Focus of discussion would be on advance protein engineering technologies, standardization for clinical and analytical strategies, development and application cell-based immunotherapies for the treatment of cancer and immune disorders. Topics include improving target identification,
optimizing product design, specificity, safety, characterization and analytics.
May focus on advanced tools, techniques, and bioengineering strategies in pursuit of developing cellular immunnotherapies for cancer and immune disorders. May include clinical progress with Chimeric Antigen Receptors (CAR), T Cell Receptors (TCR), Tumor Infiltrating Lymphocytes (TIL) and Natural Killer (NK) cells
Exosomes are nano-sized vesicles containing biological signaling molecules that mediate cell–cell signaling. Mesenchymal stem cells (MSCs) are believed to have antitumor effects and are preferred for their properties, such as immune-modulating capacity and ability to accumulate at the tumor site
Section A: Sources for exosome isolation and characterization
Section B: Regenerative application of exosomal therapy in different disease conditions
Section A: Developments and future of 3D-Organ Bioprinting
Three-dimensional (3D) printing technologies have been applied to biocompatible materials, cells and supporting elements, making a field of 3D bio printing that holds nice promise for artificial organ printing and regenerative medicine. The technology includes 3D bio printing from microextrusion bio printing, inkjet bio printing, laser-assisted bio printing, to newer technologies such as scaffold-free spheroid-based bio printing.
Innovations and recent successes of CAR-T cell therapies has renewed interest in improving bioprocessing and up gradation of manufacturing facilities required to meet the increasing demands. Discussions may include long-term consequences of automation of cost effectiveness and success in terms of autologous CAR-T cell processes, barriers and the benefits.
The Standards cover all aspects of operation from donor selection and testing to product processing, storage, clinical administration, and patient outcomes. Accreditation process ensures the facilities meet the applicable standards in providing quality products and services.
Research advancements leads to applications of Stem Cells to develop new therapies that includes cell replacement therapy, development of drugs, iPSC generated stem cells from skin or blood, using trans differentiation technology to convert a specialized cell type to a progenitor cells etc.
Gene therapy involves change or removal in the content of a person’s genetic code with the goal of curing a disease. Gene therapy can be used to reduce levels of a disease-causing version of a protein and increase the production of disease-fighting proteins or to produce new or modified proteins.
Cell-based therapies are emerging candidates for translation towards successful commercial development and patient access. Technology classifications and clinical translation challenges are governed by underlying technologies for clinical, regulatory, manufacturing and reimbursement requirements.
Regulatory certainty under the framework enables cost-effectiveness of goods, manufacturing technologies, reimbursement policies; improving product characterization and performance specification ensuring early clinical utility, cost-effectiveness and clinical adoption. Design of bioprocesses and next generation production systems are dependent upon adaptation of some of the process improvement tools, knowledge of the level of variation achieved in current processes, and the variation the product is allowed by the regulator and its application.
Systematic application of bioprocess engineering combined with cellular systems biology guides the development of next-generation technologies capable of producing cell-based products in a safe, robust, and cost-effective manner and enhances cell therapy product quality and safety, expediting clinical development.
Large-scale manufacturing of cells for tissue engineering applications require cGMP (current Good Manufacturing Practice) based large-scale manufacturing process of cell culture, expansion and cryopreservation and characterization of these cells to assure the safety and high-quality of cells for effective therapeutic use to comply with the regulations . Manufacturing challenges are considered in context of establishing the process flow and in-process controls for the manufacturing process.
Increasing number of regulatory approvals for cell and gene therapies going in for clinical evaluations, require industrial translation through automation and mass production to meet the process efficiency and cost effectiveness. Novel manufacturing technologies may aid in increase of efficiency and address the optimization issues arising from the development of large-scale manufacturing processes for modern cell and gene therapy.
Application of bioreactor engineering concepts have provided a solid foundation for use of advanced culture technologies for stem cell manufacturing. Increased role for engineers and the engineering approach require an increased investment in engineering, applied research , which would provide a foundation for the generation of new markets and future economic growth. It also will require programs that support interdisciplinary teams, new innovative mechanisms for academic–industry partnerships, and unique translational models.
