How to contextualize and optimize process and batch data exchange between CDMOs and sponsors
Are the biotech and pharma sectors slower to adopt digital technology compared to other industries? Are they lagging when it comes to extracting value out of data?
The true value of data comes from being able to contextualize it and gain insight from it, rather than just data points
We’ve all experienced the challenge of transferring information across departments: from R&D to development to manufacturing. It’s difficult enough when it’s one facility in one location. The BioPharma industry is continuing to outsource more and more of its manufacturing to CDMOs, adding yet another layer of complexity to critical data exchange like tech transfer.
And even if all three of your CDMOs have an electronic batch record (EBR) system, those might be three different EBR systems. So how do you deal with extracting, aggregating and harmonizing data that comes in varied formats or languages, from multiple partners? And how do you guarantee that data access is secure and compliant?
Check out the teaser below:
In this session, learn how to:
- Collaborate effectively with your external partners
- Reduce data silos and contextualize your data
- Overcome the challenges arising from a lack of common process terminology and a lack of transparency.
- Ensure data can be accessed in a secure and compliant environment
This fireside chat was pre-recorded but our experts answered questions live.
Meet our speakers
VP, Operations, OrganaBio
Dominic Mancini serves as Vice President of Operations at OrganaBio – a Miami-based Contract Technology Development and Manufacturing Organization (CTDMO) that supports cell and gene therapeutic developers. With a fundamental commitment to providing access to critical resources essential for therapeutic development, OrganaBio recently expanded its reach to Irvine, California. Coupled with a cGMP facility located in Miami, Florida, OrganaBio now provides coast-to-coast, hands-on expertise with customizable products and services for BioPharma and research organizations across the world. This bi-coastal presence helps our partners to further reduce manufacturing costs and timelines, ethically accelerating the development and commercialization of their cell-based therapies.
Prior to OrganaBio, Dominic spent eight years at Bluebird Bio as the company grew from 45 to 1200+ employees and from one clinical asset to a robust commercial pipeline. Dominic worked closely with the Aventior and IDBS teams to support late-stage commercial assets at Bluebird Bio.
Co-Founder and CTO, Aventior
Abhijit has been working with some of the leading pharma and biopharma companies as a solution consultant for over 20 years. As a CTO and co-founder of Aventior, he has led the development of an automated platform that enables data capture, integration and visualization of key biopharma production data. The automated process has enabled a number of biopharma companies to reduce their efforts in data collection and analysis – a key requirement in maintaining production quality and FDA compliance.
He currently oversees a 100+ member team across geographies that deliver various technology solutions to this industry.
PIMS Specialist, IDBS
Teodor has 14 years of expertise as a scientist in biotech process development, design, optimization and validation. His successful track record building and managing technology roadmaps for GMP manufacturing, including software selection, qualification and implementation, position him as a respected advisor on maximizing operational efficiency to accelerate scale-up, tech transfer and commercial release.
Before joining IDBS, Teo served as Process Development Scientist at Emergent BioSolutions, where he led science and technology for a newly developed orphan disease vaccine. Previously at Merck Healthcare, his roles spanned Bioprocess Development Scientist and Compliance Specialist for Downstream Processing.
Teo holds a BSc in Biomedical Engineering from Yale University and an MSc in Biotechnology and Bioengineering from EPFL (Swiss Federal Institute of Bioengineering).