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Ocular Diseases Drug Discovery

2018-04-202018-02-062017-11-20
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Day 1 - Tuesday, March 20, 2018
7:30
Continental Breakfast & Registration
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8:15
Opening Remarks by GTCbio
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10:30
Morning Networking Break
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Preclinical Development of Novel Technologies
Moderator: Ronald Buggage, Eyevensys
11:00
Topically Applied Novel Therapy For The Treatment of DME
 
Iain Duncan
Iain Duncan
CEO
NeuMedics Inc
About Speaker: Over seventeen years in small and startup pharma in executive positions and 20 years in various fortune 50 Corporations. Previously  VP Manufacturing and Supply Chain Operations, with Horizon Therapeutics and directly managed Product Development, Ma... Read Full Bio 
 
 
Iain Duncan
Iain Duncan
CEO
NeuMedics Inc
 
About Speaker:

Over seventeen years in small and startup pharma in executive positions and 20 years in various fortune 50 Corporations. Previously  VP Manufacturing and Supply Chain Operations, with Horizon Therapeutics and directly managed Product Development, Manufacturing, Quality Control, Distribution and Logistics functions. Mr. Duncan formulated, developed and helped commercialize Horizons’ lead product, DUEXIS© (patent pending).  Co-founder of Corus Pharma Inc. (Patent issued) and served as its V.P. of Operations until Corus was acquired by Gilead in August 2006 for $365M. In addition, Mr. Duncan was extensively involved in re positioning a nasally delivered proprietary reformulation of glucagon for acquisition in 2015 by Lilly Canada.

Mr. Duncan has been directly involved with the FDA approval of 3 drugs which are now commercial and the MAA approval of 2 drugs.

 

 
Abstract: There are no effective or preventive ...Read More 

There are no effective or preventive therapies for DME. DME is diagnosed through careful ocular retinal examinations usually after the emergence of vascular endothelial growth factor (VEGF)-induced retinal leakage. To treat this condition and the retinal damage associated with it, patients currently receive anti-VEGF intravitreal injections, the current standard of care. While anti -VEGF drugs are relatively effective in reducing VEGF-induced leakage, they do not stop other important pathophysiologic processes, including the numerous upstream signaling pathways that lead to early inflammation and subsequent disease progression. Oxidative stress, manifested through increased reactive oxygen species (ROS) and decreased antioxidant potential, has been associated with the early histopathological changes associated with DR,1  including retinal basement membrane (BM) thickening and capillary cell loss2.  The damaging effects of oxidative stress in the early stages of DME induce the activation of multiple inflammatory pathways, including the thioredoxin- inflammasome pathway interacting protein (TXNIP) Nod Like Receptors (NLRP3) 3,4,5, inflammatory pathways involving ERK, P38 and nuclear factor –kβ6, and inflammation induced by poly (ADP-ribose) polymerase-1 (PARP-1) 7,8,9 Notably, inflammation induced by these pathways persists even when hyperglycemia is subsequently corrected, 10 and strategies which target any one pathway have not been shown in multiple randomized trials to be effective for the treatment of DME11  Consequently, there are few currently approved drugs, and no topically administered drugs, to treat DME and other ocular complications of diabetes.

NeuMedics has developed NM108-MiDrops, an analogue of minocycline (NM108) formulated into a non-invasive microemulsion, as a promising new topical therapy for the treatment of DME. Minocycline, a macrolide antibiotic, has other pleiotropic properties which reduce oxidative stress and inhibit each of the DME-associated inflammatory pathways named above, resulting in the scavenging of oxygen-radicals and the reduction of the proinflammatory cytokines IL-1B, IL18 and caspase-1.6    NM108, a non-antibiotic analog of minocycline designed to retain minocycline’s many anti-inflammatory properties, is highly potent (effective at nanomolar concentrations) and can be administered at low dosages for therapeutic efficacy (0.75% solution).  It is a C9-C10 derivative of minocycline formed by the cyclization of 9 amino-minocycline with a suitable carbonylation reagent to form a benzoxazole derivative. MiDrops, a proprietary novel microemulsion used in the formulation of NM108, enhances the bioavailability of active drug in the retina following topical (eye drop) administration. The efficacy of NM108-MiDrops for the treatment of DME was tested in a well-established diabetic rat model. In this model, therapeutic concentrations of NM108 following topical administration were observed in the posterior eye segment, retina, and retinal epithelial tissue associated with a reduction of multiple inflammatory cytokines and a statistically significant reduction in visual loss. These and other data support the hypothesis that NM108-MiDrops is likely to be effective in reducing inflammation and preventing visual loss in patients with DME, ocular trauma, and other inflammatory conditions.

References:

  1. Li, C., Miao, X., Li, F., Wang, S., Liu, Q., Wang, Y., Sun, J. (2017) Oxidative Stress-Related Mechanisms and Antioxidant Therapy in Diabetic Retinopathy. Oxid Med Cell Longev. 2017:9702820. doi: 10.1155/2017/9702820
  2. Wu, Y., Tang, L., and Chen, B. (2014). Oxidative Stress: Implications for the Development of Diabetic Retinopathy and Antioxidant Therapeutic Perspectives. Oxidative Medicine and Cellular Longevity. Article ID752387. http://dx.doi.org/10.1155/2014/752387.
  3. Chen, W., Zhao, M., Zhao, S., Lu, Q., Ni, L., Zou, C., Lu, L., Xu, X., Guan, H., Zheng, Z., and Qiu, Q. (2017). Activation of the TXNIP/NLRP3 inflammasome pathway contributes to inflammation in diabetic retinopathy: a novel inhibitory effect of minocycline. Inflamm Res. 66(2):157-166. doi: 10.1007/s00011-016-1002-6
  4. Yerramothu, P., Vijay, A.K., and Willcox, M.D.P. Inflammasomes, the eye and anti-inflammasome therapy. Eye (Lond).doi: 10.1038/eye.2017.241.
  5. Shin, E.S., Sorenson, C.M., and Sheibani, N. (2014). Diabetes and retinal vascular dysfunction. J Ophthal Vis Res.9(3): 362–373
  6. Shultz, R.B., Zhong, Y. (2017). Minocycline targets multiple secondary injury mechanisms in traumatic spinal cord injury. Neural Regen Res.12(5):702-713. doi: 10.4103/1673-5374.206633.
  7. Kauppinen, A., Salminen, A., and Kaarniranta1, K. (2013). Inflammation as a target of minocycline: special interest in the regulation of inflammasome signaling. Inflammasome. 2013, 2-14. doi: 10.2478/infl-2013-0002.
  8. Kauppinen, T.M., and Swanson R.A. (2007). The role of poly(ADP-ribose) polymerase-1 in CNS disease. Neuroscience, 145(4): 1267-1272.
  9. Krady, K., Basu, A., Allen, C.W., Xu, Y., LaNoue, K.F., Gardner, T.W., and Levison, S.W. (2005) Minocycline Reduces Proinflammatory Cytokine Expression, Microglial Activation, and Caspase-3 Activation in a Rodent Model of Diabetic Retinopathy. 54 (5) 1559-1565; doi: 10.2337/diabetes.54.5.1559.
  10. Calderon, G.D., Juarez, O.H., Hernandez, G.E., Punzo, S.M., and De la Cruz, Z.D. (2017). Oxidative stress and diabetic retinopathy: development and treatment. Eye (Lond).31(8):1122-1130. doi: 10.1038/eye.2017.64.
  11. Lee, R., Wong, T.Y., Sabanayagam, C. (2015). Epidemiology of diabetic retinopathy, diabetic macular edema and related vision loss. Eye Vis(Lond) 2:17. doi: 10.1186/s40662-015-0026-2.
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11:25
Identification of Neuroprotective Drug Targets in Glaucoma
 
Derek Welsbie
Derek Welsbie
Assistant Professor, Department of Ophthalmology
University of California, San Diego
About Speaker: Derek S. Welsbie, M.D., Ph.D., is a board-certified ophthalmologist who has an active medical and surgical practice, specializing in adolescents and adults with all stages of glaucoma. An Assistant Professor of Ophthalmology at the Shiley Eye Institu... Read Full Bio 
 
 
Derek Welsbie
Derek Welsbie
Assistant Professor, Department of Ophthalmology
University of California, San Diego
 
About Speaker:

Derek S. Welsbie, M.D., Ph.D., is a board-certified ophthalmologist who has an active medical and surgical practice, specializing in adolescents and adults with all stages of glaucoma. An Assistant Professor of Ophthalmology at the Shiley Eye Institute, his laboratory studies the way in which glaucoma leads to optic nerve injury, neurodegeneration and, ultimately, vision loss. Specifically, he uses high-throughput genetic screening to comprehensively characterize the genes responsible for nerve cell death. His ultimate goal is to develop new medication- and gene therapy-based neuroprotective strategies to interfere with these deleterious genes, prevent nerve cell death and improve outcomes for patients with glaucoma.

