Exclusive: Cell therapy biotech brings on Loxo vet amid global expansion plans; Retirement beckons for Vir's George Scangos

2023-01-27

临床1期高管变更IPO

Bree Harlin , who used to be director of clinical operations at Loxo Oncology , now Loxo@Lilly , is now in the C-suite for the first time. Harlin started at TC BioPharm on Wednesday as chief clinical officer, the biotech announced Friday — but her journey starts more than 20 years before then. After graduating from college, she moved to Boston, working in academia at some of the Harvard teaching hospitals in endocrinology and CNS. She later got convinced to interview with a company her neighbor founded, which was developing a gadolinium-based contrast agent used in diagnostic imaging. That’s where she got her start in the industry, moving from a clinical trial associate position to a clinical research associate role and got her first experience filing an NDA. While that NDA was rejected, it made an impact on Harlin. “It got me really hungry to learn more about how trials are run and more about the industry and in general,” Harlin added. That impact drove Harlin to other biotech and pharmaceutical companies, including Pfizer , Forest Pharmaceuticals (pre-buyout from Actavis / Allergan ) and Shire , with her latest stint being director of clinical operations at Loxo and helping to run Phase I to Phase IV trials. For Harlin, all of those jobs working with clinical trials and being a part of NDA and IND filings have conglomerated into a cornucopia of experience that, in her words, can be applied to her new job at TC BioPharm in order to “hit the ground running.” She’s already started meeting the team, hopping on meetings and instituting plans to get clinical trial sites on board in the US and outside the UK, where TC BioPharm is based. Currently the biotech is looking at expanding its cell therapy candidate outside the UK. Harlin’s goal is to utilize her experience to start recruiting trial sites in the US and in the EU, and navigate the clinical trial process to bring on board the right people. As far as the US goes, TC BioPharm is looking to file an IND with the FDA later this year in a bid to start up a Phase I trial, most likely in acute myeloid leukemia. CEO Bryan Kobel told Endpoints News that it was obvious Harlin was the right fit for the job, calling the entire process a matter of serendipity after the previous clinical director stepped aside to pursue a personal passion. “That put us in a really weird position where we had to find a chief clinical officer, and do it quickly,” Kobel added. After company leadership put together a sort of candidate attribute wishlist, Kobel said that he started cold-calling people — and Harlin was the first interview. After talking with eight to 10 more candidates, Harlin was still the top choice, and was brought on board. The chief executive added that the company looks for people who have experience working as part of a team and know how to communicate with them in high pressure situations without adding more stress or tension. While also noting the aspects of leading by example, “It’s hard to build a culture; it’s really easy to destroy it. So we need to be really, really prudent with who we add, how we add them, and the time we take to add them,” Kobel said. — Paul Schloesser → Although he “retired” after 14 years as CEO of Exelixis in 2010, and “retired” again from the top spot at Biogen in 2016, George Scangos assured Endpoints on Wednesday that Vir Biotechnology would be the last company he leads. We don’t know what the rest of 2023 holds in the industry, but we’ll be hard-pressed to find a bigger CEO transition this year than the 74-year-old Scangos passing the baton to Bayer ’s high-flying business leader Marianne De Backer on April 3. On De Backer’s watch, Bayer would swing deals like the acquisitions of AskBio and Vividion before either of them had the opportunity to go public. “I’m going to be called the IPO terminator,” De Backer said jokingly after the Vividion buyout . After turning Biogen’s fortunes around with the approval of MS drug Tecfidera in 2013, Scangos set off for Vir, where he put the biotech on the map by teaming up with GSK on sotrovimab for mild-to-moderate Covid-19. In an interview with John Carroll where he expressed his admiration for De Backer and a desire to travel with family, Scangos also discussed his risk-taking approach — invoking Kenny Rogers in the process. “I’ve always felt in my career that I would rather go down in flames by having failed big time than live my life in mediocrity because I was afraid to try,” Scangos said. “You can’t be in this industry if you’re not an optimist, but you have to be realistic and you have to know when to hold them and when to fold them.” → Kimball Hall has left the CDMO Abzena to become president and CEO of Irish biotech Innocoll , encompassing both Innocoll Biotherapeutics and the CDMO subsidiary Syntacoll . Hall, who rose to VP of manufacturing during her 14 years at Amgen , then moved on to Genentech as SVP of manufacturing biologics drug substance. She joined Abzena in 2019 as operations chief and was elevated to president a year later. → Launched in November and scouring the “secretome” for new therapies, Juvena Therapeutics has filled several leadership positions, with chief corporate development officer Neil Berkley leading off. A business development veteran with GSK and Cadence Pharmaceuticals (which was sold to Mallinckrodt in 2014), Berkley had a yearlong stay at AbCellera as CBO before leaving on June 29, according to an SEC filing . AbCellera CEO Carl Hansen has yet to name a replacement. Juvena has also welcomed the following: Amgen and Merck vet Gayathri Swaminath (SVP of discovery); Mo Tabrizi (VP of preclinical and nonclinical development), another Merck alum and the former senior director of pharmacology for Ascendis Pharma ; and Eddie Moler (VP of data science). Mubadala Capital and Horizons Ventures headlined Juvena’s $41 million Series A financing . → Jane Henderson has landed at immunology and inflammatory disease biotech Apogee Therapeutics , which emerged from stealth with a $149 million Series B and $169 million in total. The new CFO — no relation to Apogee’s CEO Michael Henderson — owned the same title