Preclinical Development

Integrated Preclinical Development

Ora’s preclinical professionals streamline pre-develop-ment plans by designing studies that are more relevant to the drug indication and its mechanism of action. By taking a team approach to development and involving the appropriate Ora clinical experts early in the devel-opment process, Ora customizes preclinical activities around the drug’s indication as well as its clinical

significance to properly define metrics for value infection. Ora also integrates closely with CMC and formulation plans as well as clinical-regulatory business strategies. In addition, Ora manages the efficiencies of our partners’ toxicology programs in order to help them move into the clinic as quickly as possible.

Indication Preclinical Model

Allergy 48/80 (rabbit) Short Ragweed Sensitization (mouse)

Dry Eye Chronic Desiccation Stress (Scopolamine/Low Humidity Chamber CAE) (mouse)

Acute Inflammatory Stress (ConA/Low Humidity Chamber CAE) (mouse)

Ocular Inflammation Experimental Autoimmune Uveitis (EAU-rat) Endotoxin Induced Uveitis (EIU-rat) Post-operative Inflammation (rabbit)

Glaucoma-Ocular Hypertension Normotensive (rat, rabbit or monkey) Steroid-induced Ocular Hypertensive (rat)

Glaucoma-Retinal Degeneration Optic Nerve Crush (rat)

Wet AMD Laser-induced Choroidal Neovascularization (CNV-rat)

Dry AMD Light-induced Retinal Degeneration (rat)

Diabetic Retinopathy BBZDR Type II Diabetic (rat) Streptozotocin-induced (rat)

Ocular Fibrosis/Proliferative Vitreoretinopathy (PVR) Retinal Detachment (rat and rabbit)

Non-GLP Ocular Toxicity, PK, and Custom Model Development

Rabbit Rat Mouse

Contact: Claire Gelfman, PhD cgelfman@oraclinical.com

300 Brickstone Square | Andover, MA 01810 | (978) 494-4899

www.oraclinical.com

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Ora supports the preclinical development process by selecting the appropriate

indications that match the mechanism of action of the drug, designing an

effcient toxicology program, and integrating the clinical-regulatory strategy.

Our preclinical team has extensive experience across all facets of preclinical

research, from identifcation, assessment and due diligence on new com-

pounds, to conduct of animal models, including set-up and management

of GLP animal toxicology studies. We conduct our core models ourselves in

our local facilities, and Ora’s long-standing relationships with leading basic

scientists and lab facilities provide us with unique access to the most appropriate

animal models and timelines that are necessary for our sponsors. By leverag-

ing the ability to select and partner with the best models and lab facilities, and

providing in-house integration with the entire development strategy, Ora

provides the best solutions for your preclinical development and shortens the

path to the clinic.

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Preclinical Development

Naïve Eye-No Crush Optic Nerve Crush

Hematoxylin-Stained Mouse RetinaOra’s Optic Nerve Crush model is optimized to evaluate glaucomatous

retinal degeneration in glaucoma challenged mice.

Ora is your value-added partner – from molecule to marketplace:

Ora is the world’s leading independent, full-service ophthalmic CRO and product development firm with offices in the United States and Japan. Over the past 30 years, we helped our clients earn 39 FDA approvals. We support a wide array of organizations, from start-ups to global phar-maceutical and device companies, to efficiently and suc-cessfully bring their new products from concept to market. Ora’s pre-clinical and clinical models, unique methodolo-gies and regulatory strategies have been refined and proven across thousands of projects both in the US and interna-tionally. We bring together the world’s most extensive and experienced network of ophthalmic experts and R&D profes-sionals to maximize the value of new product initiatives.

Global R&D

• Strategic Consulting & Indication Selection• Study and Clinical Program Design• KOL Advisory Board Meeting• Formulation/CMC Management• Pharmacology/Toxicology• Preclinical Models• Turnkey Clinical CRO Services: Phase I – IV• Data Management• Biostatistics• IDE/510K/PMA/PIND/Scientific Advice/End of

Phase 2/Pre-NDA Meetings• Regulatory Submissions/Briefing Packages and

FDA Interface• Medical Writing and Publication Support• Marketing, Advertising, and

Product Commercialization

Business Development &

Creative Business Models

• Product/Pipeline Analysis to Evaluate Assets for Re-Purposing into Ophthalmic Indications

• New Product Incubator• Strategic Business Planning• Due Diligence• Network of Investors and Pharmaceutical Partners

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