Prior to joining UC San Diego Health, Dr. Welsbie was an Assistant Professor at the Johns Hopkins University Wilmer Eye Institute, where he won the Shafer Prize for innovative glaucoma research from the Glaucoma Research Foundation and was named Assistant Professor of the Year (2015). He also served as the Stephen J. Ryan Assistant Chief of Service and continues to have an interest in resident and medical student education. Dr. Welsbie completed a residency in Ophthalmology and fellowship training in Glaucoma at the Wilmer Eye Institute. He earned his medical degree and doctorate in molecular biology from the David Geffen School of Medicine at UCLA.

 
Abstract: Neuronal cell death in response to ax...Read More 

Neuronal cell death in response to axon injury is a key feature of many neurodegenerations. For example, axonal injury triggers the death of projection neurons called retinal ganglion cells (RGCs) in a group of diseases known as optic neuropathies, resulting in permanent loss of vision. In an effort to identify the gene products responsible for cell death, representing potential neuroprotective drug targets, we previously developed a high-throughput method for delivering small interfering RNA (siRNA) and coupled it with a primary RGC model of cell death in order to perform a high-throughput, functional genomic screen of kinases that are involved in RGC cell death. We and others identified dual leucine zipper kinase (DLK) as being a key mediator of RGC cell death in response to axon injury, including in a rodent models of optic neuropathy. This, along with its role in axon degeneration signaling and its “”druggability,”” make DLK inhibition an attractive neuroprotective strategy. However, in animal models of axon degeneration and/or cell death, inhibition of DLK provides only partial protection suggesting the participation of other as-yet-unidentified mediators.

In order to more extensively characterize the network of genes involved in RGC cell death, we have developed a series of novel high-throughput functional genomic screens. Explaining why DLK inhibition is only partially protective, we identify leucine zipper kinase (LZK) as cooperating with DLK to activate downstream JUN N-terminal kinase (JNK) signaling and cell death in RGCs, including in a mouse model of optic nerve crush. Moreover, our screening has identified four transcription factors, JUN, activating transcription factor 2 (ATF2), myocyte-specific enhancer factor 2A (MEF2A), and SRY-Box 11 (SOX11) which are responsible for RGC cell death following axon injury, both in vitro and in vivo. Highlighting the utility of our unbiased screening approach, two of the factors, MEF2A and SOX11, had previously only been shown to mediate neuronal survival. Using a clustered regularly interspaced short palindromic repeats (CRISPR)-based approach, we show that this set of four transcription factor represent the major downstream mediators through which DLK/LZK activation leads to RGC cell death. Increased understanding of the DLK pathway has implications for understanding and treating neurodegeneration.

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11:50
RNAi Based Therapies for Ocular Conditions
 
Covadonga Paneda
Covadonga Paneda
R&D Manager
Sylentis
About Speaker: Covadonga Pañeda has over fifteen years of industrial and academic experience; she is currently Sylentis’ R&D Manager. She received her M.Sc. in Biochemistry in 1998 and her Ph.D. in Biochemistry in 2001 both from Universidad Autónoma de Madr... Read Full Bio 
 
 
Covadonga Paneda
Covadonga Paneda
R&D Manager
Sylentis
 
About Speaker:

Covadonga Pañeda has over fifteen years of industrial and academic experience; she is currently Sylentis’ R&D Manager. She received her M.Sc. in Biochemistry in 1998 and her Ph.D. in Biochemistry in 2001 both from Universidad Autónoma de Madrid. During her first post-doctoral fellowship at Hospital Niño Jesús, Spain she focused on the development of animal models of human disease and gene expression in the diseased state, she subsequently held a second post-doctoral fellowship at Scripps Research Institute, CA, USA where she extended her studies on gene expression in different disease models and was co-founder of the Mouse Behavioral Assessment Core. She thereafter shifted her career towards industry where she’s held the positions of Study Director and Head of Efficacy and Multidisciplinary Development at Vivotecnia, a non-clinical CRO. Her areas of expertise include ophthalmology, neuroscience, diabetes, aging, metabolic diseases, liver biology, rare diseases, RNA interference and biotechnology derived products. She is author of 32 scientific publications, 5 patents and she is ad hoc reviewer for Medicinal Research Reviews, Behavioral Neuroscience, Ophthalmology, International Journal of Molecular Studies and British Journal of Pharmacology. She is also an external expert evaluator for the H2020 program on Topics PHC 14 – 2015 and H2020-SC1-2017: “New therapies for rare diseases”.

 
Abstract: Short interference RNAs (siRNA) are s...Read More 

Short interference RNAs (siRNA) are small molecules of double-stranded RNA of around 21 base pair long that specifically downregulate the expression of a target gene. This post-transcriptional mechanism of gene expression regulation has been thoroughly used to study gene function. SiRNAs exert their function in the cytoplasm of the cell, where they recognize complementary messenger RNAs (mRNA) and promote their degradation, thus blocking the synthesis of specific proteins. siRNAs can be exogenously introduced to mimic the action of endogenous RNAi triggers. Among the benefits of RNAi is the possibility of transiently silencing any given gene at any stage of development and to affect gene expression in specific anatomical regions without affecting non-targeted regions. These benefits are being used as a basis to develop a new class of innovative drugs that will most likely reach the market in 2018. Here we will outline the advances made in RNAi therapeutics in the field of ophthalmology, and in particular the developmental pathway taken by Sylentis from discovery to phase III. A compound named SYL136001v10, for the treatment of angiogenic diseases of the eye will be used as a model compound to show the potential of this new class of compounds.

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12:15
Translatable Preclinical Models Support Clinical Efficacy of a Novel Transepithelial Corneal-Cross-Linking (TCXL) System
 
Glen Gum
Glen Gum
Associate Director, Ophthalmology
Absorption Systems
About Speaker: Glenwood Gum, M.S., Ph.D. is Associate Director of Ophthalmology at Absorption Systems California, based in the San Diego. Absorption Systems California is an advanced research facility, accredited by the Association of Accreditation and Assessment o... Read Full Bio 
 
 
Glen Gum
Glen Gum
Associate Director, Ophthalmology
Absorption Systems
 
About Speaker:

Glenwood Gum, M.S., Ph.D. is Associate Director of Ophthalmology at Absorption Systems California, based in the San Diego. Absorption Systems California is an advanced research facility, accredited by the Association of Accreditation and Assessment of Laboratory Animal Care International (AAALAC), registered as a research facility with the United States Department of Agriculture (USDA), assured with NIH’s Office of Laboratory Animal Welfare (OLAW) and home to a team of scientists and experts who have many years of combined experience in rodent, rabbit, canine, porcine and ovine research.  Dr. Gum leads the preclinical ophthalmology team whose expertise and experience includes translating models across species, as well as developing new disease and surgical models to assess the efficacy, safety and distribution of therapeutics (small molecules and biologics), devices, stem cells and gene therapy.  Dr. Gum has many years of in vivo experience, in ophthalmic drug discovery, drug development, and toxicology.  Prior to joining Absorption Systems, Dr. Gum was Senior Manager/Principal Scientist at the Biological Test Center (BTC), a division of B. Braun Medical Inc., where he led teams of scientists and technicians performing preclinical in vivo tests of the pharmacokinetics, efficacy, and safety of drugs and ocular medical devices. At Johnson & Johnson IOLAB, in the department of Pharmacology and Toxicology, he was involved in the developed of glaucoma and anti-inflammatory drugs.  Dr. Gum had previously been on the faculty at the College of Veterinary Medicine of the University of Florida for seven years. Over the course of his long career, Dr. Gum has developed or co-developed many of the preclinical models of glaucoma, corneal anomalies, age-related macular degeneration (AMD), retinoblastoma, uveitis, dry eye, and diabetes that are used all over the world for drug testing. He has authored or co-authored more than 120 publications and several book chapters.

 
Abstract: The ability to stiffen the corneal ma...Read More 

The ability to stiffen the corneal matrix by crosslinking collagen using riboflavin and ultraviolet light was pioneered in animals in 19981 and its use in human eyes reported in 20032. Corneal crosslinking (CXL) has rapidly evolved as the only treatment proven to stop the progression of keratoconus. The original Dresden protocol, still widely used today, involves mechanical removal of the corneal epithelium to allow penetration of riboflavin into the corneal stroma2. Epithelial removal has been required as that layer of the cornea has been a barrier to riboflavin penetration and loading of the corneal stroma3. Epithelial debridement (surgical removal of the protective epithelium) leads to a variety of potential complications, pain and long recovery times for the patient 4,5,6.  Thus, multiple efforts have been made to increase riboflavin penetration across an intact epithelium, allowing safe and effective non-invasive CXL 4,7 and speedy recovery while eliminating debilitating pain.

