Preclinical

Whether you’re in early stage animal efficacy, PK, or tolerability, Ora is the only Ophthalmic CRO that can take you from preclinical through Phase III all in one place. Our in-house experts will select the ideal indication for your MOA, analyze market and regulatory conditions, and position your drug or device to enter the clinic quickly.

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Preclinical Expertise
Ora’s experience spans from preclinical to Phase III. Our strategic relationships with multiple lab facilities provide a wider selection of options and models.
Preclinical Animal Models
Ora offers a full range of preclinical models such as Dry Eye, Ocular Allergy, Age-Related Macular Degeneration, and Diabetic Retinopathy.
Clinical Endpoints
Ora’s preclinical programs focus on clinically relevant endpoints and data. We analyze all the options and select the indication/s that increase the likelihood of regulatory approval.
Business Objectives
Ora integrates your business strategy into the preclinical process, delivering data that meets your business objectives, such as raising VC funds, internal review, proof of concept, etc.

The clinical trial process can be lengthy, costly and present many challenges. Before you embark on the development process, it’s vital to begin your preclinical research with a CRO that has preclinical to phase III experience and the in-house capabilities to deliver efficiencies and reach clinically relevant endpoints.

As the largest ophthalmic-specific CRO, Ora has extensive experience across all facets of preclinical research, from identification and procurement of compounds to conduct of animal models, and management of GLP animal toxicology studies. Our Preclinical Experts focus on delivering clinically relevant endpoints and data, selecting the indication/s that correctly match your mechanism of action (MOA). We use refined endpoints in our ocular models, such as corneal staining in our Controlled Adverse Environment (CAEsm) for dry eye and redness or hyperemia in our Conjuctival Allergen Challenge (CACsm) for allergy, to efficiently screen compounds.

Ora takes an integrated approach to preclinical development, involving the appropriate Ora experts from clinical and regulatory to marketing at the early stage of the development process. Our integrated approach delivers the most informed solutions for preclinical development and shortens the path to the clinic.

Talk with Andy Whitlock
our Preclinical Expert.
(978) 685-8900 Andy Whitlock


Preclinical Expertise

As the only ophthalmic-specific CRO specializing in preclinical models to phase III trials, our preclinical experience spans across all facets of preclinical research from identification and procurement of compounds to conduct of animal models, and management of GLP animal toxicology studies. As a fully integrated CRO, Ora involves the appropriate Ora experts at the early stage of the development process, providing expertise in clinical-regulatory and program strategy, monitoring, medical writing, formulation/CMC, drug delivery, strategic business planning, and tailored marketing/advertising/commercialization solutions. Our integrated approach provides a seamless transfer of knowledge among our in-house experts and a more efficient development program. Ora customizes preclinical activities around a drug’s indication as well as its clinical significance to properly define metrics for value inflection. We also manage the efficiencies of our partners’ toxicology programs in order to help them move into the clinic as quickly as possible.

Ora offers our clients these expert preclinical services:

  • Market analysis
  • Outline for clinical, regulatory and marketing plan
  • Consulting services
  • Clinical indication selection
  • Understanding mechanism of action
  • Provide various development plans for MOA


Preclinical Animal Models

We offer a full range of preclinical models across a wide array of indications, with the focus on delivering clinically relevant data to position your drug or device to enter the clinical trial process quickly. Ora’s long-standing relationships with leading basic scientists and lab facilities, along with our internal laboratory facilities, provides us with unique access to some of the most advanced and appropriate animal models. Interfacing with GLP labs and utilizing our own local lab facilities for screening studies, Ora is able to provide the best solutions for your preclinical development and shorten the path to the clinic.

Key examples of our preclinical models include:
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 (mouse, rat, rabbit or monkey)
  • Steriod-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


Clinical Endpoints

Ora’s Preclinical Experts are focused on delivering endpoints that can take you from preclinical to the clinic quickly. We use benchmark pilot data to help guide preclinical decisions regarding specific compounds, and then design our experiments to your specific MOA and the expected time course of your drug. Using refined endpoints in our ocular models, such as corneal staining in our Controlled Adverse Environment (CAEsm) for dry eye and redness or hyperemia in our Conjuctival Allergen Challenge (CACsm) for allergy, enables efficient screening of compounds as well as later in-depth investigation based on partner needs.


Business Objectives

Ora’s Preclinical Team integrates your business strategy even at early stage of the preclinical process. Early integration allows us to deliver endpoints and data that that can be customized to meet business objectives, such as raising venture capital funding, proof of concept, dose discovery, internal review, and board member review. We provide expert market analysis and clinical, regulatory and marketing plans that enable you to make informed, predictive and profitable decisions about which indications to pursue for your MOA. Our Preclinical Team provides consulting expertise regarding all the opportunities relevant to your drug or device, assessing current and future markets and the likelihood of regulatory approval.