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A New Kind of ECM Conference

February 24, 2015

Now that the hustle of the end of the year is over, I’ve been turning to focus on Doculabs’ track of the DOCUMENT Strategy Forum (DSF), which takes place May 12 through 14 in Greenwich, Connecticut. The DSF has been going on for almost a decade, and it’s become the premier event for leaders and decision-makers in the customer communication management space – i.e. managing all the pieces of communication (e.g. bills, statements, marketing materials) that a financial services or insurance firm issues to customers, as well as all the additional pieces of communication it receives from them (e.g. applications, complaints, completed forms, signature pages).

For DSF 2014, Doculabs was asked to help extend the conference into enterprise content management (ECM) territory, creating sessions focused on the distinctive challenges and opportunities facing ECM practitioners – from building a strategy and forming a program, to transforming content-centric business processes and enforcing compliance. And in doing this, we wanted to leverage real-world practitioners working at actual organizations, rather than industry experts and talking heads (like myself).

In large measure, we were successful last year: We had 90 percent clients, 10 percent talking heads, which turned out well – because when they were freed from the responsibility of doing all the talking, our talking heads complemented the real-world experience of the organizational representatives quite well.

For this year’s forum, we’re continuing with the same formula, but have been able to attract a greater number of high-level client executives to speak about their ECM efforts, most notably Rod Masney from Owens-Illinois and Chris Cotteleer from Schumacher Group. We’ve also recruited a wider range of industries in 2015. The track is still strong in financial services and insurance, of course, but it now also includes Health Care, Life Sciences, Oil and Gas, Utilities, and a range of Manufacturers (food, high-tech, and specialty).

In the coming months, we’ll be posting more in-depth treatments of the sessions we’ve got on tap, as well as bios of the speakers, but if you’d like to read more about the conference, check out the session grid: DOCUMENT Strategy Forum.

And if you’re interested in learning more about attending, here’s a link to the registration page.

We hope to see you all there!

Operational Excellence in Oil and Gas Houston – Post-show Wrap Up

November 5, 2014

It’s been a great week in Houston for the Operational Excellence in Oil and Gas conference. All the sessions were high quality, tons of expertise and real world insights, and the networking and side conversations were fantastic. If you’re involved in O&G operations and missed it, you should definitely plan to make it next year.

Given how valuable I found the show, I wanted to highlight some of the key themes and takeaways that I got from it. So here goes.


I would say that 80% of the sessions discussed the challenge of talent: acquiring it, retaining it, developing it, managing it, utilizing it. There’s a shortage of resources in key roles and functions; resources are often located in one geo but needed in another; resource needs aren’t level, they’re subject to severe peaks and valleys, making resource allocation challenging…especially when oil prices drop or spike sharply; we struggle to attract the best and the brightest and, once we get them, often drive them away through outdated managerial styles and laggard technology. It’s estimated that 40% of the talent in O&G operations will retire out by 2020. Given all the challenges related to talent, how are we as an industry going to deal with that?

And as prevalent as discussions of talent challenges were, there were absolutely no answers at all. It’s clear that everyone is still struggling to figure out how to solve this one–but we better find answers quickly, given how soon 2020 will be upon us.


When asked what our key observations were from the event during the closing session, a 30+ year O&G veteran said that even as recently as five years ago, you wouldn’t have heard a peep about the role of corporate culture in operational excellence, whereas this week, practically every session stressed the importance of culture in achieving operational excellence. Folks came at it from different angles and with different methodologies and frameworks for understanding the role of culture, but no one discounted its importance. And the success stories from real world customers like Hess, Shell, FMC, and Oceaneering offered living proof that without cultural change, all the best practices and word class systems count for very little.


From the opening panel to the closing session, it was apparent that O&G lags other manufacturing sectors in terms of efficiency. Vince Cipresso, who is relatively new to O&G but has spent a long career in manufacturing in industries like electronics, office furniture, automotive, and specialty chemicals, shared his perspective that O&G had a long way to go in using efficiency to drive cost savings, growth, or innovation. More often than not, during boom times, O&G simply throws more money and resources at production; in bust times, they give everyone a 15% – 20% haircut to try to salvage their EPS.

