July 25-27 2017

The Hyatt Regency, Boston, MA

Day One
Wednesday July 26, 2017

Day Two
Thursday July 27, 2017

08:00
Registration, Coffee and Networking

08:45
Chair’s Opening Remarks

  • Naj Sharif Executive Director & Head, Global Alliances & External Research, Santen

INNOVATION SESSION: Pioneering Gene & Stem Cell Therapies in Ophthalmology

Synopsis

Gene & stem cell therapies are gaining momentum, with pioneering development efforts in the ophthalmology space. But how do we ensure this momentum is sustained and avoid the mistakes that have cost the field in the past? Pioneering industry and academic leaders at the forefront of the field will open the conference by sharing their insights into the key developments that will affect change over the next year.

09:00
What Is The True Potential Of Gene & Stem Cell-Based Therapeutics In Ophthalmology?

  • Michael Young Associate Professor of Ophthalmology, Harvard Medical School

Synopsis

  • Mapping out the disease areas and patients in which gene and stem cell therapies can be particularly effective
  • Overcoming delivery issues – innovations to enhance the delivery of gene therapies and stem cells to target tissues in the eye
  • Evaluating safety and efficacy – how long-lasting and potentially immunogenic are these treatments?

09:15
Overcoming The Challenges Of Stem Cell-Based Therapies

  • Maria Mirotsou Senior Director of Research, Astellas Institute for Regenerative Medicine

Synopsis

  • Sources of stem cells
  • Assay development and quality criteria (purity, bioactivity)
  • Preparation for large scale manufacturing and commercialization

09:30
Interactive Panel Discussion – Pioneering Gene & Stem Cell Therapies In Ophthalmology

  • Abraham Scaria Vice President, Ophthalmology, Casebia Therapeutics
  • Maria Mirotsou Senior Director of Research, Astellas Institute for Regenerative Medicine
  • Michael Young Associate Professor of Ophthalmology, Harvard Medical School

Synopsis

What is it going to take to turn these innovative approaches into a reality for patients? This is your opportunity to have your burning questions answered by the industry-leaders following their presentations in this morning session.

10:15
Speed Networking & Morning Refreshments

Optimizing Preclinical Development to Bridge the ‘Valley of Death’

11:30
Translatability Pitfalls Of Preclinical Models of Macular Degeneration

Synopsis

  • Improving reproducibility of preclinical models
  • Experience translating rodent models of macular degeneration to clinical trials
  • Experience investigating oral, topical and intravitreal routes of administration in preclinical models

12:00
What Does ‘Proof of Concept’ Actually Mean?

Synopsis

  • What is necessary and sufficient to demonstrate proof of concept for ophthalmic indications?
  • Efficiently translating from non-clinical to robust clinical proof of concept
  • Learning from costly translational mistakes – how can these mistakes be avoided in the future to save time and enhance cost-effectiveness?

12:30
Lunch & Networking

Enhancing the Clinical Development of Ocular Therapeutics

13:30
Establishing Effective Clinical Development Strategies From The Outset

  • Canwen Jiang Therapeutic Area Head, Global Ophthalmology Development Franchise, Novartis

Synopsis

  • Detailing key early decision points in the clinical development of ocular therapeutics
  • How can early decisions shape the course of entire clinical programs and what can we learn from past failures in this critical early stage progression?
  • Novel approaches and the impact they will have on the current clinical model

14:00
Setting & Ruthlessly Enforcing Initial Success Criteria To Minimize Late-Stage Developmental Failures

Synopsis

  • Defining success criteria across the board from the outset
  • Overcoming internal and external pressures to ensure development is set up to succeed
  • Prioritizing long-term success vs. short-term ‘benefits’ that lead to problems later on in development

14:30
Afternoon Refreshments & Networking

Pooling Industry & Academic Experience to Collectively Advance the Field

15:00
Pioneering a Gene Therapy Approach for Dry-AMD: From Concept through to Clinical Development

Synopsis

  • Investigating an innovative gene therapy approach to address the significant unmet need in the wet AMD space
  • What does it take to turn an innovative concept into a reality for patients?
  • Insights from the entire development journey from conception through lab scale preclinical work to early clinical development and preparation for later stage clinical progress

15:30
Harnessing University-Based Expertise to Benefit Ocular Drug Development

  • T. Michael Nork Associate Professor, Ophthalmology, University of Wisconsin

Synopsis

  • Strategies to collaborate more effectively to advance innovative ocular therapeutics
  • Enhancing understanding of the drug development process at every stage
  • Finding the optimal balance between commercial and academic expertise to drive progress

16:00
Breakout Roundtables: Enhancing Every Stage of Ophthalmic Drug Development

Synopsis

Drive your own learning and crowd-source ideas. Discover multiple perspectives on the key issues affecting drug development in the ophthalmology space, by joining roundtable discussions that have been specifically designed to enable you to leave with insights that you can immediately implement into your own drug development programs.

 

Topics Of Discussion:

 

  1. What characteristics define an effective preclinical animal model?
  2. Optimizing endpoint selection in ophthalmic clinical development
  3. Defining an effective regulatory strategy for novel products in the ophthalmology space
  4. Successfully implementing partnering and outsourcing strategies

 

Following discussions in the intimate and open roundtable format, the table leaders will form a panel to feed back to the entire audience on the key topics that were discussed in the session. Form a comprehensive understanding of  the ophthalmic drug development process and the strategies that are employed to overcome challenges at every point along the way.

17:00
Chair’s Closing Remarks & End of Conference Day One

  • Naj Sharif Executive Director & Head, Global Alliances & External Research, Santen