Dr. Shiva Murthy N.MBBS, MD, MBA, CEIM.

Head, Clinical Pharmacology Unit A CRO in New Delhi Area shivuindia@yahoo.com

This presentation is only for education purpose only. Not for commercial sale.

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Discovery; Refinement; Chemical & Biological characterization

Safety & Toxicity in Animals; Formulation Development Volunteer studies; Patient studies Lessons & Development
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Regulatory process

Post Registration Monitoring

Marketing

Discovery = find new active structure Development = convert it to a useful drug

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Clinical Trials are scientific studies helps to evaluate

New Drugs New therapeutic methods New ways of using known treatments

Clinical Trials help to evaluate safety and efficacy

New drugs or treatments

Carefully conducted clinical trials

Fastest and Safest way to develop new treatments that work in people.
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Prevention Trials
Vaccines Medicines Vitamins Minerals or lifestyle changes To prevent diseases

QOL Trials
To improve comfort and quality of life for individuals with chronic illness, certain diseases health conditions

Screening Trials
Lab investigations test kits, Card tests Surrogate Markers antibody level or antigen level To detect certain diseases or health conditions

Treatment Trials
Test new treatment New combination of drugs New approaches to surgery or radiation therapy

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Regulatory GuidelinesIndian and International Ethics ICMR, GCP and Schedule Y Approvals DCGI, IEC Literature Latest to Oldest Waivers Not all drugs require research Science Protocol ICFs Consent most important Appropriateness SOPs and Procedures

Society - Acceptability Patient and Doctor relationship Minors and Debilitated subjects Fraud and misconduct Safety Risk Vs Benifit Team Skilled workers Drug- availability Disease - Prevalence Development Support Difficulties Ability to withstand Documents
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Higher management - Most important

Overall Management and business continuity and risk mitigation

Training and Development To ensure that required skills are imparted and updated regularly Accounts Manage Money receipt, payments, taxes Admin department Manage day to day facility maintenance and cleaning Supply chain and purchase Identification of vendors and stock maintenance Transportation department Organize travel and meetings Human Resource To supply people and keep them happy Information technology department Ensure all information stored properly and retrieved without fail
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Sponsors Govt Departments (ICMR, DCGI, DST, DBT) Ethics committee Laboratory support BioBio-analytical support Regulatory consultants BioBio-waste management Dietician

Caterers Suppliers Calibration companies Doctors, Consultants and Hospitals Ambulance providers Volunteer development Archiving and record maintenance

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India has the potential to emerge as one of the top five innovation hubs globally in the next ten years Indias potential in R&D is underscored by its Large talent Large and diverse patient pool across therapeutic areas World-class hospitals Trained investigators for clinical trials IT talent for bio-statistical English Competency Cost Competency fast patient recruitment shorter timelines lower manpower cost etc. Project management competency ICG-GCP compliance

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

Central Lab facilities (Internationally and Nationally accredited)

Regulatory guidelines and Government policies Favorable (MOH, DCGI, ICMR, DBT. Drug and Cosmetic Act and Schedule Y)

Other analytical capabilities

Strong support and championing by the government

Good Supply of Manpower Lot of training Institutes

Lot many hospitals and medical, dental, nursing colleges

Regulatory Compliance - Indian studies approved by WHO, FDA, ANVISA, MHRA.

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INFRASTRUCTURE AVAILABLE
Over 200 Medical Colleges Over 22,000 Medical graduates per year

Clin. Res. Infrastructure

15,622 hosp., 903,952 hosp.beds >75% in urban area 14000 diagnostic labs 700,000 scientists and engineering graduates / year World class medical / lab facilities at secondary / tertiary care centers Skilled computer savvy biomedical work force Highly developed IT / ITES

IT Support
Motivated & committed personnel High quality digital connectivity

Connectivity

Excellent air/surface transport facilities across country

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INDIA : ADVANTAGES
Large No. of specialists in different therapy segments Medical Training In English Investigators 600,000 Eng. Speaking physicians PG training from Europe/US Treatment Protocols in line with West Large no. of ICH/GCP compliant Investigators / sites

Large, Diverse, therapy-nave Advantage of having 6 out of 7 genetic varieties Patient population Large pt. pool in acute/chronic disease segment Increasing no. of pts in life style disorders segment, HIV, Oncology
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45 million asthmatics 30 million diabetics 18 million hypertensive 13 million hepatitis C 10 million or more HIV patients

8 million epileptics 3 million cancer 1.5 million Alzheimer's one million schizophrenics

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Team work

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Thank You

Keep in touch at shivuindia@yahoo.com

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com