, real-world insight from patients and “the actual operational people doing these studies” helps mitigate protocol implementation challenges, unnecessary contract amendments and deviations, and other roadblocks that could potentially delay timelines. This review board has also instituted measures that have “decreased the burden of clinical trials on patients,” added Piggee.

Game-Changing Forums Help Sites Navigate COVID-19 Protocols

Like everyone else in the world, the network has had to pivot quickly in the face of COVID-19. It has begun to accelerate the adoption of emerging technologies, such as direct data transfer, telemedicine, e-consent, and remote monitoring, in response to limitations created by the pandemic. With the network’s help, sites have been able to make changes that have enabled them to continue oncology trials as COVID-19 continues to roil society. For example, some are now shipping oral drugs directly to patients. Once again, the single-point-of-contact structure has streamlined direct communication to the sites, which site management folks have appreciated—they don’t want a deluge of people reaching out to them about every minute alteration to trial operations.       

Genentech instituted COVID-19 forums, from which sites could learn new processes by observing and interacting with other sites around the globe. Piggee called it a “game changer” for US sites to be able to monitor developments in Italy early on in the pandemic. Ongoing post-forum feedback has shed light on what has and hasn’t worked for other sites, helped sites compare methods for managing the crisis across countries, and ensured consistency in managing patients. With information changing fast, forum members found it useful to disseminate updates through mass network emails.

Fillos and Piggee provided much more background on Genentech’s novel clinical trial network, so if you registered for the 2020 ASAP BioPharma Conference and you are involved in early-stage clinical trials, don’t miss this opportunity to learn how to move away from the transactional clinical trial model. But hurry, the BioPharma Conference portal will only be open until Nov. 13!

Tags:  alliance  clinical trial program  Clinical Trials  collaboration  COVID-19  CROs  Dimitri Fillos  Genentech  Jessica Piggee  Onboarding Processes  oncology trials  partnerships  relationship management  Sponsor/Site Relationship-Based 

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Moving Alliances from a Binary to a Multi-dimensional Ecosystem

Posted By Contributed by: Wissam “Will” Yafi, Founder & CEO – TIDWIT , Wednesday, October 7, 2020
Updated: Tuesday, October 6, 2020

Last year I had a memorable lunch conversation with an alliance vice president of a very large tech GSI. 

“We have had an alliance relationship with this ISV for well over thirty years. It is our oldest and largest,” he said.

“Great,” I said, “How is it going?”

“The strategy and intent are good. But execution could be better,” he answered. “Of our two hundred fifty or so thousand employees, no more than a dozen people actually engage online within the alliance.”

“Don’t you have a way to collaborate at scale?” I asked.

“We don’t really” he admitted.  “Most of our alliance work happens manually over the phone, email, and via Excel sheets.”

I have had conversations with several other alliance vice presidents, most of whom have openly confessed their partnership deficiencies. The symptoms are similar, and are getting worse as markets begin moving quicker, requiring more frequent updates, interactions, and alliance workflows—all of which places more and more stress on already tenuous relationships. 

The fundamental questions are what are the problems at the root of all these symptoms? And can they be overcome? The answers lie within three key factors from my work with a multitude of alliances:  binary (old) paradigm mentality, power plays/lack of trust, and deficient technology. Let’s look at each of these:

The traditional binary-alliance paradigm looks at relationships in simple not complex multi-dimensional terms. An organization that has only one alliance is very different from one that has dozens if not more alliances. Organizations that recognize this of each other are more able to understand the notion that they don’t sit at the center of any universe, but rather belong to one as do other organizations. As a result, they can empathize and collaborate in ways that a binary mentality is not able to.

Partner power plays are a bit more perplexing. When two organizations willingly sign an alliance to work with one another, what is the benefit of jostling for position? In fact, it only leads to distrust. Partners that respect mutual constraints and who work together to try to overcome them are much more likely to succeed in realizing joint opportunities. In a complex ecosystem of alliances, organizations cannot afford to be stuck in one-sided partnerships based on power plays—instead, they need to continuously seek ways to be on equal footing and build trust.

