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In January 2022, after months of proceedings and years of speculation, a jury found Theranos founder Elizabeth Holmes guilty of conspiracy to commit fraud and multiple charges of wire fraud (1). The trial of her former business partner Ramesh (also known as Sunny) Balwani began in March 2022. Theranos, a private medical device company in the healthcare sector, aimed to change the face of blood testing through benchtop in vitro diagnostics (IVDs) that were rapid, highly sensitive and specific, and required only small amounts of blood. It failed to achieve those goals.

Although it is an unfortunate fact that many biotechnology companies fail to achieve their underlying healthcare objectives before funds are exhausted, whether due to scientific or human failures, the story of Elizabeth Holmes and Theranos has captured the public’s imagination. It serves as a cautionary tale for healthcare investors and management. The financial rise and fall of the company were dramatic (the company was at one point valued at $9 billion) (2); the names associated with the company (officers, investors) were well-known (former US Secretary of State Henry Kissinger, media tycoon Rupert Murdoch, Oracle Corp cofounder Larry Ellison). With the benefit of hindsight, the governance failures were so astonishing that the Theranos story has become a successful new industry in its own right: a best-selling book by John Carreyrou (3), a movie starring Jennifer Lawrence in the works, and at least one university class (4).

Because the biotechnology evolutionary model from start-up to pharma acquisition is now firmly established, the number of cautionary tales of failed and/or sometimes disgraced companies will naturally increase. The jury’s verdict of January 2022 sends a clear message: Certain responsibilities come with taking investors’ money. They are not only matters of ethics, but also of law. It is generally understood that “good governance is a good thing,” but how does that translate in terms of setting up a biotechnology start-up? What is good governance within that context, and how can a start-up achieve it? How can we use these stories to help companies perform optimally and avoid common pitfalls?

And perhaps most important, how can a company maximize patient benefit per investment dollar? Taking into consideration the case study learning points below, we support an approach whereby monetary investments into biotechnology programs that repeatedly fail to meet their proposed endpoints be systematically repurposed to support development of other healthcare technologies. Not to pursue this approach is arguably an expensive — sometimes multimillion-dollar — demonstration of the sunk-cost fallacy.

Governance Failures That Made the Headlines
As is common in everyday life, in enterprise we often learn through error — our own errors and those of others. Useful learning points can be gleaned from the following three case studies of companies with well-publicized governance failures. As you read these examples, we suggest that you measure their events, actions, and structures against Sir Adrian Cadbury’s definition of corporate governance:

Case study 1: Theranos Inc.
Background: Theranos Inc. was a privately held US medical device company operating from 2003 to 2018. As mentioned above, at its height it was valued at $9 billion, leading to its chair and founder Elizabeth Holmes’s being named the youngest and wealthiest self-made female billionaire in the United States by Forbes in 2015, with an estimated net worth of $4.5 billion (2). Theranos aimed to make significant advances in blood testing, claiming accurate, fast results from one drop of blood. By 2018, its year of closure, despite significant investment and claims to the contrary, the business had failed to deliver an effective medical device solution fulfilling its objectives, and stories emerged of a scenario akin to a modern biotech retelling of Hans Christian Andersen’s The Emperor’s New Clothes. Once marked out as a success story, Theranos’s reputation had been lost, and trust more widely in biotechnology investment was shaken.

Red Flag Issue 1: Voting disparity existed between the founder (Holmes) and other investor groups. For example, a letter to shareholders of 2013 aiming to protect Holmes’s control reportedly reads thus:

Potential Consequences: Deep information asymmetry among Holmes, other company officers, investors, and management was allowed to perpetuate, with decision-making power significantly in Holmes’s favor despite obvious conflicts of interest and lack of appropriate experience.

Start-Up Solution 1: Clear and engaged structures and mechanisms must be established for technical, financial, and governance oversight. Such structures include regular reviews of functional performance by independent subject matter experts — and in some cases, prohibiting the exercise of voting rights when a significant conflict of interest is present.

