Ocular Toxicology, Pharmacology and Drug Delivery: An Eye on the Future

June 27–28, 2016 | South San Francisco, California

Over the last ten years, the landscape for ocular drug development has changed significantly. Longer life expectancy and increased incidence of diabetes have resulted in rapidly increasing incidence of the major eye diseases, such as age-related macular degeneration and glaucoma (30% increase expected by 2020) and diabetic eye disease (69% increase expected by 2030). As a result, interest in the treatment of eye diseases has grown considerably. The rapid expansion of ocular drug development has revealed significant challenges for ocular toxicology, pharmacology, and drug delivery. Moreover, there is increasing evidence of retinotoxicity resulting from off-target drug effects and neurotoxicants. All of these factors led to the creation of the Society of Toxicology (SOT) Ocular Toxicology Specialty Section (OTSS) in 2009. Since then, our membership has grown rapidly to over 100 members.

This conference will provide a forum for communication and interactions between toxicologists, pathologists, clinicians, pharmacologists, basic scientists, and other professionals working in the field of ocular toxicology. The main focus will be two-fold: to improve our understanding of ocular toxicology, pharmacology, and safety assessment and to increase our understanding of the challenges associated with development of the next generation of ocular drugs and devices. In particular, the committee has focused on the two challenges which were considered to be of the highest importance in the field. The first is immunogenicity of intravitreal therapeutics, which has become a significant issue across the industry as more intravitreal protein (or protein/polymer combination) therapeutics advance to clinical trials. Immunogenicity of these therapeutics is a significant confounding factor and often makes nonclinical risk assessment difficult. The second key issue is the development of locally-administered complex long-acting delivery technologies, including polymer, device, gene, and/or cell-based therapies. The development of these technologies is complicated by their complex and novel composition, the local cellular response often observed against these systems within the eye, and a lack of clear regulatory guidance in the field.

Meeting Material

Chair: Evan Thackaberry, Genentech, South San Francisco, CA
Chair: Christopher Somps, Pfizer, Groton, CT
Vladimir Bantseev, Genentech, South San Francisco, CA
Edward Chow, Allergan, Irvine, CA
Brian Christian, Covance, Madison, WI
Donald Fox, University of Houston, Houston, TX
Alan Katz, ToXcel, Gainesville, VA
Ron Newton, Novartis, Cambridge, MA
James Render, NAMSA, Northwood, OH
Melva Rios-Blanco, Allergan, Irvine, CA
JoAnn Schuh, JCL Schuh PLLC, Bainbridge Island, WA