A host of animal studies have experimented with methods to enhance riboflavin penetration of the corneal epithelium; including increased exposure time8, the addition of excipients such as benzalkonium chloride (BAC) ethylenediaminetetraacetic acid (EDTA), 2-Amino-2-(hydroxymethyl)propane-1,3-diol (TRIS), dextran, vitamin E, and the use of iontophoresis 8, 9. There was some improvement in the trans epithelial movement of riboflavin in these studies, but none produced stromal concentrations equivalent to those seen with epithelial debridement 8,9 . Use of enhanced riboflavin formulations in patients with keratoconus produced encouraging early clinical results in patients, followed by disappointing reports of ectatic progression between 1 and 2 years postoperatively 10, 11.  Overall, the effectiveness of these trans epithelial techniques and products has been poor 12 but, despite this reduced efficacy, several riboflavin preparations are marketed in Europe for trans epithelial CXL. We report, in this presentation, preclinical studies using a new system that demonstrates extensive transepithelial penetration of riboflavin into the corneal stroma. Stromal riboflavin distribution and concentration is compared to that of a commercially available product marketed for transepithelial CXL in Europe. The studies compare the corneal penetration of 2 riboflavin ophthalmic solutions. Group 1 used the commercially available ParaCel/VibeX Xtra riboflavin transepithelial system (PVX, Avedro Inc, Waltham, MA). Group 2 was treated with the test article; a system consisting of 1) a novel trans epithelial riboflavin formulation (CLXO), without dextran, in which concentration, pH and osmolarity were optimized to enhance absorption and 2) sterile, proprietary applicators with unique shapes, materials, and pore sizes designed to optimize transfer of the riboflavin solution to the cornea and penetration of the riboflavin into the stroma without creating epithelial defects (CXL Ophthalmics, Encinitas, CA). The results from the studies indicated that the topical application of CXLO achieved a corneal stromal riboflavin concentration greater than that obtained with a commercially available transepithelial product. These data support the safety and efficacy of CXL without the need to remove the epithelium. The results have been accepted for publication in the March 2018 online edition of the Journal of Cataract & Refractive Surgery (JCRS). A companion paper now under review in JCRS shows excellent clinical efficacy of crosslinking with epi-on CXLO thereby demonstrating the translatable success of the preclinical model used.

References

  1. Spoerl E, Huhle M, Seiler T. Induction of cross-links in corneal tissue. Exp Eye Res. 1998 Jan;66(1):97-103
  2. Wollensak G, Spoerl E, Seiler T. Riboflavin/ultraviolet-a-induced collagen crosslinking for the treatment of keratoconus. Am J Ophthalmol. 2003 May;135(5):620-7
  3. Bottós KM, Schor P, Dreyfuss JL, Nader HB, Chamon W. Effect of corneal epithelium on ultraviolet-A and riboflavin absorption. Arq Bras Oftalmol. 2011 Sep-Oct;74(5):348-51
  4. Cagil N, Sarac O, Cakmak HB, Can G, Can E. Mechanical epithelial removal followed by corneal collagen crosslinking in progressive keratoconus: Short-term complications J Cataract Refract Surg 2015; 41:1730–1737
  5. Soeters N, Wisse RP, Godefrooij DA, Imhof SM, Tahzib NG. Transepithelial versus epithelium-off corneal cross-linking for the treatment of progressive keratoconus: a randomized controlled trial. Am J Ophthalmol. 2015 May;159(5):821-8.
  6. Taneri S, Oehler S. Complications after corneal cross-linking. Klin Monbl Augenheilkd. 2015 Jan;232(1):51-60.
  7. Mastropasqua L. Collagen cross-linking: when and how? A review of the state of the art of the technique and new perspectives. Eye Vis (Lond). 2015 Nov 29;2:19.
  8. Franch A, Birattari F, Dal Mas G, Lužnik Z, Parekh M, Ferrari S, Ponzin D. Evaluation of intrastromal riboflavin concentration in human corneas after three corneal cross-linking imbibition procedures: A pilot study. J Ophthalmol. 2015;2015:794256.
  9. Gore DM, O’Brart D, French P, Dunsby C, Allan BD. Transepithelial riboflavin absorption in an ex vivo rabbit corneal model. Invest Ophthalmol Vis Sci. 2015b Jul;56(8):5006-11.
  10. Artola A, Piñero DP, Ruiz-Fortes P, Soto-Negro R, Pérez-Cambrodí RJ. Clinical outcomes at one year following keratoconus treatment with accelerated transepithelial cross-linking. Int J Ophthalmol 2017;10(4):652-655
  11. Caporossi A, Mazzotta C, Paradiso AL, Baiocchi S, Marigliani D, Caporossi T. Transepithelial corneal collagen crosslinking for progressive keratoconus: 24-month clinical results. J Cataract Refract Surg. 2013 Aug;39(8):1157-63.
  12. Mastropasqua L. Collagen cross-linking: when and how? A review of the state of the art of the technique and new perspectives. Eye Vis (Lond). 2015 Nov 29;2:19.
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12:40
Lunch on Your Own
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Translational Studies & Lessons Learned
Moderator: Cristina Kenney, UC Irvine, Gavin Herbert Eye Institute
2:15
Treating Microvascular Retinal Disease Targeting Connexin43 and the Inflammasome Pathway of Inflammation
 
Brian Levy
Brian Levy
Chief Executive Officer
Ocunexus Therapeutics
About Speaker: Dr. Levy is currently CEO of Ocunexus Therapeutics a Biopharm company developing novel and differentiated products in ophthalmology targeting Gap Junction Channel Modulation. Prior to Ocunexus he was Chief Medical Officer at Aerie Pharmaceuticals dev... Read Full Bio 
 
 
Brian Levy
Brian Levy
Chief Executive Officer
Ocunexus Therapeutics
 
About Speaker:

Dr. Levy is currently CEO of Ocunexus Therapeutics a Biopharm company developing novel and differentiated products in ophthalmology targeting Gap Junction Channel Modulation. Prior to Ocunexus he was Chief Medical Officer at Aerie Pharmaceuticals developing Rho Kinase Inhibitors for the lowering of IOP in patients with Glaucoma.

Before entering the startup world he was Corporate Vice President R&D and Chief Medical Officer at Bausch & Lomb for 15 years. At Bausch & Lomb he was responsible for 3 NDA’s for pharmaceuticals (Retisert, Zylet, Besivance) all FDA approved and currently in the market. On the device side of the business he was responsible for 4 PMA’s and multiple 510K’s.   Devices included Phaco Emulsification Equipment and Intra Ocular Lenses for cataract surgery, Refractive Lasers and Microkeratomes for surgical correction of refractive errors and Contact Lenses and Care Systems for non surgical correction of refractive errors. Prior to Bausch & Lomb he was Associate Professor, Department of Ophthalmology at California Pacific Medical Center in San Francisco and prior to that in private practice in Toronto and a clinical investigator and consultant to the ophthalmic industry. He received a Doctor of Optometry degree from the University of California at Berkeley and a Master of Science in comparative anatomy and physiology of the eye at U of Waterloo in Canada.

 
Abstract: Ocunexus target is Connexin43 (Cx43) ...Read More 

Ocunexus target is Connexin43 (Cx43) a protein making up the gap junction hemichannel which is upregulated in chronic microvascular disease such as DR/DME and GA/AMD. Over expression of Cx43 results in pathological opening of the formed hemichannel resulting in ATP release into the extracellular milieu. This activates the inflammasome pathway of inflammation, releasing  multiple cytokines and a cycle of inflammation resulting in microvascular insult. Ocunexus compounds modulate Cx43 hemichannels thereby inhibiting the release of ATP, shutting down the perpetuated cycle of inflammation which in turn shuts down the activation of multiple cytokines and their effect on the microvasculature.

Ocunexus compounds are acting upstream from compounds currently in use or in development for the treatment of compromised microvasculature of the posterior segment and the company has scientifically and repeatedly demonstrated that the drug target is present in diseases of interest, not only in preclinical models, but also in fresh cadaver eyes with disease. The mechanism of action of its 2 compounds for posterior segment disease has been scientifically validated in multiple models of disease.  

