Melis­sa J. Moore

As Mod­er­na Ther­a­peu­tics drew a harsh re­view from Stat, por­trayed as a com­pa­ny in tur­moil with an of­ten em­bit­tered staff, the biotech uni­corn named Howard Hugh­es in­ves­ti­ga­tor and Uni­ver­si­ty of Mass­a­chu­setts Med­ical School Pro­fes­sor Melis­sa J. Moore as its new CSO, now in com­mand of its full mR­NA de­vel­op­ment plat­form.

Moore was plucked from the com­pa­ny’s sci­en­tif­ic ad­vi­so­ry group at a cru­cial stage in Mod­er­na’s de­vel­op­ment. The biotech has raised $1.9 bil­lion so far — a huge amount by biotech stan­dards — es­tab­lish­ing a broad rang­ing pre­clin­i­cal ef­fort to use pa­tient cells as drug fac­to­ries. That ef­fort has now led to 11 de­vel­op­ment pro­grams and a slate of new ther­a­pies wait­ing to en­ter the clin­ic.

“Melis­sa is an ex­cep­tion­al sci­en­tist whose knowl­edge and ex­per­tise in this area will have an enor­mous im­pact on Mod­er­na,” said CEO Stephane Ban­cel. “And, im­por­tant­ly, she shares our vi­sion and com­mit­ment to help pa­tients and im­prove lives. We could not be more thrilled.”

Thrilled is prob­a­bly the last word you would hear Ban­cel use to de­scribe the new­ly post­ed in­ves­ti­ga­tion at Stat, which claims that Mod­er­na’s “caus­tic work en­vi­ron­ment” has dri­ven away top staff at a time where “signs” have ap­peared that the com­pa­ny’s top projects are run­ning in­to trou­ble. Ban­cel him­self, re­ports Stat, is over-con­trol­ling, ob­sessed with se­cre­cy and im­pa­tient with set­backs.

The sto­ry is heavy with crit­i­cism and anony­mous fin­ger point­ing, but light on de­tails. Mod­er­na’s for­mer CSO, Joseph Bolen, left last fall af­ter two years at the com­pa­ny, which Stat used to il­lus­trate its claims of a tox­ic work en­vi­ron­ment at Mod­er­na. Bolen was pushed out, ac­cord­ing to un­named “in­sid­ers,” af­ter be­ing rel­e­gat­ed to a small role. Bolen him­self, though, de­clined com­ment. And Ban­cel says he tried to get him to stay on, un­suc­cess­ful­ly.

Melis­sa Moore now gets a shot at ei­ther prov­ing or dis­prov­ing Stat’s claims at a time the com­pa­ny is near­ing the rapids of mid-stage de­vel­op­ment, when it will have to start out­lin­ing spe­cif­ic proof-of-con­cept da­ta on what its drugs can do. If the com­pa­ny can ac­com­plish that with sev­er­al pro­grams, Ban­cel tells me he plans to file for an IPO.

At this stage, it’s fair to say that every­one is watch­ing to see whether Mod­er­na suc­ceeds or fails. A fail­ure would prove high­ly em­bar­rass­ing for a line­up of top in­dus­try col­lab­o­ra­tors. Suc­cess would be ground­break­ing.

Moore her­self had this to say in a pre­pared state­ment:

“As a mem­ber of Mod­er­na’s Sci­en­tif­ic Ad­vi­so­ry Board, I’ve had a front row seat to ex­pe­ri­ence their ground­break­ing progress first-hand. And through my work at the RTI and with MassTERi, I’ve come to ap­pre­ci­ate the pow­er of aca­d­e­m­ic-in­dus­try col­lab­o­ra­tion and en­tre­pre­neur­ship. My new role at Mod­er­na is a nat­ur­al next step in my own pro­gres­sion as a ba­sic re­searcher pas­sion­ate about trans­lat­ing our ever-in­creas­ing knowl­edge of RNA bi­ol­o­gy in­to prod­ucts that im­prove the hu­man con­di­tion. I look for­ward to work­ing with the in­cred­i­bly tal­ent­ed Mod­er­na team and build­ing stronger con­nec­tions and col­lab­o­ra­tions be­tween Mod­er­na and acad­e­mia, as we work to ad­vance the promise of mR­NA ther­a­peu­tics as a com­plete­ly new modal­i­ty for cre­at­ing the med­i­cines of the fu­ture.”

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.