1 / 16

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?.

rendor
Download Presentation

Companies and Organisations active in Health Care Product Development…

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript


  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

More Related