INDIA PUBLIC: PRIVATE PARTNERSHIP MODELS FOR R&D (INFECTIOUS DISEASES) OPPORTUNITIES AND CONSTRAINTS

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1 PUBLIC: PRIVATE PARTNERSHIP MODELS FOR R&D (INFECTIOUS DISEASES) OPPORTUNITIES AND CONSTRAINTS Prof. V.K.Vinayak Senior Advisor Department of Biotechnology Ministry of Science & Technology Block # 2, CGO Complex, Lodhi Road New Delhi INDIA

2 BIOTECHNOLOGY FOR HEALTH (INFECTIOUS DISEASES) R&D RELATING TO INFECTIOUS DISEASES - Diagnostics for Infectious Diseases. - Vaccines:- New Generation. - Drug Delivery System. - New Therapeutics. - Genomics Applications for better diagnostics/vaccines/new drug molecules.

3 BIOTECHNOLOGY FOR HEALTH (INFECTIOUS DISEASES) v RAPID agglutination of erythrocytes for HIV 1&2. v Peptide based ELISA System for HIV-1 & 2. v Western immunoblot for HIV-1 & 2 infection. v Mac IgM ELISA for detection of Dengue infection. v Mac IgM ELISA/RT-PCR for Japanese Encephalitis. v PCR for detection of Pulmonary/ Extrapulmonary tuberculosis. v LDH Based Test System for Malaria. v DAT for Toxoplasmosis. v IFA for Rabies - Monoclonal antibody to nuclear protein. v Haemagglutination Assay for Visceral Leishmaniasis. v ELISA for H.pylori. v IgM ELISA System for Leptospirosis. v ELISA for Amoebiasis.

4 CURRENT STATUS ON VACCINE TECHNOLOGIES DEVELOPMENT IN INDIA INDIA APPROACHES: Avirulent organism Recombinant Vaccines Tissue cultured based vaccine Genetically modified microbe DNA candidate vaccines. Plant based vaccines.

5 CANDIDATE VACCINES/VACCINE DEVELOPMENT vanti LEPROSY VACCINE Commercialized. vanti CHOLERA CANDIDATE In Phase-II Clinical Trial vanti ROTA VIRAL DIAORRHEAL VACCINE In Phase-I Clinical Trial vjapanese ENCEPHALITIS Under Preclinical Studies vanti RABIES VACCINE Awaiting approval for commercialization vanti TUBERCULOSIS Under Preclinical Studies vanti MALARIA Preclinical/Phase-I Clinical Studies vanti HIV CANDIDATE VACCINE Animal Experimentation (HIV-I - Subtype c) vplant BASED VACCINES Cholera/Rabies Animal Experimentation

6 BIOTECH SECTOR CONSUMPTION INDIA TRENDS IN INDIAN BIOTECH INDUSTRY (RS. IN MILLION) (Projected) HUMAN & ANIMAL HEALTHCARE PRODUCTS (36.9) (37.6) (39.5) AGRICULTURE (INCLUDING SEEDS) (28.3) (30.7) (32.8) INDUSTRIAL PRODUCTS (34.2) (30.3) (25.0) OTHER BIOTECH PRODUCTS 430 (00.6) 1300 (01.4) 3970 (02.7) TOTAL (100) (100) (100)

7 MARKET SCENARIO (RS. IN MILLION) 2005 GLOBAL INDIA * * Estimated potential 3-5 times

8 IMMUNODIAGNOSTICS COMMERCIAL RELEVANCE ΠCURRENT MARKET SIZE - RS. 300 CRORES ΠANNUAL GROWTH RATE - 25% ΠMARKET POTENTIAL (2005) - RS.500 CRORES ΠEXCL. IMPORTERS - 70% ΠINDG.PRODUCERS - 30% ΠSTATUS : IMPORT INTENSIVE LIMITED PRODUCTION

9 BIOTECHNOLOGY FOR HEALTH (INFECTIOUS DISEASES) * Key Academic Institutes involved in Research & Development for Infectious Diseases - Academic Institutes: -National Institute of Immunology - Central Institute of Medicinal & Aromatic Plants -Jawahar Lal Nehru University - Centre for Cellular & Molecular Biology -University of Delhi (South Campus) - Centre for DNA Fingerprinting & Diagnostics -All India Institute of Medical Sciences - National Centre for Cell Sciences -Centre for Biochemical Technology - Indian Institute of Chemical Biology -Institute of Microbial Technology - Central Drug Research Institute -Indian Institute of Science -JN Centre for Advance Research -Postgraduate Institute of Medical Education & Research

10 BIOTECHNOLOGY FOR HEALTH (INFECTIOUS DISEASES) * Key Academic Institutes and Pharma involved in Research & Development for Infectious Diseases B) Major Pharma: -Shantha Biotech Ltd. - Ranbaxy Labs. - Bharat Biotech Ltd. - Zydus Cadila - Sudershan Biotech Ltd. - Cadila Pharmaceuticals - Biological E. Ltd. - Dabur Research Foundations - Reddy s Laboratory - Panacea Biotech - Wockhardt

11 BIOTECHNOLOGY FOR HEALTH (INFECTIOUS DISEASES) PUBLIC : PRIVATE PARTNERSHIP MODELS THREE APPROACHES: Transfer of validated technologies to Pharmaceutical companies / entrepreneurs. Entrepreneurs/Pharmaceutical Companies and Public/ Academic Institute joint development of technologies/products. Public Institute/Academic Centres partnership before initiation of R&D.

