Meet the Experts

Your webinar hosts for How to Implement Your PQ Strategy.

Robert Battista

Engineering Manager

As an Engineering Manager at Modality Solutions, Robert Battista works to provide technical and regulatory guidance on all client engagements for cold chain validation. He has a successful track record with regulatory filings including over 15 successful commercial filings in the US, Europe, the UK, and Brazil for biologics and advanced therapies. Robert is an industry expert at validation master planning and implementation during the clinical stage, pre-filing preparation, and post-filing/launch changes. His expertise also extends to transport simulation design and Performance Qualification best practices.

Robert has developed industry-best methodologies for all modalities of product in the biopharma space. He has led successful cold-chain validation efforts for cell and gene therapies, monoclonal antibodies, antibody-drug conjugates, and small molecules in capsules and tablets. His achievements have led to industry recognition with a speaking role at the 2023 Supply Chain and Logistics for Cell Therapies Summit. You can find him speaking at the 2023 ISPE Annual Meeting in October.

Carson Dickey

Engineering Manager

As Engineering Manager, Carson has developed transport validation strategies for over 30+ products. This consists of developing a validation master plan, conducting risk assessments, and developing protocols to demonstrate product robustness and qualification of thermal packaging. This involves designing his own thermal/physical qualification studies, as well as evaluation of manufacturer-conducted qualifications.

Carson works alongside other engineers at Modality Solutions to provide design and validation engineering services by conducting thermal packaging design and qualification for environmentally-sensitive drug products. Carson also serves as a key technical liaison with your development team. He provides assistance with new drug product transport simulation test design, risk assessment, and protocol development. His achievements have industry recognition including a presentation at the ISTA Temp Pack Forum on Applying Heat Transfer Concepts to Evaluate Pre-Qualified Thermal Shippers in the Biopharmaceutical Industry.