Boot Camp is an intensive interactive course directed towards participants who wish to expand or update their understanding of global regulations, the translational sciences and drug development. There will also be a discussion to address policies of health, disease and cost of development of therapies.

Drug development is at a turning point in human medicine. Efficiency and Quality compliance are critical to achieve innovation and affordability. This comprehensive course will provide an in-depth overview of the basics and multi-dimensional nature of drug development utilizing technology, statistical and quality considerations. The boot camp will focus on development of novel drugs, including recombinant proteins, monoclonal antibodies, fusion proteins, cell therapy, gene therapy and gene editing technologies.

Attendees should have an understanding of the basic principles of biological science, and keen interest in practice. This course is developed for Industry, Academic and Research Professionals with minimum two year work experience or have completed their post-graduation in Biological Sciences. i) employees and management of biotechnology and pharmaceutical industry, ii) Faculty new to the discipline of drug development and iii) those seeking more information to complement their general biology, science, bioengineering, regulatory, legal or marketing training.

	Topic
Lecture 1	The drug development and risk assessment Boot Camp
Lecture 2	Defining the unmet need; disease pathology; and design of drugs
Lecture 3	Pharmacology and Toxicology
Lecture 4	Process development and manufacturing
Lecture 5	Clinical Trials and Regulatory Approval process
Statistical Concepts	Trend analysis, Comparability, management of change
Final Conclusion	Risk Assessment Summary and Conclusions
Award of Certificates	4:30 PM

Upon completion of the course, the participants should be able to:

• Become knowledgeable about the basic aspects of drug development, especially as it relates to application in various steps of the process
• The risks associated with the drug development process
• The understanding of social impact of cost of drug development
• Have the tools to develop methodologies to challenges faced during drug development
• The ability to read papers in the field of drug development
• Write and draw about complex multi-disciplinary nature of the drug development process which intersect with several other biological processes
• Have a shared understanding of academic and industry requirements

• Dr. Narendra Chirmule, Senior Vice President, Head R&D, Biocon Research Labs
• Dr. Robert Poolman, Director, Discovery & Pre-clinical Products, Clarivate Analytics
• Dr. Mihaly Juhasz, Managing Director/CEO, Accelsiors, Hungary
• Dr. Amitabh Gaur, President, Innovative Assay Solutions, USA
• Dr. Tamal Raha, Sr. Partner, Bioinnovat Ltd.

Dr. Guljit Chaudhri, Managing Director, Bioinnovat Ltd., CEO, INNONATION, Sr. Advisor, ABLE