Arkansas Research Alliance Aligns With FDA on Commercialization

Arkansas Research Alliance Aligns With FDA on Commercialization
FDA Commissioner Margaret Hamburg and Arkansas Research Alliance CEO Jerry Adams sign a partnership deal between FDA and ARA.

The Arkansas Research Alliance has entered into a partnership with the U.S. Food & Drug Administration to help commercialize the technology developed at the FDA's National Center for Toxicological Research at Jefferson.

A partnership intermediary agreement (PIA) was signed Monday night by FDA commissioner Margaret Hamburg and ARA president Jerry Adams at a Governor's Mansion reception kicking off the third-annual Global Summit on Regulatory Science being held this week in Little Rock. 

It comes two years after Hamburg and Beebe signed a memorandum of understanding (MOU) that established a nanotechnology research collaboration between FDA and the state's five research universities: the University of Arkansas, Fayetteville; the University of Arkansas at Little Rock; the University of Arkansas for Medical Sciences in Little Rock; the University of Arkansas at Pine Bluff; and Arkansas State University in Jonesboro.

ARA is a non-profit organization funded in part by the Arkansas Science & Technology Authority that is governed by a board of trustees comprised of chancellors from those research universities and business leaders from across the state.

The 2011 agreement represented the first time the FDA had entered into an MOU with an entire state, and this week's PIA is the first ever signed by the FDA.

Adams called the PIA a logistical extension of the MOU. He said it provides structure to the relationship between the state and NCTR, which is the FDA's primary research facility and considered one of the world's leading toxicology centers.

It represents one of three key components to the MOU, Adams said:

  • The establishment of regulatory science cirriculum at UAMS. The certificate program graduated its first class of 18 earlier this year with plans to evolve into a master's level and then a Ph.D level program.
  • A nanotechnology collaboration overseen by ARA between the NCTR and the state's research universities focusing on potential toxicity issues involving graphene, a common transport compound for nanoparticles.
  • Creation of a mechanism to elevate commercialization of NCTR research, as represented by the PIA.  

"The agreement opens new channels to assist the FDA and spurs economic growth opportunities for Arkansas businesses," Adams said. "Being in a position to help FDA and NCTR with technology-transfer efforts accelerates our effort to strengthen economic development locally, nationally and globally. This is an innovative agreement with wide-reaching potential for all partners involved."

NCTR has been identified as an undervalued Arkansas asset that can be leveraged to move the state forward, Adams said.

"What do we have that builds better jobs and makes us unique," he asked. "NCTR is one of those assets."

Under the agreement, NCTR will provide ARA with research with potential commercial value, and ARA will seek out business partners to commercialize that research.

"The partnership intermediary agreement with ARA will further strengthen the role and work of the FDA’s NCTR by facilitating the transfer of technology to the private sector," Hamburg said in an official statement. "This is the latest in a long and productive history of such public private partnership with NCTR and the FDA."

Adams credited Hamburg and Beebe for their diligence in supporting the MOU, as well as former NCTR deputy director, current ARA consultant and "PIA catalyst" Art Norris, who authored the MOU

According to ARA, further results from the MOU include: 

  • The establishment of a virtual Arkansas Center of Excellence in Regulatory Science. Regulatory science assures that products are safe and effective.
  • The creation of a working group to guide its implementation. Beebe appointed Mary Good, chair of the Emerging Analytics Center Management Board and a special adviser on economic development at UALR, and NCTR director William Slikker to co-chair the group.
  • The early stages of a collaborative research program in the area of bioinformatics. Bioinformatics combines the science of information technology with biological sciences.
  • A provision to develop other mechanisms of partnership between private business, the state's research universities and the federal government.

Adams called the graphene research that entails each of the state's research universities potentially of international significance. "We've had excellent collaborative progress on graphene," he said.

Earlier this month, Adams joined researchers from four of the state's research universities on Petit Jean Mountain to share ideas on collaboration and commercialization. Adams thinks the collaborative nature of Arkansans is another asset to be leveraged.

Of the PIA, Adams said, "This will be really what we make of it. This puts intentionality and structure around the process."