Redacted_J A_StrataGraft_Approved.pdf

Control No: JA16201

Justification and Approval for Other Than Full and Open Competition

1. Contracting Activity:

The contracting activity responsible for this action is the U.S. Army Medical Research Acquisition Activity (USAMRAA), in support of the Tissue Injury and Regenerative Medicine Program Management Office (TIRM PMO) of the U.S. Army Medical Materiel Development Activity (USAMMDA).

2. Description of Action:

3. Description of supplies/services:

The purpose of this contract is to conduct a phase 2 clinical trial to evaluate the safety and efficacy of StrataGraft® Skin Tissue, an allogeneic skin substitute containing both an epidermal and dermal layer, to treat complex, full-thickness skin injuries and to provide regulatory support in preparation for and during the conduct of the clinical trial.

The estimated price to execute these activities is $

4. Authority Cited:

The statutory authority permitting other than full and open competition is 10 U.S.C.

2304(c)(1). The FAR citation is 6.302-1, titled ‘Only one responsible source and no other supplies or services will satisfy agency requirements.’

5. Reason for Authority Cited:

Stratatech Corporation is the only responsible source for an allogeneic skin substitute containing both an epidermal and dermal layer for the treatment of complex, full-thickness skin injuries with sufficient clinical safety data to support proceeding into a phase 2 clinical trial for these types of wounds. Delaying the phase 2 clinical trial until other comparable products are available for the treatment of complex, full-thickness skin wounds will delay the product development efforts to improve treatment of Service Members with severe burns another other skin injuries more than three years.

The work included in this effort is a follow-on effort for the next phase of development of the StrataGraft® Skin Tissue. Wake Forest University, the AFIRM II Cooperative Agreement awardee, sub-awarded to Stratatech Corporation for the development of a clinical study protocol to evaluate the safety and efficacy of StrataGraft® Skin Tissue and to manufacture the product required to perform the clinical trial. In order for Stratatech to execute the clinical trial in its entirety, additional activities, outside the scope of the AFIRM II funded sub-award, are required. Successful completion of the phase 2 clinical trial is critical to advancing the product development to obtain FDA approval of this critical burn treatment product.

6. Efforts to Obtain Competition:

A combined Sources Sought Notice and Notice of Intent to Sole Source was posted to www.FedBizOpps.gov on 25 April 2016 with a closing date of 10 May 2016. The notice provided a description of the requirement and expressed the Government’s intent to award a sole source contract to Stratatech Corporation. No responses or inquiries were received other than an email from Stratatech Corporation asking for further information about the timeline for a sole source award.

FAR Clauses 52.244-5 “Competition in Subcontracting” will be included in the solicitation that is sent to Stratatech Corporation to ensure competition is obtained at the subcontractor level.

7. Actions to Increase Competition:

No action will be taken to increase competition as this is a onetime requirement and no other vendor currently in development of burn treatment has developed a skin substitute to the point of phase 2 clinical trials.

A redacted version of this J&A will be made publicly available in accordance with FAR 6.305.

8. Market Research:

Market research was conducted to identify qualified sources of full-thickness, allogenic skin substitutes capable of treating complex skin wounds while eliminating the use of donor skin tissue from the patient. The methods used include an independent Analysis of Alternatives (AoA), evaluation of the products in development using U.S. Army and Defense Health Agency (DHA) funding, and a broad internet search, company presentations, and site visits.

The independent AoA was completed in August 2014 and compared potentially relevant products based on their ability to address the multiple burn treatment and skin repair capability gaps. The AoA showed that while there are a multitude of products available in the burn treatment market, there are no full-thickness, allogeneic skin substitutes http://www.fedbizopps.gov/ available or in development capable of treating complex skin wounds while eliminating the use of donor skin tissue.

The Burn Treatment and Skin Repair (BTSR) Integrated Product Team (IPT) evaluated burn treatment products in development through the Joint Program Committees, the Small Business Innovation Research program, and other U.S. Army and DHA funded projects to determine if products currently in development will meet the priority capability gaps. The results identified StrataGraft Skin Tissue as the top product to meet the capability gap for full-thickness, allogeneic skin substitutes to treat complex skin wounds while eliminating the use of donor skin.

