Anna Forsythe

We started out Q1 with cautious optimism and the numbers continue to show the confidence was warranted. Biopharma M&A activity more than doubled nationally during the year’s first three months, coinciding with a rebound in venture capital deals as well as a flurry of IPOs. These are all good signs that the drug development cycle is normalizing and should translate into additional funding being available at the seed and Series A stages. Certain to be on the minds of funders and startups attending #AlignSummit24 on Thursday! https://lnkd.in/erEiJm6S  

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#AvalereExpert Mark Gooding moderated a panel at #BIO2024 on access and affordability considerations for patients and manufacturers in a post-#IRA world. Read highlights from his conversation with Anna Hyde, Valerie Reynolds, and Eric Gascho: https://lnkd.in/e_F3NZqM #patients #patientsupport #healthpolicy #healthcare #InflationReductionAct

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Interested in the latest insights from oncologists ahead of #ASCO24? 🚀 Check out perspectives on this year's conference from the front lines of cancer care in our latest blog post: https://lnkd.in/eYupPznU #ASCO24 #OncologyInsights #HealthcareMarketResearch

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Jennifer A. Woyach discusses congress insights from ASH 2024: https://lnkd.in/dSvEVgV4 In this interview she: • Summarizes BTK mutations and their impact on CLL treatment with BTKi • Adresses the impact of toxicity-related BTKi treatment discontinuation on the overall condition of CLL patients • Discusses combination therapy of BTK- and BCL-2 inhibitors in TN CLL patients The full memo inHaematology ASH 2024 SPECIAL ISSUE is coming soon! #ASH24 #Haematology #Hematology #CLL #Research

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Our recent webinar on the potential of targeting innate immunity in immunotherapy of cancer (https://lnkd.in/eSK5rBew) brought together a diverse group of experts to discuss the latest advancements and challenges in the field. The session began with a quick educational overview of the innate immune system, explaining its crucial role in detecting pathogens and tissue damage through pattern recognition receptors. The distinguished panelists -- Frank Borriello, Bjorn Frendeus, Anne Goubier, Arthur Krieg, Heidi LeBlanc, and Michael J. Newman, Ph.D. -- emphasized that while the adaptive immune system, particularly CD8+ T cells, has been the focus of cancer immunotherapy, the innate immune system offers additional pathways that can be harnessed for better therapeutic outcomes. One of the major themes discussed was the need for combination therapies that activate both innate and adaptive immune responses. Single-target approaches have shown limited success, and panelists highlighted the potential of combining multiple innate immune activators or integrating innate and adaptive strategies to enhance anti-tumor responses. This approach could help overcome resistance seen with current therapies, such as checkpoint inhibitors, and improve outcomes for a broader range of patients. The speakers noted that understanding the interplay between different immune cells and pathways is crucial for developing effective combination therapies. The discussion also touched on the challenges of translating preclinical findings into clinical success, particularly due to species differences in innate immunity. The panelists stressed the importance of human tumor biopsies and advanced technologies like spatial genomics to better understand and optimize immune responses in patients. Panelists debated the merits of systemic versus local administration of innate immune activators. Systemic administration could address metastatic disease by inducing a widespread immune response, while local administration might concentrate immune activation at the tumor site but could potentially lead to systemic effects ("abscopal") through draining lymph nodes. The role of myeloid cells, including dendritic cells and macrophages, was highlighted as crucial in transforming immune deserts (T cell-poor environments) into immune-active ones, thereby enhancing the effectiveness of immunotherapies. The concept of innate immune memory, also known as trained immunity, was discussed as an important mechanism that can provide lasting anti-tumor effects even in the absence of adaptive immune responses like T cells. In conclusion, the experts envisioned a future where innate immune activators could become a standard part of cancer treatment. #immunooncology #immunotherapy #cancer #oncology

