Translational Drug Development Core

The translational drug development core

Improving health through drug development

The Translational Drug Development Core is here to assist you in moving your compound from the lab to preclinical studies.

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Promising compounds need assistance moving from the lab into preclinical studies, which generate in vivo data needed for continued federal funding and licensing.

The CTSI Translational Drug Development Core provides services and expertise in bioanalysis, drug metabolism, and preclinical pharmacokinetics in order to help faculty bridge this gap.

With solid data, researchers can meet the short timelines from provisional to full patent to licensing, enhance federal funding, and accelerate the transformation of new therapeutic interventions for the treatment and prevention of diseases.

To help scientists succeed in this space, we provide the following:

Consultation regarding testing, collaboration, and licensing submission.

Laboratory services to assist in advancing a lead compound based on in vitro data, to transition to full blown preclinical studies.

Bioanalytical services to define the full in vivo pharmacokinetic profile (Absorption, Distribution, Metabolism, and Excretion-ADME) of a compound.

Translational Drug Development support by numbers

These metrics are current as of Oct. 2022

Translational Drug Development Core Services

Analytical method development and validation using UPLC-PDA/QDA, UPLC-MS/MS, UHPLC-Q-TOF

• Analysis of formulations for Active Pharmaceutical Ingredients (API)(Formulation Analysis)
• Analysis of complex natural products for content (Natural Product Analysis)
• Bioanalytical method development (Bioanalysis)

Physiochemical Analysis

• Solubility
• Acid dissociation constant (pKa)
• Partition coefficient

Absorption

• Stability in simulated gastric and intestinal fluid
• Permeability studies using Caco-2 cell line
• Transporter studies using transfected MDCK/HEK cell lines

Distribution

• Stability in plasma/serum
• Plasma protein binding
• RBC to plasma partitioning study

Metabolism studies

• Metabolic stability using microsomes (liver, intestinal), S9, brain homogenate, and hepatocytes
• CYP inhibition and reaction phenotyping
• In vitro (microsomes, S9, hepatocytes) and in vivo metabolite identification (Phase I and Phase II)
• UDP glucuronosyltransferases inhibition

In vivo studies

• Bioavailability/pharmacokinetic studies in mice, rats, or dogs following per-oral, subcutaneous, intravenous, and intraperitoneal routes of administration
• Gender-related pharmacokinetics
• Tissue distribution
• Dose proportionality pharmacokinetics
• Drug disposition in urine, bile, and feces
• Brain-to-plasma ratios

Modeling and simulation

• Determination of exposure-response relationships, population pharmacokinetics, in vitro-in vivo extrapolation, prediction of human dose, PBPK, and covariate modeling

Human clinical trials

• Bioanalysis of test samples from clinical trials

Equipment

Current wet laboratory and analytical space, including the laboratory space for the TDD core, are located in the Medical Science Building and is 2112 ft². The TDD core laboratory is fully equipped for pharmacokinetic studies, metabolism studies, permeability studies, analytical method development, dissolution studies and stability studies. Laboratory computers are equipped with the required statistical, pharmacokinetic and other software programs to perform graphics, spreadsheets, and word processing, curve fitting and statistical analysis. Specific equipment is listed below:

• Waters Acquity UPLC I coupled with Xevo TQ-S-Micro Triple-Quadrupole system
• Waters Acquity UPLC Iplus coupled with Xevo TQ-S-Micro Triple-Quadrupole system (N = 2)
• Agilent 1290 Infinity series UPLC equipped with quadrupole-time-of-flight (Q-TOF) Agilent 6540 mass spectrometer
• Waters Acquity UPLC I-Class with photodiode array and QDa detector
• BioTek Cytation 1 Cell Imaging Multi-Mode Reader
• Thermo Fisher II Biohazard Hoods
• BASi CulexNxT automated blood sampling system
• Dissolution apparatus

Animals

Animals for pharmacokinetic studies will be housed in the Communicore centralized animal facility (AALAC accredited) of the University of Florida. Pharmacokinetic studies will be performed in 270 ft² of animal space available to TDD core in same animal facility. The space dedicated pharmacokinetics (PK) studies is equipped with Basi CulexNxT automated blood sampling system, metabolic cages, and other instruments required for PK studies in rodents.

