Welcome to Paratek’s Investigator Initiated Research (IIR) Portal

The purpose of Paratek’s IIR program is to advance and improve patient care through high-quality research that is initiated, implemented, conducted, and sponsored by external investigators.  This portal will enable you to submit your proposal for review, and if approved, to track the progress of your study from the start to end date.

All proposals and protocols are reviewed by a cross-functional Review Committee which includes medical, clinical, safety, biostatistics, and compliance representation.  This is a competitive funding program and decisions are based on scientific merit and available funding.

Paratek’s 2020 Areas of Interest 

Paratek supports research in multiple areas, including but not exclusive to:

   - Special Patient Populations
   - Pathogens or Resistance Mechanisms of Interest
   - Additional Disease States
         - Not Included in Current Clinical Studies
   - Real World Evidence
         - Studies Describing the Use, Efficacy and Safety of Omadacycline

Overview of Process for Submission and Review

The Paratek IIR process consists of 2 stages: an initial proposal (Stage 1) and if approved, a full protocol followed by a funding decision based on the full protocol (Stage 2). Approval at Stage 1 does not guarantee funding; it only indicates sufficient interest in the proposed research project for consideration of a full protocol submission. Funding decisions are made ONLY following review of a full protocol (Stage 2). As this is a competitive funding program, not all protocols reviewed in Stage 2 can be funded.

All proposals and protocols are submitted to Paratek using the online portal. The required documents for each stage of the process are outlined here:

Stage 1 (proposal)

   - Brief Proposal, Including Study Timeline (3-4 pages maximum)
   - CV of Principal Investigator
   - W-9 (US)/W-8 (ex-US) of Institution Where the Study will be Conducted
   - Budget

Stage 2 (full protocol)

   - Full Protocol, Including Study Timeline
   - Finalized Budget
   - Data Collection Form (if applicable)
         - Only required for studies involving human subjects

If drug or standard powder is required, the exact amount must be included within in the proposal and additionally in the full protocol.

   - 1 tablet – 150 mg
   - 1 IV vial – 100 mg

Proposals will not be reviewed if all required documents are not submitted by the submission deadline.  Paratek’s IIR Review Committee meets every-other month, and all required documents must be received 14 days prior to our review meetings.  If all required documents are not received by the submission deadline, the submission will not be reviewed and will be moved to the following meeting assuming all documents are submitted.

Standard Powder Only Requests

If you are interested in only submitting a request for standard powder and no funding, please send a brief proposal via e-mail that includes the following items (1-3 page maximum) to: MedicalAffairs-Research@ParatekPharma.com.

   - Rationale/Background
   - Description of the Methodology, to include, but not limited to:
         - Testing Procedures
         - Description of Isolates. Examples:
               - Resistance Mechanisms
               - Number of Organisms to be Studied
               - Source of the Isolates (i.e., surveillance or banked strains, were they clinical?)
   - Study Timeline, Including Start and End Date
   - Publication/Presentation Plans
   - Primary Investigator’s Name, Address, and Shipping Information for the Standard Powder
   - Amount of Standard Powder Being Requested
   - Name and Contact Information of the Person who will Handle Contracting*

All standard powder requests will require a Materials Transfer Agreement (MTA).

   - Decisions will be made within one week of receipt of request.  Please allow an additional 1-3 days around US holidays. You will be notified when your request has been approved or denied by Jennifer.Kring@ParatekPharma.com, please reach out to her with any questions related to the process
   - As stated above, an MTA will need to be signed by both parties before the supply is shipped.  Once this is fully executed the shipment will be requested by Paratek, please give a 2-week turnaround for receiving the shipment after a fully executed MTA.

Paratek’s 2020 IIR Review Meetings:

   - April 28, 2020 (Deadline for Complete Submittal, April 7, 2020)
   - June 30, 2020 (Deadline for Complete Submittal, June 9, 2020)
   - August 25, 2020 (Deadline for Complete Submittal, August 4, 2020)
   - October 27, 2020 (Deadline for Complete Submittal, October 6, 2020)
   - December 10, 2020 (Deadline for Complete Submittal, November 19, 2020)

For further guidance, or to be connected to your regional Medical Science Director, please contact Jennifer Kring at Jennifer.Kring@ParatekPharma.com.

For any questions, please reach out to:

Jennifer Kring
Medical Affairs IIR Business Operations Manager
Jennifer.Kring@ParatekPharma.com

Larry Friedrich, PharmD
Sr. Medical Science Director and IIR Chair
Larry.Friedrich@ParatekPharma.com