Xiflam (small molecule) is orally administered and is Phase 2B ready targeting Geographic Atrophy (GA)/Diabetic Macula Edema (DME)

Peptagon (Peptide5) is intravitreally administered and is preclinical also targeting GA/DME

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2:40
Accelerating the Orphan Retinal Disease Pipeline
 
Brian Mansfield
Brian Mansfield
Senior Vice President, Research
Foundation Fighting Blindness
About Speaker: Dr. Mansfield joined the Foundation Fighting Blindness as the Deputy Chief Research Officer in 2011. He ensures implementation of the Foundation’s scientific research strategic plan, and leads scientific assessments of new technologies, treatments ... Read Full Bio 
 
 
Brian Mansfield
Brian Mansfield
Senior Vice President, Research
Foundation Fighting Blindness
 
About Speaker:

Dr. Mansfield joined the Foundation Fighting Blindness as the Deputy Chief Research Officer in 2011. He ensures implementation of the Foundation’s scientific research strategic plan, and leads scientific assessments of new technologies, treatments and therapies for retinal degenerative diseases. He also leads the patient registry team and the Foundations genetic testing program.

Prior to joining the Foundation, Dr Mansfield was the Chief Scientist and Vice President for Research and Development for Correlogic Systems Inc., a start-up biotechnology company developing serum-based systems for the early detection and diagnosis of cancer. Prior to that he spent 5 years as a Senior Scientist in Protein Development at Human Genome Sciences Inc. leading a mammalian expression group and as project lead for Lead Optimization. Prior to this, Dr Mansfield spent 12 years as a tenured Professor of Eukaryotic Genetics at Massey University, New Zealand and 3 years as a Visiting Professor at Georgetown University, Washington D.C.. Dr Mansfield’s academic research focused the biochemistry and genetics of early developmental genes. Since 1992, Dr Mansfield has also held the position of Adjunct Scientist with the NICHD, NIH, collaborating with Dr Janice Chou on the molecular genetics of Glycogen Storage Disease Type I (GSD-I) and the development of a gene therapy.

Dr Mansfield received an Honors degree in Physical Chemistry from Canterbury University, a Ph.D. in Biochemistry from the University of Otago, New Zealand and completed his post-doctoral training in molecular genetics at the Johns Hopkins University School of Medicine, Baltimore, with Professor Daniel Nathans.

 
Abstract: The Foundation Fighting Blindness is ...Read More 

The Foundation Fighting Blindness is a non-profit organization committed to delivering treatments and cures to slow, halt and reverse disease progression for the orphan inherited retinal diseases (IRD) like retinitis pigmentosa. Orphan retinal diseases are attractive targets for therapeutics since they provide a small, readily accessible, visible target organ that is immune-privileged. While predominantly monogenetic diseases, there are over 200 genes implicated in the different types of IRD. Therefore the IRD are very attractive for demonstrating proof of concept for various gene therapy strategies as well as cell therapies and small molecule drugs. Through leveraged funding of academic work, mentored translational work, and collaboration with biotech and pharma, the Foundation accelerates promising therapies to the clinic and regulatory approval. This presentation provides an overview of the IRD, the various therapeutic strategies employed and the investment strategies used by the Foundation to achieve its mission.

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3:05
Transforming the Eye into a Biofactory for the Sustained Production of Therapeutic Proteins
 
Ronald  Buggage
Ronald Buggage
CMO
Eyevensys
About Speaker: Dr. Ronald R. Buggage is the Chief Medical Officer of Eyevensys, a clinical stage biotech company developing its proprietary EyeCET platform, the first non-viral gene expression technology that enables the safe, local, sustained production of therape... Read Full Bio 
 
 
Ronald  Buggage
Ronald Buggage
CMO
Eyevensys
 
About Speaker:

Dr. Ronald R. Buggage is the Chief Medical Officer of Eyevensys, a clinical stage biotech company developing its proprietary EyeCET platform, the first non-viral gene expression technology that enables the safe, local, sustained production of therapeutic proteins in the eye to address a wide range of ophthalmic diseases. Dr Buggage brings more than 14 years experience from both large pharma and biotech companies having worked in senior development positions in the US and Europe, overseeing clinical development programs for a broad range of ophthalmic indications.

Dr Buggage was most recently Division Medical Officer at Sanofi Ophthalmology Unit, responsible for its ophthalmology portfolio including development programs for ocular gene therapy. He also served as Chief Scientific Officer of Novagali Pharma, where he was responsible for the global clinical and regulatory strategy; Novagali Pharma was successfully acquired by Santen. Prior to moving to France, Dr Buggage held various positions of increasing clinical development responsibility at Novartis and Pfizer. Dr Buggage obtained his MD at UCLA School of Medicine, specializing in ocular pathology and ophthalmology at Emory, and completed his training in ocular immunology and uveitis at the National Eye Institute of the National Institutes of Health (NIH).

 
Abstract: Development of new retinal disease tr...Read More 

Development of new retinal disease treatments are limited due to the challenge of delivering active drug levels to the back of the eye. To overcome such limitations, Eyevensys has developed EyeCET, a non-viral gene therapy technology platform utilizing a proprietary electrotransfection system to deliver plasmids into the ciliary muscle transforming its cells into biofactories for the sustained production of therapeutic proteins in the eye. In preclinical studies no safety concerns were raised following the electrotransfection of plasmids into the ciliary muscle of rat, rabbit and monkey eyes and intraocular protein expression of up to 9 months was observed. In uveitis models EYS606 encoding a potent recombinant anti-TNF protein now in clinical development for uveitis, reduced clinical and histopathologic uveitis scores while EYS611, encoding a neuroprotective protein in preclinical development for the treatment of retinitis pigmentosa, geographic atrophy and glaucoma preserved the outer retinal structures in animal models of retinal degeneration. Due to the simplicity of manufacturing plasmid vectors and the broad range therapeutic proteins they can be enabled to express, the EyeCET platform offers an innovative approach for the treatment of a variety of posterior and anterior segment ophthalmic diseases that may obviate the risks of systemic therapies, the burden of repeated intravitreal injections and more invasive procedures needed to implant devices or create subretinal blebs.

 Read Less
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3:30
Afternoon Networking Break
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Round Table Session

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4:00
Round Table 1: Breaking the Vicious Circle of Dry Eye Disease
Christian Roesky
Christian Roesky
CEO & Managing Director
Novaliq
 
Christian Roesky
Christian Roesky
CEO & Managing Director
Novaliq
 
About Speaker:

Dr. Christian Roesky is CEO and Managing Director of Novaliq. Dr. Roesky has more than 15 years in eye care and extensive operational experience at multiple international healthcare companies. Previously he was general manager for Bausch + Lomb GmbH in Berlin; commercial director, Central Europe of Abbott’s Diagnostics Division; general manager and speaker of the German Country Management Board of Abbott GmbH & Co. KG in Wiesbaden; and, general manager of Alcon Germany & Austria (Novartis). Prior to this, Dr. Roesky worked as marketing manager, EURMEA for Alcon in the USA, Spain and Switzerland, focusing on strategy and market access to transform global and regional commercial activities. He studied chemistry and was awarded his Ph.D. with honors from the Technical University of Freiberg, Germany.

Round Table 2: Funding Hurdles and Alternative Financing Strategies
Emmett  Cunningham
Emmett Cunningham
Partner
Clarus Ventures
 
Emmett  Cunningham
Emmett Cunningham
Partner
Clarus Ventures
 
About Speaker:

Dr. Cunningham joined Clarus in 2006 with extensive experience in the biomedical and biopharmaceutical sectors. Prior to joining Clarus, Dr. Cunningham was the Senior Vice President, Medical Strategy at Eyetech Pharmaceuticals, Inc. (NASDAQ:EYET), where he helped build and lead the team that developed and commercialized Macugen, a first-in-class product for the treatment of age-related macular degeneration. Prior to Eyetech, Dr. Cunningham was at Pfizer, Inc (NYSE: PFE), where he was responsible for the clinical development of early phase central nervous system compounds and the in-licensing of early and late-stage therapeutic candidates in ophthalmology.

Dr. Cunningham is an internationally recognized specialist in infectious and inflammatory eye disease with over 350 publications.  He is Adjunct Clinical Professor of Ophthalmology at Stanford University School of Medicine, was Clinical Professor and Director of the Uveitis service at NYU from 2002 to 2005, and was Director of both the Uveitis Service and the Kimura Ocular Immunology Laboratory at the University of California at San Francisco (UCSF) from 1995 to 2001.   Dr. Cunningham received an MD and MPH in epidemiology and statistics from Johns Hopkins University and a PhD in neuroscience from the University of California at San Diego (UCSD) for work done at The Salk Institute.  He completed both a residency in ophthalmology and fellowship training in Corneal Disease and Uveitis at UCSF and The Francis I. Proctor Foundation, a medical retina and uveitis fellowship at Moorfields Eye Hospital in London, and a fellowship in public health ophthalmology at the Wilmer Eye Institute in Baltimore.

