Magazine Article | December 1, 2016

Company Leaders Tackle The New Year's Toughest Macro Challenges

Source: Life Science Leader

By Wayne Koberstein, Executive Editor, Life Science Leader
Follow Me On Twitter @WayneKoberstein

We posed some difficult questions to biopharma-company leaders on tough political, economic, and business challenges — those likely to become even tougher for the industry in 2017. The bravest among the invited answered our queries with thoughtful responses regarding thorny issues such as Brexit and the U.S. election, drug pricing and reimbursement, new life science business models, and the industry’s technological future.

Out of almost three dozen invitations sent to CEOs and business heads in biopharma companies of all sizes, we received seven responses. Aside from two executives from large companies, most of the respondents run small, entrepreneurial companies in the precommercial stages of drug development. Unfortunately, although more than half of the invitees were women, only one woman executive agreed to participate.

It may be useful to examine the most common reasons people gave for turning down the opportunity to participate in this forum. The most frequently used word, of course, was “busy” — providing input in the form of written answers to our questions would consume too much of the executive’s time. The second most prevalent reason concerned the subject matter: Big issues are not the chief preoccupation for entrepreneurs.

Many executives apparently choose to ignore distractions such as the U.S. election and remain transfixed on the capital markets, perhaps assuming capital moves independently of politics, reimbursement pressures, business models, and technology. There is also an undeniable risk in commenting publicly on matters that seem beyond your control. Yet, as many people may be learning in the coming year, there is arguably much more risk in ignoring large-scale, extrapersonal issues. Our respondents also varied in how they managed the risk of commenting, either by the selection of questions each person chose to answer or by the degree of formality in their answers.

DONE IS DONE

As this is written, the national election in the United States still lies a week away, and our participants submitted all of their comments weeks earlier. Yet, though the election results will be known before our publication date, its actual effects will remain unknown well into next year. The executives willing to opine on the possible consequences took those conditions into account. All but one of the respondents answered the postelection question, and most saw both possible outcomes as negative, different only by degree — but to a great degree, at that. In short, most foresaw difficulty under Clinton but probable disaster under Trump.

Will the U.S. election affect your outlook for the life sciences industry in 2017? If so, to what degree and in what ways?

In a few words, Mark Gurney of Tetra Discovery Partners summed up the postelection scenario for the biopharma industry: “Drug pricing was a presidential election issue. Pricing will continue to be under pressure from the federal government.”

Marjanne Prins of OrgaNext Research, based in the Netherlands, shared her European perspective on the presidential election in the world’s leading super power. Prins expected Hillary Clinton would continue the work begun by the Obama administration with the ACA (Affordable Care Act) to vastly increase the number of U.S. citizens with health insurance, including needed reforms to the ACA legislation. Under Clinton, Prins also would expect private healthcare companies to start enforcing financial penalties for poor outcomes in line with the ACA. But if Clinton loses, the picture would be entirely different. “Trump is likely to turn back time and try to find a way to reverse the ACA and leave many millions uninsured,” said Prins.

Victory by either party in Congress could have ill effects on the industry, according to Stephen Hurst of Savant: “I’m more concerned about the outcome of the Senate majority than the presidency. A Clinton presidency combined with a Democratic Senate majority would create additional uncertainty with regard to healthcare equities and make it more challenging to raise capital for life sciences companies in 2017,” Hurst said. “It would also fuel the firestorm over drug pricing. Considering the poor job our industry leaders have done to date in responding to the issue, it certainly won’t help our industry to face further public inquiries by Congress.” Although a mixed victory with, say, Trump as president and a Democratic senate would mean a virtual status quo — in other words, stalemate, Hurst said. But the reverse could be destructive, he implied. “A Trump presidency with a Republican Senate could generate intense pressure to amend, if not abolish the Affordable Care Act, with the resulting uncertainty having a devastating effect on healthcare equity markets that could depress the entire stock market.”

The response by Vivek Ramaswamy of Roivant adds some context to industry-related public debate accompanying the U.S. election. “This election has demonstrated that large segments of the American public are unhappy with the state of the union, and Pharma is not immune from that frustration.” Ramaswamy cited a recent Kaiser Permanente poll in which only 56 percent of U.S. respondents said prescription drugs developed over the past 20 years had improved the lives of Americans, down from 73 percent eight years ago. In the same poll, the portion who said prescription drug prices are “unreasonable” climbed to 77 percent — 5 points higher since last year. “Election season is coming to an end, but public anxieties over the development and cost of prescription drugs are not going away anytime soon.”

