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Dublin, 31 October 2012

Pat O’MahonyChief Executive, Irish Medicines Board

Biopharmaceuticals Industry –Role of the Irish Medicines Board

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Agenda

• Overview of biopharmaceuticals today.

• IMB’s role in regulation of biopharmaceuticals.

• IMB’s approach nationally and internationally.

Global BioPharma Summit 2012 - Pat O'Mahony, IMB

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DNA moleculedeciphered by Watson & Crick.

Enzymeinvolved in the synthesis of nucleic acid isolated

Harris &Watkins fusemouse andhuman cells

Automaticproteinsequencer isperfected

Cohen & Boyerreproduce DNAin bacteriaYeast genes areexpressed inE. coli bacteria

First geneticmarkers fordisease found

Recombinanthuman insulin

CommercialBiotech companiesformed

Human GenomeProject

Development ofleadingBiotechproducts

Stem cellapplications

Gene therapy

ATMPs

1950s 1960s 1970s 1980s 1990s → Today

Biopharmaceuticals:An exciting history & future

Global BioPharma Summit 2012 - Pat O'Mahony, IMB

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Many patients’ needs have been served due to advances in biopharmaceutical manufacturing

Biopharmaceuticals are complex and expensive to develop and manufactureConsequently the products are costly

Biotechnology is complex

Global BioPharma Summit 2012 - Pat O'Mahony, IMB

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• More competitive business environment

• More challenging reimbursement rules

• More onerous regulatory requirements

• Patent expiry

Key influences on pharma industry

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Manufacturing operations will be more efficient in the future

Competitive business environment

• Improved process control with process analytical technology (PAT)

• Higher process yields

• Greater flexibility with equipment

• Better utilisation of capital

• Significant reduction in operating costs

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• 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.

Challenging reimbursement rules

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• 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.

Challenging regulatory requirements

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• 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: 12

Biosimilars

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0

1

2

3

4

5

2006 2007 2008 2009 2010 2011 2012

Biosimilars authorised in EEA

• Molecules: somatropin, epoetin alfa, filgrastim, epoetin zeta

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• 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.

IMB’s role

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• 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.

IMB’s role in Biopharmaceuticals (1/2)

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• 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.

IMB’s role in Biopharmaceuticals (2/2)

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• 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.

Stakeholder engagement

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• 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.

Facilitation of clinical trials

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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.

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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.

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• Member and Former Chair

• Optimisation of centralised processes

• Increasing co-operation with key regulators globally

• Convergence of guidelines

• Pilot joint assessments & inspections

EMA Management Board

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• 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).

Heads of Medicines Agencies (HMA)

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• Informal to date

• Global regulators

• Focus on common problems / challenges

• Convergence in assessment and inspection requirements

• Sharing of resources

• Mutual reliance in future?

International Summit

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• The IMB wants to ensure patient safety through scientific rigour.

• The IMB also wants to ensure patients have the possibility of treatment with innovative medicinesvia– open dialogue with applicants and manufacturers,– predictable timelines,– being an effective contributor at European and global

levels.

Conclusion

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Thank you!

Global BioPharma Summit 2012 - Pat O'Mahony, IMB