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Companies and Organisations active in Health Care Product Development…

Companies and Organisations active in Health Care Product Development…. … SMALL or large…. … sometimes need Support – RIGHT NOW!. Clinical Development Plan needed!. We need someone with experience in FDA audits. What´s the best approval strategy?. How to position this product?.

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Companies and Organisations active in Health Care Product Development…

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  1. Companies and Organisations active in Health Care Product Development… … SMALL or large…

  2. … sometimes need Support – RIGHT NOW! Clinical Development Plan needed! We need someone with experience in FDA audits What´s the best approval strategy? How to position this product? What´s the commercial potential? We need a specialist to develop the process for our antibody Someone to write the DSUR How could we get this IND? We need an IP strategy! We need a new website! What would be the best animal model? Somebody needs to plan the toxicity program Who can help us build out quality system? Should I invest? who does the due diligence?

  3. Competence Network Life Science (CONELIS e.V) • We are an association of life science experts and consultants • We operate independently or as interdisciplinary teams • We work for businesses companies/enterprises?, organisations and investors engaged in • Pharma • Biotechnology • Medical technology • Diagnostics

  4. Our Experts • cover the entire value chain from early discovery to product commercialisation • are top level experts in their field, each has at least >15 years of expertise Chemistry, Manufacturing and Control Preclinical Research & Development Clinical Development Drug Regulatory Affairs & Compliance Business Strategy & Development, Intellectual Property and Corporate Design

  5. Our Experts • rigorous member selection based on member and customer referrals ensure a high level of quality

  6. Our Website (www.conelis.org) • gives transparent information about all our experts, including details about their background and areas of expertise • Search by areas of expertise, service required, or name • Choose the expert you need or assemble your CONELIS team – customer-tailored and goal-oriented • Or ask the spokespersons of our areas of expertise to help find the right expert for you • There are no hidden costs

  7. Interdisciplinary Teams • examples of interdisciplinary projects delivered by CONELIS expert teams are given below • Evaluation of an investment opportunity for a life science fund • Due Diligence for a Biotech-company to evaluate an in-licensing opportunity • Commercial evaluation and clinical development planning for 3 pharmaceutical products in early development • Design of preclinical and clinical development plans and target product profiles for early pharma/biotech products • Advice on a “as needed” basis for a biotech company in things related to production, portfolio decisions, preclinical development and target product profile design

  8. Sustaining Members • CONELIS e.V. is supported by the following sustaining members www.bioscientia.de www.bplus-gruppe.de www.cilique.de www.c3-research.com www.ceplus.eu www.nisicom.de www.richmondpharmacology.com www.mittepatent.de

  9. Summary Competence Network Life Science (CONELIS e.V) Access to selected experts, each with >15 years extensive experience Broad spectrum of expertise, from discovery to commercialisation Customer- tailored consulting by an expert or an interdisciplinary team Transparent, customer-oriented services – no hidden costs

  10. Area of Expertise Chemistry, Manufacturing and Control • OFFERS: • API synthesis, formulation development and QC-analytics • Process development and manufacturing for biologicals • Due diligences and other project evaluations • CMC development and manufacturing strategy including life-cycle management and contract manufacturing • Submissions to authorities • Interdisciplinary workflows to ensure appropriate communication and documentation for life-cycle management

  11. Area of Expertise Preclinical Research & Development • OFFERS: • Disease specific target identification, validation and drug candidate evaluation for strategic decisions • Drug discovery project • Pharmacodynamic studies in relevant disease models (primary pharmacology) • Safety and pharmacokinetics in vitro and in animal studies (secondary pharmacology) • Toxicology studies (chronic toxicity, cancerogenicity, embryonic toxicity) • Scientific writing • Support in grant application writing and project management of funded projects • Design of preclinical drug development programmes and project management • Translational research

  12. Area of Expertise Clinical Development • OFFERS: • Design of complete clinical development programs from first in man to approval • Design of individual studies Phase I-IV • Design of cost-effectiveness studies • Evaluation of data for strategic decisions • Safety risk management • Interim management • Support of submissions to authorities • Conduct of expert meetings • Advice on biomarker programs, PK/PD and pharmacogenomics

  13. Area of Expertise Drug Regulatory Affairs & Compliance • OFFERS: • Practical experience for regulatory compliance • Design and implementation of regulatory strategies • Customer oriented project management for most cost effective analyses and tests according GLP and ISO • Quality assurance through quality systems, standard operating procedures

  14. Area of Expertise Business Strategy & Development, Intellectual Property and Corporate Design • OFFERS: • Commercial assessment and market research • Portfolio assessment and corporate strategies • In- and out-licensing support • Due diligence support • Financing support • Intellectual property law • Corporate design and branding • Scientific illustrations

  15. Contact Competence Network Life Science (CONELIS e.V) CONELIS e.V. Belziger Straße 69-71 10823 Berlin Germany T: +49 (0)30-260 315 93 F: +49 (0)30-23097322 news@conelis.org www.conelis.org

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