Because both major parties and candidates in this election have criticized drug prices, Yuval Cohen of Corbus also anticipated rising pressure from the pricing issue — but not uniformly industrywide. “Sectors exempt from this pressure will be novel drugs that offer clear benefit to patients as well as drugs for orphan diseases which serve very small, neglected populations with very high, unmet medical needs,” he said.

Kenton Stewart of Astellas gave an even more optimistic summary of the postelection landscape for the industry. “Every election provides a unique opportunity to have a forward-looking discussion on how we can make healthcare about individual patients and what is in their best interests,” he said. “Regardless of party, there’s broad agreement that we’re living in a transformative period in which medical invention will help improve, extend, and save lives.”

Stewart also made reference to a public-opinion poll, this one by the Galen Institute and Center Forward, which found nearly eight out of 10 voters want members of Congress to adopt public policies that help support new medical discoveries, and nearly two-thirds of voters hope the next president will make the issue a priority in their first 100 days. “In short, there’s significant momentum for a propatient, pro-innovation, and nonpartisan agenda in 2017. Astellas is thrilled at the prospect of continuing to lead this timely conversation,” he said.

How do you see other macro events, such as Brexit, affecting the industry in 2017?

Bayer’s Dieter Weinand placed his views on Brexit into a strong plea for measures to soften its negative effects on the industry’s role in trade, research, and medical progress — most of all, in the nation now committed to life outside the EU. “The well-being of patients and the competitiveness of the United Kingdom could be at risk if we cannot find a way of ensuring the U.K. continues to benefit from EU policies and processes related to life sciences,” said Weinand. “The EU and the United Kingdom must ensure that the British exit proceeds in a way that minimizes negative economic and social impact.

“This means that politicians will have to address complex questions, for example, related to the centralized European regulatory system. We see a strong need for harmonization and the continuity of EU regulations relevant for life sciences as well as common standards in terms of IP and patent requirements.”

Weinand said regulatory harmonization is key to achieving sustainability of research funding for the life sciences, preventing potential delay in access to medicines for U.K. patients, and avoiding additional barriers resulting from tariffs and a reduction in free movement of people. “For the pharmaceutical industry, it will be important that all parties involved can find a compromise that does not undermine patient access to life-saving drugs nor threaten innovation.”

Prins of OrgaNext envisioned a variety of possible effects of the British exit from the EU. “It will be interesting to see what will happen with the European Medicine Agency (EMA) and grants from the Horizon2020 program,” she said. “It is to be expected to take a while before we see any concrete actions — but this insecurity will make British partners in science and business less attractive for long-term projects.” Although the pound will likely deflate even more, Prins predicted, London will try to find ways to remain a major stakeholder in the financial markets, probably offering some innovative tax incentives. “But I would expect multinationals to set up shop in other EU countries, as access to money and talent in Great Britain declines in the future. Amongst my children’s peers, there has already been a shift in selection of universities for their Masters' and Ph.D. programs. The U.K. is no longer high on their lists.”

“It will take some time for the U.K. and the EU to sort things out, so I don’t see much changing in 2017. Now if other countries in the EU follow in the U.K.’s footsteps in 2017, global financial markets will face uncertainty that will hurt our industry,” said Hurst of Savant. Hurst voiced more worries about the Chinese government’s monetary policy, expecting negative effects if China continues to restrict the flow of capital out of the country. He also expects negative consequences from the contraction of foreign healthcare spending by China early in 2017. “It’s difficult to predict the magnitude of the impact, but I for one will be looking at China more than Europe with a watchful eye in 2017.”

Cohen of Corbus, dissenting from the previous views expressed by respondents, took the perspective of the “let’s not sweat Brexit” school. “While there is some concern regarding the EMA, which is based in London, I’m doubtful that such an event will have implications for the industry in the upcoming year,” he said. “If there are indeed any ramifications, it is unlikely that we will see the effects beyond the U.K.”

Tetra’s Gurney also expected most of the ill effects of the EU exit to fall on Britain itself: “Brexit may slow down partnering by U.K.-based pharma companies such as GSK. Brexit may also slow U.K. biotech growth as access to EU funding mechanisms ends.”