And he wasn’t alone: lots of folks pointed to how, in their experience, O&G could learn a lot from other manufacturing industries, like aerospace, automotive, or specialty chemicals. From my perspective, I couldn’t agree more. The firms I’ve worked with all struggle to deliver even the most basic information management capabilities to their employees, e.g., type in a functional location to a search box and get the latest documents relating to it. In fact, none of the 30+ people in my pre-conference workshop said that their organizations provided this capability, which was pretty telling. Without the ability to reliably deliver up to date asset documentation, key business processes related to asset management are less efficient than they could be, from PM/CM, to inspections and TARs, to regulatory information requests.

Boom and bust

This was a ritual complaint at the event–not surprising given the recent dive in oil prices. When times are good, O&G orgs spend money like it’s going out of style and don’t care about getting efficient…we have tons of cash, so let’s not worry about it; when times are bad, they use short-sighted measures to cut costs that damage their ability to recover from the downturn, e.g., cutting off suppliers, cancelling projects, and instituting across the board budget cuts, rather than being strategic about reducing costs through operational excellence, supply chain discipline, etc. And no one blamed O&G orgs for doing this. After all, we all know that analysts are hounding them over the last few weeks for information on how they’re going to continue to drive shareholder value/EPS despite the drop in oil prices…and a long-term strategy of thoughtful improvements to operations is not an answer that plays well on the street!

Blocking and tackling

We heard about a lot of very futuristic, very cool technologies at the show that enable some pretty amazing capabilities, e.g., real-time performance monitoring and modeling across thousands of assets, solutions that enable document management across the entire asset life cycle, from design and construction, to operation and end of life, etc. But, as valuable as all these solutions are (and as I mentioned above),everyone is still struggling to get the bare bones basics right, i.e., give operations access to the right docs at the right time. Period.

This is a huge problem that needs to be addressed. I’ve seen a variety of research out there, but I think it’s safe to say that TARs and PM/CM account for about a third of the downtime experienced at any given asset. Given the mess that asset documentation is in at most O&G orgs, it’s not hard to imagine at least a 5% efficiency gain for TARs and PM/CM if better document management were in place…not to mention the follow on benefits of improved HSE compliance and lower HSE risk.

I went through all this in my workshop and presentation, and there were lots of head nods and amens, so not sure why O&G orgs haven’t solved it. But those that do will reap significant competitive advantage and savings, so I believe it’s just a matter of time…

The final word

Well, that’s my take on the conference. If you were there, chime in and let us all know what you thought of it (and of my take on it). If you weren’t there, feel free to heckle my points above if you see the world differently. Either way–jump in, and let’s get the conversation started!



Operational Excellence in Oil and Gas Houston – Pre-Con Recap

November 4, 2014

20141103_131104So I just got back to the hotel fresh on the heels of my afternoon workshop at the Operational Excellence in Oil and Gas conference, which explored the ways that information management practices can impact O&G operations, both positively and negatively. There was too much discussion to try to reproduce here verbatim, but I wanted to capture the key takeaways I got from the session.

First, trying to stress the importance of information management to O&G operational excellence was definitely preaching to the choir for the folks in my session. Some of them certainly knew more than others about information management processes and technologies, but no one in the room doubted the centrality of information management to the success of their work.

Second, when I asked whether IT understood information management and was able to deliver value to the business in that space, the answer was a resounding no. Out of the fifteen or so firms in attendance, not a single one had anything good to say about how their IT shops handle information management.

Third, there was rampant skepticism about enterprise class software, like ERP platforms, to deliver value and meet business needs. Most of the folks in attendance felt like they were too expensive to buy, painful to use, and weren’t delivering a value commensurate with the effort (and pain) it took to get them up and running.

