Ran­somware at­tack hit clin­i­cal tri­als soft­ware play­er ERT — two weeks lat­er, they’re com­ing back on­line

One of the largest bio­med­ical ran­somware at­tacks in US his­to­ry was re­vealed last week, when IT sys­tems at 250 lo­ca­tions in a ma­jor Amer­i­can hos­pi­tal chain fell vic­tim to face­less ex­tor­tion­ists — forc­ing them to take sys­tems of­fline, di­rect­ing staff to work off pen and pa­per, and bring­ing in out­side se­cu­ri­ty con­sul­tants to mit­i­gate the dam­age.

Turns out that a week pri­or, on Sept. 20, a sim­i­lar, much small­er at­tack be­fell eRe­searchTech­nol­o­gy, a lead­ing clin­i­cal tri­al soft­ware provider to CROs and spon­sors.

Drew Bus­tos

That Sun­day, staff at ERT were locked out of cru­cial da­ta and re­al­ized they were un­der a ran­somware at­tack. “Our net­work team iden­ti­fied the is­sue quick­ly, and we took our sys­tems of­fline,” Drew Bus­tos, ERT’s VP of mar­ket­ing, told me in an in­ter­view.

The CRO gi­ant IQVIA, who us­es ERT soft­ware in some of the tri­als they run for spon­sors, ac­knowl­edged the in­ci­dent in a state­ment to End­points News and said it had a lim­it­ed im­pact on op­er­a­tions. “[IQVIA] im­ple­ment­ed back­up pro­to­cols im­me­di­ate­ly to en­sure the con­ti­nu­ity and in­tegri­ty of sev­er­al on­go­ing tri­als that use ERT, and we no­ti­fied af­fect­ed spon­sors ac­cord­ing­ly. The cur­rent tech­ni­cal is­sues af­fect­ing ERT have not in­fil­trat­ed any IQVIA sys­tems.”

Bus­tos told me that no clin­i­cal source da­ta was im­pact­ed at ERT and that the ma­jor­i­ty of their sys­tems are now back on­line.

The IQVIA state­ment con­firms no sen­si­tive da­ta have been com­pro­mised, but that an in­ves­ti­ga­tion is still on­go­ing: “At this point in the in­ves­ti­ga­tion, we are not aware of any con­fi­den­tial da­ta or pa­tient in­for­ma­tion, re­lat­ed to our clin­i­cal tri­al ac­tiv­i­ties, which have been re­moved, com­pro­mised or stolen.”

The in­ci­dent rais­es ques­tions on the bio­phar­ma in­dus­try’s pre­pared­ness to deal with se­vere cy­ber­at­tacks that could en­dan­ger the in­tegri­ty of clin­i­cal tri­als and oth­er da­ta-rich R&D ef­forts.

Er­ic Per­ak­slis

“The abil­i­ty for com­pa­nies to quick­ly with­stand this kind of at­tack is com­plete­ly de­pen­dent on how good your IT is to be­gin with,” said Er­ic Per­ak­slis, who has served as the FDA’s CIO and held se­nior IT po­si­tions at J&J and Take­da, and is now a Ruben­stein Fel­low at Duke Uni­ver­si­ty.

While Per­ak­slis isn’t privy to any of the de­tails be­hind this par­tic­u­lar at­tack, he re­it­er­at­ed that a rig­or­ous and fre­quent­ly test­ed back­up sys­tem great­ly re­duces risk to ran­somware. “If your da­ta is backed up every evening at 5pm, and you test it know­ing it can all be re­stored by 8am the next morn­ing, that’s ba­sic IT hy­giene,” he told me.

Mon­ey is the mo­ti­vat­ing fac­tor be­hind most ran­somware at­tacks. “We’re gonna cut you off from your da­ta and trans­ac­tions un­til we get paid,” is how Per­ak­slis de­scribed it to me. This sum­mer the med­ical school at UCSF paid $1.14M — in vir­tu­al­ly un­trace­able Bit­coin — to ex­tor­tion­ists in ex­change for a tool to un­lock their da­ta.

Bus­tos de­clined to say whether ERT paid any ran­som to the hack­ers, nor would he iden­ti­fy the out­side se­cu­ri­ty ex­perts brought in to mit­i­gate the is­sue. He notes the com­pa­ny has tak­en steps to pre­vent a sim­i­lar in­ci­dent in the fu­ture. “We’re fol­low­ing the ad­vice of a world-class se­cu­ri­ty firm, and adopt­ing their best prac­tices to aug­ment our ex­ist­ing de­fens­es.”

“It’s some­thing that’s un­for­tu­nate and no­body wants to be im­pact­ed by cy­ber­se­cu­ri­ty is­sues. But it is some­thing that we feel that we are work­ing to­wards re­me­di­a­tion,” he added.

The in­ci­dent was first re­port­ed by the New York Times.

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Chris Gibson (Photo By Vaughn Ridley/Sportsfile for Web Summit via Getty Images)

Re­cur­sion founders gin for­tunes as IPO back­ers show­er $436M on one of the biggest boasts in AI -- based on some very small deals

In the AI drug development world, boasting often comes with the territory. Yet few can rival Recursion when it comes to claiming the lead role in what company execs like to call the industrialization of drug development, with promises of continued exponential growth in the number of drugs it has in the pipeline.