Red Flag Issue 2: The board of directors (BoD) lacked experience and qualifications in fields relevant to the company’s core technology. The board’s members mainly reflected diplomatic/military backgrounds and included

∙ Henry Kissinger (former US Secretary of State)
∙ George Shultz (former US Secretary of State)
∙ Jim Mattis (retired Marine Corps four-star general)
∙ William Perry (former US Secretary of Defense)
∙ William Foege (former director of the Centers for Disease Control and Prevention)
∙ Richard Kovacevich (former CEO of Wells Fargo)

Potential Consequences: It can be difficult for a board comprising a large number of nonexperts in a field to assess the feasibility of a highly technical/specialist product and understand the appropriate regulatory and quality framework — as well as the resources and activities required for compliance. Lacking the appropriate expertise, such a board is likely to underestimate both risk levels and costs. It cannot easily support and mentor inexperienced management and cannot easily spot signs of declining company operations early enough for meaningful intervention.

Start-Up Solution 2: Conduct regular analyses of optional board compositions — aligning BoD functions and expertise with the stage of corporate and technical development. For example, ideally major changes to BoD composition would occur when a company reaches clinical trials, prepares to enter public markets, and so on.

Red Flag Issue 3: Former employees and commentators described a “toxic” organizational culture with high levels of secrecy and opacity within the organization. In that culture, people who asked questions of management were ignored and potentially threatened into signing nondisclosure agreements (7, 8). The company vocabulary reportedly included the expression “to disappear” someone.

Potential consequences included demotivated staff; reduced performance levels; high churn (staff retention issues and increased HR/legal costs); increased legal and reputational risks; and missed opportunities for improvement and correction. Information provided to board members and other stakeholders was likely to be incomplete, leading to suboptimal decision making. Instead of being “independent,” board members may have become disconnected from the organization’s activities.

Start-Up Solution 3: Create a corporate structure that values transparent structures, clear and transparent roles and responsibilities, and clear and open communication channels at all levels. Institute good HR practices and encourage management to listen to and invest in people (the team). Conduct at least basic risk management, and report any issues to the board. For later stage organizations, institute a sophisticated whistleblowing policy and procedure.

Red Flag Issue 4: Former employee Tyler Schultz reported that Theranos “doctored research and ignored failed quality control tests”:

Potential consequences are lack of trust in an organization, lack of confidence in all data arising from R&D activities, and lack of employee motivation and confidence.

Start-Up Solution 4: Proposed solutions would include implementation of internal peer review and/or data quality assurance processes — even in R&D laboratories. For applied R&D and clinical laboratories, a company should implement and adhere to a GxP quality management system (QMS) and prevailing sector-specific standards, such as ISO 9001 and ISO 13485.

Case Study 2: Valeant Pharmaceuticals
Background: Valeant Pharmaceuticals was a Canadian specialty pharmaceutical company, now trading as Bausch Health Companies Inc. Its roots lie in ICN Pharmaceuticals, founded in 1959. By 2016, its troubles were well publicized. Featured in the Netflix documentary series Dirty Money (the episode “Drug Short”), the company was accused of price gouging. The media suggested that Valeant, focused on its own share price as well as that of other companies, pursued a strategy of buying what it believed to be undervalued companies/assets at a low price, and then consequently implemented a policy of reducing R&D and increasing drug prices (11). Hillary Clinton famously vowed to “go after” Valeant when the price of a drug she singled out rose 356% in one year (12). A 9% decline in stock price on the New York Stock Exchange followed. Short sellers predicted that “the drug company’s price gouging, questionable tactics, and massive debt burden could not be sustained” (13). They were proven to be correct. The company lost 90% of its value.

