otss website president’s message · 2015. 5. 15. · the final speaker for the workshop was dr....

Ocular Toxicology Specialty Section Newsletter, August 2013

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President’s Message

President’s Message 2013 The Ocular Toxicology Specialty Section is doing well, especially by providing education pertaining to ocular toxicology.

At the 2013 Annual SOT Meeting, members of the OTSS organized and co-sponsored with the Medical Device Specialty Section a Workshop entitled, “ Ocular Medical Devices and Ocular Drug Delivery Systems: Challenges and Opportunities”. OTSS members contributed by giving presentations (synopsis enclosed).

Future program topics will include ocular immunotoxicology, but suggestions for other topics and formats are welcome (contact Dr. Ed Chow, Chairperson of the OTSS Program Committee).

Education includes the annual presentation at the OTSS reception by the winner of the Career Achievement Award. This year it was Dr. Jamie Jester, who gave a talk entitled “Through the Looking Glass: Multi-dimensional View of Ocular Biology". A synopsis of Dr. Jester’s achievements is enclosed. Please make a nomination for the 2014 Meeting by contacting Diana Auyeung-Kim.

Another annual award is for the best ocular paper in Cutaneous and Ocular Toxicology. Enclosed is the reference for the winning article.

Travel awards for students and postdocs are in the planning stages to help increase membership and attendance at the annual meeting. Membership is very important, so please maintain your OTSS membership.

The OTSS is currently interacting with the Japanese Society of Comparative and Veterinary Ophthalmology.

Finally, congratulations to Past President Dr. Margaret Collins and Dr. Andrea Weir for their book, “Assessing Ocular Toxicology in Laboratory Animals”. Many OTSS members were contributing chapter authors (e.g., linked article by Dr. Michael Nork).

See you at the 2014 OTSS Reception. Jim

Newsletter

Spring 2013

Officers

President James Render

Vice President

Edward Chow

Vice President-Elect Evan Thackaberry

Secretary-Treasurer

Marina Seme-Nelson

Communications Officer Chris Somps

Past President Brian Christian

Councilors Linval Depass Diana Auyeung-Kim

Student Representative

TBD

Postdoctoral Representative

TBD

Table of Contents ________________________

Treasurer’s Report…………………………………….…….2 2013 SOT Workshop Synopsis…………………………………….7 SOT OTSS Reception Highlights……………………….3 Program Committee and Book Congratulations………….9 Award Announcements ………………………………….5 Sponsorship and Call for Student Reps……..…….6

Meeting Announcement.……………………………………….…..10 Japanese Ocular Toxicology Events…………………………….11

OTSS Website

mailto:[email protected]








mailto:http://www.toxicology.org/isot/ss/otss/index.asp


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Treasurer’s Report

The numbers! Thanks for the generous gifts of our sponsors!!

Your Text Here

April 2012 April 2013

Ordinary Income/Expense

Income Contributions 6,700 6,005 Dues - - Misc. Income - - Registration 689 587 Interest - -

Total Income 7,389 6,592

Expense Awards 51 51 Plaques - - Executive Meetings - - Miscellaneous - - Newsletter - - Reception 2,452 2,069 Spring/Fall Mtg - - Web Development - -

Total Expense 2,503 2,120 Excess (Deficiency) of Revenue over Expenses 4,886 4,472 Net Assets Beginning of Year 6,238 13,019 Transfers from General Fund -

Unrestricted Net Assets at End of Year 11,124 17,491


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OTSS President Brain Christian opening the reception

Vasilis Vasiliou introducing Career Achievement Award Winner, James Jester

Reconnecting with old friends and meeting new ones.

The OTSS held its annual 2013 reception during the SOT meeting in San Antonio on the evening of March 13, 2013. Roughly 42 people showed up to learn more about the OTSS and its activities, and to celebrate Dr James Jester’s Career Achievement Award and to hear his very interesting presentation entitled “Through the Looking Glass: Multi-dimensional View of Ocular Biology”.

