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The US stands as the biopharma innovation champion of the world, a global leader on nearly all R&D indices related to investment and innovation. It also holds a tremendous amount of clout, representing half the world’s healthcare market, and the US healthcare industry itself is nearly 20 percent of the country’s GDP, employing one in every ten American workers (11 percent). Americans see innovation as intrinsic to the DNA of their country, and for good reason. Over the past two decades, the US has been the largest global funder of biomedical R&D investment – summing up all investments made by government, companies, foundations and universities – with some analyses putting the figure as high as 70 or even 80 percent. Unsurprisingly, the pharmaceutical productivity of US-based companies outstrips those from any other country; according to analysis by the European Federation of Pharmaceutical Industries and Associations (EFPIA), between 2004 to 2018, US-headquartered enterprises produced almost twice as many new chemical and biological entities as those from Europe, and three to four times as many as those from Japan or the rest of the world combined.
With drug development being a notoriously taxing and lengthy endeavor, the US biopharma industry did not flourish overnight. Decades of supportive legislation, sustained federal funding, robust IP frameworks, and vast R&D tax incentives, buttressed by the creative and bold thinking endemic within US universities, academic institutions and medical centers all came together in a perfect storm to foster a biopharma innovation ecosystem recognized by advocates and critics alike as the most innovative in the world.
However, in recent years, the system has seemingly started to buckle under the strain of its internal contradictions, the core of which is the growing gap between the innovation that the US generates, and that which the average US citizen can access and afford. The COVID-19 global pandemic, which left the US reeling with over 200,000 dead, over eight million infected, and one of the highest per capita death rates in the world, has only served to spotlight the fault lines at the heart of the US healthcare system. Despite one of the best innovation ecosystems in the world, the US sees some of the worst healthcare outcomes amongst industrialized countries. With 18 percent of its GDP going to healthcare, the US spends nearly twice as much as the OECD average, and pays some of the highest drug and medical services prices in the world, but has the lowest life expectancy, the highest chronic disease burden, and the highest obesity rate amongst OECD countries.
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The 21st Century Cures Act
Signed into law by President Barack Obama on 13 December 2016, the Act is a bipartisan agreement with three major areas: the funding and acceleration of cancer research and overall medical product discovery, development and delivery; the support of families in mental health crises; the improvement of the choice, access and quality in healthcare for Americans. Key initiatives under the first area include:
With 2020 being perhaps one of the most contentious election years in US history, healthcare has emerged as one of the hot button issues. A 2019 Census Bureau report found that 9.2 percent of Americans – 29.6 million – did not have any form of healthcare insurance in 2019, a million more than the previous year. In 2019, according to a Gallup poll, a record 25 percent of Americans said they or a family member had delayed treatment for a serious medical condition in the past year due to cost. It should come as little surprise, then, that a February 2020 Kaiser Family Foundation (KFF) poll found that, regardless of political leaning, 26 percent of respondents thought that healthcare issues were the most important factor for electing a president.
In this fashion, the intertwined themes of innovation, access and affordability pervade any conversation surrounding healthcare in the US, as the world’s most important economy and healthcare market grapples with the universal and perennial endeavor of how to discover, develop and distribute much-needed therapies to the patients that need them in a systemic and affordable manner – that can be sustained in the long run.
Barbara Lopez Kunt
With pharmaceuticals being such a regulated sector, the presence of supportive regulations has always been a critical part of the industry’s growth. In the US market, a number of key legislations were instrumental to the creation of the US biopharma ecosystem, including the 1980 Bayh-Dole Act, which conferred to universities and nonprofit research institutions the IP rights they generate from federally funded research; the Prescription Drug User Fee Act (PDUFA), beginning in 1992; the Biologics Price Competition and Innovation Act (BPCIA), part of the 2010 Affordable Care Act; and more recently, the 2016 21st Century Cures Act.
Accordingly, one of the jewels in the crown of the US biopharma ecosystem is its regulator, the FDA, widely considered the gold standard in regulatory science globally. As the Drug Information Association (DIA) CEO Barbara Lopez Kunz lauded, “the US is always going to be a critical player in global regulatory science. The FDA has a long track record of making significant advances in regulatory science and has set the stage in many areas of regulation.” According to the Center for Innovation in Regulatory Science (CIRS), between 2009 to 2018, the FDA has generally had the fastest drug approval time compared to other major regulators. In 2018, the median amount of time was 244 days, nearly three months faster than the second-quickest agency, the Japanese PMDA. Part of this is attributable to the alacrity with which the FDA uses the mechanisms available to expedite product approvals, such as the Priority Review and the Breakthrough Therapy designations, according to more data from CIRS.
Naturally, the industry’s investments in R&D are integral to US biopharma excellence. The US biopharma industry has invested an average of over 20 percent of its sales in R&D since 2000. In 2017, industry-funded, US-conducted biomedical R&D investment reached USD 66 billion. In terms of R&D intensity (R&D investment as a percentage of sales), US-based biopharma companies clustered at the top of the 2019 EU Industrial R&D Investment Scoreboard; of the top 25 companies in the study, American firms had an average R&D intensity of 25.2 percent, compared to 18.1 percent for Japanese companies and 15.5 percent for European companies.
The ecosystem in the US has also drawn foreign companies to establish their R&D operations there. Almost a third of global biopharma R&D activity occurs in the US. In addition, the innovation is often of very high quality: as of 2020, 74 percent of medicines in clinical development in the US are potentially first-in-class medicines, with the specific figures for various therapeutic areas as follow: 86 percent for Alzheimer’s, 70 percent for various forms of cancer, and 73 percent for cardiovascular diseases.
As Lundbeck EVP and head of North Ame-rica Peter Anastasiou pronounced, “innovation certainly occurs globally but I will say that the US ecosystem fosters innovation perhaps more than any other country in the world. We have some of the best universities in the world, well-funded and resourced capital markets, and thriving start-up and business environments.” For this reason, the Danish CNS company has invested heavily in their R&D footprint through strategic US acquisitions, acquiring two US biotech companies in 2019, Abide Therapeutics and Alder BioPharmaceuticals, the latter of which not only boosted Lundbeck’s CNS pipeline but also added “new capabilities in the biologics space”, explained Anastasiou.
