2015 Dashboard of Pharmaceutical & Biologics Regulatory Sciences
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The document summarizes a presentation on the pharmaceutical regulatory science landscape in 2015. It discusses: 1) Changes and emerging trends in regulatory sciences, including increased globalization and harmonization efforts. 2) Quality metrics and using data to understand industry performance and identify issues. 3) Shifting business models, including more outsourcing and the need for continuous quality improvements. 4) Ensuring data integrity and addressing challenges like lack of integrity raising doubts about safety.
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2015 Dashboard of Pharmaceutical & Biologics Regulatory Sciences
- 1. Dash Board of 2015 Pharmaceutical & Biologic Regulatory Science’s Review
- 2. Obaid Ali & Roohi B. Obaid, Pharmaceutical & Biological Regulatory Sciences Forum 26 Dec 2015, Karachi Dash Board of 2015 Pharmaceutical Regulatory Science’s Review
- 3. Learn, De-learn & Re-learn
- 4. Not the view of DRAP Current judgment of speaker No obligation on DRAP Regulatory experience It has nothing to do with any specific commercial product It is just a knowledge sharing exercise nothing more than that D I S C L A I M E R
- 5. Background Review of Regulatory Sciences Changes & Emerging shape of Regulatory Sciences Discussion, Case Studies & Explanation
- 6. Relative Scale of Concerns N G B S E Q S E Q QES
- 8. Background Review of Regulatory Sciences Changes & Emerging shape of Regulatory Sciences Discussion, Case Studies & Explanation
- 12. International Generic Drugs Regulator Pilot
- 13. Collaboration Convergence Regulatory Mandate Increased work load Globalization Scientific complexity
- 14. Mutual Reliance Work sharing Efficient use of Resource Faster review Greater availability Generics
- 17. Background Review of Regulatory Sciences Changes & Emerging shape of Regulatory Sciences Discussion, Case Studies & Explanation
- 19. Integrity Regulatory violations Contamination Particles Good Manufacturing Practices & Products
- 20. Culture of Quality Drug Shortage Program
- 22. UBER?
- 25. Quality Metrics (Russell Wesdyk, Acting Director for the Office of Surveillance, OPQ, CDER, FDA How is industry performing? Who & what is out there? Do we understand our industry? What should Regulatory Authority do when they show up at the site? Can we sum up what we have with data & transfer that data into knowledge?
- 26. Quality Metrics (Russell Wesdyk, Acting Director for the Office of Surveillance, OPQ, CDER, FDA More information is better than less information
- 27. Business Model Shifting (Monika Cahilli, Green Mountain Quality Assurance) Increased Outsourcing Paper Tiger does not always work Management needs to be fully engaged in Quality Agreements Feedback mechanism for Control Strategy Continuous review of electronic data
- 28. How many data points are involved to support the release of one product? Learn to embrace in perfection in order to accept residual risk Business Model Shifting (Monika Cahilli, Green Mountain Quality Assurance)
- 29. Data Integrity (Douglas Starn, Director Enforcement & Import Operations, FDA) Integrity & Fraud are mostly close Lack of integrity at one area raise question about others Ability to assure safety & efficacy is doubtful Data accountability is the only tool
- 30. Data integrity issues are not always easy to see and thus difficult to remediate It is better to be safe than sorry…proper control can prevent and limit data integrity issues Data Integrity (Douglas Starn, Director Enforcement & Import Operations, FDA)
- 31. Quality & Innovations are linked (Lisa Zboril, Vice President Regulatory Affairs, Pfizer) Product lifecycle … what occurs in manufacturing & how reflected in submission Quality submission is planning, control & continuous improvement Early planning to target product profile and label requirement Regular communication of uncertainties
- 32. Continuous improvements include regulatory intelligence, deficiency tracking, lessons learned & scientific rigor of data In generic world, the key to success is being efficient, timely and accurate Quality & Innovations are linked (Lisa Zboril, Vice President Regulatory Affairs, Pfizer)
- 33. Make the reviewer excited that they are getting an application from you Quality & Innovations are linked (Ted Sherwood, Acting Director, Office of Regulatory Operations, FDA)
- 34. Background Review of Regulatory Sciences Changes & Emerging shape of Regulatory Sciences Discussion, Case Studies & Explanation
- 35. Proposed Product Manufacturing Classification System Right particle Best process Difficult API Good API Ref: Lilly, GSK ……….
