2024 PDA Surfactants in Biopharmaceuticals Webinar

Featured Presenters

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  John Carpenter, PhD

  University of Colorado School of Pharmacy

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  John Carpenter, PhD

  University of Colorado School of Pharmacy

  John F. Carpenter, Ph.D. is Professor of Pharmaceutical Sciences at the University of Colorado School of Pharmacy, and a Co-Founder and Co-Director of the University of Colorado Center for Pharmaceutical Biotechnology. His research interests include mechanisms for protein degradation and stabilization in pharmaceutical formulations, during bioprocessing and in delivery systems. Also, he has worked for several years to define rational strategies for stabilizing proteins and vaccines during freeze-drying and storage in the dried solid. He has published more than 250 peer-reviewed papers and is an inventor on 30 issued patents. He is Editor for Reviews and Commentaries for Journal of Pharmaceutical Sciences. He serves on the Editorial Advisory Boards for Pharmaceutical Research, The AAPS Journal, Journal of Pharmaceutical Sciences, Current Pharmaceutical Biotechnology, Molecular Pharmaceutics and BioPharm International. He has received several teaching awards and The Ebert Prize. He is a Fellow of the American Association for Advancement of Science and the American Association of Pharmaceutical Scientists (AAPS) and has received the AAPS Research Achievement Award in Biotechnology. He also is the Organizer for the Colorado Protein Stability Conferences.
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  Tarik Khan

  Roche

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  Tarik Khan

  Roche

  Tarik Khan is a CMC Strategy Advisor in Pharmaceutical Development at Roche in Basel, Switzerland. He completed his PhD in chemical engineering at The University of Texas at Austin, and postdocs with ETH Zurich and Roche/Uni Basel spanning areas such as surfactants in biologics formulations and protein engineering. He leads the Roche parenteral formulation strategy and interfaces with the discovery teams on API developability assessments. He is also a Technical Development Leader leading a portfolio CMC team.
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  Atanas Koulov

  Clear Solutions Laboratories

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  Atanas Koulov

  Clear Solutions Laboratories

  Atanas is Chief Scientific Officer of Clear Solutions Laboratories, a company specializing in integrated analytical services for particle control in Biopharma. In his 15 years of industry experience (Novartis Biologics, Roche/ Genentech, Lonza and Clear Solutions Labs).

  Atanas has built and led several particle characterization facilities and managed various analytical and QC groups. Prior to co-founding Clear Solutions Laboratories, Atanas established, built up and led the DP Analytical Development & QC Department at Lonza. Throughout his career Atanas has specialized in the area of particle control and characterization and has published more than 50 peer-reviewed papers on these topics.

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  Ashutosh Rao, PhD

  U.S. FDA

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  Ashutosh Rao, PhD

  U.S. FDA

  Dr. Ashutosh Rao is currently a Supervisor in the Office of Biotechnology Products in the Office of Pharmaceutical Quality, CDER, FDA. Dr. Rao received his Ph.D. at the University of Texas M.D. Anderson Cancer Center in 2003. Prior to joining the FDA, Dr. Rao completed a post-doctoral fellowship at the National Cancer Institute. His extensive work and leadership experience includes the regulation of biotechnology product quality and management of a diverse research portfolio on the structure-activity relationship between large proteins and drug quality, safety or efficacy . He has contributed to multiple FDA guidance documents and policy documents, including for analytical method validation and clinically relevant specifications for impurities. He has authored numerous peer-reviewed research articles, including in high-impact journals such as Cell, Nature Reviews and PNAS. Dr. Rao also serves on the editorial board for scientific journals, ICH Expert Working Group for Q1/Q5C, the Chemical Sciences Roundtable of the National Academy of Sciences, as a government liaison to the USP, and has been recognized by national and international awards. 
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  Inn Yuk

  Genentech/Roche

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  Inn Yuk

  Genentech/Roche

  Inn Yuk is a Senior Director in Pharma Technical Development at Genentech in South San Francisco, CA, USA. In her 18+ years in Bioprocessing at Genentech (a member of the Roche group), Inn supported dozens of IND and several BLA submissions. In her global roles at Roche, Inn leads the Particles Center of Excellence and oversees all CMC aspects of a bispecific antibody program. Prior to Genentech, Inn contributed to bioprocess development for vaccines at MedImmune and oncolytic viral vectors at Onyx Pharmaceuticals. Inn completed her B.S. in Chemistry at Caltech and Ph.D. in Chemical Engineering at MIT.

Presenters

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  Roman Mathaes, PhD

  Clear Solutions Laboratories

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  Roman Mathaes, PhD

  Clear Solutions Laboratories

  Roman Mathaes is CEO of Clear Solutions Laboratories. Before that he was Head of Pharmaceutical Services at Lonza Drug Product Services. In this role he was responsible for pre-clinical Drug Product manufacturing for vials, prefilled syringes and ampoules. He also lead the packaging and combination product development department and the lab automation group. Roman joined Lonza from Roche. He is a Pharmacist by training and holds a PhD in Pharmaceutical technology from University of Munich, as well as an MBA.