Tatsuya Kaihara, corporate officer and head of the North American business for Japanese ophthalmology player Santen, who also spent nearly two years as head of innovation their US venture investment arm, concurred, “the US is one of the most innovative science and technology markets. Our global R&D and clinical development functions have been headquartered in our Emeryville, California location for a while now.” Their first anticipated product in the US market, DE-128 (PRESERFLO MicroShunt), was developed by InnFocus, a US start-up they had initially invested in and subsequently acquired in 2016.
At the same time, in recent years, the US pharma industry has faced increasing excoriation for what critics describe as exorbitant drug prices, which have been labelled the prime factor behind the impending implosion of the US healthcare system. As Johns Hopkins University Bloomberg School of Public Health professor Gerard Anderson stated baldly, “the reason the US spends more on healthcare than any other OECD country without providing more services is very simple: higher prices of goods and services.” He has coauthored papers comparing US prices for branded drugs to prices in other industrialized countries, which revealed that “on average, [while] it does vary dramatically from drug to drug – some drug prices were 80 times higher in the US and some were only 30 percent higher – the average was three to four times higher.”
Scrutiny over drug prices has intensified in the past few years, particularly in the wake of the Turing Pharmaceuticals price hike scandal in 2015 that saw the pri-ce for an antiparasitic drug surge from USD 13.50 per tablet to USD 750 per tablet, igniting a nationwide debate and Federal investigation that ultimately landed its CEO at that time in federal prison for fraud. As former president of the Association for Accessible Medicines (AAM) Chip Davis pointed out wryly, “everybody – Republicans, Democrats and Independents – all claims to want lower drug prices. Public polling shows that the public wants their policymakers to work together to lower drug prices.” Eight in ten Americans say that the cost of prescription drugs is unreasonable. One out of five voters say lowering prescription drug costs should be Congress’ top health priority. Perhaps understandably, in September 2020, weeks before the US presidential elections, US President Donald Trump signed a new executive order, which would introduce a new payment model where the US would not pay more than the ‘most-favoured-nation price’ for specific Medicare Part B or Part D prescription drugs or biological products.
One of the oft-cited factors for persistently high prices in the US is the absence of a single-payer healthcare system, according to many critics. Instead, a complex and overlapping network of players – private insurers, pharmacy benefit managers (PBMs) (companies that manage prescription drug benefits on behalf of health insurers), government programs like Medicaid and Medicare, the latter of which alone has 300 entities negotiating on its behalf, the small and large businesses that provide employer-sponsored health insurance for the 49 percent of US population – all have fingers in the USD 335 billion pie of prescription drug expenditures.
Jewels in the Crown
A healthy chunk of the innovation in the US originates from biotech companies, which represent 66 percent of US biopharma enterprises, with an average R&D intensity rate of 62 percent. Drawing from the rich pipeline of academic and research talents, cutting edge basic science, as well as the most active capital markets in the world – nearly three-quarters of worldwide VC investments in biopharmaceutical companies are made in the US, raising USD 92.7 billion in 2019 – US biotechs have been a veritable fount of novel therapies within the US market and globally. While the likes of Amgen, Regeneron and Gilead Sciences have long-since become global players and/or been acquired by Big Pharma, , the entrepreneurial biotech machinery in the US continues to churn out more innovative start-ups dedicated to novel drug discovery and development.
Today a global leader in RNA therapeutics, Ionis Pharmaceuticals’ journey began 30 years ago, when the founding team, including current CEO Brett Monia, shared frustrations about the inefficiency of the industry in the late-1980s. He reminisced, “around that time, some seminal publications suggested that a technology referred to as antisense could potentially be a new method of drug discovery. The publications were very academic in nature but we decided to create Ionis to explore this new technology.”
Ionis’ antisense platform develops drugs that bind precisely to messenger RNA in the body to prevent the creation of a disease-causing protein, offering tremendous advantages in terms of efficiency and speed when it comes to drug discovery and development. In addition, Monia crowed, “the platform allows us to target and tackle diseases previously thought to be ‘undruggable’ using traditional drug discovery platforms: conditions like Huntington’s disease, amyotrophic lateral sclerosis (ALS) and many others, particularly within the neurology space.” Another advantage is that antisense therapies can be administered in many different ways, from oral to IV to intradermal to subcutaneous and so on. For Ionis, innovation is a job never finished. Monia assured, “we create new IP and generate new insights every year,” despite the fact that the company already boasts a stunning pipeline of over 40 drugs in clinical development, along with three products already on the market and commercialized via partners.
Fellow biopharma Karyopharm’s success story began rather similarly, with avid perusal of academic research planting the seeds of an idea in president and CSO Dr Sharon Shacham, who wanted to work on a new type of drug that could be effective against many different types of cancer simultaneously, at a time where many companies tended to focus on targeted therapies that only worked for the minority of patients with very specific mutations. She realized that every time she read a paper about a tumor suppressor protein that had stopped working, it was because the protein had been removed from the nucleus by a single carrier, the Chromosomal Maintenance 1 (CRM1) protein, now called exportin 1 (XPO1); tumor suppressor proteins only work when they are present within the nucleus.
CEO Dr Michael Kauffman encapsulated, “we are working on a fundamental mechanism of cancer internal to the cell, nuclear export dysregulation, where tumor suppressor protein(s) have mutated or more typically, have been removed from the cell nucleus, which helps cancer cells evade detection from the body’s own defense mechanisms.”
While the company today has a product on the market expected to generate USD 80 million in revenues in 2020, as with most biotech ventures, the beginning looked risky. Kauffman recalled, “it was extremely scary, even for venture investors, so we invested about USD 500,000 of our own capital to start our investigations. Karyopharm’s initial patents were filed by Sharon and I.” Having worked in four other biotech companies before Karyopharm, he posited, “many great ideas actually come from people unconstrained by the conventions and cultural uniformities of large organizations. The process of developing XPOVIO® required a lot of effort and a level of risk tolerance not found within Big Pharma companies.”
