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Facilitating audience engagement is a top priority at educational meetings, allowing them to network between themselves as well as with your speakers and educators....

October 16, 2015

It was nice while it lasted. The US-EU Safe Harbor system, a triumph of diplomacy, commonsense, and rationality, was a simplified process that US companies were able to adopt to comply with the EU...

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It was nice while it lasted. The US-EU Safe Harbor system, a triumph of diplomacy, commonsense, and rationality, was a simplified process that US companies were able to adopt to comply with the EU Directive 95/46/EC on the protection of personal data.
A product of the US Department of Commerce and the European Union, Safe Harbor was a boon to all until earlier this month. Driven by Edward Snowden’s exposure of the NSA’s domestic data gathering activities, the European Court of Justice invalidated the measure (Maximillian Schrems v. Data Protection Commissioner). Of concern was the possibility that under US law, federal agencies could potentially access and utilize the data, contravening European privacy laws.
Of course, Safe Harbor had been intended to allay such concerns in the first place, by preventing accidental information disclosure or loss by US companies holding data from Europe, which generally has stricter laws on the subject. Unanticipated at the time of the Law’s creation was a scenario in which the threat to the data’s privacy would be the US Government, a reality surfaced by Snowden’s actions.
The complete implications of this decision are not yet clear, but already, huge tech companies such as Facebook and Google are facing disruption. Optimists see a potential for governments on both sides of the Atlantic to administer an orderly retreat toward some new common ground, but others see a potential disaster that could result in the loss of billions of dollars in bilateral trade.
For Life Sciences organizations, which have often made large investments in consolidating information technology resources globally, this decision could be particularly painful. For example, companies that transfer personal data — health data in particular — between jurisdictions may now have to stop the practice or constrain it in an as yet undetermined way. This, of course, potentially undoes the data consolidation, not to mention the widespread adoption of compliant public cloud resources for storage and computing. Much of this technology was put in place to meet expanding global compliance guidelines regarding payments to their customers, healthcare professionals. The inability for one region to have visibility that a key thought leader physician is being utilized and paid by another region makes regulated transfer of value reporting a manual effort.
Guidance on this matter is expected from the European Commissioners in the near future. For now, U.S. Secretary of Commerce Penny Pritzker released the following statement (reproduced in part) in response to the European decision:
“The court’s decision necessitates release of the updated Safe Harbor Framework as soon as possible. We are prepared to work with the European Commission to address uncertainty created by the court decision so that the thousands of U.S. and EU businesses that have complied in good faith with the Safe Harbor and provided robust protection of EU citizens’ privacy in accordance with the Framework’s principles can continue to grow the world’s digital economy.”
To be sure of what?, the Commerce Department had been working on improvements to Safe Harbor prior to this ruling. Presumably, some of that work can be salvaged and built upon. It is hard to imagine that mutual interest wouldn’t lead to a solution. In the meantime, however, Life Sciences companies must deal with consequence of this European court decision, namely tracking how healthcare professionals are utilized and paid around the world; which is a direct fruit of the ability to share data seamlessly.
No doubt, lawyers will be working double time, and IT people, too, in an effort to avoid running afoul of the law as it stands. The more cost effective world of third-party Software as a Service (SaaS) beckons, with the potential to actually improve security and allow Life Sciences companies to focus on what they do best, namely R&D related to improving healthcare.
In the meantime, as they say, “stay tuned.”


Contributed by:


Susan Hill, SVP, Global Products & Solutions, AHM

Susan joined AHM in June of 2013 and is responsible for the oversight and management of AHM’s Global Business Development and Solutions and Marketing team. With over nineteen years of experience in the Life Science industry, Susan brings experience in business development, product marketing, and new technology investment and optimization.

 

October 5, 2015

While the American presidential elections are still more than a year in the future, it is interesting to consider how lively and bruising the combat has been so far. Hilary Clinton, presumed by many...

