Done By Praveen Kumar Pai.P S2 MBA Roll no:28 I.M.

T Punnapra

Objectives
To understand the research and development

in pharmaceutical industry

Key players in pharmaceutical industries

Ranbaxy Dr. Reddy's Cipla Lupin Nicholas Piramal Sun Pharmaceuticals GSK Cadila Healthcare Aurobindo Wockhardt

Research and Development (R&D)

Research and Development (R&D) involves the initial stage of discovery right through to manufacturing to have product ready for the market. People working in this area would include biologists and chemists etc

Drug Discovery Process

Target Selection Compound Selection Target Validation & lead optimization 2 4 Years Proof of Concept Clinical Trials Pre-clinical Phase Proof of Concept Outcome Drug Registration FDA Approval 4 7 Years Marketing Introduction Marketing (Phase IV Clinical Trials)

Clinical Phases I, II III, IIIB*

*Key variable guiding development time

Clinical Trials: What Are They?

An organized research study designed to

investigate new methods of preventing, detecting, diagnosing, or treating an illness or disease (such as cancer).

Clinical Trials Process and Associated Regulatory Process

Phase II End of Phase II Meeting

Pre-IND Meeting IND Application

Phase I

Phase II

Phase III Pre-NDA Meeting

Phase IV

File NDA

Drug Approval

Phases of Clinical Trials

Category Phase I # of Participants Less than 10 Purpose Tests how to administer a new therapy, exam, or preventive option Phase II 30-40 Test patients responses to a new therapy, exam, or preventive option

Phase III

100-1000+

Compares new therapy exam or preventive option to a standard one

Phase IV

Varies

For marketing purposes, to compare the effectiveness of two therapies already on the market or to study new uses of therapies

Tasks Involved to Develop/Support Clinical Trials

Protocol development Volunteer recruitment Clinical conduct (management) Monitoring Data management Clinical statistics Medical writing Quality assurance

Clinical Trials Benefits & Risks

Possible Benefits of Trials Having access to potentially more effective therapies than those currently available Receiving quality medical care from leading physicians Being closely monitored for possible negative effects Sometimes receiving treatment at a reduced rate or free of charge Helping to further new research that may result in significant medical advances For patients in cancer therapy trials assigned to control groups, they still receive the top standard therapy available today Possible Risks of Trials Patients may not receive the therapy under investigation The new therapy may not be more effective than the standard, thoroughly tested therapy In Phase I trails, not knowing the safety consequences of the new therapy (risk is less in Phase III trials) New therapy may have unexpected, possibly severe side effects or may be less effective than standard of care Insurance companies may not cover all costs of clinical trials