But Ramaswamy of Roivant believed the repercussions would spread more widely over time. In the short term, he foresaw few changes until the country invokes Article 50 to formally leave the union — a rupture delayed by a court ruling requiring Parliament to oversee the exit. “The EMA is still housed in Canary Wharf for the time being, and the U.K. will almost certainly adopt ICH (International Council for Harmonisation) guidelines when it leaves,” said Ramaswamy. “But Britain’s departure from the EU will eventually result in increased regulatory complexity, and European collaboration on R&D will be hampered in various ways, both large and small. More broadly, nationalism and protectionism are growing forces on both sides of the Atlantic that could do real damage to scientific collaboration, the pace of medical innovation, and the adoption of improved therapies.”

PUBLIC POWER, PRIVATE PRESSURE

Industry advocates traditionally emphasize government interference as the greatest threat to biopharma business and innovation. But many of the measures that have proved most challenging to the industry have arisen from other healthcare business sectors, including restrictive drug formularies, therapeutic substitution, “cost-sharing” co-pays and deductibles, and other ways of limiting patient access to higher-cost medicines. Asked directly, our respondents reflected the reality on the ground.

Will private payers — healthcare insurers, managers, and PBMs (pharmacy benefit managers) — or government present the greatest challenges for pharma, biopharma, and other life sciences companies in the coming year?

Ramaswamy of Roivant refused to put the blame on either set of external players — government or payers — for challenging the biopharma model, saying the “greatest challenges for pharma, biopharma, and other life sciences companies” are internal, not external. “They include complacency and path-dependent stagnation in R&D innovation,” he said. “Instead of blaming regulatory agencies and private payers, it would be far more productive for our industry to turn our gaze inward and focus attention on improving efficiency in the process of delivering innovation. Viewing private payers and government as opponents, rather than customers and stakeholders, betrays a lack of understanding. Pharmaceutical companies, insurers, and government each want to do a better job of delivering superior healthcare to patients. This is our greatest common challenge, not one another.”

At the other end of the size-and-complexity spectrum, Bayer’s Weinand echoed the previous sentiments in advocating close collaboration by all stakeholders in the healthcare system to ensure continued patient access to innovative medicines. Yet Weinand acknowledged competition to secure funding for “new treatments with significant value for patients” will only intensify as healthcare budgets continue to come under strain, even as he expressed confidence in innovative medicines as solutions for those budgetary challenges.

“In the United States, various players such as healthcare plans or PBMs will likely further develop approaches for volume management [like step edits and prior authorizations], selective pricing pressure through formulary listing decisions, and deal-making for specific topics,” Weinand said. “Innovative medicines help put healthcare systems on a sustainable path and ensure medical progress for patients in need. But altogether the market is highly competitive and it is likely that the competitive intensity will increase over the next couple of years.”

Savant’s Hurst was less sanguine. His view of the climate for biopharma in the larger healthcare environment portended some stormy weather. “The greatest challenges will come from patients in 2017, as we’re seeing now,” Hurst said. “I cannot predict who among the payers will pick up the charge once we’re out of the election cycle, but unless our industry leaders start addressing patient concerns effectively, 2017 is going to be a tumultuous year for the industry. The current focus is on drug pricing, but devices, diagnostics, healthcare delivery, and the enormous disparity in hospital-services pricing are all likely targets.”

Prins of OrgaNext predicts private payers will present the biggest hurdles for the industry in 2017 — if only because any legislation resulting from political speeches will develop slowly. But Prins warned of more long-term pressure on the legislative front. “As power shifts to payers and people, the marketing dominance of Big Pharma is becoming less and less, while the pressure to legislate more will become stronger. I anticipate continuous loss of jobs and M&A activities. At the same time this provides an opportunity for small companies to make a difference. But this is also due to the changing demographics, as well as the outrageous pricing and shifting power plays of some pharma companies. In the Netherlands, this has resulted in legislation being prepared to financially penalize out-of-stock situations that create interruptions in the supply of vital medicines.”

Emphasizing a brighter alternative, Astellas’ Stewart called for a future where cooperation ultimately reigns among the now contentious healthcare sectors. “This highlights a clear opportunity in healthcare that no one sector has successfully achieved (at least during my career),” he said. “We have to come together as a team and fully grasp the need to refocus the healthcare conversation on what is best for individual patients, for our economy, and for the health and well-being of our nation. Above all, everyone in healthcare benefits by preventing, managing, and curing disease. In this regard, I’m hopeful that 2017 will be a turning point.”