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Prescription Affordability - Watching the Presidential Race:
While the American presidential elections are still more than a year in the future, it is interesting to consider how lively and bruising the combat has been so far.
Hilary Clinton, presumed by many to be the unchallengeable front-runner for the Democratic nomination, has seen the unexpected rise of Bernie Sanders as a competitor for the nomination, as well as a potential challenge for the nomination from the current vice president Joe Biden. As regards the race for the Republican nomination, the unpredictable and meteoric candidacy of Donald Trump has added a good deal of interest and intensity to the large and contentious field for the Republican nomination and to date, two candidates who were once widely regarded as serious contenders have dropped out. The lengthy process involved in both nominating candidates, as well as the actual election that follows, may yield even more surprises as candidates vie for attention from a fickle electorate. What is especially worth noting is that some of the issues raised during these campaigns can have a direct and profound impact on healthcare and Life Sciences.
This is not mere speculation. A quick review of history shows how important presidential politics and presidential action has been for issues which can have a direct effect on the life sciences industry. For instance, the Pure Food and Drug Act of 1906 was a key piece of Progressive Era legislation, supported and signed by President Theodore Roosevelt.
During the New Deal era, the FDA was expanded and Congress passed the Federal Food, Drug, and Cosmetic (FDC) Act of 1938. Although President Roosevelt’s role in these events wasn’t necessarily central, they occurred against the backdrop of a shift that Roosevelt was advocating at the time, to a more activist and involved government.
Some subsequent milestones also tie closely to the agenda of the occupant of the White House. For instance, The Fair Packaging and Labeling Act of 1966, one of the initiatives of President Johnson’s Great Society, required all consumer products, including OTC drugs, to have “true and informative labels”. Johnson also sought the involvement of the National Academy of Sciences and National Research Council in related efforts, in order to measure the effectiveness of 4,000 drugs which had been previously approved between 1938 and 1962 on the basis of safety alone.
More recently, President Obama made consumer healthcare coverage one of the centerpieces of his first administration and with Congress, was able to enact the Affordable Care Act, with all its substantial implications for Life Sciences.
The current cycle of presidential electioneering has already generated a detailed proposal for changing major aspects of the prescription drug market from Democrat Bernie Sanders. According to Sander’s web site, his plan includes six major policies such as enabling Medicare to more aggressively negotiate discounts, allowing prescription drug imports from Canada, eliminating the infamous “donut hole” in Medicare Part D, as well as implementing measures targeting anti-competitive behavior by drug makers.
While it is still very early along the road to November 2016, and Sanders is thought by many pundits to be unlikely to become his party’s standard bearer, Bernie Sander’s proposals are getting a certain amount of visibility and could be serve to influence the policies of other candidates in an effort to galvanize electoral support.
Sanders is far from alone in offering proposals of consequence for the healthcare and Life Sciences industries. For instance, fellow Democrat Hillary Clinton has suggested boosting benefits under the Affordable Care Act, including lower monthly caps on prescription drugs for patients with chronic or serious health conditions. She too would allow prescription drug imports from Canada. On the Republican side, many candidates have proclaimed their opposition to the Affordable Care Act, including Jeb Bush, retired neurosurgeon Ben Carson, former ophthalmologist Rand Paul, and Donald Trump. Each supports some kind of repeal or replacement for the law. Trump, in particular, has suggested “breaking the monopolies” of the insurance companies and returning to “free market principles.”
With such a wide spectrum of views on displays, everyone in the Life Sciences sector should be paying attention to the political discourse. Recognizing that healthcare issues touch nearly every voters, we as an industry should be ready to engage and inform the candidates and the public about the substance of these issues and any concerns that these issues raise, so an informed debate can occur.

Contributed by:


Lisa Keilty, Global VP of Compliance and Strategic Solutions, AHM

Lisa joined AHM after serving as founder of the Compliance Consulting firm PMC2 and spending over 26 years in the life sciences and meeting management industry. Leading such organizations as Pfizer, Bristol Myers Squibb and Biogen Idec through numerous international projects, financial transparency and reporting requirements, Lisa’s industry expertise has saved Life Sciences and Meeting Management organizations over 30 million dollars. As a member of the Business Development team, Lisa’s primary focus will be Thought Leadership,Demand Generation and Solution Design.

September 24, 2015

Last week I had the opportunity to visit Dreamforce, the annual week-long conference held by Salesforce. The event delivered over 1,500 sessions for more than 150,000 attendees covering topics across the professional spectrum. Why...

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Dream Force
Last week I had the opportunity to visit Dreamforce, the annual week-long conference held by Salesforce. The event delivered over 1,500 sessions for more than 150,000 attendees covering topics across the professional spectrum.
Why was I there? At AHM I am responsible for the Product Engineering team that builds the AHM CentrisDirectTM product, a compliance platform for healthcare professional interactions built on the Salesforce platform. Because of that foundational connection, Dreamforce is very important to what we do — an opportunity to take what we know about the needs of the Life Sciences industry and gain fresh insights into the growing capabilities of SalesForce.

I spent a good part of my time at the conference in an area dubbed the “Developer Zone”. This area focused on training, and provided hands on exposure to the latest tools, technologies, and architectures provided by the Salesforce platform. Salesforce has invested heavily into a developer training program branded as “Trailhead” and put a lot of emphasis on increasing awareness of this valuable resource which is free to anyone interested in the platform: https://developer.salesforce.com/trailhead.

One of the primary reasons AHM chose to build CentrisDirectTM on the Salesforce platform is the rapid pace of innovation it provides. For example, Salesforce delivers three platform releases a year that expand the number of features available to ISV partners like AHM. That, in turn, helps us to build new features that are relevant to our clients. Dreamforce helps to make us aware of the full breadth of the platform and allows us to dig into the details for features we think will have the largest impact on our product and clients.
At last year’s Dreamforce, I was inspired by a session on how to apply continuous integration in the Salesforce cloud environment. We leveraged what we learned there and now have a fully automated continuous integration process that streamlines our product development process. This year I focused on attending sessions geared toward independent software vendor (ISV) partners, new platform technologies, and the platform “roadmap.”
This year I was especially excited to learn about some new platform features that will provide us with additional tools for configuration management: Branch Orgs and native version control. These features will give us additional flexibility and control of our software code management and release process.

Many of the sessions I attended focused on the new Salesforce Lightning Experience user interface, which provides not only a new look and feel, but a new way to develop and deliver user interface components that can be shared between both mobile and web applications. I believe this new technology will have a huge impact on CentrisDirectTM and will allow us to converge our mobile and web user interfaces over time.

