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Biopharmaceuticals Industry –Role of the Irish Medicines Board             Dublin, 31 October 2012                Pat O’Ma...
Agenda        •     Overview of biopharmaceuticals today.        •     IMB’s role in regulation of biopharmaceuticals.    ...
Biopharmaceuticals:     An exciting history & future      DNA molecule       DNA molecule            Harris &             ...
Biotechnology is complex       Many patients’ needs have been served due to advances in       biopharmaceutical manufactur...
Key influences on pharma industry         •      More competitive                business environment         •      More ...
Competitive business environment       Manufacturing operations will be more efficient in the future        •     Improved...
Challenging reimbursement rules        •     Budgetary challenges that bring about tough decisions.        •       Heath t...
Challenging regulatory requirements        •     Stringent requirements for pre-clinical and clinical studies.        •   ...
Biosimilars        •     Biosimilar medicines are generic versions of other              biological medicines that have be...
Biosimilars authorised in EEA                                  5                                  4                       ...
IMB’s role        •     First and foremost, protection of public and animal              health.        •     Staffing and...
IMB’s role in Biopharmaceuticals (1/2)        •     Regulator of lrish based pharma industry totalling 84              med...
IMB’s role in Biopharmaceuticals (2/2)        •     IMB’s Strategic Objectives relating to Industry:               – Impro...
Stakeholder engagement        •     All biopharmaceuticals subject to centralised system              managed by EMA – Eur...
Facilitation of clinical trials       •     Clinical trials process streamlined incl.              – Removal of duplicatio...
Involvement in EMA and ICH processes        •     Consistently strong contributor as rapp/co-rapp in              centrali...
Pharmacovigilance – Updated requirements        •     Vitally important to monitor safety and efficacy of              bio...
EMA Management Board        •     Member and Former Chair        •     Optimisation of centralised processes        •     ...
Heads of Medicines Agencies (HMA)        •     Coherent approach across Member State agencies.        •     Focus on patie...
International Summit        •     Informal to date        •     Global regulators        •     Focus on common problems / ...
Conclusion       •     The IMB wants to ensure patient safety through scientific             rigour.       •     The IMB a...
Thank you!Global BioPharma Summit 2012 - Pat OMahony, IMB                Slide 22/22
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Pat O'Mahony, Chief Executive, Irish Medicines Board

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Biopharmaceuticals Industry - Role of the Irish Medicines Board

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Pat O'Mahony, Chief Executive, Irish Medicines Board