Cohen of Corbus seemed to take a middle position. “The pricing debate will present a significant but not an insurmountable challenge, mainly given that there are multiple actors with competing interests,” he said, adding a thought that somewhat anticipates our next question. “My prediction is that a compromise will be reached which will be acceptable to every party, probably in the form of further transparency on pricing/rebates and maybe even granting Medicare the ability to negotiate pricing for certain drugs. It’s the Specialty Pharma sector that I think will take the biggest hit. I expect orphan drugs to be unaffected by this debate.”

COMMON GROUND OR HARDER STANDS

Only five of the seven respondents chose to answer the following question. This may be one of the toughest of the “tough issues” we wanted to explore here, and to some extent the answer is already clear. Since our roundtable on drug pricing published in our July 2016 issue, the respective parties in the pricing debate have only reinforced their positions — in the case of industry association PhRMA, officially, and in the case of large payer groups such as Aetna and ExpressScripts, in more stringent restrictions on access to high-priced medicines.

Will pharma companies, payers, patients, and other stakeholders move toward a mutually satisfactory resolution of the drug-pricing controversy or take even harder positions on the issue in opposition to each other?

Gurney of Tetra sounded hopeful: “There has been movement toward the middle, with companies announcing voluntary price reductions, or in the case of the Mylan EpiPen, offering a generic version at a reduced cost.”

But Roivant’s Ramaswamy struck a more pessimistic, and perhaps realistic, chord. “In our polarized political culture, intransigence is more likely than reconciliation. While patients often fail to appreciate the tremendous risk and expense of drug development, it is also true that too many established pharmaceutical companies rely on price increases rather than thinking creatively about how to minimize the cost and time associated with bringing valuable new drugs to market. Instead of tired slogans, we need innovative solutions that bring down costs without sacrificing quality — and share the benefits of a more efficient R&D model with downstream stakeholders in the healthcare system (most importantly, patients). Until that happens, participants in this debate will continue to talk past one another.”

OrgaNext’s Prins put similar thoughts even more succinctly: “In the foreseeable future I am sorry to say that I expect more of the same; even harder positions would be my expectation.”

“Our industry leaders need to step up and get in front of this issue, or it is going to get much worse,” warned Hurst of Savant. “I have not seen or heard a single thing from anyone in our industry that is reassuring to stakeholders, and until that happens, we can only expect the nonbiopharmaceutical stakeholders to take even harder positions. Our highly compensated industry executives are not earning their money when it comes to this issue at this time.”

But Corbus’ Cohen voiced confidence in practical circumstances as a solution driver. “Regardless of their competing interests, none of these parties is interested in having a solution imposed on them by Congress,” he said. “I expect a compromise will be reached that will be acceptable to all. They might not like it, but the alternative is much worse for everyone.”

DEFENDING OBAMACARE

Prescription fulfillment has risen significantly in the United States under the ACA, yet PhRMA is taking a harder stance against “government interference” in pharmaceuticals and healthcare. Comment?

“It is understandable that the industry would like to have less government interference, but times have changed, and we better work with the new reality instead of clinging to the past,” said Prins of OrgaNext. “Many markets have been revolutionized by new entries like Google, Amazon, Netflix, Uber, and Booking.com. It would be naïve to expect our market can continue in the ways of the past. To work with the other stakeholders is the only winning way forward, and business models need to change in order to do so successfully.”

Savant’s Hurst elaborated on his criticism of industry leaders. “PhRMA is not seeing the big picture and is in danger of becoming irrelevant,” he said. “At last count, government is the largest source of revenue, and I believe that the days of ‘pay and look away’ are over. PhRMA needs to engage with the industry’s biggest customer and educate them as to the complexity of our industry. Fundamentally, the industry is about ethics and the tension between autonomy, in this case free markets, and the obligation, especially in healthcare, to first do no harm. This tension is where we must live and where we must engage. In the case of prescription fulfillment, it would appear that government interference is a good thing. Perhaps we should admit that, take a lesson from it, and attempt to get the same outcome in other areas of attempted government interference.”

Stewart of Astellas added these thoughts. “We welcome any and all ideas that will help improve our nation’s healthcare system. We support patients’ access to prescription medicines, which are essential to improving health and lowering costs. That is why we supported the enactment of the Medicare Prescription Drug Program [Part D]. The program, which provides affordable prescription drug coverage for more than 40 million seniors and persons with disabilities, has repeatedly come in under budget since it was implemented in 2006. Premiums have remained very low and patient satisfaction is high.”

