Issue link: http://www.e-digitaleditions.com/i/793410
14 March 2017 Tablets & Capsules become a commercially viable process. You won't need to change it after successful clinical trials. Locwin: I'd suggest W.E. Deming's advice: "It's not enough to do your best. You first need to learn what to do and then do your best." McCarty: That's a big topic. My pet peeve with CROs/CMOs is a data dump that includes no interpreta- tion. As a client hiring a CRO/CMO, you should expect to receive experimental and/or processing data that shows they made at least some effort to provide an interpretation. Moreton: Understand the big picture. Typically, start- ups focus on first-in-human studies but they need to remember that they have to go on to a clinical Phase 2, etc., and without too much delay. Making decisions based on short-term expediency has led many companies to suffer delays because they have not planned ade- quately for the continuation of the project. We should also look at the rules governing how com- panies operate financially. The current rules mean that companies are too focused on the short term, whereas new drug development is a multi-year undertaking. Even generic drug development takes a couple of years. Tousey: What our industry needs most is tablet-grade ingredients. There are very few ingredients that are truly tablet-grade, and most manufacturers of tablets don't under- stand what they need, so they're not asking for the right thing. Another big misunderstanding is about the nature of tablet ingredients. Some people think if you're only adding a half percent of this or a little bit of that, it shouldn't really make a difference, but it does. That little extra colorant or a little different flavor alters the performance. People should also understand there is no such thing as a perfect blend. There are just too many variables. We can get within a certain range, yes, but that's it, because we're only using a volume and time approach. Q Anything else? A Grenier: Companies must move products to mar- ket more efficiently in order to reduce their development and tech-transfer costs, not necessarily by offshoring but by working better. My clients are making more requests for cost reduction and efficient manufacturing processes. This will be achieved by doing things right, and if it's not done right the first time, then at least minimize the waste of time and resources with better product and process understanding. QbD is one of the great ways to achieve it from early product development stages. Moreton: I believe we're going to see progress in the oral delivery of peptide drugs. Nothing has moved beyond clinical phase 2 so far, and I think this will change. Doing so, however, will require independent approval of new chemical excipients by the FDA, i.e., the approval of the excipient would not be solely part of the drug product NDA approval. Progress has been slow. T&C Anthony Grenier, Montreal, QC Canada. Tel. 438 738 7959 Website: www.anthonygrenier.com Healthcare Science Advisors, Portsmouth, NH. Tel. 603 397 7304 IntraTab Labs, Miami, FL. Tel. 305 887 9220 Website: www.intratablabs.com FinnBrit Consulting, Waltham, MA. Tel. 781 894 2572 Website: www.finnbrit.com Techceuticals, Cleveland, OH. Tel. 843 540 1239 Website: www.techceuticals.com Allendale, New Jersey Óä£ÈÓnÓääÊUÊÜÜÜ°À>iiÀÕðV `Ài°*iÌÀVJÀ>iiÀÕðV For 35 YEARS the pharmaceutical industry has relied upon ÀBiÀ to de-dust, de-burr and convey tablets with the highest efficiency. To learn more about how to *,"6 the EFFICIENCY of your tableting lines contact Kraemer U.S. Tablet de-dusting solutions from the Global Leader