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Report on SEA-ACHR Subcommittee on Drug and Vaccine Development

32 nd Session of WHO SEA-ACHR, Thailand 11-13 October, 2011. Report on SEA-ACHR Subcommittee on Drug and Vaccine Development. N.K. Ganguly Former Director General – Indian Council of Medical Research President – Jawaharlal Institute of Postgraduate Medical Education and Research

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Report on SEA-ACHR Subcommittee on Drug and Vaccine Development

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  1. 32nd Session of WHO SEA-ACHR, Thailand 11-13 October, 2011 Report on SEA-ACHR Subcommittee on Drug and Vaccine Development N.K. Ganguly Former Director General – Indian Council of Medical Research President – Jawaharlal Institute of Postgraduate Medical Education and Research Distinguished Biotechnology Research Professor National Institute of Immunology, New Delhi, India

  2. Drug Development Efforts in India

  3. IND Molecules in Clinical Trials in India

  4. WHO Prequalified Drugs from the SEAR • 87% of drugs manufactured in the SEAR that attain WHO prequalification are manufactured in India. • HIV / AIDS Drugs (single & combo) : 93 • Tuberculosis Drugs (single & combo) : 17 • Anti-Malarial Drugs (single & combo) : 5

  5. Recombinant Therapeutic Drugs Approved for Marketing in India

  6. Biotechnology based Drugs in Development in India

  7. Indian Anti-tubercular Drug Development Initiative • AZ and PA124 are two effective anti-tubercular lead molecules developed. • CSIR has carried out Technology Transfer. • Currently awaiting further development.

  8. Vaccine Development Efforts in India

  9. Rotavirus Vaccines

  10. Rotavirus Type A: The most common cause of infections in humans Source: WHO

  11. Rotavirus Vaccines Source: CDC and WHO RotaTeq • First dose is given within the recommended age range of 6–12 weeks in infants. • The maximum age for the last dose was 32 weeks. Rotarix • 6 weeks and 14 weeks in Latin America or 6 weeks and 15 weeks in Europe. • The maximum age for the last dose was 24 weeks 6 days.

  12. Rotavirus Vaccine Efficacy Studies Source: WHO

  13. Development of Oral Rotavirus Vaccine (ORV) Using Indian Neonatal Strain116E Bhandari et al. J Infect Dis2009; 200: 421-429 Strain 116E human rotavirus Serotype G9, P with single gene coding VP4. 1×105 Focus forming unit found safe and immunogenic in clinical trials in USA and India. Robust immune response after 3 administrations. 4 fold increase rotavirus IgA titer in 89.7% of infants recipient of ORV Technical Collaborators: DBT (india) CDC (USA), NIH (USA). Stanford University and PATH Development by Bharat Biotech International Limited (Hyderabad, India)

  14. Indian Rotavirus Vaccines in Pipeline • Bharat Biotech Limited:Has plans to develop a Rotavirus vaccine “Rotavac”, priced at only USD1 in collaboration with GAVI and DBT. • Sanofi Pasteur (Shantha Biotech):In collaboration with PATH, coming up with Rotavirus vaccines.

  15. Asian Rotavirus Surveillance Network Involves 14 countries in collaboration with WHO, PATH and CDC (Atlanta). Source: Vaccine 2009; 27S: F1-F5

  16. Hib Vaccines

  17. Hib Vaccines • Polysaccharide Vaccine • The first Hib vaccine licensed was a pure polysaccharide vaccine, first marketed in the US in 1985 • Conjugate Vaccine: The shortcomings of the polysaccharide vaccine led to the production of the Hib polysaccharide-protein conjugate vaccine. Attaching Hib polysaccharide to a protein carrier greatly increased the ability of the immune system of young children to recognize the polysaccharide and develop immunity. • Hib conjugate vaccines have been effective against all manifestations of Hib disease, with a clinical efficacy between 95-100%.

  18. Hib Combo Vaccines • Multiple combinations of Hib and other vaccines have been licensed in the United States, reducing the number of shots necessary to vaccinate a child. Hib vaccine combined with diphtheria-tetanus-pertussis-polio vaccines and Hepatitis B vaccines are available in the US. The World Health Organization (WHO) has certified several Hib vaccine combinations, including a pentavalentDTP+HBsAg+Hib combos for use in developing countries. • Vaccine under development at Bharat Biotech Limited.

  19. Indian Hib Vaccine Manufacturers • Serum Institute of India • Pentavalent Combo of DTP+HBsAg+Hib • Date of WHO prequalification: September 22, 2010. • Sanofi Pasteur (Shantha Biotech) • Shan5 – A pentavalent Combo of DTP+HBsAg+Hib • Issues with Shan5: Facing Vaccine Quality issues regarding physical appearance reported to WHO by Colombia, Comoros, and Nepal ⇨ No AEFI reported so far ⇨ However, Shan5 likely to be removed from the list of WHO prequalified vaccines if corrective measures are not instituted within 2 months.