A series of headlines emerged throughout 2015 and 2016, including

∙ the dramatic increase in prices of selected drugs, as referenced above (another example is the cost of Syprine, used to treat the rare condition Wilson Disease, which increased from $652 in 2010 to $21,267 in 2015) (14)
∙ allegations surrounding Philidor Rx Services and certain affiliates (all controlled by Valeant) and associated claims of improper bookkeeping regarding sales and aggressive billing (15)
∙ prosecutions in 2018 relating to Valeant and Philidor that resulted in convictions of wire fraud and money laundering (16)
∙ a Federal Trade Commission monopoly investigation into Valeant’s increasing share of the rigid gas permeable contact lens market that coincided with price hikes (17).

Red Flag Issue 1: The company lacked a sustainable and durable strategy within a public health context (following a financial model of “buying low,” reducing costs such as for R&D, and increasing drug prices).

Potential Consequences can include the loss of public trust in a company — and potentially in the pharmaceutical and biotechnology sector as a whole. Resources can be wasted through managing adverse press, investor communications, and government relations that could be directed toward shareholders and patients more effectively.

Start-Up Solution 1: Once determined, a sustainable corporate strategy should be clearly communicated and reviewed regularly. For example, in digital health, the coexistence of SaaS (software as a service) and non-SaaS business models within the same company can make it impossible to generate a target amount of annual recurring revenue (ARR) or determine a cashflow break-even point. This can happen when legacy products upon which a company has been founded require disproportionate amounts of resources to support compared with second-generation technologies.

Red Flag Issue 2: The company focused on financials within a public- health context (e.g., share price); it was reportedly a performance-based environment.

Potential Consequences: A narrow focus on one metric of financial performance — in this case share price or price-to-earnings (P/E) ratio — will fail to assess holistically the overall health and development of an organization. In such a case, management cannot intervene quickly enough to address adverse events. For example, in this case study, a short-termist pricing strategy yielded perceived financial returns in the short term. However, a failure to monitor and manage stakeholder relationships, including reimbursement, competition, and other government agencies, ultimately led to the strategy’s being detrimental to the medium- and long-term business outlook.

Start-Up Solution 2: Developing a balanced scorecard of corporate performance and objectives that assesses a range of business functions and metrics can ensure creation of a continuous and holistic business view. Such a view can be integrated into management oversight of quality management systems and shareholder reviews of executive and governance performance.

Red Flag Issue 3: The following issues related to board composition were flagged in Canadian Business (18):

∙ Both the CFO and CEO were on the board of directors (potential independence issues)
∙ The audit committee chair reported to a board that included the CFO (thus creating conflict of interest, potential reduction of financial checks and balances, and potential confusion of segregation of duties)
∙ One third of the board members were from the same sector and hedge-fund companies (thus, they were potentially more likely to vote in tandem; and they were accustomed to working in an industry that focuses on short-term returns)
∙ The board included investor representatives (thus, it was not fully independent).

Potential Consequences: A number of potential, intertwined issues included weakened board independence and organizational/management scrutiny and oversight, conflict of interest, and reduced financial checks and balances internally. In such a scenario, there is a heightened likelihood that the board pursued a narrower set of objectives and strategies than was optimal because its member backgrounds were concentrated in one sector (a sector that was, furthermore, technically unrelated to the company’s core business). In general, misaligned objectives and incentives among shareholders can lead to both management and the BoD not acting in the best long-term interests of the business.

Start-Up Solution 3: Shareholder interests and board composition must be aligned. When this is not easily achievable — for example, as a consequence of a necessary, but aggressive refinancing/restructuring — a company can implement BoD “terms of reference” to prevent BoD members from acting in concert against the best long-term interests of an organization. This approach can be supported by the composition and role of BoD committees.

Red Flag Issue 4: The company was alleged to have “unreliable financial statements” and “shoddy accounting” (19).

Potential Consequences: In addition to the loss of investor and public trust and potential legal consequences for company officers, substandard financial statements trigger a waterfall effect of challenges for an organization during a crisis. At first, problems are obscured and/or concealed, which allows them to accumulate and grow in severity. Consequently, management and the BoD have less time to react to a problem and to allocate resources appropriately. In some cases, the time taken to uncover and investigate an issue is longer than a company’s available resources can manage and/or exhausts investor patience, leaving a company to decline into what should have been an avoidable fire sale and dilutive restructuring or bankruptcy.

