Pharma Regulatory & licensing Service


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Pharma Regulatory & licensing Service

  1. 1. Pharma Regulatory & licensing Service<br />Business.<br />A.Vikram Sathish<br />
  2. 2.
  3. 3. Indian companies have recently focused a lot on R&D in the pharmaceutical sector. <br /><ul><li>Many companies now spend 8% or more of revenues on research.
  4. 4. Many pharma companies are now actively targeting international companies for contract research and manufacturing (CRAM) deals.
  5. 5. Medicinal chemistry, custom synthesis, and clinical studies are some areas in which Indian firms are pitching and winning new business. </li></li></ul><li>
  6. 6. The global pharmaceutical outsourcing market was worth USD57.2 billion in 2007. <br />It is expected to grow at a CAGR of 10% to reach USD76 billion by 2010. <br />Global market for Contract Research and Manufacturing Services <br />(CRAMS) in 2007 is USD55.48 bn. <br />Out of the total global CRAMS market, <br />Contract research wasUSD16.58 bn,<br />growing at a CAGR of 13.8% and <br />Contract manufacturing was USD38.89 bn <br />accounting for themajor share (approximately 68%) of the total global pharmaceutical outsourcing market.<br />
  7. 7. Indian pharma outsourcing market <br />was valued at USD1.27m in 2007 and is expected to reach USD3.33 bn by 2010, growing at a CAGR of 37.6%. <br />The Indian CRAMS market stood at USD1.21 bn in 2007, and is estimated to reach USD3.16 bn by 2010.<br />
  8. 8. SCOPE<br />Pharmaceutical companies increasingly outsource to third parties to save money, speed up processes and get products into the market quicker.<br />Outsourcing allows companies to focus on their core competency areas and expedite the entire process.<br />In Asia pacific, large biopharmaceutical companies outsource to their local and regional partners. <br />CRO&apos;s (Contract Research Organizations) move up the value chain with the desire to serve only few global customers rather than diversify in different areas. <br />Additionally, they are slowly converting into SMO&apos;s (Site Management Organizations), where protocol development and monitoring takes place in addition to R&D.<br />
  9. 9. APIs<br />Discovery<br />Chemistry<br />Formulations<br />Advanced<br />Intermediates<br />Process<br />R&D<br />Outsourcing Business Space<br />Range of Services<br />From Clinical quantities to Commercial scale<br />
  10. 10. Business Space<br />Discovery Chemistry<br />Process R& D<br />Pipeline Intermediates<br />Matured Intermediates<br />BIG <br />PHARMA<br />Pipeline API’s<br />Matured API’s<br />Dosage Development<br />Commercial Drug Product<br />Discovery Chemistry<br />Process R& D<br />EMERGING <br />PHARMA<br />Pipeline Intermediates<br />Matured Intermediates<br />Pipeline API’s<br />Dosage Development<br />FINE <br />CHEMICAL<br />COMPANIES<br />Pipeline & Matured Intermediates<br />
  11. 11. Global Pharmaceutical Outsourcing Opportunity <br />Estimated Potential Market:<br />Packaging/<br />Assembly <br />Dosage <br />Form<br />Produc-<br />tion<br />Dosage <br />Form<br />Develop-<br />ment<br />Drug <br />Substance<br />Produc-<br />tion<br />Process<br />Develop-<br />ment<br />Clinical<br />Develop-<br />ment <br />Pre- <br />clinical<br />Develop-<br />ment<br />Discovery<br />Research<br />Pharmaceutical <br />R&D<br />Drug Substance<br />Supply<br />Formulated Drug <br />Supply<br />30-35<br />~50<br />60-80<br />(in $ bn)<br />Current share of outsourcing in defined Contract R&D/Manufacturing space is around ~$35 bn<br />Source: Dow Report, AD Little, Cardinal Health<br />
  12. 12. Changing Face of Industry<br /><ul><li> Declining R&D output & high costs continue to pose challenges to profitability
  13. 13. Blockbuster drug launches expected to drop from 14 in ’03 to 4 in ’08
  14. 14. Drug Product Withdrawls (Vioxx) and safety concerns (Crestor)
  15. 15. By ’08 patent expirations will account for $ 72 bn in current sales</li></ul>Leading to<br />Global Outsourcing<br />DRIVERS<br />Cost<br />Increase Productivity<br />Speed up New product <br /> Development<br />D. Expand skills & capabilities<br />Source: AT Kearney Report<br />
  16. 16. Changing Face of Industry<br /><ul><li>Declining R&D output & high costs continue to pose challenges to profitability