- 36. Highly Soluble & Highly Permeable Highly Soluble & Less Permeable Low Soluble & Highly Permeable Less Soluble & Less Permeable BCS
- 40. Direct Compression Grind drug Intra- granular excipients Granulation Wet Screen DryingDry Screen Extra- granular excipient Compression
- 41. Evolving shape of Biopharmaceuticals Regulatory PoliticalLegislative Science of Risk
- 42. Regulatory Oversight Production Quality Reducing shortage Facilitating development Price, Value, Innovation
- 43. Breakthrough Life saving therapy is being coming Hepat itis C Cholesterol lowering agents Cance r drugs Rare disease therapies 2014 41 new drugs 10 biologics
- 44. 2015 1st Bio-similar approval in US Zarxio from Sandoz Over 50 applications are in pipeline Quick response on Ebola A beautiful collaborative demonstration of different organizations & countries to combat deadly virus
- 45. Quality remains a Challenge Predictable & timely approval Reduced inspection burden Quality Metrics on way Smart & Progressive vision Able to detect quality problems before they occur
- 46. Changes Evolved • CMC from pre-clinical/clinical through review to post approval changes & generic drug development Changes in Review • Continue to oversee innovators and biosimilars Biotechnological Products • Quality aspect during development & approvalNew drug product • Post-marketing changes & generic drug developmentLifecycle • Manufacturing operation, microbiology review & preapproval inspection Collaborative Oversight
- 47. Adoption of a Risk based Model Target oversight where quality failures are most likely to harm patients Product Facilities Process
- 48. Footprints of knowledge is in your backyard to navigate you … Example Elemental impurities Ref: Pharmaceutical Technology, March 2015, Andrew Teasdale et al.
- 49. Drug Product DS Excipients EquipmentUtilities Container Closure Footprints of knowledge is in your backyard to navigate you …
- 50. Drug Substance Inorganic reagents Organic material Processing aids Equipment Metal catalysts Water & Solvents Container Closure Footprints of knowledge is in your backyard to navigate you …
- 51. Excipients 1. Mind (Talc) 2. Metal catalysts (Mannitol) 3. Plant origin (cellulose) 4. Animal origin (lactulose) 5. Without metal catalysts (colloidal SiO2) Footprints of knowledge is in your backyard to navigate you …
- 52. Limited solubility in DP & limited interaction but High metal content in packaging Highest risk (high conc. of metal in packaging; high degree of interaction b/w packaging & DP) Lowest risk (low conc. of metal in packaging; limited interaction b/w packaging & DP) Good solubility in DP, intimate contact, but low metal content in packaging From Packaging MetalContentinPackaging Metal solubility in product R I S K I N P A C K A G I N G Footprints of knowledge is in your backyard to navigate you …
- 53. Security of internal supply chain Control of vendor elemental impurity specifications & elemental impurity reporting on ingredient COA Security of external supply chain + a quality history for each vendor Audit history Level of complaints Recall etc. PRIOR KNOWLEDGE IS THE WAY TO MOVE FORWARD Footprints of knowledge is in your backyard to navigate you …
- 55. Industry & Regulatory Agencies on Global Watch Lifecycle data management & Quality System Innovative strategies to meet timeframes Global framework & collaborations to secure supply chain Drug development & Drug Pricing battle Controversy on strategies & Science Scale Modernization in Manufacturing & Quality Initiatives Efficient generic drug review regulatory framework Policies to enhance drug safety & security Reference Jill Wechsler, 2015
- 56. Lifecycle data management & Quality System Alteration in System, Formulation & Test Method Variation submission Costly & time consuming Regulatory & Post approval changes Developing International Quality Standards Integrations Review, Inspection & Surveillance
- 57. Innovative strategies to meet timeframes Expedite development & approval of innovative drug Quick results of reviews Innovative risk mitigation strategies Less stability data at submission Accepting amendment during the review process Increased post- marketing commitment Early decision for dosage form Early decision for method validation strategies before time
- 58. Global Framework & Collaborations to secure supply Storm of counterfeit & adulterated drugs Over 2000 incidences of pharmaceutical crime reported in 2014 Theft, counterfeiting, diversions, illegal drug websites Aggressive & collaborative actions June 2015 operation Pangea VIII by Interpole Poor quality medicines SSFFC (Substandard, Spurious, Falsely Labeled, Falsified & Counterfeit)
- 59. Drug Development & Drug Pricing battle Costing Therapeutic value Free economy Innovation Fee Liability Profit
- 60. Controversy on Strategies & Science Scale Quality Metrics Overworking Increased burden Reduced inspection Reduced regulatory burden on post approval Slow move
- 61. Modernization in Manufacturing & Quality Initiatives More powers of inspection Recall power New Inspection approach Unannounced inspection Tougher inspections Disregarding the delaying, denying, limiting or refusing of inspections
- 62. Efficient Generic Drug Review Regulatory Framework API focus Inspections Quality & Complaints
- 63. Policies to enhance Drug Safety & Security Meningitis outbreak IV Compounding Contamination Microbial Penicillin Standardization
- 65. Aseptic processing proven safe but not sterile IncreasedseparationofPersonnel Increased confidence in Sterility Assurance Manual aseptic fill Conventional aseptic fill Barrier System Open RABS Closed RABS Open Gloved Isolator Closed Glove Isolator Glove-less Isolator
- 66. Warm up
- 67. Inhalation of a non-sterile product (Ribavirin powder for solution) with microbial contamination …. What is harm?
- 68. Inhalation of a non-sterile product (Ribavirin powder for solution) with microbial contamination …. What is harm? Increase risk of respiratory infection Patients are usually immuno-compromised and more susceptible to infection
- 69. Inhalation of a non-sterile product (Ribavirin powder for solution) with microbial contamination …. What is harm? Increase risk of respiratory infection Patients are usually immuno-compromised and more susceptible to infection RECALL (Virazole Expiry date: Oct 2018) Valeant Pharmaceuticals, USA
- 70. If you want to go fast, go alone If you want to go far, go together
- 71. Thanks