In February, Philip Tagari will take a few days of retirement and then immediately return to industry. He won’t be leading the therapeutics discovery unit for a large biopharma, though.
He’ll trade in his Amgen hat for chief scientist at a machine learning startup that has reeled in hundreds of millions in capital to lay the groundwork for a much-hyped new model of drug discovery that aims to speed up the time to new clinical assets.
At insitro, the 24-year Amgen veteran will address what he calls the “intractable challenges” of drug R&D. His mandate, per CEO Daphne Koller in this week’s appointment announcement, is to hunt for “new targets and design therapeutic molecules.”
“The challenge was for Amgen and me, an established biopharma, is to build that airplane while you’re flying the current airplane,” Tagari said in an interview with Endpoints News.
Some introspection at Amgen, around 2018, led Tagari to take a deep dive into the three main “buckets” of challenges in the industry: what to work on (diseases, indications, targets, etc.); “how to rapidly arrive at a therapeutic entity”; and translating that work into the “right and convincing clinical experiment” so that “fantastic-looking molecules” don’t flop on efficacy and/or safety.
He became more interested in how those challenges could be addressed by automation, machine learning and other tools.
The insitro platform sparked his interest, enough to reel him in. It helped that Roger Perlmutter, whom Tagari worked for at both Merck and Amgen, was associated with insitro, as an independent board member.
As he gears up for the next stage of his career, Takari points to cancer drug Lumakras and cholesterol-lowering treatment Repatha as some highlights of his time at Amgen. From his 10 years at Merck, in the late ’80s and most of the ’90s, he still sees the fruits of his labor every day: His wife takes a generic version of an asthmatic drug on which he worked. The impact on patients is top of mind, he said, and even more so when that medicine helps somebody in your own family. Plus, the drug racked up tens of billions in sales following its launch shortly before the turn of the millennium.
During his time in the labs of Merck and Amgen, Tagari has touched multiple pockets of drug development: small molecules, biologics, antibodies, peptide therapeutics, oligonucleotides, T cell engagers, engineered cytokines and others. For the past decade, he ran Amgen’s therapeutic discovery work, brought together under one unit after the biopharma took a “self-examination” in the early 2010s, he said.
— Kyle LaHucik
→ In one of the more high-profile CEO transitions of the past year, Joaquin Duato took over for Alex Gorsky at J&J on Jan. 3, leaving Gorsky in the role of chairman. But starting in January 2023, Duato is taking that title too.
So ends Gorsky’s association with the Big Pharma that began in 1988 as a sales rep for Janssen, rising to CEO in 2012. When he announced his departure as chief executive in August 2021, it began a cascade of exits involving some of the biggest names at the pharma giant. Chief scientist Paul Stoffels retired on Dec. 31, 2021, then took on the daunting task of turning around Galapagos. And in August, head of R&D Mathai Mammen jumped ship himself. Mammen’s name popped up as a possible candidate to replace Michel Vounatsos as CEO of Biogen, but that job ultimately went to ex-Sanofi chief Chris Viehbacher.
Duato had been vice chairman of the executive committee before his ascent to CEO.
→ Immuno-inflammatory disease biotech Aclaris Therapeutics will reshuffle the leadership deck in a big way once we flip the calendar to 2023. Bristol Myers Squibb veteran and former Arena Pharmaceuticals R&D chief Doug Manion joined Aclaris in August as president and COO, but he will vault to the top spot as current CEO Neal Walker becomes chairman. Walker succeeds Christopher Molineaux, who will be the lead independent director.
The shakeup continues with the retirement of Frank Ruffo, the finance chief at Aclaris for the whole of its existence. While VP of finance Kevin Balthaser will take over as CFO on Jan. 1, Matthew Rothman’s quick ascent to general counsel and corporate secretary has already taken effect. It’s his third promotion this year, moving up to executive director, corporate counsel in January and VP, legal and compliance in June.
