Uni­ver­si­ty was tipped off to pos­si­ble unau­tho­rized tri­als of her­pes vac­cine

WASH­ING­TON — The uni­ver­si­ty that em­ployed a con­tro­ver­sial her­pes vac­cine re­searcher has told the fed­er­al gov­ern­ment it learned last sum­mer of the pos­si­bil­i­ty of his il­le­gal ex­per­i­men­ta­tion on hu­man sub­jects. But South­ern Illi­nois Uni­ver­si­ty did not pub­licly dis­close the tip or its find­ings about re­searcher William Hal­ford’s mis­con­duct for months, ac­cord­ing to a memo ob­tained by Kaiser Health News.

Last week, Kaiser Health News re­port­ed that Hal­ford con­duct­ed an ex­per­i­ment in which he vac­ci­nat­ed pa­tients in US ho­tel rooms in 2013 with­out any safe­ty over­sight and in vi­o­la­tion of US laws, ac­cord­ing to pa­tients and emails they pro­vid­ed to KHN to sup­port their al­le­ga­tions.

They told KHN those in­jec­tions oc­curred three years be­fore Hal­ford test­ed a her­pes vac­cine he cre­at­ed on hu­man sub­jects in a house in St. Kitts in 2016, again with­out rou­tine safe­ty over­sight. Hal­ford died of can­cer at the end of June.

While the uni­ver­si­ty has re­fused to re­spond to ques­tions about the 2013 in­jec­tions, an Oct. 16 memo to the fed­er­al gov­ern­ment ob­tained by KHN un­der open-records law shows that SIU learned of such pos­si­ble ac­tiv­i­ty at the end of Ju­ly. Ac­cord­ing to the memo, Ra­tio­nal Vac­cines, the com­pa­ny that Hal­ford co-found­ed, and an­oth­er SIU pro­fes­sor dis­closed that “hu­man sub­jects re­search might have oc­curred pri­or to the … clin­i­cal tri­al in St. Kitts.”

SIU re­port­ed in the memo to the De­part­ment of Health and Hu­man Ser­vices and the Food and Drug Ad­min­is­tra­tion that its in­sti­tu­tion­al re­view board, or IRB, found Hal­ford’s ac­tiv­i­ties to be a “se­ri­ous non­com­pli­ance” and said it rec­om­mend­ed the uni­ver­si­ty con­duct a “con­fi­den­tial” in­ves­ti­ga­tion to de­ter­mine if he com­mit­ted any oth­er mis­con­duct.

“Dr. Hal­ford will­ful­ly and in­ten­tion­al­ly en­gaged in hu­man sub­jects re­search with­out the ap­proval and over­sight of the IRB, in vi­o­la­tion of IRB poli­cies and in vi­o­la­tion of ap­plic­a­ble law and reg­u­la­tion,” SIU wrote in the memo.

Pre­vi­ous­ly, the uni­ver­si­ty had said it was not re­spon­si­ble for Hal­ford’s St. Kitts tri­al be­cause he con­duct­ed it in­de­pen­dent­ly through Ra­tio­nal Vac­cines.

Be­fore re­leas­ing the memo to KHN, the uni­ver­si­ty blacked out some of the de­tails. It’s un­clear whether the “se­ri­ous non­com­pli­ance” in­volved the 2013 in­jec­tions or some oth­er unau­tho­rized hu­man sub­ject re­search.

“This is a very se­ri­ous mat­ter for the uni­ver­si­ty,” said Robert Kl­itz­man, a doc­tor and di­rec­tor of the mas­ter’s pro­gram in bioethics at Co­lum­bia Uni­ver­si­ty in New York.

Kl­itz­man said the Of­fice for Hu­man Re­search Pro­tec­tions (OHRP), the HHS di­vi­sion that over­sees com­pli­ance with rules on hu­man tri­als, could halt all of the uni­ver­si­ty’s re­search as a re­sult of the find­ing. The Na­tion­al In­sti­tutes of Health could al­so freeze its fund­ing to SIU, he added, even though Hal­ford’s re­search was not fed­er­al­ly fund­ed.

OHRP and the FDA said they have poli­cies of not dis­cussing po­ten­tial or on­go­ing in­ves­ti­ga­tions. SIU did not re­spond to ques­tions.

Sev­er­al par­tic­i­pants from both tri­als told KHN they have asked SIU for help.They said Tues­day that they felt the uni­ver­si­ty should be in­form­ing them of its in­ves­ti­ga­tion in­to unau­tho­rized ex­per­i­ments and its find­ings.