  1. 1. Biopharmaceuticals Industry –Role of the Irish Medicines Board Dublin, 31 October 2012 Pat O’Mahony Chief Executive, Irish Medicines Board Slide 1/22
  2. 2. Agenda • Overview of biopharmaceuticals today. • IMB’s role in regulation of biopharmaceuticals. • IMB’s approach nationally and internationally.Global BioPharma Summit 2012 - Pat OMahony, IMB Slide 2/22
  3. 3. Biopharmaceuticals: An exciting history & future DNA molecule DNA molecule Harris & Harris & Cohen & First First Human Human Stem cell deciphered by deciphered by Watkins fuse Watkins fuse Boyer genetic genetic Genome Genome applications Watson & Watson & mouse and mouse and reproduce markers for markers for Project Project Crick. Crick. human cells human cells DNA disease found disease found Gene in bacteria Development Development therapy Enzyme Enzyme Automatic Automatic Yeast genes Recombinant Recombinant of of involved in involved in protein protein are human insulin human insulin leading leading ATMPs the synthesis the synthesis sequencer is sequencer is expressed in Biotech Biotech of nucleic acid of nucleic acid perfected perfected E. coli bacteria Commercial Commercial products products isolated isolated Biotech Biotech companies companies formed formed 1950s 1960s 1970s 1980s 1990s → TodayGlobal BioPharma Summit 2012 - Pat OMahony, IMB Slide 3/22
  4. 4. Biotechnology is complex Many patients’ needs have been served due to advances in biopharmaceutical manufacturing Biopharmaceuticals are complex and expensive to develop and manufacture Consequently the products are costlyGlobal BioPharma Summit 2012 - Pat OMahony, IMB Slide 4/22
  5. 5. Key influences on pharma industry • More competitive business environment • More challenging reimbursement rules • More onerous regulatory requirements • Patent expiryGlobal BioPharma Summit 2012 - Pat OMahony, IMB Slide 5/22
  6. 6. Competitive business environment Manufacturing operations will be more efficient in the future • Improved process control with process analytical technology (PAT) • Higher process yields • Greater flexibility with equipment • Better utilisation of capital • Significant reduction in operating costsGlobal BioPharma Summit 2012 - Pat OMahony, IMB Slide 6/22
  7. 7. Challenging reimbursement rules • Budgetary challenges that bring about tough decisions. • Heath technology assessment (HTA) challenges. • The growing number of biologic medicines for cancer therapy and other chronic conditions represents a major challenge for any cost containment measures.Global BioPharma Summit 2012 - Pat OMahony, IMB Slide 7/22
  8. 8. Challenging regulatory requirements • Stringent requirements for pre-clinical and clinical studies. • Rigorous definition of the manufacturing process for regulatory submission. • Authorisation via centralised procedure. • Meeting ongoing regulatory expectations: – dossier updates, – GMP requirements, – PhV commitments.Global BioPharma Summit 2012 - Pat OMahony, IMB Slide 8/22
  9. 9. Biosimilars • Biosimilar medicines are generic versions of other biological medicines that have been authorised • Biosimilars can only be authorised for use once the period of data exclusivity on the original reference biological medicine has expired • 1st biosimilar authorised in EEA in April 2006: somatropin • No. authorised to date: 12Global BioPharma Summit 2012 - Pat OMahony, IMB Slide 9/22
  10. 10. Biosimilars authorised in EEA 5 4 3 2 1 0 2006 2007 2008 2009 2010 2011 2012 • Molecules: somatropin, epoetin alfa, filgrastim, epoetin zetaGlobal BioPharma Summit 2012 - Pat OMahony, IMB Slide 10/22
  11. 11. IMB’s role • First and foremost, protection of public and animal health. • Staffing and processes directed towards achieving this. • Also, focus on timely completion of regulatory activities, whatever the outcome for the applicant. • Being competent authority for medical devices an advantage for combination products.Global BioPharma Summit 2012 - Pat OMahony, IMB Slide 11/22
  12. 12. IMB’s role in Biopharmaceuticals (1/2) • Regulator of lrish based pharma industry totalling 84 medicines manufacturers & supervisory authority for large number of foreign manufacturing sites. • Biopharma industry sector in Ireland has been growing since late 1990s; – 11 authorised manufacturing sites – 2 new facilities in the commissioning stages • IMB fosters proactive engagement with new companies establishing in Ireland to review plans and clarify GMP requirements.Global BioPharma Summit 2012 - Pat OMahony, IMB Slide 12/22
  13. 13. IMB’s role in Biopharmaceuticals (2/2) • IMB’s Strategic Objectives relating to Industry: – Improve service delivery within a high quality, risk- based regulatory framework; – Extend the use of risk-based and proportionate regulation. • IMB an active participant in initiatives to avoid duplication of inspections in third-countries and assists in developing tools to identify high risk sites and triggered inspections to make best use of resources.Global BioPharma Summit 2012 - Pat OMahony, IMB Slide 13/22
  14. 14. Stakeholder engagement • All biopharmaceuticals subject to centralised system managed by EMA – European process. • IMB involved in scientific advice. • Meetings with applicants / interested companies. • Nationally, regular Information Days. • Communications policy includes contributions to undergraduate and other training courses, incl. NIBRT. • Molecular Medicine Ireland on translational research.Global BioPharma Summit 2012 - Pat OMahony, IMB Slide 14/22
  15. 15. Facilitation of clinical trials • Clinical trials process streamlined incl. – Removal of duplication with role of ethics committees. – Predictable timelines. – Meet sponsors prior to Advanced Therapy Medicinal Product (ATMP) trials. – Access to specific expertise on clinical trials sub- committee and outside, where necessary. – Risk based GCP inspections to evaluate subject safety and data integrity.Global BioPharma Summit 2012 - Pat OMahony, IMB Slide 15/22
  16. 16. Involvement in EMA and ICH processes • Consistently strong contributor as rapp/co-rapp in centralised procedures. • Strong contributor at Committees and Working Parties, including development of guidelines. • Long-term involvement in ICH harmonisation activities.Global BioPharma Summit 2012 - Pat OMahony, IMB Slide 16/22
  17. 17. Pharmacovigilance – Updated requirements • Vitally important to monitor safety and efficacy of biopharmaceuticals through their life cycles. • Pharmacovigilance Risk Assessment Committee (PRAC) now operational. • Vice-Chair from the IMB.Global BioPharma Summit 2012 - Pat OMahony, IMB Slide 17/22
  18. 18. EMA Management Board • Member and Former Chair • Optimisation of centralised processes • Increasing co-operation with key regulators globally • Convergence of guidelines • Pilot joint assessments & inspectionsGlobal BioPharma Summit 2012 - Pat OMahony, IMB Slide 18/22
  19. 19. Heads of Medicines Agencies (HMA) • Coherent approach across Member State agencies. • Focus on patient safety and streamlining processes to minimise duplication. • Focus also on facilitating conduct of R & D in Europe, e.g. Clinical Trials Facilitation Group. • Closer working relationship with Competent Authorities for Medical Devices (CAMD).Global BioPharma Summit 2012 - Pat OMahony, IMB Slide 19/22
  20. 20. International Summit • Informal to date • Global regulators • Focus on common problems / challenges • Convergence in assessment and inspection requirements • Sharing of resources • Mutual reliance in future?Global BioPharma Summit 2012 - Pat OMahony, IMB Slide 20/22
  21. 21. Conclusion • The IMB wants to ensure patient safety through scientific rigour. • The IMB also wants to ensure patients have the possibility of treatment with innovative medicines via – open dialogue with applicants and manufacturers, – predictable timelines, – being an effective contributor at European and global levels.Global BioPharma Summit 2012 - Pat OMahony, IMB Slide 21/22
  22. 22. Thank you!Global BioPharma Summit 2012 - Pat OMahony, IMB Slide 22/22

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