As president and CEO of America’s Health Insurance Plans (AHIP) Matt Eyles explained, “health insurance providers negotiate with drug companies to lower out-of-pocket costs and premiums for millions of patients. Our member companies often engage directly with manufacturers on general contracting, value-based arrangements and other areas, or they use a pharmacy benefit manager to do so on their behalf to lower costs for consumers.” Even in the case of government-sponsored public programs like Medicaid and Medicare, Eyles clarified, “the vast majority of individuals who have coverage in Medicaid receive that coverage through a private Medicaid-managed care company. [Similarly], Medicare is a public-private partnership. The government tells the health insurance companies the kinds of benefits that they need to offer and sets the rules and regulations; the private companies administer the services.”
Following a spate of mergers and acquisitions, the three largest PBMs in the US presently manage three-quarters of all prescriptions filled in the US, leading some in the industry to question what they see as the increasingly outsized clout these PBMs wield in the US pricing and reimbursement debate. In a nutshell, as intermediaries, PBMs profit twice: they are paid by insurers and employers, and increasingly, they also receive rebates and discounts from manufacturers that are not typically publicly disclosed. Significant controversy has been generated over how these commercial negotiations between PBMs and pharmacos occur, and where the generated savings ultimately go, and as a result, PBMs have also been thrust into the spotlight in the past couple of years.
Most pharma companies have since sought to distance themselves from the kind of unscrupulous pricing practices demonstrated by Turing Pharmaceuticals and other so-called ‘bad apples’, and many industry players argue that high – and rising drug prices – are merely a red herring. As former National Pharmaceutical Council CEO Dan Leonard commented ruefully, “there are large gaps between the data, public discourse and government reactions. In 2019, [drug spending] growth was 2 percent; in 2018 it was 2.5 percent; in 2017, it was less than 1.5 percent. This makes 2020 the fourth year in a row where drug spending is below both healthcare and general inflation.” He also pointed out, “this is significantly less and growing at a slower rate than what we spend in other health sectors, like hospital care and providers. Yet when you listen to political arguments, some view skyrocketing drug prices as the sole reason for all of our healthcare cost concerns.”
According to an analysis of the Bureau of Labor Statistics Consumer Expenditures Survey, the average American household spent nearly USD 5,000 per person on healthcare in 2018, compared to nearly USD 2,500 per person in 1984 [amounts have adjusted for inflation for more accurate comparisons] – and the biggest reason for this increase is insurance costs, which have grown by a staggering 740 percent since 1984. A separate KFF annual employer benefits survey found that even families with employer-based insurance – around half of the US population –still pay an average of USD 6,015 in out-of-pocket expenses, about a 71 percent increase over the past ten years.
For this reason, the innovative pharma association, the Pharmaceutical Research and Manufacturers of America (PhRMA) president and CEO Stephen Ubl argued, “insurers and PBMs have increasingly shifted more healthcare costs to patients through high deductibles and coinsurance.” As an example, he highlighted, “patients with deductibles and coinsurance typically pay cost sharing based on the undiscounted list price of a medicine rather than the negotiated net price. More than half of commercially insured patients’ out-of-pocket spending for brand medicines is based on the full list price.” PhRMA calculated that in 2019 alone, the total value of rebates and discounts given to PBMs, insurance companies, the government, and other supply chain entities exceeded USD 175 billion.
As an indication, Sanofi Genzyme EVP and global head Bill Sibold revealed, “in 2019, the average aggregate list price for all our products in the US [did] increase by 2.9 percent. But the average net price – what we receive after discounts, rebates and fees paid to other actors within the system – actually fell by 11.1 percent,” pointing out, “those savings are going somewhere but if they do not reach patients, they are not serving their purpose.”
As a rejoinder, however, AHIP CEO Eyles admonished, “the pharma industry actually created prescription drug rebates. For a greater share of the market, the drug companies were willing to provide a rebate or a discount in order to receive preferred placement on a hospital or health insurance plan formulary,” adding, “we are seeing the growth of rebates that represent a small percentage of the list price to those that represent a higher percentage of the list price [because] manufacturers have consistently increased prices, year after year, multiple times a year.” Ultimately, from his perspective, “[we] are not wedded to prescription drugs rebates as long as we can use market-based tools to get a lower price for patients.”
At the same time, industry advocates generally agree that US drug prices have always been one of the main reasons for the US biopharma industry’s leading innovation position globally. With the inescapable reality that biopharmaceutical R&D is one of the riskiest endeavors in the world, with only ten percent of drugs in Phase I studies ever making it to the market, and the total cost of bringing a drug to market having grown as high as USD two billion, drug R&D can unfortunately be seen as a cash-burning machine.
Lundbeck’s Anastasiou exhorted, “reimbursement rates in Europe are comparatively much lower. If the US had a similar system, there would be less incentive for companies to take the kind of risks they have to in an industry like biopharmaceuticals, and lower incentive for capital markets to continue investing at the rate that they have been. What is important is that the US market still rewards innovation with prices that justify the significant investments – and failures – that each successful drug entails.”
In a similar vein, Danish allergy immunotherapy company ALK’s Americas president Jorge Alderete averred, “while most drugs are more expensive in the US, it is these profits that fund the innovation for new medications through research and development. Without the higher prices in the US, innovation would be reduced significantly.” As of 2020, US biopharmas have more than 3,400 drugs under clinical development, accounting for almost half of the estimated 8,000 medicines under development globally.
For instance, Dr Stephen Farr, president & CEO of rare disease biotech Zogenix, whose Dravet syndrome therapy, FINTEPLA®, was approved by the FDA in June 2020 and bears an average annual price of USD 96,000, elucidated, “many Dravet syndrome patients, despite taking multiple antiepileptic drugs daily, continue to suffer from convulsive seizures. Based on efficacy and safety profiles for FINTEPLA®, we anticipate it could become a new standard of care for Dravet syndrome.” For this reason, he posited, “in addition to the medical value, I think the price also needs to reflect the value of all the work undertaken to bring this drug to market and the drug’s value to patient communities,” highlighting, “through numerous discussions with commercial, federal and state payers, we have seen an acknowledgment of the value that FINTEPLA® brings to the Dravet patient community, and the recognition that we are talking about a rare disease with an extremely small patient community. The overall cost to any individual plan is relatively small but the drug delivers immense benefit to patients.”
