My Profile   |   Print Page   |   Contact Us   |   Sign In   |   Register
ASAP Blog
Blog Home All Blogs
Welcome to ASAP Blog, the best place to stay current regarding upcoming events, member companies, the latest trends, and leaders in the industry. Blogs are posted at least once a week; members may subscribe to receive notifications when new blogs are posted by clicking the "Subscribe" link above.

 

Search all posts for:   

 

Top tags: alliance management  alliances  collaboration  partnering  alliance  partner  partners  partnerships  alliance managers  ecosystem  alliance manager  The Rhythm of Business  partnership  Jan Twombly  Vantage Partners  biopharma  Eli Lilly and Company  governance  strategy  Strategic Alliance Magazine  IBM  collaborations  IoT  strategic alliances  ASAP BioPharma Conference  cloud  innovation  Christine Carberry  Cisco  healthcare 

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 

Share |
PermalinkComments (0)
 

We Can’t Afford “Business as Usual”: Rethinking and Reimagining Alliance Management in the Age of COVID-19

Posted By Michael J. Burke, Friday, September 25, 2020

“It’s clear that over the last eight, nine months things have changed significantly. There really is no going back. The status quo is no more. Everything that has been done in the past can, and in many instances must, be rethought.”

That was the sobering pronouncement by Jeff Shuman, CSAP, PhD, at the outset of the presentation “The Silver Lining: Reimagining Alliance Management to Focus on What Matters Most Now,” on day one of the first-ever virtual 2020 ASAP BioPharma Conference, just concluded. Shuman and his copresenter, Jan Twombly, CSAP, are the principals of The Rhythm of Business, and both they and their keen insights into alliance management are quite familiar to the ASAP member community.

Shuman was referencing the many changes wrought by COVID-19—but according to Twombly, the healthcare ecosystem was being transformed already, before the pandemic, and this process has continued and even accelerated. It’s largely a combination of three factors, she noted:

  • New technologies: including platform therapies, artificial intelligence (AI), and the Internet of Things (IoT)
  • Shifting economics: more value- or outcomes-based models, changes in government and payer reimbursement policies creating pricing pressures, and a shift in focus from treatment to prevention and cure
  • Empowered patients: reflected in greater consumer experience expectations, the rise of mobile technologies, and the ups and downs of public perceptions of the biopharma industry

In addition, new business models have been emerging due to all of the above factors, plus a declining return on investment in research. These models, according to Twombly, tend to be more patient outcomes focused, more predictable, at lower cost and higher volumes, and—similar to tech industry initiatives—easier to terminate or iterate early (which applies to both programs and partnerships).

“At every step of the way, we see that it is a significantly partnered model that has emerged,” Twombly said.

A Silver Linings Playbook of Coping Strategies

This represents an opportunity and part of the “silver lining” for those like Twombly and Shuman who believe that partnering is a key route to innovation and better patient outcomes, but there remains a thorny problem: resources. More to the point, the lack thereof for alliance management. Limited resources can result in alliances that are essentially “unmanaged,” or managed by people who have no experience in the role, and adds significant risk and potentially lost value to the equation as actual alliance managers are overwhelmed and forced to develop various “coping strategies,” including becoming reactive rather than proactive in their activities.

“If you’ve got 10 or 15 alliances that you’re managing, you can’t possibly have your finger on the pulse of the alliance,” Twombly said, before putting out polling questions online to the audience to canvass their experience of unmanaged alliances, alliance managers having to be reactive, and the like.

“Across the board there are challenges,” she summarized, as these unhappy conditions seemed to resonate with much of the audience given the poll results that were appearing in real time. And now such issues have become magnified as the number of partnerships—and new partner types—focused on tackling COVID-19 alone has multiplied, and at speed.

“New Urgency” to Reimagine Alliance Management Practices

Given these developments and the economic and societal uncertainties that accompany them, “It really becomes clear,” Shuman said, “that there is a new urgency to rethink how alliance management is done and by whom. When you throw COVID-19 on top of already busy schedules, it’s really time to reimagine alliance management.”

So how do we do that rethinking and reimagining? First we have to understand the big picture of our organization’s alliances, Shuman said. What is the portfolio? What alliance management services are required for the various alliances? And what resources are available to them?

“In 20 years of being involved with ASAP, one of the refrains we hear all the time is, ‘We don’t have enough resources,’” Shuman said. “That’s a real challenge.”

