Parex­el re­cruits top FDA on­col­o­gy ex­pert Amy Mc­K­ee for new R&D ini­tia­tive

Amy Mc­K­ee, one of Richard Paz­dur’s close al­lies in build­ing out the On­col­o­gy Cen­ter of Ex­cel­lence at the FDA, has left the agency to help com­pa­nies nav­i­gate a reg­u­la­to­ry land­scape she helped shape.

Amy Mc­K­ee

As VP of reg­u­la­to­ry con­sult­ing ser­vices at Parex­el, she joins a nascent on­col­o­gy ini­tia­tive ded­i­cat­ed to con­nect­ing dif­fer­ent busi­ness units to work up de­vel­op­ment plans — not un­like how she cre­at­ed a com­mu­ni­ca­tions struc­ture for dif­fer­ent of­fices across the FDA’s cen­ters for drug, bi­o­log­ics and de­vices.

“It was time to look at this en­tire drug de­vel­op­ment process from a dif­fer­ent an­gle,” Mc­K­ee tells me. At her new job, she says, “I’m help­ing com­pa­nies pri­or­i­tize which prod­ucts to de­vel­op in which pa­tients through which tar­gets for the best re­sponse we can get. and so that’s how I view what I will be do­ing here. I don’t view it as dif­fer­ent from my role at the FDA, I just view it as one of the dif­fer­ent part­ners who is in­volved in this en­tire drug de­vel­op­ment process.”

Dur­ing Mc­K­ee’s 11-year ca­reer at the FDA, she’s held a fron­trow seat to mul­ti­ple break­throughs from re­view­ing ola­parib — the pi­o­neer­ing PARP in­hibitor now known as Lyn­parza — to stamp­ing the fi­nal seal of ap­proval for Loxo’s tis­sue ag­nos­tic can­cer drug.

The past five to eight years have seen re­search on path­ways and im­munol­o­gy that goes back two or three decades come to fruition, lead­ing to the “ex­plo­sion of high­ly ef­fec­tive prod­ucts” and cor­re­spond­ing reg­u­la­to­ry in­no­va­tions, Mc­K­ee notes.

“That is why in on­col­o­gy we are able to look at tar­get­ed prod­ucts and say, yes, we know this is tar­get­ed and in this pop­u­la­tion we know that these re­sponse rates are re­al,” she says, “or in im­muno-on­col­o­gy agents we un­der­stand that they may take a lit­tle bit longer to work, but then you have these sus­tained re­spons­es be­cause the im­mune sys­tem has kicked in.”

Now on her third day at the CRO, news of Mc­K­ee’s ap­point­ment comes a few days af­ter an­oth­er top reg­u­la­tor — Leah Christl — of­fi­cial­ly left her po­si­tion at the FDA’s biosim­i­lar di­vi­sion.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Vlad Coric, Biohaven CEO

Vlad Coric charts course for new Bio­haven with neu­ro­science push and Big Phar­ma vets on board

What’s Biohaven without its CGRP portfolio? That’s what CEO Vlad Coric is tasked with deciding as he maps out the new Biohaven post-Pfizer takeover.

Pfizer officially scooped up Biohaven’s CGRP assets on Monday, including blockbuster migraine drug Nurtec and the investigational zavegepant, for $11.6 billion. As a result, Coric spun the broader pipeline into an independent company on Tuesday — with the same R&D team behind Nurtec but about 1,000 fewer staffers and a renewed focus on neuroscience and rare disease.

In AstraZeneca's latest campaign, wild eosinophils called Phils personify the acting up often seen in uncontrolled asthma

As­traZeneca de­buts an­noy­ing pur­ple ‘Phil’ crea­tures, per­son­i­fied asth­ma eosinophils ‘be­hav­ing bad­ly’

There are some odd-looking purple creatures lurking around the halls of AstraZenca lately. The “Phil” character cutouts are purple, personified eosinophils with big buggy eyes and wide mouths, and they’re a part of AZ’s newest awareness effort to help people understand eosinophilic asthma.

The “Asthma Behaving Badly” characters aren’t only on the walls at AZ to show the new campaign to employees, however. The “Phils” are also showing up online on the campaign website, and in digital and social ads and posts on Facebook and Instagram.

Mar­ket­ingRx roundup: No­var­tis re­cruits NFL coach for Leqvio cam­paign; Pfiz­er pro­motes ‘Sci­ence’ merch on so­cial me­dia

Novartis is turning to a winning coach to talk about Leqvio and the struggles of high cholesterol — including his own. Bruce Arians, the retired NFL head coach of the Arizona Cardinals and Super Bowl-winning Tampa Bay Buccaneers, is partnering with the pharma for its “Coaching Cholesterol” digital, social and public relations effort.

In the campaign, Arians talks about the potential for “great comebacks” in football and heart health. Once nicknamed a “quarterback whisperer,” he is now retired from fulltime coaching (although still a front-office consultant for Tampa Bay), and did a round of media interviews for Novartis, including one with People and Forbes.

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Amy West, Novo Nordisk head of US digital innovation and transformation (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: No­vo Nordisk dig­i­tal in­no­va­tion chief Amy West dis­cuss­es phar­ma pain points and a health­care 'easy but­ton’

Amy West joined Novo Nordisk more than a decade ago to oversee marketing strategies and campaigns for its US diabetes portfolio. However, her career path shifted into digital, and she hasn’t looked back. West went from leading Novo’s first digital health strategy in the US to now heading up digital innovation and transformation.

She’s currently leading the charge at Novo Nordisk to not only go beyond the pill with digital marketing and health tech, but also test, pilot and develop groundbreaking new strategies needed in today’s consumerized healthcare world.

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Benjamine Liu, TrialSpark CEO

Paul Hud­son and Tri­alSpark's mu­tu­al de­sire to speed up de­vel­op­ment con­verges in three-year, six-drug goal

A unicorn startup that originally set out to hasten clinical studies for biopharma partners dug further into its revised path of internal drug development by linking arms with Sanofi in a pact that the biotech’s CEO said originated from the top.

TrialSpark and the Big Pharma on Tuesday committed to in-licensing and/or acquiring six Phase II/Phase III drugs within the next three years.

“I’ve known Paul Hudson for a while and we were discussing the opportunity to really re-imagine a lot of different parts of pharma,” TrialSpark CEO Benjamine Liu told Endpoints News, “and one of the things that we discussed was this opportunity to accelerate the development of new medicines in mutual areas of interest.”

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New Chroma Medicine board member Jeff Marrazzo

Jeff Mar­raz­zo has found a buzzy new biotech cause to cham­pi­on. And once again, he's all in

Jeff Marrazzo is one of those biotech execs who has always been focused on the next big goal. He has a track record for meeting objectives, relentlessly staying on message, and breaking new ground.

The fact that he stayed around for a couple of years after Roche’s $4.3 billion Spark buyout, making sure the organization he founded weathered Covid-19, is one example. And that came after he carefully guided the company to the first-ever US approval of a gene therapy — no easy task.

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