PDA's latest professional resource, Biotechnology: From Idea to Market, is an invaluable guide and reference for anyone involved in the development of a product, from idea generation through commercialization.
The goal of this book is to provide this comprehensive overview for students and professionals alike in how to think about and to navigate the necessary development process for healthcare product candidates, including biologics, new chemical entities, and other related products that address medical need. This instructional text enables anyone at any level or in any sector of the industry to easily achieve a basic knowledge of the critical steps (or the questions to ask) to properly evaluate an idea or technology, develop a viable product candidate, and ultimately advance it to the marketplace.
Expertly conceived and crafted by co-editors Fred Mermelstein, Richard Prince, and Carl Novina, with a foreword by Nobel Laureate Philip Sharp, this book features 22 chapters written by renowned subject matter experts in their respective fields. Collectively, these chapters illuminate and unify the healthcare products innovation process, spanning from academia to industry, from research to commercialization. Chapters are organized into five sections:Section 1: Due Diligence (Chapters 1-6)
Section 2: Financing (Chapters 7-9)
Section 3: Operationalization (Chapters 10-16)
Section 4: Legal (Chapters 17-19)
Section 5: Commercialization (Chapters 20-22)
Gain a more integrative understanding of product development and commercialization and get all the information you need to become a successful biotechnology entrepreneur!
Table of Contents:
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Foreword by Phillip A. Sharp
Introduction by Fred Mermelstein, Richard Prince and Carl Novina
Section I Due Diligence
- First Principles of R&D — The Role of Due Diligence by Fred Mermelstein
- Translational Research in Academia — Moving towards the D side of R&D by Carl D. Novina
- The Target Product Profile Sheet — An Invaluable Tool in R&D Planning by Shani C. Missner and Matthew R. Weinberg
- Founding A Biotechnology Company by Alan Crane
- Medical Devices — From Idea to Market by John Butziger and Laurie Bourgeois
- How to Compose A Business Plan by Douglas A. Hamilton
Section 2 Financing
- Corporate Communications — Executive Summaries and Pitch Decks by Dian Griesel
- Financing Biotechnology Start-ups — The Role of the Licensed Broker Dealer by Jeff Eliot Margolis
- Industry Partnerships and Liquidity Events — Engaging with Big Pharma by David R. Boyko
Section 3 Operationalization
- Regulatory Affairs' Role in Product Development by David L. Rosen
- Clinical Testing of Biosimilars by Sarfaraz K. Niazi
- Safeguarding Clinical Development — Strategic and Quality Considerations by Richard Prince
- Performing Clinical Trials — The Role of Clinical Operations by Cassandra Erato and Angela Bartkus
- Designing and Building A Biotechnology Facility by Kim Nelson
- Manufacturing Biopharmaceuticals — From Start-up to Commercialization by Joseph Waggett and Laura Grayson Roselli
- Quality Control Testing Throughout the Product Development Lifecycle by Daniel Prince, Martell Winters and Richard Prince
Section 4 Legal
- Forming the Enterprise and Raising Capital by Travis L. Gering
- Establishing Effective Intellectual Property Protection by Christine Willgoos, John P. Dillon and Jonathan S. Caplan
- Licensing Technology From Academia and Government by Lita Nelsen
Section 5 Commercialization
- Understanding Drug Pricing and Reimbursement by Joshua P. Cohen
- Guidance to Pharmaceutical Product Launch Timelines and Post Market Organizational Expansion by Charles Bell, Suzanne LoGalbo and Elise Fellner Roth
- Portfolio Management of Corporate Assets by Douglas A. Hamilton
About the Editors
Fred Mermelstein, Ph.D. Mermelstein currently teaches at Harvard Medical School, serves as an Entrepreneur in Residence at Dana Farber Cancer Center and is a Partner of Ascentia Asset Management, Inc. He serves on several boards and scientific advisory boards, including the Harvard Institute of RNA Medicine, Rogosin Institute, Cornell-Weill Medical Center, SanaRx, NX PharmaGen, IASO Biomed and Raqia. Dr. Mermelstein was the founder of Javelin Pharmaceuticals, Inc. (JAV), which was acquired by Hospira, Inc., now Pfizer. He has served as the CEO and President of Javelin, which has brought to market in Europe Dyloject™, an injectible anti-inflammatory for the treatment of postoperative pain. He was the founder of PolaRx Biopharmaceuticals, Inc., where he also served as Chief Scientific Officer, and was responsible for bringing Trisenox ™ (Arsenic Trioxide for the treatment of Acute Promyelocytic Leukemia) to NDA completion, now marketed and sold worldwide by Teva. He also served as Director of Paramount Capital Investments, Inc. and General Partner of the Orion Biomedical Fund. Dr. Mermelstein received a Ph.D. joint degree in pharmacology and toxicology at Rutgers University and University of Medicine and Dentistry of New Jersey RobertWood Johnson Medical School (UMDNJ-RWJ) and BS,MS in Toxicology from Northeastern University.
Carl D. Novina, M.D., Ph.D. is an Associate Professor of Medicine at the Dana-Farber Cancer Institute and Harvard Medical School and an Associate Member of the Broad Institute of Harvard and MIT. He received his M.D. from Columbia University, College of Physicians and Surgeons and his Ph.D. from Tufts University, Sackler School of Graduate Biomedical Sciences. He completed his postdoctoral fellowship at the Massachusetts Institute of Technology in the laboratory of Nobel Laureate Dr. Phillip Sharp. Dr. Novina's laboratory has made several important discoveries about the biology of noncoding RNAs, their dysregulation in cancers, and their development as biomedical tools to address unmet medical needs. His laboratory has developed platform technologies to discover and drug noncoding RNA functions and has engineered tools for epigenetic and cellular therapies. Dr. Novina has established numerous collaborations with clinicians and industry partners to accelerate the translation of these tools to the clinic. Dr. Novina is the recipient of numerous awards and honors including the Doris Duke Clinical Scientist Development Award, American Cancer Society Research Scholar Award, W.M. Keck Distinguished Young Scholars Award, Department of Defense Idea Award, The NCI Director's Provocative Questions Award, and the National Science Foundation Collaborative Research Project Award. He is also the recipient of the prestigious NIH Director's Pioneer Award, which funds high-risk research with transformative potential.
Dr. Richard Prince is CEO, Now Biopharma, LLC. Now Biopharma is a boutique Clinical CRO (with a specialization in performing acute care trials) and a Life Science Consultancy (with expertise in helping start-up companies succeed). Dr. Prince has expertise in Life Science Entrepreneurship, C-level Management, Strategy, Scientific Affairs, Regulatory Affairs, Quality Operations, Clinical Development, and Operations Facilitation. Dr. Prince is also President and Partner, Pollination Ventures Management LLC, a management firm that evaluates and advises promising new life science startups on corporate structures and development.