Winter 2016 Ten Considerations for Companies Evaluating a Pre-Negotiated Acquisition By James Huie (Associate, Palo Alto) and Andrew Ellis (Associate, Palo Alto)
In recent years, there has been a shift in the research and development strategy of large pharmaceutical and medical device companies from internal development of new technology to external investment in promising young companies. As opposed to a large company facing scrutiny over the failure of an internal project, funding external development allows these large companies to abandon projects that do not meet expectations at a lesser cost. From their perspective, they want access to technology and a “finger on the pulse” of its development without a wholesale commitment to its costs. One common way to achieve this goal is through an option structure, where a cash payment is made up front to an early-stage company to fund the development of its project(s) in exchange for the right—but typically not the obligation—to acquire the technology or the company in the future. Consideration under these so-called “pre-negotiated acquisitions” often takes the form of a smaller upfront payment upon the acquisition, with more significant contingent payments occurring in the future based on milestones or a certain date. From the perspective of the target company, funds are needed to pursue its research and development strategy in what is still a difficult market for fundraising. Although the public markets have been strong for the last two years, many companies still encounter difficulty raising early-stage funds, and the market volatility seen thus far in 2016 may prove to be an additional headwind. As such, companies may need to increasingly rely on strategic investors for early-stage funds. Pre-negotiated acquisitions have the effect of front-loading the negotiation and related diligence for an acquisition at the financing stage and present unique issues for target companies. The following is a list of 10 key considerations unique to this deal structure that warrant focus when structuring these transactions.
While pre-negotiated acquisitions can be beneficial to both sides of the transaction, there are important issues to resolve beginning at the earliest stages of the process in order to avoid potential pitfalls. If you would like to discuss any of the above issues further, please feel free to contact James Huie, Andrew Ellis, or another member of Wilson Sonsini Goodrich & Rosati’s life sciences practice.
Q&A with Multiple Myeloma Research Foundation Founder and Chairman Kathy Giusti Wilson Sonsini Goodrich & Rosati attorneys Vern Norviel, David Hoffmeister, and Charles Andres recently sat down with Kathy Giusti, founder and executive chairman of the Multiple Myeloma Research Foundation (MMRF). Since its inception, the MMRF—a client of WSGR—has opened more than 60 clinical trials of 30 compounds and combination approaches and helped win FDA approval of seven new drugs. Most impressively, these treatment innovations have helped to more than double the average life expectancy of multiple myeloma patients. Q: Please tell us about your background and why you founded the MMRF.
Q: You recently testified before the U.S. Senate Committee on Health, Education, Labor and Pensions on the need to standardize the platforms for electronic health records (EHRs). How important are EHRs to the MMRF’s end-to-end system in precision medicine and what can start-up companies developing new medicines learn from the MMRF’s experience with EHRs? A: A lack of easily accessible health data remains a major barrier to progress in precision medicine. This is changing thanks in part to the Meaningful Use Program, which began in 2009 to encourage the 491,000 physicians who serve Medicaid and Medicare patients and almost 4,500 hospitals to begin to adopt and use EHR systems. At the same time, patients are increasingly able to access their digital health records through patient portals. This allows patients to follow their cancer journey through data—monitoring blood work and other lab results, for example, over time. It also allows them to share their data for research, where it can be aggregated and analyzed alongside the data of many other patients. Unfortunately, when we look at the numbers, we see that the number of patients taking advantage of these technologies is too low. According to a recent survey, only 36 percent of Americans are using patient portals and 35 percent of Americans did not even know they had a patient portal. In contrast, when we looked at MMRF data, we found that 85 percent of our newly diagnosed patients know they have a portal, and over 95 percent use their portal. This shows just how important trusted third parties—like the MMRF and other disease-based foundations—can be in raising awareness and education among our patients. Q: The MMRF has been aggregating cancer patient molecular data and pushing the data, in de-identified form, out to the public. Why is the MMRF doing this and how can interested start-ups developing new medicines and researchers access the data? A: Realizing the full promise of precision medicine requires access to data and information available at multiple levels. This data, of course, must first be shared by patients, without whose tissue and personal and health data the science would not be possible. Data must also be shared by and among the global research community, from a single academic scientist to pharmaceutical giants; together we can then take a collective approach to making sense of massive quantities of data—so big that no one person or research lab could do it on its own—and generate new hypotheses, targets, and