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Episode #21 - 2024 DIA RIM eBook - Achieving Excellence in Regulatory Information Management
54 Plays9 months ago
Welcome to The Gens & Associates Podcast, where key members of the consulting firm will discuss insights into their research, regulatory trends and hot topics, as well as converse with industry thought leaders.
In this episode, Katherine Yang-Iott is joined by Pat Shafer and Bala Balasubramanian, 2 authors of the newly published DIA RIM eBook. They share how the collaboration between thought leaders in Regulatory and DIA RIM working groups resulted in a rich compilation of ever-expanding and evolving regulatory knowledge captured in the new resource.
Pat Shafer, Managing Director, FTI Consulting, pat.shafer@fticonsulting.com 464-379-8307
"Bala" Balasubramanian, Orion Innovation, vbala@vbinsightsllc.com, 732-890-2443
Be sure to check out Pat and Bala's book, Achieving Excellence in Regulatory Information Management: https://www.amazon.com/Achieving-Excellence-Regulatory-Information-Management-ebook/dp/B0D3JFWX52/?_encoding=UTF8&pd_rd_w=kemSD&content-id=amzn1.sym.f8fbf489-893c-481c-b7fa-18e0b0ecaa0c%3Aamzn1.symc.a68f4ca3-28dc-4388-a2cf-24672c480d8f&pf_rd_p=f8fbf489-893c-481c-b7fa-18e0b0ecaa0c&pf_rd_r=S2CB14A317VYS4V9KB7G&pd_rd_wg=6JJxo&pd_rd_r=d0945e75-767f-4e68-8d7c-8a40faaa9479&ref_=pd_hp_d_atf_ci_mcx_mr_ca_hp_atf_d
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Transcript
Introduction and Guest Welcome
00:00:00
Speaker
Hi, everyone, and welcome to the Gens & Associates podcast. I'm your host, Katherine Young-Aya, consultant and analyst with Gens & Associates. I'm super delighted to welcome two guests for this episode, Pat Shafer and Bala Bala Subramanian. Bala and Pat are two of the authors of the newly released DIA RIM ebook, Achieving Excellence in Regulatory Information Management. Pat Ballo, thank you both for speaking with me on this episode. The two of you are highly sought after SMEs in your fields, especially here against the associates, where we're very familiar with you, right? You have both been um ah participants on many of our events that we've organized, such as being a panelist on our webinars. You've been SMEs at our round table discussions.
00:00:46
Speaker
and other thought leadership pieces as well. But I do believe this is the first time that you've been on our podcast. So welcome. I always like to ask my guests to give a really nice little self introduction to our listening audience. So Pat, let me
Guest Backgrounds and Roles
00:01:01
Speaker
start with you. Can you tell our audience a little bit about yourself and the kind of work that you do? Sure. Thank you, Catherine. I lead our regulatory and quality practice at FTI Consulting. um I've been there for of probably four years now. I've been serving the medical device, pharmaceutical, biotech, and in vitro diagnostic industry for probably well over 30 years and and focused in quality for probably well over 40. So I've been doing this for a while. um Appreciate the opportunity to participate. Thank you.
00:01:36
Speaker
Thank you so much. Ambala, if you could do us the honors as well. and Thank you, Catherine. Again, it's an honor to be part of this podcast along with Pat. um In terms of introduction, I'm heading the Healthcare care Life Census Solutions Practice at Orion Innovation, which is a system integrator based in Edison, New Jersey. I've been in the pharma industry for almost 30 plus years. In fact, I started in 1994 with Roche Pharma. Prior to that, I was a technologist at IBM. It's great to be part of this podcast and looking forward to sharing more about the ebook, which we have launched. Thank you.
00:02:12
Speaker
Great, thank you so much. You guys are seasoned veterans. um Thank you both again. So we are here to talk about this new DIARIM e-book.
Development of the DIA RIM Ebook
00:02:21
Speaker
So let's start from the beginning. I understand this is the third iteration of this publication. um How did the e-book actually get its start? Can you tell me a little bit more about the authors, the RIM working group, and some of the goals and objectives that you're hoping to accomplish with this e-book? Vala, I think you can probably provide us this background. Thank you, Catherine. As you all you as all know, DIA stands for Drug Information Association. It's a 60-year-old organization of ah professionals, non-profit based in Washington, DC area, doing a lot of work in the area of information management ah you know with stakeholders from the industry, from regulators, from vendors, and and so on.
