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.
 

Medical animation has in recent years become an increasingly important tool for conveying niche information to a varied audience, particularly to those audiences without expertise in the specialist area. Science programmes today, for example, have moved from the piece-to-camera of the university professor explaining how a complex disease mechanism works, to actually showing the viewer first-hand what it might look like to shrink ourselves down to the size of an ant’s foot, and travel inside the human body to witness these processes in action. Effectively communicating a complex disease pathophysiology, or the novel mechanism of action of a new drug, can be complex. This is especially difficult when the audience domain knowledge is limited or non-existent. Medical animation can help with this communication challenge in several ways.
Improved accessibility to visualisation
Visualisation is a core component of our ability to understand a concept. Ask 10 people to visualise an apple, and each will come up with a slightly different image, some apples smaller than others, some more round, some with bites taken. Acceptable, you say, we can move on to the next part of the story. Now ask 10 people to visualise how HIV’s capsid protein gets arranged into the hexamers and pentamers that form the viral capsid that holds HIV’s genetic material. This request may pose a challenge even to someone with some virology knowledge, and it is that inability to effectively visualise what is going on that holds us back from fully understanding the rest of the story. So how does medical animation help us to overcome this visualisation challenge?

As a potentially powerful flu season looms, so does a big test for Roche and its new flu drug, Xofluza. The Swiss giant just got a small boost in advance of that test as the FDA expanded Xofluza’s indication to include patients at high risk of developing flu-related complications.

Xofluza (baloxavir marboxil) was approved last October in the US, the first landmark flu drug approval in 20 years and a much-needed green light for a company that had watched its leading flu drug Tamiflu get eaten alive by generics. Like its predecessor, the pill offered a reduction in flu symptoms but not a cure.

The first-ever Ebola vaccine is on the precipice of approval after the European Medicine’s Agency (EMA) backed the Merck product in this week’s roster of recommendations.

The drugmaker $MRK began developing the vaccine, christened Ervebo, during the West African outbreak that occurred between 2014 and 2016, killing more than 11,000.

The current outbreak in the Democratic Republic of Congo (DRC) has shown case fatality rates of approximately 67%, the agency estimated. Earlier this year, the WHO declared the outbreak — which so far has infected more than 3,000 people — a public health emergency of international concern.