Transcript Dr. Kunwar Shailubhai

Kunwar Shailubhai, Ph.D. & M.B.A
Executive VP & Head R&D
Callisto Pharmaceuticals, Inc.
New York, USA
Acceleration of technological innovations in pharmaceutical
and biotechnology industries through collaborative R&D
Callisto Pharmaceuticals, Inc.

Oncology

Inflammation

Bioterrorism
A publicly traded biotechnology company
A global need for collaborative R&D in
Pharmaceutical and biotechnology Industries
Why ?
Where ?
What ?
How ?
An experience
Small World for Biotech
Challenges for Pharmaceutical Industry
 Astronomically high R&D costs
- $ 500 to 750 millions
- Pricing Control
- Increased competition from generics
 Technological Advances
- Genomics
- Proteomics
- Bioinformatics
- Computer Technologies
 Gene therapy and Personalized Medicine
Opportunities for collaborative R&D
Bringing a Drug to Market Takes on Average 8-12 Years
Drug Discovery
3-5 Years
Drug Development
FDA Approval
5-8 Years
1-2 Years
100 projects
1-3 Years
1 product
3-5 Years
1-2 Yr
• cGMP Manufacturing
• Expedited FDA Approval
• In-Licensing
• Multi-center Clinical Trials
• New Technologies
• Global Collaboration • New Technologies
• CRO’s
A high cost high risk business
Opportunities for Pharmaceutical/Biotechnology Industries
Cancer
Bioterrorism
A risky but highly rewarding business
Alliances between Big and Emerging companies are rising
A win-win situation
Growth of pharmaceutical industry in India
(Rs. Crores)
1965-66
1980-81
1997-98
1998-99
19992000
Capital Investment
140
500
1840
2150
2500
Production :
Formulations
150
1200
12068
13878
15960
18
240
2523
3148
3777
Import
8.20
113
2868
3128
3441
Export
3
46
5353
5959
6631
3
15
220
250
320
Bulk Drugs
R & D Expenditure
India is the 15th largest producer of pharma/biotech products
Areas for Collaborative R&D
Drug candidates
- Custom Synthesis
- SAR studies
- Combinatorial Synthesis
- Biopharmaceuticals
cGMP Manufacturing
- Chemical compounds
- Biologics
- Vaccines
- Generics
Drug Discovery
- Target Validation
- Animal Studies
- Genomics
- Biologics
Clinical Trials
- Safety & Toxicity
- Multi-Center Trials
- Anti-infectives
- CRO’s
Primary goal of collaborative R&D is to reduce cost and time
Market for generics is growing rapidly
 Forecasted to grow annually to US$ 263 billion in 2005
 Represents 42% of total prescriptions by volume
 More then 150 brand name patented drugs (US$105 bn)
will come off the patents and will be available for generics
by 2010.
 Patent protection laws are changing
 Consumer awareness for generics is increasing
 The current US government is supportive of generics to
Indian Drugmakers: TIME
reduce health care expenditure
 WTO agreement 2005: Indian firms have to compete globally
Indian firms are well-positioned to challenge the BIG pharma of the west
Biologics offer business opportunities for Indian firms
 Human proteins and peptides
- Insulin, EPO, Growth hormone etc.
- Antagonist peptide (D-form)
 Enzymes and cytokines
- tPA, Streptokinase, GM-SF, Interferon, Interleukins
 Therapeutic antibodies
- Humanized antibodies for cancer
- Anti-angiogenesis Abs: AVASTIN
 Vaccines
- Hepatitis, Dengue virus, Smallpox, Anthrax
- Tuberculosis, Malaria
- Cancer Vaccines, DNA/RNA vaccines
 Diagnostics
Bioterrorism: A new frontier for Pharma/Biotech
NIAID Biodefense Strategy

Broad-Spectrum Drugs
- Peptides, Antibodies
- Small compounds

Vaccination
- Smallpox, Anthrax, SARS
- U.S. Govt. Contracts

Diagnostic tests for rapid detection
- Toxins
- Bacteria
- Viruses

Manufacturing
Substantial increase in NIH biodefense budget for grants
Novel approaches to develop broad-spectrum drugs and vaccines
against deadly bacteria and their toxins
Nutraceuticals: The future of prophylactic medicines
Genomics and proteomics are paving way for the development of technologies
for early detection of the deadly diseases: Prevention and control
Nutraceuticals vs Pharmaceuticals
Cancer
Inflammation
Nutraceutica
ls
Drugs
Cardiovascular
Diabetes
Multiple targets
Multiple molecules
Low Potency
Clinical evaluation ?
Single target
Single molecule
High Potency
Clinical validation
Synergistic combination of mechanism-based compounds
for prevention of diseases
Phytonutrients for Cancer Prevention
Enzyme Targets
Biopharmaceuticals
Phase II Inducers
(QR & GST)
Antioxidants, Polyphenols (EG
Ellagic acid & Carbinol
Brassinin & Sulforaphane.
Cyclooxygenases
Resveratrol, CAPE, Curcumin
Polyphenols, CLA & Olive extracts.
ODC
Deguelin, Curcumin, Rotenoids
Protein Kinase C
DNA Topoisomerase I
NF-kB inhibitors.
Angoline, Laricirasinol,
Betulinic acid
Garlic extracts, Curcumin & C
Nutraceuticals are getting attentions from public, government and
the “Big” pharmaceutical companies
Successful strategy for small and emerging biotechnology companies
 Technical Alliances
- Preclinical discovery
- Out-Licensing
 Joint Ventures
- Clinical Trials
- Manufacturing
 Generics
- Off-patent drugs
- Patent loopholes
 Biologics
- Recombinant proteins
- Humanized antibodies
- Peptide Mimetics
 Subsidiary in USA
- Federal grant money (SBIR/STTR)
- NIH resources
- Free evaluation of compounds (NCI Program)
- Venture Capitalists funds in US
- Public listing on the financial markets
How did we use collaborative R&D strategy ?
NeoCeutix
 Co-Founded the company with VC money
 Preclinical discovery through collaborations
 Developed IP estate






Merged NeoCeutix with Synergy
Developed lead drug candidates for Hepatitis B & C
Funded through VC money & Federal grants
Out-Licensed the compound to United Therapeutics
Developing a compound for colon cancer (SBIR grants)
In-Licensed a compound for multiple myeloma





Merged with Callisto, a publicly traded company
Collaborations with NCI, M.D. Anderson and Dana Farber
Developed IP estate for cancer and inflammation
In-Licensed a technology from The Rockefeller University
Grant money from NIAID and Army
Collaborative R&D is essential for the small and emerging companies