00:03:07
Speaker
And over the years, it's done a lot of work in in actually putting standards and and and reference models together. So the DIA RIM working group was formed originally in 2015, 2016 timeframe, primarily to understand the scope of RIM and also define a standard data model for use by you know vendors as well as sponsors. Over the years, it has grown into three work streams. One is the RIM white paper work stream that's headed by PACT here on the call, RIM reference model, which is headed by me, and there's also the int intelligent automation working group headed by Carrie Smithson. So these three groups have their respective work stream objectives, leads, and members working on various deliverables. All are volunteers of course, spending endless hours over the past many years to share their expertise and also put together best practices for the betterment of the industry, ultimately to benefit patients.
00:04:04
Speaker
So in the 2016 timeframe, Peter Turbic and Sheila Mahoney formed the RIM Working Group and their original intent was to create, ah as I said, a data model as well as white paper. So they called it a RIM Consensus White Paper, which they had started working on, ah but for various reasons, people moved on and and and it was kind of languishing. So myself and Pat kind of took it up and created version 1.0, which is only about 14 pages that was released in January 2019. Subsequently, there was a lot of interest and we decided know that it it definitely needs to be enhanced because, as you know, your group GANS and Associates has a lot of input around what is the scope of RIM and so on. So we decided it should expand on some of those areas. And Pat led the subsequent version, version 2.0, with a number of other authors. And that was released in April of 2021. So that was two years later than the first version.
00:05:03
Speaker
So that was about 45 pages. And as we decided to continue working on it, and as SPAC was leading the efforts with a number of other authors who had joined since then, since 2021, it became clear that it was almost like a 150 page, ah no longer a white paper, but I know it sounded more like a book.
Educational Value of the Ebook
00:05:25
Speaker
So that's when we approached DIA and spoke to the president, Marwan Fatallah, who actually was very encouraging to really create a book and subsequently assigned a team of marketing and learning specialists within the DIA to work with us. And that's the origins of the book, which you see available online through Amazon as a Kindle version or a Kindle version as an ebook as of June of this past ah this year.
00:05:55
Speaker
and And I wanted to jump in, Catherine. One might ask, well, why why do we need 150-page ah treatise on regulatory information management? And and and the reason that Bala and I really embraced the book idea was because the regulatory ecosystem has been growing in complexity. ah There are new technologies. ah artificial intelligence, of course. And then also, um as Genz defines, what is regulatory information management? um that That has grown. it It has grown from simply, ah you know, product registration management and document management to embrace a whole host of capabilities. And so really, the expansion reflected all of these trends, new technologies, new capabilities, and new expectations about what
00:06:51
Speaker
sponsors can get out of a RIM system. Yeah, absolutely. I mean, it sounds like a labor of love. And um and like you said, Pat, you know, I know that you guys will work with Steve Gens, who is the leader here at our firm, um on defining the the scope of what RIM is. And we know that as things evolve, so does that scope, right? um So, what I'm hearing is that this e-book is a collaboration of knowledge that's built by regulatory professionals for regulatory professionals and their stakeholders. um You're starting to speak a little bit more about this already, but why why do you think this is significant? What are some of those complexities or challenges that face our colleagues today, and how does this e-book actually help address some of that? Well, I'll jump in on that. um
00:07:36
Speaker
It is certainly a collaboration by regulatory professionals. There's probably over 20 authors representing ah large pharmaceutical, you know top five pharmaceutical as well as emerging pre-revenue pharmaceuticals and biotechs. So a wide range of professionals as well as those who support those professionals in the consulting world. ah What is significant is that there has not been, and in my opinion, a definitive text to support new people entering the field. And and that can be those who are hired as interns or just out of college joining pharmaceutical companies. And it can also refer to people who are students. ah Several universities now have regulatory ah programs. And it's our hope that this book will not only serve the professionals,
00:08:33
Speaker
um and and raise the level of competency across the industry, but also um prepare students and and new entries into the industry with what is possible within regulatory. Just to add to that, Catherine, but basic I think the to your point about labor of love, right so it it was a collaboration between among maybe 20 plus authors. Each of them were experts in the various fields and the various chapters they were responsible for. That was ah that was a big success, right bringing in the right people to write the content for the right chapters.
