Emerging Opportunities in India:Why India?Mahadev Murthy, Ph. D., M. B. A.
Outlook• Drug discovery firms turn to Asian countries to evadestringent regulations Thursday, February 09, 2006 (Biospectrum)• Better access to expertise, productivity gains, processimprovements, variable costs, avoidance of capital outlaysand opportunities for companies to focus on specificniches.
Changing Competitive Elements• R&D Infrastructure• Intellectual Property Rights(IPR)• WTO Membership• Patents & Licensing• Regulatory Harmonization• International Agreements &Harmonization• Foreign Direct Investment(FDI)• Public Health Infrastructure• Generic Drug Industry• IT Infrastructure• Innovation & Tech Transfer• Clinical Base– Hospitals– Patient Groups– Bioinformatics• Trained Force• Cost• Market Access• Governance
Recent QuoteAccording to Frost & Sullivan, the $7.3 billion Indian and Chinesedrug outsourcing discovery market is evolving, with both gaining anedge in the global arena by producing a continual pipeline of drugs,which are approved faster than those produced in westerncountries. Both countries are uniquely positioned to manage anddeal with the pressures to enhance clients' profitability, increaseshareholder value and utilize the potential of new drug discoverytechnologies.
Advances in Biomedical Innovationand New Technologies are Drivingthe Pharma and Biotech Industry toNew Limits
Drug Industry Directions• Optimism About Drug Development Based on NewBiomedical Discoveries• Sequencing of the human genome• Genomic and proteomic technologies• Systems biology• Advances in medical imaging• Nanotechnology advances• Tissue engineering• Drug discovery: combinatorial chemistry andautomated micro-scale screening
Today: A Challenge• A major paradigm shift• Barriers are huge• Cost is high• Development cycle is too long• Technology is costly• Lack of lead candidates• Multiple targets
Investment DecisionBenefitsShareholder ValueDevelopment Costs(Economic Analysis)Risks-Major
Pharma/Biotech IndustryR & DInnovationManufacturingUS & GlobalMarketsMostly the USIndia contributes big
Pharm Industry DynamicsM a h a d e v M u r th y , P h . D .B a s ic R & DC lin ic a l T ri a lsI n te l le c t u a lP r o p e r t y R ig h t s( I P R ) & T R I P SW T OW I P OW H OP h a r m a c e u t ic a l In d u s t r yP r o d u c tL a u n c hH e a l th C a reD e li v e r yM a r k e tA c c e s sN e w e r T e c h n o lo g yI m p a c ts A l l A s p e c ts o f t h eI n d u s t r y
IT and Pharma/BiotechInformation Technology• India needs sound infrastructure/databases/partnerships to be effective in utilizing IT;• Although India has an opportunity to exploit IT, thereare significant constraints because of thecomplexities of the industry;• Biotechnology Requires IT-Based Strategies tomaintain dynamic market shifts, low costs andleadership position.
FDA Critical Path for Drug Discovery(March 2006)• Released March 2006.• 76 priority research projects.GOALSIllustration: Roger SchillerstromTed Agres, Deputy Managing EditorWashington Times• New drugs and Therapies tomarket more quickly and at lesscost.• Bridge the gap between the rapidpace of biomedical discovery andthe slower rate at which thosediscoveries are currentlydeveloped into therapies.
Critical Path for Drug DiscoveryBasicResearchDesign &DiscoveryPre-ClinicalClinicalDevelopmentFDA FilingApprovalLaunchPreparationTranslationalResearchOutsourcedCritical PathResearch
Drug DiscoveryTargetIdentificationTargetValidationHTSLeadOptimizationDevelopmentOutsourcedAll these componentsare up for Grab
Chemistry• Custom chemistry synthesis• Custom Library synthesis• Medicinal chemistry• Process chemistry development• Analytical chemistry• Active pharmaceutical ingredients (APIs)• Pharmaceutical intermediates• Contract research
Preclinical• Small animal resources (Constraints with largeanimals)• Toxicity/safety pharmacology• PK/PD• Efficacy testing• Drug efficacy and biomarker validations• GLP Regulations-beginning to take shape (FDA isinspecting Labs for GLP Compliance)
PreclinicalClinical Phase I, II, III, IV services-New drug and medical device trials-Constraints on Phase I trialsClinical Data Management-Computer modeling-Statistical analyses-SAS programming-Clinical databases
Clinical Trials• The number of studies containing non-US sites hasincreased over the last 2-3 years.• About 20-30 % of the data on multi-site clinical trials cancome from non-US sites.• The inspection activity on non-US sites has also increasedconsiderably over the last 2-3 years.
• FDA Does Accept Non-USClinical Trial Data• Non-IND Studies Pursuant toProvisions of 21 CFR Parts312.120 and 314.106• Multi-National Trials-Regulations (21 CFR Parts 50,56 & 312)• Inspections• Compliance/EnforcementFDA Approach
Clinical Trial Inspections1992Italy & Spain1993BelgiumIsraelNew Zealand1994PolandSouth Africa1995Argentina1996BrazilCosta RicaPeruRussia1997AustriaNigeriaPanamaPhilippines1998CzechoslovakiaSloveniaHungaryRomania2005-OnwardsIndiaChina
Results• More than seven US major CROs are now in India around Bangaloreand Hyderabad• There are many Indian CROs as well• Many multinationals are in India in a big way• Domestic companies are investing in R & D• A new breed of culture is in place and the new companies are beinglaunched• Investment environment has improved• Changing policy and regulatory environment• Global Clinical Trials Industry (10 Billion Dollars)• Bioinformatics and Data Management have expanded
Time will tellThank YouWashington Times