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

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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 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

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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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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

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Extensive outsourcing network20 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 Quality