PFIZER INDIA : Research & Development

Pfizer is one of the first pharmaceutical companies to establish a dedicated clinical research division in India. The Pfizer Clinical Research group is responsible for all clinical research across the development continuum, irrespective of phase or product custodian. The group has grown tenfold to over 46 employees since its establishment in 1995.

The Clinical Research group comprises of four organisational segments: Study Management, India regional monitoring group, Outsourced operations and Business support. About two-thirds of the clinical research portfolio relates to phase II and phase III studies executed on behalf of Pfizer Global Research & Development (PGRD) worldwide teams while the rest are phase IIIb, phase IV comparative, post-marketing surveillance, epidemiology, drug utilization and biopharmaceutical studies to support local registration, launch and marketing.

Its vast contribution to the development of clinical research in the country makes Pfizer a leader in this area. Initiatives such as the PGRD supported Academy of Clinical Excellence (ACE) in collaboration with the Bombay College of Pharmacy help provide professional training to investigators and other clinical research personnel in the country.

The key achievements of the Pfizer Clinical Research department are highlighted below -

Conducting Phase II – IV clinical trials on new medical interventions in various therapeutic areas such as Infectious diseases (including Malaria & Typhoid fever), Oncology (breast cancer), Cardiovascular diseases (hypertension, heart failure), Psychiatry, Respiratory diseases (asthma, bronchitis) and Metabolic diseases (Osteoporosis).
Training of more than 3000 investigators, ethics committee members, CROs and other professionals in clinical research methodology and GCP (Good Clinical Practices).
Establishing the Academy for Clinical Excellence: in partnership with Bombay College of Pharmacy and Suven Pharma. This training center for clinical research offers training and certification of various clinical research professionals thus raising the standards of conduct for clinical research in India.
Research infrastructure: Through clinical research studies placed at various hospitals, investments have been made in upgrading research infrastructure in India. Notable amongst these are the establishment of Osteoporosis research centers at 6 major healthcare facilities in India with donations of diagnostic equipments like DXA (bone densitometry) at the cost of UD$600,000.
Pfizer is also committed to initiatives that evolve the clinical research environment in the country. Notable amongst these initiatives are contributions to the revisions in Schedule Y, India GCP guidelines etc. Pfizer has partnered with other stakeholders including industry and academia to establish a professional society - Indian Society for Clinical Research (ISCR). The society aims to represent the interests of clinical research community and partner with all stakeholders to shape the clinical research environment in the country.

India possesses significant potential to become a preferred location for research and development (R&D). With the aim to encourage a culture of innovation that provides certainty to investors in medicinal R&D, India took the first steps in the mid-nineties with a commitment to the WTO TRIPS (Trade Related Aspects of Intellectual Property Rights) agreement. In consequence, India has seen an inflow of funds into research and development, both from local investors and multinational organizations. However, the potential is much greater.

Patent legislation enacted at the beginning of 2005 has been an important enabler for growth of the clinical research industry. Recent studies have estimated that India can become the most preferred destination for global pharmaceutical and biotech companies looking for partnerships or setting up new operations. The Boston Consulting Group estimates that the contract manufacturing market for global companies in India will touch $900 million by 2010. Furthermore, the outsourced clinical research market in India will increase to $500 million by 2010.