therapeutic approaches. We recognized this early on at the MMRF and, most recently, with the launch of our CoMMpass trial, a long-term study to identify specific molecular alterations that are driving myeloma. One thousand patients agreed to have their cancer genome sequenced at diagnosis; some will also be sequenced again when they relapse. Along the way, we’ve opened up and shared this data—the most robust look at myeloma to date—with qualified researchers through our Researcher Gateway, allowing scientists from around the world to be part of the cure. Our genomic studies have already yielded important discoveries, such as a mutation in the BRAF gene that had previously never been linked to myeloma. Treatments that target this same BRAF mutation have already been approved for other cancers and will be under study next year in our clinical network for myeloma patients who harbor the cancer-causing mutation. Q: The MMRF has a long history of providing research grants to non-profits, universities, and senior researchers. Your efforts have already made a large impact on patient care for multiple myeloma. Where do you think the biggest impacts will be made in the next 10 years to improve the situation even more? A: There are three innovations that I believe will dramatically change the way we treat myeloma in the near future. The first is genomically informed treatments; that is, those that target specific alterations in an individual—a mutated gene or errant protein, for example—that give rise to cancer or promote its spread. The second is immunotherapies, like checkpoint inhibitors and immunostimulatory antibodies, which are drugs that make use of a patient’s own immune system to fight cancer. And the third is novel and rational combinations of both, which will allow us to attack cancer in multiple myeloma and disrupt its growth. Q: The MMRF and its partners have helped gain FDA approval of seven drugs, with three more approvals expected in the coming year. What are some key factors contributing to this high success rate with the FDA? A: Because myeloma is a rare disease with an unmet medical need, certain regulatory opportunities exist—such as orphan drug designation and priority review—that can lead to faster FDA review and approval times. Still, the drugs that have been approved in myeloma were based on strong data showing robust efficacy, even among those with advanced, hard-to-treat disease. From the beginning, we have been focused and prepared to work with the FDA as needed. We have also leveraged the FDA’s willingness to meet face-to-face and have often invited representatives to our scientific strategy meetings. Q: What are the three most important lessons you have learned in implementing your precision medicine initiative? A: Precisely selecting the best treatment based on a person’s sub-type rather than a one-size-fits-all-approach has the power to dramatically transform the way we treat cancer. We’ve already seen that in some sub-types of cancers, like HER+ breast cancer or ALK+ lung cancer. Bringing these same advances to myeloma has required that we develop an end-to-end model in precision medicine. By aggregating patients’ clinical and genomic data, and making this data publicly available to researchers worldwide, we will uncover important mutations associated with the disease. We then rapidly advance the most promising discoveries into clinical trials through our clinical network, where patients can immediately benefit. This can only be done by engaging patients from the beginning and at every step of the research process. It has also proven critical to look to partners as both advisors and funders. And, lastly, staying on top of technology is an absolute must because it is constantly changing. Q: What are some ways interested individuals and companies can help the MMRF advance its mission? A: There are so many ways to join us in our mission—by bringing innovative new ideas to the table, by offering up technical expertise, by providing funding and other support. Curing cancer cannot be done alone. It takes a team. In addition to serving as the founder and executive chairman of the Multiple Myeloma Research Foundation, Kathy Giusti has more than two decades of experience in the pharmaceutical industry, previously holding senior positions at G.D. Searle and Merck. Since founding the MMRF in 1998, Kathy has led the foundation in establishing innovative, collaborative research models in the areas of tissue banking, genomics, and clinical trials. She is widely recognized as a champion of open-access data sharing and a strong advocate for patient engagement, not only in their cancer care, but as part of the research and drug development process. Kathy’s leadership has earned her several prestigious awards and recognitions. Most recently, she was ranked No. 19 on Fortune Magazine’s World’s 50 Greatest Leaders list. In 2011, she was named to the TIME 100 List of the world’s most influential people. She has been named an Open Science Champion of Change by the White House and has also received the American Association for Cancer Research Centennial Medal for Distinguished Public Service, the Harvard Business School Alumni Achievement Award, and the Healthcare Businesswomen’s Association’s Woman of the Year Award. She currently sits on the White House Precision Medicine Initiative Working Group. To learn more about the MMRF, please visit http://www.themmrf.org/. Preventing the Preventable: How to Protect Your Life Sciences Company from Self-Insuring Large-Dollar Patent Infringement and Patent Enforcement Litigation By Matthew L. Cohn, Senior Vice President, Alliant Insurance Services According to