All that being said, it remains unclear if drug prices should be seen as the culprit or a scapegoat for the contradiction at the heart of the US healthcare ecosystem. However, for Johns Hopkins’ Professor Andersen, the salient question goes beyond the individual merit, cost and value of each therapy. “The main concern is whether the US – or any country, really – can afford some of these drugs that the industry has been developing over the past couple of years?” He referred to ZOLGENSMA®, the most expensive drug in the world, a gene therapy for a rare childhood disorder, spinal muscular atrophy (SMA), that Swiss pharma giant Novartis launched in the US at an eye-watering price tag of USD 2.1 million.
Andersen queried, “can the US afford one drug like that? Yes. Can we afford 50 drugs like that? Maybe. Can the US afford 200 drugs like that? Probably not. At the individual company level, I understand why they would want to set a price like this but from an affordability standpoint, as a country, we cannot afford to have a lot of these drugs.”
Pharma companies do appreciate the link between innovation, affordability and long-term sustainability. As Genzyme’s Sibold acknowledged, “our industry’s goal is to provide transformative medicines to people. As a society, we need to have sustainable mechanisms for patients to access these innovative medications, otherwise these therapies do not benefit anyone.” For that reason, he assured, “as a healthcare company, we have made a personal commitment to not only resolve the immediate medical needs of the individual patient or address broader public health challenges like pandemics, but also societal issues like the long-term sustainability of the healthcare system,” adding, “as an industry, we need to feel and act like a partner rather than just transacting.”
LEO Pharma’s EVP US Christopher Posner concurred, “at the end of the day, it is not enough to provide innovative medicines. We also need to do our best to ensure that payers are willing to reimburse them, and patients have access to them,” supplementing, “access and affordability go hand-in-hand. We cannot address one without the other. We have implemented programs to support access for patients. For instance, the LEO Pharma Connect program helps keep out-of-pocket costs low for commercially insured, eligible patients.”
Industry Pricing Promises
Public attitudes towards the pharmaceutical industry have soured in recent years. According to Harris Poll research in early-2020 pre-COVID, only 32 percent of Americans held a positive view of the pharma industry, ranking it third from the bottom among 12 industry categories, above only government (25 percent) and tobacco (17 percent). For this reason, many pharma players in the US have invested in corporate social responsibility initiatives, including pricing promises or pledges. We take a look at two examples below:
In 2017, Sanofi announced a number of pricing principles as a way of advancing responsible leadership:
i. Provide a clear rationale for pricing at the time of launch of a new medicine (i.e. taking into account unmet medical needs, clinical trial outcomes, market activity, etc.)
ii. Not increase prices for existing drugs above the projected growth rate of US National Health Expenditures
iii. Disclose annually the average list and net price changes across Sanofi’s portfolio of products
As Sanofi Genzyme EVP Bill Sibold said, “we were the first pharma company to take such a definitive step towards supporting the long-term sustainability of the US healthcare system.”
President and COO Bradley Campbell shared, “Amicus has made a pricing promise with five core components.”
i. We will price our therapies at parity or a modest discount to existing standards of care
ii. We have pledged to never raise our prices above the Consumer Price Index (CPI)
iii. We have pledged to invest a portion of our revenue back into research until there is a cure for the diseases we are addressing
iv. We commit to providing lifetime access to medicines for any clinical trial patient
v. We pledge to provide patient services and financial support for patients that cannot access our medicines
The deep-seated challenges within the US healthcare system extend beyond pricing, however, with many players lamenting the structural complexities and uncertainties that at times seem to conspire to hinder rather than facilitate access to innovative medicines.
As Novartis Oncology US EVP Ameet Mallik deplored, despite the approval of its breakthrough and transformative CAR-T therapy Kymriah® in 2018, it “is still not covered by Medicaid in every state [because] Kymriah® is in a rather unique position.” While Kymriah® is moving towards outpatient use, today most of the usage is inpatient – unlike most cancer drugs, and as Mallik explained, “the existing Diagnosis-related group (DRG) system was not adequately set up to reflect the breakthrough innovation in this product [because] CAR-T therapies still fall in the same category as bone marrow transplants with complications.” The list price of Kymriah® falls around USD 375,000 to USD 475,000 and even with a new technology add-on payment (NTAP) measure, hospitals do not receive full reimbursement for the cost of the CAR-T therapy itself, much less the hospital services related to its administration, which means that they are less likely to offer or prioritize this therapy. However, Mallik ventured hopefully, “in May 2020, CMS proposed the creation of a new hospital payment category for CAR-T therapies, which would price these treatments more sustainably for providers [and] improve the situation significantly.”
ALK’s Alderete flagged the issue of misaligned incentives faced by physicians. For their tablet-based sublingual allergy immunotherapy (SLIT-tablets) portfolio, he explained, “the challenge is with the incentives that doctors in the US face to use subcutaneous allergy immunotherapy – injectables – instead of tablets. Doctors buy these biologic drugs and mix them in their own offices before billing insurance for the final treatment set and subsequent injections as a medical benefit, whereas they simply administer the tablets as a pharmacy benefit. The margins for injectables are higher so there is an economic incentive for doctors to continue prescribing allergy shots instead of tablets” despite the fact that data has shown that 60 to 70 percent of patients do not want to receive allergy shots.
In addition to this, Alderete added, “for a patient to access the tablets for allergy immunotherapy in the US, their doctor needs to apply for prior authorizations demonstrating that other drugs have been tried unsuccessfully, like antihistamines and corticosteroids,” which can complicate matters. For that reason, ALK launched a specialty pharmacy network for their portfolio to work with doctor offices to, as he elaborated, “to ensure that these prior authorization forms are done so patients can access their drugs [and] to let patients know about any relevant coupons that exist to reduce their copays.”
Another crucial element is that insurance plans are increasingly complicated to navigate, with patients having to wrestle with deductibles, coinsurance and copays. A Commonwealth Fund study found that Americans are increasingly concerned about the high cost-sharing requirements in their health insurance coverage. Takeda US president as well as president of global portfolio commercialization Ramona Sequeira illuminated, “we have heard from patients that they do not understand their insurance coverage. Some people have plans with very high deductibles that make medicines unaffordable. In fact, many of our own employees tell us they have a lot of questions about our insurance and we have an amazing plan!” For that reason, she stressed, “we need to find ways to make insurance more predictable and understandable for patients. Healthcare systems are extremely complex, so whenever new policies or initiatives are proposed, we must think carefully about any potential unintended consequences. Ultimately, all the stakeholders in healthcare need to be willing to work across boundaries and make compromises to reach a better solution.”
