ISPE Brings The Power Of Knowledge To Pharma

Todd S: Good morning. Todd and Todd, live from Chicago, Life Science Connect Radio's day four coverage from this great event. Todd, I have been most impressed by our partnership with ISPE. What a great organization. I'm looking forward to this conversation.

Todd Y: I could not agree with you more. I mean, anybody that's promoting the flow of knowledge as much as ISPE does, you've got to admire.

Todd S: We're going to talk to one of their board members. Say hello to Tim Howard, a member of the board and secretary, if I heard that correctly, of ISPE. Tim, welcome to the show.

Tim: Thank you, gentlemen. It's a pleasure to be here.

Todd S: The pleasure's ours, Tim. Thanks for stopping by and joining us. Before we get into our conversation about ISPE, take a quick few seconds and inform the audience a bit about you and your background.

Tim: Sure. I guess I served a little time in the Navy, on nuclear submarines. I have a mechanical engineering degree, got into commissioning and validation in the pharma industry, after my Navy days, and have spent time both with a company called Commissioning Agents and Eli Lilly. I'm currently with Commissioning Agents, and I've been involved with ISPE probably about fifteen years of that time.

Todd S: Outstanding. Todd, are you noticing a theme here? This is our third guy who's served in the Navy.

Todd Y: On nuclear submarines?

Todd S: That must be a prerequisite for the industry. Thank you for your service, by the way. Give us an overview of ISPE. Give us the mission and purpose.

Tim: Our tagline is “Connecting a world of pharmaceutical knowledge,” and that's really what we endeavor to do through many different forms, whether it be training courses, articles in our technical publications, through conferences and providing events so people can network.

When I joined the organization, I found the opportunity to network and meet people was one of the key elements in helping me broaden my industry knowledge. That in and of itself is so undervalued, I think, by people who have not had the opportunity to attend the events that we put on.

Todd S: Tim, you've got a day job, so I imagine like the rest of this, you spend a good bit of time, running around with your hair on fire. Then you still find the time and the motivation to serve as a board member with ISPE. Why?

Tim: Well, first and foremost, I'll say I'm very fortunate to work for a company that allows me the time to make it a priority to support the organization. But what I find is I get out of what I put into the organization two-, threefold. If I invest time in a society initiative, I personally benefit. 

I benefit with professional knowledge that I gain, and I benefit with friendships that I've established through that road. I don't view it as a grind or a burden, it's really a benefit to be able to contribute in that way and reap those benefits from that.

Todd S: Tim, remind me about how long you've been involved with ISPE.

Tim: I've been involved about fifteen years.

Todd S: Fifteen years, that's a lot of time. How has the organization evolved over that time?

Tim: You know, when I first was involved, the key initiative in the organization was really around baseline guidance documents, and engaging with the FDA in establishing some standards around what facilities should look like, and what design criteria should be included as you build facilities.

As we've evolved, and that knowledge has been set, two things have happened. One is what do emerging markets need from us, as an organization? They need a lot of that knowledge. How do we make that knowledge available to them in a vehicle or mechanism that's readily accessible, so they can utilize it?

The second thing is, there's been a big focus on some of the bigger industry initiatives or industry concerns, such as drug shortages, quality metric initiatives that the FDA is very concerned with, and just the quality manufacture of products. It's less about the bricks and mortar and facilities and systems and more about focusing on the quality of the product.

Todd Y: Talk a little bit about the partnership with PMMI. I think it's pretty exciting, personally, but give us some insight into the why behind that.

Tim: Yes. This was something that's relatively new. Obviously this is the first formal show that we've had together. We had a test drive last year, in Las Vegas, where there was a pharma pavilion and ISPE had a presence, but the why is really taking the best of what two organizations have to offer their respective members and multiplying that.

We have some constituents that would have a need for what a trade show like this offers them, that we didn't have in our portfolio. I think PMMI has a need for their constituents to tap into users of equipment, and we certainly have the buyers in the pharma industry that are here at this show.

