Dana-Far­ber, MD An­der­son, MIT im­pose trav­el re­stric­tions amid broad­er ef­forts to con­tain coro­n­avirus dam­age in US

As the new coro­n­avirus spreads to more states in the US out­side Wash­ing­ton, so have the re­ac­tions.

MIT is ban­ning all in­ter­na­tion­al busi­ness trav­els for stu­dents, fac­ul­ty, post­doc and staff for two months, while urg­ing them to weigh whether do­mes­tic trips are es­sen­tial. All in-per­son uni­ver­si­ty-af­fil­i­at­ed events with more than 150 at­ten­dees that will take place be­tween now and May 15 must be post­poned, can­celed or vir­tu­al­ized.

MD An­der­son in Hous­ton and Dana-Far­ber in Boston have both sus­pend­ed all pro­fes­sion­al trav­el and cau­tioned against per­son­al trav­el.

“Our can­cer pa­tients are unique­ly vul­ner­a­ble to coro­n­avirus. For this rea­son, we are com­mit­ting to in­creased work­force pre­cau­tions,” Pe­ter Pis­ters, pres­i­dent of MD An­der­son, said in state­ment, in which the in­sti­tute al­so en­cour­aged use of re­mote meet­ings.

Con­firm­ing the new pol­i­cy to End­points News, a Dana-Far­ber spokesper­son added, “While we rec­og­nize this is a sig­nif­i­cant in­con­ve­nience, our pri­or­i­ty re­mains the health and safe­ty of our work­force, and the health and safe­ty of our pa­tients.”

Such moves could put pres­sure on con­fer­ence hosts such as the Amer­i­can As­so­ci­a­tion for Can­cer Re­search.

“We were re­cent­ly made aware that sev­er­al stake­hold­ers, in­clud­ing can­cer cen­ters, aca­d­e­m­ic in­sti­tu­tions, and phar­ma­ceu­ti­cal com­pa­nies, are con­sid­er­ing or have in­sti­tut­ed tem­po­rary trav­el re­stric­tions that, if un­changed, would pre­vent their em­ploy­ees from at­tend­ing or pre­sent­ing at the An­nu­al Meet­ing,” the AACR not­ed in a state­ment Thurs­day.

The cur­rent plan is to go ahead with the gath­er­ing, sched­uled to take place in San Diego April 24-29. The Amer­i­can So­ci­ety of Clin­i­cal On­col­o­gy, which hosts an­oth­er high-pro­file can­cer meet­ing planned for late May, has adopt­ed a sim­i­lar wait-and-see ap­proach.

Oth­er or­ga­niz­ers have can­celed their gath­er­ings sched­uled for this month. The Health­care In­for­ma­tion and Man­age­ment Sys­tems So­ci­ety was the lat­est to can­cel its an­nu­al con­fab, which would have drawn up­wards of 40,000 at­ten­dees to Or­lan­do on March 9. The Na­tion­al Com­pre­hen­sive Can­cer Net­work, which had a con­fer­ence planned for 10 days lat­er in the same city, is post­pon­ing.

Mean­while in Eu­rope, the British ex­hi­bi­tions group In­for­ma has an­nounced that its up­com­ing BIO-Eu­rope Spring is go­ing all on­line.

“A sit­u­a­tion out of our con­trol is pre­vent­ing us from do­ing busi­ness in a face-to-face en­vi­ron­ment, so we’ve come to­geth­er to of­fer an al­ter­na­tive so­lu­tion,” a state­ment read. “We will now be de­liv­er­ing BIO-Eu­rope Spring as a ful­ly dig­i­tal event, of­fer­ing vir­tu­al part­ner­ing, on­line com­pa­ny pre­sen­ta­tions, pre-record­ed pan­els and a vir­tu­al ex­hib­it. The dig­i­tal event will take place March 23–27, 2020.”

The BIO Asia con­fer­ence — or­ga­nized by the US trade group and orig­i­nal­ly slat­ed for March 10-11 in Tokyo — has been can­celled; BIO has yet to make a de­ci­sion about its main San Diego con­ven­tion in June.

Back state­side, MIT is call­ing off its “sig­na­ture se­mes­ter con­fer­ences and cel­e­bra­tions,” in­clud­ing the MIT Ex­cel­lence Awards. It’s al­so de­vel­op­ing op­tions for on­line in­struc­tion should that be­come need­ed.

