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.

The book concludes with Chapter 6’s discussion of the particular ethical concerns raised by using social media data. This includes data privacy concerns, for instance the need in some contexts to anonymize unique user identifiers in all stored tweets so that not even the researchers have access to user names and such. In addition, the chapter mentions concerns frequently raised by IRB in terms of human subjects research, and some of the thorny issues raised by the terms of use of social media sites with regard to data sharing and replicability. In particular, it will walk through what scholars need to know about the limitations imposed by Twitter’s terms of use, what use cases are considered acceptable use (sharing data among researchers on the same project), and strategies for common scholarly needs that fall within gray areas (for example, providing word frequency matrices so that content analysis can be fully replicated, but the terms of use conditions regarding republication of tweets are not violated).

Before conducting an experiment with human subjects, researchers much consider a number of important ethical and regulatory constraints. This chapter reviews the leading ethical concerns that arise in the context of human subjects research in general and experimental research in particular. These ethical concerns have also set in motion regulations, such as The Common Rule, that researchers must follow before launching a study. The chapter concludes by discussing other professional norms, such as research transparency.

The path to approvability of drugs created for Alzheimer’s disease (AD) dementia, mild cognitive impairment, or associated symptoms of AD is long and expensive, involving the study sponsor, the registration authorities, a clinical research organization, and the performance site. The key to successful AD trials is the performance site, the individual investigators, the recruited subjects, and the quality of the data generated. Performance sites include academic medical centers, a division within a large multi-specialty group, and for-profit clinical trial companies. All performance sites have common elements. These include the staff (investigator, coordinator, rater/neuropsychologist, and manager), access to study participants for enrollment, appropriate training of staff, regulatory oversight (investigational review board ), and the ancillary services. Types of studies that are available include therapeutic (medication or device), longitudinal observational, and imaging. Different types of studies have different requirements for staff or infrastructure, some easy to deploy, others not. In this chapter we will describe the elements of a successful AD clinical trial site.