00:09:10
Speaker
ah Having said that, the audience is worried, right? It's regulatory has grown into a science, right? There's regulatory intelligence, there's regulatory affairs, there's regulatory operations, so but this is beyond regulatory, right? Because regulatory touches a lot of other functions, clinical safety and so on. So from an audience perspective, we believe that people in other functional areas could also benefit from the book because it touches upon the the use of regulatory information and in other parts of the value chain.
Trends and Challenges in Regulatory Information Management
00:09:38
Speaker
and And then that's key. And to add to Pat's point, the fact that it's also fairly readable and perhaps it could form a text for for students who are in the graduate programs, either in religious affairs or in form D kind of areas.
00:09:54
Speaker
Yeah, i I love that you guys are thinking about it and sort of that aspect right where you are, it's almost like passing on the torch right like how can you, you know, um put together your knowledge but then help others who are sort of um coming along into this really exciting field that's growing right this regulatory science field. um you know when we When we first spoke, I think I spoke with you guys a couple of weeks ago in preparation for this podcast, and you guys joked a little bit about the effort, you know all the blood, sweat, and tears into putting together this e-book, and Bali just mentioned it earlier as well, um you know that you guys are unofficially becoming the keeper of this knowledge, or perhaps more accurately, you're sort of the gatherer of knowledge and resources.
00:10:34
Speaker
And when you are that person, right, are all the authors that are these people, you start to get a better sense of the progress happening around you. So I guess my question is, as industry progresses, what specifically do you see accelerating or will be impacted the most in some of these areas? I see four areas that really jump out at me. oh you know the first Everyone's talking about artificial intelligence or intelligent automation right now, so use of that technology will accelerate. um At the RSIDM conference probably four years ago, just before COVID,
00:11:12
Speaker
There was a lot of speculation that there would be really little use for AI within the industry, ah particularly in regulatory affairs. And at the last conference, ah virtually everyone was talking about how to ah drive benefit out of AI. So I think that's a huge change, very much a a technology change. um I believe more important though, are some of the other changes that are afoot, specifically the beginning of health authority collaboration amongst ah the authorities and the ah opportunity for approvals like the Orbis project or ah Reliance where health authorities come together
00:11:58
Speaker
sponsors can provide a single submission and get multiple reviews concurrent by the health authorities and and ultimately get one approval covering many jurisdictions. that That is a sea change and it's going to be very important for regulatory information management to support these new paradigms of regulatory science. Another big change that I see is the need for ah ROI. We have a number of clients that we've worked with who have been implementing RIM ah with varying degrees of efficiency and success, but all claim that they have had challenges demonstrating the return on investment. And my belief is that they have done a poor job articulating what they're hoping to achieve. So it's very difficult to to achieve a return on investment if you haven't clearly articulated
00:12:48
Speaker
how you hope to achieve that. um And then finally, ah more strategic focus. RIM was developed to identify or address some tactical challenges such as which product to release in which country or when do I need to take action to maintain a ah regulatory license, <unk> etc. And so um what what's going to happen is ah people are going to be looking at speed to market or right product, right country, other more strategic benefits ah out of coming out of their RIM systems.
