Dianthus Therapeutics, Inc.’s Post

Fantastic news from Adaptimmune today regarding acceptance of their priority review BLA for Afami-Cel in the treatment of synovial sarcoma, with a target PDUFA date of Aug 4th 2024. #cellandgenetherapy #celltherapy #celltherapymanufacturing #advancedtherapies #solidtumors #regulatoryaffairs

MC2 Therapeutics gears up for Phase IIb hidradenitis suppurativa trial following early clinical results >>> lqventures.com #strategy #competitiveintelligence #marketing #pharmaceutical #biotech #productmarketing #healthcare #pharma

NOW ON-DEMAND: “Organoid Meets Microelectrode Array (MEA) – Accelerating Drug Discovery and Development” Sven Schönecker, PhD, and Sara Mirsadeghi, MSc, discuss new developments and applications of 3D Mesh Microelectrode Arrays (MEA). Watch it here ⏩ https://bit.ly/3ry2CLT #DrugDiscovery #DrugDevelopment #Pharma #PharmaWebinar

MC2 Therapeutics gears up for Phase IIb hidradenitis suppurativa trial following early clinical results >>> lqventures.com #strategy #competitiveintelligence #marketing #biotech #productmarketing #healthcare #pharmaceutical #pharma

You're all cordially invited to read “Rational Design and Synthesis of HSF1-PROTACs for Anticancer Drug Development” 👉https://ow.ly/TyaQ50PQ0u3 #mdpimolecules #molecules_mdpi

A challenge in #CGTdevelopment lies in the bespoke nature of these treatments, resulting in a multitude of proprietary solutions that demand extensive time and resources for both developers and regulators. Traditional drug development timelines and regulatory frameworks may not adequately accommodate the unique characteristics of CGTs, leading to significant delays and costs, particularly for rare diseases where patients have limited time for treatment. To ensure sustainability and broader access to CGTs, the industry must transition away from traditional approaches and streamline technological foundations to reduce costs and accelerate development timelines. A recent initiative co-sponsored by the Alliance for Regenerative Medicine and NIIMBL | The National Institute for Innovation in Manufacturing Biopharmaceuticals aimed to identify building blocks and platform technologies to streamline CGT development and regulatory review, with this whitepaper offering an overview of sector challenges, regulatory paths, and proposed building block solutions. Read more below! h/t to Lindsay Gasch, PharmD, BCPS, BCACP FDA https://lnkd.in/eU5tQwFj #cgt #fda #arm #NIIMBL #CDER #CBER #industrycollaboration #manufacturing #patientoutcomes #technologydevelopment

During #DIA2024, I was honored to sit down with Dr. Peter Marks and get his thoughts on how the industry is fairing 2024, as well as his vision for the future. ➡️ Watch the Full Interview: https://lnkd.in/ga_z9spj #regulatory #clinicaltrials #rarediseases #AI #FDA #globalcollaboration .

Making the right choices is important in today’s R&D environment. Short-term thinking can lead to long term problems. Join this event featuring speakers from Catalent, JLABS and Cardiff Advisory LLC focusing on several key considerations for developing the best small molecule drug product for patients. https://ow.ly/hMat50PKCk8

Thoughts on this? >> Pathios rakes in $25M to help start trials for GPR65 inhibitor >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #productmarketing #biotech #pharmaceutical #healthcare #pharma

Making the right choices is important in today’s R&D environment. Short-term thinking can lead to long term problems. Join this event featuring speakers from Catalent, JLABS and Cardiff Advisory LLC focusing on several key considerations for developing the best small molecule drug product for patients. https://ow.ly/hMat50PKCk8