  17. 17. Blockbuster drug launches expected to drop from 14 in ’03 to 4 in ’08
  18. 18. Drug Product Withdrawls (Vioxx) and safety concerns (Crestor)
  19. 19. By ’08 patent expirations will account for $ 72 bn in current sales</li></ul>Leading to<br />Global Outsourcing<br />DRIVERS<br />Cost<br />Increase Productivity<br />Speed up New product <br /> Development<br />D. Expand skills & capabilities<br />Source: AT Kearney Report<br />
  20. 20. Facts & Figures - INDIA<br />Highest number of FDA approved plants outside USA<br />Largely English speaking workforce<br />IT capital of the world<br />Democracy of 1 billion<br />TRIP compliant<br />UK based legal system<br />Structured and reasonably transparent financial markets & banking system<br />Dependent on oil for energy<br />Well entrenched entrepreneurial culture & developed private sector <br />Superior education level<br />Infra-structure in need of development<br />Largest market-share in generic API production<br />Export & Western oriented<br />Economic growth in terms of GDP just slightly behind China<br />
  21. 21. Changed IP Scenario in India<br /><ul><li>Global standards followed on IPM
  22. 22. CDAs, MoUs, Non-Use Agreements, etc – routinely implemented
  23. 23. Work ethics & “Need-to-know” work practices
  24. 24. Employee Contracts & Employee retention mechanisms
  25. 25. Legal provisions & remedies available</li></ul>Cheap Source of <br />intermediates<br />Qualified API source<br />And <br />Efficient Process<br />R&D Resource<br />India is now being looked at as a reliable source<br />across the value chain in pharmaceutical industry<br />
  26. 26. India Advantage / Disadvantage<br />Advantages<br />Cost<br />Flexibility<br />Speed<br /><ul><li> Language
  27. 27. Chemistry, Engineering, Regulatory & QA experience, Dosage expertise
  28. 28. Manufacturing Infrastructure</li></ul>Disadvantages<br /><ul><li> Capability in Niche Segments (Ex. Controlled Substances)
  29. 29. Communication
  30. 30. Emotional blocks (Ex. Compliance, Generic Challenges etc)</li></li></ul><li>Medicinal Chemistry<br />CMC Development<br />Formulation & Development<br />Operational Issues & Focus<br /><ul><li>Track record
  31. 31. Expertise
  32. 32. QESH Compliance
  33. 33. Capacity
  34. 34. Commercial scale
  35. 35. Scope for scale-up
  36. 36. Analytical
  37. 37. Sourcing
  38. 38. Lead times
  39. 39. Stick to timing
  40. 40. cGMP
  41. 41. IP Security
  42. 42. Skill
  43. 43. Technologies
  44. 44. Communication</li></li></ul><li>Causes for negative experiences<br />Provider specific issues:<br /><ul><li>Environmental issues; license to operate
  45. 45. Asset reliability
  46. 46. Quality issues
  47. 47. “Yes” means, I will do whatever I can, “No” is culturally impolite
  48. 48. Communication Issues </li></li></ul><li>Key Elements for Pharma Business<br />PRODUCT INDUSTRY<br />SERVICE INDUSTRY<br />DIFFERENTIATORS<br /><ul><li> Innovation First to Market
  49. 49. Cost
  50. 50. Quality
  51. 51. Geographical Reach</li></ul>DIFFERENTIATORS<br />Speed<br /><ul><li>Delivery Quality</li></ul> Cost<br /> Frequency<br /><ul><li>Communication Transparency</li></ul> Quality<br /><ul><li> Trustworthiness
  52. 52. Flexibility
  53. 53. Customer Delight</li></ul>.. Favor India as destination<br />
  54. 54. Choosing the Right Partner in India; <br />a Selection Model<br />QUALIFIERS<br />DIFFERENTIATORS<br /><ul><li>Global Interests
  55. 55. Ownership pattern
  56. 56. Regulatory Compliance
  57. 57. Financial Stability
  58. 58. Understanding IP
  59. 59. Reporting compliant
  60. 60. Capability & Infrastructure
  61. 61. Speed
  62. 62. Costs
  63. 63. Communication
  64. 64. Project Management
  65. 65. Track Record
  66. 66. Understanding the </li></ul> West<br /><ul><li> Staff Quality</li></ul>Final Partner<br />
  67. 67. Discovery<br />Chemistry<br />Formulations<br />Advanced<br />Intermediates<br />APIs<br /> Process<br /> R&D <br />Changing Paradigm<br />Range of Services<br />From Clinical quantities to Commercial scale<br />Outsourcing services + <br />In License the product for <br />Indian & Asian Markets <br />Indian Companies are <br />positioning <br />themselves as partners to <br />Innovator companies<br />
  68. 68. India’s Conclusion of Strengths…<br />Speed<br />Competitive Pricing<br />Full cGMP<br />…combining the best of both worlds<br />
  69. 69.
