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Podcast

EMA Accepts Application for Breakthrough Treatment of Genetic Form of ALS

Biogen, has announced the European Medicines Agency (EMA), has accepted its Marketing Authorization Application (MAA) for the review of torfersen – its investigational drug to treat superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS).
5th Dec 2022
Podcast

Improving Novel Theraputics and Early-Phase Trials

For this interview, Phacilitate’s Ryan Leahy speaks with Marc Wolfgang Vice President of Technical Operations for BioNTech U.S, about what to expect from his presentation ‘AAV Platform Process: Continuous Improvement for First in Human Studies’, at Advanced Therapies Week 2023.
5th Dec 2022
Podcast

Commercial Considerations in the World of Rare Diseases

For this interview, Phacilitate’s Becky Johnson-Kent speaks with Emily Chee, General Managers, Americas, at Novartis Gene Therapies, about what to expect from her presentation ‘Lessons learned from Zolgensma’ in the session, ‘Commercializing Gene Therapies: Building Your Strategy From Translation Through to Commercial’ at Advanced Therapies Week 2023
5th Dec 2022
Podcast

Ushering in a New Paradigm for Treatment with ‘Tissue Therapeutics’

In this bite-size interview, Phacilitate’s Ryan Leahy speaks to David Lennon (CEO, Satellite Bio) about what to expect from his session, ‘Tissue and Stem Cell Therapeutics: Breakthroughs for Regenerative Medicine’ at Advanced Therapies Week 2023.
5th Dec 2022
Podcast

FDA Fast Track Caribou Biosciences’ Allogeneic Anti-CD19 CAR-T

Caribou Bioscience, has announced that the FDA has granted its investigational product CB-101 with Fast Track designation and Regenerative Medicine Advanced Therapy (RMAT) in different indications.
1st Dec 2022
Podcast

Avectas, CCRM and OmniaBio’s Collaboration to Accelerate the Manufacture of Edited iPSCs

Irish based cell engineering technology company Avectas, and its Canadian CDMO partner CCRM, and its subsidiary OmniaBio, have announced the expansion of their collaboration to accelerate the development of gene-edited iPSCs using SOLUPORE® technology.
30th Nov 2022

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Are you preparing to advance your therapy into the clinic? Join us as a panel of industry experts shed light on where most early-stage biotechs go wrong in overestimating their readiness. Encouraging you to take an in-depth look at your product, capabilities, technologies, processes, and team, this panel discussion will prepare you for success as you bring your product from the bench to patients worldwide.
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Our eBooks & Infographics
In this infographic, we have detailed some key considerations when choosing your plasmids for CAR-T development.
As we celebrate 10 years of CAR-T, the Phacilitate team is delighted to present this eBook, in partnership with WuXi Advanced Therapies, as a comprehensive resource for CAR-T development.
Gaining market and patient access in Europe has presented many cell and gene therapy companies with barriers. The advanced therapies industry is currently facing a dilemma: scientific advancement is exceeding market and reimbursement adaptation.
Advanced therapies’ market access is a hot topic. Joining Phacilitate to shed some light on market access struggles are Director at NJ Redfern Limited and ex-bluebird bio UK GM Nicola Redfern, former SVP & CBO at Novartis Gene Therapies and current AviadoBio CEO Lisa Deschamps, and, Vice President and Global Head of Value and Access, at Novartis, Tay Salimullah.
What’s preventing developers from designing mechanistically relevant assays? This report examines this question, focusing on the identification and measurement of appropriate CQAs, the value of fit-for-purpose analytics technologies and what the future of CGT manufacturing analytics should look like.
May 2022 marks the month 17-year-old Emily Whitehead, the first pediatric patient in the world to receive CAR-T cell therapy, celebrates a momentous milestone: 10 years’ cancer free. All month Phacilitate will be joining to celebrate 10 years of CAR-T!
Welcome to Phacilitate’s first Women in Advanced Therapies eBook, commemorating International Women’s Day 2022.
A snapshot of the industry’s approach to commercialisation, presented as a handy infographic.
A collection of the outcomes from the roundtables and panels that took place at Advanced Therapies Connect 2020
This e-book examines 15 of the world’s leading immuno-oncology biotechnology companies, providing you with an at-a-glance view plus more detailed information on how their pipelines are developing.