There were also numerous sessions on development patterns and best practices that my team will take back and apply at AHM. All in all, Dreamforce was a great opportunity to network with Salesforce MVPs and the Salesforce development thought leaders that were presenting. If you weren’t able to attend Dreamforce this year, you can find video for many of the sessions here: https://www.salesforce.com/video
While we wait for the next Dreamforce, we will be hard at work imagining — and delivering — a better product for all our clients!


Contributed by:


Bryan Lilley

Bryan has been leading the development of AHM’s software product portfolio for over 12 years. His 20+ years in the software industry brings experience across a broad set of enterprise platform architectures, from the days of client server to our current world in the cloud.

September 17, 2015

In introducing this year’s Compliance Week annual conference, held back in May, editor & publisher Matt Kelly described the event (the 10th, in sequence), as “a chance to pause and see the larger picture...

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Compliance internal
In introducing this year’s Compliance Week annual conference, held back in May, editor & publisher Matt Kelly described the event (the 10th, in sequence), as “a chance to pause and see the larger picture of your profession and to share that experience with your peers.”
Certainly, it was a chance for observing, reflecting, and sharing. Who could miss the growth and development of the field since the first conference? From both a personal and an AHM perspective, the conference made it clear how much growth has occurred in a decade. Sure, the problems continue to change and never seem to get any easier, but in the aggregate, both the regulated and the regulators have grown more professional; clearer on their roles and responsibilities — and more sophisticated in understanding each other and the important issues at stake.
That maturity is a reflection of the fact that compliance has become deeply embedded in business and organizational practice. It is no longer a topic that draws blank stares. Everyone “gets” compliance and those of us engaged in it play key roles in the entities for which we work. Compliance has become part of the culture.
Of course, being part of our respective “corporate cultures” merely indicates that we have long-since achieved legitimacy. But that is something that must be continually earned and propagated and requires development of truly having a compliance culture. People will probably never love compliance. But with continual effort, they can be taught to practice compliance.
We were also reminded at Compliance Week 2015 of some unfinished business: getting visibility for the chief compliance officer. Other C-level folks have had to earn their “place at the table,” and it took time. Chief Information Officers (CIOs), for example, took a decade to gain credibility and real organizational clout. It’s about time every organization made the CCO a central player in management!
Effectiveness is what we aim for. We were reminded at the conference that assessing effectiveness must come from facts; being able to measure and document what we do relative to the activities an organization conducts is a necessity if we are to actually deliver compliance.
Of course, we can all continue to argue about what effectiveness really means — and we should. In fact, one of the first sessions on the agenda this year was titled, 10 Years On: Are We Defining ‘Effectiveness’ Correctly?” Effectiveness is still ill-defined and will always vary from one organization to another. But we need to continue to seek benchmarks and sound points of comparison.
Furthermore, we are forever chasing a moving target. Although some compliance drivers have become familiar, Anti-Kick Back, the specifics are always changing and new drivers are always emerging. Nothing can change that, but good people and good processes will ensure that an organization keeps up with the times and keeps its edge. A takeaway: make sure your programs are designed to evolve so that they aren’t stuck solving yesterday’s challenges.
AHM, of course, aims to support compliance and help shape best practices. We are privileged to work with some of the best organizations around and we anticipate that a decade in the future, when the 20th Compliance Week conference is held, we will be able to look back on an equally interesting and impressive record of shared accomplishment.
 

Contributed by:


Lisa Keilty, Global VP of Compliance and Strategic Solutions, AHM

Lisa joined AHM after serving as founder of the Compliance Consulting firm PMC2 and spending over 26 years in the life sciences and meeting management industry. Leading such organizations as Pfizer, Bristol Myers Squibb and Biogen Idec through numerous international projects, financial transparency and reporting requirements, Lisa’s industry expertise has saved Life Sciences and Meeting Management organizations over 30 million dollars. As a member of the Business Development team, Lisa’s primary focus will be Thought Leadership,Demand Generation and Solution Design.

September 10, 2015

August 17 – 19, 2015 brought approximately 350 industry colleagues to Washington, DC where, Center for Business Intelligence (CBI) hosted the 9th Annual Transparency and Aggregate Spend Conference. My inaugural view into this conference...

