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2015 ASAP BioPharma Conference Kicks Off with Opening Remarks and Keynote by Berg’s Science and Partnering Leaders

Posted By Cynthia Hanson, Thursday, September 10, 2015

The 2015 ASAP BioPharma Conference, organized around the theme of “Alliance Expertise at the Forefront: Leadership for the Ecosystem,” kicked off Wed., Sept. 9 at the Revere Hotel in Boston, Mass. USA with opening remarks from Michael Leonetti, CSAP, president and CEO of ASAP, and ASAP Board Chairman Christine Carberry, CSAP, senior vice president, quality, technical operations, program and alliance management at FORUM Pharmaceuticals. Their introductions were followed by a keynote address, “Taking on a Silent Killer through Partnership and Big Data,” presented by science and partnering executives from Berg, the Framingham, Mass.-based biotechnology company noted for its analytics-driven approach and innovative partnering strategy.


“Treating partnership management like a science … brings bigger success. It has to do with maturity level—companies that have been doing this for a while are more likely to be successful,” said Leonetti, who also emphasized how much the industry and its partnerships are walking the talk of consumer focus. “There’s a lot of talk about customer-centric. We have become refocused on the patient and on making sure the ultimate objective—satisfaction for the patient—is realized.”


Carberry offered several suggestions to attendees on how to maximize their learning at the conference as alliance managers entering this new era of orchestrating the life sciences and healthcare ecosystem. Engage with questions to advance the conversation, write down a particular alliance management challenge and find a tool and put it into practice right away, and look at this conference through the eyes of your CEO by asking “How does alliance management fit into your company strategy?” she advised. “No matter where you sit in the company, this is an opportunity to look at how we look at alliances for success.”


The opening keynote focused on the use of research platforms based on big data analytics and artificial intelligence algorithms to isolate the root cause of disease and develop personalized treatment options for patients. A short video from Berg founder and Chief Technical Officer Niven Narain was followed by tag-team presentations by Vipula Tailor, CSAP, vice president of business development and alliance management, and Rangaprasad Sarangarajan, senior vice president, chief scientific officer, and co-founder of biosystems at Berg.


“We are putting the patient at the center of everything we do,” explained Tailor. “One relationship Berg is highlighting is Project Survival—finding the underlying biology for pancreatic cancer.”


Berg’s novel alliance approach involves accumulating and analyzing as much data as possible, primarily by obtaining tissue samples via multiple research and hospital partners. The Project Survival multiparty collaboration is focused on search, discovery, and validation of the first-ever clinical biomarker to diagnose and treat pancreatic cancer. It includes academia and medical institutions such as Harvard and its affiliated hospitals, non-profits, and even entities such as the U.S. Department of Defense.


Berg’s scientific strategy is intricately linked to its partnering strategy. The unusual approach has allowed Berg to obtain literally trillions of data points from each tissue sample analyzed in their research. The company’s researchers then use artificial intelligence combined with fundamental biology to make sense of that data.

 “The more tissue samples we get, the smarter the machine gets,” explained Sarangarajan of the alliance-and-research strategy.


The day concluded with a reception to meet and greet partners and colleagues and network among the more than 160 biopharma industry partnering professionals in attendance.

Tags:  2014 ASAP BioPharma Conference  artificial intellegency  Berg  Niven Narain  pancreatic cancer  partnering strategy  Project Survival  Rangaprasad Sarangarajan  Vipula Tailor 

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Partnering to Create Demand Is the New Paradigm for Business-to-Business Sales—So Act Now or Be Left in the Dust

Posted By John W. DeWitt, Wednesday, November 19, 2014

Sales consulting firm Revenue Storm recently asked business and sales leaders, “Do you believe that the role of an Account Manager must expand from one that just does Demand Capture to one that includes Demand Creation?” A whopping 97% of respondents said yes—and 79% agreed that this shift in focus needs to happen immediately, according to Revenue Storm’s Chief Revenue Officer LaVon Koerner.


“Any company that is not moving from a demand capture philosophy to a demand creation philosophy is going to be left in the dust,” Koerner said bluntly. In his workshop session at the 2014 ASAP BioPharma Conference in Boston USA, Koerner challenged alliance executives to recognize the full implications of what he called “the disruption factor” caused by converging trends such as alternative information sources, current economic conditions, widespread commoditization, and the next generation of technology user. “There’s a fair amount of denial about it—it’s hard to accept that what you’ve been doing for years upon years without interruption is about to go through a major, unrelenting, irreversible transformation,” he explained.


