How family and science moved Exelixis’ new CMO to work on oncology blockbusters; While John Maraganore racks up the prizes, his old crew at Alnylam selects president
After 18 years at the FDA and climbing the corporate ladder in biopharma, Vicki Goodman is now in the biotech C-suite for the first time. The new CMO and executive VP of product development for Exelixis started on Dec. 4, flying out to the..
After 18 years at the FDA and climbing the corporate ladder in biopharma, Vicki Goodman is now in the biotech C-suite for the first time. The new CMO and executive VP of product development for Exelixis started on Dec. 4, flying out to the biotech’s headquarters just outside sunny San Francisco before returning home and flying all the way back to Philly, where she is based.
Goodman got her passion for medicine as a young child — it didn’t surprise anyone that she majored in biochemistry before going through medical school and residency, finishing up in the early 2000s with an emphasis in internal medicine, medical oncology and hematology. But for her, there was an underlying desire to use science to help people and work on problems that impact people’s health.
Part of that desire came from personal tragedy: Goodman lost her mother to breast cancer right as Goodman finished medical school. She decided to focus her career in oncology.
It was a a pivotal time in the field. Science was changing — particularly doctors’ understanding of biology and cancer.
“It was becoming very clear that our understanding of human biology — and increasing understanding of some of the molecular genetic underpinnings of cancer — could really have the potential to revolutionize treatment of patients with cancer,” Goodman told Endpoints News.
She noted Novartis’ tyrosine kinase inhibitor Gleevec for chronic myeloid leukeima was approved in 2001, near the end of her residency. The first-of-its-kind target therapy fundamentally transformed treatment of that type of cancer, and pushed her towards drug development.
“We really watched how that treatment — which was molecularly targeted — transformed the treatment of that disease from one that inexorably progressed,” Goodman said. “We didn’t have drugs that really affected the underlying disease. And ultimately, you know, patients would have a blast crisis and die of the disease. You were seeing with treatment with Gleevec, the tumors, cancer cells just melted away, the leukemic cells just disappeared.”
And going into drug development she did. After spending some time at the FDA, got hired at GlaxoSmithKline, where she spent 8 years working in clinical and medicine development before going over to Bristol Myers Squibb in 2015. While at Bristol Myers, Goodman worked as a VP, development lead before moving into the oncology senior leadership team there, ultimately working on blockbuster PD-(L)1 inhibitor Opdivo.
That’s when Goodman first got acquainted with Exelixis — she helped lead the partnership between BMS and Exelixis on the Checkmate -9ER trial, which combined Opdivo with Exelixis’ lead candidate, the now-approved drug Cabometyx for renal cell carcinoma.
After leaving BMS in 2020, she went to Merck, where she worked on PD-(L)1 blockbuster Keytruda and other Merck candidates in indications such as thoracic malignancies, head and neck cancers, breast and gynecologic cancers, and hematology.
Which brought her back to Exelixis. Goodman heard that the CMO position was open, and when they reached out to her, she didn’t want to let go of an opportunity, so she went for it.
So what’s next for Goodman and Exelixis? In Goodman’s own words, “There’s a lot to do,” especially on the data side of things. There’s expected readouts for Cabometyx for this year — some of them in Phase III trials for even more indications for the drug. There’s also pipeline expansion and setting up a registrational trial this year for XL092, the company’s new TKI inhibitor, and down the road for XL102, their new CDK7 inhibitor.
“The other key focus for me is really on the people and teams and making sure that we have the right capabilities in place,” Goodman said.
And it plays right into one of the things on her leadership to-do list: start building a development team out on the East Coast — which in Goodman’s view, is a crucial step for future success.
— Paul Schloesser
Happy 2022, Peer Review readers! The new year has started with an unparalleled deluge of appointments, so buckle up:
→ A new era at Alnylam begins now with Yvonne Greenstreet as CEO, a new siRNA deal with Novartis, and a promotion: Akshay Vaishnaw has been elevated to president after nearly four years as president of R&D with the RNAi pioneer. Vaishnaw has been an Alnylam exec since 2006, leaving Biogen to take a job as VP of clinical research, and he’s been steadily rising in the company ever since.
As for Alnylam’s former CEO, the beat goes on with John Maraganore’s mission to “be a granddad” for other companies — Peer Review may as well institute a Maraganore Meter to track all the gigs he accumulates. What’s on tap for him now? First, he became an executive partner at RTW, as detailed by our Paul Schloesser; Atlas Venture tweeted this week that Maraganore will lend his expertise as a venture advisor; next, Maraganore has been named chairman of the board at Hemab, a Danish blood disorder biotech helmed by former Codiak exec Benny Sorensen; SQZ Biotechnologies also came calling this week, tapping Maraganore as a strategic advisor; and finally, he will be chair of the advisory council at Stanley Crooke’s non-profit n-Lorem Foundation.
