the Science, the Products, the Government, the Business
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.
- 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
Chapter 2: Science of Biotechnology – Recombinant DNA Technology
Chapter 3: Science of Biotechnology – Monoclonal Antibody Technology
Chapter 4: The Science of Biotechnology: Peptides, Vaccines, Cell and 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 and Regulations Governing Biological Product Approval and Usage
Chapter 8: Biotechnology Products and Indications I. Proteins
Chapter 9: Biotechnology Products and Indications II
Chapter 10: Biotechnology Industry
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).
This work by Evens (currently research professor and consultant, Tufts Univ. School of Medicine, Center for the Study of Drug Development) is, as its title signals, an overview of the various facets of biotechnology that seeks to make the complexity of the industry accessible to non-experts, and in this respect Evens is largely successful. Experts may find particular chapters to be simplistic or superficial, but this may be forgiven as the cost of providing easy entry for the novice. The noticeable inclusion of discipline-specific terms or jargon may prove challenging to some readers, but the motivated among them should not be stymied by a specialized vocabulary in a field of interest. One remarkable strength of the book is its clear demonstration that the biotech industry integrates contributions across various domains (e.g., science, business, regulatory), thereby illuminating the synergy that drives the biotech juggernaut. The author's inclusion of lengthy lists of biotech products seems unwarranted, especially as these will likely be outdated before long. Each chapter includes a substantial bibliography, a feature that would be more useful to scholars if inline references/citations were also included in the text. That said, this is an exceedingly useful overview of biotechnology for the well-informed non-expert seeking to understand or perhaps enter the industry.
--M. S. Kainz, Ripon College, Choice Reviews and Highly Recommended
Summing Up: Highly recommended. Graduate students, faculty, and professionals. General readers.