→ Austin, TX-based Aeglea BioTherapeutics has found a permanent replacement for Anthony Quinn, tapping Jeffrey Goldberg as CEO while interim chief Jim Kastenmayer returns full-time to his post as general counsel. Goldberg’s last CEO job was with Immunitas Therapeutics, passing the baton to Amanda Wagner in November 2021. A Sanofi Genzyme alum, Goldberg also spent four years as COO of Akcea. Quinn’s exit was part of a pipeline refocus/job cut maelstrom that rocked Aeglea this summer and saw the biotech change its lead candidate from pegzilarginase (which has a checkered history that includes an RTF) to its homocystinuria drug pegtarviliase, once known as AGLE-177.
→ David Horn Solomon has resigned as CEO of Pharnext, while chairman Joshua Schafer replaces him on an interim basis. The ex-CEO of Zealand Pharma, Akari Therapeutics and Silence Therapeutics had led the company since April 2020 and hands over a biotech that’s in a Phase III trial for Charcot-Marie-Tooth disease type 1A — it’s projected to read out data at the end of next year. Athena Bioventures managing director and Silo Pharma VP of R&D Jim Kuo is slated to fill the board vacancy that Horn Solomon also created.
→ Synthetic lethality player Ideaya Biosciences has pegged Darrin Beaupre as CMO. In 2020, Beaupre left his job as Pfizer’s SVP, head of early oncology development and clinical research to join Samumed (now Biosplice) as CMO and head of R&D in oncology. Ideaya’s stock $IDYA took a hit in August when GSK declined its option to develop IDE397, a MAT2A (methionine adenosyltransferase 2a) inhibitor, but it has rebounded considerably in the months since.
→ Peer Review encourages you to read Nicole DeFeudis’ feature on where we are today with digital therapeutics, and to provide guidance in that space, Akili — the maker of FDA-approved video game EndeavorRx — has appointed ADHD researcher Scott Kollins as CMO. Kollins had a two-decade career in the psychiatry and behavioral sciences department at the Duke University School of Medicine and was CMO of Holmusk. “We have treated ADHD in the U.S. in virtually the same way for more than 50 years; providers and patients need new options,” Kollins said in a press release. “Akili is in a unique position to challenge the status quo and change the treatment paradigm with unique digital medicine to improve patient care.”
→ Syncona– and Forbion-backed IL-2 player Anaveon has given CMO duties to Eduard Gasal, who just had a brief run as CMO and then president of Eli Lilly’s sintilimab partner Innovent. A series of oncology posts at Amgen from 2008-16 caught the attention of Novartis, where Gasal was executive director and global program clinical head in oncology clinical development. Incidentally, the Novartis Venture Fund played a role in Anaveon’s $119 million Series B last year.
→ Until recently the chair of the department of neuroscience at the Mayo Clinic, Guojun Bu is now making the leap into industry, where he’ll help steer early-stage work on drugs for Parkinson’s and Alzheimer’s into the clinic. The editor-in-chief of Molecular Neurodegeneration, Bu will now take control of the discovery and pre-clinical work at SciNeuro, where he’ll be in charge of translational work as the new CSO. Earlier, he had been a professor of cell biology and neuroscience at the Washington University School of Medicine in St. Louis.
Bu won’t be new to the work at SciNeuro, which has operations in Rockville, MD and Shanghai. “Having had a longstanding association with SciNeuro as a scientific advisor, I am thrilled to join the company as chief scientific officer,” Bu said.
→ Mnemo Therapeutics, a Paris CAR-T startup with Michel Sadelain as one of the scientific co-founders, has picked up Christine Foster as CBO. Foster decamps from Metagenomi after just eight months in the same capacity. The Teva and GSK vet has also made stops at Sunovion (head of search and evaluation, corporate development & licensing), Acceleron (VP, business development) and Intellia (SVP, business development). Helmed by former Bayer exec Robert LaCaze, Mnemo has named another scientific co-founder, Sebastian Amigorena, as SVP, immunology.
