Clinical Trials in Cell & Gene Therapy

clinical trial is a research study that seeks to determine if a treatment is safe and effective. Advancing new cell and gene therapies (CGTs) from the laboratory into early-phase clinical trials has proven to be a complex task even for experienced investigators. Due to the wide variety of CGT products and their potential applications, a case-by-case assessment is warranted for the design of each clinical trial.

Objectives: Determine the pharmacokinetics of this regimen by the persistence of modified T cells in the blood of these patients, Evaluate the immunogenicity of murine sequences in chimeric anti-CEA Ig TCR, Assess immunologic parameters which correlate with the efficacy of this regimen in these patients, Evaluate, in a preliminary manner, the efficacy of this regimen in patients with CEA bearing tumours.

Related Conferences: 4th International Summit On GMP, GCP & Quality Control, 26-28 October, 2015 (Hyderabad, India); 3rd International Conference on Clinical Pharmacy, 07-09 December, 2015 (Atlanta, USA); Pharmaceutical Summit and Expo, 08-10 October, 2015 (New Delhi, India); 3rd International Conference and Exhibition On Pharmacognosy, Phytochemistry& Natural Products, 26-28 October, 2015 (Hyderabad, India); Patient-Centered Clinical Trials 2015 19-20 October 2015 (Le Méridien, Philadelphia); Quantitative Systems Pharmacology 20-22 October 2015 (Boston, MA); Clinical Development and Commercialization of Antibacterial  22-23 September 2015 (Boston, MA); Summit for Clinical Ops Executives 23-25 February 2016( Miami, FL); Clinical IT Strategy and Governance 23-25 February 2016 (Miami, FL).

A clinical trial is a research study that seeks to determine if a treatment is safe and effective. Clinical trials are regulated by the federal government. Participants must be informed, both verbally and in writing, about the risks and benefits of participation in a clinical trial. The written document is called an "Informed Consent Document". Participation in clinical trials is voluntary. In general, the informed consent process involves both written and oral components, The written Informed Consent Document provides the basic details of the study-how it will be conducted, what it involves, by whom, the risks, potential benefits, alternatives to participation, right to withdraw, whether the patient will receive payment for participation and other key information. It is equally important that patients have an opportunity to meet with researchers and discuss the study in person. While the written informed consent document is an important part of the consent process.

  • Principles of gene therapy & clinical gene therapy
  • Animal & human trails of engineered tissues
  • Emerging clinical aspects of stem cell technologies
  • Pharmacogenomics in cell therapy
  • Clinical trial design & analysis
  • Clinical genetics
  • Alternative lab models for therapeutic applications

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