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August 17 – 19, 2015 brought approximately 350 industry colleagues to Washington, DC where, Center for Business Intelligence (CBI) hosted the 9th Annual Transparency and Aggregate Spend Conference. My inaugural view into this conference was over five years ago, as a sole proprietor who had just hung her compliance consulting shingle out for the first time. Back then, there were a lot of the big guys in attendance: Cegedim, Deloitte, Huron, Porzio and ironically even AHM. With my knees wobbling together as a first time, independent attendee, I timidly made my way into the exhibit hall after picking up my name badge. Why was I hesitating? What was my dread? I had been working within the pharma industry focused on HCP Interactions for over a decade and had certainly heard of the then looming Sunshine Act before! What was I afraid of?
During that conference, I recall a small number of solution providers being in attendance, each proclaiming THE answer on what it was and how to prepare for Sunshine, (now the Open Payments Program). Attendees enjoyed and were inspired by the systems, screenshots, potential process flows and purchasing incentives for manufacturers. We were all wide-eyed! For me, I wondered how I was going to decipher this if there is no clear definition of requirements. Where was the line in the sand; the proverbial stake in the ground outlining what to do? Then it occurred to me – this is what I was afraid of! Fear of the unknown! And ya know what? I was not alone. Joining me in my apprehension were giant companies and experienced consultants. They, too, were trying to understand exactly where CMS was going to end up regarding their data points and collection requirements.
It was quite a different experience at this conference in 2015! As we know, CMS defined requirements in 2012 and data collection began August 2013. The life sciences industry has supplied over 2.6 million lines of identifiable general payments and CBI delivered a valuable and educational conference for the ninth year in a row! Topics of discussion during the preliminary workshop included Standardizing Processes for Validating and Verifying Data as well as one of our own, when our Global Director for Solutions Management collaborated with the panel on Leveraging the Customer Master. With over 70 attendees in this pre-conference workshop, organizations of all sizes and complexities fired off questions and collectively problem-solved using specific examples such as collecting data outside of spend sources, technology available to capture TOVs (transfer of values) across the pipeline, attesting data and scenarios of dispute resolution.
Data attestation and best practices to reduce compliance risk was another hot topic, suggesting a tiered approach involving a CMS Attester, Business Owner, Certification of Data Source and a Periodic/Ongoing Review. This best practice results in a definition of ownership, provides organizational accountability and identifies potential issues quicker and at a more granular level, allowing for improved accuracy and completeness.
A strong theme throughout the conference was globalization — and the challenges with unique country and HCP identifiers. Each country having their own rules around the identifier to capture is causing angst, inefficiencies and redundancies. A standard, best practice approach is certainly needed — but when and how are the questions that need to be answered. An additional trouble spot under the global umbrella was consent management for doctors in Europe. The speakers were suggesting that not only is soliciting consent from HCPs challenging but keeping the consent is not easy. HCPs can revoke their consent to share data whenever they want to, so companies need to consider an annual consent management strategy. There was a suggestion that if sales reps asked for the consent to share their data they would most likely receive it as compared to other people in the organization who many not interact with the rep as much. Additional coverage on CBI 9th Annual Transparency and Aggregate Spend can be found here: http://www.cbinet.com/conference/agenda/pc15156#.VeXOvPlVikr
Experiencing the development and path of Open Payments to date and looking to the horizon of global transparency, I can’t help but think of five years ago and appreciate the true pioneers and leaders from all stakeholder categories: life sciences manufacturers, HCOs, HCPs, industry associations and of course, solution providers who collectively thought out of the box, managed the unknown and put that stake in the ground leading us now towards a best practice for transparency.
At CBI and other conferences I’ve seen a strong desire among attendees to simply be “in the know” regarding practices among peer organizations. This is particularly evident when comparing audience engagement. The sessions presented by pharma company employees almost always generate the greatest level of interaction. Sometimes these folks know each other, sometimes they don’t, but regardless they are simply curious about other company’s experiences and how their “colleagues” are reacting to and addressing common industry problems. We have a lot of work to do still in perfecting in regards to financial transparency but collaborations and knowledge sharing which occur at these conferences are certainly paving the way!
Stepping back, I am taken by how all of this has evolved based on mutual concern and perhaps some enlightened self-interest. Subject matter experts built and then refined processes and technology, even when it was difficult to discern how best to proceed. Rather than being stymied by the fear of the unknown, we worked together, shared ideas, and built solutions together. In the words of Babe Ruth, “The way a team plays as a whole determines its success. You may have the greatest bunch of individual stars in the world, but if they don’t play together, the club won’t be worth a dime.” That sounds like the lesson we have all learned.


Contributed by:


Lisa Keilty, Global VP of Compliance and Strategic Solutions, AHM

Lisa joined AHM after serving as founder of the Compliance Consulting firm PMC2 and spending over 26 years in the life sciences and meeting management industry. Leading such organizations as Pfizer, Bristol Myers Squibb and Biogen Idec through numerous international projects, financial transparency and reporting requirements, Lisa’s industry expertise has saved Life Sciences and Meeting Management organizations over 30 million dollars. As a member of the Business Development team, Lisa’s primary focus will be Thought Leadership, Demand Generation and Solution Design.

September 2, 2015

With Dreamforce just around the corner — Salesforce’s annual showcase, which draws over 100,000 people annually to the city of San Francisco — I have been pondering the value of in-person meetings and events....