As a result, in light of all these operational complexities, pharma companies also invest heavily into support programs and other initiatives on top of manufacturing and providing the therapeutics. For instance, Novartis Oncology’s Mallik advocated, “we want to make [the patient journey] as meaningful and as easy as possible for all stakeholders.” For instance, for their first-in-class breast cancer drug Piqray®, launched in June 2019, Mallik explained, “the first [priority] was to drive awareness around the need for testing, which is still not very established when compared to lung cancer or melanoma. Outside of human epidermal growth factor receptor (HER2) and estrogen receptor (ER) testing, there is not much testing done.” Therefore, Novartis Oncology partnered with Qiagen and Foundation Medicine to create companion tests, and also one of the largest breast cancer testing labs in the US, NeoGenomics Laboratories, to expand testing support upfront. Mallik enthused, “prior to our efforts, testing was in the low-single digits but we raised it to about 35 percent today.
All Hands on Deck
Rare disease – defined in the US as a disease with a maximum patient population of 200,000 – is perhaps the most emblematic issue at the nexus of innovation, access and affordability. FDA CDER director Dr Janet Woodcock indicated, “rare diseases have been rising as a target of pharmaceutical development. Last year around 41 percent of approvals were novel approvals for rare diseases. Part of that is because of targeted therapies that make more rare diseases, and part of it is because rare diseases themselves are being targeted for development. That is a big change from two decades ago when most development was in common diseases, antimicrobials, cardiovascular diseases and so forth.”
Another supporting factor is legislation like the Orphan Drug Act (ODA), which among other things offer sponsors development incentives like qualified clinical testing and a waiver of the prescription drug user fee for the NDA filing. As the National Organization for Rare Disorders (NORD) president and CEO Dr Peter Saltonstall expressed, “before ODA, there were only 34 orphan drugs approved in the US and today, we have over 700.”
At the same time, these innovations have come at significant cost. According to AHIP data, the average annual orphan drug cost has risen from USD 7,136 in 1997 to USD 186,758 in 2017. However, NORD’s Saltonstall cautioned that the conversation should not center myopically on price: “in 2019, only 9.2 percent of the overall US drug spend was on orphan drugs so we should not obsess on ‘fixing’ that 10 percent. We believe rare diseases R&D should be encouraged, we want to retain the incentives for doing so under ODA, and we believe that it is important that companies have the ability and incentives to develop therapies for these small patient populations”, since, as he pointed out, “90 percent of patients with rare diseases still do not have any approved therapies for their conditions, so the unmet medical needs are urgent and critical.”
Furthermore, he lamented, “we are very concerned about access, and it is not about price alone. For instance, a few years ago, we did not require prior authorization from insurers for many rare disease therapies. Today, of the nearly 50 therapies we support through our Patient Assistance Program, 100 percent of them require prior authorization. It means [insurers] are influencing the decision of whether patients receive access to these therapies.”
Another aspect of promoting access, Kyowa Kirin North America president Gary Zieziula asserted, is “patient-finding initiatives”, which explains the fact that Kyowa Kirin “have digital patient-finding programs in place, and we are building much more robust digital education and communication programs to reach patients and healthcare practitioners (HCPs). We are also actively engaging with patients and advocacy groups, as well as participating in conferences and congresses.” He also hoped to leverage digital tools more fully in this endeavor, sharing, “we look forward to having a much more comprehensive digital infrastructure by 2021 or 2022, supported by a new Digital Center of Excellence., to grow our role in the community.”
Takeda US president and president of global portfolio commercialization Ramona Sequeira agreed on the importance of patient-centricity, pointing out, “with rare disease, a healthcare provider might have just one patient with that type of disease using our medication. So naturally, the provider has not had the chance to build experience around that disease or therapy. The patient might feel alone, and the doctor might feel alone.” Based on Takeda’s value system ‘Patient-Trust-Reputation-Business’, she continued, “we want to figure out how to alleviate this problem. The first step is getting close to patient communities and patient advocacy groups to really understand their needs and challenges. Based on what we learn, the second step is to increase support through medical and patient services.”
As an example, she suggested, “a provider might not need as much promotional support but would welcome more medical information to help identify the right patients and learn more about the disease progression. Patients might need help navigating a difficult diagnostic process or complex reimbursement systems.” This is what being “committed to delivering success to our customers and patients” means to Takeda.
Even as these debates persist in the US, darker clouds loom on the horizon. Deloitte has been publishing an annual Return on Pharma Innovation report for a decade now, which documents a decade of decline in biopharma innovation’s returns on investment (RoI). Another analysis by the Tufts Center for the Study of Drug Development has found that the average cost of developing a new drug more than doubled from USD 802 million in 2003 to USD 2.6 billion in 2019. One of the industry’s most urgent missions is to lower the costs and increase the productivity of their R&D efforts, which would go a long way towards making medicines more affordable and accessible to the patients that need them.
In this endeavor, there is an inevitable scrutiny of clinical trials, as FDA Center for Drugs Evaluation and Research (CDER) director Dr Janet Woodcock underscored: “conducting clinical trials is the most expensive part of drug development [and it] is becoming impossibly expensive”. For this reason, Deloitte global healthcare and life sciences leader Greg Reh supplemented, “we are starting to see the focus on the data and the realisation of benefits of utilising Real World Evidence (RWE) in R&D through innovation in trials. The race to collect impactful data to expand biopharma’s knowledge of the epidemiology of disease and to satisfy health authorities is also accelerating,” remarking, “the industry has known for some time that data was going to be the new currency of healthcare, whether it was the advent of RWE or the need to have a more integrated information flow in the development process or patient journey.”
Indeed, Big Data and AI in all its incarnations are the oft-touted panacea. As DIA’s Lopez enthused, “advances are being made with the integration and use of data. Tools are available that accelerate insights, support regulatory decision-making, and increase efficiencies and effectiveness of processes. I see these evolving fields as a huge opportunity.”