OTSS Reception Highlights


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Dr. Jester receiving his Achievement Award

2013/2014 Executive Committee members

(left-right: Linval Depass, Diana Auyeung-Kim, Evan Thackaberry, Brian Christian, Jim Render, Ed Chow, and Chris Somps)

The old and new Executive Committee members

(left-right: Linval Depass, Diana Auyeung-Kim, Brian Christian, Evan Thackaberry, JoAnn Schuh, Chris Somps, Ed Chow, and Jim Render)


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Career Achievement Award Congratulations to this year’s recipient, Dr Jamie Jester!! The award nominees are selected based on the depth and breadth of scientific contributions and significance of contributions for advancing the field of ocular toxicology. Among the factors included are the education/training/mentorship of young scientists, influence on regulatory and risk/safety assessment decisions related to ocular toxicology, and leadership and service to the ocular toxicology field. Dr Jester is well deserving of the award. He a recognized international leader in the cell biology of corneal wound healing and has had a major impact on this field of research. He currently holds the Jack H. Skirball Endowed Research Chair in Ophthalmology and is Professor of Ophthalmology and Biomedical Engineering at the University of California, Irvine. In the 1990’s Dr. Jester pioneered the development of the Ophthalmic In Vivo Confocal microscope, which is capable of 3-dimensional imaging of the living eye at high magnification and provides for sequential, temporal observation of cells and cellular responses to ocular irritants. He has also been a pioneer in ocular surface imaging and has developed an in vivo imaging approach to diagnose meibomian gland dysfunction using Meibography to identify eyelid gland obstruction. Currently, he is at the forefront of using non-linear optical approaches to evaluating corneal structure and fibrosis by imaging second harmonic generated signals the corneal collagen. Over his career he has published over 235 peer-reviewed papers published in many prestigious high-impact journals, and has trained over 35 undergraduate, graduate, master’s and postdoctoral students.

2012 Best ocular paper in Cutaneous and Ocular Toxicology 2012 Journal year (presented 2013): Sankarathi Balaiya, Robert Malyapa, Wen Hsi, Ravi K. Murthy and Kakarla V. Chalam. "Evaluation of proton beam radiation sensitivity of proliferating choroidal endothelial and retinal ganglion cells with clonogenic assay. Cutaneous and Ocular Toxicology." 31 (1): 14-19. 2012.

Ocular Toxicity Specialty Section Graduate Student/Postdoctoral Fellow Research Award OTSS is planning to offer one award (up to $500) each year to recognize outstanding student/postdoctoral candidates for their contribution to advancing the understanding of ocular toxicology and pharmacology. Please contact Councilor Diana Auyeuhg-Kim for further information.

Award Announcements



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Call for Student and Postdoc Representatives The OTSS is looking for an undergraduate student and a postdoctoral student to serve on the OTSS Executive Committee. Serving as Student or Postdoc representative to the OTSS will provide a valuable experience to young scientists interested in developing their leadership and service skills beyond the lab. Serving in a leadership role in the society of Toxicology also makes a notable addition to your resume or CV. For further information please contact Evan Thackaberry, chair of the OTSS membership committee.

We sincerely thank our sponsors for their generous support!!

Sponsorship

2012 - 2013 Sponsors

2011 - 2012 Sponsors



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2013 SOT Workshop Synopsis

provided by Molly Ghosh

A Workshop entitled, “Ocular Medical Devices and Ocular Drug Delivery Systems”, that was co-sponsored by the Ocular Toxicology Specialty Section and the Medical Device Specialty Section was held during the morning of March 14, 2013 to an audience of approximately 100 attendees. Since the eye is a unique organ that is composed of many different structures, there were diverse topics focused on the therapeutic, safety and regulatory challenges of developing ocular medical devices and drug delivery systems. The first speaker was Dr. Mary Richardson from Bausch and Lomb who discussed the regulatory aspects of developing contact lenses and lens solutions. Since contact lenses are considered medical devices, there is required biocompatibility testing per International Organization for Standardization (ISO) standards and regional regulatory guidance documents, such as ISO 10993-1 (4th Edition), ISO 9394 and ISO 14971 guidelines. A risk management process needs to be a part of the design and implementation of a biological evaluation program which takes into account the end-use application, chemical composition of the device and conditions of exposure. Testing protocols need to be designed to account for the unique chemical and physical properties of the ocular medical device being tested and a rational, science-based approach should be used to develop and justify the biocompatibility test strategy. The next speaker was Dr. Adrian Glasser from the University of Houston who discussed the challenges associated with the development of accommodative intraocular lenses (A-IOLs). This new type of IOL differs from standard IOLs in that they are designed to change shape as the ciliary body moves during accommodation. A-IOLs differ from standard IOLs in that they are bulkier, made of different materials and require more challenging surgical procedures with new surgical devices. As a result, some biological challenges still need to be resolved, such as controlling the post-operative healing response. Future potential applications include the possibility of drug administration from the A-IOL. The third speaker was Dr. Evan Thackaberry from Genentech, Inc. who discussed the safety assessment strategies and challenges for developing intravitreally administered antibody-based therapeutics. In animal models, the treatment may induce inflammation within the eye. For example, poly-lactide-co-glycolide microspheres tended to settle in the ventral aspect of the vitreal cavity ressulting in inflammation, retinal detachment and fibrosis. However, this preclinical immunogenicity may not predict clinical immunogenicity. The next speaker was Dr. Anne Wiese from Allergan. Dr. Wiese described the challenges of developing Ozurdex®, a bioerodable drug delivery system to the posterior segment of the eye. The system consists of a bioerodable implant (poly-lactide-co-glycolide) and dexamethasone. The key to the development of a system like this was the


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understanding of drug distribution and its effects in the eye, the drug release characteristics, the erosion profile of the implant and the toxicological profile of both drug and implant.

