IND, NDA, and BLA

Building a Regulatory Roadmap for IND, NDA, and BLA

Rebecca Lamb-Wharton, Ph.D.; Brenda Schlenk, RPh; Mamadou Diallo, PharmD

Nice Insight API Report

Small Molecule API Discovery and Development Trends

April Stanley, MS MBA

mRNA–LNP Manufacturing

The Innovators Bringing Continuous Manufacturing to Lipid Nanoparticles

Antonio Costa, Ph.D.; William Pasek

DIANT Pharma

Radioconjugate development

Expediting Radioimmune Conjugate Pharmaceuticals for First-In-Human Phase 0 Proof-of-Concept Human Studies from Stable Pool

Muctarr Sesay, Ph.D.; Natalia Bourguignon, Ph.D.

GBI

Viral Vectors

A Viral Vector CDMO Vision that Resonates

Drew Brennan; Chris Berger; Elie Hanania, Ph.D.; Dave Ingamells; Rami Barghout, PE

Avid Bioservices

Analytical Method Development

Harnessing Biologic Development Experience in Support of CDMO Clients: Rapid, Effective and Tailored Analytical Method Development

Xuemei Han, Ph.D.

Tanvex CDMO

Clinical Trials Representation

Leveraging Decentralized Clinical Trial Strategies to Reduce Health Care Disparities

Jennifer Urwongse

Commitment to ESG Principles

How can pharmaceutical and biopharmaceutical companies demonstrate their commitment to ESG principles in manufacturing?

Pharma's Almanac

Accelerating Product Development

What strategies are being employed to accelerate product development and commercialization without compromising quality?

Pharma's Almanac

Bispecific Antibodies

Accelerating the Development and Production of High-Quality Bispecific Antibodies

Dongyoung Park

Samsung Biologics

Pediatric Clinical Trials

Pediatric Clinical Trials: Considerations for Enrollment and Retention

Susan McCune, M.D.; Anusha Streubel, M.D.; Elizabeth Donahue

Digital Pathology

Advancing Disease Research and Drug Development on an Enterprise Pathology Software Platform

Nathan Buchbinder

Proscia

Portable CMC

Wheeler Bio Seals Agreement with Charles River to Offer Portable CMC® to Discovery Clients to Accelerate Their Journey to First-in-Human Use

Wheeler Bio

Advanceability

Right from the Start: Designing Advanceable Formulations and Processes at Phase I

Serán Bioscience

3D Printing

Exploring New Possibilities with 3D Printing of Pharmaceuticals

Thomas Kipping, Ph.D.

MilliporeSigma

CDMO - Small Biotech

Cis-Targeted Immunotherapies Need Large CDMO Expertise But Also Flexibility

Julie Trulson, Ph.D.

Tech Transfer

Transparent Communication Supports Tech Transfers Of Cis-targeted Immunotherapies

Julie Trulson, Ph.D.

Biologics Formulation

Successful Formulation Development for Biologics Using a Unique Biophysical Prediction and Screening Platform

Pawel Stanczak, Ph.D.

Tanvex CDMO

Translation

The Translational Index Score: Improving the Entire Drug Development Cycle

Jo Varshney, Ph.D., D.V.M.

Cell-Free

Cell-Free Protein Synthesis Holds Real Potential to Transform Drug Development and Manufacturing

Cynthia A. Challener, Ph.D.

Pharma's Almanac