On the other hand, FDA CDER’s Woodcock was a little more skeptical. “I believe that data and AI may be game changers in the future but not in the immediate future. We have made a huge amount of effort in this space with the Sentinel initiative [FDA’s national electronic system for the safety monitoring of FDA-regulated medical products] but the old maxim about data – garbage in, garbage out – still holds. There is a huge problem of noise in the system.” One of the issues, she criticized, is that “US electronic healthcare records are not interoperable. Even within electronic health records, a lot of the terms are not standardized. [I]f you go from one health plan to another, then we lose all identification of you.” Similarly, while the FDA has made significant progress on RWE in the last few years, she demurred, “when done correctly, RWE can provide meaningful information. However, when done incorrectly, RWE can often lead to misleading interpretations.” Ultimately, she commented, “I think data is somewhat overrated as far as its immediate impact on biology. People do not understand how complicated human biology is.”
Marc Boutin, former CEO of the umbrella national patient organization, the National Health Council, shared Dr Woodcock’s caution regarding the current usability and relevance of US health data. He explained, “we completely support the concept of being data driven [and we are] involved in a number of initiatives to harness data. [However] data today gives us very good insights but is not yet at the level of quality where it can be used to make many regulatory decisions. It is a promising tool but a product could not and should not be newly approved on the basis of real-world data only.”
A more fundamental concern, he raised, “is that many stakeholders, particularly in the AI space, see data as a substitute for patient engagement. The NHC and our patient organization members need to be in the conversation on how data will be gathered, stored, and curated.” For instance, he pointed out, “while AI can tell you if a child places their wearable on the family dog, it cannot tell you why. Patients and their families can. We can help you interpret data and ask better questions. This is an opportunity to engage patients and their family caregivers rather than seeing data as a replacement for those insights.”
Taking a step back, he contextualized, “the complexity of the US health ecosystem is part of why the patient community pushed for the creation the Patient-Focused Drug Development initiative. This prompted a cultural shift and got stakeholders thinking about what it means to customize health and understand outcomes that matter to patients. In just the last decade we have seen dramatic changes in how industry engages patients in R&D for drugs and devices and in clinical trial protocol development.”
This unwavering focus on patients is something that perhaps no biopharma company would disagree with. Amicus Therapeutics president and COO Bradley Campbell revealed that at the company’s core lies “patient-focused, scientific dialogue that champions partnerships with physicians, payers, and patients,” continuing, “we demonstrate this collaborative approach by involving patients throughout the entire drug development pathway, bringing patient advisory boards in very early to provide input that helps determine things like the endpoints of a study and which patient-reported outcomes are most meaningful. When we speak to the US FDA, we always bring patient representatives. All these actions galvanize the dialogue around what is right and important for patients.”
From Insmed CEO William Lewis’ perspective, the equation is simple: “once we do the right thing for patients, the rest of the business takes care of itself. This means not only ensuring that patients receive access to our drugs but that their experiences with our drugs are as successful as possible.” For this, it is essential to amplify the patient voice. Lewis elaborated, “we hold town hall meetings every couple of weeks and we have invited patients as well as representatives from patient advocacy groups to share with our employees their experiences with the diseases they have. We need to stay close to the patient experience.”
For Eisai US chairman and CEO Ivan Cheung, who also serves as global president of the neurology business group, there is a difficult and delicate balance to strike in Eisai’s dialogue with patient groups. As a global leader in CNS, with its most notable asset being the long-awaited for Alzheimer disease (AD) therapy aducanumab, which they are codeveloping with Biogen, he expressed, “patients and their families have been waiting for an AD drug for a very long time. The goal was always to advance from simply having a symptomatic treatment to a longer-term disease-modifying therapy for AD. This is an area of serious unmet need. At the same time, we are also aware that patients have been waiting for such a long time and have experienced so many disappointing news about failed clinical trials that they are very wary of false hope.”
For that reason, he lamented, “when I speak to patient groups, I have very mixed feelings because on one hand, I know that we have great science and promising assets, but on the other hand, I know that all these developments have taken a very long time and we have still not crossed the finish line. Am I supposed to be excited and proud of the progress we have made in AD or should I be apologetic about how slow that progress has been?”
How to Launch a Product Successfully
Insmed chairman and CEO William Lewis shared his experience launching the company’s first rare disease product, ARIKAYCE®, which was approved in September 2018. “The most important element of any drug is whether it has a meaningful impact on patient outcomes. If you get that right, everything else takes care of themselves. ARIKAYCE® received both the Breakthrough Therapy designation and the Fast Track designation, which is testament to the value that the FDA sees in our product.” ARIKAYCE® is a drug-device combination designed to treat refractory nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC). Lewis indicated, “our drug eradicates that bacteria in an unprecedentedly effective manner and protects patients from reinfection for a period of time. This is a huge advance in this area and for that reason, the market access world has been very supportive of this drug. We have not experienced significant issues in terms of pricing and reimbursement.”
Without resting on their laurels, however, he added, “we also devoted an extraordinary amount of time and energy to education and stakeholder engagement. For instance, we created a first-class patient support group, the Arikares Support Program, to ensure that the patient experience on the drug is positive and successful.”
Another topic that underpins innovation, access and affordability is manufacturing and supply chain. Having been dismissed and outsourced as lower-value or inessential parts of the industry value chain in recent years, the global COVID-19 pandemic has re-emphasized the importance of supply chain security. The dismal reality is that even as the US remains the leader in biopharma innovation and R&D, it has slipped down the rankings in terms of pharmaceutical manufacturing and production, having experienced increasing trade deficits in pharma products since 2001. One study by the US Bureau of Economic Analysis found that “between 2013 and 2017 the United States lost about 22 percent of its drug manufacturing”. According to the Bureau of Labor Statistics, since 1987 (to 2019) labor productivity in the pharmaceuticals and medicines sector actually fell by 0.8 percent a year, the worst performance by any US manufacturing industry.
That being said, US dependence on foreign drug suppliers may, just like gouging price increases, have been overstated. Presently, 75 percent of US spending on drugs goes to medicines produced domestically, while an estimated 70 percent of the medicines actually consumed in the US are manufactured domestically, according to the Information Technology and Innovation Foundation (ITIF). Moreover, the supply chain is actually quite diverse, with over 90 countries represented and in 2019, 73 percent of US pharma product imports and 61 percent of imported APIs originated from Europe.
