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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?
ThinkstockPhotos-186505203
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.