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.

New product development processes need to be compliant to regulatory requirements, and this chapter highlights the salient processes and quality systems to put into place to achieve success. Project management is made simple with specific tools provided here. Customer feedback is channeled into specific product characteristics, and the right tools are shown in this chapter. The biopharma industry has statistics showing less than 10% of starting compounds succeed in reaching market approval, and this chapter explains what causes these failures. The key issues that have repeatedly caused failure during device and diagnostic product development are also pointed out. Ethical decisions have to be made during product development as shown in this chapter. Outsourcing is a real option due to the availability of many contract research and manufacturing organizations, and judicious use of this option is discussed in this chapter. Key milestones that reduce risk and show transition from early stage to preclinical prototype stages are reviewed here. Does the popular concept of minimum viable product in software development apply in biomedicine prototyping? Other similar questions that help the reader understand pitfalls and best practices are answered here.

As vaccines are complex technologies that interact with the human body, their development is overseen by regulators in the administrative state. Countries structure the review of pharmaceutical products according to domestic rules and institutional design. As such, vaccines are reviewed as biologic products by regulatory authorities at the domestic level, such as the Therapeutic Goods Administration in Australia or the Pharmaceutical and Medical Devices Agency in Japan. The national basis of vaccine regulation inevitably leads to country-specific processes and timelines and may in some cases lead to different decisions.

This chapter focuses on the scope and content of the Intellectual Property Chapter of the TPP, to examine how strict the new IP international protection and enforcement standard is, and to determine how far it goes beyond the existing FTAs and TRIPS. TPP provisions are compared with the “Pre-TPP relevant standards” (both intra-TPP and extra-TPP), and, of course, the WTO TRIPS Agreement. We looked at the NAFTA (the US, Canada, and Mexico) and the US agreements with Singapore, Chile, Australia, the CAFTA countries, Peru, and Korea (KORUS FTA). Some references were made to agreements signed by the European Union with Korea (EU--KOREA FTA) and the one with Canada, the Comprehensive Economic and Trade Agreement (CETA), as well as to the TPP predecessor -- the P4 Agreement -- signed between Brunei Darussalam, Chile, New Zealand, and Singapore. While reviewing the enforcement provisions, comparisons were made to the Anti-Counterfeiting Trade Agreement (ACTA).

In the chapter “The Biotechnology Sector – Therapeutics”, the author covers a wide range of topics summarizing the significant role that the formation and growth of the biotechnology sector has played in the entire biopharmaceutical industry. The chapter begins with a bit of history, from the earliest days of how genetic engineering gave birth to this sector, and takes the reader through an overview of biotechnology as it exists today and how the growing innovation in science over the years has been able to both drive the sector and have a tremendous impact on healthcare overall. There is a particular focus on describing various types of innovation which have played a huge role in driving product development in the broader biopharmaceutical industry. Later in the chapter, there is a focus on many of the business aspects of the sector, as drug development in biotechnology requires enormous amounts of capital for success. The author outlines many of the key issues related to different business and financing models that we see across the sector, in addition to the unique management issues in small biotechnology companies. There is significant description and explanation of the symbiotic relationship between the larger pharmaceutical companies and smaller biotechnology start-ups with a focus on how they help each other to bring transformative medicines to patients. The chapter concludes with a discussion about international and regulatory aspects impacting the sector. Overall the author tells the story of the birth and growth of this exciting sector, and its impact on patients and drug development over the last forty years, well substantiated with current data to build the case for how biotechnology today plays a major role in driving one of the most important and exciting technological industries of our time.