the PwC 2015 Patent Litigation Study, biotech/pharma and medical devices were two of the five most active industries in patent litigation and two of the top three industries for the largest median damage awards. IP litigation in the life sciences industry is not a question of if, but rather of when, how often, and how bad. The real question is whether you are going to continue to self-insure the exposure because the insurance brokerage community is unaware of and/or intimidated by IP infringement and IP enforcement insurance coverage. Generally speaking, risk management experts do not recommend self-insuring risks that are both frequent and severe. So why is it that the vast majority of life sciences companies are completely uninsured for IP litigation? Let’s face it, the world of IP is intimidating even to the most experienced sales professionals. Unfortunately, the insurance brokerage community does an inadequate job of educating its clients on IP coverage, which results in the vast majority of life sciences executives self-insuring their IP risk by default rather than relying upon careful decision-making and due diligence. Since IP is not covered in traditional product liability policies and patent infringement claims are excluded in most if not all other liability policies, there is a need to secure stand-alone, specialty coverage for IP exposures. The Stakes Are High According to the American Intellectual Property Law Association’s (AIPLA’s) 2015 Survey, the average cost of patent infringement litigation—excluding amounts paid to settle or satisfy judgment—is $3,500,000 when the amount in controversy is extremely small ($10-25 million). Add another approximately $4 million if you lose the fight. And, of course, the greater the amount of dollars in controversy, the greater the cost of litigation. Some “Small” Numbers Patent trolls/non-practicing entities (NPEs) cost U.S companies more than $10 billion a year. This number increases substantially when factoring in indirect costs such as diversion of resources, delay in new products, and loss of market share. One common misperception is “I’m just a small company—it’s not going to happen to me.” In actuality, however, the number of lawsuits filed by patent trolls increased to 2,026 in the first half of 2015—and companies with less than $100 million in revenue were hit the hardest. Specifically, 1,410 new patent troll lawsuits (or approximately 70 percent of such lawsuits) targeted these companies in the first half of this year. It is often said that success creates conflict. All too often, smaller companies are targeted because their bigger alleged infringers believe they don’t have the financial capacity to fight. Thus, litigation sometimes is won not based on the merits of the case, but by the party with the deeper pockets. It’s Time to Even the Playing Field Below is a brief discussion of various types of IP infringement and IP enforcement insurance coverage. IP Enforcement Insurance (Abatement Insurance) With IP enforcement insurance, also known as abatement insurance, a legal fund is provided by the insurance company to help finance the enforcement of your IP against the alleged infringer. The insurance company can send out an early intervention letter to quickly alert the alleged bad actor of your financial ability to fight (paid for by the insurance carrier). This insurance coverage basically allows you to go pick a fight with the alleged infringer utilizing insurance company money. Coverage can include a legal fund/enforcement fund, expenses associated with invalidity counterclaims made by an alleged infringer, and costs associated with post-grant and reexamination proceedings. IP Infringement (Defense Cost Reimbursement Insurance) Many believe it is the patent troll’s sole objective in life to target companies (often smaller companies) that are unable to pay patent litigation defense costs, forcing them into signing licensing agreements and paying royalties. IP infringement defense cost insurance will at times deter frivolous litigation brought by patent trolls and/or competitors. Coverage can include reimbursement of your litigation expenses incurred when defending against allegations of IP infringement, costs to assert patent invalidity as a defense, costs associated with post-grant and reexamination proceedings, and optional coverage for the reimbursement of settlements or damages awarded against you. Business Interruption Coverage for IP This optional coverage can provide first-party coverage directly to the insured client for non-compensated loss of value or loss of business income that is the consequence of legal actions. Coverage can respond after the final adjudication of a civil proceeding that directly caused or gave rise to the loss of value. Perils insured can include business interruption, loss of commercial advantage, cost of redesign, remediation, and reparation. Cost-Benefit Analysis: Does IP Insurance Pencil Out? Generally speaking, the purchase of IP coverage pencils out when considering how frequent IP litigation is in the life sciences space and the average costs involved. Premiums are typically calculated based on a number of factors, including but not limited to the number and types of IP insured, how strong the IP portfolio is perceived by the IP attorneys underwriting the risk, how litigious your niche is viewed to be, and the limit of coverage desired. Additional Potential Advantages of Insuring Your IP Many insiders suggest that insuring your IP makes it more valuable when considering a transaction or exit. In addition, it may facilitate quicker and easier access to financing for smaller, early-stage companies.