Finally, folks were universally looking for simple, blocking and tackling information management capabilities rather than futuristic, rocket ship type solutions. When I asked whether the document management systems at their assets allowed workers to type in a functional location, for example, and quickly retrieve the latest and greatest documentation, the answer was definitely no. In fact, most of the participants thought that having the ability to do this would be transformational to their operations. Of course, they also thought having the ability to manage asset documentation throughout the entire life cycle, from design and construction, to turnover, operation, and end of life using workflow would be great, too. But everyone agreed that simply having a good place to store their docs with a simple, effective way to retrieve them would be game changing…and a necessary first step to reaching these more advanced capabilities.

The Final Word

So much for the pre-con. Excited to be a spectator for Day 1 (I present tomorrow) and see what folks have to offer across the industry.

Operational Excellence and Information Management

October 29, 2014

I’m gearing up for next week’s Operational Excellence in Oil and Gas in Houston, so I’ve been thinking a lot about the role information management plays in the path to operational excellence for energy firms.

On the one hand, it’s a no brainer: without accurate information about an asset and the processes that maintain and operate it, you can’t be as efficient, effective, or safe as you would be if you had that information. On the other hand, oil and gas organizations overall have been historically poor at managing information, especially compared to firms in other industries, like banking, financial services, or insurance; so it makes sense that operational information wouldn’t necessarily be optimized yet at most O&G firms.

But there’s a huge payoff for O&G firms that fix information management. Just consider a large asset like a refinery, petrochemical manufacturing plant, or offshore platform: downtime can easily cost $1M per day or more, paper drawings (often stored on site, in a blast zone) would run anywhere from $100M to $500M or more to reproduce if lost, off-PO purchasing reduces supply chain visibility and directly impacts quality, safety, and efficiency, mismanaged as-builts lead to increased downtime (from an hour or two to swap tools or supplies to a few days waiting for the right parts to come in), and poor version control on key operational documents like SOPs can have disastrous results.

A turnaround at one of these assets can last 3 – 6 weeks (at $1M a day or more in lost production) and easily cost $50M, $100M, sometimes as much as $500M and up for the largest facilities. Given these numbers, even a modest increase in efficiency (1%) would yield significant returns for an organization. And given how central information is to managing a turnaround (and how poorly most O&G firms manage their information), it’s not difficult to gain this level of efficiency by doing some simple, lo-fi things to improve information management.

For example, imagine having all relevant engineering drawings, as builts, inspection reports, SOPs, etc., in a single repository, tagged by a few key fields (such as functional location, process area) so that scheduling PM work orders, onboarding contractors, or compiling turnover documentation didn’t require tens, dozens, or hundreds of wasted hours searching for relevant information in shared drives, hard drives, email, desk drawers, file cabinets, and storage rooms.

This would lead to tremendous efficiency and safety gains even without any information management bells and whistles, like workflow, ERP integration, or social collaboration capabilities.

I’m leading a pre-conference workshop next Monday that’s going to tackle this issue head on with 20-30 practitioners from across a range of O&G firms. After a brief level set on what I mean by information management, we’re going to dig in as a group to find tangible, actionable ways that information management can transform the strategy and tactics of petroleum operations, based on our collective real world experience in the trenches working for operational excellence.

I’ll be posting here after the event about what we come up with, but if anyone’s interested in taking part, you can register here – I’d love to have you on board with us.

Operational Excellence in Oil and Gas – Houston, November 3 – 5

October 28, 2014

I’m getting really excited to be a part of the Operational Excellence in Oil and Gas show next week in Houston. I’m presenting a session Wednesday at 10:25 titled Optimizing the O&G Value Chain with Better Information Management and running a pre-conference workshop Monday afternoon, Operational excellence opportunities: Optimising data and information management to support early event detection and resolution. If you’re going to be there, of course I’d recommend my sessions, but here are some of the others I’m looking forward to attending.OPEX logo

Where the rubber meets the road: Linking strategy to operationsTues, 8:45 AM, Martin L. Morrison, Vince Cipresso, and Charles (Chuck) Davison, Jr. This is the $64,000 question, i.e., how do you take all that pie in the sky, sounds great on paper strategy and do something with it?

