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Synergistic Advantages of Drug Repurposing and Clinical Trial Off-shoring to India August 19, 2007 John Maki Pres

Synergistic Advantages of Drug Repurposing and Clinical Trial Off-shoring to India August 19, 2007 John Maki President and CEO. Pipeline of Cancer Products. 2008. X. Nutrition. Nutrition. Severe Stress. Malnutrition. Chronic. Acute. Function. Anorexia. Diet. Systemic

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Synergistic Advantages of Drug Repurposing and Clinical Trial Off-shoring to India August 19, 2007 John Maki Pres

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  1. Synergistic Advantages of Drug Repurposing and Clinical Trial Off-shoring to India August 19, 2007 John Maki President and CEO

  2. Pipeline of Cancer Products 2008

  3. X Nutrition Nutrition Severe Stress Malnutrition Chronic Acute Function Anorexia Diet Systemic Inflammatory Response (SIRS) Normal response to severe injury, trauma or infection Starvation Slower Metabolism Understanding Weight Loss Weight Loss Neuro-endocrine- Immune activation Beta Blocker NSAID ANS Dysregulation Inflammation Cachexia Faster Metabolism

  4. Enrollment Criteria • Rapid loss: >5% weight loss in 2 vs. 6 months • Advanced cancer: Stage IV • Elevated heart rate • Able to eat food Severe stress, not malnutrition driven cachexia

  5. Confounding Variables Cancer Types Therapy Status

  6. Enrollment Challenges 90+ sites required to enroll 45 subjects

  7. Off Shore Development Optimal enrollment AND low cost • Population, practice patterns and participation • 12 to 18x more subjects per site 2x+ times more patients per investigator 3x+ more not on chemotherapy 3x+ participation rates • 5 to 7 sites versus 90+ sites • 80% cost savings (fixed not variable costs)

  8. Repurposing/Off shoring Synergy • High standard of ethics combined with many years of clinical experience • No first in human regulatory limitation • Leverage 505(b)(2) • Investigator experience with class of drug • Access to drug, especially generics Synergy Creates Practical and Ethical Option

  9. Off Shoring Locations Considerations: Population, Capability, Risks, Language, Costs Eastern Europe China India Latin America Africa

  10. India: Concentrated Population Equivalent of entire US population In 31 major urban centers

  11. India: Significant Capability 300 plus experienced clinical sites Fully equipped with sponsor-initiated improvements International and Pan-Indian CROs Expedited approval for FDA-approved studies

  12. India: Reduced Risks • 60% of the MNCs are conducting studies in India • 208 studies underway (49 P2 and 131 P3) • 100s of site “audits” by multiple sponsors/CROs • Data from studies submitted to FDA and EMEA • Two FDA and EMEA audits noted no serious findings

  13. Vicus Infrastructure Vicus U.S. Newark/Delhi 14 Hours (2 staff) Reliance Mumbai Contract Manufacturers Vicus India Bangalore (2 staff)

  14. Vicus Clinical Sites Delhi Patna (Satellite) Nashik Kolkatta Pune Bangalore 5 sites + 1 satellite 10 million population base

  15. Cachexia Time Line

  16. Summary • Off-shoring enables testing of repurposed drug hypothesis in human models • Enables optimal clinical trial design to reduce risks • Significantly improves recruitment rate and costs • Repurposing synergy makes off-shoring practical • India offers advantages – especially for start-ups • Local presence and service providers key to success • VT-122 provides proof-of-concept of advantage

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