Start-Up Solution 4: Ensure that financial records and processes are reviewed regularly — at least quarterly — with independent reviews/audits of financial statements and processes. Company financial processes should be adapted continuously to the stage of business development. For example, trying to implement IPO-ready financial processes in an early stage company may not only be a suboptimal use of resources, but also may hinder and distract management from implementing more basic financial processes and tools required to monitor current challenges (for example, when dealing with precarious working capital in start-up organizations).

Case Study 3: Mylan NV
Background: Mylan Pharmaceuticals was founded in the United States in 1961. In 2020, it merged with Pfizer’s Upjohn to form Viatris, which in turn placed fifth on Fortune’s 2021 “Change the World” list for its work in transforming HIV treatment globally (20). Mylan was a generic and specialty pharmaceuticals company, at one time the second-largest such pharmaceutical company in the world.

Through an acquisition in 2007 involving a division of Merck, Mylan acquired EpiPen, a potentially lifesaving product used to treat anaphylaxis (for severe allergic reactions). The product had around 90% of the market share at the time, which was a virtual monopoly position (21). Mylan was relying on this product for ~40% of its profits by 2015.

In the years that followed the acquisition, the following news headlines emerged:

∙ The product pricing increased significantly. In 2016, The New York Times noted that “in 2007 . . . pharmacies paid less than $100 for a two-pen set. . . . In 2009, a pharmacy paid $103.50 for a set. By July 2013 the price was up to $264.50, and it rose 75 percent to $461 by last May. This May the price spiked again to $608.61, according to data provided by Elsevier Clinical Solutions’ Gold Standard Drug Database” (22).
∙ Public outrage ensued at the above price hikes; damage to Mylan’s reputation and market value followed.
∙ According to former employees, the chairman and former CEO Robert Coury used colorful language to dismiss internal and external critics of the price increases (23).
∙ Criticism was leveled at the size of executive remuneration ($98 million for Robert Coury in 2016). This news emerged amid price-hike controversies and at a time of shareholder losses and questions over good stewardship (24).
∙ In 2017, the US Department of Justice reached a deal with Mylan whereby the company would pay $465 million “to resolve claims that they violated the False Claims Act by knowingly misclassifying EpiPen as a generic drug to avoid paying rebates owed primarily to Medicaid” (25). Misclassifying a product as a generic rather than as a branded product leads to underpaying rebates to Medicaid. One review suggested that “the US government may have overpaid for EpiPens by as much as $1.27 billion between 2006 and 2016” (26).

Red Flag Issue 1: Within the company culture, internal and external criticisms were reportedly dismissed.

Potential Consequences: In such a culture, internal perceptions by senior management of company performance can become misaligned with internal realities perceived by employees and external stakeholder perceptions. (See also Theranos Case Study 1, Issue 3, Potential Consequences.)

Start-Up Solution 1: Clear and open communication, internally and externally, will build awareness of both internal and external contexts at every level of an organization. Implement clear whistleblowing policies with direct reporting of severe cases to the BoD and/or BoD audit committee. And implement clear management-review processes and SMART (specific, measurable, achievable, realistic, and timely) objectives throughout the organization that cascade up to a balanced corporate scorecard to reduce the likelihood that whistleblowing processes are used in the first place — because management should have the requisite information to resolve issues at an early stage. Ensure alignment of management performance with corporate goals. (See also Theranos Case Study 1, Issue 3, Start-Up Solution.)

Red Flag Issue 2: Pursuing a financial model/strategy without regard to the sector in which an organization operates is a risk; as is seeming to operate without regard to the effects that strategy might have on some of the most vulnerable groups in society and in life-and-death scenarios. Reports in this case indicate a high level of executive remuneration being awarded by the board during a period of shareholder losses and significant reputational damage.

