A schedule of events for Protein Aggregation Measurement in Biotherapeutics: Established and Emerging Techniques is provided below for the convenience of conference attendees.

This one-day conference scheduled for Monday, December 5, 2016, will be held at the University of Maryland School of Pharmacy, located at 20 N. Pine Street in Baltimore, Md.

The conference will focus on analytical technologies for protein aggregation, with an emphasis on sub-visible particles. Both established and emerging technologies will be presented and discussed.

For a printable version of the conference agenda, please download this document‌.

8:00-8:30 a.m. Attendee Arrival and Registration
8:30-9:00 a.m.

Welcome and Introduction
Natalie D. Eddington, PhD, FCP, FAAPS
Dean and Professor
University of Maryland School of Pharmacy

Bruce Yu, PhD
Professor of Pharmaceutical Sciences
Director, Bio- and Nano-Technology Center
University of Maryland School of Pharmacy

Ewa Marszal, PhD
Center for Biologics Evaluation and Research
Food and Drug Administration

  Session 1: Overview of Regulatory Challenges and Analytical Technologies
Rukman De Silva, PhD, Chemist, Division of Biotechnology Review and Research IV, FDA/CDER/OPQ/OBP
9:00-9:20 a.m. Scientific and Regulatory Perspectives on Measuring Protein Aggregation of Biotechnology Products
Ashutosh Rao, PhD
Laboratory Chief
Food and Drug Administration
9:20-9:40 a.m. Submicron Particle Characterization and Benchmarking Under Biologics Leadership Group of the IQ Consortium
Mario Hubert, PhD
Principal Scientist
Bristol Myers Squibb
9:40-10:00 a.m. Critical Evaluation of the Emerging Analytical Methods for Characterization of Sub-visible Particles
Atanas Koulov, PhD
Head, Analytical Development & QC
Lonza AG
10:00-10:30 a.m. Panel Discussion
10:30-11:00 a.m. Coffee Break
  Session 2: Applications and Limitations of Common Technologies
Brian Lobo, PhD, Associate Director and Group Leader, Formulation Sciences Department, MedImmune/AstraZeneca
11:00-11:20 a.m. Size Exclusion Chromatography of Biologicals: Truth or Fiction?
Christina Vessely, PhD
Senior Consultant
Biologics Consulting
11:20-11:40 a.m.

Practical Application of Analytical Tools for Characterization of an Impurity-related Particle Formation Mechanism
Jared Bee, PhD
Senior Scientist

11:40-12:00 p.m. Generalized Method for Subvisible Particles Classification and Counting Using Flow Microscopy and Random Forests
Miguel Saggu, PhD
12:00-12:30 p.m. Panel Discussion
12:30-1:30 p.m. Lunch
  Session 3: Optical Techniques -- Counting and Characterization
Dean Ripple, PhD, Leader, Bioprocess Measurements Group, National Institute of Standards and Technology
1:30-1:50 p.m. Holographic Characterization of Protein Aggregates
David Grier, PhD
Director, Center for Soft Matter Research
New York University
1:50-2:10 p.m. Estimation of Protein Aggregate Density Using Sedimentation Combined with Micro-particle Tracking
Richard Cavicchi, PhD
National Institute of Standards and Technology
2:10-2:30 p.m. Achieving Absolute Particle Sizing with Flow Cytometry
Reema Raghavendra, PhD
Scientist II
2:30-3:00 p.m. Panel Discussion
3:00-3:30 p.m. Break
  Session 4: NMR and MS Techniques
Thomas Spitznagel, PhD, Vice President of Development, Macrogenics
3:30-3:50 p.m. Applications of NMR for Assessing the Higher Order Structure of Protein Therapeutics
David Keire, PhD
Acting Laboratory Chief
Office of Pharmaceutical Quality
Center for Drug Evaluation and Research
Food and Drug Administration
3:50-4:10 p.m. Water NMR for Protein Aggregation Characterization
Marc Taraban, PhD
Research Assistant Professor
Department of Pharmaceutical Sciences
University of Maryland School of Pharmacy
4:10-4:30 p.m. Characterization of Aggregation Propensities of Protein Therapeutics by Hydrogen/Deuterium Exchange Mass Spectrometry
Richard Y. Huang, PhD
Research Investigator II
Bristol Myers Squibb
4:30-5:00 p.m. Panel Discussion