Dr. Cunningham founded and is the Chairman of the Ophthalmology Innovation Summit, a well-attended symposium held in conjunction with the annual meetings of the American Academy of Ophthalmology, the American Society of Cataract and Refractive Surgery and the American Society of Retinal Surgeons. The OIS brings together leading companies, clinicians, academics and investors in the ophthalmology space.

Dr. Cunningham represents Clarus on the Board of Directors of Annexon BiosciencesGraybug VisionRestoration Robotics, and SFJ Pharmaceuticals Group. He is a Board observer for Lumos Pharma and is on the Scientific Advisory Board of Aerie Pharmaceuticals (NASDAQ: AERI).

Previous Directorships include Neomend (acquired by Bard) and SARcode Biosciences (acquired by Shire). Additionally, he was Board Observer for AvillionFerrokin (acquired by Shire), Ophthotech (NASDAQ: OPHT), Pearl Therapeutics (acquired by AstraZeneca), and was a member of the Scientific Advisory Board for ESBATech (acquired by Alcon).  

Round Table 3: Innovative Therapies and Payer Perspective
Daniel White
Daniel White
CEO
Clearside Biomedical
 
Daniel White
Daniel White
CEO
Clearside Biomedical
 
About Speaker:

Mr. White is a founder of Clearside Biomedical and has served as the President and Chief Executive Officer and as a member of our board of directors since our inception in May 2011. From 2008 to 2011, Mr. White served as Executive Director, Global Corporate Development, for Stiefel Laboratories, Inc., a dermatology pharmaceutical company acquired by GlaxoSmithKline in 2009. From 2007 to 2008, he co-founded and served as President and Chief Executive Officer of Percept BioScience, Inc., a biotechnology company. In 2003, Mr. White co-founded, and until 2007 served as Vice President of Finance and Corporate Development of Alimera Sciences, Inc., a biopharmaceutical company focused on ophthalmology. Previously he was Head of Business Development and Licensing for CIBA Vision, a Novartis company, and Director of Licensing and Business Development for AAIPharma. Mr. White holds an M.B.A. degree from Wake Forest University and a B.S. degree in molecular biology from Auburn University.

Round Table 4: Access to the Results of Failed and Negative Clinical Studies
Brian Mansfield
Brian Mansfield
Senior Vice President, Research
Foundation Fighting Blindness
 
Brian Mansfield
Brian Mansfield
Senior Vice President, Research
Foundation Fighting Blindness
 
About Speaker:

Dr. Mansfield joined the Foundation Fighting Blindness as the Deputy Chief Research Officer in 2011. He ensures implementation of the Foundation’s scientific research strategic plan, and leads scientific assessments of new technologies, treatments and therapies for retinal degenerative diseases. He also leads the patient registry team and the Foundations genetic testing program.

Prior to joining the Foundation, Dr Mansfield was the Chief Scientist and Vice President for Research and Development for Correlogic Systems Inc., a start-up biotechnology company developing serum-based systems for the early detection and diagnosis of cancer. Prior to that he spent 5 years as a Senior Scientist in Protein Development at Human Genome Sciences Inc. leading a mammalian expression group and as project lead for Lead Optimization. Prior to this, Dr Mansfield spent 12 years as a tenured Professor of Eukaryotic Genetics at Massey University, New Zealand and 3 years as a Visiting Professor at Georgetown University, Washington D.C.. Dr Mansfield’s academic research focused the biochemistry and genetics of early developmental genes. Since 1992, Dr Mansfield has also held the position of Adjunct Scientist with the NICHD, NIH, collaborating with Dr Janice Chou on the molecular genetics of Glycogen Storage Disease Type I (GSD-I) and the development of a gene therapy.

Dr Mansfield received an Honors degree in Physical Chemistry from Canterbury University, a Ph.D. in Biochemistry from the University of Otago, New Zealand and completed his post-doctoral training in molecular genetics at the Johns Hopkins University School of Medicine, Baltimore, with Professor Daniel Nathans.

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5:00
Networking Reception & Poster Session
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Day 2 - Wednesday, March 21, 2018
 
7:30
Continental Breakfast
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Panel: Ophthalmology Funding Environment

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8:30
CHAIR
Emmett  Cunningham
Emmett Cunningham
Partner
Clarus Ventures
 
Emmett  Cunningham
Emmett Cunningham
Partner
Clarus Ventures
 
About Speaker:

Dr. Cunningham joined Clarus in 2006 with extensive experience in the biomedical and biopharmaceutical sectors. Prior to joining Clarus, Dr. Cunningham was the Senior Vice President, Medical Strategy at Eyetech Pharmaceuticals, Inc. (NASDAQ:EYET), where he helped build and lead the team that developed and commercialized Macugen, a first-in-class product for the treatment of age-related macular degeneration. Prior to Eyetech, Dr. Cunningham was at Pfizer, Inc (NYSE: PFE), where he was responsible for the clinical development of early phase central nervous system compounds and the in-licensing of early and late-stage therapeutic candidates in ophthalmology.

Dr. Cunningham is an internationally recognized specialist in infectious and inflammatory eye disease with over 350 publications.  He is Adjunct Clinical Professor of Ophthalmology at Stanford University School of Medicine, was Clinical Professor and Director of the Uveitis service at NYU from 2002 to 2005, and was Director of both the Uveitis Service and the Kimura Ocular Immunology Laboratory at the University of California at San Francisco (UCSF) from 1995 to 2001.   Dr. Cunningham received an MD and MPH in epidemiology and statistics from Johns Hopkins University and a PhD in neuroscience from the University of California at San Diego (UCSD) for work done at The Salk Institute.  He completed both a residency in ophthalmology and fellowship training in Corneal Disease and Uveitis at UCSF and The Francis I. Proctor Foundation, a medical retina and uveitis fellowship at Moorfields Eye Hospital in London, and a fellowship in public health ophthalmology at the Wilmer Eye Institute in Baltimore.

Dr. Cunningham founded and is the Chairman of the Ophthalmology Innovation Summit, a well-attended symposium held in conjunction with the annual meetings of the American Academy of Ophthalmology, the American Society of Cataract and Refractive Surgery and the American Society of Retinal Surgeons. The OIS brings together leading companies, clinicians, academics and investors in the ophthalmology space.

Dr. Cunningham represents Clarus on the Board of Directors of Annexon BiosciencesGraybug VisionRestoration Robotics, and SFJ Pharmaceuticals Group. He is a Board observer for Lumos Pharma and is on the Scientific Advisory Board of Aerie Pharmaceuticals (NASDAQ: AERI).

Previous Directorships include Neomend (acquired by Bard) and SARcode Biosciences (acquired by Shire). Additionally, he was Board Observer for AvillionFerrokin (acquired by Shire), Ophthotech (NASDAQ: OPHT), Pearl Therapeutics (acquired by AstraZeneca), and was a member of the Scientific Advisory Board for ESBATech (acquired by Alcon).  

PANELISTS
Charlie McDermott
Charlie McDermott
President & Chief Business Officer
Impact Biomedicines, Inc.
 
Charlie McDermott
Charlie McDermott
President & Chief Business Officer
Impact Biomedicines, Inc.
 
About Speaker:

Charlie McDermott serves as President and Chief Business Officer of Impact Biomedicines and has over 22 years of operating experience in the biotech industry. Most recently he served as the President and Chief Business Officer of Kala Pharmaceuticals, Inc.. Since joining Kala Mr. McDermott helped take two programs from discovery though phase 3 trials in 4 years and raised over $200 million dollars, including the July 2017 IPO. Prior to joining Kala, Mr. McDermott was Vice President of Business Development at Allergan, where he completed a variety of transactions and global partnerships that ranged from novel platforms to commercial products (such as Abicipar, RESTASIS MultiDose™, Acuvail™, Lastacaft™, and Latisse™). Mr. McDermott obtained an MBA from the University of San Diego, a M.A. in molecular, cellular and developmental biology from the University of California, Santa Barbara, and a B.S. in biochemistry and molecular biology from the University of California, Santa Cruz.

Daniel White
Daniel White
CEO
Clearside Biomedical
 
Daniel White
Daniel White
CEO
Clearside Biomedical
 
About Speaker:

Mr. White is a founder of Clearside Biomedical and has served as the President and Chief Executive Officer and as a member of our board of directors since our inception in May 2011. From 2008 to 2011, Mr. White served as Executive Director, Global Corporate Development, for Stiefel Laboratories, Inc., a dermatology pharmaceutical company acquired by GlaxoSmithKline in 2009. From 2007 to 2008, he co-founded and served as President and Chief Executive Officer of Percept BioScience, Inc., a biotechnology company. In 2003, Mr. White co-founded, and until 2007 served as Vice President of Finance and Corporate Development of Alimera Sciences, Inc., a biopharmaceutical company focused on ophthalmology. Previously he was Head of Business Development and Licensing for CIBA Vision, a Novartis company, and Director of Licensing and Business Development for AAIPharma. Mr. White holds an M.B.A. degree from Wake Forest University and a B.S. degree in molecular biology from Auburn University.

