Indian association of lady vets presentation


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this presentation was made in the all india seminar of lady vets association in bangalore

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  • Clinical Trials In clinical trials teams of physicians carry out studies designed to determine if the drug is safe in people and an effective treatment for the disease in question. Of the 250 compounds that enter preclinical testing, only five will make it this far. There are three phases of clinical trials: Phase I: The medicine is tested in a small group (20-100) of healthy volunteers - often in a hospital setting - to determine its safety profile, including the safe dose range. Pharmacokinetic studies examine how a drug is absorbed, distributed, metabolized and excreted, as well as the duration of its action. Phase I studies can take from six months to one year to complete. Phase II: Placebo-controlled trials involving approximately 100 to 500 volunteer patients who have the disease being studied. The goal of this phase is to establish the "proof of concept" - i.e., the medicine effectively treats the disease. Researchers continue to evaluate the drug's safety and look for side effects, and determine optimal dose strength and schedule (e.g., once or twice daily). Phase II studies can take from six months from one year to complete. Phase III: The medicine is tested in large, randomized, placebo-controlled trials with much larger numbers of patient volunteers - from 1,000 to 5,000, in hospitals, clinics and/or physician offices - to generate statistically significant data. Researchers closely monitor patients at regular interviews to confirm that the drug is effective and identify side effects (also called adverse events). Phase III studies can take from one to four years to complete, depending on the disease, length of the study, and the number of volunteers. While Phase I-III studies are taking place, researchers are also conducting a number of crucial parallel studies: toxicity tests and other long-term safety evaluations; dosage forms; plans for full-scale production; package design; and preparation of the complex application required for FDA approval. Back to top New Drug Application (NDA) Once all three phases of the clinical trials are complete, a company analyzes all of the data. If the findings demonstrate that the experimental medicine is both safe and effective, the company files an NDA with the U.S. Food and Drug Administration (FDA). NDAs typically run 100,000 pages or longer, just one illustration of the extensive testing a medicine must go through in order to gain FDA approval. They contain all of the information about all of the studies - including preclinical testing, all clinical trials, dosing information, manufacturing details and proposed labeling for the new medicine. Back to top FDA Review/Approval In this final stage, the FDA scientists review all the results from all the studies carried out over the years and determine if they show that the medicine is safe and effective enough to be approved. Depending on the medicine or disease in question, the FDA sometimes convenes an Advisory Committee meeting. These independent panels of experts, appointed by the FDA, consider data presented by company representatives and FDA reviewers. Committees then vote on whether the FDA should approve an application, and under what conditions. The FDA is not required to follow the recommendations of the advisory committees, but they often do. If the medicine is approved, or "cleared for marketing," it becomes available for physicians and patients. It took an average of 16.9 months for the FDA to review each medicine it approved in 2003. The proportion of rejected applications has remained constant over the years at about 10% to 15%. Back to top Manufacturing Following the R&D, and approval stages, manufacturers must build infrastructure and design processes to mass produce the drugs. Construction of manufacturing facilities often has to wait until very late in the research and development process because manufacturers can?t be sure if a particular drug will be approved. If manufacturers choose to use existing facilities, they often need to perform renovations or cut back or eliminate production of other drugs. Engineers and chemists scale-up the fabrication process from the research laboratory level to a mass production level in order to meet the global demand. This process is challenging; facilities must meet strict FDA inspection criteria for Good Manufacturing Practices to ensure high quality control of the product. Once built, the production facilities employ hundreds of highly skilled workers, including engineers, chemists, and quality control technicians. Even the most basic tasks require a more highly trained and technically savvy worker than most other manufacturing industries. Back to top Ongoing Studies Even after approval, the studies and observation continue. A much bigger group of patients may begin to use a medicine upon approval compared with the thousands of patients in clinical trials and in this larger scale rare side effects may occur, so companies must continue to monitor the drug carefully. The FDA requires them to continue to submit periodic reports, including any cases of adverse events (side effects or complications). Sometimes, the FDA requires a company to conduct additional studies. Known as Phase IV or "post-marketing" studies, they evaluate long-term safety or generate more data about how the medicine affects a particular group of patients (e.g., children or the elderly). Phase IV studies can continue for years; one study can cost between $20-30 million. Depending on the findings, a company can use the studies to submit a Supplemental NDA, seeking additional indications for the medicine. Source:
  • Indian association of lady vets presentation

