How To Protect And Secure Pharma Products From End-To-End

At Interphex 2014, Todd and Todd interview Carl Accetura, Director of Life Sciences Applications with Covectra and discuss their unique view on serialization.

Covectra was founded by Dr. David Bayer, a Harvard psychiatrist, who was just shocked at the level of abuse and diversion that was occurring in patient populations of  patients who were in great need, who weren't being served by the products that the pharmaceutical industry was delivering. From there Bayer wanted to create a company that's a multi-layer brand protection solution, which evolved into serialization.

 

Interview transcript:

Todd S:             Good morning. This is Todd and Todd, live in New York, Life Science Connect Radio on location, direct from Interphes day three. Todd, we have an exciting guest up next. I'm looking forward to that conversation, but gosh, so far so good. What a great day so far. I'm learning an awful lot.

Todd Y:             I'll tell you what, I wish we had another fifteen, sixteen days or so, so that we could talk to everybody that's here. We haven't had anything but a fascinating conversation in two days.

Todd S:             I agree with you. Based on our pre-show chat, we need about fifteen to sixteen days to talk to this guy. I'm looking forward to the conversation. Say hello to Carl Accetura. He's a Director of Life Sciences Applications with Covectra. Carl, welcome to the show.

Carl:                Thank you. Glad to be here.

Todd S:             We're glad to have you. Thanks for stopping by and joining us. Carl, before we get into it, take a few quick seconds and tell us a little bit about you and your background.

Carl:                I'm actually learning a lot at this conference, too, and I've been in this business for thirty years. We can always learn some new tricks. I started at Pfizer in March of 1984, exactly thirty years ago, and it's been a long journey. There's been major transformation in this business.

                        I spent my first fifteen years in big pharma, and then I transitioned to small pharma, a totally different life, but we all have to come up with the same solution and the same presentation FDA. When we're dealing with serialization, for example, we've got to do the same things as a small company as we do with a large company.

                        We'll come back to that. I'm an engineer by training, got my MBA, and I found my way into the supply chain which I thought was the great melding of those two areas. I've been in pharmaceutical manufacturing, IT, supply chain, along a long career. A lot of our solutions, going forward, are going to be cross-functional solutions. It's served me well.

Todd S:             I bet. Covecta, give us the 10,000-foot view. What do you and how do you serve your market?

Carl:                Covectra comes at this whole area of serialization from a very different place than the IT companies. It comes at it from multi-layer brand protection. Covectra was founded by Dr. David Bayer, a Harvard psychiatrist, who was just shocked at the level of abuse and diversion that was occurring in patient populations, around opioid addiction, pain management.

                        You had these patients who were in great need, who weren't being served by the products that the pharmaceutical industry was delivering. They came back to that and said, “Let's great a company, and let's create multi-layer brand protection solutions.” As that evolved, it evolved into serialization.

                        Serialization became the hot button for all of us. I was working on RFID and serialization pilots back in 2005, but Covectra came at it from this perspective of how do we protect the product? How do we secure it? Serialization becomes then an enabling technology.

                        What Covectra focuses on is working closely with the client, working with CMOs and CPOs, Contract Packaging Organizations, to create value-added solutions, and really, end-to-end solutions. That's the challenge of serialization.

                        It cuts across a multitude of functions. It could be led by the packaging department, it could be led by the automation department, it could be led by the IT department, it could be led by the supply chain, but all of them are going to be players. They're all going to come to that team, and what do they generally want?

                        They want somebody who's got the expertise who can come in and help deliver a turnkey solution. That's where Covectra plays, particularly in some of these special markets like pain management, opioid addiction, where controlled substances may be a special case that have to be dealt with.

Todd Y:             Carl, let's say I'm leading a serialization implementation team. What things should I be thinking about?

Carl:                Thinking about how to educate your own team. Get them out, see what's available, what the enabling technologies are that they could utilize, and then think about deployment paths. Those deployment paths within the company are going to require this cross-functional meshing.

                        I would say that's very different in a big pharma company. It becomes a major enterprise. You could have multiple work streams going in a big pharma company, but those have to be brought together, so you really need a significant project management effort in the big pharma.

                        When you get down into mid- and small size pharma – and I've been in the smallest, ten people in a company. We can get the whole team in a room at one time and make decisions very fast, and it's a lot easier, but we don't have the resources. There, we need to be thinking about who are the players, how can we go out, how can we find somebody who can create a turnkey solution?

Todd Y:             Let's talk about contract packaging organizations. What should they be thinking about? What's some advice you can share there?

Carl:                This is a great part. I wanted to do this talk on Thursday, because I wanted to walk before I talked to some of the CMOs. What you find is they're all struggling, because their business is client-driven. Until the clients come to them and ask for a solution, they don't have the ability to create one solution for all.

                        They're trying to listen to the customers to find what they want, and then be prepared to start delivering. What I would say to them is think about your strategy. What is your client base? What do you expect them to need? Listen to them, survey them, find out what their needs are, and then create options for them.

                        Covectra is not the be-all and end-all in serialization, but in certain areas, we are the best. We could deliver end-to-end, value-added solutions. In other cases, a large pharma company may come in with their own solution, and the CMO has to be able to adapt to that, and integrate that into their operations.

                        They are going to have be nimble, they are going to have set up their own expert teams. One of my partners in this business, on the contract packaging side, has set up an internal group. That group is expanding.

