Pharmacovigilance

Navigating Shifting Requirements and an Explosion of Data in Pharmacovigilance

Sally Amanuel

PrimeVigilance

Clinical Trials

Optimizing Oncology and Rare Disease Clinical Trials by Focusing on Science and Aligning with both Patients and Investigators

Dave Selkirk

Ergomed

FDA Approval

Possible New Hope for Metastatic Cancer Patients: Food and Drug Administration Grants Approval for Clinical Trials For Lamassu's Groundbreaking Cancer Treatment Protocol

Lamassu Biotech

Cell and Gene Therapy Regulatory

Navigating Regulatory Complexity for Cell and Gene Therapies

Natasha Rivas

IND, NDA, and BLA

Building a Regulatory Roadmap for IND, NDA, and BLA

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

mRNA–LNP Manufacturing

The Innovators Bringing Continuous Manufacturing to Lipid Nanoparticles

Antonio Costa, Ph.D.; William Pasek

DIANT Pharma

Nitrosamine Impurities

Addressing the Evolving Nitrosamine Contamination Issue

Olon

Business Leadership

Wheeler Bio Appoints Marc Helouin as Chief Quality and Regulatory Officer

Wheeler Bio

Alternative Excipient

Preparing Today for a Potential Ban on Titanium Dioxide in Pharmaceutical Drug Products

Almut von der Brelie

MilliporeSigma

Continuous Processing

US Food and Drug Administration (FDA) Purchase the LiFT System from DIANT® Pharma INC.

DIANT Pharma

Quality Culture

Does Your Biologics CDMO Truly Have a Culture of Quality?

Joe Payne

Scorpius BioManufacturing

Cultivated Meat

Leveraging Biopharma Sensor Technologies for Cultivated Meat Processes

Giovanni Campolongo

Hamilton

FDA New Drug Approvals

Many First-in-Class Drugs Approved by FDA in 2022, but Overall Approval Numbers Down

Cynthia A. Challener, Ph.D.

Pharma's Almanac

Interchangeable Biosimilars

The Opportunities and Challenges Posed by Biosimilar Interchangeability

Cynthia A. Challener, Ph.D.

Pharma's Almanac

Clinical Trials

Early Reports of Positive Experiences with EMA’s New Clinical Trials Information System

Kieran O’Donnell; Nicola Kidman

Pharmaceutical Consultancy

Staying Ahead of the Curve with Outsourced Program Management

PharmaLex

Controlled Substances in Clinical Trials

Controlled Substances in Clinical Trials: Considerations, Challenges, and Growing Demand

Rich Nelson; John Hufnagel; Rachel Castro

PCI Pharma Services

Overcoming the Challenges of an Ever-changing Biopharma Landscape

Integrity

PLIs

A Strategic Approach to Pre-License Inspections

William Leonardi, Ph.D.

Avid Bioservices

Opioid Conjugate Vaccines

Vaccines Present a Novel Strategy for Opioid Overdose Prevention

Muctarr Sesay, Ph.D.

GBI