→ Medicxi startup Centessa Pharmaceuticals has propped up hemophilia A and B candidate SerpinPC as its lead asset following the discontinuation of lixivaptan in June. This week, Biogen and Pfizer human resources alum Karen Anderson has ventured off to Centessa as chief people officer. Anderson, the chief human resources officer with Alnylam from 2014-19, recently held the role of HR chief at cloud-based cybersecurity company Mimecast.
→ Incyte has dipped into the Big Pharma well to appoint Peter Williams as general manager of the UK and Ireland. In his recent stint at Gilead UK, Williams was senior director or sales and marketing for both the oncology and inflammation business units. He’s also been a business unit director in oncology during his five years with AbbVie UK. A couple months ago, Incyte paid $70 million in cash to buy Villaris Therapeutics and its vitiligo asset auremolimab.
→ Through the slings and arrows of the bear market, Peter Thiel-backed mental health player atai Life Sciences slimmed down its pipeline and ditched some partnerships in an effort to save money. With new CFO Stephen Bardin in place and a $175 million term loan facility from Hercules Capital providing a financial buffer, atai has welcomed Sahil Kirpekar as CBO. In his eight-plus years at Otsuka, Kirpekar was head of business development and co-chaired its Global Investment Committee.
→ A little before Cajal Neuroscience launched this week with $96 million to tackle Alzheimer’s and Parkinson’s, Ignacio Muñoz-Sanjuán joined the crew as CEO. Muñoz-Sanjuán hails from the CHDI Foundation, where he was VP of transitional biology and was president and co-founder of non-profit Factor-H. Earlier in his career, Muñoz-Sanjuán was with Amgen.
→ Quiet microbiome player Microbiotica is having a change in the guard in its leadership team, with CEO Mike Romanos passing the baton to COO Tim Sharpington after six years at the helm as he heads to Imperial College, London. The change comes not long after the company’s $67 million cash infusion in March. Sharpington brings experience from his times at Vectura, Arakis, ICON, Sequus and Open Orphan/hVIVO.
→ A couple weeks ago, Lei Lei Wu reported on cancer detection upstart Haystack Oncology and its $56 million Series A; CEO Dan Edelstein and the crew are wasting no time fleshing out the leadership with Joel Kaufman as CFO. The ex-business chief at Navidea Biopharmaceuticals, Kaufman breaks away from Sema4, where he had been VP of finance & corporate development since May 2021.
→ Making its first appearance, French “pinpoint gene therapy” biotech EG 427 has lined up Cornelia Haag-Molkenteller as CMO. Haag-Molkenteller left the same post at Urovant Sciences in March, and she ended more than a decade at Allergan as VP and therapeutic area head in global clinical development for women’s health, internal medicine, anti-infectives, and urology from 2015-18. EG 427 is forecasting a 2024 target date to hit the clinic with its lead drug for neurogenic bladder dysfunction, EG110A.
→ Takeda gene therapy partner Selecta Biosciences has recruited Blaine Davis as CFO. The Bristol Myers business development vet and former Endo exec held this same position at Protara Therapeutics from 2020 until this past July. Selecta got slowed down by a clinical hold on its methylmalonic acidemia program SEL-302, but it’s all systems go for early-stage trials now that the hold has been lifted.
→ As CSO Denis Drygin signals his departure, San Diego mRNA biotech Regulus Therapeutics has a pair of new execs who once worked at Sanifit: Rekha Garg (SVP, clinical development and regulatory) is an Amgen and Eli Lilly vet who was SVP, regulatory affairs and safety at Sanifit from 2016-19, and Claire Padgett (SVP, clinical operations) came from Mirati to take on the role of SVP, development operations at the Spanish company that was purchased by Vifor. Drygin’s exit comes after the kidney disease drug lademirsen spit the bit in Phase II, causing its longtime partner Sanofi to shut down development in August.
