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

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David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

Three Senate Democrats are backing an FDA plan to require mandatory prescriber education for opioids as overdose deaths have risen sharply over the past decade, with almost 97,000 American opioid-related overdose deaths in the past year alone.

While acknowledging a decline in overall opioid analgesic dispensing in recent years, the FDA said it’s reconsidering the need for mandatory prescriber training through a REMS given the current situation with overdoses, and is seeking input on the aspects of the opioid crisis that mandatory training could potentially mitigate.

Just as Avoro Capital’s campaign to derail Merck’s proposed $11.5 billion buyout of Acceleron gains steam, Bristol Myers Squibb is leaning in with some hefty counterweight.

The pharma giant is planning to tender its Acceleron shares, Bloomberg reported, which add up to a sizable 11.5% stake. Based on the offer price, the sale would net Bristol Myers around $1.3 billion.

To complete its deal, Merck needs a majority of shareholders to agree to sell their shares.

The FDA late Wednesday signed off on authorizing the use of heterologous — or what FDA calls a “mix and match” of a primary vaccine series and different booster doses — for all currently available Covid-19 vaccines, in addition to separately authorizing Moderna and J&J boosters.

On the mix-and-match approach, which FDA officials insisted isn’t too confusing in a press conference, the agency offered the example of an 18-year-old who received the J&J shot at least two months ago and may now receive a single booster of the J&J, a half dose of the Moderna, or the Pfizer-BioNTech booster.