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The National Football League (NFL) was both the most popular spectator sport in the U.S. and a major economic entity, taking in roughly $10 billion a year in revenue. However through the early twenty-first century, an increased understanding of the long-term effects of head injuries on NFL players indicated a serious threat to the long-term viability of the game. Particularly concerning was the indication that some deceased professional football players had developed chronic traumatic encephalopathy (CTE)-a neurodegenerative disease which had a strong influence on a person's mental and physical health-most likely as a result of repetitive hits sustained during their football careers and which may have contributed to their deaths. Over 4,000 retired players had jointly sued the NFL over the head injuries they had sustained during their time in the NFL and the resulting health problems they attributed to these injuries. In part, the lawsuit alleged that the NFL had not been forthcoming with players about the health risks of head injuries. The two sides had reached a tentative $765 million settlement in 2013, the bulk of which would go to compensating retired players suffering from such diseases as Alzheimer's or dementia. While this settlement compensated retired players, it was not applicable to current or future players. Could the NFL preserve the sport by making it safer through new rules or equipment changes, or was football an inherently physical game that no amount of new rules or equipment could make completely safe? Were current and future players, now knowing full well the potential long-term health implications of football, tacitly accepting the risks involved? As a team owner, is now the time to sell while franchise value and fan support are at their peaks, or will the business of the NFL be viable for years to come?

This Course Outline and Syllabus gives an overview of the Spring 2017 class Building Life Science Businesses.

What do you do when your rising professional career is cut short by an unexpected cancer diagnosis? Kathy Giusti shifted careers, built a new organization that transformed how cancer research is done, and now faces the challenge of sustaining the organization and its funding for its newest venture. Since she was first diagnosed with multiple myeloma (MM) in 1996, Giusti had led an effort to better understand and treat the disease. She had co-founded the Multiple Myeloma Research Foundation (MMRF), helped form the Multiple Myeloma Research Consortium (MMRC), and brought together a diverse body of academics, researchers, pharmaceutical and biotech companies, physicians, and patients to combine their efforts around the disease. The MMRF had helped facilitate clinical trials for promising drugs, sponsored research, and raised a substantial amount of money for these purposes. In 2014, the MMRF was in the midst of its CoMMpass program; a multi-year effort to collect tissue samples from 1,000 patients at key junctures in their disease, sequence these samples to better understand the genetic underpinnings of MM and its many sub-types, and thus enable researchers to study a comprehensive sampling of patients. CoMMpass also had a patient-facing element which allowed the patient community to communicate with one another and with professional moderators. By mid-2014, some 550 patients were enrolled and 85 hospitals were participating. As a non-profit, the MMRF had historically relied on donations to fund its research operations. Giusti wanted to find a way to ensure a reliable revenue stream for the organization and give it greater financial stability. The MMRF had historically given away its resources and knowledge for free in order to speed research; Giusti worried if charging for some of its functions would be at odds with its mission and historical practices.

In May 2013 the co-founders and co-CEOs of salaUno, Javier Okhuysen and Carlos Orellana, were encouraged by the results of their fledgling start-up. salaUno was founded as a for-profit enterprise in order to have the capital needed for rapid growth and to fulfill its mission of Eliminating Needless Blindness in Mexico. salaUno had grown from doing 75 cataract surgeries in its first month of operation to a high of 388 surgeries 21 months later. This case explores the challenges in scaling up a healthcare venture within a developing country.

On September 11, 2013, the three-judge panel of the U.S. Court of Appeals for the Federal Circuit denied St. Jude's request to rehear an appeal on the "double patenting" ruling for the '439 patent. Further, it removed the injunction threat that was hanging over the company. The future looked bright for AccessClosure as 2013 drew to a close. The company expected 2014 revenues of more than $100 million with a gross margin of greater than 70%. It was also anticipating FDA approval on a significant product improvement within the next several months.

GenapSys, a California-based startup, was soon to release a new DNA sequencer that the company's founder, Hesaam Esfandyarpour, believed was truly revolutionary. The sequencer would be substantially less expensive-potentially costing just a few thousand dollars-and smaller than other sequencers, many of which were large devices costing tens of thousands or hundreds of thousands of dollars. GenapSys' device, named GENIUS, could also quickly generate large amounts of data, as it was capable of sequencing an entire human genome in less than eight hours. At this price, GenapSys' device would be attractive to customers that had been unable to afford sequencers, such as smaller laboratories or hospitals, and even expand the market to include industries such as agriculture and biofuels. As GenapSys came closer to releasing its product, Esfandyarpour and his Senior Director of Operations and Strategy, Leila Rastegar (HBS '11), sat down to decide which of three business models they would choose to bring this device to market. In the first model, the company would sell sequencers at a higher price to those entities which already purchased sequencers, primarily major research labs and pharmaceutical firms, but position its machine as a faster alternative to existing technologies. In the second model, GenapSys would sell its sequencer at a lower price but charge more for the cartridges necessary to run a sample, and earn its primary revenue from these cartridges. The third model would see GenapSys sell its device at or around cost, but use the data customers generated to create a proprietary database of genetic information. Customers could pay to access the database for research, to create genetic tests, or for many other purposes. GenapSys would also build an online store with the genetic tests customers created. Esfandyarpour's and Rastegar's decision would determine GenapSys' customer base and financial position for the coming years, and also impact develop

Course overview of The Entrepreneurial Manager.