Another note: Regulus promoted Morgan Carlson to VP, biology and Edmund Lee to VP, translational medicine.
→ Maija Hollmén has been appointed CSO of Finland’s Faron Pharmaceuticals. Hollmén co-founded Faron in 2007 and will be tasked with steering development of bexmarilimab for acute myeloid leukemia and myelodysplastic syndrome. She’s also a professor of tumor immunology at the University of Turku.
→ Gamma delta T cell developer Adicet Bio has installed Nancy Boman as chief regulatory officer. Boman’s long career in regulatory affairs included stops at Amgen, Genentech, and Alder Biopharmaceuticals before she worked on the spinal muscular atrophy drug Zolgensma as SVP of regulatory affairs — and later chief regulatory officer — for AveXis, now Novartis Gene Therapies. Since 2019, she had been chief regulatory officer of Encoded Therapeutics.
→ Bristol Myers-backed peptide shop Sapience Therapeutics has enlisted Abi Vainstein-Haras as medical chief, replacing consulting CMO Alice Bexon. To close out her seven years at Teva, Vainstein-Haras was director and clinical program leader for the multiple sclerosis med Copaxone, and since 2014 she’s had a handful of posts at BioLineRx, including CMO. NexPoint and Bristol Myers contributed to Sapience’s $41 million Series B financing in late May.
→ Speaking of peptides, Madison, WI-based Roche spinout Nimble Therapeutics has locked in Pete Gough as CSO. Gough owned the same job title at Flagship’s Inzen Therapeutics, which combined with Cygnal to form Sonata Therapeutics in May. He’s also been head of the hepatitis B virus discovery performance unit during a 15-year career with GSK.
→ Stan Musial is knocking it out of the park again in Peer Review, this time as finance chief of New York oncology biotech Promontory Therapeutics. In July 2021, we told you about Musial taking the CFO job at Aruvant after tackling CFO/CBO duties at Danish biotech Xenikos. Promontory, the company formerly known as Phosplatin, hired VPs Helene Shea and Kate Hogg Call in September.
→ Early cancer detection specialist PrognomiQ has appointed Brian Koh as CMO. Koh had several leadership roles in hematology and oncology at Kite and Gilead, then moved on to lead translational sciences and clinical development at Vividion, which was sold to Bayer in a nearly $2 billion deal last year.
→ Shane Lea has signed on as chief commercial officer of cancer-focused Cellectar Biosciences. Lea ran the hematology franchise at TG Therapeutics after nine years of marketing roles with Celgene/Bristol Myers. Cellectar’s lead program, iopofosine, is in a Phase II study for Waldenstrom’s macroglobulinemia and a Phase IIb trial for relapsed/refractory multiple myeloma.
→ Barcelona dermatology biotech Almirall has elevated longtime staffer Mercedes Diz to VP, corporate strategy. Diz joined the team in 2002 and she had been senior director of corporate strategy for the last year. Her promotion comes after Carlos Gallardo took over for his father, Jorge Gallardo, as Almirall’s interim CEO on May 6.
→ With its lead asset bezuclastinib in Phase III for gastrointestinal stromal tumors (GIST), Cogent Biosciences has brought in Rachael Easton as VP, head of clinical development. Easton’s three years at GSK have drawn to a close, and since October 2021 she was the pharma giant’s group senior medical director, oncology clinical development. She’s also held clinical pharmacology and translational medicine positions at CSL Behring and Sanofi.
→ Striking a deal with fellow radiopharmaceutical outfit Point Biopharma for $260 million upfront, Lantheus has selected Amanda Morgan as SVP, commercial as it circles the wagons around the two drugs in the alliance, PNT2002 and PNT2003. Morgan comes from Acadia Pharmaceuticals, where she was promoted to chief revenue and customer officer after serving as SVP of sales and market access. Earlier, she was Shire’s US head of sales and US head of patient services.