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With Dreamforce just around the corner — Salesforce’s annual showcase, which draws over 100,000 people annually to the city of San Francisco — I have been pondering the value of in-person meetings and events.
In our technology-saturated age — when faces, voices, ideas and information reach us instantly from across the globe — great gatherings of people, and even small person-to-person visits, can seem a little antique and, some might say, simply too much trouble and expense. However, I think that attitude is mistaken.
Dreamforce is a big event for AHM since Salesforce is the platform on which our technology is based and, although it is a large investment to attend, we believe in the value of meeting face-to-face with our Salesforce team, other partners and customers. It is a key to our growth and success. I firmly believe that the benefits gained of seeing individuals, exchanging a handshake and or a laugh and “bonding” however briefly, is a key element in developing strong and productive human relationships. Person-to-person meetings spark serendipity, create new opportunities, and expand and deepen whatever connections we have formed through other means. In other words, they are the foundation of a good, lasting business relationship!
AHM shares this belief. It is why we make significant investments each year in supporting and attending industry conferences. What you get out of the events is usually out of proportion to what you put into them.
On a personal note, my belief in the value of face-to-face is reinforced when I watch my teenagers cocooned in their technology and observe the level of discomfort they have when they need to speak a word over a phone call, much less participate in a face-to-face interaction. It honestly frightens me. That threat to the current youth generation, which I feel needs those traditional skills in order to build strong relationships and eventually take on leadership roles, is really the same challenge “we” face.
Taking the time to make direct, personal connections with others in our industry ensures that what we do the rest of the time matters and is really attuned to our colleagues, far and wide.
Of course, for AHM, the challenge is additionally complicated by the fact that we enthusiastically support both kinds of interactions — traditional, live, face-to-face meetings as well as those that are virtual. We have adopted with the industry supporting events that are virtual and those that are live, and although there has been speculation that technology would eliminate the need for the live interactions, we have not found this true. The industry has settled on a combination of live and virtual events, driven by the business situation, to interact with their customers. And we know that the ease and the economics of the latter are of vital importance; it would be unrealistic to even consider doing away with our new tools for communicating and sharing. But sometimes, it is absolutely worthwhile to step away from our screens and keyboard and reconnect in the real world.
 

Contributed by:


Susan Hill, SVP, Global Products & Solutions, AHM

Susan joined AHM in June of 2013 and is responsible for the oversight and management of AHM’s Global Business Development and Solutions and Marketing team. With over nineteen years of experience in the Life Science industry, Susan brings experience in business development, product marketing, and new technology investment and optimization.

August 26, 2015

  For those of you that know me well and or have worked with me throughout my career in the Life Sciences industry, you will hopefully recognize the following question without too much difficulty:...

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For those of you that know me well and or have worked with me throughout my career in the Life Sciences industry, you will hopefully recognize the following question without too much difficulty:
How do you know what to do if you don’t know where you are? This question can apply to a variety of scenarios within our personal and professional lives, it is true, but I often apply it in relation to the nomenclature within the Life Sciences Industry. To be more specific, I could also ask, How do you know what you are going to do if you don’t know how to explain it?
My previous and current colleagues smile — or at least I think it is a smile — when I reference a piece of work I had the honor of creating for a past employer of mine. What is it you ask? It is a Definitions Document, one that originally took one year to assemble due to the complexities of the industry and, of course, because I was working within a committee. Designed to get every stakeholder using the same language and definitions around the engagement types or meeting types within the company proved to be somewhat daunting, but in the end the company and its stakeholders embraced it and it remains part of their SOPs today. Medical Meetings / Meetingsnet.com continues to post this article, now with an infographic to walk meeting professionals, suppliers and even hoteliers through the terminology of medical meeting types and processes. Previous clients of mine continue to thank me, because it has lifted the veil of confusion and now allows them to identify where their sponsors or clients are, what meeting types they are trying to hold as well as the specific processes that need to be followed — particularly from a compliance and regulatory point of view. These definitions provide greater understanding of what questions to ask in the qualifying process leading to increased efficiencies and afford the service provider heightened confidence to perform their job functions.
Although primarily focused on the definitions of the meeting types that healthcare professionals attend; additional meeting types or interaction types were also identified and used to showcase the fundamental education necessary to be consistently successful in achieving the meeting objectives.
A meeting is a meeting is a meeting, isn’t it? One would think so, as the commonalities of logistics include choosing a date, location and who needs to attend — oh yeah, and what food and beverages will be served during the event. All those factors are collectively important but, in the Life Sciences world, especially when and where you have one or more healthcare professionals in attendance at a meeting or event, the rules are different.….The title and definition of a meeting or engagement type can have a significant impact on processes used, monitoring and auditing performance, internal and external perception, and even profit and loss statements!
I learned this by experiencing an audit many years ago. Our internal auditors came from different departments within the company and had what I thought was a good breadth of knowledge. Many of them had understanding of how the commercial side of the house ran, but not the clinical or development area of the business. They were auditing my department’s work which, was primarily in the clinical space (study-related meetings: investigator meetings, FDA hearings etc.). Based on the assumption that similar titles meant similar thing they assumed that an Advisory Board on the commercial side would have about the same objective, business need and rationale as a Clinical Advisory Board in my world. Similarly, they perceived that an Expert Panel was the same as an Advisory Board. Of course, that is SO not the case. Sure there are Key Opinion Leaders there to offer guidance or expertise, but the absolute objective as well as the regulatory requirements are quite different.
In addition to that natural confusion, due to mergers, acquisitions and just plain transition as colleagues move from one company to another carrying with them their experiences, processes and yes, terminology, this misunderstanding can grow. Of course, no one in particular is to blame for this. However, I learned quickly that this was going to cause problems during my audit and future audits if not addressed and rectified!
It is the same principle as garbage in, garbage out….
We were being audited on processes that were aligned to a different division within the company. Expectations, standard operating procedures, financial codes, HCP caps and meeting budgets were all outlined and dovetailed into specific meeting types. When auditors reviewed our meeting files, they were holding us to a different set of processes etc. Nothing lined up to the auditors’ expectations nor did it support the company’s commercial SOPs because this was the clinical side of the house. We were held to a different set of rules. Identifying this quickly saved our skin in the end, passing the audit successfully, but it resulted in an extended audit period — 2 months to be exact! We had to painstakingly but essentially educate each of the auditors on the clinical side, its nuances and similarities as well as the difference of processes, stakeholders, attendees and rules. Quite the eye opener for all!
So whether you are a meeting professional within a Life Sciences organization, an independent planner servicing your Life Sciences clients or other service providers touching medical meetings, especially those meetings that have HCPs in attendance, reference this infographic — even wallpaper your cubes with it! You will save time, avoid costly errors in contracting, auditing and even evade potential pitfalls of negative internal or external perception.
 