Potential Consequences include reputational damage to a company and sector through loss of shareholder and stakeholder trust, loss of resources required to deal with investor-relations challenges, and high turnover of staff at all levels of an organization.

Start-Up Solution 2: Establish transparency in corporate remuneration, and align individual performance with corporate goals. Develop awareness of the external context.

Red Flag Issue 3 is the allegation that a company may have misclassified a medical product.

Potential Consequences: Misclassification can lead to potential enforcement actions from regulators (financial and national competent authorities). Patient risk can increase because product-oversight requirements are dependent on classification (e.g., pharmacovigilance).

Start-Up Solution 3: Ensure that technologies go through a three-step classification process:

∙ classification proposed by internal subject matter experts based on their experience and product-specific knowledge
∙ review conducted by external specialists (e.g., legal counsel)
∙ final review/confirmation by regulators as part of clinical evaluation and/or market access processes.

Common Themes, Calls to Action
A number of common themes emerge from examining just these three case studies. Multiple, sometimes interconnecting issues relate to categories of good/bad HR, finance, quality, and regulatory practices. For example, as many HR experts would no doubt advocate, securing the right expertise and experience “fit” for a role is vital at all levels of an organization, including at board level. Appointing a preponderance of technically inexperienced (albeit senior and well-meaning figures) to a board in a highly specialized field can have significant repercussions, including contributing to the demise of an enterprise or at least hindering rescue operations when a company is failing.

Understanding External Context: Furthermore, as promoted by ISO 9001, understanding the external context of an organization is vital, including taking into account widely accepted societal views and ethics. One of the consequences of ignoring the external context of an organization can be to alienate the public and government agencies. Such a selective vision can be counterproductive to all parties and trigger a number of negative outcomes, including reputational damage, legal costs, decreases in company value, and a loss of public trust in the wider sector. Noncompliance of external frameworks with regulatory and quality controls can have deleterious effects on public health and patient care — it can endanger lives. Other examples have made the news in recent years. The case of the now-defunct French company Poly Implant Prothèse (1991–2011), manufacturer of silicone gel breast implants, provides a stark warning in this respect (27). We are yet to count the economic and societal costs of faulty Covid tests produced to suboptimal manufacturing and quality control standards (28). Elsewhere, we await to see the full consequences of Google DeepMind’s NHS app test noncompliance with UK data privacy laws (29) — a legal case by patients affected is under way (30).

In terms of Sir Adrian Cadbury’s definition of corporate governance and our definition of biotechnology corporate governance (31), the case studies do indicate that some form of imbalance can catalyze an issue or at least start a snowballing of wider problems. For instance, a founder, however well-meaning, who maintains a powerful grip on decision making a decade after company formation, may not allow for the checks and balances and objective decision making that help a company steer an optimal course. Pursuing economic goals at the expense of social goals can be catastrophic in the long term for both an organization and the public. Similarly, although asymmetric voting rights are a mathematically and legally attractive route to retaining control by key shareholders, the risks they create should not go unnoted or unmitigated. If start-ups can avoid these pitfalls, we believe it will help them to perform optimally.

To return to the sunk-cost fallacy, good governance and leadership in a start-up also should be able to recognize when it is time to quit — and back that up with action. Such a decision can stem from a number of reasons, including that the science does not work or the team is not the right fit. As Bruce Booth comments:

Inside this lies a greater truth that applies to many situations in life, as told by the late singer-songwriter Kenny Rogers in the lyrics of “The Gambler” (written by Don Schlitz). In an article focused on the utility and transformative power of storytelling, we hope that start-ups might find both consolation and a call to action from Rogers’s storytelling if the difficult moment arrives to close down operations:

References
(Accessed 28 January 2022)
1 Elizabeth Holmes: Theranos Founder Convicted of Fraud. BBC, 4 January 2021; https://www.bbc.com/news/world-us-canada-59734254.

