Lonnie Barish

SFBN Feed: The top biopharma conferences in 2025 https://lnkd.in/gEPTCKNK With rare exceptions, biotechnology and pharmaceutical companies validate their business plans through clinical trials, results from which are often presented and dissected at medical conferences throughout the year. These are the forums where executives get [...] #BayArea #SanFrancisco #Biotech #Lifescience #News

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Tomorrow, October 2nd, G&L experts will sit on the 'Maximize Your Drug Asset Value & Commercial Success' panel at Biocom California's offices in San Diego. Dr. Steven Hildemann, MD, PhD, R&D Physician at G&L, will be joined by industry experts including Krishna Allamneni, Executive Vice President, Chief Development Officer at Concarlo Therapeutics, Inc., and @Dr. Michael J. Nowak, Managing Partner, Nowak Ventures, LLC. With a focus on integrating regulatory, clinical, and commercial expertise, this discussion will help you develop novel strategies that set your asset apart. If you're in discovery, pre-clinical, or mid-phase clinical development, this is a must-attend event for gaining insights on increasing valuation at key inflection points. ***Please note, this event is now taking place at Biocom California's offices in San Diego - 10996 Torreyana Rd, San Diego, California 92121*** #HealthcareAdvisors #RegulatoryAffairs #QualityAssurance #ThoughtLeadership #Biopharma

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🚨 Governor Gavin Newsom, it’s time for California to step up and join 25 other states in regulating PBMs. By signing #SB966, you’ll put an end to PBM middlemen profiting from higher drug costs, while ensuring that independent pharmacies and patients aren’t left behind. Let’s lower drug prices and improve pharmacy access statewide! 💊🏥 #PBMReform #SupportPharmacy #PharmacyAccess #ActNow Find out how SB 966 can benefit Californians: https://lnkd.in/gzb5XBjr

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Among #cell and #genetherapy companies, the pressure for manufacturing innovation and optimization can incentivize them to seek third-party partners who possess technical, manufacturing, and regulatory expertise. In addition to industry giants that include Lonza, Catalent​, WuXi Advanced Therapies, Minaris Regenerative Medicine, and others, there are specialty CDMOs serving the CGT marketplace. For example, FUJIFILM Cellular Dynamics opened a $21M cGMP production facility to support its internal cell therapeutics pipeline, as well as serve as a CDMO for iPS cell products. Helixmith, a biotech company with an extensive gene therapy pipeline and a CAR-T program targeting solid tumors, expanded into CDMO services for early-stage CAR-T developers. ThermoGenesis launched CDMO services with expertise in CAR-T cells, T cell receptor (TCR), tumor-infiltrating leukocytes (TILs), natural killer cells (NKs), iPSCs, and MSCs. Anemocyte announced itself as the first BMO (Biotech Manufacturing Organization) in the field of cell and gene therapies. In addition to building 2000 sq. meters of GMP and GMP-compliant facilities for the production of ATMPs, its FLYn’ICE project is using drones equipped with cryogenic pods to achieve temperature controlled transit of cell and gene therapies. Excellos opened its doors with $15M in funding and access to one of the largest cellular material procurement portfolios yet to support cell and gene therapy manufacturing. RoslinCT, a cell and gene therapy CDMO based in the UK, and Lykan Bioscience, a CDMO focused on cellular therapeutics in Hopkinton, MA, merged to form an international CDMO specializing in advanced therapeutics—with a specialty in gene editing and iPSC capabilities. Of course, there have been hefty M&A deals inked within the cell and gene therapy CDMO sector as well. Thermo Fisher Scientific snagged Brammer Bio for an astonishing $1.7B, while Catalent acquired Paragon Bioservices for an impressive $1.2B and MaSTherCell for $315M. Also, HCATS, apceth, and Hitachi Chemical Co., Ltd. Regenerative Medicine now operate under Minaris Regenerative Medicine, while Charles River Laboratories (CRL) acquired Cognate BioServices for $875M. Ascend Gene & Cell Therapies raised an impressive $132.5M to launch itself as a CDMO specializing in AVV-based gene therapies. In late 2023, Bayer opened a $250M cell therapy manufacturing facility to advance regenerative medicines on a global scale. Around the same time, Ajinomoto Co. acquired CDMO Forge Biologics for an astounding $620M to enhance its Bio-Pharma Services business. In January 2024, EXO Biologics launched its subsidiary, ExoXpertTM, as a CDMO specializing in exosomes. Similarly, Esco Aster is a global CDMO that is supporting the rapidly emerging field of EVs. Finally, Novo Holdings announced it was acquiring the global CDMO Catalent for a staggering $16.5 billion in enterprise value. Learn more here: https://lnkd.in/edtzMzx

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Keeping up with regulatory changes is tough, and understanding their downstream impact to your operational SOPs can be even harder. This is why BioPhy built our generative AI platform BioPhyRx to provide immediate insight into your quality system to flag regulatory gaps based on changing guidance.