Even when alliances are able to overcome these first two factors in relationships, the next challenge they face is technology. More specifically, finding the proper technological platform architecture to allow them to conduct multi-dimensional alliances not with one but rather with an ecosystem of partners in a way that is standardized, secure, compliant, scalable, and cost effective. A cloud ecosystems network provides just that and solves for a wide range of alliance inefficiencies. A cloud ecosystem network not only allows an organization to connect with a multitude of partners with whom it has alliances, but for it to do so in a streamlined manner that provides it customization, control, compliance, data security, and integration capabilities, not to mention an impressive ROI.

Here are some compelling alliance benefits we have seen in deploying cloud ecosystems to global ISVs and GSIs:

  1. Boosting alliances and increasing the expected user footprint by as much as 800%
  2. Enabling the customization of applications to meet the needs of the organization with all its ecosystem of alliances
  3. Automating alliance processes with apps and workflows that cut across organizational boundaries—no more excel sheets over e-mail!
  4. Providing real time insight and reporting that allows alliances to be on the same page and monitor objectives together
  5. Ensuring PII and GDPR compliance, providing full protection and control over the data of each organization, while sharing what is agreed upon collaboratively and without power plays

Alliances are becoming increasingly complex, requiring more dynamic solutions to meet the ever-changing needs of the market. Going forward, organizations who want to ensure the success of their alliances have to evolve from a binary approach to a multi-dimensional ecosystems approach. They will also have to adopt a more collaborative approach that moves away from a zero-sum-game type of thinking to a whole-is-bigger-than-its-parts approach. And they will have to deploy the proper technology to realize all this and sustain it going forward. Doing all this promises to elevate the alliance from an elementary transactional state to a much more advanced state based on dynamic relationships, enabling instant “at scale” reaction to changing market needs.

This is not just theory; it is happening today.  The vice president who I had lunch with has gone from lightly involving a few handfuls of users to intricately engaging more than forty-thousand users through a cloud ecosystem launched via the TIDWIT network. The evolution to more effective, impactful ecosystems is real.  Are you ready to take the next step?

Tags:  binary-alliance paradigm  cloud  collaborative  ecosystems  multi-dimensional alliances  network  partnership  Tidwit  Will Yafi 

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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 and Tech’s Excellent Adventure: Making the Journey to Digital Health

Posted By Michael J. Burke, Monday, October 5, 2020

The road to digital health has been paved with good intentions: it’s about helping people take charge of their own health and wellness, after all. But it’s been a rocky road as well, and for pharma and tech companies taking the trip together, it’s been at times a bumpy ride filled with pitfalls, detours, and even mutual incomprehension. Nonetheless, there’s great opportunity for those hardy souls brave enough and savvy enough—and patient enough—to overcome the obstacles and stay the course.

This was among the insights gleaned from a fascinating panel moderated by Brooke Paige, CSAP, currently ASAP’s board chair and formerly vice president of alliance management at Pear Therapeutics, where she was deeply involved in digital health initiatives, called “Preparing for the Journey in Digital Health: When Healthcare’s Path Forward Leads Through Silicon Valley,” held on the final day of the recently completed ASAP BioPharma Conference.

So What Is It?

First of all, what is digital health, anyway? According to panelist Christopher Lento, head of healthcare strategic partnerships at Noom, “there are a lot of definitions floating around,” but he defined digital health as “any technology that allows patients to take ownership or engagement of their own care.”

Lento noted that nearly a thousand companies are currently working on digital therapeutics, and another panelist, Knut Sturmhoefel, CA-AM, PhD, global head of alliance management at Novartis International AG and a new ASAP board member, added that there are now many digital/biopharma partnerships. “It’s a broad spectrum of collaborations we’re starting to see,” he said, while cautioning that “we’re all learning at the moment. There’s no one model to manage these.”

That could make digital health a fertile field for the application of alliance management, of course. Lento said that in his experience, digital health often involves smaller teams, companies, and startups, especially on the tech side, and thus cofounders may get involved in managing these relationships. But he thinks there are many instances where it would be great to see a trained alliance manager stepping in and “grabbing control of the relationship” in a helpful way.

“I hope there’s an alliance manager who steps up,” he said. “It looks normal, but we’re trying to get to know each other. If you can get along, you could be on the path to great things. If there’s friction early on, you should probably take a pause.”