at Invivyd , the Tillman Gerngross antibody developer that hit the scene with a lot of flash and a boatload of money as Adagio Therapeutics . But a substantial flop with its Covid-19 candidate led to a shakeup that included the departures of Gerngross , Henderson and the dismissal of an undisclosed number of staffers. She was previously the CFO of Voyager and Turnstone Biologics , and has board seats at Akero Therapeutics , Ventus Therapeutics and Iveric Bio . → The xenotransplantation experts at eGenesis have picked up Knut Niss as chief technology officer. Niss carried the same title at Mustang Bio , and he was part of the CMC leadership team at Novartis for Kymriah before it earned the distinction as the first approved gene therapy in the US. Last April, Michael Curtis replaced Paul Sekhri as CEO of eGenesis, the CRISPR upstart that’s trying to beat its xeno competitors to the clinic with its gene editing tech. Sekhri is currently the chief executive at vTv Therapeutics . → Thyroid eye disease biotech Sling Therapeutics , located south of the University of Michigan campus, has tapped Jeffrey Kent as CMO. Kent logged more than 10 years at Horizon and was EVP, medical affairs and outcomes research when Amgen struck M&A gold with a $28 billion deal in December. Sling’s lead asset linsitinib was in-licensed from Astellas , where Kent worked as an executive medical director before joining Horizon. We caught up with Gossamer Bio chief Faheem Hasnain when he was named chairman of Sling, which debuted with a $35 million Series A last June. → It’s been an eventful week for Pliant Therapeutics , raising $250 million after touting positive Phase IIa data with its idiopathic pulmonary fibrosis (IPF) drug bexotegrast . The Pliant news continues with the selection of Lily Cheung as chief human resources officer. Cheung brings HR experience from Actelion and Rigel Pharmaceuticals , and she had been VP of human resources for Synthekine since December 2021. → Right on Cue: Matteo Levisetti has been promoted to CMO at Cue Biopharma , setting the stage for acting medical chief Kenneth Pienta to step into a clinical advisory role. We had Levisetti in this space in February 2021 when he was named SVP of clinical development at the Boston biotech, whose pipeline is centered on IL-2. He’s been around the block in Big Pharma (Merck, Roche , Pfizer ) and spent a year as global clinical lead for sitravatinib at Mirati . → Sri Ryali has signed on as CFO of Codexis , the enzyme engineering outfit that sent 18% of its staff packing in November under first-year CEO Stephen Dilly . An Amgen finance alum, Ryali just completed four years as CFO of Eiger BioPharmaceuticals and was VP of finance at Aimmune from 2015-18. Earlier, he played a few quick measures at Jazz Pharmaceuticals as senior director, financial planning & analysis. → Targeting cancer and inflammatory bowel diseases like Crohn’s and ulcerative colitis with site specific immunomodulators (SSIs), Qu Biologics out of British Columbia has enlisted Matt Cahill as COO. Cahill was on the original crew at another Canadian company, Deep Genomics , as VP of finance & business operations, and he’s still on the board of directors with founder/CEO Brendan Frey , Nessan Bermingham and others. → Shawn Levy has been promoted to CSO and SVP of applications at DNA sequencing company Element Biosciences . Peer Review introduced you to Levy in February 2022 when he first came to Element as SVP of applications and scientific affairs. → Molecular diagnostics shop BillionToOne , which kept the cash flowing with a $125 million Series C in March 2022, has installed Amgen alum Gary Palmer as CMO, oncology. The ex-VP of medical affairs at Foundation Medicine and Genomic Health also had a three-year run as CMO of Tempus Labs . → Aurora, CO-based neuro biotech Cerebral Therapeutic s has appointed Julie Foster as COO. Foster put in 35 years at Medtronic , taking on such roles as VP of the cardiac and vascular businesses in the EMEA (Europe, Middle East and Africa) region and VP of customer experience, diabetes. → IO Biotech was one of the last trains out of the IPO station in late November 2021 before things went pear-shaped in the market, and this week the IDO/PD-L1 player has recruited Devin Smith as general counsel and chief compliance officer. Smith is an EMD Serono legal vet who was general counsel at Yumanity before it reverse merged with Kineta and shipped off Parkinson’s drug YTX-7739 — along with an assortment of other candidates — to J&J back in June. → CEPI’s mRNA vaccine partner SK bioscience has a pair of new execs : Richard Kensinger (VP of R&D project management) is an 18-year Sanofi veteran who comes from Affinivax , where he was executive director of process development and protein sciences. And Kenneth Lee (VP of the biologic business development department at SK’s R&D center in Pangyo, South Korea) led the commercial division in the Americas region for GenScript ProBio , the CDMO subsidiary of GenScript that racked up a $224 million Series C last week. → Speaking of CDMOs, Columbus, OH’s Forge Biologics has $90 million more in the bank and a couple more VPs on the team. Chris McPherson (VP of GMP manufacturing), a WuXi AppTec alum, just finished a four-and-a-half-year tenure at Samsung Biologics , and Taleen Barsoumian (VP of client development) is an ex-senior sales consultant at Novartis who was recently US director of sales and business development for cell and gene therapy at Barkey . Meanwhile, Adam Davis has been promoted to VP of analytical development. Davis ventured off to Forge Biologics in October 2020 after serving as director of manufacturing for Abeona Therapeutics . → Bayer-backed cryogenic electron microscopy (cryo-EM) specialist Gandeeva Therapeutics has elected Brenda Cooperstone to the board of directors. Cooperstone had held the roles of chief development officer, rare disease and Pennsylvania site head at Pfizer, but left the Big Pharma in December after 24 years overall. → Ex- Adicet Bio interim chief Donald Santel has been given a seat on the board of directors at Aerovate Therapeutics , chaired by Kala Pharmaceuticals CEO Mark Iwicki . Santel also helmed Hyperion Therapeutics and is chairman of Tentarix Biotherapeutics and Ocelot Bio .