Discusses the Massachusetts Life Sciences Center, a major state-level industrial policy effort in the Boston region.

In the years following FDA approval of direct-to-consumer, genetic-health-risk/DTCGHR testing, millions of people in the US have sent their DNA to companies to receive personal genome health risk information without physician or other learned medical professional involvement. In Personal Genome Medicine, Michael J. Malinowski examines the ethical, legal, and social implications of this development. Drawing from the past and present of medicine in the US, Malinowski applies law, policy, public and private sector practices, and governing norms to analyze the commercial personal genome sequencing and testing sectors and to assess their impact on the future of US medicine. Written in relatable and accessible language, the book also proposes regulatory reforms for government and medical professionals that will enable technological advancements while maintaining personal and public health standards.

In the years following FDA approval of direct-to-consumer, genetic-health-risk/DTCGHR testing, millions of people in the US have sent their DNA to companies to receive personal genome health risk information without physician or other learned medical professional involvement. In Personal Genome Medicine, Michael J. Malinowski examines the ethical, legal, and social implications of this development. Drawing from the past and present of medicine in the US, Malinowski applies law, policy, public and private sector practices, and governing norms to analyze the commercial personal genome sequencing and testing sectors and to assess their impact on the future of US medicine. Written in relatable and accessible language, the book also proposes regulatory reforms for government and medical professionals that will enable technological advancements while maintaining personal and public health standards.

In the years following FDA approval of direct-to-consumer, genetic-health-risk/DTCGHR testing, millions of people in the US have sent their DNA to companies to receive personal genome health risk information without physician or other learned medical professional involvement. In Personal Genome Medicine, Michael J. Malinowski examines the ethical, legal, and social implications of this development. Drawing from the past and present of medicine in the US, Malinowski applies law, policy, public and private sector practices, and governing norms to analyze the commercial personal genome sequencing and testing sectors and to assess their impact on the future of US medicine. Written in relatable and accessible language, the book also proposes regulatory reforms for government and medical professionals that will enable technological advancements while maintaining personal and public health standards.

In the years following FDA approval of direct-to-consumer, genetic-health-risk/DTCGHR testing, millions of people in the US have sent their DNA to companies to receive personal genome health risk information without physician or other learned medical professional involvement. In Personal Genome Medicine, Michael J. Malinowski examines the ethical, legal, and social implications of this development. Drawing from the past and present of medicine in the US, Malinowski applies law, policy, public and private sector practices, and governing norms to analyze the commercial personal genome sequencing and testing sectors and to assess their impact on the future of US medicine. Written in relatable and accessible language, the book also proposes regulatory reforms for government and medical professionals that will enable technological advancements while maintaining personal and public health standards.

How do you read a patent and what subject matter is patentable? What is the purpose of a patent? Who is an inventor on the patent if work is done by many people on the project? What is the process of obtaining a patent in my country and globally? Read this chapter to see how you could lose commercialization rights to your own invention. When exactly does an invention or idea become patentable? Once you own a patent, how can you make money from it? What is the process of licensing and the key terms that should be negotiated in such a license agreement? What is the use of a copyright or a trade secret in biotech? What exactly constitutes patent infringement ? These questions and many others are addressed in this chapter on intellectual property.

The vast world of biotechnology applications to human health is reviewed and the terminology used in the rest of the book is defined here. An overview of the industry, the value chains, the specific types of human health products covered in this text are presented in this chapter. A time-tested way to analyze an industry’s attractiveness for new entrants is presented here using Porter’s five forces model. Technology trends such as mobile health, artificial intelligence, 3D printing, cell and gene therapy, and robotics are presented to the reader in the context of the mission of improving human health. The overall process of development of new products in these various segments of drugs, devices and diagnostics sectors is reviewed here. The reader will leave this chapter with a 30,000-foot view of the industry dynamics and understand the context within which product commercialization is to be done.

Drug development is a long and arduous process that requires many researchers at different types of institutions. These include researchers in university settings, researchers in government settings, researchers in non-profit organizations and researchers in the pharmaceutical industry. The pharmaceutical industry itself is heterogeneous, ranging from tiny biotech companies to large multi-national organizations. This chapte emphasizes drug development efforts by the pharmaceutical industry but will also make note of the many collaborations between pharma and researchers at other types of institutions.

Digital entrepreneurs create digital businesses through digital media funnels such as web applications, social media, mobile SMS and emails, providing digital products and services. Nowadays, it is relatively seamless for digital entrepreneurs to adopt the diverse digital tools and techniques in developing their products and services. Moreover, the avalanche that is the current digital era is changing the processes for many existing business models, in the financial sector, the health sector and many more. As a result of these changes, digital entrepreneurs are faced with new challenges and exposed to unprecedented risks. This chapter discusses the challenges faced by digital entrepreneurs and start-ups within business sectors such as fintech, insurtech, retailtech, biotech, healthtech and fashiontech. In addition, two case studies that demonstrate the existing challenges are highlighted with their corresponding focus points. The chapter concludes with a summary of the key points addressed and a few recommendations for digital entrepreneurs.

Biotech venture creation is a distinct investment strategy within the broader category of venture capital. It is specialized by both stage and target space and includes four elements: (1) sourcing and seed investing; (2) the role of entrepreneurs in residence (EIRs); (3) building and scaling; and (4) business model selection. Sourcing focuses on identifying innovative science that can be translated into novel therapeutic produces. Seed investing is a critical evaluative stage during which early science is pressure tested with focused resources to stringently determine which new opportunities to advance to full funding and business launch. EIRs, experienced R&D and business executives, play a central role during the seed period and often take on leadership roles in companies that move forward. Finally, matching the science to the business model, whether a broad product platform or a more focused asset-centric company, is a defining step which determines the business, financial, operating, and organizational strategies of new biotech companies. Increasingly, as the biotech industry matures, new venture creation is focused in economic clusters. These clusters are supportive ecosystems with large talent, capital, partner, supplier, and other resource pools that foster key transfers of knowledge, assets, and cooperative assets among industry participants. These clusters are seen across industries and are arguably determined by fundamental economic forces. Early examples include the concentration of textile manufacturing during the middle ages and renaissance in specific cities and regions in England and Italy, the concentration of the automobile industry in Detroit, and the concentration of high- tech companies in the Bay Area in California.