Overcoming Restriction Requirements on Pharma Patents By Vern Norviel (Partner, San Diego and San Francisco), David Hoffmeister (Partner, Palo Alto), Mike Hostetler (Partner, San Diego), Prashant Girinath (IP Specialist, Washington, D.C.), David Van Goor (Patent Agent, Washington, D.C.), and Charles Andres (Associate, Washington, D.C.) Patent prosecutors strive to optimize protection afforded by pharmaceutical patents for branded pharmaceutical clients. For reasons discussed below, one underappreciated way to optimize pharmaceutical patent protection is to successfully address a restriction requirement (or lack of unity of invention counterpart) raised by a U.S. Patent and Trademark Office (USPTO) examiner during a patent examination. Restriction occurs when, in the opinion of the USPTO, there are at least two inventions in a single patent application and (i) the inventions are independent or distinct and (ii) there would be a serious burden on the examiner if restriction is not required.1 The effect of a restriction requirement, if made final and not withdrawn, is that at least one invention will not be examined. The non-examined invention can be separately pursued in a divisional application.2 Overcoming a USPTO restriction is not trivial. Attempts to overcome a restriction can produce more prosecution history estoppel than simply not traversing. Additionally, because restricted claims can be separately pursued in follow-on applications, accepted thinking is often that one patent that includes claims to both a drug product and methods of making the drug is essentially equivalent to two patents—the first containing claims to a drug and the second containing claims to methods of making the drug. For some or all of these reasons, patent practitioners may choose not to contest a restriction requirement. The thinking that one patent containing two types of claims (e.g., drug product and methods of making the drug) is "about equal" to two patents each containing one claim (e.g., a drug patent and a method of making the drug) is upset by Orange Book listing rules. From Orange Book and subsequent pharmaceutical patent litigation lenses, the single patent containing two claim types can provide significantly more value. The Orange Book The Orange Book3 contains a listing of drugs approved by the U.S. Food and Drug Administration (FDA) under the Federal Food, Drug and Cosmetic Act. Among other things, the Orange Book:
Orange Book Listing Rules Patents eligible for Orange Book listing must be timely filed.4 And, only patents containing at least one claim to the approved:
qualify for Orange Book listing.5 In contrast, “[p]rocess patents, patents claiming packaging, patents claiming metabolites and patents claiming intermediates are not covered . . . and information on these patents must not be submitted to the FDA.” Thus, the only way to get issued claims to methods of making a drug, intermediates used therein, and drug metabolites into the Orange Book is to have those "unlistable" claims issue in a patent also containing at least one Orange Book-listable claim. Contesting a Restriction Requirement – An Alternative Strategy It is not unusual for a restriction requirement to be issued by a USPTO examiner, which forces a patentee to choose between:
Because drug patent claims are generally perceived to be valuable, these are often selected when responding to a restriction requirement. If restriction is maintained, the resulting patent will issue containing only drug claims and this drug patent will end up being Orange Book listed. Claims to the remaining inventions, excluding methods of treating patients with the drug, are pursued in separate divisional patents that are not Orange Book listable. But where a restriction requirement is successfully traversed or rejoinder7 is requested and affected, the Orange Book-listed patent will contain additional diverse claims drawn to potentially include key intermediates for making the drug, methods of making the drug, and a drug metabolite. Implications of Diverse Orange Book-Listed Claims The process of commercializing a generic drug begins by reviewing Orange Book-listed patents for the branded drug. If the intent is to file an abbreviated new drug application, or ANDA, before Orange Book-listed patents expire, the would-be ANDA filer then usually obtains opinions from patent counsel as to why the patents are not infringed, invalid, or unenforceable.8 Positions taken in the opinions form the basis for the notification letter that is legally required to be sent to the branded patent holder after the ANDA is filed by the FDA. Filing of an ANDA is an infringing act9 