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  71. 71.
  72. 72.
  73. 73.
  74. 74. Channel <br />Partner<br />Advt’s<br />
  75. 75.
  76. 76. Consulting <br />Partner’s<br />
  77. 77. Growth = More<br />
  78. 78.
  79. 79. Business Development ConsultingOur consulting activities consist of:- Support in business development- Organizing meetings- Developing the commercial approach for a new product or company- Co-founding new business based on promising new technology<br />
  80. 80.
  81. 81. Regulatory Services consulting<br /><ul><li>Complete database for dossier requirements
  82. 82. Quick dossier compilation
  83. 83. Draft pre-formulation, BMR, MFR, process validation, method validation, dissolution and stability studies documents
  84. 84. Clinical and non-clinical overviews
  85. 85. Justification for fixed dose combination
  86. 86. Prepare Summary of product (SmPC) and Pack Information Leaflet (PIL)
  87. 87. Prepare label and carton contents 
  88. 88. Reply to MOH queries
  89. 89. Product registration assistance
  90. 90. Product development assistance
  91. 91. Global Patent Information
  92. 92. Literature for patented product
  93. 93. Non-infringing process</li></li></ul><li>Regulatory Complaiance services <br /><ul><li>CGMP / Quality System Auditing
  94. 94. Internal GMP Audit
  95. 95. Analytical Laboratory Audit
  96. 96. Quality System Design & Management
  97. 97. Stability Program Design / Implementation
  98. 98. Regulatory Submission Preparation for </li></ul>Drug Master File (DMF) in CTD <br />Certificate of Suitability (COS) Dossiers in CTD <br /><ul><li>Standard Operating Procedure (SOP) Development
  99. 99. Revised Schedule 'M' , WHO - GMP, US-FDA,UK-MHRA , Australia - TGA , PIC/s etc. implementation </li></li></ul><li>Regulatory Affairs services<br />we offer the following services:<br /><ul><li>Technical Data Package for APIs and Intermediates
  100. 100. Drug Master Files for APIs and Intermediates in CTD format or Country specific Requirements
  101. 101. COS/CEP Filing
  102. 102. Drug Product Dossiers
  103. 103. Site Accreditation
  104. 104. Site Registration
  105. 105. Product Registration
  106. 106. Check List for Regulatory Audits</li></li></ul><li>Product Registration & Audit <br /><ul><li>CGMP / Quality System Auditing
  107. 107. Internal GMP Audit
  108. 108. Analytical Laboratory Audit
  109. 109. Quality System Design & Management
  110. 110. Stability Program Design / Implementation
  111. 111. Regulatory Submission Preparation (Product Dossier) for the following :
  112. 112. European Union (EU) - EMEA Guidelines
  113. 113. Ministry of Health - Cambodia
  114. 114. Ministry of Health - Ghana
  115. 115. Ministry of Health - Myanmar
  116. 116. Ministry of Health - Nigeria
  117. 117. Ministry of Health - Slovakia
  118. 118. Ministry of Health - Sudan
  119. 119. Ministry of Health - Ukraine
  120. 120. Ministry of Health - Vietnam       and many more........
  121. 121. Standard Operating Procedure (SOP) Development Revised Schedule 'M' , WHO - GMP , PIC/s , TGA etc. Implementation . </li></li></ul><li>Product &Process Development<br /><ul><li>Formulation Development
  122. 122. Excipient / Ingredient Selection
  123. 123. Analytical Methods Development
  124. 124. Product Development Report Writing
  125. 125. Manufacturing Process Development & Assessment
  126. 126. Process Optimization and Validation
  127. 127. Manufacturing Scale - Up
  128. 128. SOP Development
  129. 129. Technical Report Writing
  130. 130. All work is done at reasonable cost </li></li></ul><li>Technical dossier Prepartaion<br />our own databank & sources to compile ,edit and create technical dossier on various new and old Bulk drugs & Drug intermediates.<br />Each technical dossier consists of the following details : <br /><ul><li>Drug details : CAS No., ATC Code, Chemical name, Molecular formula, Chemical structure, Nomenclature(s), Licensor, Indication(s), Action , Therapeutic class.