Contributed by:
 

Lisa Keilty, Global VP of Compliance and Strategic Solutions, AHM

Lisa joined AHM after serving as founder of the Compliance Consulting firm PMC2 and spending over 26 years in the life sciences and meeting management industry. Leading such organizations as Pfizer, Bristol Myers Squibb and Biogen Idec through numerous international projects, financial transparency and reporting requirements, Lisa’s industry expertise has saved Life Sciences and Meeting Management organizations over 30 million dollars. As a member of the Business Development team, Lisa’s primary focus will be Thought Leadership, Demand Generation and Solution Design.

August 18, 2015

The Sunshine Act, now known as the Open Payments Program, was originally proposed in 2007 by senior US Senator Charles Grassley, a Republican from Iowa and Senator Herb Kohl from Wisconsin, a member of...

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The Sunshine Act, now known as the Open Payments Program, was originally proposed in 2007 by senior US Senator Charles Grassley, a Republican from Iowa and Senator Herb Kohl from Wisconsin, a member of the Democratic Party. The Act was designed to increase transparency and accountability in health care by publicly listing consulting fees, research grants, travel reimbursement, and other gifts received by US physicians and teaching hospitals from manufacturers. It is now incorporated into both the Senate health reform bill (America’s Healthy Future Act of 2009, S.1796, section 4101) and the House-passed health reform bill (Affordable Health Care for America Act, HR.3962, section 1451). Most would agree the law has probably succeeded in its sponsor’s intent but with some broader consequences. The process of complying with the law has resulted in subjecting even the most routine and necessary business interactions between HCPs and manufacturers to undue scrutiny and encouraging the public and regulators to cast a suspicious eye on all entities covered under the program.
This is a case of good intentions producing an undesirable side effect and should serve as a cautionary tale for regulators in the UK, where reports indicate that something much akin to the Sunshine law may be in the works for UK physicians and medical suppliers.
It seems The Daily Telegraph, a morning UK English language broadsheet newspaper, has been looking at the alleged activities of select employees of the National Health Services (NHS), a UK Government agency. The newspaper has reported on compromising statements made to its undercover reporters in which some officials praised the lavish accommodations provided to them by pharmaceutical firms and boasted of their ability to influence others in their purchasing decisions.1 The Telegraph article specifically notes that NHS England and Jeremy Hunt, the Health Secretary, have stated that the newspaper’s investigation “raised the question of whether the Government should legislate for full disclosure of payments made to health professionals.”2
These revelations have raised the question of whether this will drive the creation of a UK Sunshine Act in the future. At present the UK market follows the guidelines of the Association of British Pharmaceutical Industry (ABPI) which requires that companies who hold membership within the association are required to report transfers of value made to health care professionals in order to be in compliance with the European Federation of Pharmaceutical Industries and Associations (EFPIA HCP/HCO Disclosure Code) The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the pharmaceutical industry operating in Europe. Through its direct membership of 33 national associations and 39 leading pharmaceutical companies, EFPIA is the voice of EU representing 1,900 companies committed to researching and developing new medicines around the world. Besides the foreshadowing of a potential UK Sunshine to come, one might ask whether the UK Anti-Bribery Act comes into play here also. Now I am not a lawyer nor do I play one on television, but the UK Anti bribery Act3 seems to provide general scope around the intent of advancing ones business by providing improper influence to others. The Act is concerned with bribery. Very generally, this is defined as giving someone a financial or other advantage to encourage that person to perform their functions or activities improperly or to reward that person for having already done so. So one could take the perspective that this regulation could cover seeking to influence a decision-maker by giving some kind of extra benefit to that decision maker (in this case, formulary committee decision makers), rather than by what can legitimately be offered as part of a tender process.6
As transparency is rapidly expanding as a global movement, it will be interesting to see what transpires with the Daily Telegraph investigation and its aftermath as well as with the evolving application of US legislation. Here, again, there are cautionary examples.
For example, another US law that I became quite familiar with when engaging international healthcare providers for consulting work is the Foreign Corrupt Practices Act (FCPA). The Foreign Corrupt Practices Act of 1977, as amended, 15 U.S.C. §§ 78dd-1, et seq. (“FCPA”), was enacted for the purpose of making it unlawful for certain classes of persons and entities to make payments to foreign government officials to assist in obtaining or retaining business. Foreign Government officials and physicians? Apples and oranges, one might think, but when you look at it from the socialized medicine point of view, 58 Countries in the world have a universal, socialized, government subsidized / owned healthcare system. This can mean the physicians and its hospitals; those that the Life Sciences Industry interact with and have associated transfers of value for are government employees!7 The penalties for violation of the FCPA can be stiff. Several firms that paid bribes to foreign officials have been the subject of criminal and civil enforcement actions, resulting in large fines and suspension and debarment from federal procurement contracting, and some of their employees and officers have paid significant fines and gone to prison. Unfortunately, many industry colleagues feel that the US Sunshine / Open Payments Program effectively spoon-feeds data to and can support FCPA violations galore, inviting creativity on the part of those with prosecutorial inclinations.
This potential should serve as a caution to UK legislators as well as a reminder to our own of the slippery slope involved in legislating human perfection. Surely there are less onerous ways of advancing the goal of ensuring ethical behavior.