and the branded patent holder, after receiving notice, is provided the opportunity to sue the ANDA filer in a federal district court, thereby triggering an automatic 30-month stay in ANDA approval. Having a diversity of claims in Orange Book-listed patents creates significant added barriers to would-be generic manufacturers. For example, because the diverse claims are Orange Book listed, a 30-month stay of FDA approval can be based upon these claims. In the absence of having these diverse claims Orange Book listed, a patentee would need to take additional action, for example attempting to get a preliminary injunction based on diverse claims not found in the Orange Book listed patent(s). Also, the inclusion of diverse claims can force the generic manufacturer to take invalidity or noninfringement positions earlier in time than they may otherwise would. Opinions for non-Orange Book-listed claims can be finalized later in time—because of the notification and lawsuit timelines—than those for Orange Book-listed claims. Formulating invalidity positions that can survive challenge takes time and rigorous thinking. Given time pressures associated with opinions and related ANDA filings, some of these positions may end up being rushed, may be suboptimal, and therefore may be more open to successful rebuttal by the branded drug patent holder. The ANDA filer may then feel pressure to move away from these initial positions to new legal theories during litigation. Doing so can be more likely to result in sanctions and fee shifting—which can easily run into millions of dollars.10,11,12 Dealing with Restriction Requirements Successfully addressing restriction requirements can improve the protection afforded by pharmaceutical patents. While each restriction requirement is unique and must be treated as such, potential ways to increase the odds of having more diverse Orange Book-listed claims include:
Conclusion Restriction requirements (and lack of unity of invention equivalents), if not challenged and overcome, can decrease the claim diversity of Orange Book-listed patents and smooth the allowance pathway for generic manufacturers. At multiple levels, overcoming restriction requirements provides advantages for protecting pharmaceuticals. Addressing restriction requirements (and lack of unity of invention equivalents) should therefore be given appropriate attention. The authors dedicate this article to Peter Munson—friend, colleague, mentor, lawyer, scholar, Renaissance man. You are and will be missed.
3 Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations, last accessed July 27, 2015. 4 To be timely listed, U.S. patents in force at the point of new drug application (NDA) approval must be Orange Book listed within 30 days of approval. See, e.g., 21 C.F.R. § 314.53(c)(2)(R)(ii). “Within 30 days after the date of approval of its application or supplement, the applicant shall submit FDA Form 3542 for each patent that claims the drug substance (active ingredient), drug product (formulation and composition) or approved method of use . . . ” 5 See, e.g., 21 C.F.R. § 314.53(b)(1). 6 A restriction requirement between a drug, a method of treating a disease using that drug, and a pharmaceutical formulation of that drug could be useful, as it allows the separation of different Orange Book categories into putatively patentably distinct patents. It may make sense to not contest that type of restriction requirement. Restriction requirements should be evaluated on a case-by-case basis as part of a general patent strategy. 7 See, e.g., M.P.E.P. § 821.04. 8 See, e.g., D. Hoffmeister, V. Norviel, J. Guise, P. Munson, S. Williams, D. Carsten, R. Torczon, and P. Girinath, "Takeaways for Generics After Octane and Highmark," Law360, September 15, 2014. 10 See, e.g., Yamanouchi Pharmaceutical Co. Ltd. v. Danbury Pharmacal Inc., 231 F.3d 1339 (Fed. Cir. 2000). 11 For an example of method-of-making claims keeping generics off the market, see, e.g., Albany Molecular Research Inc. v. Dr. Reddy’s Laboratories Ltd. et al., case number 09-cv-4638; and Albany Molecular Research Inc. v. Sandoz Inc. et al., case number 09-cv-4639; both in the U.S. District Court for the District of New Jersey. 12 Examples of drugs that that have Orange Book-listed patents containing diverse claims include rivaroxaban and sofosbuvir. 13 When deciding to include product-by-process claims, consider the possibility that doing so may result in loss of divisional application safe harbor status and the implications thereof. Life Sciences Venture Financings for WSGR Clients By Scott Murano, (Partner, Palo Alto)
*Includes one mega deal ($100 million and over).