OpEx Fuels Growth in Oil and Gas Industry – Tues, 1:15 PM, John Boyd and Kevin Duggan. This session looks to be a good mix of operational excellence theory and real world practice drawn from FMC–always love to hear how real folks at real firms are working with best practices.

Linking your operational excellence plan to business needs and changing objectives – Wed, 8:40 AM, Alberto Consuegra. Of course, operational excellence is worth doing for its own sake, but it’s important to make sure your OpEx efforts align with the goals and work of the larger organization.

Achieving and sustaining asset integrity and reliability as part of a holistic operational excellence strategy – Wed, 11:55 AM, Roddy Evans. Hoping to get some good real-world insights from Hess in this session.

These are just four of the sessions–honestly, IQPC has put together such a great line up this year, I think all the sessions are going to be really valuable.

I look forward to seeing some of you there and to sharing insights from the conference here with you all.

Is the answer really R&D for the Life Sciences?

October 16, 2014

So I’m in the middle of researching a white paper on the changing role of regulatory affairs in life science organizations and have come across a focus/bias in the literature toward R&D that doesn’t sit quite right with me, i.e., all the challenges facing the life sciences can be solved, addressed, overcome, etc., by optimizing R&D.

What I’m gleaning is that a significant portion of the thought leaders out there believes that if R&D were only faster, cheaper, more effective, more patient-centric, more transparent to investors, or more responsive to regulators (or some combination of all of these), life science organizations would solve all the problems they currently face.

Here’s a list of a few of the key reports I’m talking about:

To me, this view of R&D optimization as a cure-all is too one-dimensional. To appreciate why, consider the short list of significant challenges facing the life science industry in the next five years:

    1. Current model of drug development is not financially viable long-term
    2. Life science sector set to grow substantially in rest of world (ROW), basically flat in US and EU
    3. Breakneck product innovation (3D printing, combination devices, growth of biotech, etc.)
    4. Rise of the patient/patient-centric influence on drug development
    5. Regulatory context shifting to pay for value/results
    6. Purchasing power moved from provider entities to payer entities

It seems to me that simply increasing the number of viable products in the pipeline and reducing the cost and time of getting them developed and to market would not solve any of these challenges on its own. Rather, we need fundamental, enterprise-level changes that span the life sciences value chain.

  • To make the cost of drug development more viable, failing faster during early R&D will help, but so will improving regulatory efficiency and effectiveness, improving patient recruitment and retention, and leaning out manufacturing, quality, and supply chain.
  • To maintain acceptable margins in ROW (where funds available for health care are fractions of the US and EU), more products won’t help; what’s needed is more efficient and cost-effective ways to got to market with products, starting with R&D, of course, but continuing through the rest of the value chain, from regulatory through quality, manufacturing, and supply chain.
  • To capitalize on the innovations made possible by new technology, requires regulatory innovation inside and outside the walls of the company, otherwise these products will never make it to market.
  • To make a portfolio more patient centric, R&D isn’t the answer–customer facing functions such as clinical, PV, commercial, etc. are; R&D will simply take their findings as input/steer for their activities.
  • To make an organization more focused on the value and results their products deliver has more to do with overall strategic direction and coordination across the entire value chain, not just the point at which those products are designed and developed.
  • To develop a business model that will succeed in a payer-centric marketplace requires a strategic vision at the enterprise level aimed at transforming the entire organization, not simply a change to how R&D works.

The final word

This is far from a definitive argument, but I wanted to get my impressions and early thoughts down to share them and see what others out there think, whether anyone has noticed them same R&D bias, whether you think I’m missing anything, etc. Jump in, and let’s get the conversation started!

RAPS 2014 Day Two Recap

September 30, 2014


Another great day at RAPS in Austin. Here’s some of the highlights from today as I prepare to head out for a night of networking at the dine around.