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Association of Northern California Oncologists (ANCO)’s ASCO24 highlights panel discussion with Eric Small American Society of Clinical Oncology (ASCO) #ANCO #ASCO #ASCO24 #Cancer #OncoDaily #Oncology

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The annual meeting of the American Society of Clinical Oncology (ASCO) ended this week. Members of our team were there. Here's brief summary of the key themes that stood out from the meeting >> https://lnkd.in/ePVjs2ZH Authors: Mary Lee, Shankar Sundar, & Tahel Noy #oncology #cancerresearch #biotech #pharmaceuticals #ASCO2024 #ASCO24

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𝐑𝐄𝐆𝐔𝐋𝐀𝐓𝐎𝐑𝐘 𝐑𝐎𝐔𝐍𝐃𝐔𝐏 ⚛️ The FDA has released new draft guidance recommending best practices for multi-regional clinical trials (MRCTs) in oncology. Sponsors are encouraged to ensure that the outcomes of global oncology clinical development programs are understandable for US patients in support of marketing applications. 🌐 The FDA's final guidance on decentralized clinical trials (DCTs) clarifies several concerns raised by clinical experts and industry stakeholders regarding the earlier draft. This includes detailed requirements for maintaining a task log for healthcare providers, guidelines for physical inspections, and addressing challenges related to data variability in DCTs. 🤖 As the use of artificial intelligence (AI) tools, particularly generative AI, expands, experts remind regulatory professionals to prioritize the human aspect. Although these tools offer significant benefits, they necessitate human oversight and interpretation to be fully effective. During the opening plenary session, experts discussed how AI can be utilized across various sectors, the potential of this technology, and the hurdles in achieving its full benefits. Panelists included Ryan Kurtzman from the City of Long Beach, Bradley Thompson of Epstein Becker Green, Michelle Jump from MedSec, and Jay Mashburn from Recursion Pharmaceuticals, with moderation by Megha Iyer of Thermo Fisher Scientific. 🧬 As biosimilars gain market presence, they are generating competition with original products. However, patient adoption of biosimilars varies based on demographics, location, care setting, prescriber specialties, and types of insurance, according to two recent studies in Health Affairs. 🌐 The FDA has observed a rise in complete response letters (CRLs) issued to sponsors of biologics license applications (BLAs) over the last decade, with facility deficiencies being the most common reason cited, according to Leslie Rivera Rosado, a supervisory interdisciplinary scientist at the agency's Center for Drug Evaluation and Research (CDER). #Pharmaceuticals #Biotechnology #LifeSciences #PharmaNews #Biotech #HealthcareInnovation #DrugDevelopment #ClinicalResearch #Biopharma #PharmaTech #MedicalResearch #Healthcare #BioPharmaceuticals #PharmaIndustry #BiotechIndustry #PharmaCareers #MedicalInnovation #NewDrugs #Genomics #BiotechNews

