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Key note session at Bangalore India BIO on Actualizing Potential of Clinical Trials

Accelerating Pharma time-to-market, cost effectively. Asia. Europe. Americas. Key note session at Bangalore India BIO on Actualizing Potential of Clinical Trials June 4 th 2010 D A Prasanna Founder & Vice Chairman Ecron Acunova. introduction.

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Key note session at Bangalore India BIO on Actualizing Potential of Clinical Trials

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  1. Accelerating Pharma time-to-market, cost effectively Asia Europe Americas Key note session at Bangalore India BIO on Actualizing Potential of Clinical Trials June 4th 2010 D A Prasanna Founder & Vice Chairman Ecron Acunova

  2. introduction EA combines domain knowledge, patient access & financial strength • Highlights • Recruited 17,000+ patients last 5 years • Full service I-IV, CDM, Central Lab, PK/PD • Oncology, CV, Metabolic, Respiratory • Lead in stem cell & diagnostic agent trails • Studies found compliant by US FDA, HC, WHO, DCGI etc. AcuNova Life Sciences Manipal Group World’s largest healthcare fund Leveraging India, Central & Eastern Europe for speed & cost Ranks amongst top 3 Indian Clinical Research Organization for Quality, Revenue and Reputation

  3. India in Clinical trial so far… • India is engaged in clinical research for the last 15 years. Starting with • size of population • English in communication • disease burden • naïve patient advantage • western medical education • We have coveted a position of interest in the minds of clinical development community. • Yet India’s share has not become significant. • What are some steps required to get a higher leverage of our potential?

  4. Clinical Trial India‘s relative position 30th November 2009, clinicaltrials.gov IN 1232PO 1714 No of registered clinical trials

  5. Foreign data acceptance by US, EU ICH E5 and 21 CFR 312.120 articulate the principles • FDA’s acceptance of foreign clinical trial data: • GCP compliance • Investigators of recognized competence • Valid Scientific evidence • Applicable to US population / medical practice

  6. Therapy area competence Expertise contributes to data quality Special experiences and knowledge in clinical studies in oncology field: • Special in- and exclusion criteria, histological results • TNM Staging (Tumor, Lymph nodes, Metastasis) • Special physical examinations, e.g. ECOG / Karnofsky-Index • Tumor evaluation (RECIST)  Cooperation with radiologists • Preparation of infusion  Cooperation with pharmacists • Evaluation of laboratory results that are specially influenced by chemotherapy (hematological values) • Assessment of special tumor markers • Side effects of chemotherapy / new chemotherapies • Side effects with other medication • AEs of special interests (drug related) • SD check • Special documentation of source data

  7. Graduate from Ph III Doing a Ph II improves likelihood of Ph III • Early years: Registration trials Ph IV • Last decade: Ph III global trials • This decade: Add Ph Ib to Ph II • Early development for top 20 Pharma calls for new Competency • PK/PD studies (insulin clamp study for eg) • cadre of drug safety specialists. • Sites with safety preparedness

  8. Breadth of expertise Helps to leverage same sites and bring perspectives • In a therapy area, research breadth from • drug delivery devices • Co-morbidity • nutritional research • life style management • Devices

  9. Qualify & support infrastructure Building an ecosystem and qualifying improves quality A. Conventional infrastructure • Trained investigators • Accredited study coordinators • Investigator networks B. Special infrastructure • Drug labeling in stem cells • Stem cell EC • Core lab in spirometry for respiratory • Special biomarker testing • Trials involving PET agent with less than one day half life • Blinded readers

  10. Credible regulatory bodies • Investigator meeting coming under MCI scanner for inducement of Physicians • Ph IV trials seeding a new variant or collection of new scientific data? • Requirement of clinical trial a qualitative trade barrier? • DCGI ‘s collaboration with US FDA and Health Canada is a great step

  11. From National to Regional CRO As a country we can participate in larger programs • Last decade National expert CRO’s in demand • This decade many sponsors are reducing number of service providers • Service providers also need to align • Regional or transnational • Follow disease burden map in geography expansion!

  12. In summary • Foreign patient inclusion – understand to get the right trial to India • Build therapy area competence in CRO’s • Extend to early development studies • Cover the breadth of a therapy area & leverage sites • Build an eco system for clinical trials • Credibility of regulatory bodies • Align with changing sourcing strategy of sponsors

  13. Thanks • Ecron Acunova team in educating me for this talk • India BIO for the platform • Attendees for your attention

  14. Contact us www.ecronacunova.com Full ServiceCRO 20+ Y E A R S Track Record We accelerate Pharma time-to-market cost effectively ASIA EUROPE AMERICAS SJR I Park, Mobius EPIP, Whitefield Bangalore – 560 066 India bd.asia@ecronacunova.com +91 80 6691 5725 Hahnstrasse 70D-60528 Frankfurt Germany bd.europe@ecronacunova.com +49 69 6680300 502 Carnegie Center Suite # 100 Princeton NJ 08540, USA bd.americas@ecronacunova.com +1 973 396 2742

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