About our work
Translational efforts to bring research discoveries into the Clinic require multidisciplinary knowledge and skills, with a central emphasis on regulatory policies related to FDA approvals for drugs and devices. Especially essential to successfully navigating this pathway is an in-depth knowledge of the specific challenges involved in modifying and adjusting techniques, tools, methodologies, and all other components necessary to meet FDA standards for IND submission and human clinical trials. This expertise, rooted in our commitment to advancing RPE (Retinal Pigment Epithelium) cell biology, histology, and physiology understanding, informs the development of appropriate preclinical models. Our research pursuits are multifaceted, focusing on simplifying, optimizing, and enhancing complex techniques, aligning with the broader goal of making these techniques more accessible to the research community, clinic, and pharmaceutical industry.
By addressing these challenges, we aim to broaden accessibility and facilitate breakthroughs in the study of degenerative diseases. This commitment compels us to generate novel animal models that can significantly advance our comprehension of such conditions. These endeavors align seamlessly with the need for adapting techniques within the translational research process, ensuring that our methodologies satisfy FDA standards while promoting innovation in preclinical model development. Additionally, our research aligns with the requirement for unbiased evaluation of preclinical data, integrating our expertise to rigorously assess outcomes and enhance the clinical applicability of our discoveries. This integrated approach underscores the interconnected nature of our research goals, spanning from regulatory compliance to innovative model development, all in pursuit of advancing clinical translation.
How we can help
The Translational Research Core is composed of a dedicated team with diverse expertise in veterinary medicine, ocular surgery, anesthesiology, and animal husbandry, each possessing extensive research experience across relevant domains. Our core objective is to establish and maintain a comprehensive set of expertise for animal models that meet FDA standards, providing essential validation data for Investigational New Drug (IND) submissions.
We are committed to offering valuable advice and consultation for all early-stage research with translational intent. Our help include:
- Funding Advisory: We can provide guidance on various funding options for translational projects, such as CRADA, M-CRADA, DIR-Funding, Commercial Contracts with Companies, NIH Extramural Collaborators, and collaboration with other government agencies. Additionally, we can assist in generating preliminary data to enhance access to these funding sources.
- Experimental Planning and Design: Our team can help in formulating robust experimental plans and designs, ensuring that research objectives align effectively with translational goals.
- FDA Approval Preparation: We offer assistance in identifying areas that require attention and modification in anticipation of seeking FDA approval, facilitating a smoother regulatory process.
- Animal Model Establishment and Tools Design: Whether establishing new animal models or modifying existing ones to meet specific needs, we provide expertise and training to support independent experimentation.
- GLP Fee-for-Service Testing Advice: We offer guidance and advise on possible pitfalls when establishing commercial Good Laboratory Practice (GLP) fee-for-service testing, that often is needed to seek FDA approvals. Additionally, we can assist in identifying appropriate regulatory compliance advisors.
Our Translational Research Core is committed to supporting researchers in navigating the complex landscape of translational research, establishing new animal models, surgical tool design, ensuring that their projects are well-positioned for success from conception to seek regulatory approval.