→ Last year, Blueprint Medicinesearned its fourth approval by crossing the goal line with Ayvakit for advanced systemic mastocytosis, and joined the M&A party by purchasingLengo Therapeutics for $250 million upfront. On April 4, Blueprint will have a change at the top as CEO Jeff Albers passes the baton to Kate Haviland, who was hired as CBO in 2016 and has been COO since 2019. Haviland ventured off to Blueprint after her tenure as VP, rare diseases and oncology program leadership at Idera; she’s also led commercial development Sarepta and PTC Therapeutics. Albers will be executive chairman until the end of the year, at which time he will continue as chairman.
Another piece of Blueprint news: Also effective April 4, Christina Rossi, the company’s chief commercial officer since 2018, will replace Haviland as COO.
→ Mike Grey’s days are up as interim CEO of Spruce Biosciences after pinch-hitting for the retired Richard King, now entrusting the company to Javier Szwarcberg. Following a short stay as VP of R&D and business development at Horizon, Szwarcberg pivoted to Ultragenyx, becoming SVP, head of program and portfolio management. Since February 2020, Szwarcberg had been group VP and head of program and portfolio development for JJ Bienaimé at BioMarin. Another Spruce note: Samir Gharib has been elevated to president and will retain his duties as CFO.
→ There will be a new sheriff in town at cancer bispecifics biotech Zymeworks as Kenneth Galbraithreplaces CEO Ali Tehrani “on or before” Feb. 1. Tehrani spent 18+ years at the helm and he’ll stick around as an advisor during the transition period. Galbraith has familiarity with the company already as a former board member from 2009-13, and the ex-CEO of Liminal BioSciences and Fairhaven Pharmaceuticals has been an entrepreneur-in-residence with Syncona since last April. There’s one more bit of C-suite activity to sort out — CFO and 15-year Zymeworks vet Neil Klompashas tacked on the role of COO with immediate effect.
→ While we were on a break (apologies to Ross from “Friends”), Hubert Chenresigned as CMO of Metacrine effective New Year’s Eve, leaving CEO Preston Klassen to fill the vacancy. Chen found another CMO gig at ADARx Pharmaceuticals, an RNA editing startup that raised the curtain on a $75 million Series B co-led by OrbiMed and SR One in September 2021. Chen joined Metacrine in August 2018 after four years with Pfenex — first as CMO, then as chief scientific and medical officer — and has previously been VP of clinical development at Aileron Therapeutics. Like many companies, Metacrine ran into a brick wall with NASH, throwing in the towel with its program in October and instead concentrating on a Phase II for inflammatory bowel disease with MET642.
→ The Grass is always greener: Joshua Grasshas succeeded the retiring Alain Baron as CEO of San Diego-based upstart Escient Pharmaceuticals, with Baron staying on as a strategic advisor through Q1. After 15 years at BioMarin, where he was SVP, business and corporate development, Grass launched the rare disease play Modis Therapeutics in 2018 while he was an entrepreneur-in-residence at F-Prime Capital. The next year, Zogenix scooped up Modis for $250 million upfront.
→ Peer Review received a statement on behalf of Spark that Joseph La Barge has stepped down “to begin focusing on his next chapter in biotech.” La Barge jumped on board at Spark in 2013 as chief legal officer and had served as CBO for almost two years, playing a pivotal role in the acquisition by Roche.
→ Simon Allen will be CEO of Anebulo Pharmaceuticals, which seeks to turn the tables on cannabinoid overdose and substance abuse. He will replaceDaniel Schneeberger, who announced his resignation effective Feb. 1. Allen returned for a second tour of duty as CBO for Ambrx in March 2019 after holding the same position at the California biotech from 2010-15. Austin-based Anebulo, whose lead candidate ANEB-001 is in a Phase II proof-of-concept study for acute cannabinoid intoxication, has also brought inScott Anderson as head of investor relations and public relations.
→ At Paris-based biotech Onxeo, Julien Miarahas replaced CEO Judith Greciet on an interim basis starting this week. A member of Onxeo’s board since September 2020, Miara’s run at Invus began more than a decade ago, earning a promotion in 2018 to lead its European team. Greciet was named CEO of Onxeo in 2011, back when the company was known as BioAlliance Pharma until it merged with Topotarget and was rebranded. The DNA damage response biotech is now chaired by Epizyme chief medical and development officer Shefali Agarwal.
→ Eric Hobbswill be reassigned from CEO “to president of the Antibody Therapeutics business line” at digital cell biology player Berkeley Lights when his replacement is found. Hobbs first came to Berkeley Lights in 2013 as senior director of R&D and was promoted to CEO in March 2017. Berkeley Lights struck while the IPO iron was hot in the summer of 2020, blowing by the standard $100 million they initially penciled in with a $205 million upsized offering.
