Fundamentals of Biologicals Regulation
Vaccines and Biotechnology Medicines
- 2nd Edition - November 1, 2025
- Imprint: Academic Press
- Authors: Rebecca Sheets, Kathryn C. Zoon, Mark Schenerman, Susan Neadle, Christopher Hamlin, Ivana Knezevic, Mehmet Tosun
- Language: English
- Paperback ISBN:9 7 8 - 0 - 4 4 3 - 2 1 9 8 8 - 7
- eBook ISBN:9 7 8 - 0 - 4 4 3 - 2 1 9 8 9 - 4
Fundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines, Second Edition serves as an introduction to the international regulatory arena in which biologica… Read more
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Request a sales quoteFundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines, Second Edition serves as an introduction to the international regulatory arena in which biologicals are developed, offering an overview of processes and insights into the scientific concepts underpinning global regulations. The book provides in-depth coverage of Quality by Design, Combination Products, Quality Target Product Profiles, Risk Management Plans, REMS, and switching from reliance on in vivo to in vitro analytical methods. It reflects new developments and processes accelerated by the COVID-19 vaccine experience, including emergency use authorizations and conditional marking authorizations. New pedagogic elements and case studies have been added to improve learning outcomes.
This book provides multiple levels of readership, with guidance on basic concepts, a detailed look at regulatory challenges, and practical insights into how regulators consider regulatory science and regulatory process issues across various regions, with an emphasis on the European Medicines Agency and the U.S. Food and Drug Administration.
- Feature new chapters on Advanced Therapy Medicinal Products (including cell and gene therapies), Combination Products, and Pharmacovigilance
- Presents new and updated case studies, including lessons learned from the development of COVID Vaccines
- Provides more in-depth coverage on Quality by Design, Quality Target Product Profiles, and Pharmacovigilance
- Focuses on the principles in regulating Biosimilars, In Vitro Diagnostics, Advanced Therapy Medicinal Products, and Combination Products
- Covers general biologicals' development, authorization, regulatory processes, and scientific principles for CMC, preclinical, and clinical development
Graduate students or professionals studying regulatory affairs and regulatory science for a biology, biotechnology, or engineering Masters, Ph.D., or Certificate program, Biologics regulators in various countries who want to learn more about how other countries regulate similar products (particularly those in developing countries who want to learn about the US and EU processes), Developers of combination products or combined use systems (e.g., oncology products that are combined with a medical device, specifically an in vitro diagnostic).
SECTION I REGULATORY PROCESS
1. Introduction to the Regulatory Process for Biologicals
2. International Regulatory Convergence
3. Quality by Design (QbD) Approach to Discovery and Development
4. Communications and Formal Meetings With Regulators: Focusing on the Process Before Clinical Trial
5. Clinical Trial Authorization and investigational New Drug Applications
6. Marketing Authorization
7. Alternative Regulatory Pathways and Special Programs
8. Variations or Changes to an Approved Application
9. Good "X" Practices
10. Audits and Regulatory Compliance inspections
SECTION II REGULATORY SCIENCE
PART I PRECLINICAL
11. Preclinical Safety and Toxicology
12. Preclinical Pharmacology , Proof-of-Principle
13. Institutional Biosafety Committees and Regulation of Genetically Modified Organisms
14. Risk Assessments
PART II PRODUCT
15. Product Construction, Manufacture, and Process Validation
16. Analytical Method Development and Validation Leading to Control Strategy and Lot Release
PART Ill CLINICAL
17. Regulatory Aspects of Clinical Trials
18. Pharmacovigilance and RiskMAPs
19. Clinical Trial Ethics, Human Subjects Protections, and the Informed Consent process
20. Independent Ethics Committees and Institutional Review Boards
SECTION Ill PRODUCT-SPECIFIC REGULATORY PROCESSES
21. Biosimilars
22. In Vitro Diagnostics and Biotech Medical Devices
23. Combination Products
24. Regulatory Policy and Public Health Policy
1. Introduction to the Regulatory Process for Biologicals
2. International Regulatory Convergence
3. Quality by Design (QbD) Approach to Discovery and Development
4. Communications and Formal Meetings With Regulators: Focusing on the Process Before Clinical Trial
5. Clinical Trial Authorization and investigational New Drug Applications
