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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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Mashup or Culture Clash? When Biopharma and IT Meet Up in Digital Health Alliances

Posted By Jon Lavietes, Monday, August 3, 2020

It’s generally accepted that the alliance management profession is entrenched in IT and biopharma more deeply than in other industries. In these vertical markets, no business can sustain significant growth without developing an alliance practice and a deep portfolio of partnerships. No one company could develop a full stack of hardware, software, and cloud services on its own and still keep pace with the blisteringly fast tech sector, nor could a single pharmaceutical entity complete the entire drug life cycle solo for an entire portfolio of drug candidates.

Yet for many years these industries have operated largely in separate spheres based partly upon vastly different alliance principles. This is starting to change with the advent of digital health, an umbrella term that encompasses a variety of initiatives that utilize digital technologies to advance and streamline patient care in the form of preventive treatment, hyperpersonalized medicine, more accurate drug discovery, and a more efficient patient-provider relationship, among other applications. (See “Digital Health at the Crossroads,” Strategic Alliance Quarterly, Q4 2019, for more on this rapidly expanding area.)

Suddenly, cross-industry alliances are popping up everywhere, from GE Healthcare’s Edison intelligence platform (see “It’s the Data—and a Lot More,” Strategic Alliance Quarterly, Q1 2020), to the alliance between AstraZeneca and Flex spinoff BrightInsight, to the myriad data-driven pharma collaborations hard at work today. Now, Big Pharma, biotechs, and academic medical researchers are increasingly mingling with tech-industry startups, midsize companies, and Global 1,000 enterprises, necessitating the coalescence of these two alliance cultures.

Mind the Gaps

In their on-demand 2020 ASAP Global Alliance Summit session “The Alliance Management Mashup: Bridging a Digital Divide,” the proprietors of alliance management consultancy The Rhythm of Business laid out a common alliance framework that would help digital health partners on both sides better understand each other and function together more successfully.

Or course, to close gaps, you must first identify them. According to Jeff Shuman, CSAP, PhD, principal at The Rhythm of Business, the most glaring of these disparities is the timeline in which these industries innovate and bring solutions to market. In tech, companies develop products iteratively through agile processes in order to bring offerings to market in the tightest of windows—the “next big thing” can become yesterday’s news in a hurry. By contrast, it can take up to a decade to commercialize a therapy thanks to a stricter regulatory climate and pharma’s more methodical drug-development processes, although Shuman noted that today’s exceptional circumstances have led to some COVID-19 research being conducted in an “accelerated manner” using iterative techniques.

“‘Move fast and break things.’ That may help promote innovation, but it’s not a good principle when people’s health and lives are at stake,” said Shuman, referencing the famous operating philosophy Mark Zuckerberg used to take Facebook to stratospheric heights. Not a great recipe for pharma, to say the least.

Tech and biopharma differ in many other ways as well. Generally speaking, tech is solution-centric while the pharma market revolves around products. Tech solutions are code-driven, while pharmaceutical offerings involve complex manufacturing processes that are “highly customized for each drug and drug formulation, often requiring a dedicated cold chain to get from factory to patient,” said Shuman.

Technology products are peddled in large part through channel sales and collaborative selling efforts, while pharmaceutical firms spend lots of resources comarketing and copromoting joint products. Tech companies—particularly software vendors—can sell and distribute products through distributors, resellers, and system integrators,  or by “white labeling” their products­ via OEM agreements. Patients buy drugs from pharmacies, while pharma companies often rely on combination therapies. Where new subscription-based business models are predicated on the “land, adopt, expand, and renew” approach, pharma’s product-based life cycle management is usually expressed in the form of “new indications and new formulations.”

Disparities Extend to IT, Pharma Alliance Practices

Alliance portfolios, partnerships, and alliance manager roles look much different in these industries as well. Pharma alliances are negotiated individually and often underpinned by detailed long-term contracts with multiple subagreements, while tech partnerships can often be grouped along a particular area of focus and covered by blanket contract terms that apply to an entire partner program. Today, technology companies partner on platforms around common APIs, while pharma companies license individual assets. The pharmaceutical industry banks on partnerships at all stages of the drug-development life cycle, from research to commercialization, while tech usually partners when it is time to go to market.

Just about everything a tech alliance manager does is in the name of driving revenue—in fact, alliance practices are expected to generate new streams. Although revenue generation is a major imperative to pharma alliance managers, it is secondary to risk mitigation and maximizing the value of joint assets; pharma managers spend more time monitoring contract compliance—determining when amendments or entirely new agreements are necessary—than their tech counterparts do.

Tech alliance managers must earn the commitment of partner resources, while pharma contracts usually spell out resource obligations. Instead, biopharma alliance managers focus their energy on giving higher-ups “all the data they need to make smart decisions,” according to Shuman. Given the distributed nature of tech alliance management, the alliance division must actively engage field sales to get salespeople to actively shop an alliance solution. In biopharma, the field “doesn’t have choice,” in Shuman’s words.