→ Francis Sarenahas signed on to be COO of Apexigen, whose CD40 agonist sotigalimab is in Phase II studies in a number of cancer indications, namely melanoma. From 2011-21, Sarena was an exec with Five Prime, serving as chief strategy officer from 2016 until Amgen padded its oncology pipeline by purchasing the company for $2 billion. This is Apexigen’s second major executive appointment in the last several months after bringing in CMO Frank Hsu from Oncternal Therapeutics.
→ Michael Skynner has pedaled into a new post this week at Bicycle Therapeutics, shifting from COO to chief technology officer for CEO Kevin Lee’s squad while VP, human resources and communications Alistair Milnes steps into the COO slot. Skynner, Bicycle’s COO since 2018, first arrived in 2016 as VP, operations and discovery after his days as head of external alliances, rare disease research unit with Pfizer. Bicycle put a little air in Ionis’ tires in July 2021 with an oligonucleotide deal that saw Ionis fork over $45 million upfront.
→ Stephen Squinto’s nucleic acid gene therapy biotech Gennao Biohas peggedJoseph McIntosh as CMO and Anuj Goswami as general counsel. McIntosh was in this space a mere eight months ago when he took the CMO job at Jaguar Gene Therapy, spending the previous year as the medical chief of Aruvant. This is Goswami’s first foray into biotech after a 21-year career in private practice with Philadephia-based Ballard Spahr.
→ Rare disease player Fulcrum Therapeuticshas found a new CFO in Esther Rajavelu, who most recently served as a senior equities research analyst at UBS. Rajavelu’s experience also includes stints at Deutsche Bank and Oppenheimer & Co. Fulcrum’s stock price went through the roof last summer on the strength of data for its sickle cell drug FTX-6058.
→ New York’s Indaptus Therapeuticshas tappedBoyan Litchev as CMO, the latest move in a whirlwind of stops the last five years. Let’s break it all down: Litchev had only led global clinical development at Shoreline Biosciences since the summer of 2021, and as we told you then, he spent his previous 16 months as head of clinical development, oncology at Poseida. Litchev was briefly the executive medical director, head of clinical development, oncology at Halozyme after two years with Akcea, and he joins Indaptus in time to push its lead cancer candidate Decoy20 into Phase I sometime this year.
→ Danish biotech Galecto, part of the 2020 IPO frenzy, has waved inStephanie Oestreich as CBO. After 12 years with Novartis, Oestreich was the international business leader for Avastin at Roche, then jumped over to Evotec, where she was head of academic partnerships and investments, North America & Asia. She just finished an abbreviated run as VP of operations and head of alliance management with Mnemo Therapeutics. Galecto’s lead product, GB0139, is an inhaled galectin-3 inhibitor in a Phase IIb trial for idiopathic pulmonary fibrosis.
→ David McIntyrehas been named CFO of cardiovascular disease player Anthos Therapeutics, launched nearly three years ago by Blackstone and Novartis. An ex-partner at Apple Tree Partners, McIntyre just had a year-long stint as finance chief at Tessa Therapeutics. Anthos’ lead candidate, the monoclonal antibody abelacimab, is being developed as an anticoagulant to prevent or treat venous thromboembolism.
→ GI disease player 9 Meters Biopharma out of Raleigh, NC has namedSarah Liu chief commercial officer and Al Medwar head of investor relations. Liu spearheaded global commercial strategy for the spinal muscular atrophy drug Zolgensma while she was VP and head of worldwide new product planning and VP, global marketing at Novartis Gene Therapies. The Takeda and Abbott vet has also been VP of commercial operations and strategic planning at Melinta Therapeutics. Medwar swings into 9 Meters from Aruna Bio, where he was EVP of corporate & commercial development.
→ Kevin Lynchis making his way over toNotable Labs as CBO. Lynch comes aboard after careers as CBO of Recursion and VP of business development at Vir Biotechnology. Not only that, but earlier in his career, Lynch ran a 20-year stint over at Abbott/AbbVie as VP, search and evaluation.
→ Marie-Louise Fjällskog has left Sensei Biotherapeuticsto become CMO at Finnish immunotherapy biotech Faron Pharmaceuticals. While Fjällskog was CMO at Sensei, the company rolled to a $152 million IPO in early 2021. In addition to her new role at Faron, Fjällskog also serves as associate professor of oncology at Uppsala University in Sweden.
→ Christopher Horanhas answered the bell as chief technical operations officer at Artiva Biotherapeutics, Merck’s CAR-NK partner that doubled the fun in 2021 with a $120 million raise and a Nasdaq debut. After 13 years at Merck and another 14 with Genentech where he rose to head of product and global supply chain management, Horan served as chief technical operations officer at Dermira and, most recently, SanBio.
→ UK-based 4D pharma made the SPAC-tacular move of reverse merging with blank check company Longevity Acquisition Corporation and has now recruited John Doyle as CFO. Doyle had a quick cup of coffee as Chiasma’s finance chief last year after three years at Verastem, where he was promoted to VP, finance and investor relations.
