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NerPharMa Nerviano Contract Development & Manufacturing Organization About NerPharMa • NerPharMa is a recently established company, operating since January 2010. It was created as a spin-off from Nerviano Medical Sciences (see ahead). It is a fully owned subsidiary of Nerviano Medical Sciences. • NerPharMa operates as a CDMO (Contract Development and Manufacturing Organization) and offers unparalleled expertise in bringing highly potent compounds to the marketplace Contents • Overview of Nerviano Medical Sciences: facts and figures • Focus on NerPharMa About Nerviano Medical Science (NMS) Nerviano Medical Sciences is a research-based company dedicated to the discovery and development of breakthrough new molecular entities for the treatment of cancer Nerviano is the largest private pharmaceutical R&D center in Italy and among the largest oncology-focused, integrated R&D sites in Europe. Our R&D organization includes all disciplines for the discovery and development of cancer drugs from target validation to clinical proof of concept Farmitalia and Carlo Erba merge 1965 Nerviano Research Center Founded by Farmitalia 1980 Pharmacia and Upjohn merge 1992 Farmitalia-Carlo Erba acquired by Pharmacia 1995 Pfizer buys Pharmacia 2000 2002 Pharmacia&Upjohn merge with Monsanto/Searle taking the name of Pharmacia NerPharMa & NerPharMa DS span-off 2004 Spin-off from Pfizer: NMS is born 2010 2012 Ownership to Region Lombardy NMS – Track Records In the 70’s and 80’s Nerviano’ s center strongly contributed to the definition of the foundamentals of chemotherapy through the discovery of antracyclines, an antitumoral class including: daunorubicin, in the treatment of hematological malignancies doxorubicin and epirubicin, in solid tumors and hematological malignancies idarubicin, acute leukemia treatment Outline of companies/entities within NMS Discovery Research core functions: Chemistry and Biology Pre-clinical Development: toxicology, pharmacokinetics, safety pharmacology, regulatory, IND packages, etc. Clinical Development of Innovative Drugs from PC stage to Phase III High Containment Manufacturing of Drug Substances and Drug Products for clinical phases and market Consorzio Facility Management One stop shop opportunity Preclinal Phase Target Timelines (years) Discovery HitID 1 H2L 1 / 1.5 Clinical Phase LO IND PC 2 / 2.5 1 PH I PH II 3/4 PoC Reg. PH III PH IV 3 1 Core of the R&D process Priority HITS/LEADS PC Characterization IND Pack Support to Clinical Development Clinical Development of Innovative Drugs from PC stage to PhaseIII. High Contaiment Drug Substances Development and Manufacturing on lab and pilot scale, both for R&D Products and marketed drus Formulation of the Drug Substance and Manufacturing of batches in High Containment plants, on lab and pilot scale, both for R&D producs and marketed products NMS – The site NerPharMa Drug Product NMS Discovery Accelera Drug Metabolism Accelera Toxicology NerPharMa Drug Substance NMS MIO Clinical Development NerPharMa DP Industrial Direction DS Industrial Direction NerPharMa - Profile DP division Mission Type of compound Technology assets Services offered Headcount HC Development and Manufacturing of Drug Products for NMS and ext. customers, from formulation to packaging and distribution Highly potent and non high potent 1 lab- scale lyophilizer 1 lyophilizer 1 sterile production suites 4 solid forms production suites Analytic equipment: NMR, GC, HPLC Mass Formulation identification and early development Analytical Development Formulation scale-up to pilot and commercial stages Clinical trial supply and distribution Commercial manufacturing and packaging Full regulatory support 79 DS division HC Development and Manufacturing of Drug Substances for NMS and ext. customers, from lab stage to batches for the market Highly potent oncology only 4 suites for 0.5 – 5 kg API production Multipurpose pilot plant (batch up to 30 Kg) Low temperatures, hydrogenator Chromatography (180 kg SiO2) Special unit for hazard testing State of the art analytic equipment: NMR, GC, HPLC Mass. Prep HPLC API process development and scale up Analytical Development Commercial manufacturing Regulatory file preparation 29 Manufacturing Authorizations NerPharMa DP plant has a GMP certificate and the