There’s been a major shift in what your customers and partners value more from you—according to research cited by Koerner, 82% seek partners who challenge their thinking, proactively bring innovative ideas, and provide thought leadership. Only 18% value how you execute requests, provide the best offering or price, and respond and listen when approached. Increasingly, the latter types of interaction are being automated—the analyst firm Gartner now predicts that by 2020, 85% of interactions between businesses will be executed without human intervention. As a result, Koerner says, of the 18 million salespeople currently working in the US, only about four million will be left in five years.


Koerner’s message resonated with biopharma alliance executives—while most are not accountable for revenue today, many alliance execs at the ASAP BioPharma Conference agreed with Koerner’s premise that in the future, their jobs will be more closely linked to value and revenue creation, as it is for many alliance leaders in high tech and other industries. ASAP Media caught up with Koerner this week to ask him about his well-received ASAP BioPharma Conference session and how he thinks alliance executives in biopharma and other industries should respond to impending (or rapidly unfolding) disruption. Here’s what he had to say.


ASAP Media: The data points you presented at the ASAP BioPharma Conference are eye-opening—everyone talks about disruption, but I don’t know if people are grasping just how profound this disruption will be for them, their companies, and their industries. How do you explain what’s going on?


LaVon Koerner: What exactly is happening? The old business-to-business sales paradigm is built on a philosophy of demand capture. There’s enough demand out there—“go get it you guys!”  You capture demand with your best products or pricing or relationships or whatever—and assume the demand is out there to be captured. Now, because of a number of converging trends, there is not going to be enough demand to capture for companies to reach their growth targets. … Those 4 million sales executives left standing will be those who excel at creating demand, not capturing demand. All the old sales training will all be antiquated and will not mean a hill of beans—it’s now about creating demand.


ASAP Media: Can you explain more precisely about what you mean by creating versus capturing demand—and how that impacts the B2B sales process?


LaVon Koerner: In the past, capturing demand is where you go in and discuss “known points of pain.” That’s a key phrase. That will be changed, so that a salesperson will go in and talk about “unknown points of gain.” Another way of saying it is, instead of going out into the market and finding customers, your charge will be to go out into the market and make customers.


The whole world of RFPs—those are going to be drying up because they will be accomplished all through the Internet or a call center. You won’t need the live body interfacing for those kinds of discussions. But discussions built on thought leadership, or a “value encounter,” would be of interest. In the future, every meeting with senior people has to be a value encounter with three important facets:


  1. You have to take the executive’s mind to places it’s never been before
  2. You have to put options on the executive’s table that he or she has never considered before
  3. You have to get the executive to draw lines of connection that he or she has never drawn before


If you can do those three things, you’ve earned the right to ask that executive to do things he or she has never done before—and in that moment demand will have been created.


ASAP Media: How do companies and their salesforces create these “value encounters”? What will value encounters look like five years from now?


LaVon Koerner: It used to be that we, the salespeople, would bring privileged data to the customer of which they were not privy, and they would find that exciting and of high value. Customers can be in data smog in a few minutes just by Googling. So the 90s then migrated towards information—if you can put summaries on data you now have information and that became important. … That did well except that the trends are so quick and accelerating, now that is done. Now the business professional salesperson has to take the information and translate it one more step into insight. You have to take all the information and be able to pontificate on the “so what?”—here are the implications; here is the significance of that. If you can do that before the customer solidifies its information, then you become a strategic resource.


By 2020, it will take yet another step forward, and insight will not be enough. At that point, it will have migrated towards prediction—what this new insight will produce in their company—and it will be necessary for the sales professional to be able to offer a gain-sharing arrangement around the prediction. So they will now become a partner with the customer, built on a prediction. If you follow that evolutionary ladder, it goes from data to information to insight to prediction—that’s how value is being redefined as we speak.


ASAP Media: So how does this create opportunity for the alliance management community?


LaVon Koerner: I believe that strategic alliances will be a major part of the sales professional’s worlds. Today it’s a minor part, but that will completely flip-flop. You will have to have that [partnership] to create the value. I think ASAP’s best days are probably four to five years from now. Proactive partnering that creates demand—not the reactive partnering that companies have practiced in the past—will be standard operating procedure in a few years from now.

Tags:  2014 ASAP BioPharma Conference  Demand Creation  LaVon Koerner  Proactive partnering  Revenue Storm 

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Lowest Cost Provider—or the Best Partner? BioPharma Sponsors and Contract Service Providers Debate the Value and Management of Strategic Partnerships

Posted By John W. DeWitt , Monday, September 22, 2014

Are strategic partnerships between biopharma sponsors and service providers an oxymoron? Or are partnerships with clinical research organizations (CROs) and contract manufacturers (CMOs) an idea whose time has come? John Barry, MBA, department head, vendor strategy management for Merck Research Laboratories, led a robust panel discussion exploring this topic on Thursday, Sept. 4, at the 2014 ASAP BioPharma Conference in Boston, Mass., USA.


