Real-World Evidence

Overcoming Challenges and Unlocking the Potential of Real-World Evidence

David Alvaro, Ph.D.

Pharma's Almanac

Fermentation

Achieving Scalable and Sustainable Precision Fermentation Using Process Analytical Technology

Charlotte Hughes, Ph.D.

Hamilton

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