Seeing the Elephant

Another panelist, Davina Pallone, vice president for product at Fruit Street, addressed the big elephant in the room: the vast differences in outlook, timelines, and methods between tech or digital companies and those in the biopharma sphere. She noted that the tech side tends to operate with a “fail-fast mentality” derived from agile software development, marked by rapid code release, quick product launch, and ongoing, nearly continuous iteration and improvement of the product.

“It is a mismatch for the life cycle on the pharma side,” she acknowledged. “You don’t ‘fail fast’ with human subjects.” Or, as Lento described the pharma reaction: “What?! You’re changing the product on a daily basis?” Sturmhoefel also added that “quick changes are not what you can introduce in a product” when regulatory agencies such as the FDA are involved.

Thus, as Pallone put it, a tight collaboration and cooperation between the product and regulatory teams is absolutely necessary for success, ideally leading to a “happy medium” where you fail fast, but don’t put patients at risk.

“Fresh Tracks in the Snow”: The Promise of Digital in the Age of COVID-19

Still, because there’s so much opportunity in the area of digital health, “we’re watching so many great things happen,” according to Lento. Companies are engaging in partnerships of all kinds that are patient focused and centered on improving both access to and quality of healthcare. These partnerships are definitely breaking new ground in many cases, or as he said, “making fresh tracks in the snow.”

Pallone noted that telemedicine, one of the subsets of digital health, has certainly been “given legs” by the demands of COVID-19. “Everyone is really rethinking how often brick and mortar needs to be involved in the delivery of care.”

Lento even opined that the coronavirus has accelerated and even created more space for digital health initiatives. “As horrible as the global pandemic has been, there is some light here,” he said, pointing to cognitive behavioral therapy programs and coaching that can be delivered direct to consumers via digital therapeutics, perhaps helping to ease isolation and stress suffered by “those in need.”

“There’s a tremendous opportunity for those looking to make that jump” into the field—especially if they can help bridge the divides between digital and pharma, he said.

Pallone noted “the promise of digital: you can keep making it better and better. It’s not always well understood on the pharma side.” Still, there are going to be bumps in the road, and even failures, she said.

“What’s causing the failure is massive amounts of learning,” she explained. “You have to get out there and you’re going to take some knocks.”

The solution? More collaboration, and more buy-in from providers and patients. Better and better products and solutions. And while we’re at it, more peace, love, and understanding between “the pharma side” and “the tech side,” and more willingness to fail fast and keep iterating while still protecting patients’ health.

If you registered for the 2020 ASAP BioPharma Conference, don’t forget that you can still access both livestream and on-demand content from the conference until Nov. 13. And keep checking this space for more posts on some of the great sessions like this one featured as well.

Tags:  alliance management  Brooke Paige  Christopher Lento  collaborations  Davina Pallone  Digital Health  digital therapeutics  engagement  Fruit Street  healthcare  Knut Sturmhoefel  life cycle  Noom  Novartis digital/biopharma partnerships  patients  pharma  regulatory  strategic partnerships  tech 

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How Do You Propel a Big, Complex Oncology Alliance Forward at Breakneck Speed? Very Carefully

Posted By Jon Lavietes, Friday, September 25, 2020

Lou Gerstner once asked, 'Who says elephants can't dance?' For the past year and a half AstraZeneca and Daiichi Sankyo have been making their pachyderm sprint like a cheetah. Last week, at the 2020 ASAP BioPharma Conference, Jonathan Bell, director of alliance and integration management at AstraZeneca, and Kenji Shigeta, vice president of DS-8201 strategy in the Global Brand Strategy Unit of Daiichi Sankyo, shared the story of their companies’ fast-moving collaboration around the cancer drug Enhertu (aka DS-8201) in a presentation titled “Executing the Biggest, Most Complex Oncology Alliance in Recent History—Learnings from the First 18 Months Together.”