1. http://www.policymed.com/2015/07/could-undercover-report-on-drug-company-relationship-with-nhs-pave-way-for-uk-sunshine-law.html
2. http://www.policymed.com/2015/07/could-undercover-report-on-drug-company-relationship-with-nhs-pave-way-for-uk-sunshine-law.html
3. https://www.gov.uk/anti-bribery-policy
4. https://en.wikipedia.org/wiki/Universal_health_coverage_by_country
5. https://en.wikipedia.org/wiki/National_Health_Service_(England)
6. http://blogs.wsj.com/pharmalot/2015/07/27/uk-may-require-doctors-to-report-their-financial-ties-to-drug-makers/
7. http://www.sgrlaw.com/resources/%20trust_the_leaders/leaders_issues/ttl15/836/


Contributed by:


Susan Hill, SVP, Global Products & Solutions, AHM

Susan joined AHM in June of 2013 and is responsible for the oversight and management of AHM’s Global Business Development and Solutions and Marketing team. With over nineteen years of experience in the Life Science industry, Susan brings experience in business development, product marketing, and new technology investment and optimization.

August 12, 2015

A sampling of statistics prove the point; we are in a high speed (and high intensity) age. Consider that there are five babies born every second1; that there are an estimated 20 million billion...

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A sampling of statistics prove the point; we are in a high speed (and high intensity) age. Consider that there are five babies born every second1; that there are an estimated 20 million billion bits of information moving around our brains every second of every day2; or that when a drug is held back from the market for any reason, it means a loss of sales. In the case of a true blockbuster drug, that could amount to $4-5 million dollars per day in lost revenue3.
No wonder we are all working and living at the speed of light trying to be leaner, faster – chasing money, power, success and a wilder, ride out of life! Don’t pause, don’t reflect. You win or lose. You’ll fall behind and fail if you stop moving. Fast at any cost is the mantra of a stressed American society today. Does anyone have time to reflect on who they are, what they are doing or more importantly why they are doing it in the first place?
What if this speed in which we live and work has consequences? Physical, mental and spiritual consequences…and yes even financial ones. Discovering one of the latest blogs from eyeforpharma, http://social.eyeforpharma.com/; “Exploring the Power of Purpose” spoke to me in many ways and addresses the need to define the WHY in which we do things as well as what makes an organization and its constituents excel.
We all are used to rolling out of bed after hitting the snooze button once or twice reciting…”time to make the donuts” with our to-do list of the day hanging over our head. Who actually thinks of the why of what they are doing? The company you work with, what is their why? Great leaders often inspire us by leading with the purpose for which they operate, their why. Author Simon Sinek’s Start with Why reviews what sets organizations apart from each other – what makes them great or, phrased a little differently, WHY are they great? And, WHY do they have loyalty from their customers?
A thought provoking question: What is your why? What is your organization’s passion for doing what it does? Does its why align with your why?
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Looking at the Life Sciences industry and the area in which I have spent over 18 years, I realize what gets me out of bed in the morning…my why. I recognized early on that there is a ripple effect among the stakeholders I serve. Life Sciences develop breakthrough therapies and medicines to save the lives of patients every day. Their slogans speak to their purpose: “Live to save Lives” or Pfizer’s often quoted slogan, “Working Together for a Healthier World®” Physicians spend almost a decade of post graduate study in order to understand and treat patients resulting in a healthier, more beneficial way to live. Patients seek medical care in order to live their longest, most impactful life for themselves and their loved ones.
So how does my work as a compliance and strategic solutions director expand out to these stakeholders? I believe that because we at AHM pursue solutions to remove barriers that can limit healthcare professional interactions and impede innovation, development of new modalities to treat diseases can thrive! Technology and services drive communication and collaboration amongst industry and private practice impacting patients globally – that is what we do. Why we do it: AHM remains committed to significantly investing in solutions that will “provide continuous efficiencies, enhance the customer experience, advance strategic decision making and ensure comprehensive compliance reporting to mitigate risk.” There is no one in the industry more committed to investing now and in the future to support its clients.
The good news…although we all are operating in a stressed, fast-pace environment with plenty to do and multi-tasking most of the time, our average life expectancy is on the rise at a current average of 78.8 years – so technically you may have a little bit more time to search for that why and deliver the what and the how because of your why than your ancestors before you.
So whether your WHY is personal: “You want your future bigger than your past;” or professionally driven “challenging the status quo,” the why needs to make you cry! After all, it is the WHY that leads us to the answers of who we really are.
 