“Hal­ford test­ed his vac­cine on hu­mans us­ing SIU’s fa­cil­i­ties and re­sources,” said one Col­orado woman who has tried to talk to the uni­ver­si­ty about her ex­pe­ri­ence in the St. Kitts tri­al. “They [SIU] de­ny know­ing any­thing about it. SIU hasn’t been very forth­com­ing.”

Kl­itz­man said the uni­ver­si­ty did have a re­spon­si­bil­i­ty to the par­tic­i­pants who were in­ject­ed with Hal­ford’s vac­cine. Two of them — in­clud­ing the Col­orado woman — have filed so-called ad­verse event com­plaints with the FDA, say­ing that Hal­ford’s vac­cine may have caused side ef­fects.

“Eth­i­cal­ly, the uni­ver­si­ty should con­tact the par­tic­i­pants to let them know that some par­tic­i­pants have de­vel­oped ad­verse events,” he said.

By Marisa Tay­lor. Orig­i­nal­ly post­ed at Kaiser Health News, a na­tion­al health pol­i­cy news ser­vice that is part of the non­par­ti­san Hen­ry J Kaiser Fam­i­ly Foun­da­tion.

The top 10 block­buster drugs in the late-stage pipeline — Eval­u­ate adds 6 new ther­a­pies to heavy-hit­ter list

Vertex comes in for a substantial amount of criticism for its no-holds-barred tactical approach toward wresting the price it wants for its commercial drugs in Europe. But the flip side of that coin is a highly admired R&D and commercial operation that regularly wins kudos from analysts for their ability to engineer greater cash flow from the breakthrough drugs they create.

Both aspects needed for success in this business are on display in the program backing Vertex’s triple for cystic fibrosis. VX-659/VX-445 + Tezacaftor + Ivacaftor — it’s been whittled down to 445 now — was singled out by Evaluate Pharma as the late-stage therapy most likely to win the crown for drug sales in 5 years, with a projected peak revenue forecast of $4.3 billion.

The latest annual list, which you can see here in their latest world preview, includes a roster of some of the most closely watched development programs in biopharma. And Evaluate has added 6 must-watch experimental drugs to the top 10 as drugs fail or go on to a first approval. With apologies to the list maker, I revamped this to rank the top 10 by projected 2024 sales, instead of Evaluate's net present value rankings.

It's how we roll at Endpoints News.

Here is a quick summary of the rest of the top 10:

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John Reed at JPM 2019. Jeff Rumans for Endpoints News

Sanofi's John Reed con­tin­ues to re­or­ga­nize R&D, cut­ting 466 jobs while boost­ing can­cer, gene ther­a­py re­search

The R&D reorganization inside Sanofi is continuing, more than a year after the pharma giant brought in John Reed to head the research arm of the Paris-based company.
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How small- to mid-sized biotechs can adopt pa­tient cen­tric­i­ty in their on­col­o­gy tri­als

By Lucy Clos­sick Thom­son, Se­nior Di­rec­tor of On­col­o­gy Pro­ject Man­age­ment, Icon

Clin­i­cal tri­als in on­col­o­gy can be cost­ly and chal­leng­ing to man­age. One fac­tor that could re­duce costs and re­duce bar­ri­ers is har­ness­ing the pa­tient voice in tri­al de­sign to help ac­cel­er­ate pa­tient en­roll­ment. Now is the time to adopt pa­tient-cen­tric strate­gies that not on­ly fo­cus on pa­tient needs, but al­so can main­tain cost ef­fi­cien­cy.

In­vestor day prep at Mer­ck in­cludes a new strat­e­gy to pick up the pace on M&A — re­port

Mer­ck’s re­cent deals to buy up two bolt-on biotechs — Ti­los and Pelo­ton — weren’t an aber­ra­tion. In­stead, both ac­qui­si­tions mark a new strat­e­gy to beef up its dom­i­nant can­cer drug op­er­a­tions cen­tered on Keytru­da while look­ing to ad­dress grow­ing con­cerns that too many of its eggs are in the one I/O bas­ket for their PD-1 pro­gram. And Mer­ck is go­ing af­ter more small- and mid-sized buy­outs to calm those fears.

John Chiminski, Catalent CEO - File Photo

'It's a growth play': Catal­ent ac­quires Bris­tol-My­er­s' Eu­ro­pean launch pad, ex­pand­ing glob­al CD­MO ops

Catalent is staying on the growth track.

