FOR IMMEDIATE RELEASE
PHILADELPHIA, PA – October 8th, 2019 – SCiAN Services and Biocatalyst 4 Development have partnered together to discuss how drugs designated as “breakthrough therapies” benefit from expedited drug development and how drug development processes must address challenges in trial logistics and data collection/analysis/reporting to mitigate increased risk to patients’ safety.
The presentation will be held in the Quorum Center at 3675 Market Street, Philadelphia on October 10, 2019 from 11:30 am to 1:00 pm.
“FDA’s goal to expedite programs for drugs that address unmet medical need in serious/life-threatening conditions has opened-up opportunities to significantly shorten drug development timelines. We look forward to a vibrant discussion with our early clinical stage Biotech attendees to discuss the challenges that stem from running multiple studies under a master protocol with compressed timelines.” – Miklos Schulz, CEO.
The agenda will cover the following topics:
- Considerations in selecting a lead indication for oncology.
- Overview of clinical development programs in oncology.
- Challenges associated with of accelerated programs.
To register for the Smart Talk session please visit: https://sciencecenter.org/engage/smart-talk?org=1854&lvl=100&ite=294&lea=97970&ctr=0&par=1&trk=a145A000007mnAwQAI.
About SCiAN
SCiAN Services is a leading North American contract research organization (CRO) providing customized clinical trial services for clinical-stage start-ups and mid-size biotechnology companies.
For clinical-stage start-ups, we set-up, manage and execute all study activities from trial design, regulatory filing, trial management, DSMB, safety/DSUR updates, pharmacovigilance, data management, biostatistics and medical writing.
For mid-size bio-pharma companies, we offer large-scale biostatistics, statistical programming and data management services with high quality standards, timelines and deliverables maintained throughout the trial.
With 30+ years of experience in IND stage clinical trials and 690 studies completed, SCiAN’s therapeutic area expertise includes immune-oncology, oncology, CNS, infectious diseases, inflammatory / autoimmune diseases and diabetes.
For more information, please contact:
Jasna Szwagiel
Corporate Communication
Email: jszwagiel@scian.com
URL: www.scian.com
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