Mala Dutta
Mala Dutta
Lead, Office of Translational Research
NEI, NIH
 
Mala Dutta
Mala Dutta
Lead, Office of Translational Research
NEI, NIH
 
About Speaker: Mala Dutta completed her graduate studies in Immunology and T-cell signaling from the National Human Genome Research Institute (NHGRI), NIH, under the NIH-GWU Partnership Program. After brief post-doctoral research, she joined the Technology Transfer and Intellectual Property Office (TTIPO) at the National Institute of Allergy and Infectious Diseases (NIAID) as a Technology Development Specialist. She came on board the National Eye Institute’s Office of Translational Research as a Presidential Management Fellow and now leads the office in its technology development, collaboration, translational and inter-agency initiatives.
Firas Rahhal
Firas Rahhal
Partner
ExSight Ventures
 
Firas Rahhal
Firas Rahhal
Partner
ExSight Ventures
 
About Speaker:

Dr. Rahhal is a partner at ExSight Ventures, a venture capital firm specializing in early-stage impact investments in innovative ophthalmic diagnostic and treatment solutions. He is a senior partner at Retina-Vitreous Associates Medical Group in Los Angeles, and is Associate Clinical Professor of Ophthalmology at the UCLA Geffen School of Medicine. He has published extensively in respected peer-reviewed ophthalmology journals and has been an investigator in over 100 ophthalmology clinical trials. Dr. Rahhal completed an Ophthalmology Residency at Cornell University Medical Center, followed by a Fellowship in Vitreoretinal Diseases / Surgery and Uveitis at UCSD Medical Center.

1
1
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Panel: Regulatory Challenges

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9:20
CHAIR
Jonca Bull
Jonca Bull
VP, Regulatory Consulting; Ophthalmology Therapeutic Area Director
PPD
 
Jonca Bull
Jonca Bull
VP, Regulatory Consulting; Ophthalmology Therapeutic Area Director
PPD
 
About Speaker:

Jonca Bull, M.D., serves as vice president of PPD® Regulatory Consulting within Global Product Development. In that role, she works to advance clinical development programs to ensure that new medical therapies are made available to patients in a rapid and cost efficient manner. As a regulatory affairs authority with therapeutic expertise in ophthalmology, she guides therapeutic, protocol and safety reporting training to internal teams at startup and to sites at investigator meetings.

Based in PPD’s Washington, D.C., area office, Dr. Bull joined PPD in 2017 following a career with the U.S. Food and Drug Administration (FDA) and in the pharmaceutical industry. In addition to ophthalmology, she has significant therapeutic experience in clinical regulatory development consulting for biopharmaceutical products in the areas of diabetes and sub-population disparities, non-opioid pain management in osteoarthritis, and sickle cell anemia. She is a subject matter expert in bioethical considerations in clinical trials and patient centricity and patient voice. Prior to joining PPD, Dr. Bull served as assistant commissioner at FDA with a focus on diverse populations and clinical trials; vice president for U.S./North American regulatory policy for Novartis Pharmaceuticals; and director of clinical regulatory policy for Genentech. From 1994 to 2005, Dr. Bull held various senior leadership roles with the FDA across various disease areas and programs. From 1982 to 1994 she cared for patients at a medical/surgical practice in the Washington metro area. She is a diplomat of both the American Board of Ophthalmology and the National Board of Medical Examiners. 

Dr. Bull holds an undergraduate degree from Princeton University, a medical degree from Duke University, and she completed residencies in general medicine and ophthalmology at George Washington University Hospital in Washington, D.C., where she also serves as an assistant clinical professor.  She is a recipient of a 2017 Year of Women Award in recognition of great accomplishment to the field of ophthalmology by Women in Ophthalmology.

PANELISTS
Judy Gordon
Judy Gordon
Founder & President
ClinReg Consulting Services, Inc
 
Judy Gordon
Judy Gordon
Founder & President
ClinReg Consulting Services, Inc
 
About Speaker:

Dr. Gordon is president of ClinReg Consulting Services, a clinical and regulatory consulting practice, and has taken multiple NDAs and PMAs through the FDA review process. She has been involved in conducting clinical trials and obtaining FDA approval for a broad range of drugs, biologics and devices including the first intravitreal sustained release drug delivery system (Vitrasert), intravitreal drugs/biologics for AMD and DME, drug delivery systems for glaucoma drugs, prostate cancer and other oncology drugs, combination products, injectable polymers for tissue bulking in GERD and urinary incontinence, drug-eluting sinus stents, CAD systems for tumor detection, coils and polymers for aneurysm treatment, intracranial stents for stroke prevention, breast biopsy devices, femtosecond lasers for LASIK and cataract surgery, phakic and accommodating phakic IOLs, excimer lasers, and other novel products.

Dr. Gordon has been active in chairing several industry-FDA working groups on guidance documents and has served as the industry representative to FDA’s Ophthalmic Devices Advisory Panel and the CDRH Dispute Mediation Panel

Paul Stone
Paul Stone
Associate Vice President, Regulatory Affairs
Allergan
 
Paul Stone
Paul Stone
Associate Vice President, Regulatory Affairs
Allergan
 
About Speaker:

Paul is the Regulatory Therapeutic Area Head for Ophthalmology and Biosimilars at Allergan. He has overall responsibility for global regulatory strategy for all ophthalmology projects worldwide. In addition, Paul leads the global regulatory development of biosimilars for Allergan.

Paul has held various positions at Allergan. He started his career in Allergan in the UK where he was responsible for the Ophthalmology portfolio in Europe, Africa and Middle East. Since moving to the USA, Paul has been responsible for Global Regulatory Development for the Urology, Dermatology, Neurology & Pain therapeutic areas within the Allergan pharmaceutical portfolio.

Prior to joining Allergan, Paul worked in Regulatory Affairs and Medical Writing at Covance supporting development of a broad range of pharmaceutical products with a variety of pharmaceutical companies.

Paul gained his PhD in Biochemistry & Molecular Biology from the University of Leeds whilst working with Wellcome Biotech. He also has an MSc in Pharmaceutical Medicine from the University of Surrey and a BSc in Biochemistry & Biotechnology from the University of Birmingham, UK.

Balbir Brar
Balbir Brar
VP, Research & Development
Aciont
 
Balbir Brar
Balbir Brar
VP, Research & Development
Aciont
 
About Speaker:

Dr. Brar has over 25 years of experience for drug and device development and world vide registration of 8 major drugs including Botox. His experiences include working with major pharmaceutical companies i.e. Lederle /Wyeth (NYSE: WYE) where he developed Azmacort for asthma and topical Aristocort for atopic dermatitis, both multimillion dollar Drugs and at SmithKline & Beckman (NYSE: GSK/AGN) as Senior Director of Drug Safety, participated in the development of Tazarotene for Psoriasis and Acne.

At Allergan Inc. (NYSE: AGN) as Vice President Drug Safety/Clinical/non clinical PK, Toxicology, Pathology, Life sciences, he made major contributions towards the development and Regulatory submission of 50 IND's/510K's 505(b) 2 and worldwide approval of 8 NDA's which became very successful drugs currently on the market. This included Botox for the treatment of (Cervical dystonia, Cerebral palsy, migraine headache, post stroke dystonia, urinary incontinence, excessive sweating, blephrospasm and strabismus as, medical and Cosmetic), Betagan, Alphagan, Lumigan, Restasis (Dry Eye) Combigan, Ofloxacin, Azelex acne and Avage (Retinoid for wrinkles).

For the past 12 years he has played a leadership role in helping start up Biotechnology Companies where he has held positions of Board member, President, Executive VP R&D, Chief Technology Officer in the field of Diabetic Nephropathy, Oncology, Ophthalmology , Dermatology, and Cardiovascular drugs for plaque reversibility and stabilization. His responsibilities have included participation in fund raising, selection of CRO's for GMP chemical synthesis of API, Drug Product development, manufacture of clinical/non-clinical supplies, stability testing, Non-clinical Studies, Clinical studies, Phase I, II and III, IND and 505(b)2 filing for Virtual companies. Strong contacts with CRO's and experience of working with FDA and Regulatory Agencies worldwide.

