cGMPs

A Conversation with AAPS executive director John Lisack, Jr.

A PharmaManufacturing.com Exclusive

By Steven E. Kuehn, Editor in Chief

For many attending the American Association of Pharmaceutical Scientists (AAPS) annual meeting in San Antonio November 10-14, the setting was the perfect backdrop for the collaboration and networking of members in pursuit of personal, professional and business goals. With more than 7,500 attending and some 480 exhibitors, the mix of pharmaceutical scientists, technologists, contract manufacturers and other key players created an ideal forum for the exchange of ideas in support of advancing the creation and production of new medicines and therapies. It’s a big tent, but there is one individual who’s got an eye on the entire meeting inside: AAPS executive director John Lisack, Jr., CAE. Pharmaceutical Manufacturing Magazine had a chance to sit down with Lisack and talk to him about some of the broader themes and dynamics of the association and members attending AAPS’s 27th annual meeting.

PhM: I understand your directorship spans 11 years; that coincides to a large extent on the rise of cGMP and the current risk-based drug manufacturing environment. Over time how has this affected the annual meeting and your constituencies?

 John Lisack: “Well, we certainly have become more global in our outreach. I think that's one thing that has strongly impacted the show. And we've become more dynamic in our delivery systems. In other words, we keep on looking at our members to see what they need and how they need it. The electronic world has also enhanced this. We tape some of our sessions here, in particular, our opening, then play it on our web so that people can see it around the world. The size of the show obviously has grown over the years. Our exhibits have grown tremendously. We'll have the equivalent of probably 1,100 10 by 10 booths representing between five and six hundred companies.”

PhM: Certainly impressive, who is coming to AAPS meetings; are you attracting new attendees?

John Lisack: “It is a big show. And we attract people from all over the world. I think it's very fair to say that we are the largest and probably the most successful pharmaceutical sciences conference meeting in the world. I just had a meeting with some scientists and they're interested in partnering with us to bring our science to their country. What we're interested in is ‘what do you need and how do we market to you?’ That is, how do we develop programs that are appropriate to the interests of Chinese scientists, and of course, their culture is really quite different from ours. But we are happy to be working with the Chinese, and individuals from many other nations, and helping them through our programs.

PhM: You mentioned that culturally the Chinese are different. How so?

John Lisack: Their focus is often more medicinal. When I say that, I mean “medicinal” chemistry … we have a broad range of programs and services that we market to our members and to non-members for that matter. We’re reaching out to them and asking: ‘Is there anything in our inventory that would be useful to you?’ In the end, we try to develop partnerships. We've entered into a partnership most recently with the American Foundation for Pharmaceutical Education, but we have worked with FIP and other organizations for years. In fact, we have over 40 international partners.

PhM: That sounds like perfect synergy.

John Lisack: A good marriage at the very least. We're also in the process of developing our own foundation. And many people ask; ‘Well, why would you develop a foundation when you're a non-profit as it is; why create a foundation when you do all that good with what you have?’ – We think this enables us to go above and beyond what our ‘normal’ delivery system would be. In other words, special programs or events or special sponsorships or grants for researching a particular area that may not garner needed support.

PhM: In other words, offer your constituents more than your normal advocacy, collaborative tools and information sharing. Is that fair to say?

John Lisack: Advocacy yes, but to be clear we stay out of the government. No lobbying at all, we're strictly professional, we deal with the sciences and promoting a really noble profession. You're talking about people something like 7,500 people at the 2013 Annual Meeting and Exposition who are interested in improving global health for human kind.

PhM: I think everyone can agree with that; certainly that is one of the industry’s cultural pillars, built on a foundation of good science and methods. There’s certainly a shared passion among your members don’t you agree?

John Lisack: “I’m glad you mentioned that. People who have been involved in the organization remain involved. I came out of a meeting a couple hours ago where the leaders of our foundation were working on developing a business plan. And of the four individuals sitting around the table, three were former presidents of this organization. So it isn't like they became president and then went away. It’s obvious they have a real love for the science and for the organization. That has a little bit to do, I think, with the culture that we've been able to develop. It's a very transparent, very team-oriented culture where we all work together for a common cause were we come together to look at challenges and try to move forward.”

PhM: There's an interesting juxtaposition of manufacturers, pharma scientists, researchers, students and other experts in the various fields attending this year. AAPS is a place where academics and the technocracy are meeting. Would that be fair to say?

John Lisack: Yes, fair enough—we embrace everything from drug discovery and development all the way to manufacturing. And in fact, we have section that deals just with manufacturing, engineering, and science. And we actually worked with another sister organization, the International Society of Pharmaceutical Engineers in previous years. But yes we are very involved with manufacturing, and it's becoming more and more important now that manufacturing capacity is moving overseas.

PhM: Yes, especially in light of the growing complexity of managing global supply chains.

John Lisack: Exactly! How do you ensure the quality globally? We have good relationships with the FDA, which is responsible for the health and welfare of all the products and not just drugs but food as well. [The FDA] is concerned about ‘how do they ensure the quality of drugs?’ The funny part about it is that in countries like China, India and Brazil, places where a lot of the research and manufacturing is taking place, are also the capitals of counterfeit drugs.

PhM: Is that trend impacting your members?

John Lisack: It's a dichotomy in some ways. Over a dinner I spoke to an individual who indicated that because of the difficulties we're facing, his company needed top management to go overseas to oversee operations, to ensure the quality. That is putting pressure on companies to push salaries up to ensure the best talent is available to provide oversight global markets. Salaries and wages are also going up as those economies grow stronger. So now, whereas it was a benefit to manufacture overseas before because of lower wages and low relative risk—the gap is shrinking. It was my friend’s opinion that some of those companies are going to be moving back to the United States with their manufacturing efforts. So that's good news.

PhM: People are competing for access to higher wages jobs and of course the pressure to raise their wages and living standards just like anybody else. Here at the meeting there is active recruiting and career development going on. What do you think the challenges are? Is academia meeting the needs of the Pharma industry? At this point where would you say we are along this continuum?

John Lisack: That's a good question and a great segue for me to get into one of the projects we're working on: our e-learning courses. We found a gap in one of the areas in biotechnology. We brought our top scientists to put together an e-course through which we could fill that gap, that knowledge gap so to speak. Since that time, three more have popped to the surface and a fourth one is on the horizon. AAPS is continually looking at ways to deliver and to bring people together for the exchange of information relative to the development of good and safe and effective drugs in a cost effective way. We have approximately 90 student chapters, 15 of which are international. We are reaching out to young people to hopefully get them engaged so they have access to the knowledge they need to be the most successful scientists. And that's our goal to make people the most successful scientists they can possibly be. So it's an exciting adventure.

PhM: How do you see the mission of AAPS going forward?

John Lisack: I think to continue to do what the existing mission is and that is to provide the conduit for the exchange of information relative to the science and to expand it. What we're finding more and more is that our scientists are no longer necessarily coming from schools of pharmacy which was the usual source. Now we're finding that they’re coming from chemistry, engineering… and biology. So we're reaching out to those schools to try to attract students and to make them aware of the opportunities.

 

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