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Introduction to Diamond Pharma Services

Introduction to Diamond Pharma Services. Diamond Pharma Services. April 2009. Diamond Group. Diamond Pharma Services is a provider of technical services that conforms to latest EU standards, supporting the scientific activities of pharmaceutical and biotechnology companies

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Introduction to Diamond Pharma Services

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  1. Introduction toDiamond Pharma Services

  2. Diamond Pharma Services April 2009

  3. Diamond Group • Diamond Pharma Services is a provider of technical services that conforms to latest EU standards, supporting the scientific activities of pharmaceutical and biotechnology companies • Regulatory Affairs • Pharmacovigilance & Medical Information • Quality & Compliance • Diamond Pharma Services founded in 2005 • Managing Director - Maureen Graham • 15 employees • Head Office in Harlow, UK • good connections to London Airports • Stansted (20 min), London City (30), Luton (45), Heathrow (60) • close to Central London • Liverpool St Station (30 min), connection to London Underground

  4. Chronology Oct-05 Regulatory Diamond BioPharm Ltd May-06 PIL Testing Diamond Clear PILS Ltd Feb-07 Quality Diamond Compliance Ltd Jun-07 Pharmacovigilance Diamond PV Services Ltd

  5. RegulatoryAffairs

  6. Regulatory Affairs • High-quality EU consultancy • Experts – Biotech and Centralised MAAs; Scientific Advice Meetings • Additional resource - in the EU but which require additional resources • Non-EU companies – unfamiliar with European systems and legislation • Virtual companies – out-sourced regulatory department • Supplementary Services • PIL User Tests • High quality, and compliant with EU guidelines • Conducted in UK, and with reports written in English • eCTD Templates • EU distributor for StartingPoint documents (EU guidelines) • eCTD Publishing • Implementation project ongoing - available from August 2009

  7. Regulatory Affairs • Typical client relationships • Manage Centralised Procedures (SME status) • Scientific Advice Meeting planning, preparation and leadership • IMPD/CTA planning and application • EU Reg Affairs function – small, biotech and non-EU companies • PIL User tests • MA applicant and sponsor • POM to P switches • Orphan Drug applications • Assist other forms of MA applications (DCP, MRP, National) • Due diligence – dossiers and MAs • MA variations

  8. PV

  9. Pharmacovigilance • What is Pharmacovigilance? • Constant assessment of the safety profile of drug products and medical devices to ensure risk-benefit profile is appropriate • not all side-effects are seen during drug trials (e.g. thalidomide) • Governing Law • EU Volume 9A – Marketed Products • EU Volume 10 – Products Undergoing Clinical Trials • MEDDEV 2.12-1 rev 5 – Medical Devices • What does it mean for pharma companies in EU? • Risk Management Programmes for clinical trials - incl Biostudies • Monitor Adverse Event information for marketed products • Submit regular safety reports to Health Authorities - PSUR/ASR • Provide PV training to staff who may interface with customers • MAAs must include PV management process (module 1.8.1)

  10. Pharmacovigilance • Flexible PV Solutions • Out-source – PV & Med Info for smaller companies • Efficiency – when out-sourcing is more cost-effective • Typical client relationships • 24-hour PV and Med Info service • Electronic reporting using in-house ARISg database • PV for EU companies with no direct presence in UK & Ireland • Literature Search and ASPR reviews • Periodic Safety Reports (PSURs, ASRs) • Audit in-house PV systems, and prepare corrective action plan • PV training

  11. Diamond PV PV Process Complaint / Enquiry Customers Client Adverse Events Complaint / Enquiry Query handling Signal Detection PV Summary/Downloads ICSRs & PSURs Product Alerts ASPR Summaries Literature Health Authority

  12. Compliance

  13. Compliance • EU Compliance Experts • Resources - additional Quality support • Audits – GMP, GCP and GLP • Typical client relationships • contract QP service • quality systems reviews (EU cGMP compliance) • training services for GMP, GCP and GLP • Independent audits of third party API facilities • study monitoring for GCP and GLP compliance • due diligence – sites and systems

