7 Reasons to Hire Regulatory Consultants

by

“Why should I hire a consulting firm? I can just do it myself!” This statement is often made without a complete understanding of the real value provided by Regulatory Drug Development Consultants (RDDC). An effective consulting firm is there to supplement your business proceedings, never to imply that they know better than you do. In fact, there are a number of misconceptions that exist so let’s re-evaluate some of the often forgotten facts relating to effective regulatory drug development consultants. RDDCs have deep industry expertise. Consultants have the rare privilege of working with a plethora of different companies on a Read More

Bill Buckner’s Encore: When a Miscalculation Decides the Outcome

by

Bill Buckner Revisited: When an Error Decides the Game (When a Decision Decides the Outcome) Beginning with spring training through the dog days of summer to the stretch drive, after eight months of baseball, the Astros and Dodgers are putting their mark on the 2017 World Series. One lesson of the postseason however may be miscalculation in the field. The ball that trickled through Bill Buckner’s legs in Game 6 of the 1986 World Series between the Boston Red Sox and New York Mets felt as if it would carry a never-ending stigma, well at least until 2004, when the Read More

12 Reasons You Should Invest in Biotech Consulting

by

Effective usage of biotech consulting allows you to maintain your focus on the pharmaceutical you’re creating. Biotechnology firms are cropping up all over the place, and growing at an unbelievable rate. California alone is home to over 3,000 life sciences companies, employing over 287,000 people[1] and the global industry is expected to be worth $727.1 billion by 2025.[2] One way to ensure you stay ahead of the competition is to truly understand the value provided by biotech consulting. Effective usage of biotech consulting allows you to maintain your focus on the pharmaceutical you’re creating while consultants provide specific and complementary Read More

Breakthrough Therapy Designation Tips: Invest early in impurity control and comparability

by

Drug development has always walked a bit of a tightrope between the need to get safe, efficacious and profitable new products approved and doing so in a way that is both timely and cost effective. When it comes to decisions about investing resources in the drug development process, timing is just as important to ultimate success as it is in investments in the stock market. Invest when there is high risk, at the top of the market, and you are doomed. Pick the turning point at the bottom of the market and you are set for a big profit.   Read More

What The SUPERBOWL Can Teach Us About CMC Strategy?

by

EVER CHANGE YOUR PLAYBOOK IN A CROWDED HUDDLE?   “Clinical Phase Appropriate” assignment of CMC activities can serve as relief from the pressure of limited resources for carrying out your CMC regulatory compliance strategy. Phase Appropriate is defined as “matching the extent of completion for a CMC activity, as well as its timing for completion, to the patient safety risk associated with each clinical development phase.”   What are you trying to accomplish? You may not be trying to win a game, but it’s likely you’re considering how to make decisions to drive development, satisfy commitments with increasing expectations, appease Read More

Let Your Creativity Bubble Up

by

The Primer… For the purposes of my practical explanation, it is necessary to produce an admittedly unbalanced discussion that shortchanges some sections of the Quality modules but that includes considerable discussion of other sections that can largely influence the ultimate success or failure of an application. The Quality Modules 2 and 3 are well defined components of the Common Technical Document (CTD) containing both drug substance (active ingredient) and drug product sections, each containing required presentations of Chemistry, Manufacturing and Controls (CMC) information, covering processes and key control parameters, and various justifications supported by qualification and validation studies. The information Read More

Does Your Program Need A CMC Or CMC Regulatory Expert? Don’t Wait Too Long!

by

When a CMC emergency crops up, you grit your teeth, your blood pressure spikes and you pledge to bear down and make the right decision. And that’s exactly why you might make the wrong decision. In today’s biotech industry, (where MONEY and, TIME, can make you or break you) it can be harder to bounce back. When you get subjective about a tough choice, you’re more likely to make a mistake. An independent CMC expert or team of experts can help take emotion out of your decision-making. They can help you create a budget so you have a better understanding Read More

Traversing the Regulatory Landscape of Combination Products

by

An ice cream shop offers customers the choice of a cup or a cone. It offers a choice of three different flavors: chocolate, vanilla, or strawberry. It also offers three different toppings: sprinkles, nuts, or hot fudge. How many different combinations result from choosing a cone or a cup, one kind of ice cream, and one topping? The concept of the combination product is simple and straightforward. In short, it is a single product consisting of two or more regulated parts, which can be either drugs, devices, or even biological parts. However, it is important to remember that simple concepts Read More

How a falling apple inspired the understanding of gravitational force.

by

Challenges of CMC Development for Emerging Biotech Companies It is one of the most famous anecdotes in the history of science. The young Isaac Newton is sitting in his garden when an apple falls on his head and, in a stroke of brilliant insight, he suddenly comes up with his theory of gravity. The story is almost certainly embellished, both by Newton and the generations of storytellers who came after him. But from today anyone with access to the internet can see for themselves the first-hand account of how a falling apple inspired the understanding of gravitational force. Today, in Read More

Developing the Appropriate CMC Matrix. Part 1: The Role of Time?

by

The Reasoning With venture capitalists and other investors looking to put money into an industry that is unceasingly seeking innovative new products and where small to mid-sized companies compete for their share of the financial pie, the race to show positive clinical results is intense. In an intensely competitive environment, sponsors from small biotech to large pharma are continuously seeking resourceful ways of fast-tracking their development process. Timelines to begin clinical trials are becoming shorter as companies seek conclusive results that would demonstrate or contradict their product’s potential. In order to gain a competitive clinical edge, these companies may look Read More