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Catherine Shaffer

cathshaffer

Catherine Shaffer is a freelance biotech writer with a background in biochemistry and pharmaceutical research. Having received early training in laboratory wetwork, she transitioned to science communication. She specializes in the biotech industry--where cutting edge science intersects the business world--with the goal of keeping all of its various stakeholders (scientists, investors, patients) informed and up to date on developments in a rapidly shifting landscape. She has covered the industry for more than ten years, writing news and features for science and trade journals.

Recent Articles by Catherine Shaffer

May 13, 2014 by Catherine Shaffer

What Biotech Investors Need to Know About Phase 2 Trials

Phase II is an in-between time in clinical development and results can be difficult to place in context. Investors should take into account factors such as rigor of study design, validation of mechanism or concept, and emerging safety signals.

Apr 21, 2014 by Catherine Shaffer

Biotech Investing 101: What Investors Need to Know About Phase 1 Trials

Early clinical trial results can be tricky to interpret. Phase I studies are designed to assess safety and tolerability, but early signs of therapeutic potential can be difficult to ignore. Here's what to look for in Phase I and how to avoid getting carried away.

Apr 8, 2014 by Catherine Shaffer

Merck Launches Hail Mary Lung Cancer Trial

After a phase 3 failure in non-small cell lung cancer, Merck is pushing ahead with a second phase 3 trial based on promising results in a group of patients within the original trial.

Apr 1, 2014 by Catherine Shaffer

Idera Pharmaceuticals, Inc. Bouncing on Phase 2 Success

Idera's strugging stock was partially redeemed by good Phase II trial results in psoriasis. The moderate efficacy left investors unenthused, but Idera is touting its candidate as more than just another psoriasis drug, but a potential first-in-class contender in cancer and autoimmune disease.

Mar 28, 2014 by Catherine Shaffer

Overall Survival Will Be Critical for Endocyte's Vintafolide

The CHMP decision recommending European approval is great news for Endocyte, but success in the U.S. will require meeting a more stringent standard for efficacy.

Mar 26, 2014 by Catherine Shaffer

Is Idera's Sell-Off Premature?

Idera took a 25 percent stock hit when the FDA approved Celgene's competing psoriasis drug Otezla. But investors who unloaded Idera may regret it if upcoming Phase II results are positive for Idera.

Mar 26, 2014 by Catherine Shaffer

ThromboGenics Plays Long Game for Eye Disease

ThromboGenics's expansion from the small neighborhood of vitreomacular adhesion to the big city of diabetic macular edema is a solid long term strategy for building is pipeline of ophthalmologic drugs.

Mar 14, 2014 by Catherine Shaffer

Is Celldex's Loss Alexion's Gain?

Celldex's potential Soliris-killer bites the dust, leaving Alexion large and in charge in its corner of the complement-mediated rare kidney disease world.

Mar 7, 2014 by Catherine Shaffer

3 Things to Know About Omeros Corporation

Omeros's newest clinical program, OMS721, for thrombotic microangiopathies, together with its lead drug program OMS302 for lens replacement surgery, show a lot of promise and all by themselves would be worth paying attention to. But a peek at Omeros's early stage pipeline shows some potential for pants-wetting excitement.

Mar 3, 2014 by Catherine Shaffer

What This FDA Decision Means for Amarin Investors

Investors barely twitched when Amarin Corp. (NASDAQ: AMRN) announced earlier that the FDA had denied new chemical entity status for Vascepa, its fish oil-based therapy for high triglycerides—and for good reason. Amarin's stock hit bottom hard in October when the EMDAC vote went against the drug, and the biotech's flatlined stock is unlikely to do anything interesting until the outcome of its legal wrangling with the FDA is determined.

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