00:13:24
Speaker
Yeah, so Bella, before I let you sort of comment on maybe some of the things that Pat just said, I just have a couple of, you know, follow up sort of i maybe maybe more reactions, Pat, but, you know, your first two points, the first one being, you know, that everyone is excited about AI and talking about how to really sort of and incorporate that into into their organizations sooner than later. and you know Steve and I talk about this often, right? And it seems like, you know if Steve were here, I think he might say there's a lot of hype around AI um and perhaps Greg Brolin would too. And so I'm just curious, I know the conversations have been getting louder about you know the practical applications of AI, but you know but what do you think? right Do you think this is more hype? Do you think it's it's realistic for the near future? I guess that's one sort of question that I have. And the other one on the return on investment,
00:14:10
Speaker
um That's a really good point. you know We just finished up our 2024 rural classroom study, and you know one of the things that we measure is you know the business benefits realized by companies for um some of these technology-based um investments that they have done over the past couple of years. and And you're right, the return on investment is an interesting area. It's hard to measure when there's no base baseline measure, but there's also a time lapse that needs to happen for um for things to start working the way that they're supposed to, right? Oh, absolutely. Well, let's address your comments in reverse order on the ah ROI. I've seen people express objectives such as, oh, I want to get control of my data.
00:14:59
Speaker
or I want to be able to find stuff and and getting control of data and finding stuff are are abstract compared to I will be able to cut my submission development time by 12 weeks which will deliver a 500 million dollar net present value. If we start defining success in terms of business objectives rather than ah tactical efforts or or tactical achievements, we're going to be better able to measure the value of investment in RIM or any other technology. So ah let's focus on the strategy, not on on the lower level tactics. Secondly, ah going back to your first question around artificial intelligence, there's for all technologies, there is a hype cycle. We're all familiar with Gartner's view of technology.
00:15:54
Speaker
I think there's a lot of excitement about AI right now, but we're very much in the exploratory stages. What will happen though is the technology matures. I think you'll see benefit in multiple areas. A lot of talk around Gen AI and the ability to develop content narrative from facts and and data. My thinking, though, is that as the industry moves from a document paradigm to a data paradigm, that's going to be less important. So it may be that the ah by the time Gen AI is ready for prime time, it's no longer that important. On the other hand, using AI to query, for example, with regulatory intelligence, to query ah all of your health authority correspondence across the globe and be able to
00:16:46
Speaker
output the ideal ah submission in terms of what evidence is required, how long, how much data do you need. um I think there's tremendous potential for AI to accelerate submissions and and bring products to patients that much faster. Yeah, okay. Thank
Importance of Data Governance and AI
00:17:04
Speaker
you. Just just to add to Pat's point around regulatory of becoming more data centric I mean that's been the case of the last 10 plus years I believe regulators are looking for data regulatory function itself is looking for data. So, we I call it the back to the future thing right we went from data to documents now back to data.
00:17:24
Speaker
because data is going to be key for analysis and and so on. So with that said, I think the the need for regulatory information management is a lot more and which which also means ah data quality is important. That means you need to have robust you know data governance programs. And only then you'll have advantages of of using technologies like AI or Gen AI, whatever may be the case. So and the quality of data is still important and people must focus on that. And I'm a pragmatist when it comes to AI, Gen AI. I believe there's a lot of potential, but at the end of the day, at least with the technologies today, there's a lot of human in the loop that's required in order to make sure that the
00:18:09
Speaker
outputs that are generated are valid and verified and explainable to the authorities. i I literally can't say that better myself, Bala, about the importance of data quality and of course data governance to sort of ensure that data quality sustainability, right? That's sort of key. um So let me move on a little bit. So um you I think, I can't remember where I heard this, maybe a little bird told me, but that the DI is developing a course based on the content of this ebook.
DIA Courses and RIM Working Group Involvement
00:18:36
Speaker
um Can you confirm this, deny this? If so, you know how will the content and the curriculum be delivered?
00:18:43
Speaker
I'll jump in on this. So, yes, DIA is thrilled. This is their first e-book and ah there's a tremendous amount of excitement there. DIA also has ah a host of courses and they felt that this information, the the subject of the book would make for an excellent course. So, the plan is currently to develop a series of courses, the first one being a four-hour live slash virtual ah course that Bala, myself and Kerry will be delivering most likely. And that will be the starter, sort of an overview of regulatory information management. And then the plan would be to do deep dives
00:19:35
Speaker
on specific topics, whether it's labeling or regulatory intelligence or any of the other areas covered in the book um as as a follow up. Well, that sounds really exciting. um Ball anything to add? And then if not, I will do a quick recap of this conversation for our listeners. That's good. Pat covered it all. Thank you. Okay, great. So um a quick recap. um So this new version of this ebook was recently just published. um You can access it through um Amazon Kindle, I believe you said Bala. There will be courses um from the DIA to dive into some of this content. um Let's see.
