Gene Therapy

Gene Therapy at a Crossroads: What the Sarepta Crisis Reveals — and What Comes Next

David Alvaro, Ph.D.; April Stanley, MS MBA; Sophie Lutter, Ph.D.

Pharma's Almanac

Legislation

Pharma and Biopharma Outsourcing Association on Advocating for CDMOs

Gil Roth

PBOA - Pharma and Biopharma Outsourcing Association

Rare Disease Equity

Advancing Equity in Rare Disease Trials: Global Realities, Local Solutions

Rose Blackburne, M.D., MBA; Radojica Savic, M.D.; Galina Nesterova, MD

PPD clinical research business of Thermo Fisher Scientific

Australia

Australia as a Strategic Gateway: The Economic and Regulatory Advantages of Clinical Manufacturing Down Under

Mark W. Womack; Jan Bekker; Melissa El Khouri

BioCina

Gene Editing

What are the key ethical and regulatory considerations as gene editing technologies advance toward widespread clinical use?

Pharma's Almanac

Inclusive Trials

Inclusive Trials Are Better Trials: Why Women’s Health Can’t Be a Footnote Anymore

Emilee Kudla

Pharma's Almanac

Sex Differences

Half the Data, Half the Science: The Cost of Ignoring Sex Differences in Preclinical Research

David Alvaro, Ph.D.

Pharma's Almanac

DSCSA

Understanding the Drug Supply Chain Security Act

Leandro Moreira

Frontier Scientific Solutions

Food Dyes

What’s Really in Your Rainbow Cereal? The Truth About Synthetic Food Dyes and Why They’re (Finally) Getting the Boot

Emilee Kudla

Pharma's Almanac

Animal Testing

The End of an Era: What the FDA's Move Away from Animal Testing Means for Biopharma

Daniel Smith, Ph.D.

Nice Consulting

RNA

Is mRNA a Gene Therapy? Unpacking the Evolving Regulatory Debate

Cynthia A. Challener, Ph.D.; April Stanley, MS MBA

Pharma's Almanac

Drug Approvals

How can the industry balance the need for faster drug approvals with the necessity of ensuring patient safety and efficacy?

Pharma's Almanac

Global Trials

Clinical Trials Without Borders: The Evolution of Global Drug Development

David Alvaro, Ph.D.

Pharma's Almanac

Advocacy

From Patients to Partners: The Rising Power of Advocacy in Drug Development

David Alvaro, Ph.D.

Pharma's Almanac

Accelerated Approval

30 Years of Accelerated Approvals: Fast-Tracking Innovation in Drug Development

Cynthia A. Challener, Ph.D.

Pharma's Almanac

Orphan Drugs

From Market Failures to Lifesaving Innovations: The Evolution of Orphan Drugs

Cynthia A. Challener, Ph.D.

Pharma's Almanac