Just two months after committing $1.2 billion to pick up Paragon and take a deep dive into the sizzling hot gene therapy manufacturing sector, the CDMO is bouncing right back with a deal to buy out Bristol-Myers’ central launchpad for new therapies in Europe, acquiring a complex in Anagni, Italy, southwest of Rome, that will significantly expand its capacity on the continent.

There are no terms being offered, but this is no small deal. The Anagni campus employs some 700 staffers, and Catalent is planning to go right in — once the deal closes late this year — with a blueprint to build up the operations further as they expand on oral solid, biologics, and sterile product manufacturing and packaging.

This is an uncommon deal, Catalent CEO John Chiminski tells me. But it offers a shortcut for rapid growth that cuts years out of developing a green fields project. That’s time Catalent doesn’t have as the industry undergoes unprecedented expansion around the world.

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Right back at you, Pfiz­er: BeiGene and a Pfiz­er spin­out launch a new­co to de­vel­op a MEK/BRAF in­hibitor that could ri­val $11.4B com­bo

A day af­ter Pfiz­er bought Ar­ray and its ap­proved can­cer com­bo, BeiGene and Pfiz­er spin­out Spring­Works have part­nered in launch­ing a new biotech that has an eye on the very same mar­ket the phar­ma gi­ant just paid bil­lions for. And they’re plan­ning on us­ing an ex-Pfiz­er drug to do it.

In a nut­shell, Chi­na’s BeiGene is toss­ing in a pre­clin­i­cal BRAF in­hibitor — BGB-3245, which cov­ers both V600 and non-V600 BRAF mu­ta­tions — for a big stake in a new, joint­ly con­trolled biotech called Map­Kure with Bain-backed Spring­Works.

Sanofi aligns it­self with Google to stream­line drug de­vel­op­ment

Tech­nol­o­gy is bleed­ing in­to health­care, and big phar­ma is rid­ing the wave. Sanofi $SNY ap­point­ed its first chief dig­i­tal of­fi­cer this Feb­ru­ary, fol­low­ing the foot­steps of its peers. By May, the French drug­mak­er and some of its big phar­ma com­pa­tri­ots joined forces with Google par­ent Al­pha­bet’s Ver­i­ly unit to aug­ment clin­i­cal tri­al re­search. On Tues­day, the Parisian com­pa­ny tied up with Google to ac­cess its cloud com­put­ing and ar­ti­fi­cial in­tel­li­gence tech to spur the de­vel­op­ment of new ther­a­pies.

UP­DAT­ED: Roche fields first ap­proval for Ro­z­lytrek in the run-up to a show­down with Bay­er, Pfiz­er

While it’s wait­ing to hear back from FDA reg­u­la­tors, Roche is be­gin­ning the vic­to­ry lap for en­trec­tinib in Japan.

Roche is giv­ing Bay­er a run for their mon­ey with this tu­mor-ag­nos­tic drug, which tar­gets NTRK gene fu­sions. Now dubbed Ro­z­lytrek, it’s sanc­tioned to treat adult and pe­di­atric pa­tients in Japan with neu­rotroph­ic ty­ro­sine re­cep­tor ki­nase fu­sion-pos­i­tive, ad­vanced re­cur­rent sol­id tu­mors.

Arc­turus ex­pands col­lab­o­ra­tion, adding $30M cash; Ku­ra shoots for $100M raise

→  Rare dis­ease play­er Ul­tragenyx $RARE is ex­pand­ing its al­liance with Arc­turus $ARCT, pay­ing $24 mil­lion for eq­ui­ty and an­oth­er $6 mil­lion in an up­front as the two part­ners ex­pand their col­lab­o­ra­tion to in­clude up to 12 tar­gets. “This ex­pand­ed col­lab­o­ra­tion fur­ther so­lid­i­fies our mR­NA plat­form by adding ad­di­tion­al tar­gets and ex­pand­ing our abil­i­ty to po­ten­tial­ly treat more dis­eases,” said Emil Kakkis, the CEO at Ul­tragenyx. “We are pleased with the progress of our on­go­ing col­lab­o­ra­tion. Our most ad­vanced mR­NA pro­gram, UX053 for the treat­ment of Glyco­gen Stor­age Dis­ease Type III, is ex­pect­ed to move in­to the clin­ic next year, and we look for­ward to fur­ther build­ing up­on the ini­tial suc­cess of this part­ner­ship.”