Early Stage Preclinical Development
Agreements and protections are needed to ensure successful translation of the research discovery to clinical application in the future. Patent protection is a critical element for successful translation of new drugs to clinical application. You need to ensure you are taking steps to protect your research discovery for future patentability.
OTRS can help guide you through the processing and timely execution of agreements and invention disclosures you may need for your research discoveries.
Material Transfer Agreement (MTA) for incoming or outgoing research material
- MTAs protect the rights of both parties in the transfer of research materials
Confidential Disclosure Agreement (CDA), also known as Non-Disclosure Agreement (NDA), for protection of confidential information
- Needed for transfer of confidential information between a company and University investigators
- Must be signed by a University official
Intellectual Property Agreement (IPA) for compliance with sponsored research agreement terms and conditions
- A school or college may require staff and students to enter into an IPA
- For disclosure of inventions and compliance with provisions of sponsored research agreements
Invention Disclosure Report (IDR) for equity review and potential protection of your discovery
- All discoveries by UW-Madison faculty, staff or students must be disclosed in an IDR to WARF
- Once the IDR is processed by WARF, the Graduate School will complete an equity review to determine who has ownership rights to the invention
- Following that, the inventor may have the option to work with WARF for patent protection
- IDRs / patent protection ideally should be in place before public disclosure
Sources for Additional Forms and Information
Several areas of preclinical testing require completion before a new drug can move into clinical research. OTRS can assist you with finding resources to complete your preclinical testing research. See OTRS Services and Research Connections.
- Determine formulation
- Establish route of administration
- Methods to test drug/blood/tissue interactions of the intended formulation
- Methods to analyze drug characteristics (solubility, pH, stability, and test against safety specifications) of the intended formulation
- Show drug bioavailability (orally bioavailable drug is ideal)
- Single dose administration to determine the amount of drug in blood/tissue
- Administration, Dose, Metabolism, Excretion (ADME) in a preclinical model gathered from three different sources (animal model/tissue collection/bioanalytical testing)
- Establish Maximum Tolerated Dose (MTD)
- Establish efficacy against disease model/drug target in vivo
As preclinical testing research is coming to completion / preclinical efficacy is demonstrated, preparation for an IND application should begin, including IND-required toxicity studies and clinical protocol development.
What is an Investigational New Drug (IND)?
The Investigational New Drug (IND) Application fulfills the following two regulatory requirements:
- Federal law requires that a drug be FDA approved before it can be transported across state lines. The IND is a technical request for exemption from the federal law.
- The IND is a request for permission to conduct clinical trials by supplying relevant non-clinical, CMC and previous human experience (if applicable) in the application.
What is the purpose of an IND?
To assure data quality and study subject safety by requiring the following:
- Animal pharmacology and toxicology data
- Manufacturing information
- Clinical protocols and Investigator information
Types of INDs:
- Investigator IND – submitted by a physician who both initiates and conducts the investigation, and under whose immediate direction the investigational drug is administered or dispensed.
- Emergency Use IND – allows the FDA to authorize use of an experimental drug in an emergency situation that does not allow time for submission of an IND in accordance with 21CFR, Sec 312.23 or Sec. 312.34.
- Treatment IND – submitted for experimental drugs showing promise in clinical testing for serious or immediately life-threatening conditions for which there are no satisfactory alternative treatments. The experimental drug is made available while the final clinical work is conducted and the FDA review takes place.
Pre-IND meeting with FDA:
- Novel indication (new use for marketed drug)
- No current Guidance Documents available from the FDA on the new agent
- Unique (new) molecular identity, studies, or indications
- New sponsors or new to area of drug development
- Guidance in Pharm/Tox studies
- Problematic Pharm/Tox studies
- Avoid protocol amendments
- Review and reach agreement on the design of animal studies needed to initiate human testing
- Discuss the scope and design of Phase 1 testing, plans for studying the drug product in pediatric populations and best approach for presenting and formatting data in the IND
IND content and format requirements
Contents of IND application (reference 21 CFR 312.23)
- FDA Form 1571
- Table of Contents
- Introductory Statement
- General Investigational Plan
- Investigator's Brochure
- Investigator data
- Facilities data
- IRB data
- Chemistry, Manufacturing and Control data
- Environmental assessment or claim for exclusion
- Pharmacology and toxicology data
- Previous human experience
- Additional information to be considered
- FDA IND Application Information