To meet that challenge, Shuman and Twombly said, alliance managers need to apply agility to their alliance practice. Not exactly software agility, but agile principles: what matters most now. There are various elements of this process, but the overarching one is to focus on the North Star: “What is it we’re really trying to do?” Shuman explained.

Three key areas Shuman highlighted in this regard were resourcing the alliance portfolio, increasing the agility of alliance management practices, and adapting the alliance management organization to these new requirements. “By this time we know what works and what doesn’t, and what we want to do is take time out of the process. With all the pressure worldwide to develop a [coronavirus] vaccine, there’s bound to be myriad changes to the processes we have always used, to do a faster job of getting to that North Star,” he said.

Journey Through the Front Door

Resourcing decisions need to be part of a coherent and transparent governance process, according to Twombly, “across the board.” The profile of a given alliance then dictates what services are needed. “We call this a front-door process—part of the stable backbone, and collaborative leadership process, that any alliance requires,” she said.

Alliances can thus be segmented into complex, typical, and simple. A “simple” alliance might be a research alliance that doesn’t need a lot of management per se, but can be overseen by project managers. More complex alliances with many moving parts and requirements might then get the lion’s share of attention from more experienced alliance managers and leaders. Twombly recommended applying expertise and alliance management focus to each segment as needed, and having a standard way to resource each segment.

The bottom line? “We have to do things differently and smarter,” Twombly explained. She also referenced the first day’s keynote and panel led by CEO Rusty Field of Upsher-Smith and his colleagues, which described alliance management as a “mindset” rather than merely a group or department.

“Partnering is an organization-wide initiative, not just for the alliance management team,” Twombly elaborated. The key is for alliance professionals to work to engage the rest of the organization and get them involved. “No doubt about it—it’s a journey,” Twombly added.

There’s No Going Back

So what are the steps toward reimagining alliance management? Shuman outlined five:

  • Define your destination, i.e., your North Star
  • Build a “destination back to the present” plan and work backwards from that goal
  • Determine the first steps that will have an impact
  • Enroll a small number of stakeholders who are champions for change
  • Grab the license you have now to fix what’s broken, improve what’s inefficient—and own it!

Alliance management must be rethought and reimagined because the older processes within organizations—and not only for alliance management—were created for “what used to be normal,” Shuman concluded. “We’re never going back there to the way business was done. We’re going to go to the next normal. So stick with it. Make it happen. The one thing you don’t want to do is continue with business as usual.”

Tags:  alliance  Alliance Management  collaborative leadership  governance process  Jan Twombly  Jeff Shuman  Rusty Field  The Rhythm of Business  Upsher-Smith 

Share |
PermalinkComments (0)
 

“Humanity Is Relying on You!” Ed Cox Tells BioPharma Conference Attendees to Embrace the Challenge of Ending the Pandemic

Posted By Jon Lavietes, Thursday, September 17, 2020

Ed Cox, executive vice president of strategic alliances and global head of digital medicine at EVERSANA, was given the task of closing the 2020 ASAP BioPharma Conference on an inspiring note. He did it with a bang!

“Right now, humanity is relying on you. That’s thrilling! I want my work to matter,” he said. “This exact moment, at this exact time, what you do matters more than almost anything else in the world. There are very few occupations on the planet that are more critical to what we are doing [in this world] than what we [as alliance managers] are doing right now [in our jobs]. That’s exciting. You should be proud, you should feel challenged, and you should step up to that challenge.”

Your Interests Are Mine—Pharma Licensing Agreements Require Unparalleled Levels of Trust

Alliance management is indispensable for more reasons than the fact that the world is pinning its hopes on a handful of biopharma industry partnerships working furiously to develop COVID-19 treatments. The alliance management skill set was made to hurdle the obstacles presented to us by the virtual workplace. The nature of pharmaceutical collaborations of this magnitude normally necessitate a level of in-person interaction that is near-impossible at the moment.

Cox explained that the level of complexity of a licensing agreement dwarfs that of any other type of business transaction. If you think about transactions on a four-point spectrum, the easiest ones to consummate are those centered around everyday commodities like sugar or salt, where you don’t need to interact with salespeople any more than to hand over change, let alone trust them. The next-simplest transactions are ones centered around more durable products, such as furniture—more dialogue is needed to hammer out a sale, but a previous relationship is hardly required. Further up the complexity scale are highly technical services, such as software-as-a-service solutions. Although these types of customer agreements tend to last at least a year—often longer—and entail a deeper relationship with the seller, the level of trust required in these relationships pales in comparison to the most complex type of transaction: the pharma licensing agreement, with its arcane regulatory requirements; loads of phase 1, 2,  and 3 data; and various IP threats.