In mid-2013, as FasterCures celebrated its 10th anniversary as a center of the Milken Institute, Executive Director Margaret Anderson thought about what the organization should do to ensure it had even more impact in its next 10 years. FasterCures was a non-profit "action tank" whose mission was to speed up the process of moving new therapies from discovery to patients in need. Although their annual conference ("Partnering for Cures") to improve how government research was organized was a huge success, Anderson considered refocusing their resources on greater challenges.</p><p>For example, current trends in the US showed that investors were increasingly supporting late stage research with higher probabilities of success while funding for riskier early stage research was drying up. Should FasterCures raise money and direct it toward early stage breakthrough therapies? Another issue was the US clinical trial process system. It's complicated, takes a long time, and is very expensive. Should FasterCures reorganize to better understand this issue and make a high-level push to improve it? Or perhaps FasterCures should look at drug reimbursement decisions. Anderson needed to determine where FasterCures should get fully involved, what it should do, and whether it could make a difference.

It was January 2013, and Fred Khosravi, chairman of the board of AccessClosure Inc., wondered what the new year had in store for him and AccessClosure, the company he founded in late 2002. Khosravi was cautiously optimistic-the Mountain View, California-based medical device company had been cash flow positive for seven consecutive quarters with annual revenues over $70 million. Since 2007, it had shipped well over 1.5 million of its vascular closure device (VCD), the Mynx, which was stocked in more than 1,200 catheter labs worldwide. However, a 2008 patent infringement lawsuit filed by St. Jude Medical, the VCD market leader, loomed large. The case was on appeal, and a three-judge panel would hear arguments in March 2013. If AccessClosure lost its appeal, it faced a $27.1 million judgment for patent infringement and a permanent injunction from selling its Mynx family of VCDs, its sole source of revenue.

Ron Laufer is the new Senior Managing Director of MedImmune Ventures', the corporate venture capital arm of AstraZeneca, a leading pharmaceuticals firm. Laufer has to decide whether to pursue a high-potential, but very risky, early-stage investment. The decision Laufer will make will reflect his vision for MedImmune Ventures and more broadly the incentives he faces as a corporate venture capitalist.

This Course Outline and Syllabus gives an overview of the Fall 2013 class Building Life Science Businesses.

Course overview of The Entrepreneurial Manager.

Shelby Givens, a recent business school graduate, returned home to Raleigh, North Carolina to help rescue her family's ailing and outdated bowling alley, Westlake Lanes. Although she cut costs and addressed inefficiencies, moving the business from near-bankruptcy to profitability in nine months, market conditions threatened the long-term viability of the business. Givens then sold her family on a new, more youth-oriented concept, an urban lounge called Sugar Bowl that could generate sizable revenues from the food and beverage businesses already embedded in Westlake Lanes. The case follows Givens as she builds Sugar Bowl into a turnaround story through shrewd decision-making in finance, operations, and marketing while contending constantly with challenging surprises and disappointments. The case also captures Givens's reflections on how the entrepreneurial drive that has motivated her. Sugar Bowl may be taught alone or after "Westlake Lanes" (4431), which follows Givens through the initial turnaround process.

Spreadsheet Supplement for Product #913537

Supplement for case 809011

The FDA approvals of novel therapeutics were seen as signs in the personalized medicine community of real progress in the growth of personalized medicine; The FDA's approval of such drugs, along with companion diagnostics, suggested a shift in thinking and regulatory practices at the agency. Beyond the regulatory questions, many considered the reimbursement system archaic, dispersed, unpredictable, and unnecessarily time consuming. Many questioned whether the traditional models of reimbursement were relevant in the era of personalized medicine, and who should be covering the cost of tests needed to identify the sometimes small number of patients who could benefit from expensive targeted drugs. This case focuses on the array of possibilities and the ambiguity surrounding these regulatory and reimbursement issues.

Supplements the (A) Case, 813043 Deborah Denenberg reflects on the results and actions taken during the 12 months following her first 6 months on the job.

Looking back at five years of losses, Rivka Belzer, a newly minted MBA, steps into her family owned business with their mandate to turn it around or close it. In her first six months, she has made a number of changes, with mixed results, but is beginning to show a profit. Many strategic, organizational, marketing, control, and operational decisions lie ahead as she plans for the next year and tries to manage a difficult board of directors in the challenging entertainment industry.

Spreadsheet supplement for case 4431.

Shelby Givens, a new MBA, is the general manager of Westlake Lanes, a near-bankrupt bowling alley that her grandfather founded decades earlier. Givens has been given one year to turn a profit; if the goal is not met Westlake will close. During the first few days on the job, Givens learns that the business is in worse shape financially than she - or the board - thought. She also finds that Westlake's employees exhibit minimal productivity. Givens tackles these two issues, creatively uncovering ways to reduce costs while building morale. After nine months, the business has its first profitable month in over two years. Yet Givens is worried it is too little, too late and begins to sketch a bolder long-term strategy based on pursuing one of two alternative new markets. Students are invited to consider whether the board should accept her potentially transformative proposal, maintain existing operations, or liquidate to pay off pressing loan responsibilities. The case includes a quantitative assignment for students.