Biotechnologies Track

11:00 - 12:00

"Intraocular Lens Design: The Confluence of Biosafety and Biofunctionality"

Steve Van Noy

Surgical Products R&D
Alcon Research, Ltd.

Based on unmet needs, biomedical implants for the treatment of cataracts and refractive errors are moving towards providing more predictable customized products that mimic those in the youthful eye. In parallel, the benefits of less invasive surgery drive the need to implant a more complex technology through smaller incisions. These paradoxical drivers related to IOL design, delivery system, and surgical technique must also be leveraged into platform technologies that permit expansion of the product line and its useful life. Solutions to unmet medical needs provide the most impactful and sustainable product designs that result in tangible benefits to practitioners and their patients. For cataract and refractive surgery, the core needs center around restoring vision during treatment through intraocular lens solutions that address a range of unique optical aberrations. Successful concepts must be innovative as well as meet best in class biocompatibility and biofunctionality requirements to provide a value-added benefit over the life of the implant. Final products are both nurtured and challenged through laboratory, in vivo, and clinical scientific studies in order to assure that their performance meets the intended objectives. Specific preclinical material, optical, mechanical, toxicological, and microbiological criteria must be addressed before final product safety and efficacy are established through rigorous clinical studies. In the future, increasing customer demands will require intraocular lenses to integrate with eye biology and demonstrate clear mechanisms of action in order to provide the intended benefits and address issues related to the procedure or tissue degradation of the aging eye. This presentation will describe the research and development process along with the issues and synergistic solutions that were developed for several intraocular devices as well as provide a glimpse into the direction the industry is moving for future devices. 2:00 – 3:15 Presentation: “Beta Cell Replacement Therapy for Type 1 Diabetes” Bashoo Naziruddin, Ph.D Director, Islet Cell Processing Laboratory Baylor University Medical Center Dallas, TX 75246 Incidence of diabetes is increasing at an alarming rate in different populations all over the world. Diagnosis of Type 1 Diabetes (T1D) is also following this increasing trend, constituting 5-10% of the total diabetes cases. Exogenous insulin therapy is proving to be adequate for majority of T1D patients; however, for “brittle” T1D patients control of blood glucose levels is very difficult using this treatment. Four broad types of approaches are currently being pursued to replace the beta cells of pancreatic islets destroyed by the autoimmune response. While some of these approaches have progressed well enough to find clinical application, others are lagging behind due to technological deficiencies. Transplantation of allogenic pancreas organ is an established clinical procedure and has shown excellent outcome in terms of sustaining long term glucose control. However limited organ supply and high morbidity associated with the procedure has restricted its application. Transplantation of isolated pancreatic islets is a minimally invasive procedure that has shown the most progress in the past decade. In pre-clinical trials conducted at select centers, islet transplant recipients have shown improved glycemic control comparable to whole organ pancreas transplant recipients, while experiencing fewer adverse events. This procedure is currently considered experimental in the United States and is awaiting clearance by the Food and Drug Administration. Islet transplants are also limited by the lack of suitable organ supply, requirement of a cGMP processing facility and a lack of islet-friendly immunosuppression. Transplantation of islets from animal source such as pig could overcome the hurdle of donor organ shortage and a few clinical trials have already been performed with limited success. Major problems with such xenogeneic combination are the concern about transmission of animal viruses and also poor long term function/survival of transplanted islets. Finally, replacement of beta cells derived from alternative sources such as stem cells has the potential to offer unlimited supply of beta cells and is currently receiving greater attention from the research community.