SBIR_Contract_E-Cig_Webinar.pdf

Developing a Standardized Electronic Cigarette for clinical research studies

Slides will be posted with the solicitation https://www.fbo.gov/spg/HHS/NIH/NIDA-01/N43DA-15-

8921/listing.html https://www.fbo.gov/spg/HHS/NIH/NIDA-01/N43DA-15-8921/listing.html https://www.fbo.gov/spg/HHS/NIH/NIDA-01/N43DA-15-8921/listing.html https://www.fbo.gov/spg/HHS/NIH/NIDA-01/N43DA-15-8921/listing.html https://www.fbo.gov/spg/HHS/NIH/NIDA-01/N43DA-15-8921/listing.html https://www.fbo.gov/spg/HHS/NIH/NIDA-01/N43DA-15-8921/listing.html https://www.fbo.gov/spg/HHS/NIH/NIDA-01/N43DA-15-8921/listing.html https://www.fbo.gov/spg/HHS/NIH/NIDA-01/N43DA-15-8921/listing.html https://www.fbo.gov/spg/HHS/NIH/NIDA-01/N43DA-15-8921/listing.html

NIH Interest in Electronic Cigarettes Impact on Public Health is Unknown

Questions of interest include:

• Can e-cigarettes reduce harm to smokers

• How safe are the e-liquids?

• Can e-cigarettes be used to quit smoking?

• How safe is “second-hand” vapor?

Providing scientific data to inform public policy decisions is part of the NIH mission

How to Answer the Questions Electronic Cigarette Clinical Research

Inpatient Laboratory Studies (1-3 years duration)

• Nicotine absorption studies

• Craving studies

• Vaping style / efficiency studies (Puffing Topography)

Outpatient Studies (2-5 years duration)

• Comparisons of e-cigarettes

• Preferences vs. tobacco cigarettes

• Smoking cessation, harm reduction, etc

Clinical Studies Need a Defined Standard

• E-cigarette must be well characterized with known nicotine delivery capabilities (per puff, duration of cartridge / tank, etc).

• The chosen design must be available for a substantial period (5+ years).

• Clinical studies that could support a therapeutic claim will require an FDA-approved Investigational New Drug application (IND).

What is an IND?

Study design

• Clinical study protocol provided by investigator.

Consists of two parts:

Drug Master File (DMF)

• Chemistry Manufacturing and Controls (CMC) Shows all ingredients are manufactured according to current Good Manufacturing Practices (cGMP).

• Safety and device delivery characteristics.

Why Participate in Developing a Clinical Standard?

• Informing Product Development- Characterizing your existing product will aid future design efforts.

• Diversified Income Stream- Clinical researchers in the US (and beyond) represent a limited / no-competition market niche, where a stable device design is prized.

• “Free” Clinical Data- The supplier would be free to publicize the source of the standard used in a clinical study.

• Other Benefits- Corporations have found individual ways to benefit from an association with the world’s largest medical research funding agency (NIH).

What is an SBIR?

Small Business Administration

SBA

Promotes development of American owned business with < 500 employees.

National Institutes of Health

NIH

27 Institutes and Centers that conduct and sponsor

Public-Health related scientific research

What is an SBIR?

Small Business Innovation Research

SBA NIH

SBIR Awards and Contracts

Research with a viable commercial product or service as the end-product and scientific / public health value.

What Are SBIR Contracts?

Differs from a Build & Supply government contract:

• SBIR funds enable development of a viable business venture in an area of significance to Public Health.

• The final product is not supplied exclusively to the US government.

SBIR Contracts have two phases:

Phase1 Data generation to demonstrate product feasibility.

Phase2 Product development phase.

Details of the Phase 1 Contract

Phase 1: Development and filing of a DMF, including:

• Certificate of Analysis (CoA) for the e-liquid ingredients.

• CoA for the vapor produced using a standard puffing protocol.

• Demonstration of cGMP manufacturing capacity for both device and e-liquid.

• Demonstration of batch reproducibility.