    1. 2. Rudolf Virchow <ul><li>“Between animal and human medicine there is no dividing line, nor should there be” </li></ul>
    2. 3. Post patent era : An update & role of lady vets in it Dr (Capt) Tanweer Alam
    3. 4. Indian Pharma Market
    4. 5. Evolution of patent laws in India.. <ul><li>Western style patent regulation and recognized </li></ul><ul><li>majorly product patent </li></ul>. (Upto 1970) <ul><li>Foreign companies prospered well with over 90% </li></ul><ul><li>of IPI market share and 80% of ownership </li></ul><ul><li>Heavy dependency on import of bulk drugs </li></ul><ul><li>and formulations </li></ul>
    5. 6. Evolution of patent laws in India.. <ul><li>New drugs were available cheaply and import got </li></ul><ul><li>substituted with reverse engineered drugs by local companies </li></ul>Introduction of DPCO Indian Patent Act 1970, which recognized process patent (1970-2005) Two major steps of Indian Govt <ul><li>Foreign ownership decreased to just 36% in 1995 as </li></ul><ul><li>compared to 80% in pre 70’ period </li></ul>
    6. 7. Evolution of patent laws in India.. <ul><li>Patent mandated to the inventor for 20 years </li></ul><ul><li>Amendment in 1970 Patent Act to introduce </li></ul><ul><li>product patenting in three sectors </li></ul>(Jan 2005) Pharma Agro-chemicals and Food
    7. 8. Present Impact of New Patent Era <ul><li>Impetus on </li></ul><ul><li>NCE research </li></ul>
    8. 9. 2003 1975 1987 $138 $318 $802 $115 $318 $802
    9. 11. Pharmaceutical Research and Development (R & D) Process Definitions IND = Investigational New Drug Application FDA = U.S. Food and Drug Administration NDA = New Drug Application Source:
    10. 12. Economics of Pharmaceutical Intellectual Property (IP) Best Case Patent Filing Marketing Authorisation Granted Exclusivity Period (~11.5 Years) Elapsed Time (8.5+ Years) ?
    11. 13. <ul><li>1. Indian pharmaceutical industry is now poised to take full advantage of the size they have achieved with the help of process patents </li></ul><ul><li>2. India is a huge market with </li></ul><ul><li>(I) a high intellectual capital and capable work-force </li></ul><ul><li>(II) low cost of drug development and clinical trials </li></ul>Opportunities include:
    12. 14. Present Impact of New Patent Era <ul><li>New drug </li></ul><ul><li>introduction </li></ul>
    13. 15. <ul><li>Organizations are confidently investing in </li></ul><ul><li>hard core research for NCEs </li></ul>Present Impact of New Patent Era
    14. 16. Present Impact of New Patent Era Consolidation effort in R&D activities <ul><li>In 2003, licensing deals contributed to 20% of </li></ul><ul><li>total sales and set to increase to 40% by 2009. </li></ul>For many, it is a biz model as well <ul><li>Contract Research in drug discovery and clinical trials </li></ul>
    15. 17. Present Impact of New Patent Era Still, the focus is on generics … Two prong Global Market Domestic Market
    16. 18. Till 1995 1995-2005 2005 onwards <ul><li>Generic version of branded products already off patent before 95 </li></ul><ul><li>Generic version developed for branded products patented before 95 </li></ul><ul><li>Generic versions of the branded drugs patented between 1995 and 2005 </li></ul><ul><li>Generic versions of the branded drugs patented after 2005 </li></ul>
    17. 19. Present Impact of New Patent Era No major impact on pricing
    18. 20. <ul><li>Still a vast Global market Vs Indian market gap </li></ul><ul><li>Phyto-chemical based research works in full throttle </li></ul>Present Impact of New Patent Era On herbal segment…
    19. 21. New Approach of Herbal Drug Development Ethno-medical information Selection and standardization of in vitro assays Validation of safety and efficacy using in vivo models Marketing <ul><li>Screening program </li></ul><ul><li>Select plants </li></ul><ul><li>Select plant parts </li></ul><ul><li>Select solvent </li></ul>Bioactivity guided fractionation Development of prototype formulation (Based on compatibility studies) Standardization and Chemical fingerprinting
    20. 22. Indian Vet Pharma – Post patent Era Indian Vet Pharma Post patent Era <ul><li>DOMESTIC FORMULATIONS </li></ul><ul><li>IPR Regime </li></ul><ul><li>Likely to witness higher growth </li></ul><ul><li>In Licensing </li></ul><ul><li>GENERICS BUSINESS </li></ul><ul><li>Increasing competitive landscape </li></ul><ul><li>Pricing pressure </li></ul><ul><li>Aggressive build up of products </li></ul><ul><li>Acquisitions </li></ul><ul><li>Export potentiality </li></ul><ul><li>CONTRACT MANUFACTURING </li></ul><ul><li>JV/ Alliances </li></ul><ul><li>INDIGENOUS R&D </li></ul><ul><li>NDDS/NCE/ANDA </li></ul><ul><li>Out Licensing </li></ul><ul><li>High Investment </li></ul>
    21. 23. % % % Gender gap in patenting… 1 1.4 1.5 1.7 2.8 * HARVARD GAZETTE ARCHIVES
    22. 24. Patenting Procedure… <ul><li>Patent search </li></ul><ul><li>Confirming the patentability of the claim </li></ul><ul><li>(i) Novelty (ii) Inventiveness (Non-obviousness) (iii) Usefulness </li></ul><ul><li>Patent filing with requisite fee followed by request for examining the patent </li></ul><ul><li>Opposition,sealing & granting of patent </li></ul><ul><li>Patent protection </li></ul><ul><li>International patenting </li></ul>
    23. 25. Opportunities for Lady Scientists <ul><li>CRO </li></ul><ul><li>Bioinformatics, Regulatory Affairs , IPR field </li></ul><ul><li>R&D – key driving area for all organisations </li></ul><ul><li>Patent Attorney consultants </li></ul>
    24. 26. [email_address] 09341263965