Authors
Anita Michael is RCA’s Executive Pharma Compliance Expert & Principal Consultant. She has 24+ years of global regulatory and quality experience, including 16 years direct FDA experience operating globally as their Pharmaceutical Expert, FDA Investigator and FDA Pre-Approval Manager. Anita has excellent interpersonal, empathetic communication and client management skills that enable her to skillfully coach and collaborate with clients at the highest levels of an organization and prepare them for successful FDA inspections (ANDA/NDA/BLA/PMA Pre-Approvals) and global regulatory and quality assurance audits across Biotech, Biologics, Sterile Operations, Drug Substances, and 503A/B. She has been Keynote Speaker for the Pharma Industry and internally to the FDA throughout her career.
Eron Kelly is ceo of ConcertAI.
Arianna Melchiori is product specialist, Vial Platform, at Stevanato Group.
Shada Warreth is Global Partnerships Implementation senior manger at NIBRT and PhD Candidate at TU Dublin, Ireland.
With extensive leadership experience in pharmaceutical logistics and advanced therapy supply chains, Marco Hogenboom currently serves as Global Head of Personalized Supply Chain at Cencora’s World Courier. In this role, he focuses on advancing supply chain solutions for advanced therapy medicinal products (ATMPs) while driving operational excellence across the clinical and pharmaceutical sectors. Previously, Hogenboom spent more than nine years at Marken, where he led global business growth initiatives and cross-functional collaboration efforts. His expertise includes strategic planning, budgeting, forecasting, and building high-performing international teams within the life sciences and healthcare industries.
Svyatoslav Borshchenko is CEO and cofounder, GxPilot.
Joe Compton is senior director, Business Development and Alliance Management, TPU (Tjoapack US).
Robert Popilock is strategic marketing manager at DWK Life Sciences LLC, Millville, NJ.
Lauren Schoukroun-Barnes, PhD, is associate manager of Regulatory Affairs, Sia/LBG.
Dr. Theuer is Chief Medical Officer at Halozyme where he is responsible for providing leadership and guidance to Halozyme and its partners/collaborators in subcutaneous drug development with ENHANZE® technology and auto-injectors.
Katie Edgar is chief business officer at KBI Biopharma.
Balasubramanian Venkatakrishnan, PhD, is a staff application scientist at Beckman Coulter Life Sciences and an AAV structural virologist by training.
Dr. Quay has served as Chief Executive Officer, President, and Chairman since founding Atossa Therapeutics in 2009. A specialist in Anatomic Pathology, he completed his residency at Massachusetts General Hospital (Harvard) and served on the faculty at Stanford University School of Medicine. An accomplished innovator, he holds 96 U.S. patents and developed seven FDA-approved pharmaceuticals. He earned an M.D. and Ph.D. from the University of Michigan. His board leadership is rooted in his status as a founder and his role as the principal researcher directing the clinical and regulatory advancement of the company’s pharmaceutical programs.
Lars Hahn is senior vice-president, Global Sales Organization, at Vetter.
Dana Tilley is vice president and general manager, Life Sciences North America, Jacobs.
Riccardo Prete is product manager, Vial Platform, at Stevanato Group.
Giedrius Gasiūnas, PhD, is chief scientific officer at Caszyme.
With over 25 years of experience across general, specialty and precision medicines including biologics, vaccines and over-the-counter medicines, Dr. Juby brings deep clinical insight and a strong commitment to patient-centered innovation.
Shaalan Beg, MD, is chief medical officer, oncology, at ConcertAI.
Jane Zhang, Co-Founder & Co-CEO, ETCH Sourcing
John Muganga is senior manager, Regulatory Affairs at ICON plc.
Matt Cushing, VP of Quality and Science, Nelson Labs.