Stewart maintained the structure of the Medicare Part D benefit, in which private-sector negotiations between drug manufacturers and insurers keep costs low and provide seniors choices of plans, has been proven to work and serves as a guiding example for industry cooperation with government. “We must assess how to ensure and protect both sides when developing healthcare policy today. We’ll continue to work hard to show what’s possible when our collective efforts are focused squarely on the patient.”

“It is a mistake to present all governmental involvement as unnecessary interference,” said Ramaswamy of Roivant. “In our present system, the federal government has a vital role to play in ensuring patient safety and access to care as well as funding basic research. PhRMA is right to push back against proposals that would stifle the development of new treatments, but not all change is negative. Instead of the status quo, what we need is better funding for the FDA so they have the requisite resources to clear the ANDA (abbreviated new drug application) backlog and promote greater competition among generics. Rather than simply reacting to alleged government overreach, the industry as a whole ought to be more proactive in supporting positive changes that help patients.”

MODELING FOR FUTURE

The next question drew responses from five of the seven participants. Because specialty pharma has ballooned as a sector and also attracted most of the public criticism for “price-gouging,” it is fair to ask whether it or any other business model will grow to dominate the industry.

What are the business models or model that will become (or remain) most prevalent or popular in the industry next year — e.g., specialty pharma, “traditional” (rDNA-based) biotech, orphan-drug, crowdsourced, and so on?

Tetra’s Gurney gave the briefest response to the question, “All of the above,” and Bayer’s Weinand gave the most comprehensive one. “As an industry, we can create the greatest value for patients and all of our stakeholders through innovation. As such, I expect next year and for many years to come, the most prominent business models in the industry will be those that endeavor to discover and develop innovative therapies that address serious unmet medical need. At Bayer, we expect innovation that produces breakthrough therapies to be increasingly important in the competitive healthcare industry.”

Yet Weinand also recognized an important role for incremental innovation such as specialty drugs that employ improved formulations or delivery. “Medical progress also happens in incremental steps, and these improvements can turn out to be game changers, finally transforming fatal diseases into more and more manageable chronic diseases,” he said. “Additionally, companies need to demonstrate the value of their products to patients, providers, and payers through robust clinical data and real-life evidence in a way that effectively uses all relevant channels so they have credible information when and how they need it.”

Weinand added an important element for the dominant model among large biopharma companies such as Bayer, now or in the foreseeable future— externalization of R&D. “Open innovation is a crucial element of pharmaceutical R&D and a key element of our innovation strategy at Bayer. With respect to the sources of innovation [e.g., “traditional” biotech, academic collaboration], I would not expect a dramatic change next year. Companies continue to collaborate with more traditional sources but also will continue to experiment with different approaches.” He also endorsed the idea of crowdsourcing in research, citing examples in Bayer. “With our Grants4Targets program we have been an early adopter of crowdsourcing in drug discovery. Based on the success of this open innovation tool, we have expanded it by Grants4Apps, PartnerYourAntibodies, Grants4Indications, and even Grants4Traits [in CropSciences].”

Weinand’s multiple-model description resonated with a more prescriptive treatment by Roivant’s Ramaswamy, who eschewed the idea of a dominant model. “We will continue to see a proliferation of different approaches tailored to specific sectors of the industry,” he said. “New business models in healthcare are already emerging that draw upon ideas from other industries: an emphasis on the ‘long tail’ of overlooked conditions instead of the usual suspects (Netflix), a turn to sharing resources and assets instead of outright ownership (Airbnb), vertical integration and optimization up and down the supply chain (Amazon) value investing (Berkshire Hathaway), and the like. Traditional one-size-fits-all pharmaceutical business models are a thing of the past. We will continue to see more innovation not only in the context of scientific advances, but also in the business models through which scientific innovation is delivered.”

“I don’t expect a revolutionary change in business models in 2017, but I anticipate more involvement of ordinary people in patient groups, crowdfunding, and advocacy for more access to care,” said OrgaNext’s Prins. “I also believe that the success of immunotherapy will attract different players to the arena, such as stem cell treatment labs for, amongst others, oncology and Alzheimer's.

Cohen of Corbus had a list of specific “models” or new trends among existing and emerging industry players: “I expect to see an acceleration of the shift from Big Pharma developing drugs in-house toward acquiring early and late-phase assets. I expect to see more and more personalized medicine and biomarker- driven developments such as CRISPR and CAR-T accelerate, although they will encounter pricing challenges. I expect to see an increasing proliferation of companies targeting orphan diseases which are lacking in treatment options and offer some clear pricing and IP benefits. I expect to see more and more patient advocacy groups, like the $4B Cystic Fibrosis Foundation, take a role in financing the development of drugs for their diseases.”

