Mobile Healthcare Communications Conference for 2012

Posted in Social Media

Increasingly, healthcare professionals, patients and consumers are turning to and using their mobile devices for healthcare information. Further, development of mobile software platforms and associated are allowing patients to more regularly directly communicate with their physicians. To help sort out the growing complexity of the mobile healthcare communications industry, the Business Development Institute (BDI) entitled “Mobile Healthcare Communications 2012:Case Studies and Roundtables” will be held on Thursday, January 26, 2012 from 8:00 AM to 1:00 PM at The Graduate Center of the City University of NY (365 5th Ave, NY, NY 10016).

Registration fee for the event is $195 per attendee. BioJobBlog readers who wish to attend should use promo code BC for a discounted rate of $175.

Speakers and roundtable moderators include:

  1. Lance Hill, CEO, Within3
  2. Scott Hopkins, Executive Vice President, Anderson Direct Marketing
  3. Dr. Katherine Malbon, Assistant Professor of Pediatrics, Division of Adolescent Medicine, Mount Sinai Hospital
  4. Talya Miron-Shatz, PhD, Marketing Department, Wharton, University of Pennsylvania 
  5. Jenna Mons, Consumer Product Manager for LAP-BAND®, Allergan 
  6. John Vieira, Daiichi-Sankyo

Event sponsors include:

BioCrowd, PR NewswireWithin3 ; Anderson Direct MarketingCinchcastJournal of Communication in HealthcareManhattan ResearchNew York UniversitySociety for Healthcare Strategy and Market DevelopmentPixels & Pills

For event related questions and registration, please contact Maria Feola-Magro at mfeola@bdionline.com or 212.765.8043.

For sponsorship/speaking opportunities, including pricing, please click here or contact Jennifer Brous at jbrous@bdionline.com or 212-765-8358.

For additional information, including registration, please click here to visit the event website.

See you at the conference!

Until next time….

Good Luck and Good Job Hunting!!!!!!!

EyeonFDA Blog: Why FDA Needs to Be Clear About Social Media

Posted in Social Media

Mark Senak, author of the EyeonFDA blog and a life sciences/healthcare social media enthusiast, wrote a fantastic piece yesterday that provides cogent ideas and insights into the need for FDA to expeditiously craft guidance on the use of social media in the pharmaceutical and healthcare industries.

Here are the facts. First, according to the Pew Internet and American Life Project, social media has fundamentally changed the way in which we interact with one another and ushered in a new era of communication. Unlike the old, so-called “broadcast communication method”—information is continuously streamed from a static source, websites, television, radio etc, to perspective customers and stakeholders—the new paradigm requires that communications must be personal, portable and participatory for effective messaging. Second, the primary source of information sought by most persons who use the Internet is healthcare and medical information. While much of the content is accurate, some is not; which may put persons seeking medical information at great risk. In other words, social media is not just about marketing and medical education; it is also about preserving public health.

The agency has historically been unable to issue guidance on new forms of communication. For example, FDA held its first public meeting in 1996 on Internet use by life sciences and healthcare companies. Sadly, the agency has yet to issue any official guidance on this topic. In late 2009, FDA held another public meeting and promised that draft guidance on the internet and social media would be forthcoming by the end of 2010. Unfortunately the guidance did not materialize in 2010 and it has been delayed twice in 2011. Recently, the agency publicly reaffirmed its commitment to issuing the guidance but without a specific timetable for its release. Consequently, it is anyone’s guess when or if the guidance will be released.

Unlike many, I do not believe that FDA guidance on the Internet and social media is absolutely necessary. However, I will admit that issuance of said guidance will provide drug and healthcare companies with some of the assurances that they need in order to actively use social media to engage patients, physicians and other stakeholders. For this reason alone, FDA ought to issue the guidance (which is never perfect and always a work in progress) and end the social media stalemate that currently exists. Failure to do so may have serious consequences on the public health of many Americans.

Hat tip to Mark!

Until next time…

Good Luck and Good Job Hunting!!!!!!!!

 

Alternate Career Options: So You Want to Be a Medical Science Liaison (MSL)?

Posted in BioJobBuzz

One of the new “hot career” opportunities in the life science industry is something called a medical science liaison or MSL. Increasingly, graduate students and postdocs are beginning to mention MSL as a possible career option. Of course, the first thing that I ask these persons is “Do you know what an MSL is or does on a daily basis?” In most cases, most of these would-be MSLs sheepishly admit that they don’t!

With this in mind, I invited Dr. Samuel Dyer an experienced MSL and CEO and Founder of the Medical Science Liaison Corporation and MSL WORLD to better inform those who may be interested in pursuing a career as an MSL.

What is a Medical Science Liaison?

By Samuel Dyer

The MSL is a therapeutic specialist (e.g. Oncology, Cardiology, Infectious Diseases, Central Nervous System) within pharmaceutical, biotechnology, medical devices, and clinical research organizations (CRO) who has advanced scientific training and generally a "terminal D" degrees in the life sciences (PhD, PharmD, MD).  It’s important to note that MSL’s are not sales reps and their function is very different.  The primary purpose of the MSL role is to be scientific or disease state experts for internal colleagues (sales and marketing), but more importantly for doctors in the Therapeutic Area of the Medical community in which they work (i.e. Oncology, Cardiology, CNS etc.).  The focus of the role has changed over the years, but the primary responsibility of the MSL role remains to establish and maintain peer-peer relationships with leading doctors, referred to as Key Opinion Leaders (KOL’s).