6. Marketing Authorization
7. Alternative Regulatory Pathways and Special Programs
8. Variations or Changes to an Approved Application
9. Good "X" Practices
10. Audits and Regulatory Compliance inspections
SECTION II REGULATORY SCIENCE
PART I PRECLINICAL
11. Preclinical Safety and Toxicology
12. Preclinical Pharmacology , Proof-of-Principle
13. Institutional Biosafety Committees and Regulation of Genetically Modified Organisms
14. Risk Assessments
PART II PRODUCT
15. Product Construction, Manufacture, and Process Validation
16. Analytical Method Development and Validation Leading to Control Strategy and Lot Release
PART Ill CLINICAL
17. Regulatory Aspects of Clinical Trials
18. Pharmacovigilance and RiskMAPs
19. Clinical Trial Ethics, Human Subjects Protections, and the Informed Consent process
20. Independent Ethics Committees and Institutional Review Boards
SECTION Ill PRODUCT-SPECIFIC REGULATORY PROCESSES
21. Biosimilars
22. In Vitro Diagnostics and Biotech Medical Devices
23. Combination Products
24. Regulatory Policy and Public Health Policy
- Edition: 2
- Published: November 1, 2025
- No. of pages (Paperback): 450
- Imprint: Academic Press
- Language: English
- Paperback ISBN: 9780443219887
- eBook ISBN: 9780443219894
RS
Rebecca Sheets
Dr. Rebecca Sheets is currently the Vice President for the International Alliance of Biologicals Standardization, North American affiliate. She is the former Vaccine Scientific and Regulatory Specialist at the National Institute of Allergy and Infectious Diseases. Dr. Sheets served 9 years as a Scientific Reviewer in the Viral Vaccines branch of the Division of Vaccines and Related Products Applications at the Center for Biologics Evaluation and Research at the FDA. From 2006-2014, she served as Co-Chair of the World Health Organization’s Study Group on Cell Substrates and as Chair of the Adventitious Agents Sub-committee, as well as authoring several WHO guidelines and publications over the past two decades. She also taught for a decade at the Catholic University of America. Before retirement, she was the Principal Consultant at Grimalkin Partners from 2013-2021.
Affiliations and expertise
Principal Consultant and Subject Matter Expert, Grimalkin Partners, Silver Spring, MD; Adjunct Professor, Catholic University of America, USAKZ
Kathryn C. Zoon
Dr. Kathryn C. Zoon is a U.S.-based immunologist, elected to the U.S. Institute of Medicine in 2002 for her research on human interferons and administrative public health contributions. She is the former scientific director of the Division of Intramural Research at the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) in Bethesda, Maryland (2006-2015). From 1992 to 2002, Dr. Zoon was director of the FDA Center for Biologics Evaluation and Research (CBER). She is currently Scientist Emerita, NIH and on the Board of Directors of Emergent Biosolutions, Inc. and the International Biomedical Research Alliance. Dr. Zoon obtained her B.S. cum laude from Rensselaer Polytechnic Institute in 1970 and her Ph.D. in biochemistry from Johns Hopkins University in 1976. Soon after receiving her Ph.D., she undertook a training fellowship in the NIH laboratory of Christian B. Anfinsen, who had won the 1972 Nobel Prize in Chemistry.
Affiliations and expertise
Scientist Emeritus, Cytokine Biology Section, NIAID/DIR, Bethesda, MD, USAMS
Mark Schenerman
Dr. Mark Schenerman is currently Graduate Program Director and Professor of the Practice of Biotechnology at UMBC. He is also President of a consulting firm (CMC Biotech-MAS Consulting) that he founded and is advising academic, industry, and regulatory agency groups. He is an experienced biopharmaceutical scientist and executive (over 25 years) who was responsible for leading cross-functional Chemistry, Manufacturing, & Control (CMC) strategy and teams at Novavax and MedImmune/AstraZeneca. Dr. Schenerman headed an R&D group at MedImmune/AstraZeneca that performed structural and biological characterization of preclinical and clinical products, stability and release testing, technology transfer to quality control and ongoing product development support. Since joining MedImmune in 1994, Dr. Schenerman played an integral role in developing and leading the company’s Analytical Biochemistry function, supporting all stages of product development. Prior to joining MedImmune, Dr. Schenerman held positions in biologics development and research and development at Bristol-Myers Squibb Company and was a post-doctoral fellow at Cornell University. He earned his Bachelor’s degree in Medical Technology at the University of Maryland and his doctorate in Biochemistry and Molecular Biology at the University of Florida.
