In this groundbreaking webinar, discover the latest in retina therapy programs and clinical research to enhance success in ophthalmic trials with insights from industry experts. With over 250 individual therapies in development to address these challenging-to-treat conditions including inherited retina diseases, diabetic retinopathy and macular degeneration, the innovation within this space is likely unsurpassed by any other. Excitingly, many of these include novel mechanisms of action or gene therapies that show potential for different therapeutic impacts from current therapies on the market, such as treating conditions where there are no therapies with approved indications or targeting earlier-stage disease interventions.
As companies explore new therapies to address these disease states, new strategies are needed for clinical designs that measure therapeutic impact appropriate for the target patients and stage of disease. Join Ora’s Vice President of Posterior Segment Keith Lane, and Retina Specialist and Ora Head of LATAM Operations Dr. Joao (John) Trein, as they share lessons learned and important considerations for novel retina therapy programs.
Ora Inc. is the only ophthalmic clinical trials company with a research and development (R&D) department focused on the evolution of clinical trials. Previous endpoint breakthroughs include the launch of the Ora Visual Navigation Course (Ora-VNC), a mobility course with validated endpoints for inherited retina disease programs, with several additional novel endpoints for retina in development. Currently running over 35 programs across a multitude of retina conditions, including multi-country programs, Keith and John are uniquely positioned to discuss clinical industry trends for retina trials and to share their hard-earned knowledge on how to design the right program for your therapy that reduces risks and increases chance of program success within this challenging development field.
Join this webinar to gain insights into retina therapy programs in clinical research from industry experts to maximize success in the challenging field of ophthalmic clinical trials.
Keith Lane, Ora Vice President Posterior Segment
With Ora since 2003, Keith Lane has dedicated his career to ophthalmology. As Vice President, Keith leads clinical operations and regulatory strategy activities of Ora’s Posterior Segment division.
Prior to his current role, Keith held several senior management positions, including leading Ora’s research & development department where he directed the creation and validation of clinical models, endpoints and trial processes for nearly a decade. Keith also led the development, launch, clinical operations and regulatory strategy of Ora’s Visual Navigation Challenge (Ora-VNC™). This mobility course is used as a functional endpoint in clinical trials worldwide to evaluate gene therapies targeting inherited retinal diseases.
Keith has published numerous articles in peer-reviewed journals and has spoken at many industry conferences. He also holds a number of patents on techniques, formulations, and research methods. Keith earned a Health Sector Management Master of Business Development with honors from Boston University’s Questrom School of Business and a bachelor of science in biology from Bates College in Lewiston, Maine.
Dr. Joao (John) Trein, Ora Head of LATAM Operations, Retina Specialist
Dr. Joao (John) Trein Junior is an experienced Ophthalmologist and Retina Specialist with more than 20 years in the field. He completed his residency and retina fellowship at the University of Sao Paulo in Brazil. His career was dedicated extensively to clinics and surgeries, community programs and research. Currently, in the US, Dr. Trein contributes with his leadership to Ora’s global operations, bringing critical guidance to the international strategy. Simultaneously, he’s a cornerstone in upholding patient safety, applying his expertise across a diverse range of studies worldwide.
Who Should Attend?
This webinar will attract a diverse audience of professionals involved in clinical research, including:
- Clinical trial sponsors
- Investigators and medical professionals executing clinical trials in their practice
- Leaders of clinical development start-ups
- Ophthalmic medical professionals interested in clinical research
What You Will Learn
Attendees will gain insights into:
- Lessons learned and important considerations for novel retina therapy programs
- Insights from the latest published research and regulatory agency reviews of clinical designs
- Patient sample considerations and how working with certain outside-USA locations can improve timelines and be better suited to find the best-fit patients for studies.
- Overview of various endpoints within the retinal space, with an understanding of how condition-dependent endpoints can provide the best chance of program success.
Ora is the world’s leading full-service ophthalmic drug and device development firm with offices in North America, South America, Europe, Australia, and Asia. For over 45 years, we have proudly helped our clients earn more than 80 product approvals. We support a wide array of organizations, from start-ups to global pharmaceutical and device companies, to efficiently bring their new products from concept to market. Ora’s pre-clinical and clinical models, unique methodologies, and global regulatory strategies have been refined and proven across thousands of global projects. We bring together the world’s most extensive and experienced team of ophthalmic experts, R&D professionals, and management executives to maximize the value of new product initiatives. For more information, please visit www.oraclinical.com, and follow us on LinkedIn.
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