“You as the buyer, you as the partner, are relying on the seller to have your best interests in mind. None of those other stages that we talked about have that dynamic,” said Cox. “[The sales rep] has my interest in mind just as much as theirs.”

Holy Smokes! Alliance Managers Help Shepherd Deals Through the Last Mile

That’s in normal times. The COVID-19 pandemic has heaped on another layer of complications. Cox said pharma business transactions generally develop over three broad stages: 1) the beginning of a relationship upon the introduction of two parties, 2) the advancement of the conversation, and the 3) actual signing of the agreement. The coronavirus has all but completely quashed the ability to forge the new connections needed in the first stage, while the elaborate private equity and licensing deals that characterize the last one have dropped 50 percent. While alliance managers are primarily responsible for—and currently have their hands full with—that middle phase, the rest of the world cannot walk that last mile to that final stage because closing deals of this nature has also traditionally necessitated in-person interaction.

“The only way we as a civilization will be freed is by the life sciences industry innovating our way out of it, except the life sciences industry cannot close complex transactions, because so many people are used to being in the room together. Holy smokes! Those are the stakes, but that’s the exciting part,” Cox said.

How else are alliance managers vital today? For one, “Trust has gone from critical to existential,” according to Cox, and few apply trust-building as a science the way alliance professionals do.   

“I can advance these deals, close these deals, hold on to these deals, and make them work [without being in person] so that these products get to the patients that [need them] and we get out of this crisis,” Cox explained.

Communicate Value and Ration Negativity to the CEO

Cox was just as insightful in the Q&A that followed his address. ASAP president and CEO Michael Leonetti, CSAP, began by asking Cox how alliance managers can overcome the age-old problem of feeling underappreciated or not fully understood by senior management. Cox urged alliance managers to frame things to CEOs in terms of the future. He acknowledged that alliance managers are inherently disadvantaged because CEOs are more involved in the signing of the deal and the initial press release announcing it, when stock prices are soaring and optimism is high. The partnership is then handed off to the alliance manager only “to make sure it doesn’t break.” From that point on, the alliance manager more often than not only involves the CEO when there is a crisis or a problem with the partner. Cox strongly recommended against shielding yourself behind the rationalization that you are just the messenger.

“The messenger is not a role you want to be in. The fixer, the leader, the driver. That’s the role,” he said. Instead, he urged alliance managers to find ways to create new value, and to involve the CEO when you have a proposal that could result in higher revenue or increased earnings per share.

Obviously, there are some times where alliance managers won’t be able to avoid delivering bad news. However, Cox exhorted listeners to “ration” negativity. Besides, most of the time, the fire isn’t at five-alarm levels that require the CEO’s attention, and it’s almost worse to burn precious CEO time on a false alarm.  

“Don’t cry wolf if it’s not [completely] broken,” he said.   

Alliance Managers Must Let Go of “Control Issues”—and Failures

When asked what lessons people can take from alliances that didn’t reach their end goal, Cox said that it is important to understand that most alliances fail due to external factors, which goes against human nature and, to some extent, our business culture which insists that we control our own fate. Most of the time, alliance managers cannot overcome market factors, regulatory hurdles, and inadequate science. 

“There are great partnerships with really smart people collaborating well that fail because of external factors. There are alliances that are held together with duct tape that succeed because the demand for the product was so great it didn’t matter anyway,” said Cox.

If a failure was avoidable, Cox advised to be “real and authentic” about why the collaboration didn’t reach its goals.

What drives Cox at EVERSANA? He loves the fact that he is in a nascent field—EVERSANA is part of the growing contract commercial organization (CCO) market. Pharmaceutical companies have recently begun outsourcing go-to-market activities in the way they have contracted out manufacturing and research duties over the past two decades. Sometimes EVERSANA is running an entire commercial operation. Other times, the company is managing a single vertical for a large pharmaceutical organization or helping a smaller outfit get to the next level.  

EVERSANA is seeking to build the first CCO that can be accessed through partnerships.