2 Forbes Announces Inaugural List of America’s 50 Richest Self-Made Women. Forbes, 27 May 2015; https://www.forbes.com/sites/forbespr/2015/05/27/forbes-announces-inaugural-list-of-americas-50-richest-self-made-women/?sh=497b891424c1.

3 Carreyrou J. Bad Blood: Secrets and Lies in a Silicon Valley Startup. Alfred A. Knopf: New York, NY, 2018.

4 611.35 Readings: Theranos: Leadership, Corporate Governance and Ethics. Duke University School of Law, 2021; https://law.duke.edu/academics/course/section/2021/fall/611.35.

5 Iskander MR, Chamlou N. Corporate Governance: A Framework for Implementation. World Bank: Washington, D.C., 2000; https://documents1.worldbank.org/curated/pt/831651468781818619/pdf/30446.pdf.

6 Cohan P. Theranos Letter Shows Elizabeth Holmes Tightened her Voting Control. Forbes, 3 November 2015; https://www.forbes.com/sites/petercohan/2015/11/03/theranos-letter-shows-elizabeth-holmes-tried-to-take-control-from-shareholders/?sh=5edb36b62c53.

7 Dunn T et al. Ex-Theranos Employees Describe Culture of Secrecy at Elizabeth Holmes’ Startup. The Dropout Podcast Ep. 1. ABC News, 12 March 2019; https://abcnews.go.com/Business/theranos-employees-describe-culture-secrecy-elizabeth-holmes-startup/story?id=60544673.

8 Former Theranos Employees Claim Toxic Work Culture: Part 3. ABC News; https://abcnews.go.com/2020/video/theranos-employees-claim-toxic-work-culture-part-61720603.

9 Chua ML. Bad Blood: 5 Lessons in Company Culture from the Rise and Fall of Theranos. Medium, 15 October 2019; https://medium.com/swlh/company-culture-lessons-from-theranos-5dfc7cfba072.

10 Carreyrou J. Theranos Whistleblower Shook the Company — and his Family. WSJ, updated 18 November 2016; https://www.wsj.com/articles/theranos-whistleblower-shook-the-companyand-his-family-1479335963.

11 Surowiecki J. Valeant: Why Moneyball Failed in the Pharmaceutical Industry. The New Yorker, 7 April 2016; https://www.newyorker.com/business/currency/valeant-why-moneyball-failed-in-the-pharmaceutical-industry.

12 Crow D. Price of Valeant Drug Singled Out By Clinton Rose 356% in a Year. The Financial Times, 2 February 2016; https://www.ft.com/content/fff89b8e-c922-11e5-be0b-b7ece4e953a0.

13 Celarier M. Hacked Printers. Fake Emails. Questionable Friends. Fahmi Quadir Was Up 24% Last Year, but It Came At a Price. Institutional Investor, 9 January 2019; https://www.institutionalinvestor.com/article/b1cmcvhk61k8zl/Hacked-Printers-Fake-Emails-Questionable-Friends-Fahmi-Quadir-Was-Up-24-Last-Year-But-It-Came-at-a-Price.

14 Thomas K. Patients Eagerly Awaited a Generic Drug. Then They Saw the Price. The New York Times, 23 February 2018; https://www.nytimes.com/2018/02/23/health/valeant-drug-price-syprine.html.

15 Rockoff J, Whalen J. Valeant and Pharmacy More Intertwined Than Thought. WSJ, 25 October 2015; https://www.wsj.com/articles/valeants-ties-to-pharmacy-scrutinized-1445817449.

16 Ex-Valeant, Philidor Executives Get Prison for Fraud. CNBC, 30 October 2018; https://www.cnbc.com/2018/10/30/ex-valeant-philidor-executives-get-prison-for-fraud.html.

17 Ornstein C. Federal Investigators Looking at Valeant’s Contact Lens Dealings. ProPublica, 27 October 2015; https://www.propublica.org/article/federal-investigators-looking-at-valeant-contact-lens-dealings.

