Large Molecule

Managing Pharmacovigilance Challenges for Biosimilars

Ivana Lisec, MPharm

PrimeVigilance

Regulatory

Adapting Medical Information Services to Japan’s Distinct Needs

Jim Leaver, Ph.D.

PrimeVigilance

Bioassays

State-of-the-Art, Multi-Modality Bioanalysis in Brisbane

Resolian

RNA

Optimized Residual dsRNA Detection for mRNA Therapeutics

Eunseo (Ency) Lee, Ph.D; Namhyun Kim; Hwanjun Yoon, Ph.D.; Sukhwan Kim; Ahyeon Hwang

Samsung Biologics

Bioassays

Developing a Toolbox of Functional Bioassays for Optimizing ADCC

Anke Hartung, Ph.D.,

Tanvex CDMO

Sequence Variants

Accelerating Protein Sequence Variant Analysis

Kyoungmin Lee; Yunjeong Heo; Jongbae Park

Samsung Biologics

Pharmacovigilance

Navigating Shifting Requirements and an Explosion of Data in Pharmacovigilance

Sally Amanuel

PrimeVigilance

Genomics

Integrated Spatial Genomics: Real Potential to Provide Truly Novel Biological Insights

Cynthia A. Challener, Ph.D.

Pharma's Almanac

Chromatography

Navigating HPLC Method Development: Tips for Success

Ransom Jones

Mikart

Failing Fast

Maximizing Resources and Potential for Success by Failing Fast

Nazar Elkarim, Ph.D.

Mikart

Risk Management in mRNA Manufacture

Managing Risk in Cutting-Edge mRNA Therapeutics

Jessica Madigan; Normand Blais

BIOVECTRA

CMC

The Biopharma Industry is Well Prepared for an Overhaul of the Lead-to-Clinic CMC Process for Antibodies

Jesse McCool, Ph.D.; David Schmidt, M.B.A., M.Sc.; Oren Beske, Ph.D.; Stephen Monks, Ph.D.

Wheeler Bio

Bioprocess Analytics

Collaboration is Key to the Development of Effective Bioprocess Analysis Solutions to Address Complex Data Needs

Nick Pittman; Magnus Wetterhall, Ph.D.

Waters Corporation

Preclinical Data

Transforming Drug Development with Frictionless Access to Real-Time Preclinical Data

Mark Mintz; Kristen M. Eisenhauer

Charles River Laboratories

Viral Vector Manufacturing

Considerations in Viral Vector Analytical Development to Enable Smooth Transfer to Quality Control

Chris Berger; Kilian Witzel

Avid Bioservices

Electronic Documentation

Duplicated Document and Data Creation Must Stop!

Remco Munnik

Cell and Gene Therapy Analytics

Accelerating the Development of High-Quality Cell and Gene Therapies with Comprehensive, In-house Analytical Support

Hui Chen, Ph.D.

Porton Advanced Solutions