Featured Covid Fireside Discussion with Pfizer

As Executive Director- DPDD (Head of Nanoparticle Development), Advait Badkar, PhD, is accountable for drug product aspects for all the mRNA/LNP and the nanoparticle-based portfolio. The responsibilities include scientific, technical, strategic, and regulatory leadership of the area as well as specific programs. Dr Badkar is also accountable for establishing internal capabilities and expertise for nanoparticle formulation, process development, scale-up, tech transfer to enable clinical and commercial supplies. In addition to this, there is a focus on externally focused strategic alliances and collaborations. Dr Badkar also continues to lead the Drug Product Design and Development organization within Pfizer’s Biotherapeutics Pharmaceutical Sciences organization focused on identifying and developing drug product to support Pfizer’s entire biotherapeutics portfolio (proteins, monoclonals, vaccines, etc.) that focuses on all things related to Drug Product from the early Research stages up to Licensure including Commercial and Life Cycle Management support. Dr Badkar also has the responsibility of leading, coaching and mentoring the group members and developing an effective succession plan for the department through the recruitment and retention of high caliber colleagues.

David Cirelli is a Senior Director in Pfizer Inc.’s Analytical Research and Development department located in Andover, MA where he leads a group responsible for development and validation of biological and impurity assays for Pfizer’s biotherapeutics and vaccine portfolio.  More recently, Mr Cirelli led the COVID-19 mRNA vaccine (COMIRNATY) analytical team responsible for technical strategy, method development, validation and transfer, product and process characterization, and quality control. Mr Cirelli earned his MS in Quality Assurance & Regulatory Affairs from Temple University, School of Pharmacy and his Bachelor’s degrees in Biology and Exercise Sciences from Gettysburg College.

Paul Rohlfing is Executive Director, Global Regulatory Affairs CMC, Pfizer, accountable for development and implementation of Global Regulatory CMC strategies for initial registration and post-approval maintenance for vaccines and other biologics including more than 9 development programs and 10 licensed products. These include three BLA approvals between June and August 2021 including the mRNA COVID-19 vaccine Comirnaty®, and 20-valent pneumococcal conjugate vaccine PREVNAR 20™. In previous roles, Mr Rohlfing was accountable for developing production process improvements and new applications of technology, as well as transferring technology into production facilities in the US and Europe.  These have included processes for production of the Prevenar 13 Pneumococcal Conjugate vaccine and other vaccines in Pfizer’s historical portfolio and early large-scale application of flexible containers to storage of biologic drug substances. Prior to his current focus on vaccines, he has had a broad  range of experiences over more than 25 years with Pfizer and its predecessor companies, including responsibilities for validation, process troubleshooting, production management, training, and quality assurance; working on both biological and classical pharmaceutical platforms.  Prior to joining Pfizer, Mr Rohlfing worked with Novartis and Allergan. He holds a BS Chemical Engineering degree from the University of Nebraska—Lincoln.