The Solid team is headed back to Orlando this week to engage with the Duchenne community at Parent Project Muscular Dystrophy’s 30th Annual Conference, June 27-29.
At the conference, our Chief Medical Officer, Gabriel Brooks, M.D., will participate in an industry panel “Research Row: Gene Therapy – Current and Evolving Landscape Session” on Friday, June 28, 1:45 p.m. to share insights about gene therapy and INSPIRE DUCHENNE, Solid’s first-in human clinical study evaluating SGT-003.
We look forward to engaging with the Duchenne community in Orlando!
For more information, visit: https://lnkd.in/gMhB4CUA#GeneTherapy#DuchenneMuscularDystrophy#PPMD30
Less than a week to go for #EUCROF24!
CROs are telling us sponsor study protocols are becoming increasingly complex and sample-intensive.
What we often hear:
🏨 More sites, more patients, and strict timelines...
..... Will the kits be customized for study needs?
..... Will sites have the kits in time for FPI?
..... Are the kits easy to use? What if the site makes collection errors?
🔍 More endpoints and specialized testing. It's hard to find the right labs...
..... Is there a lab near the site to process short-stability samples in<24h?
..... Can the lab develop and validate this biomarker assay on-time?
..... Can the lab do the testing according to protocol?
✈ Thousands of samples scattered across sites, labs, and with couriers...
..... Where is sample X? Is it collected?
..... Do I have sample visibility? How will I keep the sponsor informed?
..... Can I ensure sample & data integrity?
📊 Millions of data points generated - from disparate data sources...
..... When and how will data be transferred? What about ad hoc transfers?
..... Will I have a unified dataset in time for submission?
..... Is the data accurate, consistent and usable?
Sounds familiar?
Stop by our booth #4 if you're open to learning more about how we help CROs and sponsors generate endpoint data for their complex trials - while preventing delays and reducing costs.
#clinicalresearch#clinicaltrials#clinicaloperations
Will we see you in Prague? #EUCROF24 kicks off February 19 – 20 and we look forward to seeing you there.
Come meet our team at Booth #4 to learn how we can partner together to accelerate the development of new medicines.
LabConnect is an independent, global, one-stop-shop focused on delivering Central Laboratory Services and Functional Service Provider Solutions that are tailor-made, timely, and flexible to meet the evolving study demands from traditional to more complex cell and gene therapy (ATMP) trials.
Schedule a meeting: https://3ly.link/1vkOO
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Be sure to Follow LabConnect to stay up to date on our conference schedule.
#LabConnect#ClinicalTrials#CentralLab
It was an absolute pleasure to attend and speak at the Gene Therapy Patient Engagement Summit again last week! A few takeaways:
📩 Direct and indirect engagement with the patient community should start even before the pre-clinical phase, as soon as a target condition has been identified
🤝 Early internal cross-functional alignment is critical to ensure patient advocacy is integrated into and considered in every functions' outputs
🏥 More consideration is needed when communicating the commitment of the long-term follow-up required post-gene therapy trials; for patients who have lived around hospital appointments and procedures for decades, we cannot underestimate the burden of having to continue this for a further 15 years
📺 When planning engagements and outreach to patients, it is critical to meet the communities where they're at
Thank you to everyone who joined Isabelle Blomfield and Lauren Coleman-Bennett's presentation on "The importance of early patient engagement in cell and gene therapy development" at the Gene Therapy Patient Engagement Summit last week. We hope you found the session interesting!
If you missed it, keep an eye out for the presentation recording coming soon...
To learn more about the support we can offer in gathering and using patient insights with maximum impact, get in touch at contact@amiculum.biz#GeneTherapy#PatientEngagement#PatientInsights
As clinical trials grow in complexity, study sponsors and investigators are adapting with agile and risk-based approaches, focusing oversight on critical data and high-risk processes.
Join Kelsey Schertz. MPH, CCRC, CCDM of NMDP BioTherapies at #ACRP2024 for the session "Understanding Roles and Responsibilities in a World of Increasing Data Complexity" to gain insights into risk-based monitoring and strategies for cell and gene therapy clinical trials.
Explore more session details > https://bit.ly/49qKvst#GoForIt#GoForEducation#ClinicalTrials#ClinicalResearch#Study#SiteManagement#Data
Only one week until our 'Overcoming Challenges in the Industrialisation of iPSC-derived therapies' webinar!
Cell and Gene Therapy Catapult's Márcia F. Mata, will be discussing examples of how we are working to address key manufacturing challenges within the allogeneic cell therapy field; developing scalable, automated, and controlled processes to help bring these pioneering advanced therapies to patients will be discussed.
Register now: https://buff.ly/3y9Z5XJ#iPSC#AdvancedTherapies#CellTherapies#GeneTherapies
Critical starting materials such as plasmid DNA make a world of difference when it comes to cell and gene therapy, regenerative medicine and vaccine development. This Endpoints Webinar will focus on how you need the right manufacturing partner to support long-term clinical success. Join Aldevron's Matthew Howard and Tyler Kozisek on May 2! Register today! https://lnkd.in/gmV_x8vY
Check out this on-demand webinar on long-term follow-up (LFTU) considerations for cell and gene therapy studies featuring our colleagues from Thermo Fisher Scientific as well as industry experts.
Our Development Head of Cell and Gene Therapy, Carolyn Sasse, recently shared her predictions on #clinicaltrial trends for the #biopharma industry in 2024 as part of Citeline’s #ScripAsks series. Explore Carolyn’s perspectives on the importance of patient centricity in clinical trials: https://bit.ly/42uY7Ae
Check out this on-demand webinar on long-term follow-up (LFTU) considerations for cell and gene therapy studies featuring our colleagues from Thermo Fisher Scientific as well as industry experts.
Sr. Director, Legal at Solid Biosciences Inc.
1moExciting!