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Erfaringer fra et firma – muligheter for og utfordringer ved samarbeid …..med myndigheter? …… firmaer imellom? Tone Veiteberg VP QA & Regulatory Affairs Clavis Pharma SLV-LMI 11 Mar 08 1 Presentation Clavis Pharma overview What is an SME? Collaboration & other interactions Experience • Authorities - Companies • Company - Company Future opportunities SLV-LMI 11 Mar 08 2 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 SLV-LMI 11 Mar 08 2001 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 SLV-LMI 11 Mar 08 4 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 SLV-LMI 11 Mar 08 5 Extensive outsourcing network 20 employees + > 160 external specialists working on Clavis products today. SLV-LMI 11 Mar 08 6 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 € SLV-LMI 11 Mar 08 7 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: • ??? SLV-LMI 11 Mar 08 8 Collaboration & Other interactions SLV-LMI 11 Mar 08 9 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,…..) SLV-LMI 11 Mar 08 10 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 SLV-LMI 11 Mar 08 11 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? SLV-LMI 11 Mar 08 12 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 SLV-LMI 11 Mar 08 13 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 SLV-LMI 11 Mar 08 14 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 SLV-LMI 11 Mar 08 15 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 SLV-LMI 11 Mar 08 16 Balancing Speed Economy SLV-LMI 11 Mar 08 Quality 17