Traditionally, sponsor’s relationships with service providers have been transactional vs. collaborative—and efforts to forge genuine partnerships directly confront the challenge that CROs and biopharma companies operate very differently.


“CROs don’t have an upside like pharma companies—they have fundamentally different business models,” noted panelist Joshua Schultz, corporate vice president, peri/post-approval services, Parexel International.  However, he argued, partnership represents a better way to work. “The transactional model—with very little alignment of incentives—is old school and not particularly efficient. If you can align incentives, even though there are different business models, you can work together effectively.”


Schultz noted that there’s been a “shift from purely transactional model, and we now have a wide variety of strategic approaches—it’s very different from seven to nine years ago.” He then answered the question Barry posed: “What is the asset that you mobilize the team around?”


The answer, Shultz explained, is “different in a partnership construct than an individual project.” Partnership is tied to corporate strategy. “It’s not just a project, but a much larger asset, a relationship, against which you can make incremental investments. ….  What’s the future opportunity and what investments can and should we make to ensure this is a robust relationship?”


Partnership is essential to the Cubist Pharmaceutical business model, according to panelist Mary Kachinsky, CPSM, CPM, the company’s senior director, strategic sourcing. 


“We’re a virtual company, everything is done externally – so our biggest relationships are with CMOs and CROs in this case,” she explained. “We’re a small company, four commercial products, and three in late stage development, working with global development and commercialization. Now we’re trying to review what our needs are. We went from a one-product company, made two acquisitions, and brought in new assets. When I joined Cubist in 2011, they … were hands off, ‘here’s my study, when you’re done come back to me,’ and there was very little oversight.” Cubist recognized the need for a different strategy and today takes a more hands-on approach to manage (but not micromanage) its service provider partnerships.


“It’s not about cost—yes, we want competitive rates, but I’d rather pay more if I have to for the quality.  I would rather pay more for the timeline, and I’d rather pay more for the expertise that the CRO will bring to me, because we may not have the expertise. We need expertise, quality, speed, and feel that it needs to be at a competitive rate so it’s a fair price to Cubist. We’re not looking for the lowest cost provider, but the best partner.”


Barry commented that today, “it strikes me that suppliers we have in our industry have a much better lens on what’s happening and our knowledge is getting a little bit stale. … Merck, not unlike other pharma companies, has publicly said that much of its value is outside the organization now and it depends on various types of collaborations.”


Barry then asked panelist Solomon Babani, CA-AM, global vice president of alliance management at Covance, to address the issue from a service provider perspective. “How do you create the partnering opportunities for a Covance?”  


“Last year at this conference, a point that came up is our ability to lead with alliance management,” Babani recalled. “A lot of folks commented that often alliance management is brought in late in the game. If you can’t come up with a book of business and show what’s coming forward, then CROs will be reluctant to come forward. But that’s wrong—you need to demonstrate the ability to lead with alliance management. Someone who can develop trust, build relationships, all the things you want in the relationship, should be involved from day one. The CRO needs to be willing to make the investment.”


And increasingly, he added, players of all sizes want to partner. “That’s a lot of the feedback I’ve gotten at Covance from biotechs—they’re looking for a relationship, not for something that’s very transactional.”


Audience member Christine Carberry, CSAP, asked panelists, “How do you deal with the challenge that business models are so different? How do you deal with the fact that the risks and rewards are different?”


Kachinsky answered, “Because we are small, we have to align with that CRO, determine the expectations. When I first went to Cubist, we didn’t spell out deliverables, it was just a cost plan. … now we’ve educated our clinical team to be much more specific about that deliverable. Having that clarity has begun to make a real difference for us. We have maybe 60 people on a clinical team, so you have to be aligned, you can’t have your finger on all the dikes.”  


Barry commented, “Merck isn’t interested in transferring medical or commercial risk to our suppliers—but we will transfer capacity management risks and economic risks.” Therefore, to achieve alignment, you need “to get a lot more specific in the risk discussion. What’s important to Merck is a well-controlled environment.”  