→ Giving the Teva reject laquinimod another go for patients with non-infectious non-anterior uveitis, Sweden’s Active Biotechhas named Big Pharma vet Erik Vahtola as CMO. Vahtola was based in Finland when he worked for Roche from 2013-16, and since 2019 he had been head of medical affairs, oncology at Bayer. Elsewhere at Active Biotech, CSO Helena Eriksson’s 23 years with the company have come to a close, but she’ll stay active, so to speak, in a consulting role.
→ Travere Therapeutics, the company formerly known as Retrophin which was operating under “Pharma Bro” MartinShkreli, has tacked onJula Inrig as CMO. Inrig joins the company from IQVIA, where she served as global head of the renal center of excellence, right as they try once again to push for the accelerated approval of sparsentan.
→ DiaMedica, focused on developing treatments for neurological disorders and kidney diseases, has namedKirsten Gruis as CMO. Gruis brings with her a wealth of experience from her former stints at Edgewise Therapeutics (CMO), Roche (neuromuscular franchise head), AgilisBiotherapeutics, Wave Life Sciences, Idera, Alnylam and Pfizer.
→ Salt Lake City-based Elevar Therapeutics changed CEOs in 2021 when Kate McKinley took over for Alex Kim. As we ring in 2022, Elevar has selected Bristol Myers vet Jenny Gizzi as chief people officer. Gizzi was the VP of human resources for Arena Pharmaceuticals, Pfizer’s M&A jewel to close out last year, after a year with Mirati as head of human resources and site operations. Among the drug candidates in Elevar’s pipeline is rivoceranib, developed by Hengrui and approved in China for gastric cancer and second-line advanced hepatocellular carcinoma.
→ Eye drop developer Oculishas turned its eyes onWebb Ding as its next COO and general manager, China. Ding makes his way to Oculis from Fresenius Kabi, where he served as country president for China. Prior to that, Ding was with Novartis in China for a decade and notably served as general manager of Novartis Vaccines Greater China and Tianyuan Bio-Pharma. Earlier in his career, Ding also served in roles at Bristol Myers Squibb and Xi’an Janssen.
→ Biosionhas welcomedAnthony Yeh as chief strategy officer and head of China business development. Yeh hails from CStone Pharmaceuticals, where he served as VP, head of corporate strategy, investor relations and capital market.
→ Terns Pharmaceuticals is giving it the old college try with NASH and brings two appointments to this week’s Peer Review: Jeffrey Jasper as SVP, head of research and Diana Chung as chief development officer. Most recently, Jasper was VP, drug discovery at Rubedo Life Sciences, and he also served as executive director, research science at Merck Research Laboratories. Chung has been at Terns since September 2019, where she started as VP, clinical development and operations before moving to SVP in November 2020.
→ Australian eye disease biotech Optheahas appointedJudith Robertson as chief commercial officer. Robertson is no stranger to Opthea, where she has served on the board of directors (chaired by Ovid chief Jeremy Levin) since June 2021. Robertson has held the position of CCO at both Eleusis and Aerie Pharmaceuticals, and at J&J‘s Janssen, she was global commercial VP, immunology and ophthalmology.
→ Cancer-focused Curishas locked in three new execs: Felix Geissler (VP of medical affairs) just held the same post at Horizon, which plunked down $25 million upfront in a deal with Alpine Immune Sciences last month; Kimberly Steinmann (VP of clinical development) is a Boehringer Ingelheim vet who had been a consultant for Takeda’s oncology development program and was executive medical director for orphan diseases with Grifols; and Dora Ferrari (VP of clinical operations), who had a 10-year career at ArQule, comes to Curis from Aileron Therapeutics, where she was VP, clinical development and program management. Curis’ IRAK4 kinase inhibitor CA-4948 is in a Phase I/II study for acute myeloid leukemia or high-risk myelodysplastic syndromes, both as a monotherapy and in combination with azacitidine or venetoclax.
→ Everything’s coming up Chemomab in Peer Review, whether it’s Dale Pfost hitting the scene as CEO and later becoming chairman or naming David Weiner as interim CMO. This time the Israeli fibrotic and inflammatory disease biotech has installedJack Lawler as VP of global clinical development operations. Lawler hails from Goldfinch Bio, where he was VP, clinical operations and data management, and he was director of clinical development operations at ViroPharma before Shire’s $4.2 billion acquisition.
→ Putting mutations of the MAPK and mTOR pathways under the proverbial microscope, Immuneeringhas picked upEisai and Merck alum Rimma Steinhertz as VP, project and alliance management. Steinhertz had spent the last two years as executive director, global program leader, portfolio & program management, oncology at Glenmark sub Ichnos Sciences, and she was the group director, external collaborations, oncology during her time at Merck.
