Clara Campàs Moya

SCION 2025 equips participants with insights into cancer immunotherapy clinical trials - Society for Immunotherapy of Cancer (SITC) #Cancer #OncoDaily #Oncology #SCION #SocietyForImmunotherapyOfCancer

24

Tomorrow (7/17) between 8.30 am - 10:00 am PDT, Clear Labs' Chief Scientific Officer/Chief Operating Officer Ramin Khaksar and Aviagen's Laboratory Director Lola Crespo will be co-presenting at #IAFP2024 Symposia S50 about how proactive #SalmonellaSerotyping using the #ClearSafety solution can enhance consumer protection with data-enriched insights and support unified efforts in policy, industry, and biotech in Room 104AB. See you there! International Association for Food Protection #Salmonella #Serotyping #Listeria #Surveillance #NextGenerationSequencing #NGS #tNGS #LiberateGenomics #FoodSafety #Automation

26

Ariel Berger and Almudena Olid Gonzalez discuss the expanding role of real-word evidence in drug development and the importance of early planning in this expert Q&A with Drug Discovery & Development.

72

1 comentario

𝐆𝐢𝐠𝐚𝐆𝐞𝐧 𝐁𝐞𝐠𝐢𝐧𝐬 𝐏𝐡𝐚𝐬𝐞 𝟏 𝐓𝐫𝐢𝐚𝐥 𝐟𝐨𝐫 𝐀𝐧𝐭𝐢-𝐂𝐓𝐋𝐀-𝟒 𝐎𝐧𝐜𝐨𝐥𝐨𝐠𝐲 𝐃𝐫𝐮𝐠 𝐆𝐈𝐆𝐀-𝟓𝟔𝟒 GigaGen Inc. GigaGen Inc, a subsidiary of Grifols Grifols, announced the dosing of the first patient in a Phase 1 clinical trial for its anti-CTLA-4 oncology drug, GIGA-564, targeting metastatic or locally advanced solid tumors. “This Phase 1 trial with GIGA-564 marks a significant milestone as GigaGen’s first oncology asset to enter the clinic,” said Carter Keller Carter Keller, senior vice president of Grifols and head of GigaGen. “We hope to translate the superior anti-tumor performance and reduced immune-related toxicity observed in pre-clinical studies into clinical success. There is a pressing need for innovative solid tumor therapies, and we believe GIGA-564 can improve patient outcomes.” The trial is conducted in partnership with the National Cancer Institute (NCI), part of the NIH. #GigaGen #Grifols #Oncology #CancerResearch #ClinicalTrials #Immunotherapy #Phase1Trial #CancerTreatment #InnovativeTherapies #Biotechnology

44

1 comentario

#BioSimilarsInLATAM:  Insights into different markets and trends As of late 2020, #Mexico, #Brazil, and #Argentina topped the list for the #largest #numbers of approved similar #biotherapeutic products (SBPs) in Latin America. Notably, Mexico emerges as the #leading #investor in #biosimilars,  followed by Argentina and Brazil. However, disparities exist, with smaller economies like Costa Rica and #Peru #investing significantly less, and others, like #Uruguay and #Venezuela, lacking records of #spending altogether. Moreover, the #market is fragmented, with varying levels of #accessibility and investment opportunities across countries. While some nations, including #Chile, #Colombia, #Uruguay, and #Peru, exhibit steady growth and fewer #barriers to marketing and commercializing #biosimilars, others, like #Bolivia, #Ecuador, #Paraguay, and Uruguay, face challenges due to their #smaller #economies. Additionally, Venezuela and Cuba's information remains #unverified, adding further #complexity to the landscape. According to the insights of our CEO Mike Rizo, Pharm.D, MBA, CDR, CPh and our Global Director of Operations Dr. Juan Carlos Velazquez, despite the mentioned challenges, the biosimilar market in Latin America presents significant #opportunities for growth and #collaboration, with Mexico, Brazil, and Argentina #leading the way in #investment and market penetration.    Find more perspectives and information on biosimilars in Latin America in https://t.ly/CTMvd

5

Take a sneak peek inside our recent white paper on considerations for commercialization of cell and gene therapies outside of non-orphan indications: https://lnkd.in/es86YMsS #CGTs #advancedtherapies #drugdevelopment

13

🔬New paper out in Cell Reports! "BRAF Isoforms and Resistance to MAPK Inhibitors in Melanoma"👇 ✍️ Francisco Aya, Pablo Lanuza, Abel Gonzalez-Perez, Sophie Bonnal, Estefania Mancini, Núria Lopez-Bigas, Ana Arance, and Juan Valcarcel. Highlights ✅ Alternative BRAF isoforms (altBRAFs), related to resistance, are caused by genomic deletions. ✅ altBRAFs in BRAF inhibitor-resistant models are not generated by alternative splicing. ✅ altBRAFs also occur in treatment-naive tumors and regardless of BRAF mutational status. Read more here ➡️ shorturl.at/rKTY0 📌https://lnkd.in/gaPm_6eE Centre for Genomic Regulation (CRG) Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS) Hospital Clínic de Barcelona Universitat Pompeu Fabra ICERCA - Centres de Recerca de Catalunya Barcelona Institute of Science and Technology (BIST) #IRBScience #CancerResearch #Melanoma #Research