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Immunovant 𝗶𝘀 𝘀𝗵𝗶𝗳𝘁𝗶𝗻𝗴 𝗶𝘁𝘀 𝗳𝗼𝗰𝘂𝘀 𝗳𝗿𝗼𝗺 𝗯𝗮𝘁𝗼𝗰𝗹𝗶𝗺𝗮𝗯 𝘁𝗼 𝗜𝗠𝗩𝗧-𝟭𝟰𝟬𝟮, 𝗮𝗻𝗼𝘁𝗵𝗲𝗿 𝗙𝗰𝗥𝗻 𝗶𝗻𝗵𝗶𝗯𝗶𝘁𝗼𝗿 𝘄𝗶𝘁𝗵 𝗽𝗿𝗼𝗺𝗶𝘀𝗶𝗻𝗴 𝗽𝗼𝘁𝗲𝗻𝘁𝗶𝗮𝗹 𝗶𝗻 𝘃𝗮𝗿𝗶𝗼𝘂𝘀 𝗮𝘂𝘁𝗼𝗶𝗺𝗺𝘂𝗻𝗲 𝗱𝗶𝘀𝗼𝗿𝗱𝗲𝗿𝘀, 𝗶𝗻𝗰𝗹𝘂𝗱𝗶𝗻𝗴 𝗠𝘆𝗮𝘀𝘁𝗲𝗻𝗶𝗮 𝗚𝗿𝗮𝘃𝗶𝘀. This decision gives argenx’s Vyvgart, a competing treatment for myasthenia gravis (MG), more market lead time. Immunovant is also a competitor of UCB in the treatment of myasthenia gravis (MG). Both companies are developing or marketing FcRn inhibitors for this autoimmune disorder. Immunovant's focus is on IMVT-1402 and batoclimab, while UCB is on rozanolixizumab, another FcRn inhibitor for MG. Yes, UCB has received European Commission (EC) authorization for rozanolixizumab, marketed as RYSTIGGO on January 2024. The competition in this therapeutic area is centered around offering effective treatments for MG, with each company aiming to demonstrate the efficacy and safety of their respective candidates. Immunovant plans to start several registrational studies for IMVT-1402 by March 2025 and additional trials by March 2026. Results for batoclimab in MG and Graves’ disease are expected soon, influencing its future development strategy. ------ I am Matteo and I support you in market knowledge and strategy. How? Since 2001, I have been involved in business, market, and competitive intelligence, helping companies define strategies in line with market and competitive scenarios. #marketintelligence #competitiveintelligence #strategy #marketsmind #pharmaceutical

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#NEWS: #AnthosTherapeutics today announced that 84% of all eligible patients have voluntarily transitioned to once-monthly abelacimab 150 mg in the AZALEA-TIMI 71 extension study of #atrialfibrillation patients at a moderate-to-high risk of #stroke, including 75% of patients in the rivaroxaban arm of the study. To read the press release in full, click here: https://bit.ly/4c7EPV5. In Sep. 2023, the TIMI Study Group and the data monitoring committee recommended ending the study early due to a 67% reduction in major or clinically relevant non-major (CRNM) bleeding events favoring abelacimab over rivaroxaban. They also suggested an optional open-label extension for eligible patients to benefit from abelacimab treatment. To access the full results of the AZALEA-TIMI-71 study presented at #AHA23, click here: https://bit.ly/3HLiujf. #afib #afibawareness #stroke #strokeawareness #FactorXI #FactorXIa #thrombosis #hemostasis #anticoagulant #anticoagulation #TIMIStudyGroup

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Led by Markus Renschler, MD, Light Horse Therapeutics has made significant progress in the oncology space with a $62M #SeriesA funding round led by MPM BioImpact and Omega Funds, alongside Novartis Venture Fund. This marks a big step for their work in developing LHT-001, a promising candidate targeting critical cancer pathways. In parallel, their partnership with Novartis could be worth up to $1B, combining Light Horse's innovative pipeline with Novartis' expertise in oncology drug development and commercialization. This collaboration has the potential to address unmet needs in cancer treatment and accelerate progress in this critical field. #Biotech #Oncology #Immunology #Innovation #LightHorseTherapeutics #Novartis #MPMBioImpact #OmegaFunds

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💊 #Wegovy Advances in #MASH Treatment but Faces Limits as a Long-Term Solution GLP-1s strike again... ❗ Wegovy’s results offer meaningful progress in addressing MASH, a complex and increasingly prevalent #liverdisease that currently lacks effective long-term treatments. However, while #GLP-1 receptor agonists like semaglutide show promise, they’re unlikely to revolutionize MASH management on their own, as evidenced by modest fibrosis improvement and the need for polypharmacy to address multifaceted disease pathways. This outcome aligns with broader trends in the field, where combination #therapies appear crucial to tackling the advanced stages of MASH. As Wegovy and similar drugs progress, their ultimate value may lie in complementary roles alongside other #treatments, reshaping MASH care without single-handedly transforming it.