The BTSR IPT conducted a broad internet search for full-thickness skin substitutes.

The search resulted in 7 sources and 13 related products. In addition to the information available on the internet, information is also available through an in-person presentation by the manufacturer of one of the products. Further, a site visit at the manufacturer of another product was completed in June 2016. All of the data collected confirmed that there are no full-thickness, allogeneic skin substitutes available or in development capable of treating complex skin wounds while eliminating the use of donor skin tissue

The internet sites and articles below were used for this market research and provide background information on skin substitutes and burn treatments.

a. Varkey, Mathew; Ding, Jie; Tredget; Edward E. Advanced in Skin Substitutes— Potential of Tissue Engineered Skin For Facilitating Anti-Fibrotic Healing; J.

Funct. Biomater. 2015, 6, 547-563.

b. Van Zuijlen, PPM; Gardien, KLM; Jaspers, MEH; Bos, EJ; Baas, DC; van Trier, AJM; Middelkoop, E. Tissue Engineering in Burn Scar Reconstruction; Burns & Trauma. 2015, 3, 18.

(https://burnstrauma.biomedcentral.com/articles/10.1186/s41038-015-0017-5)

c. Shevchenko, Rostislav V.; James, Stuart L.; James, S. Elizabeth. A Review of Tissue-Engineered Skin Bioconstructs Available for Skin Reconstruction; J.

Royal Society Interface. 2009 (http://rsif.royalsocietypublishing.org/content/7/43/229)

d. http://www.dermnetnz.org/procedures/bioengineered-skin.html

e. http://misc.karger.com/gazette/67/Sheridan/art_2.htm

f. http://www.woundcarecenters.org/article/wound-therapies/skin-substitutes

g. https://clinicaltrials.gov/ct2/results?term=full+thickness+skin+substitute&Search=

Search

9. Interested Sources:

To date, no other sources have written to express an interest in this acquisition. The notices required by FAR 5.201 shall be published, and any proposals received shall be considered. In accordance with FAR 5.207(c)(15), a notice was published in FedBizOpps (FBO) announcing the Government's intent to acquire these clinical trial services on a non-competitive basis. The announcement indicated the intended source, Stratatech Corporation, and the Government's justification for the lack of competition.

No responses from interested parties were received in response to this notice.

https://burnstrauma.biomedcentral.com/articles/10.1186/s41038-015-0017-5 http://rsif.royalsocietypublishing.org/content/7/43/229 http://www.dermnetnz.org/procedures/bioengineered-skin.html http://misc.karger.com/gazette/67/Sheridan/art_2.htm http://www.woundcarecenters.org/article/wound-therapies/skin-substitutes https://clinicaltrials.gov/ct2/results?term=full+thickness+skin+substitute&Search=Search https://clinicaltrials.gov/ct2/results?term=full+thickness+skin+substitute&Search=Search

10. Other Facts:

a. Procurement History:

(1) Predecessor work (protocol development, applied research, etc.) was provided under consortium awards issued through the AFIRM I and AFIRM II Cooperative Agreements. Previous awards were made to Wake Forest University (W81XWH- 08-2-0032 and W81XWH-13-2-0054). Wake Forest University sub-awarded to Stratatech Corporation to develop the Stratagraph skin substitute.

(2) The cooperative agreements listed in (1) were awarded based on peer and programmatic review of the proposals performed by the Government. Each was awarded to a consortium. Because of the type of awardee, the Government was not allowed to select individual projects from those proposed. Wake Forest University competitively selected the projects included in their proposal based on a call for collaborators that fit the focus areas of the program announcement.

(3) The previous cooperative agreements under which related work was performed were awarded based on full and open competition.

(4)

(5) No unusual procurement patterns have been found.

(6) A justification was not prepared to support previous procurements because they were not sole source awards.

b. Other facts.

None.