12 BIOTECHNOLOGY FOR HEALTH (INFECTIOUS DISEASES) Bio-Medical Technologies transferred and launched in the market Technology Developed By Launched By Leprosy immunomodulator NII, New Delhi M/s Cadila pharmaceutical s, Ahmedabad Leishmaniasis detection kit CDRI, Lucknow Span Diagnostics Ltd. Western Blot for HIV-I & II CRI, Mumbai M/s J.Mitra & Co., New Delhi Naked Eye agglutination system for HIV-I&II Hepatitis C Diagnostics ELISA Based University of Delhi, South Campus ICGEB, New Delhi Cadila pharmaceuticals, Ahmedabad Xcytron, Bangalore

13 BIOTECHNOLOGY FOR HEALTH (INFECTIOUS DISEASES) Bio-Medical Technologies Transferred (not yet Launched) Technology Developed By Transferred to The IgM Mac ELISA - Dengue NIV, Pune Zydus Cadila Health Care, Ahmedabad The IgM Mac ELISA - Japanese Encephalitis The IgM Mac ELISA - West Nile ELISA -alphafeto protein levels. An IgM - Hepatitis A do do----- IICB, Kolkata NIV, Pune -----do do----- Shantha Biotechnics, Hyderabad Bharat Biotech Ltd., Hyderabad

14 BIOTECHNOLOGY FOR HEALTH (INFECTIOUS DISEASES) Bio-Medical Technologies Transferred (not yet Launched) Technology Developed By Transferred to Urine based systems (ELISA) - Four Reproductive Hormones. Yarrowia lipolytica expressing system. hcg expression Pichia patoris system. Recombinant candidate Anthrax Vaccine IRR, Mumbai University of Baroda,Baroda IISc, Bangalore JNU, New Delhi and CBT, Delhi. Zydus Cadila Health Care, Hyderabad Biological evans Ltd., Hyderabad Cadila Pharmaceuticale, Ahmedabad Panecea Biotech, Delhi

15 JOINT DEVELOPMENT OF PRODUCT/PROCESS - Anti-Rota Virus Vaccine: AIIMS/Bharat Biotech - Antimalaria Vaccine: ICGEB/MRC/Bharat (recombinant) Biotech - Anthrax Vaccine: JNU/ Panacea Biotech. (recombinant) - Antirabies DNA Vaccine: IISc/Indian Immunologicals

16 PUBLIC: PRIVATE INTERACTION LEADING TO COMMERCIALIZATION OF PRODUCTS - Antileprosy Vaccine: NII/Cadila Pharmaceuticals - r Hepatitis B Vaccine: CCMB/ Shantha Biotech - NEVA diagnostic for HIV-I/II: DU(sc)/Cadila Pharmaceuticals -Western immunoblot for HIV-I/II: CRI/ J Mitra & Co. - ELISA for Hepatitis C ICGEB/ Xcytron Co. - Amoebiasis detection kit NII/ Span diagnostics.

17 INDIAN SCENARIO Π12 PRODUCTS APPROVED HUMAN INSULIN FSH *STREPTOKINASE ERYTHROPOIETIN *HBsAg HGH INTERLEUKIN GSF GCSF *a INTERFERON BLOOD FACTOR VII g INTERFERON * Products indigenously manufactured

18 CONSTRAINS IN TRANSFER OF TECHNOLOGIES INDIA Lack of interactions at the initial stages of technology process development. Market need & techno-economic feasibility not conducted seriously Lack of funds/facilities at inventor level to upscale bench level processes Entrepreneurs do not take risks with unproven/untried technologies. Procedural delays in various approvals.

19 BIOTECHNOLOGY FOR HEALTH (INFECTIOUS DISEASES) FOUR DISTINCT ROUTES: Diversification from chemical manufacturing to use of Biotechnological tools/tie up with MNC. Start up on indigenous production of first generation recombinant therapeutics/vaccines. Investing profits in discoveries (R&D set up). Utilising / grafting biology onto IT Bioinformatics & genomic companies.

20 OPPORTUNITIES FOR INDIAN PHARMA A) Global Partners Tie Up With Indian Pharma - Low cost of innovation in India - Chemical capabilities Cheap & World class - Drug discovery: 80-90% cheaper in India - Alliance of upstream & down stream activities. B) Positioning to partners to enter American & European markets.

21 BIOTECHNOLOGY FOR HEALTH (INFECTIOUS DISEASES) SIGNIFICANT BARRIERS: Complicated regulatory system. Uncertainty about Intellectual property protection Slow pace of integration between academic and pharma companies.

22 TO OVERCOME BARRIERS Government Environment for innovation & entrepreneurship Strong patent protection Predictable regulatory mechanism(s). Create more business friendly environment.

23 SUMMARY v Several lessons have been learnt. v Great opportunities for public/private partnership. More successes with mid level and start up pharmaceuticals companies. v Need to create business friendly environment. v Indian industry is looking out for global partners for joint innovation research.

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