• Initiation of stability studies. 30 day stability data to be included in Phase 1 report.

Six month contract with a value of $225,000

Up to four Phase 1 contracts will be issued

Details of the Phase 2 Contract

Phase 2 : human studies

• Part I: Clinical study to assess nicotine delivery to the blood stream (12 subjects). NIDA may assist with study design and finding clinical partners.

• Part II: One week outpatient study to evaluate the palatability, usability and durability of the device (24 Subjects).

REQUIRED MILESTONE: >15ng/ml nicotine in blood after 30 minutes use.

If device fails the milestone, another Phase 2 applicant will be invited to initiate studies.

Up to two contracts will be issued, with a value of $1.5 million for a period of 18 months.

How Does One Apply for Phase 1?

• Read the Solicitation (RFP). Complete project details and deliverables are on p44-46.

https://www.fbo.gov/utils/view?id=802d74c2caa07b040ee9a3891a790c8c

• Examine SBIR Eligibility Requirements.

http://grants.nih.gov/grants/funding/sbir/eligibility.htm

• Register with Award Management. http:// www.sam.gov

• Register with SBA Company Registry. http://sbir.gov/registration

• Submit an Intent to Apply by Aug 31 2014.

http://www.drugabuse.gov/funding/funding-opportunities/nida-requests-contract-proposals-rfps/proposal-intent-response-sheet

• Submit paper copies of your full proposal by Sept 30 https://www.fbo.gov/utils/view?id=802d74c2caa07b040ee9a3891a790c8c http://grants.nih.gov/grants/funding/sbir/eligibility.htm http://sbir.gov/registration http://www.sam.gov/ http://www.sam.gov/ http://sbir.gov/registration http://www.drugabuse.gov/funding/funding-opportunities/nida-requests-contract-proposals-rfps/proposal-intent-response-sheet http://www.drugabuse.gov/funding/funding-opportunities/nida-requests-contract-proposals-rfps/proposal-intent-response-sheet

Item 1: Technical Element (1 Original, 10 Copies)

• Proposal Cover Sheet (Appendix A) -http://grants.nih.gov/grants/funding/SBIRContract/ContractAppendixA.docx

• Table of Contents

• Abstract of the Research Plan, (Appendix B) -http://grants.nih.gov/grants/funding/SBIRContract/ContractAppendixB.docx

• Technical Element Contents

Item 2: Pricing Proposal (Appendix C, 1 Original, 10 copies)

• http://grants.nih.gov/grants/funding/SBIRContract/ContractAppendixC.docx

Item 3: SBIR Application VCOC Certification (If applicable)

Item 4: Proof of Registration in the SBA Company Registry

How Does One Apply for Phase 1?

The proposal has four parts:

http://grants.nih.gov/grants/funding/SBIRContract/ContractAppendixA.docx http://grants.nih.gov/grants/funding/SBIRContract/ContractAppendixB.docx http://grants.nih.gov/grants/funding/SBIRContract/ContractAppendixC.docx

Important information:

Mr. Brian O’Laughlin Phone: (301) 443-6677. E-mail: bo50d@nih.gov

Address: NIDA R&D Contracts Management Branch, Office of Acquisitions, NIDA 6001 Executive Boulevard, Room 4211, MSC 9559 Bethesda, MD 20892-9559 (use Rockville, MD 20852, if hand-delivered or by overnight service)

• Please communicate any questions as early as possible. The Contract Officer may be unable to respond 2- 3 weeks prior to application deadline.

• Questions and responses may be publically posted.

In order to equally inform all applicants, Q&A will be published on the solicitation web site.

Address proposals and questions to:

mailto:bo50d@nih.gov

Questions and Answers Q: Will the e-cigarette reference device identify the manufacturer and model?

A: No, the device will be unmarked or carry a generic label such as “Reference Electronic Cigarette”.

Q: Could the clinical standard supplier publicize the results of NIH supported studies using their device?

A: NIH strongly encourages researchers to publish the data from their studies. As such the results would be public information.