Tags:  2014 ASAP BioPharma Conference  Christine Carberry  Covance  John Barry  Joshua Schultz  Merck Research Laboratories  Parexel International  Solomon Babani 

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ASAP BioPharma Conference Keynote Address, Part Two: John Maraganore Describes the Roadmap for Success in the Alnylam-Genzyme Partnership

Posted By John W. DeWitt , Thursday, September 18, 2014

Petra Sansom, head of alliance management at Genzyme, described Alnylam as “a very collaborative partner—from senior management to project teams.” In particular, she commented after listening to Alnylam CEO John Maraganore speak in-depth about the two companies’ landmark alliance, “I have very strong CEO engagement for this alliance. For me as an alliance manager, it makes it really valuable. We have a very rich portfolio on the rare disease side and a shared vision of a multiyear, multi-asset collaboration.”


In his keynote address at the 2014 ASAP BioPharma Conference in Boston USA on Thursday, Sept. 4, Maraganore described this shared vision, honing in on Alnylam’s deal strategy and framework for managing its partnership with Sanofi-owned Genzyme. In January, Alnylam, a pioneer in the development of RNA interference (RNAi) therapies, signed a far-reaching deal to expand its Genzyme partnership, which began in October, 2012. (Click here for Part One of our coverage of Maraganore’s lively and richly detailed keynote address.)


Maraganore described some of Alnylam’s “strategic considerations in December of last year before we did this deal” with Genzyme, including:


  • The success of the underlying science. “The science works. It’s a modular, reproducible platform, and opportunities abound with ‘just’ liver delivery alone,” he explained. “Even with liver delivery, we have more on our plates than we can deal with.”
  • How to access capabilities and funding. “With the complexity of product development and commercialization, $1 billion was required to reach profitability.” But Alnylam couldn’t give away the farm to get that funding. “We felt we needed to retain significant product rights to build maximal value—we want to build billion-dollar biotech, and felt we needed to maintain development and commercial control to fulfill our commitment to patients with Alnylam’s urgency.” 
  • How to maximize value while maintaining independence. Maraganore went on to ask rhetorically, “If it goes to your partner, have you given away the company?” For Alnylam, he emphasized, there was “absolute desire at the level of the board to build an independent company, because we believe we can build a lot more value than if we get acquired by somebody else.”

On the backbone of the success of Alnylam’s first alliance in 2012 with Genzyme (“ for Japan and Asia/Pacific, with $22.5 million up front , additional milestone payments totaling $50 million, and tiered royalties”) “we generated some very critical human data in our TTRsc program. These data were the validation of our potential to expand the pipeline—they convinced our technical colleagues at Genzyme and cemented the impression that this approach could be transformative.”


Maraganore and his counterpart David Meeker, CEO of Genzyme, deliberately set out to create a “Roche-Genentech-like expanded alliance” and forged the deal on a “rapid timetable from August 2013 to January 2014, with the contract signed right before JP Morgan [Healthcare Conference]” in San Francisco. “The world loved it, there was lots of media coverage and fanfare—that was all a lot of fun,” Maraganore commented before getting down to the nuts and bolts of what he described as “a transformational alliance to expand and accelerate global product value.” Key elements include:


  • Multiproduct, option-based scope and structure.
  • Geographic license structure – Alnylam retains North America and Western Europe, with Genzyme having the option (expires 2019 or no later than 2021) for the rest of the world
  • Rare disease field only.
  • Eight programs must hit Proof of Concept.
  • An overall alliance built and managed around the “Alnylam 5x15 pipeline” and future RNAi therapeutics as genetic medicines.

“It is a good deal for Genzyme because they are coming in after human studies,” Maraganore pointed out. “The default mode is Alnylam keeps North America and Europe, but there are exceptions – e.g. areas where there’s significant market development needed and we can do it leveraging the infrastructure and resources of Genzyme and Sanofi.” Another exception was in the area of hemophilia—Genzyme “wanted more product rights to justify the investment,” he explained, adding that “equity agreements were very important, [therefore] very heavily negotiated.”


The ongoing relationship is carefully managed through what Maraganore called an “Alliance Management Best Practice Framework.” He emphasized executing on the “basic but critical” elements of effective alliance management—“start off well and keep it up!” with

  •  Shared mission
  • Clear goals, roles, and expectations
  • Explicit governance and decision-making
  • Collaborative relationships and communication
  • Senior commitment, supportive culture, and champions
  • Proactive management of scientific challenges

Indeed, senior executives from both companies are deeply involved in alliance governance and day-to-day operations, Maraganore said.


“The Alliance Joint Steering Committee (AJSC) is the highest level of our alliance team, with very senior people—our president is on that team, the head of rare disease at Genzyme, our chief medical officer, and so on,” he said. “CEOs get involved if the AJSC can’t achieve consensus. The AJSC coordinates overall activities and coordinates disputes—it’s the decision-making body. We also have product-specific steering committees, a portfolio advisory committee, [and other committees including] pipeline advisory, intellectual property, manufacturing, and finance.”


