Consulting Services

How Can OSOD Can Help Me?

 

OSOD is a fully functional organization equipped to assist industry at all stages of the development process. OSOD can assist companies (1) on-site (in-house) at their facilities, (2) through conduction of studies executed with our strategic partner, Covance, Inc., and (3) by serving as a portal into OSOD members' laboratories, located at universities across North America. Companies engage OSOD in a variety of ways, from full integration into drug development teams, to performing specific ocular procedures, to providing peer review of pathology findings. It is also possible to have an OSOD employee embedded within a company to facilitate execution of studies and facilitate engagement and communication with the distributed network of experts in vision science that comprises OSOD.

OSOD members are readily available to:

  • Participate in strategic planning
  • Consult on study design
  • Assess company needs for pilot studies, non-GLP or GLP pre-clinical and clinical evaluations
  • Participate as regular members of drug development teams
  • Participate in conduction of studies "in-house" at the company
  • Provide support for electrodiagnostic, OCT, clinical evaluations or other specialized procedures
  • Perform specific ocular surgeries
  • Assist in the analysis of data
  • Schedule pathology review or peer review

Study Types

OSOD provides support for preclinical toxicology (safety and efficacy assessments), ocular pharmacology, in vitro assays, and cell-molecular biology to support the efficient development of treatments for ocular disease. 

We can help you with:

  • Optimizing the design of programs to accelerate IND/IDE filings
  • Discovery, proof of concept, and study designs 
  • In vitroex vivo and in vivo methods and models 
  • Preclinical evaluations
  • Ocular surgical techniques
  • Ocular pharmacology
  • Electrophysiology

Safety Assessments

OSOD vision scientists work with preclinical toxicology specialists at Covance, Inc. to provide access to a wide variety of highly sensitive and accurate in vivo, in vitro, and ex vivo safety studies. Study types include:

  • "Eye-target” safety studies
  • Routine ocular toxicity screening
  • Anterior segment ocular irritation studies, including irritation scoring
  • Contact lens studies
  • Surgical implantation of controlled-delivery platforms and ocular devices

Ocular Pharmacology

Ocular pharmacological studies are designed to assess the impact of novel drugs on ocular diseases and to assess their potential for off-target effects. Research methods may employ a combination of in vivoin vitro, and ex vivo techniques to address the pharmacokinetic and pharmacodynamic potential of a drug to diagnose, prevent, or treat ocular diseases.

Pharmacodynamics

Pharmacodynamics is the study of how a drug works on the body to elicit a biological response.  A large part of pharmacodynamics at OSOD involves studying relationships between drug dose and response magnitude and duration. In addition, these studies are often used to provide mechanistic data explaining how a drug induces a specific physiological response, such as disrupting specific cellular or biochemical processes, altering the production or secretion of proteins, or inhibiting enzyme activities.

Pharmacokinetics

Pharmacokinetics is the study of how the body works on a drug.  These studies include assessing drug delivery, distribution, metabolism, and clearance within various species.  Understanding these parameters is essential for determining the optimal dose level, frequency, and route of administration in the development of any new drug.  

Pharmacokinetic study capabilities at Covance, Inc. currently include:  models of ocular drug delivery, ocular tissue distribution, and metabolism and clearance.

In Vitro Assays

OSOD laboratories could provide support for the following in vitro/ex vivo assays. If the assay you seek is not listed here, please let us know and it is likely that we can provide it.

  • Live dead cell assays. These are used for assessing viability on various cell lines.  Two-color fluorescence assays provide accurate counts of the numbers of live and dead cells. 
  • Evaluation of toxicity, proliferation, and migration of retinal endothelial cells, pericytes, and astrocytes from C57BL/6J mice and human retinal pigment epithelial (RPE) cells following in vitro exposure.
  • Tube formation assays. These provide a model for the study of how endothelial cells work to disrupt neighboring membranes, directionally align and migrate toward a stimulus where additional cells are produced to create new vessels, and ultimately yield a network of three-dimensional vascular structures.  Understanding of inhibition and how induction of new blood vessels impact existing vasculature through angiogenesis may provide clues to understanding developmental processes associated with diabetic retinopathy, tumors, and wound healing.
  • Ocular penetration assays.  These are being used to assess the beneficial and adverse effects of inflammation on the intraocular penetration of various compounds on ocular infections, corneal wound healing, and intraocular pressure.

Cell & Molecular Biology

Within our cell and molecular biology service, OSOD ophthalmologists, veterinarians, and vision scientists conduct a wide range of studies evaluating healthy physiological processes as well as potential inhibitors and activators in the development of pathological processes.  We have access to the latest technologies and employ advanced molecular techniques in our efforts to identify pathways to improvement in the identification and treatment of visual disease.

Animal Models

Over many years, members of our team at OSOD and our colleagues at Covance, Inc. have collected considerable experience in the development, establishment, and characterization of in vivo models of ocular disease. These models are critical in the investigation of ocular disease pathophysiology, characterization of molecular and cellular mechanisms of pathology, and efficacy evaluation of ocular drugs and devices. With Covance, some of the most common animal models we work with include: 

  • Laser-induced choroidal neovascularization (CNV)
  • Corneal wound healing
  • Corneal implantable devices
  • Laser-induced glaucoma
  • Meibomian gland dysfunction

OSOD's university-based experts also have experience with a broad range of models in a variety of species (rodent, rabbit, dog, cat) including:

Rodent Models

  • Choroidal neovascularization (CNV)
  • Retinopathy of prematurity (ROP)
  • Ocular cancer
  • Ocular infection
  • Delayed skin wound healing
  • Glaucoma
  • Neuroprotection
  • Cataract formation
  • Herpetic keratitis
  • Ocular vascularization
  • Corneal wound healing
  • Corneal transplantation

Rabbit Models

  • Experimental dry eye
  • Non-infectious and infectious uveitis
  • Corneal wound healing using an excimer laser

Other Animal Models

  • Dog: spontaneous dry eye, corneal wound healing, implantable corneal devices
  • Feline models of herpetic keratitis

If the study type or animal model you seek is not listed, do not hesitate to CONTACT US. We may very well have access to the validated model or the capacity to execute a study in one of our laboratories. If not, we are very happy to help you locate it through our network of collaborations and our knowledge within the field.