  131. 131. Synthesis scheme.
  132. 132. Drug characterisation (by UV,FTIR,NMR, DSC etc.)
  133. 133. Physico-chemical properties.
  134. 134. Analytical methodology.
  135. 135. Impurity Profile.
  136. 136. Patent abstract details. </li></li></ul><li>Quality Assurance services<br /><ul><li>WSite Master File Preparation
  137. 137. Validation e offer the following services:
  138. 138. Master Plan Preparation
  139. 139. Quality Manual Preparation
  140. 140. Facility Validation
  141. 141. Process Equipment Qualification
  142. 142. HVAC/AHU System Validation
  143. 143. Water System Validation
  144. 144. Blending Validation
  145. 145. Micronisation Validation
  146. 146. Process Validation
  147. 147. Cleaning Validation
  148. 148. Standard Operating Procedures
  149. 149. Documentation as per GMP regulations
  150. 150. GMP Audits
  151. 151. Check lists for Regulatory Audits
  152. 152. Annual Product Review
  153. 153. GMP Training Programmes
  154. 154. Preparation of Product Manuals </li></li></ul><li>Quality Control services<br />We offer following services:<br /><ul><li>Quality Control Department Establishment as per GMP requirement
  155. 155. Specification and Analytical Procedure Development
  156. 156. Standard Operating Procedures
  157. 157. Instrument Logbook as per GMP requirements
  158. 158. Instrument Qualification
  159. 159. Stability Study Protocols
  160. 160. Preparation of Calibration Planner
  161. 161. Preparation Stability Study Schedule
  162. 162. Documentation as per GMP regulations
  163. 163. Test Protocols as per GMP requirements </li></li></ul><li>Partnering Search<br />Our Partnering Search offers advanced and enhanced partnering support.<br />Actively working for you, our service enables you to utilize our knowledge and expertise.<br />A fully comprehensive solution designed to complement your existing business developement activities.<br />As part of the service:<br />Based on your brief, our partnering experts will search for partners on your behalf and provide a fully qualified list of target companies (Prospect List)<br />On your instruction they will contact target companies on your behalf to make introduction and coordinate initial contact/conference call etc (Hot List)<br />
  164. 164. Company profiles<br />Our profiling service maximizes your potential of finding the most suitable partner for your opportunities by targeting our focused global business development and licensing audience.<br />Pharma licensing Service provides potential partners from all around the world. Whether you are looking to in- or out-license, your profile allows interested parties to contact you directly with solutions that match your needs.<br />post detailed information about company and its business development strategy,In- or out-licensing opportunities, or services, Fully categorised listings by sector, therapeutic target and disease<br />
  165. 165. Partner Identification<br />comprehensive consultancy services to support your partnering activities.<br />Our unique service provides you with all of the elements of the licensing process whilst also enabling you to minimize the time and costs associated with it.<br />Fitting around your timescale and needs, we work with you as you move through the individual elements of licensing at your own pace.This flexible approach ensures you remain in control as you progress from initial groundwork, through partner identification, to negotiating and closing the deal.<br />
  166. 166. Partner Introduction<br />Our partner introduction service helps you to progress from a list of companies into active discussions. Following initial review we will, where necessary, work with you to write or improve your non-confidential dossier. This then forms the basis of our initial approach and presentation to potential partners. Building on these initial approaches we arrange meetings for you to take negotiations further.<br />We work predominantly on a success fee basis; however the initial upfront fee will vary depending on the status of your non-confidential dossier at initial approach. It is vital that we represent you with the best possible offering to potential partners and will work closely with you to ensure this.<br />
  167. 167. Partnership for <br />Due Diligence Execution<br />with Panel team partnership We are proud to offer comprehensive Service for Due Diligence Execution.<br />For the first online research company and has access to a global network of professionals experienced in assessing Intellectual Property ,product, Process & Facility acquisition for clients including top tier pharmaceutical and biotechnology companies.<br />.<br />
  168. 168. Representation & Deal Closure<br />We provide you with a named industry expert who is on hand to support and guide you at any time as you move forward with your deal negotiations. Offering you as much or as little assistance as you require, we bring experience of many successful deals to the table to guide your negotiations as they move through to closure.<br />All work is to pre-agreed contractual terms, which are heavily biased towards success payments.<br />
  169. 169. Thank You <br />Vikram Sathish.A<br />Director -Marketing &Sales<br />Tri Inpharmex Services Pvt.Ltd<br />