“Nobody’s ever built one of these before,” he said. “There are a lot of products that wouldn’t have a chance to get to market, or wouldn’t have the chance to be the first thing in the bag if they get licensed to a large or midsize pharma. If they partner with us, they can be first thing in the bag.” 

Although the 2020 ASAP BioPharma Conference is officially over, registrants can still play back sessions or watch presentations they couldn’t tune in for live at our conference portal. We strongly encourage you to check out the rest of Cox’s session, which includes his take on digital health, when he realized the importance of alliance management, and what he would never do again in a partnership, among other learnings.

Tags:  alliance  Alliance management  alliance managers trust-building  biopharma  complex transactions  digital medicine  Ed Cox  EVERSANA  life sciences  pharma business transactions  Pharma Licensing Agreements  pharmaceutical collaborations  skill set  strategic alliances 

Share |
PermalinkComments (0)
 

Why Are We Here? Partnering to Make Good Things Happen

Posted By Michael J. Burke, Thursday, September 17, 2020

Melinda Richter’s journey began very humbly, in a small wooden house with no running water in northern Canada. Growing up in that harsh environment with her parents and seven siblings wasn’t easy, especially in winter. But she was determined, she says: “I was going to change my story.”

That story and its implications rippled through Richter’s day three keynote address at the 2020 ASAP BioPharma Conference, “The Power of Partnership: Driving Innovation for Patients.” And for Richter, now global head of JLABS for Johnson & Johnson Innovation, another key phrase to ponder might be “the power of why.”

A subsequent chapter in her story found Richter living in Beijing and working for a tech company. She was making pretty good money and, as she said, “I thought I had the world by the tail.” Then she was literally “bit by a bug” while walking outdoors and wound up very ill in a Beijing hospital room, where the doctors sadly told her there was nothing they could do for her and she should call her family and say goodbye.

“That changed my life,” she said. She decided that if she lived, she would go to work in healthcare. Somehow she did survive, quit her corporate job, “sold everything,” and went to San Francisco. She was not a scientist but a businessperson, and she thought she might be able to apply some of her tech industry experience to healthcare by identifying problems and coming up with creative solutions.

Using Tech Savvy to Change Life Sciences

This is all in a day’s work for tech, but in the life sciences it’s a little more complicated, given that “before you even turn the lights on” you have to have infrastructure, make investments in capital equipment, follow the scientific process, understand the regulations, and then resign yourself to the fact that it may take 8 to 12 years or more to get a drug to market. If you’re an investor, Richter asked, where would you rather put your money—on the next Instagram, or an oncology drug development program?

Yet Richter persisted, raising $6 million initially to open her first facility and dedicating 50 percent of its common space to help incubate and innovate fresh ideas and new science. A few years and about a billion dollars in deals later she found she needed to expand, and secured a meeting with Johnson & Johnson representatives in San Diego where she pitched the wild notion that “if we put our respective strengths together, we could maybe change the scale in life sciences.”

Maybe not so wild, because the result was JLABS, which has grown from its first facility in San Diego to encompass a number of locations in North America, and recently in Europe and China as well. All of these, Richter stressed, are collaborations—public-private partnerships with government entities such as BARDA (the US Biomedical Advanced Research and Development Authority), as well as partnerships with startups, pharma companies, and others.

Getting the Best Solutions to the People

One of the BARDA collaborations is focused on trying to sniff out the next coronavirus-type pandemic. Called “Blue Knight,” its purpose is to “anticipate the next COVID-19 challenge, take the best solutions, and then amplify them out to our global citizens,” Richter explained.

So far, according to Richter, JLABS has done nearly $40 billion worth of deals, amounting to some 150-plus collaborations with 673 companies in its network. What’s more, the organization is 30 percent women-led—vs. 1 percent in the industry—and 29 percent minority-led—vs. 8 percent industry-wide.

Companies apply to JLABS for space, investment connections and opportunities, and coaching that will help them get to the next level and help solve our greatest healthcare problems—aiming at not only more and better treatments, but also better quality of and access to healthcare.

Or as Richter put it, JLABS seeks “to accelerate solutions to patients and make them cheaper, so everyone can have access and everyone can afford it.” Currently this includes working on solutions to the COVID-19 crisis—“If there’s a bigger cause I don’t know about it,” Richter acknowledged.

