The Waterside Conference

Speakers

  • Karin Gedda

    Head of Gothenburg Biobank, BioSamples, Precision Medicine and Biosamples, Oncology R&D

    AstraZeneca AB

    Biobanking — from Primary Cells to Clinical Trial Samples

  • Stefan Yohe, PhD

    Principal Material Science Engineer, Pharma Technical Innovation

    Genentech, a Member of the Roche Group

    Enhancing the Visible Particle Control Strategy through Raw Material Understanding and Controls

  • Christine Elizabeth Coffman

    Senior Associate I

    Biogen

    Rapid Identification of Raw Materials for Release in GMP Manufacturing

  • Andy Bailey, PhD

    CEO / Operations Director

    ViruSure GmbH

    Understanding and Controlling TSE Risk: The Value of TSE Clearance Studies

  • Tenneille Ludwig, PhD

    Director - WiCell Stem Cell Bank

    WiCell Research Institute

    Characterization of Human Pluripotent Stem Cells: Standards vs. Practices

  • Jim Vaught, PhD

    Editor-in-Chief

    Biopreservation and Biobanking

    Biobanking During the COVID-19 Pandemic

  • Ting Wang, PhD

    Principal Engineer

    Amgen Inc.

    Application of Data Analytics to Enhance Raw Material Understanding and Control — Framework, Progress, and Lessons Learned

  • Christopher Korch, PhD

    Assistant Clinical Professor, Medicine-Medical Oncology, Anschutz Medical Campus

    University of Colorado School of Medicine

    Imposter Cell Lines — A Continuing Threat to the Validity of Biomedical Research

  • Nathan E. Lewis, PhD

    Associate Professor of Pediatrics and Bioengineering

    University of California, San Diego

    Enhancing Product Quality Through CHO Cell Engineering

  • Ewelina Flamm

    Associate Director, Engineering, Raw Material Center of Excellence

    Merck & Co., Inc.

    Raw Materials: Considerations of Risk (from Development to Commercial) and Forays Into the Digital Age

  • Arifa S. Khan, PhD

    Principal Investigator/Supervisory Microbiologist, Office of Vaccines Research and Review

    FDA CBER

    Updates on Using NGS for Adventitious Virus Detection in Biologics

  • Marian L. McKee, PhD

    Vice President, Biosafety

    Eurofins Lancaster Laboratories, Inc.

    Characterization and Safety Testing Considerations for Viral Vectors

  • Harika Vemula, PhD

    Staff Scientist, Cell Culture and Cell Therapy, BioProduction

    Thermo Fisher Scientific

    Data Management Initiative for a Better Perspective on Cell Culture Raw Materials

  • Michael Brewer

    Director, Global Principal Consultant, Regulatory, BioProduction

    Thermo Fisher Scientific

    Application of Rapid Molecular Methods for Monitoring Manufacturing Cell Culture Processes

  • Nathaniel Golden

    Senior Associate Scientist I

    bluebird bio Inc.

    Raw Material Characterization: A Phased-Based Approach to Quality by Design

  • Xiaoxi Wei, PhD

    Founder & CEO

    X-Therma Inc.

    Magic on Ice: Next-Generation DMSO-Free Biopreservation

  • John M. Baust, PhD

    President and Lead Scientist

    CPSI Biotech

    Enhancing Cryopreservation Outcome through Molecular and Device-Based Strategies

  • Raymond Nims, PhD

    Senior Consultant

    RMC Pharmaceutical Solutions, Inc.

    SARS-CoV-2 and Other Emerging Enveloped Viruses: Surface and Hand Hygiene

  • Kelvin G.M. Brockbank, PhD

    CEO

    Tissue Testing Technologies LLC

    Ice-Free Cryopreservation of Large Tissue Samples with Retention of Cell Viability and Biomechanics Functions

  • Quality Control in Large Induced Pluripotent Stem Cell Biobanks

  • Xiaoming "Shawn" He, PhD

    Professor, Fischell Department of Bioengineering

    University of Maryland

    Minimizing DMSO for the Cryopreservation of Induced Pluripotent Stem Cells

  • Afshin Sohrabi, PhD

    Principal Scientist, Head of Near Real-Time Testing Lab, Process Solutions Services

    MilliporeSigma BioReliance® Services

    Assay Development to Assay Validation: A Contract Testing Organization Perspective

  • Allen L. Burgenson

    Global Subject Matter Expert – Testing Solutions

    Lonza Walkersville, Inc.

    Beyond LAL: The Monocyte Activation Test and Non-Endotoxin Pyrogens

  • Philip J. Cross

    President

    Philip J. Cross & Associates, Inc.

    Release of Gene-Modified Cellular Products — Ensuring Safety and Quality

  • Alissa M. Resch, PhD

    Scientific Advisor to the President

    Coriell Institute for Medical Research

    Bioresource Center Biobanking

  • Marcin Łoś, PhD, DSc

    Chief Executive Officer

    Phage Consultants

    Crouching T1, Hidden DE3 — How Lysogeny, Pseudolysogeny, and Hibernation May Camouflage Phages in the Process

  • Troy Bigelow, DVM

    Senior Veterinary Medical Officer

    USDA APHIS

    So You Want to Import an Organism or Vector? The In’s and Out’s

  • Snehal Parikh

    Supplier Collaboration Manager, Global Supplier Quality

    Genentech, a Member of the Roche Group

    Zero Defect: A Continuous Improvement Journey

  • Stephanie Moore, PhD

    Senior Scientist

    Amgen, Inc.

    Implementation of Handheld Raman Spectroscopy for Raw Materials

  • David J. Pasnik, DVM

    Senior Staff Veterinarian, Strategy and Policy

    USDA APHIS

    Animal Byproducts and the Import of Kits and Reagents for Human Testing (Including COVID-19 Testing)

  • Geetha B. Srinivas, DVM, PhD

    Section Head, Virology, Center for Veterinary Biologics

    USDA APHIS

    Ingredients of Animal Origin: What is Expected to Ensure Purity for Use in Biologics

  • Marlin Frechette

    Chief Quality & Compliance Officer

    FUJIFILM Irvine Scientific, Inc.

    Controlling Raw Material Variability in Cell Culture Media

  • Tom Millner

    Senior Technical Sales Representative

    Lighthouse Instruments