7:30 - 7:55 Registration & Breakfast
7:55 - 8:00 Welcome Remarks
Remarks from AAPOS
|
Michael X. Repka, MD, MBA |
8:00 - 8:30 Opening Presentation
8:00 - 8:15 - Age as a Barrier: The ongoing Evolution of IOL Indications, What We’ve Achieved and What’s Next | Malvina Eydelman, MD  |
8:15 - 8:30 - Why Pursue On-label IOLs for the Pediatric Population: The Clinical Importance of approval | M. Edward Wilson, MD |
8:30 - 10:20 - Session 1
Current Marketing Framework and How to Bridge the Gap
|
8:30 - 8:40 - Regulatory History of IOLs Bennett Walker, PhD |
|
8:40 - 8:50 - Bridging Adult Standards and Modifications to incorporate Pediatric cases Don Calogero, MSE |
|
8:50 - 9:00 - Defining a Pediatric IOL Patient, Who, When, & What Michael X. Repka, MD, MBA |
|
9:00 - 9:10 - Appropriate Age Brackets, Anatomical Differences, Eye Growth Considerations for Pediatric IOL Marie-José Tassignon, MD, PhD |
|
9:10 - 9:20 - Bridging the Gap Between Existing Regulatory Framework and What’s Known About Pediatrics Patients Aisha Traish, MD |
|
9:20 - 9:30 - Historical Data & Control Arms: What’s a Valid Comparator in Pediatrics? Aracelis Torres, PhD, MPH |
|
9:30 - 9:40 - What Data Do We Need Scott Lambert, MD |
|
9:40 - 9:50 - Impact of Laterality on VA and IOP Outcomes Deborah VanderVeen, MD |
Moderator:
Michael X. Repka, MD, MBA
Panelist:
- Bennett Walker, PhD
- Don Calogero, MSE
- Marie-José Tassignon, MD, PhD
- Aisha Traish, MD
- M. Edward Wilson, MD
- Scott Lambert, MD
- Aracelis Torres, PhD
- Deborah VanderVeen, MD
10:20-10:40 - Morning Break
10:40 - 11:45 - Session 2
Stakeholder Perspectives and Ethical Considerations
|
10:40 - 10:50 - How Long of Follow-up is Necessary Scott Lambert, MD |
|
11:00 - 11:10 - Practical Expectations from Pediatric Eye Surgeons Michael X. Repka, MD, MBA |
|
11:10 - 11:45 - Industry Panel Discussion Moderator: Natalie Afshari, MD Panelists: Samuel Masket, MD Jim Ellis, MD President/CEO JelliSee Ophthalmics Rosanne Melikian, PhD J&J Regulatory Affairs Rachael Peterson, PhD Alcon Clinical R&D Paul Swift, MS Zeiss Regulatory Affairs Richar Packard, MD Medical Director of CAPSULaser |
11:45 - Group Photo
11:50 - 12:35 - Lunch Break
Future of Ophthalmology Round Table
Ophthalmology Residents and Pediatric Fellows invited to join roundtable discussion
12:35 - 14:15 - Session 3
Current Data
|
12:35 - 12:45 - Pediatric IOL Implantation in India Ramesh Kekunnaya, MD 12:45 - 12:55 - Pediatric IOL Implantation in Brazil Bruna Ventura, MD, PhD 12:55 - 13:05 - Pediatric IOL Implantation in China Weirong Chen, MD 13:05-13:15- Pediatric IOL Implantation in Europe Darius Hildebrand MD 13:15-13:25 - Pediatric IOL Implantation in Japan Tetsuro Oshika, MD, PhD 13:25-13:35 - Real World Data, Real World Evidence Ken Nischal, MD 13:35 -13:45 - Challenges with Utilizing Data Between Different Studies Vicki Chen, MD 13:45 - 14:15 - Panel Discussion Moderator: Scott Lambert, MD Panelist:
|
14:15 - 14:45 - Session 4
Defining a Path Forward: Aligning FDA, ISO, and Clinical Realities
Optimizing the FDA Regulatory Pathway for a Small-Volume Product
14:45 - 15:00 Closing Remarks
Key Takeaways and Action Items
Natalie Afshari, MD, Malvina Eydelman, MD