How to Find the Right CDMO Partner

CMC plays a critical role in the development of a biological product. While it may not be possible for early stage and mid-size biotech companies to have all the necessary CMC resources to steer through the maze and tangle of drug development challenges, there are steps you can take to ensure success. So far, we have covered three essential steps to[…]

The Right Technology – A Critical Element in your CMC Strategy

CMC plays a critical role in the development of a biological product. While it may not be possible for early stage and mid-size biotech companies to have all the necessary CMC resources to steer through the maze and tangle of drug development challenges, there are steps you can take to insure success. So far, we have covered two essential steps to[…]

Steps to Success – Top Ten CMC Strategies for Biotech Companies Part 2

CMC plays a critical role in the development of a biological product. While it may not be possible for early stage and mid-size biotech companies to have all the necessary CMC resources to steer through the maze and tangle of drug development challenges, there are steps you can take to insure success. The first step was covered in our previous blog[…]

Steps to Success – Top Ten CMC Strategies for Biotech Companies

Chemistry, manufacturing, and controls (CMC) plays a critical role in the development of a biological product from the research lab to preclinical to clinical stages and through to drug approval/licensure and commercial manufacturing.  The right CMC strategy and perfect execution are important to the success of drug development in the biotech industry.  In an intensely[…]

Compliance. It’s Never a Problem Until it’s a Problem

  These are the words I often share with clients when talking about compliance problems.  What I mean by, “It’s never a problem, until it’s a problem,” is that: It is difficult to foresee everything when it comes to compliance Most problems will not rear their ugly head until late in the game Don’t try[…]

Shining Light on the Sunshine Act

After the Physician Payment Sunshine Act (PPSA) passed in March 2010, most companies took a “wait-and-see” approach. They planned to wait until they absolutely, positively had to deal with its requirements. And with companies juggling so many priorities, it’s understandable that it would slip to the bottom of the list. The PPSA has now forced[…]

SOP Training for Clinical Research – Can it be Fun?

The mere mention of SOP training can make even the veterans among us shudder. But does it really have to be this way?  Does compliance training really differ from any other training?  Shouldn’t we apply the same principles of instructional design?  Does it always have to be the dull, boring, uninteresting, and monotonous “check here[…]