The final speaker for the workshop was Dr. Chandramallika (Molly) Ghosh from the Office of Device Evaluation, Center for Devices and Radiological Health (CDRH), Food and Drug Administration (FDA). CDRH regulates all medical devices. Dr. Ghosh discussed the regulatory aspects of developing ocular medical devices. Medical devices are classified into Class I, II, and III. Medical device classification is primarily risk based. Regulatory control increases from Class I to Class III. Class I devices are low risk devices and most Class I devices are exempt from a premarket submission. Examples of Class I ocular medical devices include visual acuity chart and perimeters. Class II devices are moderate risk devices and a premarket notification (510(k)) is required for marketing clearance. A 510(k) requires demonstration of substantial equivalence to another legally marketed device in the U.S. Examples of Class II ocular devices include daily wear contact lenses, contact lens care products, and tonometers. Class III devices (e.g. intraocular lenses, excimer lasers, endotamponades, and viscoelastics) are the highest risk devices and require an approved Premarket Approval (PMA) application prior to marketing the device. The PMA application needs to contain sufficient valid scientific evidence to provide reasonable assurance that the device is safe and effective for its intended use. A review of a 501(k) involves preclinical studies (and clinical studies in some cases) and the decision is typically rendered in 90 days. A review of a PMA involves preclinical and clinical studies, and takes 180 days for a review. Additionally, there is De Novo application for the device “types” that have never been marketed in the U.S. but whose safety profile and technology are now reasonably well understood and HDE (Humanitarian Device Exemption) application for devices for orphan diseases (<4000 patients/year in the U.S.). FDA has a pre-submission program and the purpose of this program is to provide the opportunity for an applicant to obtain FDA’s feedback prior to intended submission of an application. There are several FDA guidances available for ocular devices. They are non-binding but very useful in streamlining the regulatory approval process. FDA’s Device Advice website (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm) is a good resource of information for device submission to FDA. If an ocular device contains a drug or biological component, it is considered a combination product. FDA’s Office of Combination Product (OCP) determines which FDA Center will lead in the review of a combination product and the combination product then follows the regulatory processes applicable to that Center.

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm


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OTSS Committee Update Program Committee One of the benefits of the OTSS is having an opportunity to influence the content of the scientific program at the annual meeting through sponsorship of proposals for meeting sessions. This is our chance to highlight areas of particular interest in our specialty. The Program Committee, under the previous leadership of Brian Christian, has submitted a proposal for a symposium entitled “Ocular Immunotoxicology: A Privileged View”. The session, co-sponsored by the Immunotoxicology SS, will highlight unique aspects of the immunology of the eye and the associated implications for ocular toxicology and the development of ocular therapeutics. For 2015 and beyond, several topics, including retinal toxicity, biomarkers for ocular injury, and in vitro methods for evaluating ocular toxicity, are being considered as possible symposium proposal and there are additional ideas for CE courses as well. The current committee members include: Ed Chow (chair), Brian Christian JoAnn Schuh, Evan Thackaberry Melva Rios-Blanco, and Don Fox

Congrats goes to Margaret Collins and Andrea Weir for the publication “Assessing Ocular Toxicology in Laboratory Animals” Weir, Andrea B; Collins, Margaret (Eds.), New York: Springer, 2012. The idea for the book originated from content provided in the 2010 OTSS continuing education course and is intended for toxicologists and other scientists involved in regulatory toxicology. It provides a concise reference addressing ocular anatomy and physiology across species, approaches for assessing ocular toxicity and regulatory expectations regarding ocular toxicology. OTSS Members Only: Take a look at a sample from the book, click here...

