My ISPE Annual Meeting Experience, Part 2: Interviews with Mentors

Last issue, Ivana Vukancic wrote about her experiences at the 2019 ISPE Annual Meeting. During that show, she and other members of the Emerging Professionals Committee interviewed their mentors about their experiences at the show.

What is your main goal for attending the 2019 ISPE Annual Meeting?

Ana Collins: From a marketing perspective, our main goal is to showcase our Subject Matter Experts to promote our people and the services that we provide. For this particular conference we were really focused on launching CarTon, which is our new end to end solution for compliance geared toward cell and gene therapy. That was what pretty much occupied a lot of the planning leading up to ISPE and certainly during ISPE.

Dave Goswami: The main goal for attending the ISPE conference really is three-fold. One for IPS is to network, also to showcase where we are today to the others and the third is more personal is to learn what’s new. So those are the two reasons, but my personal is more of trying to see where the industry is headed and what’s new. For IPS it would be networking and also to let other clients, or other people in the industry know where we are today, so we have a booth, we are showcasing where we are, what we are doing. So there are three parts to it.

Dan Leorda: Networking was one of the main goals. The others were also to sit through one of the educational courses that they had, like the Pharma 4.0. I wanted to sit through that, just to understand and get other perspectives, but part of the networking is also discussing with clients; new clients, or existing clients to see some of their challenges currently and see how we can help them.

Jason Collins: The first one was to attend the face to face meeting of the Sterile Products Processing Committee. I was excited to attend that meeting not only to get together with the team because we have monthly calls, but often it’s nice to see everybody face to face at the conference. Also, I knew I was up for election to be the co-chair of the committee so I was looking forward to hopefully gaining that position and I was elected to be co-chair so I was happy about that.

The other reason is generally why I like to attend the conferences in general it’s to see a lot of the learning courses. It’s often an opportunity to get a little bit of insight in different areas in our industry that we don’t have as much experience in, particularly cell and gene therapy.

Mark Butler: At IPS our focus is on the pharmaceutical industry and ISPE is the organization of choice for pharmaceutical engineering. I have been a member of ISPE since 1997 and attend both local events and national events. I am an active ISPE member and volunteer on several COPs and committees. I am helping to organize the ISPE Facilities of the Future conference for the 4th year in a row. For me my main goal in attending is business development and networking with committee members. I have also been a speaker in the past.

What is one thing that captivated you the most at the 2019 ISPE Annual Meeting?

AC: Honestly, I think what captivates me, especially for ISPE, as opposed to INTERPHEX, is the education part of it. ISPE is different because they are tailored to education series and people get their points. I’m always pretty impressed with just how many topics and how many different sub-industries there are within life sciences. I think that cell and gene therapy right now is just so huge in biologics in general, but cell and gene in particular. The new therapies associated with that, to combat some of these illnesses, that’s always very impressive and to get the speakers to talk about that was super amazing.

We’re trying to get a copy of the keynote speaker presentations; hopefully we’ll get it because we would want to show that to our employees. That definitely always captivates me just how much knowledge is out there.

DL: I don’t know if I have one thing, but during the seminar on Pharma 4.0, the way the process was described gave me a different perspective on what it means to the industry and how can we as IPS help. It’s new things, technology and how they are looking at digitalizing all the data that’s being collected, streamlining it because I think we in everyday business we get very busy with more dashboard reporting, a lot more data collection and there is really no need for everything.

DG: That is just personal obviously and that would be that speech, the John Crowley speech. I think most would say that. It was so moving, it just captured the essence. He started by saying that unfortunately you have the politics side, where people are constantly saying that the pharma companies are making profits and they are not thinking about people and then you hear these kind of things and how powerful that could be, right? It was really good.

JC: The one thing coming to mind that captivated me is something that probably surprised me at the same time. Just out of interest I went on one of the tours that’s offered on the last day and it happened to be on a cannabis facility. I went out of curiosity just to see what’s really going on in the industry and I know very little about how they grow the plants and how they process them.

What was surprising to me was to learn about the medical applications that they’re really considering, especially using it as a product to get people off of opioids and the more addictive drugs that are prescribed every day.

Marijuana has such a taboo associated with it, but when you talk to these people who are very serious about its use, not only for recreation but for medical field, that was pretty interesting.

It was also interesting to see some of the similarities in what we do in pharmaceutical facilities. In other words, you can see them trying to do things that we do every day with the facility, to maintain cleanliness and to protect the plants from harmful bacteria or mold. I was surprised how easily we could adapt our knowledge to healing that industry.

MB: I felt the one thing that captivated me at this year’s conference was the heartfelt “Why” Amicus Therapeutics CEO John Crowley presented to the industry his personal story about the drug company he founded to save his children’s lives. Powerful. Emotional. Captivating.

Can you tell me something that you took away from the conference that you would like to share with IPS employees?

AC: Going back to what captivated me around the stories. I think one of the things that we are always challenged that we face to connect what we do, from a design standpoint, from a construction standpoint, to what the project ultimately provides, which is products to help people who are sick, people who are dying. That is always something that is so difficult to put at the forefront of our minds because we are so deadline driven.

We have to do stuff at laser speed and there is so much that gets lost and if we can somehow always be reminded of why we’re doing what we’re doing, I think would help with at least the frustrations that are going on with our day to day projects. That is something I would like to share with the IPS employees; just remember why we’re doing what we’re doing.

DL: I took a tour of the Cannabis facility, which is something I haven’t seen before. That was new and a different type of facility. It is amazing how simplistic the actual facility is from a technology, from a planning perspective and the actual quality of the facility, but on the same token they have not looked at the details that we are looking in Pharma.

That’s something that they haven’t looked at and if that were to become a federal or FDA, there might be some regulations in the future, they would probably have to redo a lot of the work flows that they have in their current facility. Facilities are really bare bones: just growing plants indoors.

DG: This is more on my side, is the reason I go there is to look at what’s going on. The two things that really stood out; one was digitization of EVERYTHING, going digital, rather it’s AI or Pharma 4.0, what that means and a lot of talks about the polarity of digital data as well as data Integrity. But, my main thing is: it is moving to a digital platform, EVERYTHING!

The other part was cell and gene therapy, which is obviously taking over. You can see everything, every talk and where it’s going, so what I want to share to our employees would be, we need to focus on those two areas. We can’t ignore where it’s headed: the digital platform and cell and gene therapy.

JC: After sitting through yet another session with representatives from the different regulatory agencies it has become increasingly apparent that asking regulators for specific guidance, or their interpretation of a guideline in an open forum is not the best use of time. We often criticize the inspectors for not answering the questions directly, but in all fairness, they are never really given enough information to provide a response and it is probably a good thing that they do not provide an answer as it might cause more harm than good if it is taken out of context. The vagueness of the guidelines and the “not answering the questions” actually provides us with a tremendous opportunity. For those brave enough to move away from design which is based on perception, it actually allows us to move the industry forward to new norms which are based on science and the logical mitigation of real risks. I believe the roles should be reversed. Instead of asking the regulators to tell us what to do, we should leverage our knowledge and experience to show them what can be done through the practical application of science and technology.

MB: We serve customers in a volatile market that is transitioning to cell and gene therapy drugs that have the potential to cure not just treat. This emerging C&GT market is under significant pressure to deliver lifesaving drugs to patients faster and cheaper than has been done in the past. This tells me there is a lot of opportunity for IPS to win more market share as long as we can deliver on what the customer need to be done. I would like all IPS employees to know what we do is extremely important and we need to stay customer focused on helping them achieve their goals.