Transcript muligheter for og utfordringer ved samarbeid

Erfaringer fra et firma
– muligheter for og utfordringer ved samarbeid
…..med myndigheter?
…… firmaer imellom?
Tone Veiteberg
VP QA & Regulatory Affairs
Clavis Pharma
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1
Presentation
Clavis Pharma overview
What is an SME?
Collaboration & other interactions
Experience
• Authorities - Companies
• Company - Company
Future opportunities
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Clavis Pharma at a Glance
Oslo-based pharmaceutical company developing new, improved drugs
based on well-established drugs with room for improvement
Patented Lipid Vector Technology (LVT) enables a series of new drug
candidates
Primary focus on cancer therapy
March 2008: 20 employees
Life Science Venture Funds
NeoMed
MVM
Braganza
2002
2005
IPO
Norsk Hydro
> 10 years of basic research
& substantial investments
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2006
3
Business Model
Develop selected oncology drug candidates through
Clinical Phase I – II. Seek partners for Clinical
Phase II-III
Consider partnering out other selected drug candidates at
an earlier developmental stage.
Collaborate with Pharma/Biotech companies for the
development of LVT derivatives of their compounds
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Development choices
Clavis Pharma
Drug Candidate
Parent Drug
ELACYT solid tumor (iv)
Melanoma
Colorectal Cancer
Additional PhII in planning
ELACYT hematology (iv)
Leukemia
ELACYT oral
Cytarabine
CYTOSAR™
CP-4126 solid tumors (iv)
All comers
CP-4126 oral
Gemcitabine
GEMZAR™
CP-4200 (iv)
Not disclosed
Exploratory compounds
various
Feasibility
Preclinical
Clinical Phase I
Clinical Phase II
Pipeline in other disease areas
Viral
CP-4010
CP-4018
acyclovir
gancyclovir
Inflammatory
CP-4112
CP-4114
betamethason
prednisolon
+ library of more than 250 additional LVT compounds
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Extensive outsourcing network
20 employees +
> 160 external specialists working on Clavis products today.
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Micro, Small or Medium sized Enterprise?
246 companies located in 21 countries
across EEA (Feb 08)
7 Norwegian based SMEs (Dec 07)
Headcount
Annual turnover
Annual balance
sheet
Medium - sized
< 250
≤ 50 mill €
≤ 43 mill €
Small
< 50
≤ 10 mill €
≤ 10 mill €
Micro
< 10
≤ 2 mill €
≤ 2 mill €
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Declaration of SME status
Fast, non-bureaucratic process
• Application (in English) to EMEA 28 Sep 2006
Annual report + Declaration + Company certificate
• Qualification as a SME 30 Oct 2006
Annual renewal
Pros:
•
•
•
•
Informal guidance to legislation, format of applications, etc.
Easy access to EMEA assessors
Fee reductions
..…
Cons:
• ???
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Collaboration & Other interactions
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Interactions with authorities
SME office at EMEA, London
• Workshops
• Attendance at pre-submission meetings
• Informal communication (E-mails, phone calls)
SAWP at EMEA, London
• Scientific Advice/Protocol Assistance
Food & Drug Administration (FDA)
• Guidance per email
• Formal meetings/tcons (preIND, EOP1, EOP2, preNDA)
National agencies
• Norwegian Medicines Agency (NMA)
• Other institutional bodies in Norway (REK, Datatilsynet, SHDir..)
• Other national regulatory agencies (MHRA/UK, MPA/S,…..)
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SLV - a collaborative partner for the industry?
YES!
Examples:
Interpretation of legislation and guidelines
•
•
•
•
Design of preclinical studies
Timing of CTAs
Transfer of manufacturing
Content and format of applications/individual documents
Interpretation of Compendia
• Ph. Eur.
National ”Scientific Advice”
• Prior to a CTA
• During drug development
• Initiation of a second formulation
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Collaboration with other companies
Are we always competitors?
Win – win or one winner and one looser?
Possible to save time and resources and get a better
result?
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Topics of interest?
Development of a Quality Management System
• Which SOPs should be given priority
• Reasonable requirements?
Licence according to Personal Data Act (Datatilsynet)
Contract Research Organisations (CROs)
• Small, medium-sized or large?
Clinical Trial Applications
• Topics of particular interest at the authorities
• Real timelines
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Further topics of interest?
Compliance of procedures
• Preparing for intenal revisions
• Preparing for an inspection by an agency
• Preparing for an audit of a common supplier
Collaboration with CROs
• Contracts
• Day to day follow up business (DM, monitoring, PhVigillance)
• Audits
Biobank
• Application
• Annual reporting of a general biobank
Archiving systems
• Paper based vs electronic archiving
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Future opportunities (1)
Exchange of information/update from conferences
and/or use of procedures
• DIA annual meetings (Europe, USA)
• Stability testing of API, IMP and MP
• Scientific Advice by SAWP or national agencies
Insurance of patients in clinical trials
QP Association initiative
• GMP audit database for shared audits
• Identification of suppliers of excipients and APIs
• Share cost and resources by third party auditing
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Future opportunities (2)
ICH Q8, Q9 and Q10
New for the companies AND for the authorities
•
•
•
•
Pharmaceutical development
Quality by Design (QbD)
Quality Risk Management
Pharmaceutical Quality Systems
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Balancing
Speed
Economy
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Quality
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