Umbilical cord blood (UCB) has been shown to be a suitable source of hematopoietic stem cells (HSCs) for hematopoietic reconstitution. Other potential applications of UCB include immunotherapy, tissue engineering and regenerative medicine. Government agencies need to provide regulatory and safety oversight, for accreditation of professional organization including ethical issues and access to UCB banking and use as therapy for diseases other than hematological and metabolic disorders
Applications of cord blood stem cells are being explored for Type 1 diabetes; cardiovascular repairs to improve overall heart function; central nervous system to repair damaged brain tissue and as autologous source for regenerative medicine.
Umbilical cord blood (UCB) is considered to be the biggest reservoir of cells and to have regenerative potential for many clinical applications. UCB mainly used against blood disorders, also has been shown to provides effective therapy in non-hematopoietic conditions. UCB has also been used as source for regenerative cell therapy and immune modulation. Discussions may concentrate on issues related to collection, processing and long-term storage and its potential clinical applications for new therapies.
This group works on topics such as donor issues for public banking (recruitment, consent, screening/testing), manufacturing, storage and transport challenges, licensure, international issues, and private and family banking issues.
In veterinary medicine, stem cell therapy has been used primarily used in soft tissue injury and wound healing. Therapeutic applications of stem cells for the treatment of contractor injuries in horses and dogs. New technologies use the properties of spermatogonial stem cells to preserve vulnerable animal species or generate transgenic animals for the production of pharmaceuticals or for use as biomedical models.
Regulatory requirements of human cells, tissues, and cellular and tissue-based products (HCT/P) intended for implantation, transplantation, infusion or transfer into a human recipient, including hematopoietic stem cells. May include review of the process for manufacturing and assurance of the products.
The regulation of stem cell research is an issue of major consideration. Issues in stem cell medicine need to address regulations right from laboratory to commercialization in light of ethical, legal, social and safety issues and the goals of governance.
Intellectual property rights relating to regenerative medicine products are mainly protected by patents and data/market exclusivity. research institutions and companies need to reexamine their IP, regulatory, and commercial strategies on a jurisdictional basis and remain abreast of current patent law developments. The field of regenerative medicine continues to be influenced by both government policies and court rulings in respective jurisdictions.
Takes account of the ethical, legal, social and safety issues raised for Cellular Therapies and the goals of governance, regulatory updates and framework directives on human tissues, medical products and devices.
Market authorization of advanced therapy medicinal products for gene therapy, cell therapy, and tissue engineering requires a rigorous scientific evaluation by stringent requirements for quality, safety, and efficacy. This ensures that patients will have access to a therapy that is manufactured to high commercial standards, and is supported by robust clinical safety and efficacy data.
Generate new markets and future economic growth, require programs that support interdisciplinary teams, new innovative mechanisms for academic–industry partnerships, and unique translational models. Global community benefits from developing strategic partnerships between countries can leverage existing and emerging strengths in different institutions. To implement such partnerships will require multinational grant programs with appropriate review mechanisms.
The ICMR-DBT guidelines are the basis for stem cell research in India. The future of stem cell therapy in India is dependent on institutions involved in stem cell research with the support from Indian government. Very few private entrepreneurs are involved in research. Adult stem cells are the focus of intense research, designed to treat a variety of human diseases. India has capacity to play a lead role in the scientific, clinical and commercial development of stem cell research. The high patient demand, vibrant pharmaceutical or biotechnological companies, a large intellectual pool of scientific talent and a mature information technology industry have together converted has made India a big platform for research and clinical translation. Collaborative efforts between the academia and industry partners in stem cell medicine to translate new products to the market is challenging. A drastic policy changes in the manner that facilitate scientific temper, output and entrepreneurship.
The Partnership approach to research and development in regenerative medicine requires collaborations between academia and industry by sharing resources and expertise. Strategic partnerships combine bringing together of strong complementary skills, expertise and infrastructure across disciplines with innovative ideas and cutting-edge technologies to provide a platform to enable accelerate discovery and development of new therapeutic in regenerative medicine. Global partnerships and collaborations would synergize the regulatory systems to deliver the great promise of regenerative medicine to the benefit of both patients as well as to the industry.