Why Are You Here? To Walk Through Walls

To do this work, of course, it helps to be passionate about what you do—or as Richter said, to “walk through walls to get it done.” In explaining her mindset, she admitted that when things don’t go well, even today she returns in her memory to that hospital room in Beijing where she wondered whether she was even going to live to see another day. “Then I dust myself off, pick myself up, and get back to work.”

Richter nudged the virtual audience to ask themselves: “Why are you here? Why do you do what you do?” This would seem to have great resonance with our biopharma contingent, who regularly remind themselves and others that the purpose of all their painstaking alliance management effort is ultimately to bring about better outcomes for patients who desperately need that help—thus, Richter said, “fighting for something that’s bigger than you.”

In alliances and partnerships, too, it’s useful to return to these “existential” questions: “What is the purpose that is bigger than ourselves? What are we trying to accomplish together? What can we all do to get over this hump?”

A Powerful Proposition

Not that it isn’t frustrating at times. Richter noted that while she and others started as early as two years ago trying to anticipate something like COVID-19, “we were still too late. We haven’t done this well enough.”

Moreover, organizations doing this important work also need to take a hard look at their own composition—specifically their gender and ethnic diversity. “Our leadership teams don’t look enough like our population,” she said, adding that she had to keep revisiting her own organization’s record, challenging her own assumptions, and striving for improvement. “Which ethnic minorities are absent?” she asked. “It’s something we all need to do better. What are we missing?” This is not just about fulfilling arbitrary quotas, she stressed, but about organizations better understanding the needs of the communities and populations they serve.

Finally, in answer to a question during the Q&A portion of the presentation, Richter acknowledged that JLABS—a series of collaborations that now stretches across the globe—began with one conversation, one meeting, one pitch, and one agreement based on trust, honesty, and transparency. It was important for J&J to understand the risks of Richter’s proposal, and for her to answer their concerns, but also for her to be honest that “things can go wrong.”

And as in any alliance, there has to be the faith and trust on both sides that, as Richter articulated it, “We’re going to figure it out and solve things in the moment. That’s a very powerful proposition.”

Tags:  alliance  BARDA collaborations  collaborations  J&J Innovation  JLABS  life sciences  Melinda Richter  partnerships  strategic  trust 

Share |
PermalinkComments (0)
 

GE Healthcare CDO Outlines Vision of Precision Health Using AI

Posted By Jon Lavietes, Wednesday, September 16, 2020

In the third and final session of the second day of the 2020 ASAP BioPharma Conference, medtech took center stage. Derek Danois, chief data officer at GE Healthcare, outlined his company’s nascent efforts to transform basic healthcare delivery models in his presentation “Artificial Intelligence in Clinical Care Delivery and the Opportunities to Accelerate Your Development and Commercial Strategy.”

Artificial Intelligence (AI) is one of the principal tools at the heart of a larger movement in the healthcare industry around “precision health.” The concept is simple: Rather than prescribing medications based on a set of generic symptoms, doctors will integrate lots of relevant data, such as genetic profile, family history, and environmental factors, in designing a custom treatment plan. Precision health will be built on precision diagnostics, therapeutics, and monitoring (e.g., wearables).

Data: the Source Code for AI and the Key to Early Detection

With the overarching mission of precision health explained, Danois showed the audience a video that told a story set in the future where a woman detects a lump on her breast, sends the self-exam directly to her doctor right from her bathroom, gets scheduled for a consult immediately, and is put through a battery of tests at the healthcare facility while doctors and technicians analyze the resultant data. The verdict: they caught a malignancy early enough to expect a full recovery. 

The video is meant to inspire, said Danois, but it also conveys GE Healthcare’s vision for the future.

“What can we do to intervene now in helping to spot the early signs of diseases? How can we intervene in a little bit more of an effective manner? How do we help patients feel less fearful and engage more with their clinicians?” he said. “We’ve got to start thinking even earlier. We have to start thinking about the data that is being collected around the world that allows us to think about this journey. Data truly is the source code for AI.”

AI, Danois explained, has to be educated, taught, and trained over a long period of time in order to be effective. For example, an AI program must be exposed to a trusted radiologist’s annotation of a tumor on an x-ray over and over again before it can learn to recognize a similar tumor on its own and become a “true companion source” and a reliable second opinion for doctors. 

