Nonclinical Development Expertise

Little Creek Research specializes in the development and implementation of nonclinical development strategies for drug products, with a special focus on innovative ophthalmic technologies.  Having worked in multiple small and mid size companies, we are well versed in the need for speed, efficiency, and management of cost, while producing quality data to support fundraising activities and regulatory submissions. 

Over the last 15 years, we have established relationships with trusted and experienced contract research organizations (CROs) that will ensure that your studies are done correctly, within budget, and on time, with an end product report that is appropriate for regulatory submission.  We have also developed long term relationships with subject matter experts, including veterinary specialists, pathologists, and developers of relevant and reproducible nonclinical models.

We have a broad range of experience in relevant ophthalmic therapeutic areas with multiple modes of delivery.  Previous experience includes:

  • Topical solutions, emulsions, and suspensions for glaucoma, dry eye, allergic conjunctivitis, bacterial conjunctivitis, and blepharitis
  • Intraocular delivery of solutions, suspensions, and extended release implants for glaucoma, post-surgical inflammation, uveitis, diabetic macular edema, and age-related macular degeneration
  • Small and large molecules, as well as drug delivery systems and technology platforms
  • Testing and refinement of drug delivery devices such as intraocular injectors

Additional therapeutic area experience includes:

  • Inhaled aerosol for the treatment of cystic fibrosis
  • Dermal ointment for burn pain
  • Oral, intravenous, and intravaginal administration of antivirals
  • Intranasal aerosol for allergy
  • Intravenous infusion to reduce platelet aggregation during pulmonary bypass surgery