**This is a truncated average that excludes the highest and lowest amounts raised in the calculation of the average. The data generally demonstrates that venture financing activity decreased during the first half of 2015 compared to the second half of 2014 with respect to total amount raised and number of closings. Specifically, the total amount raised across all industry segments during the first half of 2015 decreased by 20.5 percent compared to the second half of 2014, from $725.52 million to $576.66 million, and the total number of closings across all industry segments decreased by 2.6 percent, from 78 closings to 76 closings. The industry segment with the largest number of closings—medical devices and equipment—experienced a decrease in number of closings during the first half of 2015 compared to the second half of 2014, but saw an increase in total amount raised. Specifically, medical devices and equipment decreased 12.8 percent in number of closings, from 47 closings to 41 closings, but increased by 20.5 percent in total amount raised, from $254.15 million to $306.32 million. Conversely, the industry segment with the second-largest number of closings—biopharmaceuticals—experienced an increase in number of closings during the first half of 2015 compared to the second half of 2014, but saw a decrease in total amount raised. Specifically, the number of closings in the biopharmaceuticals industry segment increased 46.2 percent, from 13 closings to 19 closings, while the total amount raised decreased by 46.6 percent, from $261.99 million to $139.93 million. Meanwhile, the digital health and genomics industry segments experienced an increase in number of closings and in total amount raised during the first half of 2015. Specifically, digital health experienced a 50 percent increase in number of closings, from four closings to six closings, and a 105.9 percent increase in total amount raised, from $9.75 million to $20.07 million, while genomics experienced a 100 percent increase in number of closings, from two closings to four closings, and a 151.8 percent increase in total amount raised, from $5.10 million to $12.84 million. All remaining industry segments were either flat or down during the first half of 2015 compared to the second half of 2014 on both measures. In addition, our data suggests that Series A financing and bridge financing activity compared to Series B and later-stage equity financings and recapitalization financings increased during the first half of 2015 compared to the second half of 2014. Specifically, the number of Series A closings as a percentage of all closings increased from 26.9 percent to 38.2 percent, while the number of bridge financing closings as a percentage of all closings increased from 26.9 percent to 31.6 percent. Offsetting those gains, Series B financing, Series C and later-stage financing, and recapitalization financing activity compared to all other financings decreased during the first half of 2015 compared to the second half of 2014. Specifically, the number of Series B closings as a percentage of all closings decreased from 19.2 percent to 15.8 percent, the number of Series C and later-stage financing closings as a percentage of all closings decreased from 16.7 percent to 10.5 percent, and the number of recapitalization financing closings as a percentage of all closings decreased from 7.7 percent to 2.6 percent. Pre-money valuations for life sciences companies decreased at all stages of financing during the first half of 2015 compared to the second half of 2014. The average pre-money valuation for Series A financings decreased by 41.3 percent, from $14.6 million to $8.57 million; the average pre-money valuation for Series B financings decreased by 41.3 percent, from $81.62 million to $47.91 million; and the average pre-money valuation for Series C and later-stage financings decreased by 5.2 percent, from $114.75 million to $108.75 million. Other data taken from transactions in which all firm clients participated in the first half of 2015 suggests that life sciences is now the third-most attractive industry for investment, down from second during the second half of 2014. For the first half of 2015, life sciences represented 14 percent of total funds raised, while the software industry—historically the most popular industry for investment—represented 34 percent of total funds raised and retail represented 23 percent of total funds raised. Overall, the data suggests that access to venture capital for the life sciences industry has decreased during the first half of 2015 compared to the second half of 2014. Deal activity has declined and pre-money valuations are down. It is also worth noting that financing activity during the second half of 2014 had decreased from the first half of 2014, so the lackluster activity during the first half of 2015 represents the second-straight six-month period of declining financing activity in life sciences. Looking closer at the data, Series A financings now represent a greater percentage of all deals, suggesting that whatever investor appetite remains is moving to earlier-stage deals—and the success of those deals may translate into improved activity at the later stages. Whatever the case may be, life sciences is still the third-most-popular industry for investment among all sectors in which our clients participate, and while it may be down, it’s definitely not out.
