Issue link: http://www.e-digitaleditions.com/i/793410
reduce misunderstandings and missteps—lack of bioavail- ability, for example—that lead to failure and delay. It may take up to 2 years to get back on track, and return to clinical Phase 1 studies after an initial bioavailability fail- ure. Most small pharma companies cannot survive such a set back because their financial backers will pull out. Tousey: I was in sales and service and when I'd go to service a tablet press, the formula wouldn't work. So I started understanding more about how products per- form. Now I help people to improve all across the manu- facturing process, not just at the machine. The compa- nies that supply machines are spires of genius, but we cover a full range of equipment. We can put the puzzle pieces together. Otherwise, if you're a manufacturing company, you're really relying on islands of expertise from equipment suppliers. Customers have these great machines but the performance between them—the process—isn't working as well as it could. Who is mak- ing the connection between all those operations? That's a lot of what I'm doing. Q What type of work and projects are most rewarding? A Grenier: The most rewarding projects are the ones where you apply your expertise to help a customer in a field you had never explored before. For example, I have a customer, a biopharmaceutical company, that is developing a bioprocess to produce a lyophilized product as the active ingredient. They have great bioprocessing engineers and can produce the active ingredient up to the early clinical stage. But when it came to making some capsules, they had no clue how. I assisted them by identi- fying the right equipment and partner to do the R&D, and then the transition to clinical. While I have a good background in solid dosage forms from working in the traditional pharmaceutical industry, I would never have dealt with the biotech world if I weren't consulting. The beauty is that I learned a lot about how this live product is made and the way in which their process could impact the powder's physical properties downstream. In another case, a customer turned to me after months of looking for a solution or a manufacturing partner, and I was able to help them. That made a difference; it actually resolved their sourcing issue. Locwin: It's gratifying any time my work impacts how a healthcare or pharma company approaches their strate- gic offerings, how a brand reaches the market, its success with the public, and the numbers of effectively treated patients. Those are the important things. I do enjoy inno- vating behavioral marketing approaches in pharma and healthcare, where we can dramatically influence the pub- lic's perception of healthcare treatments by how we approach the messaging and how we manage the data analysis of social media. McCarty: The most rewarding are projects that solve truly unmet medical needs, smoking cessation therapy, for example. Our sublingual nicotine tablet delivers nicotine rapidly, similar to cigarette smoking and vaping, with a time to maximum plasma concentration—Tmax—in the range of 5 to 14 minutes. About 443,000 people die pre- maturely every year from smoking or exposure to second- hand smoke, and another 8.6 million have serious illnesses caused by smoking. We spend almost $100 billion annu- ally in the US on medical treatment of smoking-associ- ated diseases and about the same—these are estimates— on lost productivity due to smoking. There is a lot of room for improvement with smoking cessation and healthier nicotine alternatives. Gums and lozenges have a Tmax in the range of 40 to 90 minutes, which does not satisfy nicotine cravings. Yet very few new NRTs—nico- tine replacement therapies—have been introduced. We need a faster-acting NRT that resembles the nicotine pharmacokinetics that people get from smoking a ciga- rette, which our product does and is available for licensing worldwide. Moreton: I enjoy all formulation projects and formula- tion development work; problem solving, working with my clients to achieve a successful formulation, be it for clinical use or commercial use. From a professional devel- opment perspective, often the more rewarding projects are the more challenging ones because one learns so much more. For example, working through the interplay between formulation variables and analytical discrepan- cies can be very challenging. Other challenges include the development of dissolution tests for poorly water-sol- uble drug formulations. Tousey: I love seeing the lights go on. It's one of the greatest things about doing training. I've had people stand up and ask "Why did I have to wait 10 years for someone to put all these pieces together for me? I get it now!" I also love solving a problem and solving it quickly. I don't want to camp out at somebody's manufacturing site. It's very unusual for me not to have something wrapped up in a few days. Q If you were king for a day, what changes would you like to see in how your clients operate? A Grenier: My role as a consultant is to adapt to my client's reality and recommend a path forward. But it would help if companies—before outsourcing the devel- opment or manufacture of their product either commer- cially or clinically—would have the end in mind. Risk assessments should be performed diligently. Why off- shore production for an immediate gain in the cost of goods if it results in a need to hire more people for qual- ity or technical oversight? If that infrastructure is already in place that might work, but small pharma companies will face challenges with that model. Similarly, don't allow a contractor to develop a nonvi- able process for your clinical needs, because that will have a severe impact later. It's better to take a bit more time with the right CMO so your Phase 1 work can Tablets & Capsules March 2017 13