Program: Monday, June 27, 2016

Day 1: Ocular and Retinal Toxicology and Pharmacology

8:00 AM–9:45 AM	SESSION I: Ocular Toxicology: Preclinical Models and Specialized Endpoints Chair: Evan Thackaberry, Genentech, South San Francisco, CA Welcome and Overview Evan Thackaberry, Genentech, South San Francisco, CA The Function Morphology of the Vertebrate Eye Christopher Murphy, University of California Davis, Davis, CA Electroretinography in Preclinical Studies Jim Ver Hoeve, University of Wisconsin, Madison, WI State-of-the-Art Ocular Imaging Techniques Michael Twa, University of Alabama Birmingham, Birmingham, AL
9:45 AM–10:15 AM	BREAK
10:15 AM–11:45 AM	SESSION II: Advances in the Development of Protein-Based Intravitreal Therapies Chair: Edward Chow, Allergan, Irvine, CA Nonclinical Safety Assessment of Lucentis® and Clinical Translatability Florence Lorget, Genentech, South San Francisco, CA In Vitro Tools to Control Product Quality Attributes Related Risk Assessments for Ocular Biologic Drugs Swati Gupta and Joe Zhou, Allergan, Irvine, CA Unexpected Toxicity with a Novel Bispecific Fab for Intravitreal Administration: Pharmacology or Immunogenicity? Evan Thackaberry, Genentech, South San Francisco, CA
11:45 AM–12:45 PM	LUNCH
12:45 PM–2:15 PM	SESSION III: The Emerging Role of Ocular Immunology and Immunomodulation in Ocular Disease and Drug Development Chair: JoAnn Schuh, JCL Schuh Consulting PLLC, Bainbridge Island, WA Immunomodulation of Diseases at Ocular Surfaces Neal Barney, University of Wisconsin, Madison, WI Glial Reactivity: Key Roles in Inner Retinal Neurovascular Disease Jeremy Sivak, Toronto Western Research Institute, Toronto, ON, Canada Toll-Like Receptors and Ocular Immunotoxicology Curtis Brandt, University of Wisconsin, Madison, WI
2:15 PM–2:30 PM	BREAK
2:30 PM–4:00 PM	SESSION IV: Drug and Toxicant-Induced Retinal Toxicity, Drug Metabolism, and Translation across Species Chair: Donald Fox, University of Houston, Houston, TX Retinal Toxicology Resulting from Off-Target Effects of Drugs and Occupational Exposures Donald Fox, University of Houston, Houston, TX Translation of Ocular Drug Disposition from Animals to Humans Mayssa Attar, Allergan, Irvine, CA Species Differences in Ocular PK and Drug Molecular Characteristics Kay Rittenhouse, Bayer, New York, NY
4:00 PM–5:00 PM	Roundtable Discussion: Immunogencity of Intravitreal Therapeutics: Lessons Learned Discussion Leader: Edward Chow, Allergan, Irvine, CA

Program: Tuesday, June 28, 2016

Day 2: Toxicology of Novel Ocular Drug Delivery Systems

8:00 AM–9:30 AM	SESSION V: Regulatory Challenges for Developing Novel Ocular Therapies Chair: Evan Thackaberry, Genentech, South San Francisco, CA Regulatory Considerations for Preclinical Ocular Programs in Support of Clinical Trials Mark Vezina, Charles River, Senneville, QC, Canada Regulatory Challenges for Novel Ophthalmic Drug Delivery Gary Novack, PharmaLogic, San Rafael, CA
9:30 AM–10:00 AM	BREAK
10:00 AM–11:30 AM	SESSION VI: Next Generation Biomarkers to Assess Ocular Injury Chair: Melva Rios-Blanco, Allergan, Irvine, CA MiRNAs As Potential Predictors of Retinal Toxicity Qinghai Peng, Pfizer, San Diego, CA E2012-Induced Cataract and Its Predictive Biomarkers Kyoko Nakano, Eisai, Tsukuba, Japan
11:30 AM–12:30 PM	LUNCH
12:30 PM–2:30 PM	SESSION VII: Toxicology Assessment of Novel Slow Release Ophthalmologic Formulations Chairs: Christopher Somps, Pfizer, Groton, CT; and Evan Thackaberry, Genentech, South San Francisco, CA Drug Delivery to the Eye Overview Uday Kompella, University of Colorado, Denver, CO Slow-Release Formulations and Ocularimmunology: Microscopic Observations Vito Sasseville, Novartis, Cambridge, MA Vitreal/Peptide Deposits as a Slow Release Formulation Margaret Collins, Charles River, Reno, NV Challenges of Slow-Release Intravitreal Therapeutics for Age-Related Macular Degeneration James Chastain, Alcon, Fort Worth, TX
2:30 PM–3:00 PM	BREAK
3:00 PM–4:30 PM	SESSION VIII: Developing the Future: Safety Assessment of Gene and Stem Cell Therapies Chairs: Ewa Budzynski, Covance, Madison, WI; and Ron Newton, Novartis, Cambridge, MA IND-Enabling Preclinical Toxicity and Efficacy Studies for an RPE-Patch Developed from AMD-Patient-Specific iPS Cells Kapil Bharti, NEI-NIH, Bethesda, MD Development of Subretinal Gene Therapies for Retinitis Pigmentosa Mark Milton, Novartis, Cambridge, MA Safety and Efficacy of an AAV-Vector Following Subretinal Injection in Mouse Model of Achromatopsia Ewa Budzynski, Covance, Madison, WI