Affiliations and expertise
Professor and Graduate Program Director, University of Maryland Baltimore County, Biotechnology, Rockville, MD, USASN
Susan Neadle
Dr. Susan Neadle is a recognized international Combination Products, Medical Device, and Digital Health expert with over 35 years industry experience. She is well networked, published, and highly active in numerous industry groups with links to teaching institutions. Neadle’s leadership, innovation, and best practices have been recognized with multiple awards, including the Johnson Medal, Johnson & Johnson’s highest honor for excellence in Research & Development, and most recently, as a Finalist in TOPRA’s 2021 Awards for Regulatory Affairs Excellence. Neadle retired from a distinguished and impactful 26-year career at Johnson & Johnson. She is now Principal Consultant at Combination Products Consulting Services LLC, providing international Q&C, regulatory and design excellence services, to the pharm, biotech and device industries. Neadle serves as Chair of the ISPE Combination Products CoP, and Lead Author in Combination Products Working Groups through ASTM International, AAMI and PQRI. She teaches curricula in Combination Products through UMBC and AAMI, as well as customized training upon request.
Affiliations and expertise
Principal Consultant and President, Combination Products Consulting Services LLC, Saint Johns, FL, USACH
Christopher Hamlin
Christopher Hamlin is Senior Manager of Regulatory Affairs – CMC at PCI Pharma Services, where he leads a Regulatory Affairs team supporting manufacturing sites across the United States and in Europe. Prior to joining PCI, he was an employee at Division of AIDS at the National Institute of Allergy and Infectious Disease with the U.S. National Institute of Health (DAIDS/NIAID/NIH) where he contributed to the development and translation of HIV vaccine candidates into clinical trials. He was with the Walter Reed Army Institute of Research (WRAIR) and participated in the U.S. Military’s HIV Research Program in the Laboratory of Antigen and Adjuvant Research where his protein characterization work contributed to multiple scientific publications. He holds a Master of Science degree in Biotechnology from the Catholic University of America in Washington, DC and Bachelor of Science in Biochemistry Marietta College in Marietta, OH.
Affiliations and expertise
Senior Manager of Regulatory Affairs, CMC at PCI Pharma Services, Bedford, NH, USAIK
Ivana Knezevic
Dr. Ivana Knezevic, MD, PhD Scientist, Technologies, Standards and Norms Team, Group Lead, Norms and Standards for Biologicals, Department of Essential Medicines and Health Products (EMP), Health Systems and Innovation (HIS) Cluster, World Health Organization (WHO), Switzerland. She is a specialist in medical microbiology and parasitology. She received her MD from the University of Novi Sad, MSc in medicine (microbiology) and PhD in medicine (virology) from the University of Belgrade, Republic of Serbia. Ivana Knezevic has 24 years of professional experience in standardization, scientific and regulatory overview of biologicals. Dr. Knezevic is the author of many publications that made broad audience aware of WHO initiative in the development, establishment, and implementation of standards for vaccines and biotherapeutic products. She is also contributing to the peer-review scientific journals with the international reputation.
Affiliations and expertise
World Health Organization (WHO), Department of Essential Medicines and Health Products, SwitzerlandMT
Mehmet Tosun
Dr. Mehmet Tosun is a physician-scientist with over 15 years of experience in clinical trials and research endeavors. He is an adjunct faculty member in the Biotechnology Program at the University of Maryland, Baltimore County. He served as the Director of Research to develop mRNA-based cell therapy for autoimmune diseases, rare disease and cancers in a clinical-stage biotechnology company in Gaithersburg, Maryland.
He worked as a Project Scientist in tissue engineering group to develop biomaterials for the repair of visceral hollow organs at University of California, Irvine, School of Medicine. He joined the team to identify the systems-level machinery governing vertebral segmentation during embryonic development at Albert Einstein College of Medicine, Department of Genetics. He completed his postdoctoral fellowship at Baylor College of Medicine, Department of Pediatrics at Texas Children Hospital. He specifically focused on neuronal stem cells resides in hippocampus to explain the adult neurogenesis mechanism. He developed a unique method to characterize the complex lipid features of the different parts of the brain. He has expertise in clinical drug development, translational clinical research, immunotherapy, and clinical data monitoring.
Affiliations and expertise
University of Maryland