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Read on for a recap of the World Bispecifics Summit 2024 👇 𝟏. 𝐁𝐢𝐬𝐩𝐞𝐜𝐢𝐟𝐢𝐜 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐋𝐚𝐧𝐝𝐬𝐜𝐚𝐩𝐞 • CLDN18.2 x 4-1BB bispecific: anti-4-1BB VHH that targets the membrane proximal region can be further optimized with unidirectional Fc effector function towards TAAs. (Biotheus Inc.)  • ABBV-383: a novel bispecific antibody with enhanced tumor targeting & optimized t-cell engagement in multiple myeloma. (AbbVie)  • Endogenous T cell reactivities as drivers of TCE response & resistance (leveraging TCE immune perturbations to establish predictive biomarkers and novel personalized cell therapies). (Broad Institute of MIT and Harvard Institute)   𝟐. 𝐀 𝐍𝐞𝐰 𝐆𝐞𝐧𝐞𝐫𝐚𝐭𝐢𝐨𝐧 𝐨𝐟 𝐈𝐦𝐦𝐮𝐧𝐞 𝐂𝐞𝐥𝐥 𝐄𝐧𝐠𝐚𝐠𝐞𝐫𝐬 • Solving the combinatorial matrix puzzle and fast-tracking bispecific generation for early-stage functional assessment through multiparametric, high throughput in silico-driven molecular optimization to derisk programs as early as possible. (IPA (ImmunoPrecise Antibodies)) • There is growing evidence of T-cell engagers with clinical benefit for solid tumors, not just in hematological malignancies. (Amgen) • Selectively activating subsets of T cells present in tumor-infiltrating lymphocytes of solid tumors to promote more potent anti-tumor activity by uncovering associations between Vβ T cell subsets and diseases. (Marengo Therapeutics) 𝟑. 𝐋𝐚𝐭𝐞𝐬𝐭 𝐍𝐨𝐯𝐞𝐥 𝐅𝐨𝐫𝐦𝐚𝐭𝐬 • XmAb541: 2+1 CLDN6 x CD3 bispecific has two tumor-antigen binding domains and one T-cell binding domain, to treat ovarian cancer & other CLDN6+ solid tumors. (Xencor) • Azymetric platform used to optimally format T-cell engagers & bispecific ADCs with a robust Fc heterodimer solution. E.g. Zanidatamab, a bi-paratopic anti-HER2 antibody undergoing clinical studies. (Zymeworks Inc.) • FAST-Ig platform used to produce bispecific antibodies and improve antibody pharmacokinetics. E.g. NXT007, a next-gen version of emicizumab for hemophilia A. (Chugai Pharma USA, Inc.) • Overcome tolerability challenges with bispecifics targeting CD47 on tumor cells and regulate CD28-mediated T-cell co-stimulation, overcoming tolerability challenges while avoiding systemic toxicities associated with CD47 and CD28 targeting, respectively. (Light Chain Bioscience | Novimmune SA) Read the full recap here: https://lnkd.in/ecNZmcNx #Biointron #Antibodies #Immunotherapy #PharmaNews #DrugDevelopment #Bispecific #ClinicalTrials #Innovation #Networking

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Dana-Farber Cancer Institute - Five Efforts by the Centers for Early Detection and Interception https://lnkd.in/d6YKr-5r #Cancer #Medicine #Health #CancerDiagnosis #EarlyDetection #Oncology #OncoDaily

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NewAmsterdam Pharma Corporation releases topline results of BROOKLYN showing significant decreases in LDL-C, ApoB, Lp(a) and very good drug tolerance with oral obicetrapib 10 mg in patients with heterozygous familial hypercholesterolemia (HeFH). I am excited to see cardiovascular outcome results of PREVAIL when they are available. https://lnkd.in/ep5ynEhS #cholesterol #ldl #lipids #cardiovascularprevention #cardiovascular

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