00:20:17
Speaker
But did I leave out anything? um And more importantly, for the people out there listening who want to be more involved with the e-book or the REM working group, what what can they do, guys? Bala, do you want to jump in on this? Yes, yes thank you. ah They could reach out to either of us because we are the two of us and plus a few others are in all the three working groups. ah So i mean they can reach out to us to get involved. Definitely, we need more volunteers and with the RIM Reference Model, which has been a lot of work over the years.
00:20:47
Speaker
It's almost five years now. We hope to have the version 2.0 release in the next couple of months. It's quite a lot of work. It's a handful of volunteers. We definitely need more people to validate what we're doing, even start looking at adoption. We're looking for sponsors, especially drug sponsors, who are either starting the RIM programs or already have RIM programs, but they would like to make things better. It'll be great to kind of do pilots with them, with the reference model itself. and they can reach out to either of us. And of course, the e-book definitely will have you know changes in our versions coming up and people could be involved with it. And so also the intelligent automation working group, we're actually planning to, you know,
00:21:32
Speaker
introduced a survey on AI and GenAI technologies that are currently being used for different use cases and what's the level of adoption and so on. So there's definitely a lot of need for input and volunteers from from the industry, from sponsors, from from system integrators and so on. That's great. Yeah, we have a really sort of robust, you know, an active research community. And I know plenty of people listening are going to be interested in this. You talked about the RIM reference model. So before I can wrap this up, do you want to just say a little bit more about that? You know, we talk about, um you know, how things are moving, you know, back towards being a more data centric model when I think the RIM reference model is, you know, kind of speaks more to that. Would you like to just tell the audience a little bit more?
RIM Reference Model and Podcast Conclusion
00:22:15
Speaker
Great, thank you. Yes, um the reference model is actually a set of, I would say, I wouldn't call it data standards. It's a set of data objects or entities and the relationships and the attributes that define them. I know we have about 55 plus objects that have been defined with various levels of detail. And basically this is the way information within regulatory is captured and managed and and shared with other organizations. So the idea is to create a fairly robust conceptual, what I call an entity relationship model that is available for general purpose use. People can use that as a basis for their requirements, and documents saying that, okay, at a minimum, we'd like ah any of them capability to satisfy this this data requirements, right? um Or people could be using this as a way to map existing data for migration purposes or when they have M&A activities
00:23:13
Speaker
So the idea is to create an interoperable data model that's generic, that's system or vendor agnostic, and that's available for general purpose use, just like other reference models, like the TMF reference model that has been adopted by the industry over the past 10 years. So that's the ultimate goal. We hope to have it released, or version 2.0 released in the next couple of months. Great, amazing. um Thank you both so much for sharing your time with me. This e-book is full of so much useful information for anyone in regulatory or anyone in life sciences in general who wants to learn more about regulatory sciences, right? The materials are a soup they're they're so substantial. um I know that I'm starting to reference some of the things that I've been reading um and the work that I do here at Gens and Associates, um you know the REN reference model you just talked about. I know that there are things in in the e-book about that as well.
00:24:02
Speaker
um So for those who are listening, definitely go check this out. It's a great way to stay up to date on anything room related. um Before I say goodbye to everyone, I'd like to turn this back over to you both for any closing comments. ah Just that, as Bala suggested, there there is opportunity to be involved. This may be the first ebook, but it won't be the last. The industry is changing, so please ah come join us and and take it to the next level. Absolutely. Thank you. Yeah, I second that and definitely there's a lot more work that's that's in the works. So definitely we need help and thank you Catherine for this podcast so that we can spread the word and and hopefully get people engaged more.
00:24:51
Speaker
Yes, let's let's all let's get you some new and new folks for for the groups and for working on this. um Thank you both so much for being here with me. Listeners, if you've heard something today that you have questions or comments about, you can either reach out to me or you can take a look at the contact information on the episode description of your streaming platform. It should contain information specifically about the ebook and where you can find it and also how to connect with Bala and Pat as well. So until next time, guys, cheers.