Right now is an exciting time for retinal therapy development. Advances in retinal research and exploration of new therapies surpass any previous efforts for these disease states. Current plans and investments predict that over the next ten years there will be significant therapeutic development in retina research. These developments will address the challenges of treating diseases such as macular degeneration and inherited retinal diseases where currently there are treatment gaps in need of solutions.
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The speakers will share strategies to execute retinal therapy development with excellence, covering topics such as:
- Improving study success by thinking global-to-local, applying global operational excellence models and proven approaches while tapping into local insights and cultural nuances from sites, CRO staff and retina patients
- Assessing meaningful quality of life (QOL) impact of potential therapies by using endpoints beyond traditional visual acuity, demonstrating efficacy and impact while creating therapy differentiation
- Leveraging clinical trial advocacy to create study awareness and accessibility, with clinical trial access as part of patient standard of care
While traditional approaches have worked until now, more will be needed to overcome the current challenges of clinical research and bring much needed novel retinal therapies to market. The featured speakers and the team at Ora have already begun implementing tailor-made approaches to address these challenges.
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Register for this webinar to discuss the solutions to problems already found, and the innovative approaches still needed to continue moving clinical retina research for these patients forward.
Speakers
Keith Lane, Vice President, Ora 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 for 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 several patents on techniques, formulations and research methods.
Message Presenter
Dr. Sally Tucker, Vice President, Ora Europe
Dr. Sally Tucker has more than 20 years’ experience within the ophthalmology industry. She has held positions in marketing, training and education and clinical for global pharmaceutical and medical device companies.
As Vice President of Ora Europe, Sally leads the focus on building a high-quality, expert and efficient clinical operations team within Europe. She brings her dedication to quality assured outcomes, clinical excellence and accreditation, sound process development, regulatory compliance and project excellence to growing and expanding Ora’s presence within the EU.
Sally’s expertise includes all phases of clinical research activities — from first-in-human, Food and Drug Administration (FDA) investigational device studies and investigational new drug/medicinal product trials to numerous post-marketing evaluations. She is also seasoned in developing relationships with international key opinion leaders. She has directed and financially managed both international medical device and pharmaceutical trials, with a primary focus on Europe.
Message PresenterWho Should Attend?
- Anyone from new to experienced Ophthalmic Medical Professionals involved in clinical trials
- Those involved in the planning or execution of clinical trials for novel therapeutics
- Clinical Trial Sponsors
- Start-up Clinical Development Leaders
- Investigators and Medical Professionals executing trials in their practice.
What You Will Learn
Attendees will learn about:
- The current challenges in retinal research and strategic approaches to drive study success
- Leveraging global operational excellence with local insights to maximize trial performance
- Opportunities for novel endpoint integration for retinal studies to better assess therapy quality of life (QOL) impact
- Using clinical trials as part of standard of care for challenging retinal disease states
Xtalks Partner
Ora
Ora is the world’s leading full-service ophthalmic drug and device development firm with offices in the United States, United Kingdom, Australia, and Asia. For over 40 years, we have proudly helped our clients earn more than 50 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.
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