Data management and digitalization adoption challenges in BioPharma manufacturing

Dominic Mancini

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 the IDBS teams to support late-stage commercial assets at Bluebird Bio.

Abhijit Ray

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.

Teodor Leahu

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).