Dr. Brar has a Ph.D. in Toxicology/Pathology from Rutgers University and D.V.M. from India with finance training from Harvard Business School. Dr.Brar is a recipient of numerous achievements awards for excellence, belongs to a number of scientific organizations and is the author/coauthor of over 55 scientific publications.

ssclaas=mixsessionprlval=1Array ( [3132] => 1 )
10:10
Morning Networking Break
ssclaas=mixsessionprlval=1Array ( [3132] => 1 )
Partnering between Industry, Academia, and CROs to Advance Research
Moderator: Matthias Birkhoff, Aptar Pharma
10:40
Formulation of Lipophilic Test Agents for Topical Ophthalmic Administration with MiDROPS™
 
Rafal Farjo
Rafal Farjo
Chief Executive Officer
EyeCRO LLC
About Speaker: Rafal Farjo, Ph.D. is Chief Executive Officer for EyeCRO. He has been involved in ophthalmic research for over 20 years and received his bachelor's degree in Cell and Molecular Biology from the University of Michigan and his Ph.D. in Cell Biology fro... Read Full Bio 
 
 
Rafal Farjo
Rafal Farjo
Chief Executive Officer
EyeCRO LLC
 
About Speaker:

Rafal Farjo, Ph.D. is Chief Executive Officer for EyeCRO. He has been involved in ophthalmic research for over 20 years and received his bachelor's degree in Cell and Molecular Biology from the University of Michigan and his Ph.D. in Cell Biology from the University of Oklahoma. During his time at the University of Michigan, Dr. Farjo established a genomics core facility with a special emphasis on discovering genes and pathways associated with Age-Related Macular Degeneration and Diabetic Retinopathy. At the University of Oklahoma, Dr. Farjo's research focused on the characterization of preclinical retinal disease models and the development of new treatment modalities. During this tenure, he published the first study demonstrating the feasibility of using non-viral DNA nanoparticles as a method for gene therapy to ocular cells. He is an author of multiple patents relating to ophthalmic drug delivery and has also published in several prestigious journals, including The Journal of Cell Biology, Genome Biology, Molecular and Cellular Biology, and Investigative Ophthalmology and Visual Sciences.

 
Abstract: The topical delivery of compounds int...Read More 

The topical delivery of compounds into the eye with a suitable eyedrop formulation is the ideal route of administration as it is non-invasive, doses can be easily tailored, and is unlikely to affect other organs due to a low amount of systemic drug exposure. There is a strong desire to advance formulations which can deliver lipophilic molecules into the eye by means of a stable and comfortable eyedrop formulation. EyeCRO has developed MiDROPS™, a proprietary library of thermodynamically stable micro-emulsions which can solubilize very hydrophobic small molecules and deliver them in abundant quantities.

We have formulated and are developing cyclosporine-A (CsA-MiDROPS™), to demonstrate the power of this platform technology. In rabbit studies, CsA-MiDROPS™ deliver significantly more cyclosporine-A into the eye as compared to Restasis®, and was extremely well tolerated. In a mouse model of Dry Eye Disease, we demonstrate that CsA-MiDROPS™ applied once-per-day conferred a significant reduction in corneal permeability as compared to Restasis® applied twice-per-day. Clinical studies are planned in 2018 to further demonstrate the utility of MiDROPS™ to safely formulate therapeutics for topical ophthalmic delivery.

 Read Less
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11:05
Challenges for Modern Drug Development: What to Outsource, When to Partner and Who to Trust to Deliver?
 
Neil  Poloso
Neil Poloso
Director, Biological Research
Allergan
About Speaker: Neil Poloso received his B.S. in Biology from the University of Delaware (1997) and Ph.D. in Immunology from Emory University (2002). While at Emory University, he helped develop a method of deriving cancer vaccines from primary tumor tissue using pr... Read Full Bio 
 
 
Neil  Poloso
Neil Poloso
Director, Biological Research
Allergan
 
About Speaker:

Neil Poloso received his B.S. in Biology from the University of Delaware (1997) and Ph.D. in Immunology from Emory University (2002). While at Emory University, he helped develop a method of deriving cancer vaccines from primary tumor tissue using protein transfer of lipid-linked immune-stimulatory molecules. Following graduate school, Dr. Poloso moved to the National Cancer Institute for a postdoc in the laboratory of Paul Roche studying protein trafficking in antigen presenting cells. While there, he published three papers on the association of MHC class II with lipid rafts. Following his time at the NCI, Dr. Poloso moved into the biotech industry, first with Alba Therapeutics, working on characterizing immune effects of their lead compounds for Celiac disease, and shortly thereafter moving to Allergan, Inc. (2008) in Irvine, CA. At Allergan, Dr. Poloso is currently a Director of Biological Research working to discovery of new therapeutics in the areas of prostaglandins and prostamides in inflammation, hair biology, and metabolic disease.

 
Abstract: In this era of increased externalizat...Read More 

In this era of increased externalization of drug development, the reliance on contract science organizations and academic institutions to deliver high quality research in a timely manner is of the utmost importance. While the nature of how projects are executed is changing, the expectations and speed to decision points has not. How then does one ensure that projects move along at a faster speed with less internal hands to do it with? Outsource! Of course, it’s not that simple. One must decide what functions can be externalized, the nature of the experiments being done, and how to pick amongst an array of potential partners. The farther away you are from your experiment, the more you must trust the partners you choose to drive your overall drug development project forward.

In this presentation, I will walk through some common traits to look for in a partner whether at a CRO or in academia, as well as, provide relevant examples of successful partnering for different types and stages of drug development projects.

 Read Less
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Panel: Partnering between Industry, Academia, and CROs to Advance Research

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11:30
CHAIR
Matthias Birkhoff
Matthias Birkhoff
Vice President, Marketing
Aptar Pharma
 
Matthias Birkhoff
Matthias Birkhoff
Vice President, Marketing
Aptar Pharma
 
About Speaker:

Matthias Birkhoff is Vice President, Marketing, of Aptar Pharma. In this role Matthias is responsible for Aptar Pharma’s Eye Care program and coordinates research and development activities, microbiological assessment and commercial strategies. Matthias started his career in pharmaceutical sales in a major multinational pharmaco before joining Aptar sixteen years ago.

Before getting involved in Business Development and Marketing, Matthias was in charge of sales in the AsiaPacific region. Matthias studied medicine at the University of Dusseldorf, Germany and holds a nursing degree.

Matthias has recently spoken at international events, such as NDD (Nasal Drug Delivery), London/UK, PMP (Pharmaceutical Plastics), Copenhagen/Denmark, Interphex, Tokyo/Japan, CPHI, Pharmapack, AAPS, or the IPA conference in Mumbai/India.

PANELISTS
David  Culp
David Culp
Director, Research
Powered Research
 
David  Culp
David Culp
Director, Research
Powered Research
 
About Speaker:

W. David Culp, Jr., Ph.D. is the Director of Research for Powered Research, LLC. In this role he is responsible for management and oversight of all studies including model development. His training includes modeling and analyzing neovascularization, with specific training in analyzing choroidal neovascularization complexes from the Biological Imaging Core Facility in the Division of Intramural Research at the National Eye Institute (NEI). Furthermore, as a postdoctoral fellow at the University of North Carolina, he evaluated compounds and interfering RNAs in rat models of oxygen-induced retinopathy (OIR). He has significant surgical and microdissection experience and can image, analyze, and interpret data. Prior to joining Powered Research, Dr. Culp worked as a Senior Scientist at Affinergy, LLC, identifying novel peptides using phage display. Dr. Culp has also worked in the Laboratory of Cellular and Molecular Immunology at the National Institutes of Allergy and Infectious Disease developing anti-tumor vaccines. He has authored research articles, intellectual property documents, and has raised over 7 million dollars through the NIH Small Business Innovative Research (SBIR) program. Dr. Culp holds a B.S. in biology from Hampden-Sydney College, and a Ph.D. in experimental oncology from the Karolinska Institute.

Michael Naimark
Michael Naimark
Director, Business Development
CBSET
 
Michael Naimark
Michael Naimark
Director, Business Development
CBSET
 
About Speaker:

Michael is the Director of Business Development at CBSET Inc., a not-for-profit GLP-compliant preclinical research organization based in Lexington MA. Michael holds an MS degree in Human Anatomy & Neurobiology from the University of Tennessee Medical Center and professional certifications in Medical Device Regulatory Affairs, Biologics Regulatory Affairs, and Project Management. Michael has worked in the preclinical research field for 15 years as a study director and study surgeon and most recently served as Project Manager at the Neural Stem Cell Institute (NSCI), where he oversaw the development of a cell-based therapy for macular degeneration under a 4-year award from the New York Stem Cell Foundation. Since joining CBSET Michael has focused on client-centered outreach and the development of new programs and capabilities to expand CBSET's translational research services.

