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• Article | NEJM Catalyst Innovations in Care Delivery | September–October 2020

  The Past, Present, and (Near) Future of Gene Therapy and Gene Editing

  Julia Pian, Amitabh Chandra and Ariel Dora Stern

  Emerging gene therapy and gene-editing technologies will have a growing impact on patient lives and health-care delivery. We analyzed a decade of data on clinical trials and venture capital investments to understand the likely trajectory of genetically focused therapies in the years ahead. The number of clinical trials and venture capital deals increased substantially from 2006–2017. We observed particularly notable growth in both industry-sponsored trials and trials involving specialty fields of drug development, including oncology, neurology, hematology, ophthalmology, and neurology. As the number of gene-therapy and gene-editing technologies continues to grow, we expect that such therapies will have a significant and heterogeneous impact on health-care delivery, including a shifting of resources from chronic disease management to more intense acute episodic care, an increase in the complexity of required intellectual property and manufacturing know-how, and the potential expansion of biopharmaceutical companies into service-based business models.

  Keywords: gene therapy; gene editing; Impact; Health Care and Treatment; Technological Innovation; Health Testing and Trials; Venture Capital; Change;

  Citation:

  Pian, Julia, Amitabh Chandra, and Ariel Dora Stern. "The Past, Present, and (Near) Future of Gene Therapy and Gene Editing." NEJM Catalyst Innovations in Care Delivery 1, no. 5 (September–October 2020).  View Details

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• Case | HBS Case Collection | August 2020

  1928 Diagnostics: Fighting Antibiotics Resistance

  Ariel D. Stern and Daniela Beyersdorfer

  In 2019, the co-founders of the Swedish medical start-up 1928 Diagnostics, CEO Dr. Kristina Lagerstedt and COO Dr. Susanne Staaf, had to pick the right business model to commercialize their novel technology to hospitals and health care providers. Developed in partnership with research hospitals to help fight the global antibiotic resistance crisis, the firm’s cloud-based technology platform helped partners identify resistant genes and mutations in bacteria more quickly and accurately, allowing for easier outbreak cluster tracking in support of hospital infection control management, as well as better diagnostics and antibiotic selection. By 2019, they had raised $5 million, employed 16 people, and had their tool deployed at 24 partner sites in 10 different countries. Their decisions on which markets to focus on and with which business model would crucially impact the young firm’s chances at successfully converting existing users and attracting new clients.

  Keywords: Health Care and Treatment; Entrepreneurship; Leadership; Science-Based Business; Growth and Development Strategy; Business Growth and Maturation; Business Model; Technology; Health Industry; Medical Devices and Supplies Industry; Technology Industry; Europe; Sweden;

  Citation:

  Stern, Ariel D., and Daniela Beyersdorfer. "1928 Diagnostics: Fighting Antibiotics Resistance." Harvard Business School Case 621-025, August 2020.  View Details

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• Article | npj Digital Medicine

  Germany's Digital Health Reforms in the COVID-19 Era: Lessons and Opportunities for Other Countries

  Sara Gerke, Ariel D. Stern and Timo Minssen

  Reimbursement is a key challenge for many new digital health solutions, whose importance and value have been highlighted and expanded by the current COVID-19 pandemic. Germany’s new Digital Healthcare Act (Digitale–Versorgung–Gesetz or DVG) entitles all individuals covered by statutory health insurance to reimbursement for certain digital health applications (i.e., insurers will pay for their use). Since Germany, like the United States (U.S.), is a multi-payer health care system, the new Act provides a particularly interesting case study for U.S. policymakers. We first provide an overview of the new German DVG and outline the landscape for reimbursement of digital health solutions in the U.S, including recent changes to policies governing telehealth during the COVID-19 pandemic. We then discuss challenges and unanswered questions raised by the DVG, ranging from the limited scope of the Act to privacy issues. Lastly, we highlight early lessons and opportunities for other countries.

  Keywords: COVID-19; reimbursement; digital health reforms; Health Pandemics; Health Care and Treatment; Online Technology; Governing Rules, Regulations, and Reforms; Germany;

  Citation:

  Gerke, Sara, Ariel D. Stern, and Timo Minssen. "Germany's Digital Health Reforms in the COVID-19 Era: Lessons and Opportunities for Other Countries." Art. 94. npj Digital Medicine 3 (2020).  View Details

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