On Friday, the Salt Lake City-based biotech translated its unicorn-sized boasts into a killer IPO, pricing more than 24 million shares at the high end of its range and bringing in $436 million — with a large chunk of that promised by some deep-pocket backers.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

UP­DAT­ED: New Kaiser analy­sis shows how lim­it­ing price ne­go­ti­a­tions to tar­get­ed drugs may bet­ter fo­cus up­com­ing leg­is­la­tion

As Congress considers whether to adopt sweeping new legislation to lower prescription drug prices across the board, the Kaiser Family Foundation is out with a new report on Monday showing how a more targeted approach on a subset of drugs might be a more efficient way to save government funds.

“This analysis shows that Medicare Part D and Part B spending is highly concentrated among a relatively small share of covered drugs, mainly those without generic or biosimilar competitors,” wrote Juliette Cubanski, deputy director of the program on Medicare policy at KFF, and Tricia Neuman, SVP of KFF. “Focusing drug price negotiation or reference pricing on a subset of drugs that account for a disproportionate share of spending would be an efficient use of administrative resources, though it would also leave some potential savings on the table.”

When is a drug re­al­ly a de­vice? Court knocks down FDA ap­peal in try­ing to sort that grey area

It’s always a surprise when a court has to step in to tell the FDA that it erred in performing one of its main duties: classifying whether a medical product is drug or a device.

But that’s what the US Court of Appeals for the District of Columbia did on Friday, making clear to the world’s top drug regulator that Genus Medical Technologies’ contrast agent barium sulfate (also known as Vanilla SilQ) should not be considered a drug, as the FDA had said, but a medical device.

Tillman Gerngross (Adagio)

Till­man Gern­gross' Covid-19 an­ti­body moon­shot scores $336M with the help of new ace CFO. Is an IPO next?

Less than a year into its existence, serial biotech entrepreneur Tillman Gerngross’ antibody play Adagio has raced ahead into a pivotal trial for its lead drug for Covid-19 on the back of some very promising preclinical data. Now, crossover investors led by Peter Kolchinsky at RA are rolling up the Brinks truck — and that could spell an IPO in the offing for Adagio.

Adagio has bagged $336 million as part of a Series C round led by RA Capital to advance lead single-shot antibody ADG20 through a pivotal Phase I/II/III trial for the treatment of mild to moderate Covid-19 patients at high risk of infection, the biotech said Monday.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 107,200+ biopharma pros reading Endpoints daily — and it's free.

Q1: A flood of in­vestor cash drove biotech's num­bers to new record highs, and the tor­rent of cash is mov­ing up­stream fast

If you thought biotech was booming last year, wait until you get a load of the numbers from Q1 2021.

On virtually every level, with one exception, the money engine was working around the clock in the first 3 months of this year. Venture capital has reached such a fever peak that the average B round now weighs in at an average mega-weight value of $100 million. The money flow is also finding its way to the mouth of the R&D river, where discovery work now merits the big bucks instead of cautionary seed funds.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Jami Rubin (EQRx)

Ja­mi Ru­bin, once fa­bled for grilling bio­phar­ma ex­ecs, de­camps to head fi­nance at drug pric­ing dis­rupter

As Goldman Sachs’ top pharmaceutical analyst, Jami Rubin was known for asking the tough questions. Now, as she takes the lead on EQRx’s mission to rewrite the rules of drug pricing, we’ll see how good her answers are.

Rubin made the jump to biotech on April 5, becoming EQRx’s new CFO, the company said Monday. She’s coming from PJT Partners, where she’s been a partner providing strategic guidance for biotech and pharmaceutical companies for the last couple years. With EQRx’s recent $500 million Series B round in the books, it wouldn’t be a surprise if she was already lining up a public debut.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 107,200+ biopharma pros reading Endpoints daily — and it's free.

Seagen gets Au­gust PDU­FA for Pad­cev ex­pan­sions; Adap­tate pulls in new cash for gam­ma delta T cell an­ti­bod­ies

Seagen is riding the wave of two new priority reviews straight to the FDA.

The Bothell, WA-based biotech and their partners at Astellas announced Monday that two supplemental BLAs for Padcev had been accepted by US regulators. FDA has set Aug. 17 as the PDUFA date for the reviews.

“With our recent regulatory submissions, we intend to provide the highest level of clinical evidence supporting Padcev use — overall survival data from a randomized Phase III trial — and expand availability in multiple countries where there is unmet medical need,” said Astellas oncology chief Andrew Krivoshik.

Ben Carson (Evan Vucci, AP Images)

UP­DAT­ED The doc­tor is in: Trump in­sid­er Ben Car­son joins NASH play­er Galectin as a 'spe­cial con­sul­tant,' part-time spokesman

In the few short months since President Donald Trump left office, his former department heads are reportedly having a difficult time finding employment. But for Ben Carson, Trump’s former housing secretary, that’s not a problem anymore after biotech came calling.

Carson, a former GOP presidential candidate and erstwhile HUD head, has joined Galectin Therapeutics as a “special consultant” the biotech hopes will help raise its profile and provide an entrée to key business partnerships, the company said Monday.