David  Woodward
David Woodward
CTO, JeniVision
Senior Research Investigator, Imperial College London
 
David  Woodward
David Woodward
CTO, JeniVision
Senior Research Investigator, Imperial College London
 
About Speaker:

David F Woodward is the author of almost 200 manuscripts and invited reviews and inventor of approximately 100 patents, including the patents on Lumigan and Latisse. A former GSK and Allergan employee, David F Woodward is now co-founder and CTO of JeniVision Inc. and holds a part-time academic position at Imperial College London, England.

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12:20
Lunch Provided by GTCbio
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Lunch Session: Start-Up Showcase
Moderator: Jerry Cagle, Independent Pharmaceuticals Professional
12:40
 
Christian Roesky
Christian Roesky
CEO & Managing Director
Novaliq
About Speaker: Dr. Christian Roesky is CEO and Managing Director of Novaliq. Dr. Roesky has more than 15 years in eye care and extensive operational experience at multiple international healthcare companies. Previously he was general manager for Bausch + Lomb GmbH ... Read Full Bio 
 
 
Christian Roesky
Christian Roesky
CEO & Managing Director
Novaliq
 
About Speaker:

Dr. Christian Roesky is CEO and Managing Director of Novaliq. Dr. Roesky has more than 15 years in eye care and extensive operational experience at multiple international healthcare companies. Previously he was general manager for Bausch + Lomb GmbH in Berlin; commercial director, Central Europe of Abbott’s Diagnostics Division; general manager and speaker of the German Country Management Board of Abbott GmbH & Co. KG in Wiesbaden; and, general manager of Alcon Germany & Austria (Novartis). Prior to this, Dr. Roesky worked as marketing manager, EURMEA for Alcon in the USA, Spain and Switzerland, focusing on strategy and market access to transform global and regional commercial activities. He studied chemistry and was awarded his Ph.D. with honors from the Technical University of Freiberg, Germany.

 
Abstract: Novaliq GmbH, founded in 2007, is a s...Read More 

Novaliq GmbH, founded in 2007, is a specialty pharmaceutical company focused on the development of innovative water-free ophthalmics and located in the Heidelberg Technology Park, Germany. The company evolved from a start-up company with the first breakthrough therapy approved in 2013 to a leader with the richest Dry Eye pipeline in the ophthalmic industry today.

All product developments are based on Novaliq’s water-free drug delivery technology called EyeSol® which enhances the topical bio-availability, stability and safety of traditionally unstable APIs improving the delivery, efficacy and convenience of treatments for ocular diseases through preservative free and multi dose formulations. Novaliq’s clinical pipeline addresses all key indications in ophthalmology including but not limited to Dry Eye Disease (DED), glaucoma and retinal diseases.

Dry eye disease (DED) is the most advanced therapeutic area for Novaliq. In the US alone approx. 16 million patients are diagnosed while less than 2 million patients are being treated. Clearly this indicates the need for effective therapies for this multifactorial disease. Novaliq’s aspiration is to develop therapies to break the vicious cycle of this growing and sight impairing disease by addressing DED from multiple angles with differentiated therapies under development: (1) first drug treatment addressing meibomian gland dysfunction (MGD) and evaporative-caused DED with NOV03 (2) bestin-class anti-inflammatory treatment for moderate to severe or chronic forms of DED with CyclASol® and (3) first-in-class simultaneous treatment of signs and symptoms in DED associated with ocular pain with NOV07.

Redefining dry eye therapies requires Novaliq to think beyond single product developments. Understanding the disease evolution, identifying and validating new non-invasive diagnostic endpoints and developing objective assessments for patients reported symptoms are critical for short and long-term success. This requires Novaliq’s researchers and managers to constantly adapt new skills & processes, truly think and act globally and to foster external collaboration to get access to non-core competencies in a small but fast learning company.

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12:55
 
John Higuchi
John Higuchi
CEO
Aciont
About Speaker: John Higuchi is CEO of Aciont. Higuchi is a former VP of Business Development and Corporate Treasurer for Lipocine (Nasdaq: LPCN) and currently serves on its Board. Lipocine is a late clinical staged, oral drug delivery company that has filed an NDA ... Read Full Bio 
 
 
John Higuchi
John Higuchi
CEO
Aciont
 
About Speaker:

John Higuchi is CEO of Aciont. Higuchi is a former VP of Business Development and Corporate Treasurer for Lipocine (Nasdaq: LPCN) and currently serves on its Board. Lipocine is a late clinical staged, oral drug delivery company that has filed an NDA for the first oral drug to treat hypogonadism in men and it has an oral drug for the prevention of pre-term birth entering late stage clinical development. Higuchi also is a co-founder and Board member of Spriaso, LLC, which has an FDA approved combination drug product for respiratory therapy and has other primary care products under development. He received his BS degree in Chemistry at Hope College and his MBA and MS in Information Systems from The George Washington University.

 
Abstract: Aciont Inc. is a mid-clinical stage, ...Read More 

Aciont Inc. is a mid-clinical stage, specialty biopharmaceutical company in Salt Lake City, Utah, focused on developing noninvasive therapeutics for sight threatening diseases including severe uveitis, macular edema and other ocular inflammation related indications.

Aciont has two noninvasive, transscleral drug delivery platforms employing an eye applicator system which wears similarly as a scleral lens that administers a drug formulation. One, called Visulex-P, is used to deliver small molecules passively and the other, called Visulex-I, based on iontophoresis, enables the transport of macromolecules. Both treatment modalities currently entail 10 minute or less treatments in a clinical setting administered by a nurse, technician or physician. Preclinical studies also demonstrate that small molecules penetrate the back of the eye tissues efficiently from a topical administration using Visulex-P.

Aciont recently has completed a phase 1/2, multicenter, double-masked, active controlled, clinical study under a US IND filing for the treatment of noninfectious, anterior uveitis with Visulex-P combined with a proprietary formulation of dexamethasone sodium phosphate (DSP-Visulex). This clinical study examined the DSP-Visulex treatment in patients with noninfectious anterior uveitis over a period of 4 weeks. The study shows that 4 to 5 doses of DSP-Visulex therapy provides similar efficacy as the standard treatment for this indication (i.e., 112 eye drops of prednisolone acetate). Although some side effects were reported, DSP-Visulex was determined to be safe and well tolerated in this study.

Benefits:

–Aciont is one of several companies featured in the Start-up Showcase and its presentation will share findings of its preclinical and clinical research.

–Transscleral drug delivery recently has seen advancements in development for the treatment of various intraocular indications (e.g., periocular and microneedle injections) and Aciont’s approach is similar albeit applied topically and noninvasively from the front of the eye.

–This presentation provides insights in the fate of drugs (pharmacokinetics) following topical transscleral treatment administration as well as understanding the pharmacodynamic effects of a pulsatile method of DSP-Visulex therapy.

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1:10
 
John Freshley
John Freshley
President & CEO
ONL Therapeutics, Inc.
About Speaker: John Freshley has 20+ years in leadership roles of start-up companies. His expertise spans the assembly of multi-disciplinary leadership teams, product and business strategy development, partnership development, and fundraising. John joined ONL Thera... Read Full Bio 
 
 
John Freshley
John Freshley
President & CEO
ONL Therapeutics, Inc.
 
About Speaker:

John Freshley has 20+ years in leadership roles of start-up companies. His expertise spans the assembly of multi-disciplinary leadership teams, product and business strategy development, partnership development, and fundraising. John joined ONL Therapeutics in 2013 after serving the company as a mentor-in-residence through the technology transfer office at the University of Michigan. Prior to ONL, John was chief business officer of Compendia Bioscience through its acquisition by Life Technologies in 2012. He launched the company in 2006 with co-founders from the University of Michigan and served as its interim chief executive officer. In this role, he assembled the management team, secured early funding and the company’s initial round of customers. Previously, John had been president and chief executive officer of Genetics Squared (now Everist Health).

 
Abstract: ONL Therapeutics (ONL) is a biopharma...Read More 

ONL Therapeutics (ONL) is a biopharmaceutical company committed to protecting the vision of patients with retinal disease and pioneering an entirely new approach to preserving sight. It is the first and only company focused on preventing Fas-mediated retinal cell death, which is a root cause of vision loss, a leading cause of blindness and a completely unaddressed medical need.

Lead product candidate ONL1204 is a first-in-class small peptide Fas inhibitor that has been shown to protect multiple retinal cell types in a range of retinal disease models by blocking both direct cell death activation as well as immune response signaling which amplifies death signaling.  These disease models include in vivo models of retinal detachment, dry AMD, and glaucoma. ONL1204 is initially being developed for the treatment of retinal detachment, a condition for which the company has been granted orphan drug designation by the FDA.

ONL has assembled an experienced management team and scientific team with thought-leaders in retinal cell protection and drug development.

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Keynote Panel Discussion

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3:15
Conference Concludes