Biotechnology – Breakout

1. Clinical trials & development of new therapies
Prof Asita de Silva
MBBS, DPhil (Oxon), FRCP (Lond)
Clinical Trials Unit
Faculty of Medicine
University of Kelaniya

2. Quality of evidence
I Well-designed randomized controlled trial
II-1 Well-designed controlled trials without randomization
II-2 Well-designed cohort/case-control studies from more
than one group
II-3 Important results from uncontrolled experiments
III Opinions of respected authorities, based on
experience, descriptive studies, or reports of expert
committees
Rating evidence: US preventive service task force
US Preventive Service Task Force. Guide to clinical evidence, 2nd edition. Williams & Wilkins, Baltimore, 1996

3. Development of new therapies: long & unpredictable process
Drug
Discovery Pre-Clinical Clinical Trials
FDA
Review
Large Scale
Manufacturing
/ Phase IV
250 Compounds 5 Compounds
Phase I
20-100
Volunteers
Phase III
1000-5000
Volunteers
INDSubmitted
NDASubmitted
10,000
Com-
pounds
1 FDA
Approved
Drug
Phase II
100-500
5 years 1.5 years 6 years 2 years 2 years
Volunteers
Cost to develop new biotech product - average US$1-2B
Clinical trials: approximately 40% of R&D cost

4. Our collaborators & research
Academic centres of excellence / research institutes
• Universities - Oxford, Liverpool, Duke, Duke-NUS
• George Institute
Research-based pharma & biotech companies
• Sanofi, Merck, Eli Lilly, Boehringer-Ingelheim, Takeda, Anthera
Therapeutic areas
• Snakebite, CVD, Diabetes, Stroke, Hypertension, Arthritis,
Dengue, Cancer, Neurology, Ophthalmology & Renal

5. Future direction & required support
• Improve regulatory environment – by enacting the proposed
legislation on clinical research & improve efficiency of
regulator
• Comprehensive policy framework to position Sri Lanka as a
Centre of Excellence for Global Research & Development to
produce innovative therapies and for Pharmaceutical
Manufacturing