Introduction to Diamond Pharma Services

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
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 Graham PhD 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 Generics Regulatory Affairs Director 2y
• Amgen Director, European Reg Affairs 5y
• Norton Healthcare Regulatory Affairs Director 4y
• MSD Regulatory Affairs Manager 9y
• GSK Senior Registration Officer 3y

17
Pharmacovigilance

• Miranda Tasko BSc (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
• Roche Drug Safety Specialist, Global Drug
  Devt 6y
• Early career as diagnostic radiographer in
  hospitals

18
Quality Compliance

• Geoff Ansell BPharm 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 Mason MB 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
• Bioglan CSO Board Member 12y
• Bedford Hospital Clinical 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
Compliance
Pharmacovigilance
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
Quality
Drug Safety
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
Pharma
PIL User Tests
eCTD
Gene Therapy
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
• MA 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