‘Bio­hack­er’ Tray­wick dead at 28 — known for self-in­ject­ing a DIY her­pes drug

Con­tro­ver­sial bio­hack­er Aaron Tray­wick was found dead on Sun­day in a spa room in Wash­ing­ton, DC, ac­cord­ing to mul­ti­ple me­dia re­ports cit­ing the DC po­lice. He was 28.

Aaron Tray­wick

Tray­wick, the CEO of As­cen­dance Bio­med­ical, was known for his view that in­di­vid­u­als should be able to self-de­sign and self-ad­min­is­ter un­ap­proved treat­ments — like gene ther­a­py — with­out the re­quire­ment of a health­care pro­fes­sion­al. He gained wide pub­lic­i­ty in Feb­ru­ary when he in­ject­ed him­self with a DIY treat­ment that he hoped would cure his her­pes on­stage at a bio­hack­er con­fer­ence in Texas. The whole process was broad­cast live on Face­book.

Ac­cord­ing to News2Share, which first re­port­ed the news (and filmed Tray­wick in Feb­ru­ary), Tray­wick was found in a floata­tion tank — a sound­proof pod filled with body-tem­per­a­ture salt­wa­ter meant to pro­mote “sen­so­ry de­pri­va­tion” and “deep re­lax­ation.”

A death in­ves­ti­ga­tion is still on­go­ing, though law en­force­ment not­ed they have no ev­i­dence sug­gest­ing foul play at the mo­ment.

Last Oc­to­ber, Tray­wick at­tract­ed the at­ten­tion of the FDA by stag­ing a live demon­stra­tion of an untest­ed HIV treat­ment. Tris­tan Roberts, an HIV pa­tient, vol­un­teered to in­ject him­self with the pur­port­ed gene ther­a­py. Nei­ther of them had for­mal train­ing in med­i­cine or ge­net­ic en­gi­neer­ing. Short­ly there­after, with­out nam­ing names, the FDA is­sued a warn­ing against self-ad­min­is­tra­tion of gene ther­a­py prod­ucts, con­cerned about the safe­ty risks in­volved.

While he did not get the re­sults he want­ed (his vi­ral load rose in­stead of falling), Roberts pre­vi­ous­ly said he still be­lieved in the po­ten­tial of the ther­a­pies be­ing de­vel­oped.

“Aaron was a pas­sion­ate vi­sion­ary. He seem­ing­ly nev­er tired as he brought peo­ple to­geth­er to work on some of the most im­pos­ing chal­lenges fac­ing hu­man­i­ty,” Roberts said in a state­ment pro­vid­ed to Vice News. “While many in the bio­hack­ing scene dis­agreed with his meth­ods, none of them doubt­ed his in­ten­tions. He sought noth­ing short of a rev­o­lu­tion in bio­med­i­cine; the de­moc­ra­ti­za­tion of sci­ence and the open­ing of the flood gates for glob­al heal­ing.”

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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Brid­get Martell on tak­ing Yale spin­out 'to adult­hood'; Cul­li­nan On­col­o­gy CEO an­nounces res­ig­na­tion as Bris­tol My­ers hema­tol­ogy ex­ec is wel­comed aboard

Bridget Martell’s first clinical trial was an unorthodox one.

Then a resident in internal medicine at Yale, she was given an award to explore a career in clinical research — which was how she wound up leading a Phase I study for a therapeutic cocaine vaccine designed to help overcome addiction. She ended up overseeing the trial from Patient 1 to Patient 110 and, in the end, the early trial was positive.

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 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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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.

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.

No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty

 

I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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