Authorization to manufacture and package Medicinal Products issued by the Italian Regulatory Agency (AIFA). The plant holds several FDA approvals for the production of commercial products. The plant is approved by PMDA for the production of a commercial product. NerPharMa DS plant has a GMP certificate and the Authorization to manufacture Active Pharmaceutical Ingredients issued by the Italian Regulatory Agency (AIFA). The plant holds the FDA approval for the production of a commercial product. Our Customers - geography Territories 2013 75 14 11 USA Europe 2012 61 32 2011 7 51 41 0% 20% 40% % on turnover vs third parties 60% 8 80% 100% ROW Our projects - segmentation Product mix 2013 66 30 4 NCE 2012 72 23 Generics 5 Clinical supply 2011 67 29 0% 20% 40% 60% 4 80% 100% % on turnover vs third parties Our projects - segmentation Development phase 2013 75 25 marketed product 2012 64 under development 36 2011 56 44 0% 20% 40% % on turnover vs third parties 60% 80% 100% NerPharMa Services - At NerPharMa we have expertise in all product life cycle phases and we can assit our partners providing the following services: - Dosage form development - Manufacturing for clinical trials and commercial productions - Analytical services - Clinical supply management - Documentation support services Manufacturing capabilities • NerPharMa can manufacture the following pharmaceutical forms both for commercial and clinical trial purposes: – Oral solid dose and semi-solid products: - Tablets as direct compression, wet and dry granulation - Hard Filled Capsules:direct mixing, wet and dry granulation, liquid and semisolid – Sterile products: - Bulk solutions and suspensions aseptically produced and terminally sterilized in vials. - Freeze-dried vials – Both oral and sterile products can be produced using high containment facilities • Versatility and Flexibility: batch size as low as 50-200 g and as high as 250 L and 50 Kg for sterile and non sterile products, respectively Clinical supply management • • • • • • • Packaging design Primary & Secondary Packaging Drug Supply Management and Worldwide Distribution Study Randomization Label Design and Generation Domestic and International shipping Study return management Documentation support services • • • Regulatory Guidance and Consulting CMC Section support for IND, NDA filings (EU, US, Japan) Post filing/post marketing support Authorities inspections 1996 FDA Dostinex (Cabergoline) PAI for commercial manufacturing 1996 FDA Idamycin and Idamycin PFS PAI for development activities 2003 Italian Ministry of Health: GMP inspection to be authorized to manufacture Investigational Products and for commercialization 2005 AIFA.: periodic GMP inspection 2008 AIFA: periodic GMP inspection 2008 FDA: PAI for a Sterile Injectable Lyo product and relative diluent 2009 FDA: PAI for a Sterile Injectable Lyo product 2010 FDA: PAI for two products, one Sterile Injectable form and one Oral 2010 AIFA: periodic GMP inspection 2010 PMDA: PAI for a Sterile Injectable product 2012 FDA: PAI for two products, both Sterile Injectable forms 2013 AIFA.: periodic GMP inspection 2015 FDA: general GMP inspection GMP Certificate • AIFA manufacturing Authorization aM- 89/2014 Issued on June, 5th 2014 MANUFACTURING OPERATIONS FOR COMMERCIAL MEDICINAL PRODUCTS Sterile products: Aseptically prepared: Lyophilisates Small volume liquids Terminally sterilized: Small volume liquids Non-sterile Products: Hard shell capsules Tablets GMP Certificate MANUFACTURING OPERATIONS FOR INVESTIGATIONAL MEDICINAL PRODUCTS Sterile products: Aseptically prepared: Lyophilisates Small volume liquids Non-sterile Products: Hard shell capsules Other solid dosage forms Tablets SECONDARY PACKAGING SPECIAL REQUIREMENTS: CYTOTOXICS AND CYTOSTATICS Contact Details Address: NerPharMa Viale Pasteur 10 – Casella postale n.11 20014 NERVIANO (MI) ITALY Contact Details • Davide Taffurelli, CEO: [email protected], tel: +39 0331 581 672, mobile +39 348 89 04 435 • Germano D’Arasmo, Business and project manager: [email protected], tel +39 0331 581 259, mobile +39 335 13 02 967 • Ombretta DeCesare, Logistic and Customer manager: [email protected] tel +39 0331 581 152, mobile +39 348 570 12 00 • Attilio Tomasi, Industrial director & QP drug substance [email protected] tel +39 0331 581 619, mobile +39 348 890 49 70