Q&A with Metrics' David Varley - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Q&A with Metrics' David Varley
Varley, director of commercial operations, discusses one-stop shops and timelines.

Pharmaceutical Technology
Volume 34, Issue 7, pp. 74




PharmTech:
What is the biggest industry challenge you're now facing?

Varley:
Our customers want the fastest possible timeline from development to commercial manufacturing. A client might use a powder-in-capsule for first-in-man studies, but it might not be the best dosage form if they want to scale up to commercial quantities quickly. We then have to come up with a dosage form that's scaleable and can move into commercial production. It's a matter of balancing speed with cost and efficiency.

PharmTech:
Do you see a new industry trend emerging?

Varley:
I think most of our customers are looking for a one-stop shop where they can go all the way from development through clinical, scale-up, and registration batches to commercial manufacture. Metrics has a depth of experience, we're in a single facility, and we collaborate with our development colleagues on a regular basis. In fact, I attend development-staff meetings, and they attend the commercial-operations staff meetings. So, we maintain that contact and are involved, to some extent, in each other's operations, so that when projects or products do cross the fence from development to commercial manufacturing, we don't expect any surprises.

PharmTech:
Has your manufacturing department ever influenced how your development department approached a particular project?

Varley:
We do, in fact, get involved in development. If they're looking at a particular formulation that may lead us down a path where we don't think our technology base is as strong, and we have an opportunity to influence it early in the process on the development side, we may influence the final decision. Some of the commercial-operations individuals work on the development side, particularly when we get to a registration-batch issue. Those development scientists also help us with the initial launch batches. We maintain that continuity and keep the scientists involved. That continuity, again, goes a long way toward reducing the number of issues we deal with.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
29%
Attracting a skilled workforce
27%
Obtaining/maintaining adequate financing
13%
Regulatory compliance
31%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Report: Pfizer Makes $101 Billion Offer to AstraZeneca
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Source: Pharmaceutical Technology,
Click here