R Principles

C Strategy - overall direction & operational plan o Goals - strategy, shared learning & generation of support o Product champion (scientist) c Multidisciplinary team c Strategy & plans evolve over time r Pre-Clinical Phase (CDP-1) c Initiated 1 year prior to CTA IND c Start of phase 1 r Early Development Phase (CDP-2) c Initiated 9-12 months prior to phase 2B o Lead country chosen o Global leader needed r Late Development Phase (CDP-3) c Initiated at phase 2B c Continues through phase...

Goals

Eminent & Evolving Enterprise by Employees who Excel & Enjoy Fig. 2.4. The Essentials of Excellent Leadership new ideas and approaches that fosters creativity and innovation), and finally enjoy (having fun in the workplace with our respective job a happier workforce is a more productive workforce in general). The ultimate corporate goal in leadership, as stated succinctly in the diagram, again is six elements an enterprise that becomes eminent yet continues to evolve through employees...

Clinical Development Strategy

Corporate management determines which disciplines will provide the organizational leadership in the drug development process. Companies may drive the development process through their program management organization, their clinical organization, or their regulatory organization. Regardless of the source of development team leadership, as in any sport, team chemistry and good communication are the critical underpinnings required to be successful. The players and...

Info

Than drugs in the human body, may be duplicates of naturally occurring substances, and are susceptible to many degradative processes. Proteins are quite large molecules with specificity of their amino acid sequence, disulfide bridges, tertiary structures (carbohydrates), three-dimensional conformation, isoforms of the same molecule, and other properties. These many structural features necessitate more testing in number, variety, and sophistication to ensure the integrity of the molecule...

Contract Research Organizations CROs

As the pharmaceutical industry has expanded and matured, industry managers have become increasingly sensitized to the need to operate the clinical operations area as a scientific business in relation to the maintenance of large in-house clinical development organizations (Fig. 8.28). In response to these concerns, contract research organizations (CROs) began to spring up during the 1970s and to play a progressively more prominent role in the industry over the subsequent three decades. CROs have...

Compliance Quality Assurance

Compliance with the regulations, and the assurance that a company is in compliance, underlies all the regulatory aspects that have been discussed thus far in this chapter. The FDA requires that any drug or biologic product, whether at the investigational stage or being marketed, is manufactured, studied, and marketed in accordance with its regulations, and the FDA has substantial power to enforce their compliance to the regulations. Even the most innovative product for a highly unmet medical...

Acknowledgments

The members of the editorial board of this book have been professional associates in health care and research in the industry and academia during the editor's career, as well as friends. Each brings his own base of experience and talents to this scholarly work. Their advice and engagement as editorial advisors and authors have enriched the content and were indispensable to me as the editor. The authors comprise 24 talented group of researchers, clinicians, and educators in health care, both...

Helping the Public Get Accurate Science Based Information

The FDA is responsible for regulating the communications between the pharmaceutical, biotechnology, and medical device companies and the prescribing physicians, other providers, institutions, and patients who use their products. First and foremost, FDA fulfills this mission through approving the language in the package inserts of all drug and biological products, and regulating the educational and advertising materials for drug products. FDA communicates directly to the public through press...

Editors and Authors

The book is authored by a multidisciplinary team of researchers, clinicians, and marketers from industry and the medical pharmaceutical community. They collectively have done extensive work in drug development, measured by the many product applications prepared and ushered through regulatory authorities, by scope and quality of institutions and companies at which they worked, by number of years devoted to research and product development, and by hundreds of publications. The experience base in...

Rx to OTC Switch

Dozens of products have been switched from prescription status to being available over-the-counter OTC without a prescription Fig. 7.13 . In order for a drug to be switched, the product must be used to treat or prevent symptoms in a disease where physician oversight is not necessary. The patient must also be able to self-diagnose the condition being treated. Sinus congestion, headache, pain, upset stomach, and itching are examples of symptoms a patient can recognize. Drugs that must be...

Value of PKPD

In drug development, the ADME processes of a compound are experimentally determined Figs. 6.2 and 6.3 . Absorption studies are conducted to answer the basic question whether the drug can reach the systemic circulation from the site of administration. There are several factors that can influence the absorption of the drug after oral administration. The drug needs to have a high solubility and high permeability in order to be absorbed adequately. A Biopharmaceutics Classification System BCS was...