→ Fueled by a $120 million raise from April, ophthalmology upstart Aurion Biotech has named Sherita Hall as VP, clinical operations and Sterling Chung as VP, global regulatory affairs. The former VP of both clinical operations and program management at Ocular Therapeutix, Hall also led the wet AMD team at Regenxbio. Chung had been in charge of regulatory affairs at Neoleukin Therapeutics and Molecular Templates; earlier, he had regulatory gigs at Abbott, Takeda, Gilead and Seagen.
→ Last we heard from Rewind Therapeutics, they were bringing in Irene Knuesel as CSO. Now, the Belgian company is recruiting Stephen Burbidge as head of research and discovery. Burbidge currently serves as director of discovery and preclinical projects at 3D Consultants, Cambridge (UK) and in the past has been with Proximagen and GlaxoWellcome/GSK.
→ California AI startup Terray Therapeutics has opened up some space on the board of directors for Xencor president and CEO Bassil Dahiyat. The brothers Berlin at Terray, Eli and Jacob, teamed up with Alphabet sub Calico Life Sciences on developing multiple undisclosed targets in October.
→ ReCode Therapeutics, which topped off its Series B in June with an additional $120 million, has elected ex-Metacrine CFO Trisha Millican to the board of directors. Previously, Millican had a board seat at Amunix, the Angie You-led company that Sanofi bought last year.
→ Former LEO Pharma CEO Christopher Posner is taking a seat on the board of directors at KemPharm. Posner currently serves as president and CEO of Cara Therapeutics and has formerly had stints at Bristol Myers, Pfizer, Wyeth and Endo.
→ Wrestling with layoffs and the “business decision” to shelve its only clinical trial, PACT Pharma CEO Scott Garland has clinched a spot on the board of directors at ALX Oncology. The ex-Portola CEO also has board seats at Day One Biopharmaceuticals and Calithera Biosciences.
→The PhRMA Foundation is bringing in more firepower to its board of directors with the appointments of Aida Habtezion (Pfizer CMO), Maha Radhakrishnan (Biogen CMO), George Addona (Merck Research Laboratories SVP and head. of discovery, preclinical and translational medicine), and Lori Reilly (PhRMA COO).
→ Frédéric Legros is joining the board at Arthex Biotech as executive chairman. Legros most recently served as COO of Dynacure and was the former VP and corporate head of business development at Valneva.
→ Former Pfizer chairman and CEO Henry McKinnell is heading over to the advisory board of AI player Quris. McKinnell also boasts stints as chairman of the boards of Moody’s and Accordia Global Health Foundation.
→ Oxford, UK-based Pathios Therapeutics is welcoming aboard Jeanmarie Guenot to its board of directors. Guenot is currently the founder, president and CEO of Toreador Therapeutics and has served in the same capacity at Amphivena, Harpoon Therapeutics and Maverick Therapeutics.
→ Two new faces are joining the board of directors at Bryn Pharma. Sandy Loreaux, Covis Pharma’s US president, will take one and the other will be taken by Isosceles Pharmaceuticals CEO William Humphries. In addition to their current stints, Loreaux formerly served in roles at Mallinckrodt, Bausch Health and Sanofi, while Humphries joins with experience from prior stints at Ortho Dermatologics, Merz, Stiefel Laboratories and GSK.
→ As Synairgen greets new board member Amanda Radford, Iain Buchanan is retiring after a 12-year run. Radford has been group financial controller with BSI Group since July.
Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.
As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.
Unlock this article along with other benefits by subscribing to one of our paid plans.
Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.
That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.
As the global biologics market is expected to hit nearly the half-trillion-dollar mark this year, new JAMA research points to the importance of timely biosimilar entry, particularly as fewer biosimilars are entering the US than in Europe, and as monthly treatment costs for biosimilars were “substantially higher” in the US compared with Germany and Switzerland.