→ Repare Therapeuticshas brought onPhilip Herman as its EVP of commercial and new product development. Herman most recently served as CCO at Y-mAbs Therapeutics, where he oversaw the launch of the neuroblastoma drug Danyelza. Herman has also served as head of marketing at Dyax and director of marketing at Vanda Pharmaceuticals.
→ Peter Kolchinsky orchestrated Point Biopharma’s Nasdaq debut through a SPAC deal in March 2021, and this week the radiopharmaceutical player has welcomedMatthew Vincent as SVP, business development. Vincent had held the same title at Avacta Life Sciences since 2017. A month ago, Point promoted Justyna Kelly to COO and bid farewell to chief commercial officer Michael Gottlieb, who left “to pursue other opportunities.”
→ Announced on Christmas Eve, Danielle Campbellhas returned to aTyr Pharma, this time as VP of human resources after working in HR there for a brief period in 2015-16. Campbell just closed out her five years with Poseida as senior director, facilities operations after starting out in HR for Eric Ostertag’s crew. San Diego-based aTyr is seeking redemption with lead candidate ATYR1923 for patients with pulmonary sarcoidosis after stumbling with Project ORCA in 2018, triggering a 30% reduction in its staff.
→ Philly-based Context Therapeuticshas namedChristopher Beck as SVP of operations and Mark Fletcher as VP of R&D. Additionally, the company will be parting ways with its current head of CMC Bill Rencher as he plans for retirement. Beck joins the women’s oncology-focused company from GaleraTherapeutics, where he served as VP of program management. Prior to that, Beck spent nearly a decade with Shire and had stints at Merck and AstraZeneca. Meanwhile, Fletcher comes aboard with experience from his time at PharmaceuticalAssociates, Hikma Pharmaceutical US Operations, DouglasPharmaceuticals, Endo Health Solutions and LigandPharmaceuticals.
→ South San Francisco heart disease biotech Tenaya Therapeutics, which hit Nasdaq last summer not long after a $106 million crossover round, has enlistedJoanna Auch — formerly the head of HR North America for Santen — as SVP of people and culture. Tenaya has also named Ultragenyx chief legal officer and EVP Karah Parschauer to the board of directors, which also includes Eli Casdin and June Lee. The ex-associate general counsel at Allergan is on the boards of Evolus and Anebulo Pharmaceuticals.
→ The pandemic crushed Esperion’s hopes of making its cholesterol therapy Nexletol into a blockbuster, promptingTim Mayleben to throw the CEO keys to Sheldon Koenig and put someone with commercial bona fides into the top spot. After drastic cutbacks in October, Esperion has turned toBenjamin Looker to be general counsel. Looker comes from Trillium, where he was general counsel for a biotech that Pfizer purchased for more than $2 billion. At MorphoSys from 2017-19, Looker — an EMD Serono alum — was VP, head of US legal and global business operations.
→ T-knife needed just a year to pull together a $110 million Series B in August 2021 after its initial financing round, and the biotech focused on T cell receptor (TCR) engineered T cell therapies has enlisted Ronald Krasnow as general counsel. Krasnow had a 10-year run as Relypsa before moving on to Menlo Therapeutics as general counsel, secretary and chief compliance officer and his most recent stop as the COO of Arch Oncology.
→ Jared Cohenhas moved into the role of general counsel at Boston-based Entrada Therapeutics, now targeting neuromuscular diseases like Duchenne with oligonucleotide therapies and nabbing $116 million in funding last March to do so. Since April 2020, Cohen had served as Entrada’s VP, head of IP and legal affairs. Prior to that, he served as VP of legal affairs at Repertoire Immune Medicines.
→ Rahul Kharahas taken on the role of general counsel at Disc Medicine, which pluckedbitopertin out of mothballs from Roche and recently raked in a $90 million Series B. Before Merck backed up the Brinks truck, Khara spent three years at Acceleron as VP, legal and chief compliance officer. In another Acceleron connection, its former R&D chief and one-time Celgene CMO Jay Backstrom has joined Disc Medicine’s board of directors.
→ Westlake Village BioPartnersis welcomingMira Chaurushiya to the fray as a senior partner. Chaurushiya hops aboard after a six-year stint at 5AMVentures. During her time to 5AM, Chaurushiya invested in and served as director or observer on the boards of multiple organizations, including Precision Nanosystems (acquired by Danaher), IdeayaBiosciences, EnlivenTherapeutics, Escient Pharmaceuticals, MagneticInsight, NovomeBiotechnologies, PurigenBiosystems, and TMRW.
→ Legend‘s CEO Ying Huangis now taking a seat on its board of directors as a Class I director. Huang has served in the position of CEO since September 2020 after his predecessor Frank Zhang was placed under house arrest as part of a customs investigation involving GenScript. Prior to his role at the helm of the company, Huang started as Legend’s CFO after stints at BofASecurities, Wells Fargo, Credit Suisse and Schering-Plough.