                        They're hiring as fast as they can, and we're all challenged to grab the same resources. That's a dynamic, too, is the CMOs are going to have to get their strategy in place, think about their options, think about who they need to hire and bring internally to support their clients. It's a challenging time.

Todd Y:             I can see a challenging time. What are the blind spots, the common blind spots, when you're looking at a manufacturer, be they small or medium or large? Are there common things that folks are just not thinking about as much as they should?

Carl:                The first blind spot would be the timeline. A presumption that, because of federal legislation, doesn't require full implementation until November of 2017, one could think – I actually had a – we're in March Madness season. I met a client and he's talking about this and he says, “Well, Carl, the full court press is off.”

                        I said, “It's 40 minutes of basketball here.” Even if the full court press is off, you'd better be ready to play two halves of basketball. You'd better get your game together. You'd better be practicing, and you'd better bring five starters and you'd better have a bench, or you're not going to survive in this tournament.

                        I think time, and then it's those resources. Where are you going to get the resources? Are you going to educate your own people internally and bring them up to speed? You've always got to do that, but where can you find external resources to bring in? With the expertise that can jumpstart your activity. As we said, for some of the small or mid-sized, that's probably going to mean looking for the best and getting a turnkey solution.

Todd Y:             You talked about external resources, go get them – are they there? Are there enough external resources with the knowledge available, or do I really need to focus more on growing my own knowledge?

Carl:                I think, particularly big pharma, they're going to have to grow their own and they're good at that. They've got training departments. They've got to come up to speed fast. I thought about, before I joined Covectra, doing this on a consulting basis.

                        I said, “Boy, I could probably make a lot of money,” but the ability to impact through a company like Covectra, for me, was greater. But even at Covectra, we're thinking day to day, where do we add to our resources? That's a lot of time about who you know, what you know. I think there's going to be a big push in the next, a lot of education, a lot of training.

Todd S:             Carl, you've been a keen observer of the marketplace now for a handful of years. You've been walking the hallowed halls of Interphes, observing what people are doing and thinking and implementing. If you could expand the thinking of your colleagues and your peers in a general direction, what would that be?

Carl:                It's don't think of this as a compliance program that you're going to implement that is going to somehow come off the shelf. I go back to 2008, when California pedigree was beginning to scare people. What did the people here at Interphes – on the other side of the hall, at Interphes in those years, there was the e-pedigree solution showcases, right?

                        Everybody, it's like, “We've got the California readiness package for you.” It was trying to cobble some things together, but then say to the client base, the manufacturers, “We've got a solution for you.” Do not think that there's going to be a solution, because what you'll face is you'll be the round hole and they'll be putting a square peg in you.

                        You've got to think about what are my real needs? As you do that, you can go beyond this narrow view of complying with a mandate and start thinking about if you can serialize your product into the marketplace, how can you do business differently? How can you change some of your business process to your advantage?

                        One example that I always come back to, and I'll beat up today, is the point of return. We as pharmaceutical manufacturers take back returns all the time. When a product goes off-patent, everybody clears out their stock and sends it back. Counterfeit product, illicit product, one of the major pharmaceutical companies had bottles filled with TicTacs that were returned.

                        Now you start thinking about a different world where you've got serialized product that you can actually authenticate and verify when these returns are coming back. But you can do that on a day to day basis then, and you can start taking out one flow of counterfeit goods into the supply chain. Stop at the point of return, and we can do that.

                        Forget about the mandate. Forget about 2017. Get your plant equipped, serialized, and when you ship product out, it'll be serialized out there and you can authenticate every return that comes back on that. We're all going to find out. Dirk Rogers at RX Trace has already found out, looking at these things, how significant the amount of counterfeit or illicit good that wind their way back into the returns process.

                        Ron Guido was on your show earlier. Ron talks about the treacherous pathways that are out there. If we think about serialization, instead thinking about, “How do we comply with this law?” think about how we change our business to have a more secure product in the marketplace.

                        We'll meet the mandate. Actually, the mandates are going to be the easy part. The harder part is going to be challenging ourselves across those functions of the business to say, “Where can we get some return?”

Todd Y:             Carl, no small amount of time and effort and money goes into attending Interphes and being here. Why are you here?

Carl:                I never miss it. I took a few years off. I was working on some other projects. I took a few years off, and when I came back – it's the energy. It's the buzz. I was actually at [INAUDIBLE 00:11:12] last week, so [INAUDIBLE 00:11:15]'s a little more API-focused on the pharma side.

                        Tremendous energy and buzz at Interphes. You can learn so much here in three days that you would kill yourself, trying to fly around to all the different sites and meet all the people that you see here.

Todd S:             Carl, I hate to say it, but we're about out of time. Before we let you go, how can people get in touch with you and where can they learn more about Covectra?

Carl:                Our website is www.Covectra.com, and I am available anytime to work with people. I'm from the life sciences. Think about application.

Todd S:             Carl Accetura, director of life sciences applications with Covectra, Carl, it was great to have you. Thanks for stopping by and joining us.

Carl:                Absolutely. Just tell people, “Don't wait for 2017. Get ahead of it.”

Todd Y:             I hear you. Timeline, timeline.

Todd S:             Alright, that wraps this broadcast on behalf of our guest, Carl Accetura, my co-host, Todd Youngblood, I'm Todd Schnick, Life Science Connect Radio's live coverage at Interphes. We'll be right back.