61

1 comentario

#Skyreg #FDA update #Oncology FDA Launches New Oncology Crowdsourcing Effort: Project 5 in 5 FDA’s Oncology Center of Excellence (OCE) has launched the Project 5 in 5 crowdsourcing initiative. OCE is gathering ideas from providers, researchers, patients, and others on clinically relevant questions that can be answered through use of pragmatic clinical trials over the next ~5 years. Pragmatic trials are more reflective of routine clinical practice and aim to collect only minimal information needed to answer the research question. OCE wants to hear the questions you would like addressed using pragmatic clinical trials in oncology. After this crowdsourcing initiative ends, OCE plans to identify the top 5 questions to share with the oncology community. Please note that submitting a research question will not result in funding or guaranteed collaboration on clinical trials after the initiative. Submissions to Project 5 in 5 must be received by July 5, 2024.

2

2024 Prediction Fact Check : Are trial sponsors (biopharma companies) becoming increasingly intolerant of inefficiency and budget overages? Appears to be TRUE ✅ as there is a shift underway in CRO contract models.   For outsourced clinical activities, increasingly today’s top biopharma’s are shifting to an FSP contracting approach versus a full-service outsourcing model. According to Samir Shah, “Nearly 80% of respondents agreed that the ‘one-stop-shop’ claim that many large CROs market is not a cost-effective business model due to the lack of seamlessly integrated service delivery.”   Great article from Clinical Leader and check out Auxilius’ other 2024 Industry Predictions. https://lnkd.in/ev9drTVG

17

Exosome Diagnostics and Therapeutics Market worth $6,848 million by 2032 Download PDF Brochure @ https://lnkd.in/dA3GUxgi Exosome Diagnostics and Therapeutics Market is projected to grow from USD 59 million in 2024 to USD 6,848 million by 2032 at a CAGR of 108.9%. Emerging potential of exosome-based liquid biopsy is one of the key driving factors of the market growth. Exosomes have gained traction in clinical research, primarily attributed to their stability & ability to carry genetic material such as cellular DNA, mRNA, and miRNA. Exosomes serve as a novel source of biomarkers suitable for diagnostic applications. Recently, exosomes have emerged as a promising liquid biopsy tool offering non-invasive options for disease diagnosis, prognosis, and treatment response monitoring in both communicable and non-communicable diseases. Bio-Techne, NanoFCM, System Biosciences, Capital Biosciences, AMSBIO, INOVIQ Ltd (ASX:IIQ), Direct Biologics, Regeneus Ltd, Curexsys GmbH i.L., Aegle Therapeutics, Mercy BioAnalytics, Inc., NanoSomix, Inc., Exonox Biosciences, Inc. 胞泌體生技, Capricor Therapeutics, Inc., Evox Therapeutics Ltd

4

Join Allucent experts Sugato De, MS (VP, Regulatory Strategy, Head of MedTech) and Alex MacDonald, PhD (VP, Model Informed Drug Development) in our newest podcast hosted by BioPharma Dive and titled, "Advancing Oncology Research: Regulatory & Development Path for ADCs & RDCs". In this podcast, our experts delve into the world of #antibodydrugconjugates (ADCs) and #radionuclide conjugates (RDCs) by exploring the tremendous growth potential of these targeted oncology therapies, the challenges faced by small and mid-sized biotech companies, and strategies for navigating the complex regulatory landscape. Click the link below to access the podcast: https://lnkd.in/g8uSZp7X #Allucent #BringNewTherapiesToLight #Oncology #ADCs #RegulatoryAffairs #CancerResearch

71

1 comentario

[Article] KOL Engagement Dynamics - KOL Activities by Phase In this part 2 of 3 on "Navigating KOL Engagement Dynamics", we present our second key insight from our KOL engagement strategy report. This article addresses the type of activity pharmaceutical companies seek from KOLs who possess specific experiences suited to support the activities of the pharmaceutical organization during particular times within a product lifecycle Read on here: https://lnkd.in/eZRZxgUg #medicalaffairs #msl #msls #thoughtleader #pharmaceuticalindustry #healthcare