I think, as we continue this relationship, I think we'll continue to explore ways that the organizations will just add more and more value. But those are the two big holes I think that we fill, with respect to organizations in Year One.

Todd Y: It makes all the sense in the world.

Todd S: Yes, it does. This is day four of the Pharma Expo exhibition. What's your takeaway on it? What's your read on it? Any key takeaways, observations? How are we going to improve in 2015?

Tim: I wear two hats while I'm here. I'm representing ISPE, and I think, from an organization perspective and partnering perspective with PMMI, I think it's been fantastic. We've heard very good feedback from the people that have been in the Pharma Expo hall to be associated with a show of this magnitude. It really adds some credibility to the organization, quite frankly.

As a vendor who's exhibiting in this hall, we've found not only the volume of the traffic but the quality of the traffic and the interest level in the respective vendors to be very good. I think, from both perspectives that I look at this event, it's been a success.

Todd Y: Part of the responsibility of a board member is to look into the future and help build the vision for the organization. Talk a little bit about your vision for ISPE, moving ahead.

Tim: I think we want to continue to anticipate the needs of what our constituents are looking for in the way of knowledge and solutions, and work with regulators to solve what they assess as the issues related to the quality of products. 

We're actively engaged – I mentioned two initiatives earlier in the interview, but the drug shortages initiative is really moving into the next phase of what ISPE will do, and that's starting to come up with real hardcore solutions that companies can implement.

With the metrics initiative, working hand in hand with FDA and other regulatory agencies around the world, it's really to set a common baseline of how do you assess a quality manufacturing operation? 

I think as we drill down into both of those topics, we'll start to find some core knowledge, some core information that we're able to produce, train on, share with people, and ultimately, influence the quality of products and the availability of products worldwide.

Todd S: We are all heading out today and going back into the world. Walk us through some of the activities and initiatives of PMMI over the next six months or so. Anything coming that we ought to be paying attention to?

Tim: Well, I'm keenly aware of the PMMI expo show in Philadelphia early next year. ISPE has got several conferences that we've lined up the first half of next year. We've got an aseptic conference in February, we've got a statistics forum that happens in April, and then a metrics workshop that will happen in April a few weeks after that. Thats one that obviously is very important to us. We've got a lot of work going on behind the scenes with the FDA to make that a success.

Todd S: Alright, Tim, before we let you go, real quickly, walk through how an organization who's currently not a member – how do they do that and cite a couple of benefits.

Tim: Yes. The easiest thing to do, if you're here on site, is stop over at the ISPE pavilion, here on the west hall. There's many people that will help them with that. If not, our website, www.ISPE.org provides a mechanism for people to enroll online. Then, we have local chapters throughout the world, that have representatives that can help people as well, at local events, get enrolled.

Todd S: Alright. Then, I'm going to give you a quick chance to do a quick, 10,000-foot pitch on commissioning agents. What do you do? How do you serve your market?

Tim: We're a technical services provider. Our core competency is commissioning qualification validation of pharmaceutical facilities. We do a range of things, from process validation to tech transfer consulting to design reviews. 

We've even helped companies find facilities, where they're looking for a facility to place a product, providing audit services of third party suppliers, helping with contract manufacturing organization relationships and being their man in the plant to protect their interests, so a range of technical services, everything except actually designing and building the facilities.

Todd S: Where do people get more information about you?>

Tim: We're at www.CommissioningAgents.com.

Todd S: Alright, Tim Howard with Commissioning Agents and a member and board of directors of ISPE, Tim, it was great to have you. Thanks for stopping by and joining us.

Tim: Thank you, gentlemen. My pleasure.

Todd S: The pleasure was ours. Alright, that wraps this segment. This has been Life Science Connect Radio, Todd and Todd signing off from Chicago, our live coverage. We'll be right back.