Added Discovery Work

Even before clinical trials have been initiated, it's important to consider other ways in which the product could be used Fig. 4.36. Such consideration not only involves alternate indications for how the existing therapeutic could be used but also includes new formulations or constructs that may allow product expansion into new areas. The advantages of these product extensions are noted in figure 4.36, along with the example of alpha-interferon. Added preclinical work in pharmacology, ADME, or...

Info

R NMEs - New Medical Entities (Novel) (e.g., kinase inhibition in cancer) k Second generation molecule (e.g., Neulasta vs Neupogen ) Ist-in-Class versus 2nd-in-Class products (e.g., Prevacid vs Crestor ) k Molecular manipulation (e.g., TNKase vs Activase ) r Route of use additions (Oral vs injectible) k Formulation improvements (XL) k Product delivery systems (Insulin pen) k Manufacturing process improvements Fig. 3.8. Molecule & Product Opportunities a large patient population with the...

Ich E9

Statistical Principles for Clinical Trials PI (principal investigator) is responsible for conduct of trial, including ensuring safety of participants (patients or volunteers). Co - investigator(s) assist principal investigator. Both principal and co - investigators listed on FDA Form 1572. Monitoring of investigational sites required under FDA CFR regulations and performed by IND sponsor Investigator following protocol, subjects being informed of study and providing informed consent, data...

Organization of a Pharmaceutical Company

A pharmaceutical company that is complete in all the necessary research and business operations and divisions is called a fully integrated pharmaceutical company (FIPCO). A FIPCO contains eight operating divisions. The eight divisions of a FIPCO are presented in the next diagram (Fig. 1.23). Research and development (R& D) and Fig. 1.23. Fully Integrated Pharmaceutical Company Fig. 1.23. Fully Integrated Pharmaceutical Company sales and marketing (S& M) divisions house the largest number...

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...

References

Available at HIV DrugStrategies.html 2. Gordon EJ, Myers KJ, Dougherty JP, Rosen H, Ron Y. Both anti-CD11a (LFA-1) and anti-CD11b (MAC-1) therapy delay the onset and diminish the severity of experimental autoimmune encephalomyelitis. J Neuroimmunol 1995 62(2) 153-160. 3. Werther WA, Gonzalez TN, O'Connor SJ, McCabe S, Chan B, Hotaling T, Champe M, Fox JA, Jardieu PM, Berman PW, Presta LG. Humanization of an anti-lymphocyte function-associated antigen (LFA)-1 monoclonal antibody and...

Cdm

Functional group within clinical operations that is responsible for storing, preparing, and processing data derived from the clinical trials. Functional group that applies statistical methods to data derived from clinical trials, creates data tables, and writes statistical report to be incorporated into study reports. Database is secured (locked) to prevent any further changes from being made. Analysis then can proceed. Audit is a formal examination and verification of accounts and processes in...

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...

Nps

Discovery and Licensing for Products* *Amgen, 2002, Public disclosures Dates approximate research milestones and have less risk of failure), one molecule versus a family of related molecules, and the amount, extent, and timelines of research to be done. The discovery partner will obtain a higher percentage of future royalties for late-stage molecules. In this example, Amgen obtained neurogenic molecules (BDNF and NT3) from Regeneron company in early 1990s, but both molecules have...

Dosage Form Decisions

One of the initial steps in the drug development process is to select a desirable product profile and create the dosage form that fits well the product and disease (Fig. 9.1). This profile is based on the physicochemical characteristics of the active ingredient, disease-related issues, how the product will be used by providers and patients, and marketplace issues (e.g., competition). Characteristics such as permeability, solubility, stability, safety, potency, half-life, and molecular size will...

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...

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...

INDEnabling Studies

The discovery and early development process culminates when a decision is made to advance the product candidate into human clinical trials. To do so within a corporate setting, an Investigational New Drug (IND) application is filed with the FDA prior to initiating trials (Fig. 4.32). The IND summarizes many aspects of the discovery and development of the product candidate, as well as how the product is manufactured and controlled and how it will be used in the clinic. From the preclinical...

Nonclinical Development and Testing

Having moved beyond target and product discovery, the next steps in the development process involve obtaining a more complete picture of the activities and properties of the lead compound (Fig. 4.24). Most commonly, this involves a more thorough investigation of the compound in in vitro assays as well as more extensive evaluations in animals. Clearly, it is the goal of these preclinical studies to provide the information necessary to initiate clinical trials. As such, they are heavily driven by...

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...

Discovery and Nonclinical Development

The Discovery Process Targets Products Nonclinical Development and Testing IND-Enabling Studies Added Discovery Work The discovery of new products for patient use takes place in laboratories at universities, in the government, or in pharmaceutical companies actually, it starts in the minds of scientists with a scientific innovation or idea for creating a new therapeutic molecule that may be a biological or drug. This research is performed through carefully done studies, either with the...

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...