European Regulatory Environment

It was a great first session on changes to clinical data requirements in Europe. This would have been a great presentation for folks in the business to attend, because the speakers did a good job painting the complexity of the EU regulator landscape and the tremendous risk and uncertainty this imparts to the product development process. But beyond this, the session also did a good job sorting out what has and hasn’t changed and what that means tactically for regulatory affairs. And David Rutledge from Abbott and SengDao VanMany from Hollister provided real-world examples of how their organizations were adapting to align with the EU regulatory environment for Class III and Class I devices respectively.

The Future is Now

There was a wonderful session on 3D printing that was inspiring and just plain cool. It began with a short history of 3D printing, which has been around since the early 1970s and (until recently) used primarily for prototyping. The big innovation lately (and the thing that has everyone excited about this “new” technology) is the reduced cost of the technology, which has allowed innovation in its use beyond prototyping, i.e., to printing finished products for consumer end use. Beyond that, the speakers talked about the range of current applications for 3D printing in life sciences, from breast and facial reconstruction to print-on-demand surgery templates, individualized patient “models” of internal organs to aid doctors, to printed human tissue samples for use in clinical trials–awesome stuff. There was also a lot of talk about the emerging nature of regulatory guidance for 3D printing, which is a matter of wait and see.

Social Media

I went to the two back to back social media sessions. The first was a panel discussion that began with Stella Stergiopoulos from the Tufts CSDD presenting their recent survey data on social media usage for PV. I’ve seen Stella speak on this topic before, and she’s always excellent–plus the CSDD has such rich data that it’s always worth hearing what they have to say. In addition, there were regulatory practitioners from Lundbeck (Ilze Kurins Antons) and AstraZeneca (Matthew Boyd), as well as a true blue digital marketing person (Sue Niedrich)–a very valuable perspective to have in the conversation.  The second was a situation room where everyone let down their guards and talked openly about challenges with social media. Without betraying the “what happens in the situation room stays in the situation room” pledge, I can say that some common themes were the fine line between product marketing and patient education/disease awareness, the nuts and bolts of running a social media monitoring function, and the complexities of AE reporting.

The Final Word

Ok, so much for day two–off to network and enjoy Austin. Would love to hear what you all out there found valuable on day two!

A Modest (Regulatory Affairs) Proposal

September 29, 2014

Siting in a session on the strategic value of Regulatory Affairs to THE BUSINESS, it became clear to me that we needed a complete paradigm shift if we had any hope of getting all of this right. Both sides of the equation (regulatory and the business) are so entrenched in their own perspectives that they’re each unable to raise up the level of discourse and approach regulatory as a strategic part of the life sciences value chain.

With that in mind, I wanted to make a modest proposal, which might be as poorly received as Swift’s was almost 300 years ago…but here goes.

Imagine what our life sciences organizations would look like if, as a part of business as usual, we rotated regulatory resources through the key business functions, from R&D, through manufacturing and quality, to commercial/sales, medical affairs, etc., and assumed that deep business knowledge was as important as regulatory domain knowledge for their success.

The result, I think, would be Regulatory Affairs professionals who viewed their work through the lens of do this so we make more money as an organization rather than the lens of do this or else (and we’re okay being a cost center/administrative overhead).

And it’s not like this idea is science fiction. I sat in a presentation today where folks shared that they participated in professional development programs similar to this one at real life organizations. But these are the exception that proves the rule. Most life sciences organizations don’t have such a program in place–RA is a backwater cut off from the business and trapped in being considered a cost center.

So what I think is needed is to adopt an industry standard pathway for RA professionals that exposes them directly to every stage in the product development lifecycle at a life sciences organization, which would kill two birds with one stone.

First it would ensure that RA professionals understood the context of their work and wouldn’t do regulatory for its own sake, but rather to achieve tangible business goals.

Second it would help the business understand RA by giving them broad exposure not only to RA professionals but to the complex work RA does day in and day out to get products out the door in life sciences orgs.

In the end, such a program would give an organization strong competitive advantage over its peers, because the ability to bring complex products to market globally in a diverse compliance environment is a tremendous leg up over the competition.

