Your Drug Target Audience

Your Drug Target Audience Whether drug companies like it or not, the FDA is pushing patient-reported outcomes in trials. So what are they good for? By Ed Silverman ARTICLE EXTRAS Putting It All Together Bruce Montgomery remembers the moment he came faceto-face with a quality-of-life issue. It was the summer of 2004, and he had traveled to Maryland to meet with staffers at the Food and Drug Administration to discuss an inhaled antibiotic, which his company

| 10 min read

Register for free to listen to this article
Listen with Speechify
0:00
10:00
Share

By Ed Silverman

Putting It All Together

Bruce Montgomery remembers the moment he came faceto-face with a quality-of-life issue. It was the summer of 2004, and he had traveled to Maryland to meet with staffers at the Food and Drug Administration to discuss an inhaled antibiotic, which his company, Corus Pharma, was testing for cystic fibrosis. He was optimistic that the medication would eventually pass muster with the agency, given that Phase II results looked promising.

Then, officials threw him a curveball. "They looked at me and specifically said they wanted a questionnaire showing patient-reported outcomes for respiratory symptoms for Phase III," says Montgomery, who founded Corus in 2001 and later sold it to Gilead Sciences, the Foster City, Calif., biotech where he now works as senior vice president and head of respiratory therapeutics. "I took a deep breath and said, 'okay, let's see if this could be done.'"

Although ...

Interested in reading more?

Become a Member of

The Scientist Logo
Receive full access to digital editions of The Scientist, as well as TS Digest, feature stories, more than 35 years of archives, and much more!
Already a member? Login Here

Keywords

Meet the Author

  • Ed Silverman

    This person does not yet have a bio.

Published In

Share
3D illustration of a gold lipid nanoparticle with pink nucleic acid inside of it. Purple and teal spikes stick out from the lipid bilayer representing polyethylene glycol.
February 2025, Issue 1

A Nanoparticle Delivery System for Gene Therapy

A reimagined lipid vehicle for nucleic acids could overcome the limitations of current vectors.

View this Issue
Considerations for Cell-Based Assays in Immuno-Oncology Research

Considerations for Cell-Based Assays in Immuno-Oncology Research

Lonza
An illustration of animal and tree silhouettes.

From Water Bears to Grizzly Bears: Unusual Animal Models

Taconic Biosciences
Sex Differences in Neurological Research

Sex Differences in Neurological Research

bit.bio logo
New Frontiers in Vaccine Development

New Frontiers in Vaccine Development

Sino

Products

Tecan Logo

Tecan introduces Veya: bringing digital, scalable automation to labs worldwide

Explore a Concise Guide to Optimizing Viral Transduction

A Visual Guide to Lentiviral Gene Delivery

Takara Bio
Inventia Life Science

Inventia Life Science Launches RASTRUM™ Allegro to Revolutionize High-Throughput 3D Cell Culture for Drug Discovery and Disease Research

An illustration of differently shaped viruses.

Detecting Novel Viruses Using a Comprehensive Enrichment Panel

Twist Bio