HYBRID EVENT: You can participate in person at Baltimore, Maryland, USA or Virtually from your home or work.
Sudhakar Bangera, Speaker at Vaccines Conferences
Fellow-vaccinology managing partner AILEEN clinical research services AILEEN, India
Title : The need for separate regulations for prophylactic vaccines


Biological therapeutics, also referred to as Biologicals, are those diverse group of medicines that are grown and then purified from large-scale cell cultures of bacteria or yeast, or plant or animal cells. Biologicals include a wide range of products such as vaccines, allergenics, somatic cells, gene therapy, tissues, growth hormones, interleukins, immune modulators, growth factors, monoclonal antibodies, recombinant therapeutic proteins, blood and products derived from human blood and plasma. What distinguishes biologicals from other medicines is that these are generally large, complex molecules and can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues, whereas other medicines are considered as ‘small molecules’ and are either made synthetically or purified from plants.

Biologicals, including prophylactic vaccines, cell and gene therapy, and pharmaceuticals are all subject to the same regulations in terms of research and development, manufacture, pre-clinical and clinical studies, marketing authorisation, and post-licensing usage surveillance and monitoring. Designing a clinical trial for prophylactic vaccine is a challenge starting from validation process, selecting appropriate biomarkers, target population, defining inclusion criteria, laboratory investigations, out come measures in terms of antibody titres in a defined time period. These complexities make prophylactic vaccine stand apart from a pharmaceutical product.

The implementation of a strong regulatory system is critical for vaccines because they are inherently more difficult to develop, characterize, and manufacture than most drugs or biologicals. The regulatory documents for an intended prophylactic vaccine needs to be reviewed by a separate, trained and experienced agency, rather than by the central licencing agency that deals with pharmaceutical products, a process being followed in few advanced countries. Technical committees appointed by the regulatory agency has to include experienced immunologists in the panel. To keep in pace with the regulatory agency, Institutional Ethics Committees, scientific review boards must have expert immunologists, microbiologists and public health personnel in their team for comprehensive review. Hence, in view of their peculiarities and important differences, vaccines should be regulated differently and separately.

Audience Take Away:

  • Peculiarities and important differences between drugs/ biologicals and vaccines
  • Regulatory, scientific oversight and public oversight are not same, as they should be for vaccine


Dr. Sudhakar Bangera did his MBBS from KIMS, Bangalore; MD (Pharmacology) from KMC Mangalore; and MMedSc (Clinical Trials Methodology) from the University of Hong Kong. Dr. Bangera is also trained on India Vaccinology Course with CMC Vellore, and funded by Bill & Melinda Gates Foundation for International Vaccinology at IVI, Seoul. He has extensive work experience of 30 years in healthcare, of which 26 years are in global and local CRO, ARO, SMO, Medical Imaging, Clinical Bioavailability and Bioequivalence, Public Health, Government agency, Pharmaceutical and Vaccine manufacturing companies in various capacities as COO, Country Manager, Vice-President, Director, Project Manager in national and international organisations. Dr. Bangera has worked on several hundred BA-BE and phase 1 to 4 clinical trials for new pharmaceuticals, vaccines, medical devices, biologicals and cosmetics, He has been a speaker on several topics in the clinical research domain in more than 150 invited talks. He was responsible for phase 1 clinical trials of Chikungunya, Zika and other vaccines in later phases. Currently, Dr. Bangera is managing his consulting firm, AILEEN Clinical Research Services as Managing Partner at Hyderabad India, and a medical technology translation advisor to students, faculty and healthcare startup entrepreneurs at several bioincubators on clinical development and regulatory requirements. Dr. Bangera is an author of two books – Medical Device – Concept to Commercialisation: India Perspective, and The CRA.