→ Speaking of Legend, ex-CEO Yuan Xuis the latest addition to the board of directors at Xilio Therapeutics — chaired by Dan Lynch — after Sara Bonstein and the aforementioned Christina Rossi became board members last year. Xilio made the Nasdaq leap in October 2021 with a nearly $118 million IPO.
→ Led by first-year CEO and former Ovid president and CMO Amit Rakhit, Houston portfolio company Sporos Bioventureshas given ex-Black Diamond CMO Rachel Humphrey a seat on the board of directors. Humphrey, who also is on the board at Xilio, is the CEO of an unnamed “biotech startup focused on immunotherapies.”
→ Lonnie Moulder’s US/China startup Zenas BioPharmahas madeJohn Orloff a member of the board of directors. Orloff, the former R&D chief at AstraZeneca sub Alexion, has changed course as a venture partner for Agent Capital.
→ Ex-Five Prime CFO David Smithhas claimed another board seat, this time with Sonny Hsiao’s antibody-cell conjugation outfit Acepodia, which has another $109 million to work with from last month’s Series C round. Smith is also a board member with Codexis and Neurelis. Acepodia has also supplemented its scientific advisory board with Elizabeth Smith and Richard Lopez.
→ Taking its VLP “soccer ball” technology to Nasdaq with a nine-figure IPO last summer, Seattle’s Icosavaxhas made space available for John Shiver on its board of directors. After 22 years at Merck and seven more at Sanofi, Shiver is IGM’s chief strategy officer for infectious diseases.
→ Crinetics, which spun out its radiopharmaceutical pipeline into a new company calledRadionetics Oncology last fall, has named Rogério Vivaldi to the board of directors. Since August 2018, Vivaldi has been president and CEO of Flagship’s Sigilon.
→ LaurenceReid, the CEO of DecibelTherapeutics, is taking a seat on the board of directors of Cambridge, MA-based GarudaTherapeutics. Prior to taking the helm of Decibel, Reid was an entrepreneur-in-residence at Third Rock Ventures and formerly CEO of Warp Drive Bio. Additionally, Reid served as CBO and SVP of Alnylam.
→ Down in New Orleans, Revolo Biotherapeutics — once known as Immune Regulation — has appointed ex-Mallinckrodt CMO Tunde Otulana to the board of directors. Otulana, the current CMO at Veloxis Pharmaceuticals, was SVP, clinical development & medical affairs during his time at Boehringer Ingelheim.
→ Sebastian Guthhas been appointed to the board of directors at New York oncology player Phosplatin Therapeutics. Guth currently serves as president of Bayer Pharmaceuticals Americas, and sits on the boards of the Pharmaceutical Research and Manufacturers of America, BIO and Children’s Aid.
→ RA Capital-backed Boundless Bio, a San Diego cancer biotech that raked in $105 million in a Series B last April, has appointedJennifer Lew to its board of directors. Lew, who currently serves as EVP and CFO of Annexon Biosciences, will also act as chairperson of Boundless Bio’s audit committee.
→ At the same time as paying $1,452,724 in amounts owed to Numus Financial as part of a debt settlement, Sona Nanotechhas brought onNeil Fraser and Walter Strapps to its board of directors. Fraser is president of MedtronicCanada, while Strapps most recently served as CSO of Gemini Therapeutics and previously led discovery at IntelliaTherapeutics.
→ John Varianhas been added to the board of directors at Acorda, which sang a familiar tune by slicing what’s left of its workforce by 15% in September. Varian, the ex-CEO of XOMA, is a board member at AmMax Bio and Sellas Life Sciences.
→ Paris-based Pharnexthas welcomedElisabeth Svanberg as chairman of its board of directors, succeeding Michelde Rosen who will continue to serve the company as non-executive director. Svanberg brings with her experience from her time at Serono, BMS and Janssen.
→ French hearing loss outfit Sensorion has tappedAniz Girach on the shoulder as successor to Jean-François Morin on its board of directors. Girach currently serves as CMO of ProQR Therapeutics and formerly served in the same role at Nightstar Therapeutics and Oxurion.
→ Ideaya Biosciences, the company that picked up a $50 million IPO back in 2019 to fuel the clinical drive on synthetic lethality, has picked up former Onyx Pharmaceuticals founder and CSO Frank McCormick as chair for its scientific advisory board.
If you are suffering with chronic pain, diabetes, heart problems or any other condition, you want to be confident that your doctor will offer you an effective treatment. You certainly don’t want to waste time or money on something that won’t work, or take something that could do you harm.
The best source of information to guide treatment is medical research. But how do you know when that information is reliable and evidence-based? And how can you tell the difference between shoddy research findings and those that have merit?
There’s a long journey to the publication of research findings. Scientists design experiments and studies to investigate questions about treatment or prevention, and follow certain scientific principles and standards. Then the finding is submitted for publication in a research journal. Editors and other people in the researchers’ field, called peer-reviewers, make suggestions to improve the research. When the study is deemed acceptable, it is published as a research journal article.