  14. ManagementTeam

  15. Diamond Pharma Services Management Team • Maureen Graham – Regulatory • Managing Director, Diamond BioPharm Limited • Miranda Tasko – Pharmacovigilance • Managing Director, Diamond PV Limited • Geoff Ansell – Quality & Compliance • Managing Director, Diamond Compliance Limited • Rupert Mason – Physician • Medical Director, supports all DPS divisions

  16. Regulatory Affairs Maureen GrahamPhD BSc (Hons) Dip Reg Affs MRPharmS FTOPRA • Founded Diamond BioPharm Limited in Oct 2005 • Qualified pharmacist, with PhD in Pharmaceutical Sciences • 26 years experience in pharma industry • Niche GenericsRegulatory Affairs Director 2y • AmgenDirector, European Reg Affairs 5y • Norton HealthcareRegulatory Affairs Director 4y • MSD Regulatory Affairs Manager 9y • GSK Senior Registration Officer 3y

  17. Pharmacovigilance Miranda TaskoBSc (Hons) MSR • Joined Diamond in Aug 2007 • Qualified radiographer • 11 years experience in pharma industry • Schering-Plough Training & Quality Mgr, European PV 2y • PPD Senior Scientist, European PV 1y • RocheDrug Safety Specialist, Global Drug Devt 6y • Early career as diagnostic radiographer in hospitals

  18. Quality & Compliance Geoff AnsellBPharm MSc MRPharmS FRSM MTOPRA Qualified Person • Joined Diamond in Feb 2007 • Qualified pharmacist, with MSc in Biopharmaceutics • 30+ years experience in pharma industry • Niche Generics*Technical Director,Devt and Quality 6y • Sanofi Winthrop*Technical Director, Devt & Quality 1y • Norton Healthcare*Director of Quality Assurance 13y • MCA(now MHRA) Pharmaceutical Assessor 4y • Beechams Formulation Devt/Regulatory Affairs 7y *Qualified Person for respective companies

  19. Clear PILs Rupert MasonMB BS, LRCP, MRCS, Dipl RCOG • Joined Diamond in May 2006 • Qualified as a Medical Practitioner • 19 years experience in pharma industry • Ind. Consultant Medical & Pharmaceutical Advisor 7y • BioglanCSO & Board Member 12y • Bedford HospitalClinical Assistant, Dermatology 12y* • GP Principal Baldock, Hertfordshire 13y • GP Auckland, New Zealand 2y *part-time role during period with Bioglan

  20. Summary

  21. Client Mapping Pharmacovigilance Compliance Regulatory &Clear PILs

  22. Diamond Pharma Services Our focus is “Quality of Service” Diamond aims to be a cut above the rest The goal of extracting the greatest beauty from a Diamond, is to have light enter a Diamond, disperse the light as it bounces inside the Diamond, thereby producing the different prismatic colours and brilliance, finally returning as much light to the eye as possible.

  23. Summary Drug Safety Quality Diamond PV Services Limited Diamond Compliance Limited Product Devt Plans (GCP) DiamondPharmaServices Pharmacovigilance Medical Information Service (24 hour) Compliance Training (GxP) Auditing & SOPs Contract QP PV Training Site Audits Regulatory Diamond BioPharm Limited Gene Therapy Pharma eCTD PIL User Tests Biotech

  24. Thank You Diamond Pharma Services Gemini House Flex Meadow Harlow Essex CM19 5TJ United Kingdom +44 (0)1279 441616 www.diamondpharmaservices.com

  25. Glossary AE – Adverse Event ASR – Annual Safety Report … like PSUR, but for products undergoing CTs CT – Clinical Trial CTA – Clinical Trial Application DCP – Decentralised Procedure EU – European Union … comprises of 27 countries GCP – Good Clinical Practice GLP – Good Laboratory Practice GMP – Good Manufacturing Practice IMPD – Investigational Medicinal Product Dossier … for “first in man” studies M&A – Mergers and Acquisitions MA – Marketing Authorisation MAA – Marketing Authorisation Application MRP – Mutual Recognition Procedure PIL – Patient Information Leaflet PSUR – Periodic Safety Update Report PV – Pharmacovigilance QP – Qualified Person RA – Regulatory Affairs

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