“For our cam­pus com­mu­ni­ty, the cur­rent risk lev­el as­so­ci­at­ed with COVID-19 is low,” MIT pres­i­dent Rafael Reif wrote in his let­ter to the uni­ver­si­ty. “How­ev­er, glob­al hotspots shift, and the con­ta­gion pat­tern is not well un­der­stood. With that un­cer­tain­ty, we need to make pru­dent choic­es to pro­tect the health of our own com­mu­ni­ty and the broad­er com­mu­ni­ties we be­long to, with­out cre­at­ing un­nec­es­sary dis­rup­tions to the nor­mal pur­suit of our ed­u­ca­tion­al and re­search mis­sion.”

While Mass­a­chu­setts has on­ly re­port­ed two covid-19 cas­es, Bio­gen dis­closed late Thurs­day that three of its em­ploy­ees (re­sid­ing in the US and oth­er parts of the US) test­ed pos­i­tive for SARS-CoV-2 af­ter at­tend­ing a meet­ing in Boston.

A host of or­ga­ni­za­tions across the coun­try are tak­ing pre­cau­tions against a brew­ing epi­dem­ic of covid-19. The most dras­tic mea­sures, though, ap­pear to be con­cen­trat­ed in the state of Wash­ing­ton, which has seen the largest clus­ter of cas­es at 44. Fred Hutchin­son Can­cer Cen­ter, home to the re­searcher who warned of pos­si­bly hun­dreds of un­re­port­ed ac­tive in­fec­tions in the state, adopt­ed a manda­to­ry work-from-home pol­i­cy ear­li­er this week along­side Seat­tle-based tech gi­ants.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

The End­points 11: They've got mad mon­ey and huge am­bi­tions. It's time to go big or go home

These days, selecting a group of private biotechs for the Endpoints 11 spotlight begins with a sprint to get ahead of IPOs and the M&A teams at Big Pharma. I’ve had a couple of faceplants earlier this year, watching some of the biotechs on my short list choose a quick leap onto Nasdaq or into the arms of a buyer.

Vividion, you would have been a great pick for the Endpoints 11. I’m sorry I missed you.

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Dave Lennon, former president of Novartis Gene Therapies

So what hap­pened with No­var­tis Gene Ther­a­pies? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Albert Bourla, Pfizer CEO (Evan Vucci, AP Images)

Covid-19 roundup: Pfiz­er tees up 500M vac­cine dos­es for do­na­tion in ex­pand­ed US pact; Ear­ly remde­sivir helps stave off hos­pi­tal­iza­tions — study

Pfizer and BioNTech will sell 500 million doses of their Comirnaty Covid-19 vaccine to the US at cost as part of an expanded agreement to drive donations to low- and middle-income nations, the drugmaker said Wednesday.

The expanded pact doubles Pfizer/BioNTech’s commitment to the US effort, which will ship donations to COVAX, a global clearinghouse for up to 92 target nations, as well as the 55 member states of the African Union, Pfizer said. Deliveries started in August and are expected to run through September 2022.

FDA+ roundup: Bs­U­FA III ready for show­time, court tells FDA to re-work com­pound­ing plan, new guid­ance up­dates and more

The FDA has now spelled out what exactly will be included in the third iteration of Biosimilar User Fee Act (BsUFA) from 2023 through 2027, which similarly to the prescription drug deal, sets fees that industry has to pay for submitting applications, in exchange for firm timelines that the agency must meet.

This latest deal includes several sweeteners for the biosimilar industry, which has yet to make great strides in the US market, with shorter review timelines for safety labeling updates and updates to add or remove an indication that does not contain efficacy data.

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Jean Bennett (Brent N. Clarke/Invision/AP Images)

Lux­tur­na in­ven­tor Jean Ben­nett starts a new gene ther­a­py com­pa­ny to tack­le rare dis­eases left be­hind by phar­ma, VCs

A few years ago Jean Bennett found herself in a surprising place for a woman who invented the first gene therapy ever approved in the United States: No one, it seemed, wanted her work.

Bennett, who designed and co-developed Luxturna, approved in 2018 for a rare form of blindness, had kept building new gene therapies for eye diseases at her University of Pennsylvania lab. But although the results in animals looked promising, pharma companies and investors kept turning down the pedigreed ophthalmology professor.

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.