Congratulations!

http://toxchange.toxicology.org/p/do/sd/sid=5756&fid=12545&req=direct


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Meeting Announcement

Thursday September 26

th

8am: Introductions

8:30 – 9:30: Informal case presentations and discussions

9:30 – 10: Break

10 – Noon: Informal case presentations and discussions

Noon – 2pm: Lunch

2:30- 3:30: Gems from other meetings

4 - 5:30pm: Poster Session - McPherson Eye Research Institute

(Atrium HSLC)

5:45 – 6:45: Distinguished Guest Lecturer Timothy Goldsmith

(Rm 1325 HSLC)

Dinner – On your own

Friday September 27th

8:30: - 10: Business meeting

10:30 to noon: Case presentations, Comparative morphology

Noon – 2pm: Lunch

2:30 to 3:30: Rob Nickells, The cell biology of glaucoma

3:30 to 4:30: Gregg Heatley, Glaucoma phenotypes in humans

Evening entertainment/Dinner (Remarks by David Gamm, Director of McPherson

Eye Research Institute)

Saturday September 28th

8:30 – 10:00: Informal case presentations and discussion.

10 – 10:30 Break

10:30 – 11:30: A discussion about appropriate terminology

Case presentations can be anything from recycled presentations at other meetings, case

reports with interesting pathology, discussion of a toxicologic pathology issue, a wild

idea that would benefit from discussion, an anatomic feature, or an expanded presentation

like phenotyping transgenic mice. Come prepared to discuss.

(If interested, please contact the OTSS President)

http://www.vetmed.wisc.edu/ce/upcoming-courses/

Best Western Inn Towner

2424 University Avenue, Madison, WI 53726

Cost is $250


http://www.vetmed.wisc.edu/ce/upcoming-courses/


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Events in Japan pertaining to Ocular Toxicology

Regular Meetings in Japan Related to Ocular Toxicology

Annual conference of JSCVO: once a year, in July or August, with around 120 participants including veterinarians, toxicology researchers and technicians. All the topics are related to ophthalmology

JSCVO fundamental division seminar: once or twice a year, in June and/or in December, with around 40 participants including toxicology researchers and technicians. All the topics are related to ophthalmology

Annual conference of JSOT: once a year, in June or July, with around 1500 participants including toxicology researchers and technicians. Only a few topics are related to ocular toxicology

Annual conference of JSTP (Japanese Society of Toxicological Pathology): once a year, in January or February. Only a few topics are related to ocular toxicology

Topics Related to the Fundamental Division of JSCVO in the Past Two Years Thirty-first annual conference of JSCVO in 2011 ERG collaborative study: comparison between LED build-in contact electrode

system and Ganzfeld dome system Rats

ERG recordings in rats administered to sodium iodate with a contact lens electrode with built-in white LED

ERG recordings in rats administered to sodium iodate with Ganzfeld full-field stimulator

Comparison in rats between the LED system and Ganzfeld system Rabbits

ERG recordings in rabbits administered to sodium iodate with a contact lens electrode with built-in white LED

ERG recordings in rabbits administered to sodium iodate with Ganzfeld full-field stimulator

Comparison in rabbits between the LED system and Ganzfeld system Beagles

ERG recordings in dogs administered to sodium iodate with a contact lens electrode with built-in white LED

ERG recordings in dogs administered to sodium iodate with Ganzfeld full-field stimulator

Comparison in dogs between the LED system and Ganzfeld system Monkeys

ERG recordings in monkeys administered to sodium iodate with a contact lens electrode with built-in white LED

ERG recordings in monkeys administered to sodium iodate with Ganzfeld


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full-field stimulator Comparison in monkeys between the LED system and Ganzfeld system

Fundamental division session

Training of Ophthalmologists for nonclinical safety assessment How to prepare case repots and to collect background data

Oral presentation

Corneal endothelial cells in monkeys Case report of a melanoma in a Crl:CD(SD) rat Malfunction of retinal inner cells in vitamin A-deficient rats Visual damage in pigmented rats administered to PDE5 inhibitors Effects of sevoflurane on VEPs in dogs Evaluation of visual acuity in healthy dogs by using pattern VEP Case report of a dog with negative ERG Effects of beta estradiol on function and anatomy of retinal neurons with N-

Methyl-D-Aspartate-induced damage Thirty-second annual conference of JSCVO in 2012 Oral presentation

Evaluation of visual acuity in dogs by using pattern VEP (Second report) Dark adaptation time in dogs for ERG recordings Periodical evaluation of inner ocular pressure in monkeys Measurement of corneal thickness in monkeys Assessment of eye irritation with the Bovine Corneal Opacity Case report of a F344/DuCrlCrlj rat with nystagmus Spontaneous findings in macula and optic disc in monkeys

Spontaneous ocular findings in Wistar Hannover (RccHan™: WIST) rats

(If interested, please contact the OTSS President for an individual program contact)


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