The Final Word

It’ll take more than a single blog post to get organizations to adopt a new RA paradigm, but hopefully the change in attitudes and approaches I saw today at RAPS signals a sea change in how life sciences organizations are going to approach RA going forward. In the meantime, I’d love to hear from my RA compadres out there about how there organizations are approaching RA–jump in, and let’s get the conversation started!

RAPS 2014 Day One Recap

September 29, 2014

RAPS logoSo day one at RAPS 2014 exceeded expectations. The sessions were great, networking was superlative, and social media usage was active from not only vendors, but also practitioners and industry thought leaders.

Although we still have lots more RAPS 2014 to go, I wanted to get my first day thoughts and impressions down while they’re still fresh in my mind…


This was a great session, not only for the information it provided about TransCelerate, an industry consortium focused on improving R&D operations, but for the larger issues it raised about the future sustainability of the drug development process as it currently operates. It was great to see major life sciences orgs teaming up in a non-competitive way to develop common standards, streamline operations, reduce supply chain overhead, and work together to bring transformative therapies to the patients who desperately need them more quickly. I’m excited to see where this initiative takes the industry over the next few years–it seems to hold a tremendous amount of promise.

 Regulatory Intelligence

If you thought Reg Ops was a red headed stepchild, you should spend some time Reg Intelligence folks. They’re tasked with monitoring all the chatter from the FDA and other regulators (as well as pundits who report on them), culling it for relevant, actionable information, and sharing their analysis of the information with the larger organization. What came through loud and clear in the session I attended, however, was that RI, done properly, is a significant strategic differentiator in the organization. Problem is, most business folks have no idea that this is the case, and RI practitioners haven’t done a good job of making the case for relevancy–we’re too focused on getting the research right rather than articulating how our research impacts the larger organization’s value chain.

Regulatory as a Strategic Partner

This was not only the best session of the day, it was one of the best sessions I’ve ever attended, full stop. A common complaint, not only in Life Sciences, but in every heavily-regulated industry, is that regulatory compliance is viewed as administrative overhead rather than as a strategic partner. And most conference sessions on the topic are little more than stitch and bitch sessions: woe is me, we are so misunderstood, the rest of the organization has no appreciation of the important work we do, blah blah blah.

This one was 180 degrees away. The organizer, Kathleen Wessberg, director of Reg Affairs and Reg Ops at Abbott, managed to bring together a wide range of business stakeholders to speak to the strategic partnership between regulatory and “the business”. Three of them showed up in person; the other seven or so recorded video responses to her panel questions–all of them were superlative. As a regulatory practitioner, this was gold…especially if you weren’t fortunate enough to work at an organization as forward thinking as these companies are. I hope that this session is the beginning of a widespread evolution that ends with regulatory being as strategic as R&D, Clin Ops, and Commercial…time will tell.

 The Final Word

So much for day one–I look forward to what the next two days bring. In the meantime, I’d love to hear from you all out there–what were your impressions of day one? Did you have different takes on the sessions I attended? General heckling to offer? Jump in, and let’s get the conversation started!




RAPS 2014 Austin

September 24, 2014

RAPS 2014 is in Austin next week, and I’m excited for the event. There’s a good slate of sessions and, given the venue, lots of opportunities for networking with colleagues. Although it’s hard to predict what the most valuable session will be beforehand, I wanted to share some of the sessions I’m looking forward to.

Enhancing Regulatory Efficiency Through Good Review Practices (GRevPs) and Good Submission Practices (GSP)

Monday 1:30–3:00 pm

  • Mike Ward, manager, international programs division, Bureau of Policy, Science and International Programs, Therapeutic Products directorate, Health Canada
  • Marilena Bassi, director, Office of Planning, Performance and Review Services, Therapeutic Products Directorate, Health Canada
  • Deborah Jansen, center quality manager, CBER, FDA
  • Li-Ling Liu, director, Division of Medicinal Products, Food and Drug Administration, Ministry of Health and Welfare, Taiwan
  • Toshihiko Tsunenari, Japan Pharmaceutical Manufacturers Association