  20. Indian Hib Vaccine Manufacturers • Panacea Biotec • Easy five - Pentavalent Combo of DTP+HBsAg+Hib • Issues with Easyfive:During site audit (27 June-1 July 2011) at Lalru, Panacea failed to meet the quality requirements for WHO prequalification ⇨ As per the recommendations of the ad hoc Committee, Easyfive has be delisted from the WHO prequalified list of vaccines.

  21. H1N1 Vaccines

  22. H1N1 Vaccine Manufacturers India • Serum Institute of India • NASOVAC - Human, Live Attenuated Pandemic (H1N1) (Freeze-Dried). • Sanofi Pasteur • VAXIGRIP -Split virion inactivated H1N1 vaccine (Susp. for Injection). • Influenza virus, split, inactivated, containing antigens equivalent to: A/New Caledonia/20/99 (H1N1) like strain; A/Fujian/411/2002 (H3N2) like strain; B/Shanghai/361/2002 like strain • ZydusCadila • Vaxiflu-S – Single-shot H1N1 vaccine created from a strain obtained from WHO. • Costs only INR 350. • Cadila Biopharmaceuticals • H1N1 vaccine developed using Virus-like particle (VLP) platform.

  23. H1N1+Seasonal Flu Combo Vaccine Chiron Panacea Vaccines • Agrippal– Injectable vaccine that offers dual protection against H1N1 and seasonal flu virus. • Agrippal is a single-shot vial (0.5 ml), and costs INR 390. • A dose of 0.25 ml is advised for children < 3 years. • A dose of 0.5ml is advised for adults.

  24. Vaccines for Pneumonia

  25. Pneumonia Vaccines • Prevnar • Heptavalent vaccine, manufactured by Wyeth. In the USA, vaccination with Prevnar is recommended for all children <2 years, and for unvaccinated children (24-59 months) at high risk for pneumococcal infections. • Synflorix • Decavalent vaccine, produced by GSK. Contains 10 serotypes of pneumococcus (1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F), conjugated to a carrier protein. • Synflorix received a positive opinion from the European Medicines Agency for use in the EU in January 2009. • GSK received European Commission authorization to market Synflorix in March 2009.

  26. Pneumonia Vaccines • Prevnar 13 • A 13-valent vaccine produced by Pfizer. • Contains 13 serotypes of pneumococcus (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F), conjugated to a carrier protein. • Prevnar 13 was approved by the US-FDA on February 24, 2010. • It is to be given on the same schedule as was Prevnar.

  27. Vaccines from Serum Institute of India • M-VAC • Live attenuated measles virus (Edmonston Zagreb Strain) propagated on Human Diploid Cells. • SII Measles Vaccine (M-VAC™) fulfils the relevant requirements of WHO. • Meningitis A, Y, C, W-13 QuadrivalentVaccine • Pneumococcal Polysaccharide and Conjugate Vaccine

  28. Major Recommendations • Institutional Capacity and Framework • Mapping of research capacity and networking. • Creation of Bio-repositories. • Need to strengthen Public-Private-Partnerships. • Need for initiatives for product development for public health emergencies. • Vaccine Quality Regulatory System • Laboratory testing of vaccine for QC and QA. • Fast-track clearance of vaccines needed for emergencies. • Clinical trials of vaccines as per GCP. • Strengthening and streamlining IPR and Tech Transfer.

  29. Major Recommendations • Vaccine Production and Supply • Need for financial sustainability plan (FSP) for immunization. • Creation of expanded vaccine fund through innovative financing mechanism. • Vaccine Introduction in UIP • Indentifying vaccines of local relevance. • Setting criteria for selection of vaccines e.g. Grades of Recommendation Assessment, Development and Evaluation (GRADE) System. • Role of the National Technical Advisory Group on Immunization (NTAGI) in the decision-making process.