Maraganore and his counterpart, Genzyme CEO David Meeker, are not just champions but also very actively engaged in the day-to-day of the alliance. “I have a close working relationship with David, both formal and casual,” Maraganore said. “I get texts from my wife, kids, and David. We see each other in meetings, we meet monthly, and we have dinner together occasionally.”

Tags:  2014 ASAP BioPharma Conference  Alliance Joint Steering Committee  Alnylam  David Meeker  Genzyme  John Maraganore  Petra Sansom  Roche-Genentech  TTRsc program 

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John Maraganore: Alnylam’s Alliance with Genzyme ‘Transformed Our Balance Sheet, Giving Us Financial Independence’

Posted By John W. DeWitt, Monday, September 15, 2014

Alliance executives often struggle with measuring the value delivered by alliances and the alliance management function. Alnylam CEO John Maraganore has no such difficulty. His company is a pioneer in the development of RNA interference (RNAi) therapies. Amidst great fanfare preceding the JP Morgan Healthcare Conference, in January of this year Alnylam signed a far-reaching partnership deal with Sanofi-owned Genzyme. In his lively and richly detailed keynote address at the 2014 ASAP BioPharma Conference in Boston USA on Thursday, Sept. 4, Maraganore clearly articulated this alliance’s growth and financial implications for Alnylam business.


“This provided a major capital infusion as well as expense sharing going-forward,” he explained in a talk entitled “Alnylam-Genzyme: Breakthrough Therapy Made Possible by Breakthrough Partnership. “Our deal with Genzyme took our balance sheet from $325 million to over $1 billion. It transformed our balance sheet, giving us financial independence all the way to becoming profitable.”


Yet this financial payoff still isn’t what Maraganore considers the most significant value of this alliance. “More than the money, we were convinced that working with Genzyme would increase the pie,” he said. “Without this deal, we probably would have been more stepwise in building our pipelines.”


RNAi therapeutics, Maraganore explained to a rapt audience of biopharma industry alliance executives, are a new class of innovative medicines based on a clinically validated platform that harnesses natural pathways for therapeutic gene silencing. “Hundreds of diseases can be knocked down with our strategy—the ‘Alnylam 5x15 Strategy’—which provides a reproducible and modular path for genetic medicines.”


Maraganore’s talk began with an overview of the science that brought Genzyme and Alnylam together.


“What we do, and why it’s so potentially powerful, is we change nothing but the sequencing of the drug to make it attack a different gene. In part one of our development, we’ve figured out the targeting of liver-expressed genes. You know with almost complete certainty that you will impact by targeting that gene,” he explained. “The second part of our strategy helps to stack the odds in our favor. If we can learn in Phase One trials that our drug is working, and if we can learn in that study how we get to the right dose regimen, we get through another critical unknown. A lot of drugs fail in Phase Three because you don’t get to the right dose.”


Maraganore frankly acknowledged that the final part of Alnylam’s strategy—getting through regulatory approval and on the market—“has no free lunch.” However, the company’s product strategy has allowed it to reduce the scope and cost of Phase Three trials.


“We really focused on areas with a definable path to approval and market … where our Phase Three program would be comprised of hundreds of patients as compared to thousands or tens of thousands of patients. We’re a small company, so our strategy has led us into the rare disease space,” he explained, emphasizing that Alnylam has taken a “collaborative approach with patients, payers, and regulators.”


Even just with an initial focus on the liver, Alnylam has no shortage of diseases to target—“almost everything in genetic disease space,” Maraganore said. Current examples include:


  • Transthyretin-Mediated Amyloidosis (ATTR). “This is an unmet need and product opportunity. It presents middle of life and can result in liver or heart failure ultimately. There are 50,000 victims worldwide.”
  • Hemophilia. “Why would knockdown strategy work if caused by a genetic lack? By knocking down anticoagulants,” Maraganore said. “It’s a $9 billion market with high unmet need.”
  • Porphyria, an ultra-rare orphan disease.  

In ASAP Media’s next blog post on Maraganore’s speech, we will delve into the Alnylam CEO’s fascinating review of his company’s groundbreaking partnership with Genzyme—what he described as “a transformational alliance to expand and accelerate global product value.”

Tags:  •Transthyretin-Mediated Amyloidosis (ATTR)  2014 ASAP BioPharma Conference  Alnylam  Genzyme  Hemophilia  John Maraganore  Porphyria  Sanofi 

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