The partnership has amassed impressive milestones to date. In what Shigeta termed a “speed marriage,” the two organizations announced their partnership in the spring of 2019, a mere five weeks after negotiations began in February. Shigeta also claimed that the $1.35 billion upfront payment and the subsequent $5.5 billion in milestones and other transactions represented the largest pharma deal for a single compound that has not been approved yet. The collaboration, which began with 17 programs, consisted of 43 initiatives by the time Shigeta spoke to ASAP members last week—“2.5 times larger in one year,” he said, highlighting the rapidly growing scale of the alliance.

High Response Rate: Powerful Early Results Drive Stakeholder Engagement

To move a collaboration of this magnitude forward in such a short timeframe, experienced pharma-industry observers might guess that the asset at the center could be truly special. They would be correct. Enhertu has demonstrated unprecedented efficacy in treating breast, lung, colorectal, and gastric cancers, and has already garnered national recognition in the United States—Shigeta told the audience that interviews with patients who attended the 2019 San Antonio Breast Cancer Symposium (SABCS) were syndicated over several CBS stations last December.   

The win-win for both companies is clear. Daiichi Sankyo is relying on AstraZeneca to help commercialize the drug outside of Japan, particularly in the United States, United Kingdom, and China. AstraZeneca gets a cut of the profits of a “best-in-class therapy,” said Shigeta. As is often the case in pharma, stakeholders on both sides of the alliance are highly motivated by Enhertu’s promise. Shigeta relayed an anecdote detailing how the alliance team received 80 responses to a survey it issued to a mix of 100 employees from both companies. He joked that the “response rate is higher than what we saw in Enhertu efficacy.” He then said that, kidding aside, this eagerness to participate in the survey illustrated a “pattern of high-level engagement and dedication” in the alliance.

“Good Collaborative Attitude” Sets the Right Tone for the Partnership

Governance, always a critical part of any partnership, takes on even greater import when an alliance of this size and magnitude moves at breakneck speed. With a little trial and error, AstraZeneca and Daiichi Sankyo came up with a model that is arguably worthy of a business school or ASAP Handbook of Alliance Management case study. A Joint Executive Committee (JEC) sat at the top of the governance chain. Five individual committees dedicated to development, medical affairs, finance, supply chain, and commercialization, respectively, reported directly to the JEC. Underneath the Joint Commercialization Committee (JCC) sat three regional committees, one each for affairs pertaining to the United States, European Union, and all other geographies.

The first meeting of the eight senior leaders—four from each company—that made up the JEC was a fruitful one. The committee developed a joint vision statement: “Our obligation to patients is beyond what one company can achieve alone.” After the kickoff meeting, the companies communicated this vision statement, strategy, and goals of the alliance to new patients. Shigeta praised the JEC for setting the right tone for the alliance, and for creating a culture that allowed stakeholders on both sides to thrive, calling them “solution-oriented leaders” that have a “good collaboration attitude.”

“We are quite lucky to work with those exceptional leaders,” he added.

Collectively, the alliance team never stops. When employees start their day in Japan, they can take handoffs from workers in America who are wrapping up their activities for the evening. Toward the end of the Japanese workday, European stakeholders start their mornings and eventually overlap with US alliance colleagues in the afternoon and early evening.

Bogged Down: Top-Heavy Decision Making Stalls Out the Alliance Engine

When Bell took the virtual podium, he dove deeper into the machinations of the governance operation. He told the audience that the alliance had a few things going for it immediately after the launch, at least on the surface. First, the oncology lead of Sankyo’s R&D unit used to work at AstraZeneca and was thus familiar with the partner’s inner workings. In addition, both companies utilized similar cross-functional Global Project Teams (GPTs). With similar working structures, the companies initially figured they could get away with relatively simple rules of engagement—why overcomplicate governance if you don’t have to? Although well intentioned, this directive backfired to a degree. The lower committees felt they had to defer all decisions to senior management, “so what should have been relatively easy, high-level discussions at the JEC got bogged down into hours of negotiation about clinical design. It simply wasn’t working at the pace we needed to go,” said Bell.

AstraZeneca and Daiichi Sankyo decided to hold a two-day workshop under the guidance of an external agency aimed at developing course corrections. The companies administered a health check and the agency conducted one-on-one interviews prior to the event. On the first day, the joint development teams analyzed the findings and surfaced difficulties faced by stakeholders in both companies. The second day was spent driving home the idea that “a contract is not an instruction manual or a recipe book,” said Bell, making the point that beyond the JEC, the characteristics of which were spelled out in the contract, the underlying governance represented a “gray space” that could be treated as a “sandbox” for devising a structure that best fit the needs of the collaboration.