WSGR Hosts Successful 22nd Annual Phoenix Conference On October 21-23, 2015, Wilson Sonsini Goodrich & Rosati hosted the 22nd annual Phoenix Conference at The Ritz-Carlton in Half Moon Bay, California. The exclusive event brought together more than 160 high-level executives from large healthcare companies and CEOs of venture-backed firms for an opportunity to discuss critical issues of interest to the medical device industry today, as well as to network and gain insight from industry leaders and peers.
Recent Life Sciences Client Highlights
Benvenue Medical Secures $60 Million in Financing
Biotech Board of Directors and Senior Executives Reception rEVOLUTION Symposium 2016 24th Annual Medical Device Conference Phoenix 2016: The Medical Device and Diagnostic Conference for CEOs
Click here for a printable version of The Life Sciences Report This communication is provided as a service to our clients and friends and is for informational purposes only. It is not intended to create an attorney-client relationship or constitute an advertisement, a solicitation, or professional advice as to any particular situation. © 2016 Wilson Sonsini Goodrich & Rosati, Professional Corporation |
A: When I was diagnosed in 1996 with multiple myeloma, a rare and incurable cancer, the landscape was bleak. The same drugs had been used to treat the disease—and not very effectively—for the past several decades. There was very little research into the disease and few drugs on the horizon. I was given a life expectancy of about three years, but I was determined to beat those odds. My hope was that the business acumen I first developed at Harvard Business School and then honed as a pharmaceutical executive could be used to build a new kind of cancer research foundation—one that was optimized to run like a Fortune 500 company. In 1998, I founded the MMRF along with my identical twin sister, Karen, a corporate lawyer. By taking a business approach to science, the MMRF removed barriers that have impeded progress in other research efforts and, in their place, built collaborative research models that have accelerated the development of life-extending treatments. 
Matthew L. Cohn is senior vice president and leader of the Global Life Science and Medical Product Solutions Group at Alliant Insurance Services, one of the nation’s leading distributors of diversified insurance products and services. He specializes in complex commercial insurance risks across the United States and abroad, and oversees an extensive client portfolio that includes medical device, pharma, bio, dental, and nutraceutical manufacturers and distributors; contract manufacturers; CROs; and healthcare organizations. For more information, please contact Matthew at 
The two-day conference featured presentations on a variety of topics, including the opportunities and challenges of medical device investment, the role of analytics in driving more precise patient engagements, the shifts taking place in consumer healthcare, and medtech company exit strategies. The event also included a lunch with speaker Paul Yock, M.D., the founder of Stanford’s BioDesign program, who discussed the market conditions faced by medical device innovators and the criteria for future healthcare technology development. In addition, interviews were conducted with Gary Pruden, the head of Johnson & Johnson’s medical device business, and John Capek, executive vice president of venturing at Abbott Laboratories, as part of the event’s Corporate Spotlight series.
In connection with the event, the Phoenix Hall of Fame for Medical Device & Diagnostic Leadership recognized the accomplishments of companies and individuals at a reception, dinner, and awards ceremony on the evening of October 22. The NeuroPace RNS System, the world’s first closed-loop responsive neurostimulation system, was honored with the “Most Promising New Product” award and Nevro, a leading innovator in the field of spinal cord stimulation technology, was presented with the “Emerging Growth Company” award. Mark Deem and Hanson Gifford of The Foundry received the “Phoenix Innovator Award,” while Mike Mussallem of Edwards Lifesciences was named the “Lifetime Achievement Award” recipient. As such, Mike participated in a discussion the following morning with David Cassak of the Medtech Strategist, during which he discussed his career path that led up to the honor.
