As part of ef­forts to pre­pare for the con­tin­ued rise in da­ta-rich ap­pli­ca­tions and to help fill the gap sep­a­rat­ing sci­en­tif­ic ad­vances and new ther­a­pies, the FDA on Wednes­day un­veiled its Tech­nol­o­gy Mod­ern­iza­tion Ac­tion Plan (TMAP).

Near-term mod­ern­iza­tion in com­put­er hard­ware and soft­ware tech­nolo­gies are the fo­cus of the FDA’s TMAP, which of­fers a broad overview of how the agency needs to adapt. For in­stance, the TMAP re­port notes that the FDA will need to have a tech­ni­cal in­fra­struc­ture that can ac­cept, eval­u­ate and an­a­lyze nov­el sources of da­ta (e.g., re­al-world da­ta) and ap­ply that da­ta to reg­u­la­to­ry de­ci­sion mak­ing over the next sev­er­al years.

“FDA’s ac­tion plan has three el­e­ments: (1) mod­ern­iza­tion of FDA’s tech­ni­cal in­fra­struc­ture; (2) en­hanced ca­pa­bil­i­ties at FDA to de­vel­op tech­nol­o­gy prod­ucts to sup­port its reg­u­la­to­ry mis­sion; and (3) com­mu­ni­ca­tion and col­lab­o­ra­tion be­tween FDA and stake­hold­ers, in­clud­ing the tech­nol­o­gy in­dus­try and oth­er gov­ern­ment agen­cies, to dri­ve tech­no­log­i­cal progress that is in­ter­op­er­a­ble across the sys­tem and de­liv­ers val­ue to con­sumers and pa­tients,” the re­port says.

Over­seen by the FDA’s Of­fice of In­for­ma­tion Man­age­ment and Tech­nol­o­gy (OIMT), in the com­ing months the FDA will en­gage with stake­hold­ers to de­vel­op a strat­e­gy and un­der­stand­ing of com­mon pri­or­i­ties for the agency’s ap­proach to da­ta.

“Is­sues to ad­dress in this con­text will in­clude: How FDA will en­sure that reg­u­la­to­ry de­ci­sions at the Agency con­tin­ue to be in­formed by high-qual­i­ty da­ta; How FDA will pro­mote ef­fi­cient da­ta use and da­ta stew­ard­ship across the Agency; How FDA will con­tin­ue its on­go­ing com­mit­ment to a high­ly se­cure da­ta and IT en­vi­ron­ment,” the re­port notes.

The FDA al­so ex­plains how it will start with “small pi­lot use case projects” to link reg­u­la­to­ry ex­per­tise with tech­nol­o­gy know-how by bring­ing FDA re­view­ers and tech­nol­o­gists to­geth­er to tar­get prob­lems and op­por­tu­ni­ties that will ad­vance mod­ern­iza­tion ef­forts.

“These so­lu­tions high­light what is pos­si­ble with­in FDA’s cur­rent en­vi­ron­ment. Ex­am­ples for con­sid­er­a­tion in­clude Pre­ci­sionF­DA, 7- and 15-day safe­ty re­port­ing for In­ves­ti­ga­tion­al New Drug (IND) ap­pli­ca­tions, and up­dat­ing the PRE­DICT mod­el with ma­chine learn­ing,” the re­port notes.

The agency will al­so look to build new tech­nolo­gies to en­able re­al-time FDA op­er­a­tional man­age­ment dash­boards, a col­lab­o­ra­tive project with Of­fice of the Na­tion­al Co­or­di­na­tor for Health In­for­ma­tion Tech­nol­o­gy on the “life of a da­ta el­e­ment” and tech­no­log­i­cal so­lu­tions for the FDA’s im­port op­er­a­tions.

Plan

RAPS: First pub­lished in Reg­u­la­to­ry Fo­cus™ by the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety, the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care prod­ucts. Click here for more in­for­ma­tion.
 

Just before Christmastime, Howard Federoff got a tip from Washington: There was a new virus in China. And this one could be bad.

A single news report on the virus had not yet appeared. Federoff, a neuroscientist, was briefed because years before, he was vetted as part of a group — he didn’t give a name for the group — to consult for the US government on emerging scientific issues. His day job, though, was CEO of Aspen Neurosciences, a Parkinson’s cell therapy startup that days before had come out of stealth mode and gave word to investors they were hoping to raise $70 million. That, Federoff realized, would be difficult if a pandemic shut down the global economy.

Despite worries about regulatory delays due to new work arrangements under Covid-19, the FDA appears intent to go full speed ahead with its everyday work, not only granting priority review to a stem cell therapy for acute graft versus host disease but also plotting an advisory committee meeting for it.

With a PDUFA date of September 30, the journey of the drug — remestemcel-L, or Ryoncil — could shed light on the agency’s capacity to facilitate drug development unrelated to Covid-19.

→ Flexion may be hitting the brakes on clinical trials, including one for its osteoporosis Zilretta, but that’s not stopping the biotech from plotting regulatory action in China. Hong Kong Tainuo has committed $10 million upfront to seize the development and commercialization rights to Zilretta, with plans to apply for a clinical trial in China by the end of the year. Flexion, which said it has 10 months of finished goods in the US and 12 months of active pharmaceutical ingredient available, will supply all products to the Chinese partner.