Biotechnology: the Science, the Products, the Government, the Business, 1st Edition (Hardback) book cover

Biotechnology

the Science, the Products, the Government, the Business, 1st Edition

By Ronald P. Evens

CRC Press

208 pages | 54 B/W Illus.

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Hardback: 9780367024673
pub: 2020-06-09
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Description

The over-riding premise for biotechnology in this book is bringing novel products to market to substantially advance patient care and disease mitigation. Biotechnology, over its relatively brief existence of 40 years, has experienced a mercurial growth. The vast educational need for biotechnology information in this rapidly burgeoning field is a basic rationale here. However a more prominent underpinning is that, bringing biotech products to market for patient care involves success in the following four areas of engagement simultaneously - scientific advances for healthcare technologies, novel and varied products for untreated diseases, regulatory authorities, and biotech companies.

Features

  • Comprehensive coverage of biotechnology science topics used in development and manufacturing
  • Addresses all the scientific technologies within biotechnology responsible for products on the market and the pipeline
  • Presents business issues such as marketing and sales of the products, as well as companies engaged, and how biotech business has evolved

Table of Contents

Chapter 1: Introduction

  • History of biotechnology
  • Current Biotechnology Product Status
  • Biotechnology Industry overview

Chapter 2: Science of Biotechnology – Recombinant DNA Technology

Chapter 3: Science of Biotechnology – Monoclonal Antibody Technology

Chapter 4: Science of Biotechnology - Peptides, Vaccines, Cell & Tissue Therapy, Liposomes, Nanobiotechnology, Animal sourced Products

Chapter 5: The Science of Biotechnology – Molecular Engineering [Proteins, Monoclonal Antibodies, Biosimilar]

Chapter 6: The Science of Biotechnology – Oligonucleotides and Genetics

Chapter 7: Laws & Regulations Governing Biological Product Approval & Usage

Chapter 8: Biotech Products and Indications I. Proteins

Chapter 9: Biotech Products and Indications II

Chapter 10: Biotechnology Industry

References

About the Author

Dr. Evens is Adjunct Research Professor & biotechnology consultant at Tufts University, School of Medicine, Center for the Study of Drug Development. Dr. Evens is President of MAPS 4 Biotec, Inc, his consulting company to biotechnology industry for strategy, planning, & operations of medical affairs groups for drug research, medical education, medical liaisons, provider/patient services, and product launch. Clients have included Amgen, Amylin, Bertek, Cheladerm, Oragenics, Pharmacyclics, plus advising Banyan, Prevacus, MLM, Nanotherapeutics, and St. Charles. He is editor of 2 books, "Drug & Biological Development, From Molecule to Product & Beyond", Springer Publisher, 2007; BioPharma Language, Acronyms and Terms, Jones and Bartlett Publisher, 2009. Dr. Evens also authored 16 review articles and book chapters in biotechnology.

Dr. Evens was professor of pharmacy at University of Florida and then University of Pacific for 15 years focused on biotechnology education. At Amgen (13 years, worldwide leader in biotech industry), he created & was Senior Director of Professional Services Department (a staff of 140 and a budget of $60+ MM), including clinical research, medical education, medical information, and executive management with 8 products and 7 groups, plus international coordination of medical affairs. He also created PeriApproval Research group for pipeline products. He participated in redesign of Amgen’s research and development process, the sales and marketing group, and the leadership development program. He was a Clinical Professor at University of Southern California at that time. Before Amgen, Dr. Evens was Associate Director, Clinical Research & Medical Services at Bristol-Myers Co. (6 yrs) covering CNS drugs. As a professor, Dr. Evens was Associate Professor & acting Chairman of Department of Pharmacy Practice, University of Tennessee (3 yrs); and Associate Professor & Director of Drug Information Center, University of Texas at Austin and University of Texas Center for Health Sciences at San Antonio (7 yrs). Dr. Evens received a B.S. in Pharmacy at University of Buffalo, N.Y (1969). Graduate work was at University of Kentucky for both Pharm. D. & clinical practice residency (1971-74).

Dr Evens has served on 12 Boards of Directors or Advisory Boards for professional societies. He was on the Boards of Cheladerm and Oragenics companies, including interim CEO. Scientific, professional, and industry presentations exceed 150 at national and state professional society meetings. Publications exceed 100, including 14 book chapters and editor of 2 books. University of Buffalo recognized with him four awards; Roger Mantsavinos (Biochemistry), Robert Ritz (Pharmacology), Rexall (1st in class), and Rho Chi Honor Society, and University of Kentucky awarded him the clinical residency "Impact Award". American College of Clinical Pharmacy recognized him with their fellowship. Otherwise, Ron’s interests are the environment, support of disadvantaged in society, pharmacy & medical education; blues music, history, travel & sports; and mostly his family (loving partner and three adult children, 2 physicians and a botanist).

About the Series

Drugs and the Pharmaceutical Sciences

Learn more…

Subject Categories

BISAC Subject Codes/Headings:
MED071000
MEDICAL / Pharmacology
SCI013000
SCIENCE / Chemistry / General