  30. Major Recommendations • Operational Efficiency of UIP • Improving vaccine coverage • Robust AEFI and VPD Surveillance System • Vaccine forecasting, procurement and management • Accountability for vaccine wastage • Management of the cold-chain • Stockpiling vaccines for disasters/outbreaks • Management of Human Resources • Advocacy and Communication • Ethics and Equity – Need for ethical use and equitable access to vaccines

  31. Innovation

  32. Open Synthesis and Exchange of Knowledge Candidate Targets Lead Molecules Drug PRECLINICAL & CLINICAL TRIAL in silico SCREENING in vivo VALIDATION Mycobacterium tuberculosis Wiki Portal Contract Research Organisations Academia & Hospitals Exchange of Ideas/Results Community Participation Open Source Drug Discovery (OSDD) Model “Team India Consortium with International Participation” Some partner organizations Lead Organization Current Partners Council of Scientific and Industrial Research (CSIR), India

  33. OSDD: Many Eyeballs make the Bug Shallow Public Funding of Clinical Trials

  34. Status: OSDD Projects 18 Other projects aim to develop tools, databases and repositories for the OSDD community 19 9 6 2

  35. Affordable Healthcare for All OSDD : A Global Community - 4511 members from more than 130 countries

  36. Collaborations, Partnerships and Networks

  37. Mapping Exercises are a pre-requisite for establishing networks…

  38. WHO/TDR Project: Mapping of Products R&D Landscape in Drugs, Diagnostics and Vaccines in India

  39. Brief Outline of the Project • Mapping of the product R&D landscape for infectious diseases of public health importance in India through literature surveys, and internet/database searches. • The Mapping included the following: • Cover R&D activities in the area of drugs, diagnostics and vaccines for infectious tropical diseases. • b. Identify gaps and opportunities for product innovation in India. • c. Create a database of institutions (public and private) with relevant R&D capacity for discovery and development and manufacturing. • Create a database of available resources including technologies, pathogen strains, screening assays as well as potential regional funding sources that could support such regional efforts. The link of the database in the form of web portal: http://www.indiandi.org

  40. Mapping Outline Questionnaire Administration to Organizations Associated with R&D / Manufacture of DRUGS, DIAGNOSTICS and VACCINES PUBLIC SECTOR PRIVATE SECTOR 9 Diseases Targeted as per TDR Mandate: Malaria, TB, HIV-AIDS, Dengue, Filariasis, Leprosy, Leishmaniasis, Helminthiasis, STDs

  41. Diagnostics: Examples of Information Gathered Genomix Molecular Diagnostics (P) Ltd, Hyderabad, (A.P) is developing and testing POC instrumentation for Lateral Flow and Isothermal PCR (LAMP) assays for Malaria, Dengue, Chikungunya etc. Also, developing antibody Lateral Flow assays for Taeniasis and cysticercosis in collaboration with Dr. Patricia Wilkins, CDC, USA PCR (900 gm) Machine Lateral Flow Machine

  42. Example of Malaria Diagnostic Development by National Institute of Malaria Research, Banagalore

  43. Diagnostics: Challenges • India is an endemic country for several Infectious diseases. • Diagnostics is still unavailable for some of the diseases. • Evaluation is a problem. • Lack of networking among investigators. • Lack of platform technology development, a change visible in recent times. • Kits and chips also were not in sight earlier, which are coming up now. • Insufficient Industry-Academia partnership. • Hurdles in IP procedure.

  44. Diagnostics: Gaps and Roadblocks • As identified from the inputs collected from the Principal Investigators: • Finance. • Infrastructure. • Reagents. • More basic research for neglected tropical diseases. • Inability to differentiate between active and latent disease or active disease vs. contacts. • Not enough clinical samples. • Lack of containment facilities. • Lack of human resources. • Quality assurance. • Limited option for test validation. • Inaccessibility to good quality validated panels of sera. • Imported kits, chips, reagents make diagnostics costly.

  45. MAPPING OF DRUGS

  46. Drugs: Gaps and Roadblocks • Gaps and roadblocks, as perceived by respondents from Academia : • Lack of manpower. • Lack of funding. • Lack of infrastructure. • Neglect of some diseases over others.

  47. Vaccine Manufacturing in India Vaccine manufacturers from India started the journey by manufacturing EPI vaccine, a niche created by exit of few multinationals from the area. But they have gone a long way after that … WHO prequalification regulations getting more stringent. Older public sector units have been converted to testing centers. New manufacturers have entered the scene. Few have done very well .

  48. An Example: Serum Institute of India Limited, Pune New Concepts New Products • Aerosol measles vaccine • In phase III clinical trials • Acellular Pertussis vaccine • Ready for preclinical studies • Rotavirus vaccine • Ready for preclinical studies • Pandemic influenza vaccine • In development • Liposomal vaccines • For simplifying the vaccinedelivery • Liposomal anticancer products • Conjugated therapeutic proteins • To increase the half life of the products

  49. Meningitis Vaccine Project • Created in 2001 as a partnership between WHO and PATH • Affordable pricethroughinnovative international partnerships PROJECT STATUS • Phase I clinical trials completed • Phase II clinical trials completed: Vaccine is highly immunogenic • Phase III clinical trials started in Mali, Senegal and India in 1Q 2010 • Applied for WHO prequalification

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