But a lot can go wrong on this long journey that could make a research journal article unreliable. And peer review is not designed to catch fake or misleading data. Unreliable scientific studies can be hard to spot – whether by reviewers or the general public – but by asking the right questions, it can be done.
While most research has been conducted according to rigorous standards, studies with fake or fatally flawed findings are sometimes published in the scientific literature. It is hard to get an exact estimate of the number of fraudulent studies because the scientific publication process catches some of them before they are published. One study of 526 patient trials in anesthesiology found that 8% had fake data and 26% were critically flawed.
As a professor in medicine and public health, I have been studying bias in the design, conduct and publication of scientific research for 30 years. I’ve been developing ways to prevent and detect research integrity problems so the best possible evidence can be synthesized and used for decisions about health. Sleuthing out data that cannot be trusted, whether this is due to intentional fraud or just bad research practices, is key to using the most reliable evidence for decisions.
Systematic reviews help suss out weak studies
The most reliable evidence of all comes when researchers pull the results of several studies together in what is known as a systematic review. Researchers who conduct systematic reviews identify, evaluate and summarize all studies on a particular topic. They not only sift through and combine results on perhaps tens of thousands of patients, but can use an extra filter to catch potentially fraudulent studies and ensure they do not feed into recommendations. This means that the more rigorous studies have the most weight in a systematic review and bad studies are excluded based on strict inclusion and exclusion criteria that are applied by the reviewers.
To better understand how systematic reviewers and other researchers can identify unreliable studies, my research team interviewed a group of 30 international experts from 12 countries. They explained to us that a shoddy study can be hard to detect because, as one expert explained, it is “designed to pass muster on first glance.”
As our recently published study reports, some studies look like their data has been massaged, some studies are not as well designed as they claim to be, and some may even be completely fabricated.
Our study provides some important ideas about how to spot medical research that is deeply flawed or fake and should not be trusted.
The experts we interviewed suggested some key questions that reviewers should ask about a study: For instance, did it have ethics approval? Was the clinical trial registered? Do the results seem plausible? Was the study funded by an independent source and not the company whose product is being tested?
If the answers to any of these questions is no, then further investigation of the study is needed.
In particular, my colleagues and I found that it’s possible for researchers who review and synthesize evidence to create a checklist of warning signs. These signs don’t categorically prove that research is fraudulent, but they do show researchers as well as the general public which studies need to be looked at more carefully. We used these warning signs to create a screening tool – a set of questions to ask about how a study is done and reported – that provide clues about whether a study is real or not.
Signs include important information that’s missing, like details of ethical approval or where the study was carried out, and data that seems too good to be true. One example might be if the number of patients in a study exceeds the number of people with the disease in the whole country.
Spotting flimsy research
It’s important to note that our new study does not mean all research can’t be trusted.
The COVID-19 pandemic offers examples of how systematic review ultimately filtered out fake research that had been published in the medical literature and disseminated by the media. Early in the pandemic, when the pace of medical research was accelerating, robust and well-run patient trials – and the systematic reviews that followed – helped the public learn which interventions work well and which were not supported by science.
On the other hand, a systematic review of corticosteroid drugs like dexamethasone found that the drugs help prevent death when used as a treatment for COVID-19.
There are efforts underway across the globe to ensure that the highest standards of medical research are upheld. Research funders are asking scientists to publish all of their data so it can be fully scrutinized, and medical journals that publish new studies are beginning to screen for suspect data. But everyone involved in research funding, production and publication should be aware that fake data and studies are out there.
The screening tool proposed in our new research is designed for systematic reviewers of scientific studies, so a certain level of expertise is needed to apply it. However, using some of the questions from the tool, both researchers and the general public can be better equipped to read about the latest research with an informed and critical eye.
Lisa Bero is Senior Editor, Research Integrity for Cochrane, an international non-profit organization that publishes systematic reviews.
According to sources familiar with the matter, the Wall Street Journal reported that Pfizer Inc (NYSE: PFE) was in advanced discussions to acquire pharmaceutical company Global Blood Therapeutics (NASDAQ: GBT) for $5 billion.
Pfizer, too, acquired Global Blood Therapeutics
Pfizer wants to close a deal soon, but there are still other interested parties, according to the article.
Global Blood Therapeutics, which manufactures Oxbryta, the blood disorder medication, saw its shares jump 44% on Friday afternoon to a two-year high. As of Thursday’s closing, the company’s market cap was $3.12 billion.
A spokesman for Global Blood stated the company does not “comment on market rumors or speculation,” while Pfizer declined to respond on the matter.
With plenty of cash left over after selling its COVID-19 vaccine, New York-based Pfizer is searching for deals that may generate billions of dollars annual sales by 2030.
Its $11.6 billion acquisition of migraine medication manufacturer Biohaven Pharmaceutical Holding (NASDAQ: BHVN) in May was the most recent in a series of purchases that also included Trillium Therapeutics and Arena Pharmaceuticals in recent years.
