SLV-LMI 11 Mar 08 1 Erfaringer fra et firma – muligheter for og utfordringer ved samarbeid...
-
Upload
georgiana-bryant -
Category
Documents
-
view
225 -
download
2
Transcript of SLV-LMI 11 Mar 08 1 Erfaringer fra et firma – muligheter for og utfordringer ved samarbeid...
1SLV-LMI 11 Mar 08
Erfaringer fra et firma – muligheter for og utfordringer ved samarbeid
…..med myndigheter? …… firmaer imellom?
Tone VeitebergVP QA & Regulatory Affairs
Clavis Pharma
2SLV-LMI 11 Mar 08
Presentation
Clavis Pharma overview
What is an SME?
Collaboration & other interactions
Experience • Authorities - Companies• Company - Company
Future opportunities
3SLV-LMI 11 Mar 08
Clavis Pharma at a GlanceOslo-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
NeoMed MVM
Norsk Hydro
2001 2002> 10 years of basic research& substantial investments
Life Science Venture Funds
2005
Braganza
2006
IPO
4SLV-LMI 11 Mar 08
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
5SLV-LMI 11 Mar 08
Pipeline in other disease areas
Clavis PharmaDrug Candidate
Parent Drug Feasibility Preclinical Clinical Phase I Clinical Phase II
ELACYT solid tumor (iv)Melanoma
Colorectal CancerAdditional PhII in
planning
ELACYT hematology (iv)Leukemia
ELACYT oral
CytarabineCYTOSAR™
CP-4126 solid tumors (iv)All comers
CP-4126 oral
GemcitabineGEMZAR™
CP-4200 (iv) Not disclosed
Exploratory compounds various
ViralCP-4010CP-4018
acyclovirgancyclovir
InflammatoryCP-4112CP-4114
betamethasonprednisolon
+ library of more than 250 additional LVT compounds
Development choices
6SLV-LMI 11 Mar 08
Extensive outsourcing network20 employees +> 160 external specialists working on Clavis products today.
7SLV-LMI 11 Mar 08
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 €
8SLV-LMI 11 Mar 08
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: • ???
9SLV-LMI 11 Mar 08
Collaboration & Other interactions
10SLV-LMI 11 Mar 08
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,…..)
11SLV-LMI 11 Mar 08
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
12SLV-LMI 11 Mar 08
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?
13SLV-LMI 11 Mar 08
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
14SLV-LMI 11 Mar 08
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
15SLV-LMI 11 Mar 08
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
16SLV-LMI 11 Mar 08
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
17SLV-LMI 11 Mar 08
Balancing
Speed
Economy Quality