Rick Mo­di

VCs love few things more than a proven ex­ec­u­tive team when it comes to launch­ing a new com­pa­ny. And now a group of A-lis­ters has turned to a pair of top ex­ecs out of AveX­is to steer the lat­est gene ther­a­py play­er in­to the clin­ic.

The biotech is Waltham, MA-based Affinia and the two ex­ecs are Sean Nolan and Rick Mo­di — the for­mer CEO and CBO re­spec­tive­ly of AveX­is, the gene ther­a­py pi­o­neer that fetched $8.7 bil­lion in a sale to No­var­tis. Nolan has now tak­en the chair­man’s role at Affinia while Mo­di moves up to the CEO post at the com­pa­ny.

Sean Nolan

Both were key play­ers on a team that steered Zol­gens­ma to the mar­ket as the most ex­pen­sive once-off drug now avail­able. They worked close­ly with CSO Bri­an Kas­par, who was blamed by No­var­tis for in­clud­ing ma­nip­u­lat­ed da­ta in their mar­ket­ing ap­pli­ca­tion, trig­ger­ing a scan­dal that con­sumed No­var­tis for weeks. Kas­par ve­he­ment­ly de­nied the ac­cu­sa­tion, though, and the scan­dal qui­et­ly dis­si­pat­ed with the FDA tak­ing none of the ac­tions it had threat­ened.

The biotech’s pro­mo blast this morn­ing sug­gests Affinia is on to a bet­ter AAV tech plat­form than what’s cur­rent­ly in cir­cu­la­tion. Back­ing up that boast are 3 sci­en­tif­ic founders:

Luk Van­den­berghe, Botond Ros­ka and Aaron Tward.

— Van­den­berghe, a pro­fes­sor at Har­vard Med, is cred­it­ed as a co-in­ven­tor of AAV9. He de­vel­oped the tech that was de­vel­oped at the Grous­beck Gene Ther­a­py Cen­ter un­der a col­lab­o­ra­tion be­tween Lon­za and Mass­a­chu­setts Eye and Ear.

— Ros­ka is the di­rec­tor of the In­sti­tute of Mol­e­c­u­lar and Clin­i­cal Oph­thal­mol­o­gy Basel.

— Tward is an as­sis­tant pro­fes­sor at UC-San Fran­cis­co.

Luk Van­den­berghe

“Affinia Ther­a­peu­tics is bring­ing to­geth­er com­ple­men­tary ex­per­tise al­low­ing us to re­al­ize a ra­tio­nal de­sign fu­ture for AAV vec­tors, pro­mot­ers and oth­er com­po­nents of gene ther­a­pies. By lever­ag­ing syn­thet­ic and sys­tems bi­ol­o­gy com­bined with high-through­put screen­ing and tis­sue and sin­gle-cell res­o­lu­tion, we are as­pir­ing to achieve much-need­ed im­proved phar­ma­co­log­i­cal con­trol of this nov­el modal­i­ty in med­i­cine,” said Van­den­berghe in a pre­pared state­ment.

That line­up war­rant­ed a $60 mil­lion launch round from the seed in­vestors at F-Prime Cap­i­tal and New En­ter­prise As­so­ci­ates, with At­las jump­ing in for the first time.

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.