MedDay Pharmaceuticals SAS

None  Welcome to this week's Chutes & Ladders, our roundup of hirings, firings and retirings throughout the industry. Please send the good word—or the bad—from your shop to Max Bayer or Gabrielle Masson, and we will feature it here at the end of each week.  Editor’s note: We won’t be publishing Chutes & Ladders next week on Nov. 25 due to the Thanksgiving holiday, but will be back to our regular schedule the following week. FDA pillar Janet Woodcock set to retire in early 2024 Food and Drug Administration The FDA has long been plagued by turnover, given the lucrative industry salaries that can lure career regulators away from Washington. But Janet Woodcock, M.D., has been an outlier, a stalwart leader of the organization who’s worn almost every hat in the drug development arm of the agency. That nearly 40-year career is coming to an end, however, with Commissioner Robert Califf, M.D., confirming her plans in an all-staff email posted by the agency’s spokesperson. Califf said Woodcock will depart early next year, though an exact timeline wasn’t mentioned. His message came after reports of her retirement broke.  “While no one can fill Janet’s shoes, I’ll share news about her successor in the future,” Califf wrote.  Woodcock’s career began in 1986 as director of the Division of Biological Investigational New Drugs at the Center for Biologics Evaluation and Research (CBER) before leading the center’s Office of Therapeutics Research and Review. In 1994, Woodcock was named the director of CBER’s sibling, the Center for Drug Evaluation and Research. She also at one point served as interim commissioner of the agency, from January 2021 to February 2022. The list of her accomplishments and contributions could be kept in a scroll. Califf called her a “legend in every sense of the word.” Tweet Madrigal swiftly names new CCO with potential launch imminent Madrigal  New Madrigal CEO Bill Sibold has landed on a commercial chief, bringing on a former colleague at Sanofi who helped lead the launch of blockbuster Dupixent. Carole Huntsman has taken the gig a little more than a month after Remy Sukhija departed shortly after Sibold’s arrival. Her arrival gives Sibold a critical executive partner with the FDA set to decide on the company’s nonalcoholic steatohepatitis (NASH) drug, resmetirom, by the middle of March 2024. And Huntsman is a familiar face, having worked with Sibold at Sanofi as SVP and head of speciality care, U.S. and North America lead. She directed some 2,600 employees on the rollout of numerous drugs, including Dupixent. The unit she led was responsible for more than $10 billion in net sales in 2022, just what Madrigal wants to hear and see as it plans to debut the first approved NASH treatment. Before joining Sanofi in 2012, Huntsman was SVP of U.S. neurology and rheumatology at EMD Serono and VP of U.S. marketing for the neurology unit at Serono. Source Alkeremes cancer spinout launches with $275M and a couple seasoned development execs Mural Oncology Alkermes has formally unveiled its new cancer spinout, Mural Oncology, equipped with $275 million in committed capital and interleukin-2 (IL-2) candidate aimed at solid tumors. The move has been in the works for about a year. Leading Mural will be a couple of veteran clinical artists, with Caroline Loew, Ph.D., set to take the CEO mantle and Vicki Goodman, M.D., hired as chief medical officer. Loew was previously the CEO of Glympse Bio and before that was head of R&D strategy and planning at Bristol Myers Squibb. Goodman was the chief medical officer at Exelixis after working at Merck for almost two years. Goodman and Loew overlapped at BMS for about three years, during which Goodman was a vice president. The two’s top priority will be nemvaleukin alfa, the asset atop Mural’s pipeline. The company says registrational trials are ongoing with initial readouts slated for the first quarter of 2025. Source > Two former Amgen scientists are joining Halia Therapeutics’ leadership team, with Lisa Shamon, Ph.D., taking on the role of VP of regulatory affairs and Xianne Penny, Ph.D., as senior medical director. Before joining Halia, Shamon held various roles across Alza Corporation, Exelixis, Aeglea BioTherapeutics, FivePrime Therapeutics and Amgen, while Penny served as Amgen’s senior principal clinical immunologist for more than five years. Release > Nereid Therapeutics has named Michael Kauffman, M.D., Ph.D., to serve as president and CEO, taking the reins from Apple Tree Partners venture partner and acting CEO Spiros Liras, Ph.D. Most recently, new Nereid leader Kauffman served as longtime CEO and co-founder of Karyopharm. Release > Wendye Robbins, M.D., will be taking the top spot at Incendia Therapeutics. With more than 20 years of industry experience under her belt, Robbins continues to also serve as an independent director for Rapt