Reconcilable Differences

How do you actually reconcile these differences? Jan Twombly, CSAP, The Rhythm of Business’s president, illustrated the answer with an anonymous case study where a Big Pharma corporation and a technology outfit leveraged the latter’s IoT platform to codevelop apps and medical devices and collect real-world evidence (RWE) from patients that would ultimately enable highly personalized care. Their business model rested on software subscriptions paid for by the biopharma entity to the tech company, which is “different from what biopharma companies are used to,” said Twombly. A collaborative framework was established in several key areas—the two organizations settled on joint development, cocommercialization, and revenue sharing arrangements. However, the pharma company was tasked with deciding what it wanted in the device, what the device would do, and what outcomes it would produce, while the tech company determined how to take the platform itself to market.

On a broader level, the companies needed to align on the intended outcomes, regulatory pathway, decision-making processes, and go-to-market messaging. This turns out to be easier said than done. Pharmaceutical companies are used to applying software to internal processes but not to product development, nor are they well versed in working with tech companies in a true vendor-relationship capacity. On a practical level, IT and pharma alliance managers have drastically different titles and functions.

“It may be challenging to engage in stakeholder mapping and getting the right people in the meetings,” said Twombly.

Extensive regulatory-, safety-, and quality-related processes are new to tech, which forced the IoT vendor in this case to rely on the pharmaceutical company’s expertise.

“[Pharmaceutical companies] should be in the lead when it comes to determining what the regulatory pathways are going to be,” said Twombly.

Lighter and Leaner Governance, Stronger Champions, and More Listening

Both entities needed to reimagine the governance process and the role of their joint steering committee (JSC).

“Governance-through-committee doesn’t work all that well in a lean tech company,” said Twombly, before noting that this presented an opportunity for the biopharma alliance managers to try on a lighter, “more agile” governance where teams met more frequently but for less time.

Governance is especially important in ensuring transparent decision making; it may require especially rigorous stakeholder management and a different decision hierarchy from what either side might be used to. In particular, the parties must devise a governance structure that helps partners align on evidence standards so that the tech company can produce data that will “pave that [regulatory] pathway” to meet the biopharma entity’s standard.

Senior leadership champions are especially important in getting stakeholders to understand the value of digital health partnerships and engage in the new modus operandi required for their execution. To foster collaboration, Twombly spoke of “listening to understand,” a process that involves creating a “common language with shared meaning” that helps leverage each party’s strengths. 

Follow the North Star—and Respect Culture’s Hearty Appetite

Twombly urged partners to boil down their discussion of desired outcomes to three points: 1) Align on a North Star—“know what it is that you are trying to produce, know what the outcome is that you want from this partnership, and keep everybody focused on achieving it”; 2) Agree to milestones and metrics; and 3) Make status against plans visible to all.

Twombly also reminded the audience of the old saying that “culture eats strategy for lunch.” To remedy cultural differences, she recommended that tech alliance pros assume the best of intentions on the part of their biopharma counterparts and speak up and provide alternatives when something won’t work in their environment. On the flip side, pharma companies need to explain their world, with visual aids showing how their organizations work, wherever possible. As with all alliances, everyone must celebrate successes and learn from mistakes.  

Twombly closed with a series of “tips and traps.” For the former, she outlined the following:

  1. Take time to understand how each partner innovates, goes to market, and what partnership looks like to them.
  2. Understand your counterpart’s focus, job, and core responsibilities.
  3. Use the alliance management foundation to decide how to bridge differences—the toolsets provided by ASAP “give you a common baseline which you can work from.”

The three traps to avoid?

  1. Allowing stakeholders to think that a digital health partnership is like all the others—“you’re really going to have to adapt new behaviors and ways of looking at things” because the status quo will not suffice, warned Twombly.
  2. Make sure each side appreciates and leverages what the other brings to the alliance.
  3. Don’t fail to champion your partner and partnership.

Above all, Twombly exhorted companies on both sides to recognize the high stakes and the game-changing potential of these collaborations.

“The promise for digital health is significant for both technology and biopharma companies, never mind the patients,” she said. “Allow these new therapies, applications, and ways of developing drugs to thrive.”

If you registered for the 2020 ASAP Global Alliance Summit, don’t miss out on the bounty of career- and partnership-boosting tips and tricks from some of the profession’s most senior practitioners. The three days of live Summit sessions, plus more than a dozen prerecorded presentations, are available to you on demand until Aug. 18. Log on to the Summit portal soon to access them before they’re gone! 

Tags:  Alignment  alliance practice  alliance principles  Biopharma  biotechs  cloud services  cross-industry alliances  Digital Health  digital technologies  drug candidate  Jan Twombly  Jeff Shuman  metrics  milestones  North Star  partners  partnerships  pharmaceutical  software  The Rhythm of Business 

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