Communicating Actionable Regulatory Intelligence

Monday 1:30–3:00 pm

  • Kimberly Belsky, executive director policy, labeling, and adpromo, regulatory affairs, Valeant Pharmaceuticals
  • João Duarte, regulatory intelligence and policy manager, H. Lundbeck A/S
  • Alexander Gaffney, RAC, manager, regulatory intelligence, Regulatory Affairs Professionals Society (RAPS)
  • Alan Minsk, JD, partner, Arnall Golden Gregory LLP

Medical Devices in Latin America

Monday 3:30–5:00 pm

  • Seth Goldenberg, PhD, senior principal scientist, NAMSA
  • Anne Blanchard, CEO and clinical operations manager, Blanchard & Asociados
  • Marisa Carcione, regulatory manager, IPRAT
  • Luciano Ferreira, RAC (Global), regulatory intelligence manager – Latin America, GE Healthcare
  • Lílian Garcia Orofino, senior regulatory and government affairs manager – Latin America, Boston Scientific

AdPromo: Implications of US/Global Noncompliance on Your Company, Processes and People

Monday 3:30–5:00 pm

  • Kimberly Belsky, executive director policy, labeling, and adpromo, regulatory affairs, Valeant Pharmaceuticals
  • Philomena McArthur, senior director, regulatory and health care compliance, Johnson & Johnson PRD LLC
  • Alan Minsk, JD, partner, Arnall Golden Gregory LLP

Regulatory as a Strategic Partner Within the Business

Monday 3:30–5:00 pm

  • Kathleen Wessberg, director regulatory affairs, regulatory operations, established pharmaceuticals division, Abbott
  • Liam C. Feely, PhD, vice president, manufacturing science & technology, AbbVie
  • Virginia Giddings, director strategic R&D, Abbott Nutrition
  • Ben Verwer, vice president strategic initiatives, BD Diagnostics

Impact of the New Proposed Regulations on Clinical Data Requirements in Europe

Tuesday, 8:30–10:00 am

  • Bassil Akra, PhD, director clinical affairs, TÜV SÜD Product Service GmbH
  • David Rutledge, PharmD, FCCP, FAHA, director, clinical research, Abbott
  • SengDao VanMany, senior clinical research scientist, global clinical operations, Hollister Incorporated
  • Daniel Whitter, clinical project leader, NAMSA Medvance

3D Printing: Crossing the Boundaries of Regulatory

Tuesday, 11:00 am–12:30 pm

  • Laura Bosworth-Bucher, CEO and co-founder, TeVido BioDevices
  • Jim Rosa, vice president, QA/QE consulting, Dohmen Life Science Services

Understanding the Challenges of Bringing a Mobile Medical App to the Market

Tuesday, 11:00 am–12:30 pm

  • Michael Swit, JD, special counsel, FDA law practice, Duane Morris LLP
  • Daniel Olivier, president, Certified Compliance Solutions Inc.
  • R. William Soller, PhD, principal, and faculty, University of California San Francisco

Implementing Social Media in a Regulated Landscape

Tuesday, 1:30–3:00 pm

  • Ilze Kurins Antons, senior director, US regulatory affairs, Lundbeck
  • Matthew Boyd, director digital and social media, global commercial excellence. EMD Serono Inc.
  • Suzanne (Sue) Niedrich, director, digital marketing, digital center of excellence, neurology, Lundbeck LLC
  • Stella Stergiopoulos, project manager, Tufts Center for the Study of Drug Development

Bringing Novel Devices to Market

Tuesday, 1:30–3:00 pm

  • Seth Goldenberg, PhD, senior principal scientist, NAMSA
  • Jennifer Bolton, manager, regulatory affairs, vascular surgery, Boston Scientific Corporation
  • Chris Mullin, MS, director, regulatory, biological safety, strategic consulting services, NAMSA
  • Ronald Rakos, MEng, PhD, MBA, team leader vascular, BSI Americas
  • Nicole Wolanski, Capt, USPHS, director, PMA Program, Program Operations Staff, ODE, CDRH, FDA

Ok, so much for my take on RAPS 2014–what about you all out there? What sessions are you planning to attend? What are you most looking forward to next week?