Paul Thomas from pharmamanufacturing has submitted a list of what 13 “experts” believe to be occurring during 2012.  Take a look at these to determine if you concur, disagree or have other thoughts to add.

What Can Pharma Expect in 2012? The Glass is Half Full (and Half Empty)

Submitted by pharmamanufacturing on Thu, 01/05/2012 – 18:29.

Opinions are like noses . . . everybody’s got one. (That’s the polite version of the maxim, of course.) Never has this been more true than about what to expect in pharma and the life sciences for 2012. We’ve been trolling the blogs and media outlets, and here is what 13 “experts” are saying about the coming year:

Forbes’ Matthew Herper sees five key trends shaping biotech and medicine in 2012, including the continued rise of costly “super drugs.”

On Beaker’s Blog, Jeffery Clark predicts the “Great Slimdown of 2012,” in which companies become smaller, faster, and “swing for hits, not home runs.”

Life Sci VC’s Bruce Booth says the glass is half full for our industry in 2012, especially in terms of a healthy amount of venture capital for startups that need it. predicts more “hard times before the harvest” in 2012.

The Philadelphia Inquirer’s oft-critical Daniel Hoffman looks ahead with trepidation: “While 2012 may hold some bright spots for pharma, it will also contain its share of setbacks and people who continue to act as if it was still 1994 or even 1984.”

The perspective from PhRMA’s John Castellani is, not surprisingly, rosy: “We have the science to propel medical care to previously unfathomable levels of targeted care.”

Sparta Systems’ KR Karu is optimistic about regulatory matters, noting that many key “regulatory walls are falling down” to allow the industry to move forward.

On Compliance Zen, John Avellanet looks ahead at what to expect from FDA in 2012, and the outlook is not optimistic: “Expect Republicans in Congress to try to make the most of any FDA missteps. This will act as a drag on agency momentum and further drive downward agency morale . . . Sadly, this will result in more retirements from the agency, continuing the loss of institutional knowledge.”

The QA Pharm offers up its resolutions for QA professionals to adhere to. Here is #2: “I will find my voice and speak up when I see unacceptable quality and regulatory compliance risks. I may need personal coaching on how to deliver negative messages, but I will not stop going up the chain of command until I am satisfied that reasonable action has been taken.”

Consultant Ali Afnan contemplates what the Quality by Design movement needs for 2012: “Should QbD be mandatory? I believe it always has been and will continue to be so.”

FierceBiotech notes how 2012 will reveal whether Eli Lilly’s decision to, for the most part, buck the M&A trend sweeping the industry was the right thing to do and will serve as a test case for other major manufacturers.

Consultant Barry Friedman offers an overview of recent FDA 483 letters and anticipates an increased scrutiny of aseptic processing facilities.

And, finally, Rushworth Kidder, editor of Ethics Newsline, reminds us that, whatever they are, it’s important to have resolutions for each new year. One of his? To “see sharp-edged distinctions despite the world’s blur.”

My prediction for 2012? Few dull moments.

Happy New Year!

–Paul Thomas

About Barry A. Friedman, PhD LLC

Regulatory Compliance, Expert Witness, Pharmaceuticals, Biotechnology, Aseptic Processing, GMP, GLP, Quality Control, Positron Emission Tomography (PET), Microbiology, Process Validation, Validation of Analytical and Microbiological Methods
This entry was posted in FDA Compliance, Regulatory Compliance and tagged , , , , , , . Bookmark the permalink.

Leave a Reply

Fill in your details below or click an icon to log in: Logo

You are commenting using your account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s