3

🧬 𝐖𝐞𝐞𝐤𝐥𝐲 𝐈𝐧𝐯𝐞𝐬𝐭𝐦𝐞𝐧𝐭 𝐍𝐞𝐰𝐬 𝐢𝐧 𝐁𝐢𝐨𝐭𝐞𝐜𝐡 & 𝐇𝐞𝐚𝐥𝐭𝐡 🎯 🚀 Myricx Bio raises £90M ($114M) in Series A funding, co-led by Novo Holdings and Abingworth, to advance ADC therapeutics into clinical development. 💰 SciRhom secures €63M ($70M) in Series A financing, co-led by Andera Partners, Kurma Partners, and Wellington Partners, to develop treatments for autoimmune diseases. 🔬 Flagship Pioneering raises $3.6B for new ventures, focusing on AI-powered drug discovery and developing novel biotech platforms. 🏥 Endoron Medical raises $10M in Series A funding, led by Sofinnova Partners, to accelerate clinical validation of its AAA EndoStapling solution, Aortoseal. 💡 Opyl partners with L39 Capital to launch an AI-driven Biotech Fund aimed at transforming the biotech industry. 📈 Gelomics lands $2.2M in pre-seed funding, led by Jelix Ventures and QIC, to advance 3D tissue culture systems for pharmaceutical drug development. 🔍 NOWDiagnostics | NOWDx secures $22.5M in Series B funding, led by DigitalDx Ventures, to expand at-home diagnostic solutions. 🌱 Spotlight Medical raises €6.2M in seed funding, led by Kurma Partners and Heal Capital, to enhance cancer treatment strategies with AI-powered prognosis tests. 💉 AIRS Medical secures $20M in Series C funding, led by BSK Investment and Shinyoung Securities Co., LTD., to advance AI-powered preventive healthcare solutions. 🚀 Element Biosciences raises $277M in Series D funding, led by Wellington Management (with Samsung Electronics among the investors), to commercialize its DNA sequencer AVITI. 🔬 Biovance Capital debuts with €51M to invest in early-stage biotechs across southern Europe. 📈 Immuneel Therapeutics Pvt. Ltd. raises Rs 100 Cr in Series A round extension, backed by Taiba Middle East, to advance CAR-T cell therapy in India. 🔍 Sydney Neuroimaging Analysis Centre secures A$3.75M ($2.5M) grant for AI-powered brain disease analysis and monitoring solutions. 💉 Morphic Therapeutics acquired by Eli Lilly and Company for $3.2B, enhancing Lilly’s inflammatory bowel disease treatment pipeline. 📈 Bedal raises $11M to boost growth of its FlexGRIP® catheter securement devices, led by White Fund SA and SFPIM. 💡 Courier Health raises $16.5M in Series A funding, led by Norwest Venture Partners, to enhance patient engagement for life science manufacturers. #Startups #Biotech #Medtech #LifeSciences #Investments #VentureCapital

7

Exciting Developments in the CDK Space 🎉 At Concarlo Therapeutics, we are continually inspired by advancements in the field of CDK inhibitors, especially as we explore p27 modulators as novel therapeutic strategies for CDK inhibitor-resistant cancers. The recent study presented at the 2024 ASCO Annual Meeting on PF-07220060, a first-in-class, next-generation CDK4-selective inhibitor, is particularly exciting as it holds significant promise for patients with HR+/HER2− metastatic breast cancer (mBC) who have progressed after prior CDK4/6 inhibitor therapy. PF-07220060 has shown remarkable specificity for CDK4 while sparing CDK6, which is a crucial distinction given the potential side effects associated with CDK6 inhibition. Notably, the study’s updated safety data revealed a high incidence of neutropenia among treated patients (Neutropenia in the pooled 1B-C cohort (54.5% [18.2% G3]), and in Parts 2B-C (61.8%/36.1% [23.5%/11.1% G3]). This finding prompts us to consider the broader role of CDK6 in neutropenia. Given the data, it is imperative to investigate further the impact of selective CDK4 inhibition on hematological adverse events, specifically neutropenia. Understanding CDK6’s role in this context could open new avenues for mitigating side effects and improving patient outcomes. What are the implications of these findings? What is the significance of selective CDK4 inhibition and its sparing effect on CDK6? How to best enhance the therapeutic index of CDK inhibitors? We believe that these discussions will be instrumental in refining our therapeutic strategies and reinforcing our commitment to developing innovative, safe, and effective treatments for patients with CDK-resistant cancers.

5

New article in Drugs in Context Feasibility and reliability of a quality indicator system for an ambulatory dispensing service Andrea Jetzú Bautista Gómez, Maricela López Orozco, Liliana Barajas Esparza, Hermelinda De la Cruz Durán, Alejandro Chehue Romero, Isis Beatriz Bermudez Camps, ANA MARIA TELLEZ LOPEZ, Laura Cristina López Vargas, María Isabel Valverde Merino, Fernando Martínez Martínez, Ivette Reyes Hernández Article discussing the feasibility and reliability of a quality indicator system for a drug dispensing service for paediatric outpatients in two Mexican hospitals. #drugsincontext #drugdispensing #pharmacology #hospitals #qualityindicator https://lnkd.in/dfVfrtcC

3