Leaping Regulatory and Economic Hurdles to Make Leaps in Precision Health

The technological piece is one challenge. There are also regulatory, economic, and administrative obstacles to contend with. Healthcare providers are generating loads of valuable data, but this information is fragmented around the world, making it difficult to get the right data in the hands of clinicians at the right time. Moreover, hospitals still aren’t convinced that the cost-benefit ratio is in their favor yet. They still haven’t seen enough evidence of positive long-term outcomes, plus there’s a question as to whether health insurance plans will reimburse for AI-based treatments. Even if a health provider is sold on a new concept, it is difficult to deploy it in a highly regulated industry like healthcare.

Still, despite the hurdles that still need to be cleared, nobody disputes that the payoff is going to be transformative, to say the least, down the road in terms of fluid and effective healthcare delivery. Danois likened where we are today in digital health to the first iPhone more than a decade ago. Back then, there were only a few apps, but everyone saw tremendous possibilities. Now, we perform many of our day-to-day functions on our phones. Healthcare can get to the same place, in Danois’s view.

“It starts with understanding and thinking about the various data content that exists in these organizations. How can those be made available for, not just research but practical product development, AI development, collaboration with industry partners,” he said. “Thinking about how those can be turned into AI applications that can be deployed in the right workflows, what challenges exist from a security and privacy perspective? And then thinking about how those get injected into intelligent applications that can be deployed either on the devices in hospitals right now, or they can be deployed in a hybrid model using cloud infrastructure.”

Ultimately, said Danois, we need to get to a point where doctors don’t even think about the technology behind AI-powered apps and devices, where all it takes is a simple Internet connection in order to take advantage of them.

Alliances, of course, are a must if we are going to get there. GE Healthcare realized early that it couldn’t do it alone, despite the great investment it made into AI technology, software engineering, and data science. (For more details about GE Healthcare’s Edison AI platform, see “It’s the Data—and a Lot More,” Strategic Alliance Quarterly, Q1 2020.)

“We needed to open our technology. We needed to create an ecosystem. We needed to create the landing platforms for other partners to work with us. We’ve been encouraging others to think about doing similar things,” he said. “When you can have ethically compliant ecosystems, when you can think about what each party brings to that challenge and help solve it, and that there’s a known entity at the end of that workflow stream, either in the provider or the patient, that will allow us to take advantage of these tools and technologies and leverage these delivery models, we know that we can achieve amazing precision outcomes.”

The FDA’s Position on AI in Healthcare Devices

With that, Danois fielded a few questions from the audience. The first dealt with privacy and security concerns that come with AI apps and devices. Danois explained that these apps are like any digital health technology in that they are designed “in a thoughtful way” to do a task.   

“These get deployed into an already-existing, highly regulated environment for medical devices, whether it is in the US, in Europe, or for most other countries around the world. There’s some regulatory process where these devices need to be approved from a technology point of view, both physical and digital hardware. Those AI applications will exist in those environments,” he said, before adding that the FDA’s position is that if you incorporate AI into an existing piece of hardware, you must treat the new product as an entirely new device. You can create a separate AI app instead, but whatever you produce must be delivered in a “in cybersecurity-hardened and technically thoughtful way.”

Danois was also asked if the partnering language and mindset is different in these partnerships, given the disparities between tech and pharma corporate and alliance cultures. He responded first by making an important distinction between pure technology ventures that are focused solely on creating AI apps and services and medtech initiatives which use diagnostic tools and technologies to deliver AI-powered services. The latter already undergo a rigorous three- to five-year approval process—Danois cited pet scanners as an example. His larger point was that many collaborations are already comfortable with the longer-term regulatory and alliance cycles.

Danois had plenty more to share during his presentation. ASAP BioPharma Conference registrants can review “Artificial Intelligence in Clinical Care Delivery and the Opportunities to Accelerate Your Development and Commercial Strategy” anytime this week and beyond to benefit from his knowledge and expertise. They can also enjoy a dozen other prerecorded on-demand presentations, as well as the rest of this week’s completed livestreamed sessions.

Keep checking this blog for updates from the conference throughout this week!

Tags:  AI  AI-based treatments  alliance culture  Artificial Intelligence  Clinical Care Delivery  Derek Danois  diagnostics  FDA  GE Healthcare  health  partnering  partnerships  pharma  strategy  tech  therapeutics 

Share |
PermalinkComments (0)
 
Page 1 of 93
1  |  2  |  3  |  4  |  5  |  6  >   >>   >| 
For more information email us at info@strategic-alliances.org or call +1-781-562-1630