Trevor Bed­ford, Cigall Kadoch among this year's in­com­ing HH­MI in­ves­ti­ga­tors

Trevor Bed­ford

The Howard Hugh­es Med­ical In­sti­tute — the non­prof­it known for dol­ing out gen­er­ous in­ves­ti­ga­tor awards to bio­phar­ma’s ris­ing stars — has se­lect­ed its Class of 2021.

This year’s list of 33 in­ves­ti­ga­tors fea­tures some note­wor­thy names, in­clud­ing Fred Hutchin­son’s Trevor Bed­ford, who sound­ed the alarm on the first known com­mu­ni­ty trans­mis­sion of Covid-19 in the US last Feb­ru­ary; Foghorn founder and Dana-Far­ber re­searcher Cigall Kadoch, who re­cent­ly joined End­points News for a pan­el dis­cus­sion dur­ing #ES­MO21; and award-win­ning Johns Hop­kins stem cell re­searcher Xin Chen.

Cigall Kadoch

“HH­MI is com­mit­ted to giv­ing out­stand­ing bio­med­ical sci­en­tists the time, re­sources, and free­dom they need to ex­plore un­chart­ed sci­en­tif­ic ter­ri­to­ry,” pres­i­dent Erin O’Shea said in a state­ment.

So far, the in­sti­tute has churned out 32 No­bel Prize win­ners, in­clud­ing gene ther­a­py pi­o­neer Jen­nifer Doud­na and RNA ex­pert Thomas Cech. And the fund­ing is noth­ing to scoff at.

HH­MI says it’ll in­vest $300 mil­lion in this year’s new in­ves­ti­ga­tors, who are join­ing HH­MI’s com­mu­ni­ty of about 250 sci­en­tists. Each new in­ves­ti­ga­tor will re­ceive rough­ly $9 mil­lion over a sev­en-year term, which is re­new­able pend­ing a sci­en­tif­ic re­view.

Xin Chen

A few years ago, HH­MI land­ed it­self in some hot wa­ter when two for­mer in­ves­ti­ga­tors, Jean­nie Lee and Vi­vian Che­ung, al­leged they were un­fair­ly de­nied re­new­al of grants be­cause of their sex, age, na­tion­al ori­gin or dis­abil­i­ty. In re­sponse to a Sci­ence piece about the al­le­ga­tions pub­lished in 2019, O’Shea wrote that the in­sti­tute is “ful­ly con­fi­dent in the in­tegri­ty of our re­view process.”

Em­ploy­ing sci­en­tists as HH­MI In­ves­ti­ga­tors, rather than sim­ply hand­ing out re­search grants, al­lows HH­MI to fo­cus on “peo­ple, not projects,” O’Shea said in a state­ment about the new class of in­ves­ti­ga­tors on Thurs­day.

This year’s full class in­cludes:

Emi­ly Bal­skus of Har­vard Uni­ver­si­ty; Gre­go­ry Bar­ton of UC-Berke­ley; Di­ana Bautista of UC-Berke­ley; Trevor Bed­ford of the Fred Hutchin­son Can­cer Re­search Cen­ter; Flaminia Cat­teruc­cia of Har­vard Uni­ver­si­ty; Xin Chen of Johns Hop­kins Uni­ver­si­ty; Rhi­ju Das of Stan­ford Uni­ver­si­ty; Ka­fui Dzi­rasa of Duke Uni­ver­si­ty; Nels El­de of the Uni­ver­si­ty of Utah; Cagla Eroglu of Duke Uni­ver­si­ty; Cas­san­dra Ex­tavour of Har­vard Uni­ver­si­ty; Chenghua Gu of Har­vard Uni­ver­si­ty; Sun Hur of Boston Chil­dren’s Hos­pi­tal; Mar­tin Jonikas of Prince­ton Uni­ver­si­ty; Cigall Kadoch of the Dana-Far­ber Can­cer In­sti­tute; Shin­go Ka­jimu­ra of the Beth Is­rael Dea­coness Med­ical Cen­ter; Daniel Kro­nauer of The Rock­e­feller Uni­ver­si­ty; Fred­er­ick Mat­sen IV of the Fred Hutchin­son Can­cer Re­search Cen­ter; Ian Maze of the Ic­ahn School of Med­i­cine at Mount Sinai; John Mc­Cutcheon of Ari­zona State Uni­ver­si­ty; Michelle Mon­je of Stan­ford Uni­ver­si­ty; Daniel Mu­ci­da of The Rock­e­feller Uni­ver­si­ty; Dana Pe’er of the Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter; Kristy Red-Horse of Stan­ford Uni­ver­si­ty; Vanes­sa Ru­ta of The Rock­e­feller Uni­ver­si­ty; David Sav­age of UC-Berke­ley; Mikhail Shapiro of the Cal­i­for­nia In­sti­tute of Tech­nol­o­gy; Vin­cent Tagliabrac­ci of the UT-South­west­ern Med­ical Cen­ter; Ben­jamin Tu of the UT-South­west­ern Med­ical Cen­ter; Kay Tye of the Salk In­sti­tute for Bi­o­log­i­cal Stud­ies; David Veesler of the Uni­ver­si­ty of Wash­ing­ton; Eliz­a­beth Vil­la of UC-San Diego; and Jochen Zim­mer of the Uni­ver­si­ty of Vir­ginia.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data is messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data is exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

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Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

Sen. Richard Durbin (D-IL, foreground) and Sen. Richard Blumenthal (D-CT) (Patrick Semansky/AP Images)

Sen­a­tors back FDA's plan to re­quire manda­to­ry pre­scriber ed­u­ca­tion for opi­oids

Three Senate Democrats are backing an FDA plan to require mandatory prescriber education for opioids as overdose deaths have risen sharply over the past decade, with almost 97,000 American opioid-related overdose deaths in the past year alone.

While acknowledging a decline in overall opioid analgesic dispensing in recent years, the FDA said it’s reconsidering the need for mandatory prescriber training through a REMS given the current situation with overdoses, and is seeking input on the aspects of the opioid crisis that mandatory training could potentially mitigate.

Suresh Katta, Saama CEO (via YouTube)

As AI con­tin­ues to en­tice Big Phar­ma, a Car­lyle-led drug­mak­er syn­di­cate shells out $430M for cloud com­put­ing play­er

The AI revolution permeating Big Pharma took a big financial step forward Wednesday, with VCs and major drugmakers coming together to acquire a cloud-focused company.

Led by the Carlyle Group, the investors will put up $430 million for a majority stake in Saama, a company that collects patient data to help speed along the drug development process. The investment arms of Pfizer, Merck, Amgen and McKesson all participated in the financing, in addition to other prominent life sciences VCs like Northpond.

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Raju Mohan, Ventyx Biosciences CEO

Ven­tyx sprints to Wall Street less than a year af­ter emerg­ing from stealth

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

It took seven months from exiting “quiet mode” for Ventyx Biosciences to land its very own stock ticker, raising $165 million in venture funds along the way.

Now, after pricing a massive $151.5 million IPO, the Encinitas, CA-based biotech is gunning for Phase II.

Ventyx priced close to 9.5 million shares at $16 apiece on Wednesday, the midpoint of its $15 to $17 range. CEO Raju Mohan filed the S-1 papers at the end of September, just over a week after unveiling a $114 million Series B round. He penciled in the standard figure of $100 million at first, likely knowing that in the last year, it’s been common for biotechs to raise much more than those initial estimates.

Bris­tol My­ers pledges to sell its Ac­celeron shares as ac­tivist in­vestors cir­cle Mer­ck­'s $11.5B buy­out — re­port

Just as Avoro Capital’s campaign to derail Merck’s proposed $11.5 billion buyout of Acceleron gains steam, Bristol Myers Squibb is leaning in with some hefty counterweight.

The pharma giant is planning to tender its Acceleron shares, Bloomberg reported, which add up to a sizable 11.5% stake. Based on the offer price, the sale would net Bristol Myers around $1.3 billion.

To complete its deal, Merck needs a majority of shareholders to agree to sell their shares.