Alliance Tax Break Pays Off in Efficient Development Operation

The result was a new look for joint drug development procedures. The companies formalized the role of Joint Leadership Teams (JLTs) that sat beneath the Joint Development Committee (JDC). The JLTs and JDC were to agree upon all of the finer details before presenting initiatives to the JEC for final approval.

The new configuration had the desired effect. Loaded with relatively senior personnel, empowered to obtain approvals underneath the JEC, and now meeting weekly, the JLTs moved development items through the chain of command efficiently—fully vetted proposals were approved by the JEC 100 percent of the time after the workshop. The alliance now expects to approve as many as 15 late-stage study registrations this year. Bell said the “alliance tax bill” is much lower thanks to this expediency.

Bell concluded by imparting four lessons to BioPharma Conference attendees. First, he credited a thorough download session conducted by Daiichi Sankyo that brought alliance stakeholders up to speed on Enhertu for setting a precedent of transparency and trust. Second, kickoff meetings are especially important in an alliance of this magnitude. Partners must agree on ways of doing things early, remain flexible during the first tests of the initial configuration, and make changes wherever necessary. Third, he recommended building “workflow archetypes”— that is, alliance managers should explore incorporating internal processes into a plan. Finally, leverage experience from other alliances. To this last point, Bell said he was fortunate to have worked on other “Goliath-Goliath” alliances in the past, such as AstraZeneca’s collaboration with Merck.

The Reward for an $18 Million Q1? The Alliance Teams Get to Do It Again

The work has paid off. On Dec. 20, 2019, the two companies received accelerated approval by the FDA two months after filing. Enhertu then amassed $18 million in US sales in this year’s first quarter. Shigeta said the clinicians are reporting exceptional responses to the drug in patients thus far.

“We cannot achieve this without fantastic and tight collaboration by two companies,” he said.

Buoyed by the success of their first year and a half working together, the joint teams entered into another major alliance initiative this past summer centered around a compound known currently as DS-1062.

In the Q&A that followed, the presenters were asked how they specifically aligned on governance before the deal was signed. Bell explained that a lot of this was covered in the five weeks of negotiations. The negotiators outlined a development plan and approved a joint business plan for US operations. Shigeta said the compressed timeframe actually spurred the teams to prioritize matters effectively.

“We had a clear goal in front of us—to launch the product within 12 months,” he said, adding that this focus was a “driving engine” for the partnership’s first year.

Asked if any executives served on both the JLT and JDC committees, Shigeta estimated a 20 to 30 percent overlap, which helped bridge the cross-functional JLT teams and the JDC when the latter had to make recommendations to the JEC. Bell added that it was important for the people serving on both committees to have a certain amount of authority if the lower committees were to obtain alignment under the JEC.

Another viewer asked if this approach is translatable to a biotech-pharma alliance of two large organizations.

Bell felt it could be, provided that the organizations, particularly the big pharma company, weren’t entrenched in their way of doing things. A 50-50 alliance suggests no hierarchy and calls for each player to remain flexible. Shigeta noted that resource allocations may not be 50-50 in another collaboration, but that doesn’t have to derail a collaborative spirit. The companies just have to tailor a structure to their needs if the AstraZeneca–Daiichi Sankyo model doesn’t fit.

We captured all of the other live sessions from last week’s events on this blog, and we will be bringing recaps of several more prerecorded on-demand presentations over the course of the next month. However, if you registered for the BioPharma Conference, we strongly urge you to check out the full recordings on the conference portal. Our blog posts capture only a fraction of the great insights in each session, so don’t miss out on any of the great wisdom that has been shared during the livestream and on-demand portions of the event.

Tags:  Alliance  AstraZeneca  cancers  collaboration  Daiichi Sankyo  Enhertu  integration management  JDC  JLT  Jonathan Bell  Kenji Shigeta  Oncology Alliance  partnership  pharma-industry 

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