MANIA FOR MERGER

Late this year, several Big Pharma deals, such as Pfizer’s purchase of Medivation, raised speculation that merger mania may strike the industry once again in 2017. Three of our respondents commented on the situation.

To what extent will merger fever overtake the industry going into next year?

“I predict it will increase,” said Corbus’ Cohen. “Pipelines are in dire need of exciting new drugs and often latestage ones at that. The only choice is to buy those at a premium through either M&A or licensing.” Tetra’s Gurney concurred. “Buyers for small to midsize companies are active in the marketplace. Look both to Pfizer and Allergan to pursue acquisitions of $1-10 billion companies to acquire products.”

Ramaswamy of Roivant had a different view of the matter. “Fueled by low interest rates, expiring patents, declining productivity in R&D, and a need for new blockbuster drugs to maintain revenue growth, the frenzied pace of M&As has received top billing in the trade press. But in many ways, the more interesting story of the past few years has been the simultaneous increase in spinoffs of internal divisions — including divestitures of promising R&D-stage assets. Instead of a straightforward story of industry consolidation, what we are seeing is increased specialization in a hasty effort to come up with the ‘next big thing.’ As companies shed prior assets in order to focus their attention on that search, there will be tremendous opportunities for scientifically minded buyers who can sort the valuable from the dross.”

WHERE TO BIOPHARMA?

Our last question here may seem wholly technical, but the answers — here best presented verbatim — reveal the strategic importance of this topic.

Is biopharma moving away from biotech — now, next year, beyond (more small molecules/peptides/bispecifics vs. rDNA proteins/fermentation)?

The response from Savant’s Hurst forecasts a diverse technological and scientific future for what we now call the biopharma industry. “Small molecules tend to fail early and cheap, whereas biologics tend to fail late and at great cost. The tendency is to move from higher-risk to lower-risk opportunities over time. We’ve seen the venture capital industry do exactly that over the last 20 years, leaving drug development for diagnostics, devices, and so on. Not completely, of course, but it is certainly harder to find money for a drug project today than it was in 1995. I like to think the current trend is toward wellness rather than disease treatment. Helping the body to do its job even better, immuno-oncology being but one example. Gene editing holds the promise of repairing potential problems before they become diseases. This is very exciting.

“Using drugs to return a patient to normal function is incredibly exciting. Many brain diseases are the result of the dysregulation of neurotransmitters and the ability to return the patient to normal regulation by either drug therapy or gene editing [neurotransformational medicine] could fundamentally change neuroscience.”

Comments by Bayer’s Weinand also recognize a wide variety of options for industry platforms short and long term, with certain standouts among them. “In line with industry forecasts, we expect small molecules and biologics to remain the core platforms in the industry for the foreseeable future. According to forecasts, biologics [defined as antibody, antibody derivatives, and recombinant protein] and small molecules still will represent greater than 80 percent of the market by 2021. Nevertheless, other technologies, such as gene therapy, are outpacing other platforms. We participate in these potentially disruptive technologies. For example, in December 2015, Bayer and CRISPR Therapeutics agreed to create a joint venture named Casebia Therapeutics to discover, develop, and commercialize new breakthrough therapeutics to cure blood disorders, blindness, and congenital heart disease.”

Cohen of Corbus shared one example of an alternative platform his own company is exploring. “We will see more of everything, including technologies that are entirely new. In our case, for example, we’re focusing on using the body’s own endocannabinoid system to modulate the immune system. This has never been attempted before, and the results could potentially change the way we think about how to treat chronic inflammation.”

Tetra’s Gurney focused on emerging platforms in his company’s space, “At least in CNS, most drug programs are small molecules or antibodies. Look to increased enthusiasm for oligonucleotide/DNA therapeutics when Ionis-Biogen release their Phase 3 data for nusinersen in spinal muscular atrophy.”

STORMY SEAS

It is good to end on an optimistic note, especially when the earlier responses from the executives portend dangerous waters for the industry in all possible directions next year. As this publication appears, the past and future will have already begun to meld into the moving present, and some of the predictions presented here may have been validated or otherwise by real events. Yet, all together and individually, the contributions from the brave leaders in this forecast illuminate a great deal about how the contemporary industry thinks about the issues of the day — and may it simulate further thoughtfulness in this community.