IND- Investigational New Drug

1. IND ENABLING
STUDIES
Submitted By -
Anurag Chourasia
M.Pharma

2. Contents
■ Definitions
■ Categories of IND
■ Pre IND meeting
■ Content and Format of IND
■ FDA Form
■ Pre IND Development
■ INDClinical Development
■ NDA/BLA
■ Marketing
■ Overview of the Regulatory Process

3. Definitions
■ Sponsor
A sponsor is an individual, company, institution, or organization that takes responsibility for and
initiates a clinical study
■ Investigator
An investigator is an individual under whose immediate direction the study drug is administered or
dispensed. If a team is involved, the leader is the investigator; other team members are sub-
investigator
■ Sponsor-Investigator
A sponsor-investigator is an individual who both initiates and conducts a study and under
whose immediate direction the study drug is administered or dispensed.This person must
follow the requirements pertaining to a sponsor and those pertaining to an investigator

4. IND
■ An IND is a submission to the food and drug administration (FDA) requesting permission to initiate a
clinical study of a new drug product.
■ The Federal Food , Drug and Cosmetic act requires that drugs have an approved marketing application
before they can be shipped in interstate commerce.
■ The IND application allows a company to initiate and conduct clinical studies for their new drug Products.

5. Regulatory Process

7. When DoWe Need IND
■ An IND is required any time when we want to conduct a clinical trial of an unapproved drug.
■ An IND would be required to conduct a clinical trail if the drug is :
-- A new chemical entity , not approved for the indication under investigation in a new dosage form.
-- Being administered at a new dosage level.
--In combination with another drug and the combination is not approved.

8. Categories of IND
■ COMMERCIAL IND : Goal is to obtain marketing approval for a new product.
■ NON-COMMERCIAL IND : It includes :
INVESTIGATOR IND : In this case ,the physician is both the sponsor and investigator.
EMERGENCY IND : FDA authorize immediate dispensing of a non-approved drug in a life threatening
situation when no standard acceptable therapy is available.
TREATMENT IND : FDA will permit investigational drug to be used to treat a serious or life threatening
disease or if there is no comparable alternative drug available.

9. Pre IND Meeting
■ A meeting between the sponsor and the FDA frequently is useful in resolving questions and
issues raised during the preparation of an IND.
The FDA encourages such meetings to the extent that : They aid in the solution of scientific
problems and
To the extent that the FDA has available resources.
Most issues and questions are usually related to
Design of animal studies needed to initiate the clinical trials.
The scope and design of the initial study in Humans.

10. Content and Format of IND Application
■ The content and format of an initial IND is laid out in 21 CFR(code of federal regulations) part 312 .
■ 1. Cover sheet – 312.23(a)(1) FDA form 1571
■ 2.Table of contents – 313.23(a)(2) 3. Introductory statement and general investigational plan –
312.23(a)(3)
■ 4. Investigators brochure – 312.23(a)(5)
■ 5. Clinical protocol – 312.23(a)(6)
■ 6. Chemistry , manufacturing and control data – 312
■ 7. Pharmacological and toxicological information – 312.23(a)(18)
■ 8. Previous human exposure – 312.23(a)(9)
■ 9.Additional information – 312.23(a)(10) 10. Relevant information – 312. .23(a)(10)
■ 10. Relevant information – 312.23(a) (11)

11. FDA Form 1571
1.Name of the sponsor :
He/she is the person who takes responsibility for and initiates a clinical investigation.
May be a pharmaceutical company, a private or academic organization, or an individual
2.Date of submission :
It is the date when the application is mailed to FDA.
3. Address :
It is the address to which written correspondence from FDA should be directed
4.Telephone number :
It is the number where the sponsor is usually available during normal working hours.A telephone number must
be provided.
5. Name(s) of Drug :
List the generic name(s) and trade name, if available. Also, state the dosage form(s)

12. FDA Form 1571
6. IND Number :
If an emergency IND number was previously assigned by FDA, or the Form FDA 1571 is being included with
an amendment to the original IND, then that IND number should be entered here; otherwise, the space
should be left blank.
7. Indication.
8. Phase of clinical investigation to be conducted.
9. list number of all investigational new drug application.
10. Serial number.
11. Contents of application
12.Name and title of the person responsible for monitoring the conduct and progress of clinical
investigation
13. Is any part of the clinical study to be conducted by CRO.

13. FDA Form 1571
■ 14. Name of sponsor’s authorized representative
■ 15.Signature
■ 16.Address
■ 17.Telephone no.
■ 18.Date

14. Pre-IND Development
• The regulatory approval process usually begins with the submission of an Investigational New
Drug (IND) application, which contains information that the FDA needs to decide if a drug is safe
to study in humans.
• The information included in the IND application must be generated before clinical studies can
occur, sometimes called the Pre-IND or Pre-clinical phase of development.
• Although the FDA is not required to be involved during the Pre-IND phase, the FDA can guide
sponsors in putting together an IND package through the Pre-IND Consultation Program.
>>
Critical Question:
Is the drug safe?

15. IND Clinical Development
A series of progressively larger clinical trials are conducted as more information is learned about the safety
and potential efficacy of the drug.The trials are typically separated into three phases of development:
Phase I: THESETRIALS include several small trials designed to learn how the drug is broken down by the
body and to begin studying the drug’s safety in humans.
Phase II: These larger trials look for evidence that the drug is acting as expected and compare different
ways of giving the drug in order to find a safe and potentially effective dosing strategy.
Phase III: These MUCH larger trials are intended to verify that the drug is safe and prove that the drug is
effective.
Critical Question:
To what extent is it
safe?
>>
Phase 3
>>
Phase 2
Phase 1

16. New Drug Application (NDA)/
Biologics License Application (BLA)
• If the results of the Phase 3 trials show that the drug is safe and effective, then the Sponsor may submit a
New Drug Application (NDA) or Biologics LicenseApplication (BLA). If the NDA/BLA is approved, then the
drug may be sold and used by the public.
• The FDA and Sponsor agree upon the drug’s label, which provides information to help physicians and their
patients decide if they wish to use the drug and provides instructions for how it should be used.
Critical Question:
To what extent is it
safe?
>>
Phase 3
>> NDA/BLA
Application
Phase 2

17. Post-Marketing
• The FDA may require that additional non-clinical studies or clinical trials be completed after the NDA/BLA is
approved. For example, an additional clinical study might be conducted to provide information for a group of
people who might benefit from the drug but who were not included in previous trials.
• The FDA continues to receive and review long-term safety information for approved drugs. Identification of
new safety issues could require changes to the drug’s label or, in extreme cases, withdrawal of the drug from
the market.
Phase 3
Phase 2
Phase 1
>> NDA/BLA
Application
>>
More Trials Manufactured>>
Manufactured>>
Continualoversight

18. OVERVIEW OF THE REGULATORY PROCESS
>>
Critical Question:
Is the drug safe?
>>
IND
Application
Critical Question:
To what extent is it
safe?
>>
Phase 3
Phase 2
Phase 1
>> NDA/BLA
Application
>>
More Trials >> Manufactured
>> Manufactured
Continualoversight

19. References
■ http://www.bioscience.org/2013/v5e/af/627/fig1.jpg
■ https://image.slidesharecdn.com/ctp-150215132923-conversion-gate02/95/clinical-
trial-phases-8-638.jpg?cb=1424007678
■ https://www.researchgate.net/publication/260606556/figure/fig3/AS:273652612595733
@1442255275238/The-drug-development-process-from-preclinical-development-to-
approval-The-focus-of-this.png