Oxbryta received approval last year for sickle cell disease management
In 2019, the US government approved Global Blood’s Oxbryta to manage sickle cell disease in individuals aged 12 and over. The oral medication was approved in December 2021 to treat the illness in younger children. The drug’s sales increased by almost 50% to $194.7 million in 2021.
After a gloomy start to the calendar year, when a lack of significant purchases and clinical-stage treatment failures lowered investor morale and restricted funding, the biotech dealmaking pace has recently picked up again.
Also, Amgen Inc (NASDAQ: AMGN) also decided to purchase ChemoCentryx Inc on Thursday for $3.7 billion to obtain access to a possible breakthrough medication for inflammatory illnesses. AstraZeneca’s $39 billion acquisition of Alexion Pharmaceuticals in 2020 has put the realm of immune diseases in the limelight. The deal, which was announced before trading opened, will also give the corporation control of at least two investigational immune disorders medicines.
Please make sure to read and completely understand our disclaimer at https://www.wallstreetpr.com/disclaimer. While reading this article one must assume that we may be compensated for posting this content on our website.
Researchers at the University of British Columbia have discovered a key vulnerability across all major variants of the SARS-CoV-2 virus, including the recently emerged BA.1 and BA.2 Omicron subvariants.
Credit: Dr. Sriram Subramaniam, UBC
Researchers at the University of British Columbia have discovered a key vulnerability across all major variants of the SARS-CoV-2 virus, including the recently emerged BA.1 and BA.2 Omicron subvariants.
The weakness can be targeted by neutralizing antibodies, potentially paving the way for treatments that would be universally effective across variants.
The findings, published today in Nature Communications, use cryo-electron microscopy (cryo-EM) to reveal the atomic-level structure of the vulnerable spot on the virus’ spike protein, known as an epitope. The paper further describes an antibody fragment called VH Ab6 that is able to attach to this site and neutralize each major variant.
“This is a highly adaptable virus that has evolved to evade most existing antibody treatments, as well as much of the immunity conferred by vaccines and natural infection,” says Dr. Sriram Subramaniam (he/him), a professor at UBC’s faculty of medicine and the study’s senior author. “This study reveals a weak spot that is largely unchanged across variants and can be neutralized by an antibody fragment. It sets the stage for the design of pan-variant treatments that could potentially help a lot of vulnerable people.”
Identifying COVID-19 master keys
Antibodies are naturally produced by our bodies to fight infection, but can also be made in a laboratory and administered to patients as a treatment. While several antibody treatments have been developed for COVID-19, their effectiveness has waned in the face of highly-mutated variants like Omicron.
“Antibodies attach to a virus in a very specific manner, like a key going into a lock. But when the virus mutates, the key no longer fits,” says Dr. Subramaniam. “We’ve been looking for master keys — antibodies that continue to neutralize the virus even after extensive mutations.”
The ‘master key’ identified in this new paper is the antibody fragment VH Ab6, which was shown to be effective against the Alpha, Beta, Gamma, Delta, Kappa, Epsilon and Omicron variants. The fragment neutralizes SARS-CoV-2 by attaching to the epitope on the spike protein and blocking the virus from entering human cells.
The discovery is the latest from a longstanding and productive collaboration between Dr. Subramaniam’s team at UBC and colleagues at the University of Pittsburgh, led by Drs. Mitko Dimitrov and Wei Li. The team in Pittsburgh has been screening large antibody libraries and testing their effectiveness against COVID-19, while the UBC team has been using cryo-EM to study the molecular structure and characteristics of the spike protein.
Focusing in on COVID-19’s weak points
The UBC team is world-renowned for its expertise in using cryo-EM to visualize protein-protein and protein-antibody interactions at an atomic resolution. In another paper published earlier this year in Science, they were the first to report the structure of the contact zone between the Omicron spike protein and the human cell receptor ACE2, providing a molecular explanation for Omicron’s enhanced viral fitness.
By mapping the molecular structure of each spike protein, the team has been searching for areas of vulnerability that could inform new treatments.
“The epitope we describe in this paper is mostly removed from the hot spots for mutations, which is why it’s capabilities are preserved across variants,” says Dr. Subramaniam. “Now that we’ve described the structure of this site in detail, it unlocks a whole new realm of treatment possibilities.”
Dr. Subramaniam says this key vulnerability can now be exploited by drug makers, and because the site is relatively mutation-free, the resulting treatments could be effective against existing—and even future—variants.
“We now have a very clear picture of this vulnerable spot on the virus. We know every interaction the spike protein makes with the antibody at this site. We can work backwards from this, using intelligent design, to develop a slew of antibody treatments,” says Dr. Subramaniam. “Having broadly effective, variant-resistant treatments would be a game changer in the ongoing fight against COVID-19.”