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CMS has published the Final Notice: Transitional Coverage for Emerging Technologies (CMS-3421-FN), effective August 12, 2024. The TCET pathway replaces MCIT, expediting Medicare coverage for FDA-designated Breakthrough Devices. Eligible devices include: - FDA-designated Breakthrough Devices - Determined to be within a Medicare benefit category - Not already the subject of an existing Medicare NCD - Not otherwise excluded from coverage through law or regulation The AltaQ team brings vast experience in the FDA Breakthrough Device program and developing clinical protocols for CED. Coverage under TCET NCD will last as needed to support informed patient and clinician decisions. #TCET #BreakthroughDevices #AltaQ

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Looking forward to Dr. Dan DeAngelo’s comprehensive review of the pivotal, Phase 3 results investigating standard salvage CT +/- Uproleselan in relapsed and refractory AML. This is a large, multi-national, placebo-controlled dataset (N=388) that may help address many important questions in the management of R/R AML.

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#ICYMI: Last month we announced that we raised $132.5 million in an oversubscribed #SeriesC financing to advance our pipeline of potential therapies for fibrotic lung diseases and oncology. We are thankful for the support of our investors, board, #biotech community and the entire Endeavor BioMedicines team.     In this BioSpace article, get more details about what this financing means for the future of our pipeline and our goal to restore hope for patients with life-threatening diseases: https://bit.ly/4aVqAmo    #biotechnews #fundraising #venturecapital #oncology #lungdiseases

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We would like to express our gratitude for one of founding sponsors, Armata Pharmaceuticals, Inc.🔬🧪👏 Your generous support made the Los Angeles chapter of WIB a reality 💙 Armata Pharmaceuticals, Inc.'s mission is one of the hot topics of the 21st century: antibiotic resistance. Through the use of phage therapeutics, Armata’s developments target the most resistant bacteria. Interested in joining Women In Bio? You can learn more about WIB membership and gain access to our video library, mentorship opportunities, and more here: https://lnkd.in/gkWMuhdp #BiotechLA #HealthTechLA #WomenInSTEM #Networking #WomenInLifeSciences #WomenInBiotech #WomenInPharma #WomenInResearch #WomenInBio #WomenInBioLosAngeles #WIB #WIBLA

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SFBN Feed: BioMarin taps Amgen, Roche vets in executive reshuffle https://lnkd.in/g7inWmNT Listen to the article 4 min This audio is auto-generated. Please let us know if you have feedback. BioMarin is recasting some of its executive team, announcing Wednesday the appointments of two pharmaceutical industry veterans to [...] #BayArea #SanFrancisco #Biotech #Lifescience #News

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The biopharma industry is facing a $183 billion patent cliff as major drugs lose exclusivity through 2030, with companies like Amgen, BMS, and Merck most exposed. However, Morgan Stanley analysts highlight a $383 billion opportunity for M&A to address this revenue gap. With challenges like the patent expiration of Amgen’s Prolia, BMS’s Eliquis, and the elephant-in-the-room - Merck's Keytruda that generated $25 billion in sales last year - companies are leveraging acquisitions to secure their future pipelines. For example, Amgen’s $27.8 billion Horizon buyout and BMS’s acquisition spree of Karuna, Mirati, and RayzeBio underscore the role of M&A in mitigating risks. As competition for innovative assets intensifies, it is likely that the M&A will be more and more prominent. In fact Morgan Stanley's report estimates that Big Pharma has over $380 billion available for making deals. The evolving landscape highlights how strategic dealmaking remains critical for biopharma's ability to innovate and grow. Read more in the article in Fierce Biotech: https://lnkd.in/eykM7HPN #manda #pharma #patentcliff #innovation #merck #bms #amgen

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As we approach the 15th Annual @World ADC meeting in San Diego, we are excited to explore potential partnerships and collaborations in the cutting-edge field of Antibody Drug Conjugates (ADCs) for oncology. ADCs are transforming cancer treatment by precisely targeting cancer cells, administering potent therapies directly where they are needed, while protecting healthy tissue in the process. We are particularly looking forward to Scientific Officer Lynn Kamen’s presentation titled, "Bioanalytical Strategies for Antibody Drug Conjugate Development," scheduled for November 5th from 6:30-7:30 PM. In her talk, Dr. Kamen will delve into vital bioanalytical strategies for assessing ADC pharmacokinetics and immunogenicity, emphasizing the significance of both molecular components for ensuring efficacy and safety. Join us in connecting with researchers and industry leaders as we work towards advancing oncology treatments. We can't wait to see you at booth 518 in San Diego! https://bit.ly/4dTJZVa #WorldADC #ADC #PharmaInnovation #Biotech #DrugDevelopment #BioAgilytix #AntibodyDrugConjugates #InnovationInBiotech

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