Consultations

Having a clear, precise plan is critical in moving a compound forward. Our expert team will individually evaluate your needs and provide direction for the next steps.

Plan needs for bioanalytical or animal testing

Direct to appropriate collaborators for measurement of other endpoints where necessary, or to other services/companies for outsourcing when most appropriate

Assistance/guidance on preparation of relevant data for licensing submission

Publications

2018 – 2019 TDDC Publications

Publications from 2018 – 2019 that highlight research that was conducted with the support of the CTSI’s Translational Drug Development Core.

2020 – 2022 TDDC Publications

Publications from 2020 – 2022 that highlight research that was conducted with the support of the CTSI’s Translational Drug Development Core.

CTSA funding citation

In accordance with NIH requirements, all publications, news releases, or other documents about research supported in whole or in part by the UF-FSU CTSA hub or its services must cite the appropriate NIH grant number(s) and ensure compliance with the NIH Public Access Policy.

Below is the recommended language for all investigators who use data compiled by the Core:

Research reported in this publication was supported by the University of Florida Clinical and Translational Science Institute, which is supported in part by the NIH National Center for Advancing Translational Sciences under award number UL1TR001427. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Core leadership

To open the following faculty profiles in a new tab, right-click the corresponding “view profile” link and select “open link in a new tab” from the available menu.

Professor of Medicinal Chemistry

Christopher R. McCurdy, PhD, FAAPS

Phone: (352) 294-8691 | Email: cmccurdy@cop.ufl.edu

Assistant Professor of Pharmaceutics

Abhisheak Sharma, PhD

Phone: (352)294-8690 | Email: asharma1@cop.ufl.edu

For general information or to set up a consultation, contact:

Educational Collaborations

PART OF THE UF CENTER OF EXCELLENCE FOR REGENERATIVE HEALTH BIOTECHNOLOGY (CERHB)

UF Biotility

Please see the link below that will route you to educational opportunities on drug development and regulatory sciences.

Forms and shipping

Shipping address:

University of Florida CTSI Translational Drug Development Core
1345 Center Drive, Room P1-08
PO Box 100497
Gainesville, FL 32610

Requested shipping guidelines:

1. Be sure to verify guidelines and requirements for shipment of biological materials provided by the shipping service company you will be utilizing (FedEx, UPS, DHL, USPS, etc.)
2. Our Core cannot accept weekend or evening deliveries. Please ensure your samples will arrive no later than 4:00 PM EST Monday through Friday. Also, our laboratories are closed on many federal holidays, so please contact the Core to verify we will be able to accept your delivery if you believe it will arrive on a holiday.
3. Label all samples. Be sure that the sample labels correspond with the information provided in our Sample Submission Form.
4. Sample Submission Form: Include completed submission forms inside of a separate plastic zip-type bag to prevent damage. Incomplete submission forms may result in a delay in sample processing. Please use the submission forms found here.
5. Fluid-containing Samples: Use a leak-proof container and place the sample inside a zip-type bag with absorbent material such as paper towels. Using sealing tape around the lid/tops of the containers to prevent leakage is recommended.
6. Ambient Samples: No ice packs necessary for shipping.
7. Refrigerated Samples: Use commercial grade frozen ice packs. Do not utilize ice cubes. Using a foam-type cooler box inside a cardboard box is recommended.
8. Frozen Samples: Ship on dry ice or if allowable, ship on a sufficient amount of ice packs to keep sample viable. Again please do not utilize ice cubes.
9. If shipping ambient along with refrigerated and/or frozen samples, please pack the samples separately in the shipping container to avoid the ambient samples from freezing.