Many industry stakeholders believe that while it may be too late to repatriate traditional pharma manufacturing, advanced manufacturing capabilities are critical to safeguard the future of US biopharma innovation and production. As FDA CDER’s Woodcock emphasized, “we have been pushing advanced manufacturing for almost 20 years. Traditional manufacturing has a lot of environmental liabilities [and] also requires a large workforce and physical footprint. Advanced manufacturing deals with those liabilities, so it is much more feasible to do advanced manufacturing in the US.” For this reason, the FDA has launched a number of programs in the past few years. For instance, CDER created the Emerging Technology Program, which has a dedicated team available to provide pre-submission support on issues such as the development of process control measures for continuous manufacturing of drugs while its sister center, the Center for Biologics Evaluation and Research (CBER) established the Advanced Technologies Team, which works with prospective developers on issues such as technical considerations for platform technologies in gene therapy.
Gene therapy is a field where the line bet-ween product innovation and process development is perhaps nonexistent. Two of the most critical challenges in gene therapy are scalability and manufacturability, since gene therapies are administered typically to waiting patients and cannot sit waiting in stockpiled inventories. As Deloitte’s Reh explain-ed, “you have no choice but to have a smooth orchestration of the lifecycle stages of therapy order management, product manufacturing, and order delivery. Some would say that the product is the process.”
For this reason, the FDA CBER has taken a special interest in gene therapy. As director Dr Peter Marks declared, “we are trying to take a fair amount of leadership in gene therapies. We are very interested in helping to move the field forward by looking at how one can develop gene therapies for small patient populations in what would ultimately be a commercially viable manner.” Due to the incredibly small patient populations – often fewer than 100 patients treated per year – and the immense expenditures involved in R&D, regulatory approval and commercialization, these therapies are not seen as commercially viable targets for companies. However, Marks anticipated, “if regulatory frameworks and science could be developed for the manufacture of gene therapies, such as reusing certain vectors and changing out inserts, or the use of common manufacturing protocols and techniques, manufacturing costs could be reduced sufficiently to interest more companies into working on gene therapies for patient populations of 50 or 100 people.”
On the other side of the coin, as COVID-19 has led to a wave of manufacturing and supply chain nationalism, generic players maintain strongly that diversified supply chains are essential to reliable access to affordable medicines. As Sandoz US president Carol Lynch noted, “many stakeholders are advocating for more national and local manufacturing. But the reality is that not every country can build its own manufacturing capabilities in every industry. That is simply not feasible or sustainable,” continuing, “like most medicine manufacturers, we have a broad manufacturing network globally with sites across multiple regions, including the US. The important thing is maintaining reliability throughout the network.” While she allowed that “there will be instances where specific circumstances require or incentivize local manufacturing in some form, generally, a broad manufacturing network is a way to guarantee the reliability of supply.”
Biocon commercial head of global generics and SVP marketing Abhijit Zutshi agreed, “a longer-term view needs to be taken rather than any kneejerk reactions. The fact is that lower manufacturing costs in other parts of the world including but not limited to India is something that have helped lower the costs of medicines for patients in the US. There needs to be more regulations to help patients gain access to affordable medicines rather than shutting down that access.”
To Glenmark North American president Robert Matsuk, a balance between US and global production is ideal, sharing, “several years ago, we initiated the development of our US manufacturing facility and we were finally granted our first approval in 2019. It is important to have capabilities in the geographies that a company is operating in. Regardless of regional geography, it pays to diversify manufacturing activities.” He also pointed out astutely that, “having manufacturing locally opens the possibility to access some government markets which we would have not been able to reach otherwise.”
In any case, on the topic of the repatriation of more production to the US, former AAM CEO Davis put forth, “our members are absolutely willing to engage in that discussion, provided it is realistic and viable – and that policymakers, both members of the administration and of Congress, are willing to recognise that generic drugs are under-reimbursed in the US.” The huge roadblock, he continued, is the fact that “generic drug prices in certain categories have gone down to a point where they are so low that the market price is below the cost of manufacture. If we do not get to the heart of that issue, the ability to increase domestic manufacturing will not be fully realized,” emphasizing, “even though we are a very different industry [from] the branded drug business in terms of how the markets operate, the commitment to manufacturing is equally high, and it is not an easy or quick process to and initiate or stop manufacturing particular types of products.”
Despite the challenges and complications of operating in the US market, the world’s largest and most innovative pharma market simply cannot be ignored – and for companies that invest adroitly, the market continues to generate handsome rewards.
Echoing the sentiments of perhaps many of his Big Pharma peers, Sanofi Genzyme’s Sibold exhorted, “the US will always be one of the most important markets for us, even as we grow in developed and emerging countries. We are the only Sanofi business unit that is headquartered in the US,” stressing, “the US is a market that rewards innovation.” For instance, their flagship blockbuster Dupixent® has been approved and launched for all available indications in the US but not yet globally. For Sanofi’s specialty care arm specifically, the US represented 60 percent of global revenues in Q1 2020, compared to the US market only being a third of Sanofi’s overall group revenues.
However, one should by no means see the US market as an easy win. As IBSA US CEO Aldo Donati described, “the US healthcare system is based on a complex system of private providers and insurance companies that is regulated both at federal and state levels. The market is very large geographically and demographically, making commercial operations and supply logistics quite challenging and expensive to manage. Finally, the environment is in continuous evolution compounding its complexity.” That said, he insisted, “in the global economy we are operating in, the US market cannot be ignored and if successful, the financial rewards and growth opportunities can be extremely interesting for an expanding pharmaceutical company.” While large corporations have the critical mass and leverage to navigate the US market, he believed that midcaps like IBSA can succeed as long as they leverage the “increased flexibility of their business model, fast decision-making processes, and the ability to think and adopt out of the box strategies.”
With European midcaps increasingly drawn to the lucrative US market, French plasma player LFB US CEO Jose Antonio Moreno Toscano drew upon his extensive US industry experience to advise, “for a typical pharma company, US revenues would range between 35 to 45 percent of global revenues and represents the most important single market. This is a very sensitive topic for European midcaps because while the US is the largest single market, taking the European bloc as a whole, Europe is bigger.” In addition, he cautioned, “the US market is not really a country market but a continental or regional market, and that is important to understand when a company set up US operations. It is not sensible to treat US affiliates or its management like a single country. The US is much bigger and more important to the global organization so there is a need to take into consideration the individuality and complexity of the US market.”