Among the three countries, biosimilar market share at launch was highest in Germany, but increased at the fastest rate in the US, the authors from the University of Zurich’s Institute of Law wrote in JAMA Network Open today.
Gilead is going behind the scenes of some of the HIV initiatives it funds through grants in a new film series narrated by the people helming the projects.
The first four films and leaders come from across the US — Arianna Lint in Florida and Puerto Rico, Cleve Jones in San Francisco, June Gipson in Mississippi and Kirk Myers in Texas. Their HIV-focused efforts range from addressing unmet needs of the transgender community to delivering social services and high-quality health care in underserved communities.
Unlock this story instantly and join 154,000+ biopharma pros reading Endpoints daily — and it’s free.
The European Medicines Agency said Friday that it’s pulling from all European markets pholcodine-containing medicines, which are an opioid used in adults and children for the treatment of dry cough and in combo with other drugs as a treatment for cold and flu.
The decision to pull the medicines comes as the EMA points to the results from the recent ALPHO study, which show that use of pholcodine during the 12 months preceding anesthesia is linked to a risk of an anaphylactic reaction related to the neuromuscular blocking agents (NMBAs) used (with an adjusted OR of 4.2, and a 95% confidence interval of 2.5 to 6.9).
The FDA wanted more information on four key areas before it would let Beam Therapeutics proceed with human testing for a cell therapy in a certain type of leukemia. It appears the biotech has answered the agency’s queries.
The US regulator cleared the base-edited, off-the-shelf CAR-T, Beam said Friday morning, lifting a hold from this summer. More details on specific next steps for the Phase I will come out next year, the Boston-area biotech said.
Unlock this story instantly and join 154,000+ biopharma pros reading Endpoints daily — and it’s free.
A relatively unknown clinical-stage biotech — backed by a Korean lighting company and focused on a cancer vaccine out of a Thomas Jefferson University lab — is headed to Nasdaq via the blank check route.
Liminatus Pharma will get about $316 million in proceeds from the SPAC combination to fund its ongoing Phase IIa study of a cancer vaccine, bring a CAR-T therapy into the clinic and prep a CD47 immune checkpoint inhibitor for human trials, the company said this week.
Unlock this story instantly and join 154,000+ biopharma pros reading Endpoints daily — and it’s free.
With the market cap on Horizon Therapeutics $HZNP pushed up to the $23 billion mark today, one of the Big Pharmas in the hunt for a major league buyout deal signaled it’s playing the M&A game with cash.
Paris-based Sanofi, where CEO Paul Hudson has been largely focused on some risky biotech acquisitions to win some respect for its future pipeline prospects, issued a statement early Friday — complying with Rule 2.12 of the Irish takeover rules — making clear that while the certainty or size of an offer can’t be determined, any offer “will be solely in cash.” And Amgen CEO Robert Bradway came right in behind him, filing a statement on the London Stock Exchange overnight that any offer they may make will “likely” be in cash as well.
Unlock this story instantly and join 154,000+ biopharma pros reading Endpoints daily — and it’s free.
Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.
In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.
Unlock this story instantly and join 154,000+ biopharma pros reading Endpoints daily — and it’s free.
Bioscience & Technology Business Center
The University of Kansas
Lawrence, Kansas
© Endpoints Company 2022
If you’re already an Endpoints subscriber, enter your email below for a magic link that lets you log in quickly without using a password. Please note the magic link is one-time use only and expires after 24 hours.
We’ll e-mail you a link to set a new password. Please note this link is one-time use only and is valid for only 24 hours.
ENDPOINTS NEWS Daily at 11:30 AM ET
EARLY EDITION Daily at 7:15 AM ET
ENDPOINTS PHARMA Daily at 2 PM ET
ENDPOINTS MARKETING RX Tue at 2 PM ET
ENDPOINTS FDA+ Wed at 2 PM ET
ENDPOINTS MANUFACTURING Thu at 2 PM ET
ENDPOINTS WEEKLY Sat at 6 AM ET