1.CDC: http://www.cdc.gov/nchs/fastats/life-expectancy.htm
2.Life Expectancy 1900’s: http://demog.berkeley.edu/~andrew/1918/figure2.html
3.DiMasi, J. A., Hansen, R. W. & Grabowski, H. G. The price of innovation: new estimates of drug development costs. J. Health Econ. 22, 151–185 (2003)

 

Contributed by:


Lisa Keilty, Global VP of Compliance and Strategic Solutions, AHM

Lisa joined AHM after serving as founder of the Compliance Consulting firm PMC2 and spending over 26 years in the life sciences and meeting management industry. Leading such organizations as Pfizer, Bristol Myers Squibb and Biogen Idec through numerous international projects, financial transparency and reporting requirements, Lisa’s industry expertise has saved Life Sciences and Meeting Management organizations over 30 million dollars. As a member of the Business Development team, Lisa’s primary focus will be Thought Leadership, Demand Generation and Solution Design.

August 5, 2015

So many of the issues facing the world today demand perspective – at least in the dictionary definition of the word, namely, “a true understanding of the relative importance of things; a sense of...

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ThinkstockPhotos-180256577
So many of the issues facing the world today demand perspective – at least in the dictionary definition of the word, namely, “a true understanding of the relative importance of things; a sense of proportion.”When it comes to the vastly important field of medicine, regulations and guidelines are critical. A variety of structures and frameworks keep chaos at bay, regularizing treatments around accepted, clinically proven practices and delivering outstanding outcomes. These guardrails have evolved over time through regulatory agencies such as the FDA and professional organization such as the AMA, as well as through the evolution of law and practice.Sometimes, the process gets skewed. Thus, sadly, one of the most vital aspects of medical progress is now under threat; sacrificed to a well-intentioned but clumsy regulatory framework that aims to protect consumers from the presumed excesses of marketers at medical and pharmaceutical suppliers.
Because of a few seemingly egregious practices in the past that may have influenced the judgement of a small minority of medical practitioners, an entire ecosystem of vital information exchange is now clouded by suspicions and encumbered with onerous and deadening reporting requirements. Of course, the ultimate loser is the patient.
The professional events that attract practitioners encompass far more than company sponsored presentations, though company presentation are in fact extremely useful. They provide an environment for intense information exchange among practitioners. Outside of medical school, the opportunities for practitioners to spend this kind of quality time at the leading edge, sharing experiences, information, and ideas with peers, are few and far between. And they are invaluable. Sandra Raymond, CEO and president of the Lupus Foundation of America, made essentially this point in testimony to Congress when she stressed that up-to-date and detailed information is vital to patient care, especially regarding less familiar ailments and conditions.
Physician education is a vitally important cornerstone of providing great medical care, whether delivered through Continuing Medical Education (CME), office visits, or larger scale sponsored meetings, doctors thrive on abundant, quality information. Their rigorous training makes them inherently impervious to the kind of simplistic promotional strategies employed by suppliers in other industries. They are simply too smart. That’s why the public need not fear quality medical information shared through these mechanisms.
For now, the expressed desire by physicians for more and better information and for exchanges with peers has so far kept regulations from stifling this process, as explained in our AHM white paper, Promotional Programs Thriving in Open Payments. Despite the added complexities involved, physicians continue to participate in interactions with industry because they desire the education, value exchanges with their colleagues and peers, and because they have a pressing need to address key issues that their patients and their practices face.
We think the goal of ensuring practitioner objectivity is a good one. However, Congress and the regulatory community can do better. Guidelines, reasonable transparency, and above all good old fashion professionalism, are the best ways to advance medical practice and keep the lively and critical dialogue going amongst medical professionals and the enterprises that support medical advancements.
Whatever regulatory framework is devised, it needs to be clear and reasonable. Also testifying, Alan Bennett, senior counsel at Ropes & Gray and co-leader of the Medical Information Working Group, citing recent case law that could undermine the current regulations, tried to make the importance of free information clear. Bennett added, that a “patient and his or her physician should have access to the best information, for which companies are the most valuable source.”
And, whether it is in the arts, science, technology, or medicine, creativity and innovation only thrive with open communications.


Contributed by:


Lisa Keilty, Global VP of Compliance and Strategic Solutions, AHM

Lisa joined AHM after serving as founder of the Compliance Consulting firm PMC2 and spending over 26 years in the life sciences and meeting management industry. Leading such organizations as Pfizer, Bristol Myers Squibb and Biogen Idec through numerous international projects, financial transparency and reporting requirements, Lisa’s industry expertise has saved Life Sciences and Meeting Management organizations over 30 million dollars. As a member of the Business Development team, Lisa’s primary focus will be Thought Leadership, Demand Generation and Solution Design.