Anthony S. Lubiniecki, ScD, Member, AL Associates LLC, BS Biological Sciences, ScD in Public Health Microbiology, 43 years of industry experience including Genentech, SmithKline Beecham and GlaxoSmithKline, and Centocor/Janssen (18 years at Director/Senior Director level, 21 years at VP level). Member of ICH Q5 Expert Working Group for 14 years. Worked with teams that brought 14 biopharmaceutical and 1 pharmaceutical product to market.