Clinical Research Scope for Pharma Management

Dr. Meeta Mahar Health Technical Expert C.R.S.

Introduction to CR

What is Clinical Research?

Clinical research is a systematic study for new drug in human subject that determines the safety and efficacy of
Drugs, Biologics, Medical devices, Diagnostic products

It generates data for discovering and verifying the Clinical, Pharmacological (including pharmacodynamic and pharmacokinetic) and adverse effects with the objective of determining safety and efficacy of the new drug.

NEW DRUG DEVELOPMENT

DRUG DISCOVERY AND SCREENING PRECLINICAL SAFETY AND TOXICITY TESTING EVALUATION OF DRUGS IN HUMANS

Process of Drug Development

Source: Defined Health

Drug Development Timelines

2-4 yrs

3-6 yrs

PHASES OF CLINICAL TRIALS

A Clinical Trial is a systematic study for new drugs in human subjects.
PHASE-I : HUMAN PHARMACOLOGY PHASE-II : THERAPEUTIC EXPLORATION PHASE-III : THERAPEUTIC CONFIRMATION PHASE-IV : POST-MARKETING STUDIES

Clinical Trial Activities

Plan
Protocol Design Investigator Identification

Setup

Conduct

Analyze

Report

Patient Recruitment and Management

Site Setup
Drug Supplies

Data capture and management

Analysis and Reporting

Training

Adverse Event Reporting

Trial Monitoring & Supplies Management Trial Management

Sponsor Subjects
Investigator Team /Site

Clinical Trial Regulatory Bodies Laboratory

IEC/IRB

Clinical research scenario

Indian Scenario Clinical Trials

80 Indian hospitals are presently involved in clinical trials. This figure is likely to go up to 14,000 and will mean an involvement of 5 lakhs doctors, 7 lakhs bed's, 17,000 medical graduates in 160 medical colleges. The total numbers of clinical trials conducted in India were 221 in 2007 and had increased to just over 1300 trials in 2009. The country is projected to conduct nearly 5% of the global clinical trials by 2012.

Indian Scenario
India is increasingly recognized as the most promising hub for global clinical research The clinical trial outsourced market in India is forecasted to grow at a rate of around 30% during 2010-2012. From $70 million pumped in by just a few pharmaceutical companies to India in 2002, the revenue from clinical research outsourcing has leaped to $800 million.

Indian Clinical Research Market

Clinical Trial Industry

Source: Mckinsey Report

Job Opportunities

Career Opportunities
More than 50,000 professionals will be required in the field of Clinical research in India alone. Source : Mckinsey Report

Thus pharma management graduates can look forward to exciting and rewarding career opportunities in clinical research.

The players in Clinical Research

Regulatory Agency

Sponsor Monitor

Institutional Ethics Committee

INVESTIGATOR

Data quality & Integrity

PATIENT

Human rights and safety Informed consent

Training Manager Clinical Research Manager Medical Monitors Clinical Research Associate

Auditors

Business Development Manager Co-investigator Investigator Site Manager Study Coordinator Research Officer Study Nurse Biostatistician

Documentation Manager
Quality Assurance Manager Regulatory Manager BA/BE Unit Data Validation Officer Data Coordinator IT Support Medical Writer

Data Manager

CRF Designers

Career Path

19

What is Pharmacovigilance
Pharmacovigilance (PV) is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines. The monitoring and assessing of responses to pharmaceuticals to detect and prevent adverse effects

Why Pharmacovigilance
"Regulatory bodies such as the Food & Drug Administration (FDA) and European Medicines Agency (EMEA) are intensifying safety regulations, thereby boosting the adoption rates of pharmacovigilance systems by pharmaceutical companies,
The need to operate in a cost-effective way is inducing pharmaceutical companies to outsource/offshore their pharmacovigilance operations." Companies in Pharmacovigilance- Accenture, Wipro, Cognizant, TCS, HCL etc

Pharmacovigilance market

The world pharmacovigilance market was worth $1859.9 million in 2008 and is estimated to reach $2252.2 million in 2015 - Source Frost & Sullivan

Career Path
Head/CEO/COO

Team lead or Team manager

Aggregate report scientist

DSS (Drug Safety Scientist)

DSA ( Drug Safety Associate)

Demand Supply Gap 2010 in India

Leading Companies in Clinical Trials

Major CROs
Quintiles Synchron Lambda Siro Clinpharm I-Gate Reliance Clinical Services PPD Onmnicare ICONClin TracPharmaNet Pharm-Olam Lotus Labs Vimta GVK BioServe Clinical Research Apothecaries Kendle Bioassay Clinworld Perinclinical Quest Life Sciences

Major Pharma Companies

Ranbaxy Johnson & Johnson Pfizer Glaxo Smith Kline Roche Sanofi Aventis Novartis Astra Zeneca Abbot Laboratories Merck Wyeth Eli Lilly Bristol Myers Squibb