Something that often slip the mind is the fact that “it is expensive to do business in the US. The cost of doing business in the US has risen faster over the past 15 years when compared to Europe,” explicated Antonio, who suggested, “European companies need to adapt to this. If you want to be part of the very attractive US market with high prices and high margins, you need to pay the price of higher costs as well.”
Ferring is another example of a successful European midcap in the US market. US president Brent Ragans illuminated, “Ferring is 70 years old this year. For the first few decades of our existence, we were very focused on our home markets in Europe. We only started building our direct presence in the US from the 1980s, and even then, we were fairly small for a while. Therefore, the US affiliate is fairly new but we already represent roughly 35 percent of global revenues – the largest affiliate in the global Ferring network.” Innovation is critical here; as he delineated, “if you look at our pipeline, many of the products, including the first product coming from our Rebiotix acquisition, are being developed for the US market. Our future is very much in innovation and R&D, and that is in our DNA.”
The Japanese pharma companies are also fairly new entrants to the US market but their performance has proceeded well, anchored on an astute understanding of the US’ innovation imperative. Japanese specialty pharma company Kyowa Kirin is a prime example of this. President of North America Gary Zieziula revealed, “three years ago, our revenues were USD 25 million. This year, we expect to contribute over half a billion dollars in revenue to the global organization!” Looking forward, he forecasted, “we are looking to represent 50 percent of global revenues outside of Japan within the next five years. We currently stand at around 29-30 percent.” He attributed this to the company’s focus on “advancing innovations that can address unmet needs,” outlining, “we excel in specialty care and rare disease, and we work hard to meet unmet medical needs in these areas. Kyowa Kirin is definitely punching above our weight class when it comes to our pipeline, and as our portfolio continues to grow, we are adding important commercial capabilities to be more successful in market. In addition to our three existing products, we also have an exciting pipeline with several new investigational products we hope to bring to the market in the 2025-2030 timeframe.” For all these reasons, he anticipated, “[we can] become a multi-billion-dollar affiliate over the next three to five years.”
Fellow Japanese pharmaco Eisai has also reaped the rewards of delivering innovation to the US market. US chairman and CEO Cheung stressed, “in most Asian markets, you can typically find a very balanced and diversified portfolio composed of both new and legacy products. Based on how the US healthcare system is structured, however, that business model does not exist. The US business model relies solely on new patented drugs, which means it is more cyclical.” His insight, he revealed, is that “to perform well in the US, we need to have a consistently robust pipeline instead of relying on just one or two blockbusters.” While the Americans currently represent just over 18 percent of the global business in 2019, which is still the second-largest market for Eisai globally after their home market of Japan, he declared, “looking at the projections within our current ten-year plan from 2016-2025, we expect the US business potentially to comprise around 40 percent of our global business by 2025, which would then make us the largest Eisai affiliate.”
With innovation being critical for Eisai’s US and certainly global growth, the company has decided to invest significantly to leverage the country’s cutting-edge innovation capabilities. Cheung listed, “we have four major R&D hubs in the US, helping not only patients in the US but also patients globally, through our work on breakthrough medicines: two discovery facilities in Cambridge (H3 Biomedicine, which focuses on cancer genomics based drug discovery, and already has multiple clinical-stage assets; and the Center for Genetics Guided Dementia Discovery (G2D2), which works in the area of immuno-dementia); a hub is in Pennsylvania, Epochal Precision Anti-Cancer Therapeutics (EPAT), with a focus on antibody-drug conjugates (ADCs) and bispecific antibodies, and has multiple clinical-stage assets; and a fourth is in New Jersey, which houses our global clinical development and regulatory affairs operations for both oncology and neuroscience.”
Takeda has gone a step further, with Sequeira, who heads both the US market and global portfolio commercialization, illuminating, “connecting the role of global commercialization with our largest market, the US, this approach brings a certain pragmatism to the commercialization process [that] allows us to make decisions with a strong understanding of what is best for patients across multiple markets.”
While the COVID crisis has brought the worst of the US healthcare gaps to the forefront, it has also illuminated the best of the US pharma industry, as companies have banded together at unprecedented scale and speed to develop vaccines and therapeutics against the novel coronavirus. As the pharma industry’s reputation has taken a battering in the past few years, many industry players see this period as a critical moment for the industry to recall its purpose and mission.
As Takeda’s Sequeira averred, “through the global COVID response, we have seen the walls between companies and across sectors come down as the industry thinks about tackling this public health crisis together. From a reputational perspective, I think as an industry we will see a positive impact if we handle this well,” advocating, “we must make sure we put the science first, focus on safety and efficacy, and make therapies available and accessible to patients once they are approved. The pharma industry hasn’t always had a positive reputation, and I see this as our chance to rise to the occasion. So far, we seem to be doing quite well on this aspect.
LFB’s Antonio has already seen some positive impact, venturing, “[the COVID response] has also improved the public perception of the industry, which has not been so good in the past few years – for good reasons in some cases, as sometimes companies have placed money ahead of patients,” emphasizing, “this crisis is a good opportunity for the whole industry to show that they know and believe that patients are the foundation and the entire reason for the existence of the industry.”
Taking a broader perspective beyond immediate pandemic concerns, Karyopharm’s Kauffman reflected, “looking broadly, as a society, I think we are at a state of civilization where it is all about innovation. We have the choice of contributing to that innovation and creating novel products or being critics of innovation.” After all, he remarked, “one of the beauties of the biotech industry is that we have the ability to treat and maybe even cure diseases. There are so many diseases out there that still require treatments and cures, so the work is not even close to being done.”
This is an aspirational sentiment that Sanofi Genzyme’s Sibold – and quite probably most of his industry peers – held, and he marveled, “I have worked in this industry my entire career. I love this industry and I genuinely believe it is the greatest in the world,” pointing out, “no other industry saves and transforms lives every day – literally.” As the industry presses on in its vocation to treat and cure disease, despite all the headwinds and missteps, it is always essential to re-energize and recall the fundamental purpose of the sector, and Sibold rallied, “we have advanced to a point where science can work on targeted solutions for exceptionally complicated and serious diseases. I believe there are so many exciting opportunities to work on breakthrough therapies and cutting-edge science.”
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