18 Bosanac A. Why the Trouble At Valeant Starts with Its Board of Directors. Canadian Business, 24 March 2016; https://archive.canadianbusiness.com/companies-and-industries/why-the-trouble-at-valeant-starts-with-its-board-of-directors.

19 Eavis P. Valeant’s Accounting Error a Warning Sign of Bigger Problems. The New York Times, 28 March 2016; https://www.nytimes.com/2016/03/29/business/dealbook/valeants-accounting-error-a-warning-sign-of-bigger-problems.html.

20 2021 Change the World: Viatris: 5. Fortune; https://fortune.com/company/viatris/change-the-world.

21 Johnson C, Ho C. How Mylan, the EpiPen Company, Maneuvered to Create a Virtual Monopoly. The Washington Post/Chicago Tribune, 25 August 2016; https://www.chicagotribune.com/business/ct-mylan-epipen-monopoly-20160825-story.html.

22 Parker-Pope T, Peachman RP. EpiPen Price Rise Sparks Concern for Allergy Sufferers. The New York Times, 22 August 2016; https://well.blogs.nytimes.com/2016/08/22/epipen-price-rise-sparks-concern-for-allergy-sufferers.

23 Mole B. Mylan Chairman: Drug Pricing Critics Ought to Go Copulate with Themselves. Ars Technica, 5 June 2017; https://arstechnica.com/science/2017/06/mylan-chairman-drug-pricing-critics-ought-to-go-copulate-with-themselves.

24 Egan M. EpiPen Maker Faces Revolt Over Exec’s $98 Million Pay Package. CNN, 13 June 2017; https://money.cnn.com/2017/06/13/investing/epipen-mylan-exec-pay-shareholder-revolt/index.html?sr=twCNN061417epipen-mylan-exec-pay-shareholder-revolt0246AMStoryLink&linkId=38675750.

25 Mylan Agrees to Pay $465 Million to Resolve False Claims Act Liability for Underpaying EpiPen Rebates. The United States Department of Justice (Office of Public Affairs), Press Release Number 17–921, 17 August 2017; https://www.justice.gov/opa/pr/mylan-agrees-pay-465-million-resolve-false-claims-act-liability-underpaying-epipen-rebates.

26 Mylan Finalizes $465 Million EpiPen Settlement with Justice Department. CNBC, 17 August 2017; https://www.cnbc.com/2017/08/17/mylan-finalizes-465-million-epipen-settlement-with-justice-department.html.

27 Martindale V, Menache A. The PIP Scandal: An Analysis of the Process of Quality Control That Failed to Safeguard Women from the Health Risks. J. R. Soc. Med. 106(5) 2013 173-177; https:// doi.org/10.1177/0141076813480994. PMID: 23761525; PMCID: PMC3676226.

28 Anthes E. CDC Virus Tests Were Contaminated and Poorly Designed, Agency Says. The New York Times, 15 December 2021; https://www.nytimes.com/2021/12/15/health/cdc-covid-tests-contaminated.html.

29 Google DeepMind NHS App Test Broke UK Privacy Law. BBC, 3 July 2017; https://www.bbc.com/news/technology-40483202.

30 DeepMind Faces Legal Action Over NHS Data Use. BBC, 1 October 2021; https://www.bbc.com/news/technology-58761324.

31 Carter A, et al. Biotechnology Governance 2.0: A Proposal for Minimum Standards in Biotechnology Corporate Governance. Rejuvenation Research. June 2019: 254–260. http://doi.org/10.1089/rej.2018.2122.

32 Booth B. Painful Truth: The Successful Failure of a Biotech Startup. Forbes, 17 November 2017; https://www.forbes.com/sites/brucebooth/2017/11/17/painful-truth-successful-failure-of-a-biotech-startup/?sh=2d44b97bd025.

Corresponding author Alison R. Carter ([email protected]) is senior partner, and David A. Brindley is managing partner at Biolacuna, Belsyre Court, 57 Woodstock Road, Oxford, OX2 6HJ, UK; 177 Huntington Avenue, Boston, MA 02115, USA.