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Author Archives: Mark Cierpial

RAPS Regulatory Convergence 2017: A Recap

October 11, 2017 | Mark A. Cierpial, PhD, RAC; Principal Regulatory Consultant | Regulatory Affairs

The Regulatory Affairs Professionals Society (RAPS) held another successful annual meeting (or “Regulatory Convergence” as it’s called) last month. This year’s Convergence was held at the Gaylord Resort at National Harbor on the DC Waterfront and offered more than 70 educational sessions presented by over 200 expert speakers from around the world. In addition, 135 companies, offering a wide range of regulatory services and solutions, were in attendance in the exhibit hall.

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RAPS Turns 40 and Holds Successful Annual “Convergence” in San Jose: A Recap

October 12, 2016 | Mark A. Cierpial, PhD, RAC; Principal Regulatory Consultant | Regulatory Affairs

Congratulations to the Regulatory Affairs Professionals Society (RAPS) on turning 40 this year, and for conducting another successful annual meeting (or “Regulatory Convergence” as it’s called) at the end of last month. This year’s Convergence was focused around the theme of innovation, so the location, San Jose, CA, in the heart of Silicon Valley, was the perfect backdrop.

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A Tale of Two Drugs … One with a Golden (aka Pediatric PRV) Ticket

September 9, 2015 | Mark Cierpial, PhD, RAC, Chief Executive Officer | Regulatory Affairs

In a recent post, I provided some background information on FDA Priority Review Vouchers (PRVs) and the steadily increasing sales prices we’ve been seeing for them over the past year. That post ended with a question … How much is one of these so-called “golden tickets,” good for one priority review by the FDA, really worth?

money Taking a new drug or biologic through the development process can take over a decade and cost hundreds of millions of dollars, so being able to start selling your product as soon as possible is obviously desirable.
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FDA Priority Review Vouchers – A Bull Market!

September 2, 2015 | Mark Cierpial, PhD, RAC, Chief Executive Officer | Regulatory Affairs

Given the recent volatility in the Stock Market, here’s another investment opportunity for you … FDA Priority Review Vouchers!

If you had bought one in mid-2014 for a measly $67.5 million you could be asking $350 million or more for it today; a return on investment of over 500% in just over one year. Ask your financial advisor to top that!

So what are Priority Review Vouchers (PRVs) and why does the industry believe they are so valuable?

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Direct-to-Consumer Advertising of Prescription Drugs

August 20, 2015 | Mark Cierpial, PhD, RAC, Chief Executive Officer | Regulatory Affairs

We’ve all seen or heard them – either in popular magazines and newspapers or on television and radio – advertisements directed to us, the consumers of prescription medications.

These so-called direct-to-consumer (DTC) ads have their supporters and opponents.

Some say they provide useful information to consumers, educating us on diseases we may not be aware of and promoting discussions with healthcare professionals. Others say they can easily mislead the general public about the risks of prescription drugs and promote the overuse of the expensive medications that appear in ads.

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