Katrina’s Blog™
News and Commentary
on the science and technology of drugs and medical devices, including discovery, development, manufacturing, and regulation.
Regulatory Guidance for Your Rare Disease Therapy
Feb 13, 2024 | Product Development
February is Rare Disease Month because the 29th is the rarest of days. This month prompts a crucial exploration into the challenges of developing therapies for rare diseases. These conditions, often affecting children and encompassing serious or life-threatening...
Katrina’s Reading List – Making the Cut
Jan 23, 2024 | Leadership
Another year, another Katrina's Reading List. For those not yet aware of the fact, reading is my superpower. I read, on average, 65 published books a year (I keep score!) and numerous reports, journal articles, and non-book publications. You’ll find some of this...
Katrina’s Reading List from 2023
Jan 11, 2024 | Leadership
Every year, I put together a reading list of interesting books that have broadened my horizons, covering a range of genres from nonfiction to speculative fiction. This carefully chosen collection represents my varied interests and reminds me of how knowledge and...
Preparing for Strategic Investor and Partner Meetings
Jan 4, 2024 | Product Development
This post explores the art of building investor and partner relationships at conferences like JPM Healthcare. We share insightful strategies for small companies and startups to use these platforms for growth effectively. From aligning your yearly plan with strategic...
Do Value-Based Agreements for New Medicines Work?
Dec 12, 2023 | Product Development
In February 2020, I posted about a value-based agreement (VBA) for Alnylam Pharmaceuticals RNAi treatment for acute hepatic porphyria, a group of rare genetic diseases due to one or more deficiencies in the heme biosynthesis pathway in the liver. [1] I re-shared the...
Categories
Latest Posts
The Importance of Rare Disease Research
Feb 20, 2024 | Product Development
In the U.S., a rare disease or disorder is defined as one that affects fewer than 200,000 persons. Cumulatively, more than 7,000 rare diseases affect more than 30 million Americans. [2] “As many as 95% of rare diseases have no specific treatment or curative options,”...
Regulatory Guidance for Your Rare Disease Therapy
Feb 13, 2024 | Product Development
February is Rare Disease Month because the 29th is the rarest of days. This month prompts a crucial exploration into the challenges of developing therapies for rare diseases. These conditions, often affecting children and encompassing serious or life-threatening...
Katrina’s Reading List – Making the Cut
Jan 23, 2024 | Leadership
Another year, another Katrina's Reading List. For those not yet aware of the fact, reading is my superpower. I read, on average, 65 published books a year (I keep score!) and numerous reports, journal articles, and non-book publications. You’ll find some of this...
Katrina’s Reading List from 2023
Jan 11, 2024 | Leadership
Every year, I put together a reading list of interesting books that have broadened my horizons, covering a range of genres from nonfiction to speculative fiction. This carefully chosen collection represents my varied interests and reminds me of how knowledge and...