Therapeutics. Release > Memo Therapeutics has tapped Erik van den Berg to helm the antibody-focused biotech. Van den Berg joins from AM-Pharma, where he was CEO for 12 years, and succeeds Karsten Fischer, who led Memo for five years. Release > Nucleome Therapeutics has nabbed Stephen Harrison, Ph.D., to serve as chief scientific officer. Before joining Nucleome, Harrison held executive leadership positions at Engine Biosciences, Relypsa (divested to Galencia), Nektar Therapeutics and KAI Pharmaceuticals (acquired by Amgen). Release > Theseus Pharmaceuticals is shrinking its head count by 72%, including R&D head William Shakespeare, Ph.D., although he will continue to support the biotech in a consulting role until the end of June 2024. Fierce Biotech > Melissa Faris has departed GSK to take up a spot as OMass Therapeutics’ chief business officer. Faris spent years with the Big Pharma, most recently serving as VP and head of immunology business development. Release > 1910 Genetics has promoted SVP and Head of Chemistry Bridget Cole, Ph.D., to chief scientific officer. Before 1910, she served as Nocion Therapeutics’ SVP of drug discovery, and has held past roles at Axial Biotherapeutics, Flatley Discovery Lab, Surface Logix and Pfizer. Release > Noema Pharma has chosen Robert Lasser, M.D., to serve as the company’s chief medical officer. Most recently, Lasser served as an executive leader for Sage Therapeutics and has held past leadership roles across Medday Pharmaceuticals, Roche, Shire Pharmaceuticals (acquired by Takeda), Johnson & Johnson and Novartis. Release > IMIDomics is building out its leadership team, tapping Eric Perakslis, Ph.D., to serve as SVP and chief technology officer, and Ramon Felciano, Ph.D., to serve as strategic adviser in biomedical artificial intelligence and data science. Perakslis has held leadership roles at the FDA, Datavant, Takeda and Johnson & Johnson, while Felciano is the founder and CEO of Digital Alchemy. Release > Affini-T Therapeutics, an immunotherapy company planning an IPO in 2024, has appointed Kathy Bergsteinsson as chief financial officer. Bergsteinsson most recently served as managing director and head of healthcare equity capital markets for Morgan Stanley. Release > Attorney Graham Owens has been tapped to serve as executive director of the Rare Disease Company Coalition. Owens also serves as regulatory and oversight counsel for the Senate Small Business Committee. LinkedIn > Former venture partner at Versant Ventures and CEO of Inception Therapeutics Jeremy Caldwell, Ph.D., has joined Red Tree Venture Capital as a partner. Release > Ori Biotech is preparing for the commercial launch of its cell therapy manufacturing platform, tapping Gillian Bonthron to be chief financial officer and John Machulski to be chief operating officer as well as promoting Thomas Heathman, Ph.D., from VP of commercial operations to chief commercial officer. Bonthron joins with experience at Healx and Perspectum under her belt, while Machulski joins from Catalent and has past experience at Lonza, GE Life Sciences (now Cytiva), Sanofi, Pfizer and Johnson & Johnson. Release > Sofinnova Partners is bolstering its medtech leadership team, bringing on Mano Iyer as a partner and promoting Cécile Dupont to partner. Iyer is the founder of ReCor Medical, and Dupont has been with Sofinnova since 2019. Release 

BASEL, Switzerland, Nov. 15, 2023 (GLOBE NEWSWIRE) -- Noema Pharma, a clinical-stage biotech company targeting debilitating central nervous system (CNS) disorders, today announced Robert Lasser, M.D., M.B.A has joined the Company as Chief Medical Officer (CMO). “Dr. Lasser brings over 25 years of CNS experience with a successful track record of medical leadership for neuroscience development and commercialization, and I am excited to welcome him to our leadership team,” said Ilise Lombardo, M.D., Chief Executive Officer Noema. “Rob’s insight and experience leading global development programs will be invaluable as he spearheads the execution of our ongoing clinical studies. I look forward to working with Rob as we continue our mission of developing new and transforming medicines for patients across multiple disease indications.” Dr. Lasser is a seasoned biopharma executive with over 25 years of experience in the CNS space, spanning clinical practice, academic research, large pharma and biotech. Most recently, he held an executive role at Sage Therapeutics, where he led the development of zuranolone (ZURZUVAE®) in depressive disorders. Before that, he was the Chief Medical Officer at MedDay Pharma. Prior to joining MedDay, he was the Head of Neurodegenerative disorders at Roche, where he oversaw the Phase 2 and 3 programs for gantenerumab through 2017. Earlier in his career, Dr. Lasser held various roles at pharmaceutical companies, including managing the medical launch and lifecycle of lisdexamfetamine (VYVANSE®) at Shire, the first medicine for treating Binge Eating Disorder, the launch of the first long-acting injectable atypical antipsychotic RISPERDAL CONSTA® at Johnson & Johnson, and developing iloperidone (FANAPT®) at Novartis in the late 1990’s. Dr. Lasser completed his Geriatric Psychiatry fellowship at the National Institute of Mental Health, and his residency in psychiatry at McLean Hospital. He obtained an M.B.A from the University of Pennsylvania Wharton School of Business, a M.D. from Boston University School of Medicine, and a B.A. in Biochemistry from Dartmouth College. “I am excited to join Noema Pharma ahead of a catalytic year of important milestones that set the stage for the next phase of the Company’s growth,” said Dr. Lasser. “Throughout my career, I have sought to join companies with a clear dedication to Neurology and Psychiatry disorders to match my commitment to those patients and families. Working with the dedicated team at Noema to bring novel therapies to those fighting devastating CNS conditions is part of that continuing devotion.” About Noema Pharma Noema Pharma ( ) is a clinical-stage biotech company targeting debilitating central nervous system (CNS) disorders. The Company has a well-differentiated pipeline with four mid clinical-stage therapeutic product candidates in-licensed from Roche. Noema currently has four active clinical trials in highly undertreated CNS conditions: Ph2b Childhood Onset Fluency Disorder (persistent stuttering), Ph2/3 pain in Trigeminal Neuralgia and Ph2b seizures in Tuberous Sclerosis Complex. The Company has completed a Phase 2a clinical trial in adult patients with Tourette Syndrome that is currently being extended with an adolescent cohort. The Company has also completed preclinical validation studies with its triple reuptake inhibitor with plans to enter clinical development in 2024. Noema Pharma was founded in 2019 by the leading venture capital firm Sofinnova Partners. Current investors also include Forbion, Gilde Healthcare, Invus, Jeito Capital, Polaris Partners, UPMC Enterprises, and an undisclosed investor. Contacts: Alex Lobo Stern Investor Relations, Inc. alex.lobo@sternir.com

SA Health, together with the Commission on Excellence and Innovation in Health, will start collecting and analysing patient-reported measures across South Australia through its new programme. The Patient Reported Measures (PRM) programme will support clinical services to deliver "high-quality, patient-centred, and value-driven care" by encouraging patients to report on health outcomes and experiences. SA Health and CIEH have chosen digital health company The Clinician via an open tender process to help implement the programme. They will leverage the latter's ZEDOC platform, which will be integrated with SA Health's IT systems to automate the distribution, collection, and analysis of patient-reported outcomes and experience measures. WHY IT MATTERS According to The Clinician, the implementation of patient-generated data in clinical services will ensure that both patients and clinicians will have "all the information they need to make the best decisions together." Patients can complete the questionnaires on their preferred devices from anywhere with clinical teams able to access real-time results within their own IT systems. The ZEDOC platform will be rolled out in several stages at select SA Health services with an initial implementation set for the middle of 2023 and subsequent deployments over the next two years. The programme targets to enrol about a million patients and approximately 5,000 clinical staff using the system by mid-2025. THE LARGER TREND Two of the largest hospitals in Victoria, Cabrini Health and The Alfred , also recently adopted The Clinician's PRM technology to automate their collection and analysis of health data from colorectal cancer patients. In late 2021, Singapore's health tech agency Integrated Health Information Systems began rolling out the ZEDOC platform across the island city-state's public health system. Meanwhile last year, Melbourne-based Northern Health deployed a configured version of the ZEDOC platform, which replaced its old patient registration and intake platform. This came as part of the statewide expansion of the Victorian Virtual Emergency Department. ON THE RECORD "The introduction of real-time visibility of patient-reported measures has been proven to enhance patient and clinician partnerships through improved decision making and delivers healthcare that is driven by patient values," said CEIH PRM programme director Megan Scott. "Leveraging our purpose-built platform and experience with large-scale PRMs deployments, we are committed to supporting South Australia on their journey towards patient-centred, outcomes-driven and value-based care delivery," The Clinician CEO and co-founder Ron Tenenbaum also commented.