Medical Science Liaison’s (MSLs) were first established by Upjohn pharmaceuticals in 1967 as a response to the need for professionally-trained field staff that would be able to build rapport with Key Opinion Leaders (KOLs) in various therapeutic areas of research. Although originally called Medical Science Liaisons by Upjohn, over the years and today, pharmaceutical companies have used various names for the role including: Medical Liaisons, Medical Managers, Regional Scientific Mangers, Clinical Liaisons, and Scientific Affairs Managers among others.  

Originally, the first MSLs were selected from experienced sales representatives that had strong scientific backgrounds to bring a higher degree of clinical and educational expertise to the medical professionals they were working with to influence sales. Over the years, MSL teams have been made up of individuals with various scientific backgrounds including: “super” sales reps, those with nursing backgrounds, those with various doctoral level degrees or other clinical backgrounds.  However, the required educational and scientific background and purpose of MSL’s has progressively changed over the years since they were first established.  In the late 1980’s, a number of companies began to require those applying to MSL roles to hold a terminal “D” degree such as an MD, PharmD, or PhD degrees.  

Although, historically, the educational standard in the industry did not require MSL’s to have a terminal “D” degree, however, today the terminal “D” degree has become standard in the industry.  Today according to one benchmark study more than 90% of current MSLs hold terminal “D” degrees.  

While the MSL role has received some attention, including a CNN Money article entitled "#1 Job in Pharmaceuticals-10 Jobs for Big Demand-Good Pay”, it remains one of the best kept secrets and one of the most difficult roles to break into.  Few people know about it, and little is written about the role.  In fact, the MSL community is quite small when compared to other professions in the pharmaceutical industry however there has been an explosion in the growth of the position. According to a recent benchmark study, there has been an average growth of 76% of the MSL role since 2005 across the industry in the U.S.

To learn more about the MSL role and find free resources go to www.mslworld.com

Until next time…

Good Luck and Good Job Hunting!!!!!!!!

 

Social Media Update: US Food and Drug Administration To Regulate Mobile Apps?

Posted in Social Media

Mark Senak, author of the highly informative and well written Eye on FDA blog, reported today that a recent article that appeared on the American Medical News website suggests that the US Food and Drug Administration (FDA) may be considering regulating mobile apps that contain medical or clinical components. While the agency has yet to officially publish guidance on the use of social media in the life sciences industry, it now appears that FDA may be turning its attention on the development of mobile apps; one of the fastest growing segments of the social media movement.

The reason why FDA is taking notice of mobile apps is because a handful of app developers have sought and received FDA clearance for their mobile apps that—because of clinical components —are considered to be “medical devices.” As many of you may know, medical devices which include band-aids, surgical instruments, heart monitors, cardiovascular stents and diagnostic kits, all must receive marketing approval by the agency before they can be sold in the US. Although the agency yet to craft any guidance for clinical/medical app development, it makes sense that FDA ought to evaluate and regulate these products to insure that they are medically-effective and safe. 

According to the American Medical News article, the first app developer to receive FDA market clearance was AirStrip Technologies in San Antonio, for its AirStrip OB application. The app, which was approved in 2009, allows physicians to monitor mother and newborn remotely during delivery. In February, the FDA granted clearance to MobiUS, an app developed by Mobisante, a medical device company in Redmond, Wash. The app permits viewing of medical images for diagnostic purposes. Mobile MIM, a remote diagnostic imaging tool developed by Cleveland-based MIM Software, was also granted market clearance that month. A number of pharmaceutical companies, most notably Pfizer, have been extremely active in the mobile clinical app development space.

The reason why it makes sense for FDA to regulate certain clinical/medical apps is because physicians will rely on them to make medical decisions. For example, the AirStrip OB mentioned above will ostensibly allow physicians to remotely monitor a mother and neonate during delivery. Consequently, the app, aka device, must be evaluated by the agency to determine whether or not it can be used safely and effectively by physicians during childbirth. In this case, the app is similar to a heart monitor that is used during childbirth. And, like all other medical devices, the heart monitor required FDA clearance to determine its safety and effectiveness, before it could be used in real-life childbirth situations. To that end, the agency has hinted that it will be much more proactive in monitoring this new class of devices.

I have no doubt that many pharmaceutical companies and medical devices manufacturers will not be pleased when they learn that the agency is going to “stick its nose” into mobile app development. Nevertheless, in my opinion, if a mobile app is going to be used in possible “life or death” situation, then it ought to be regulated by FDA—the agency that is legally responsible for regulating these types of products. That said, Eye on FDA’s Mark Senak raises a number of valid and insightful points about FDA and its possible role in mobile app development.

“Related to a possible guidance for apps, there are a lot of questions that need to be answered when considering its development – when is an app a medical app?  When does it require regulation?  Who will pay for the oversight – will there be App Developers User Fee Act (ADUFA?) and if so, what will that do to the price and to access.  Will insurance companies have to cover apps?  And what will the process for approval be – something like a 510(k)?”

Finally, I think that the app developers who proactively approached FDA for guidance abut the clinical apps that they were developing “got it right.” This will get the agency “thinking” about clinical/mobile apps and how they ought to be approved and regulated in the future. In turn, this will provide future app developers with a clear regulatory framework that will guide the development of cost effective, safe and efficacious mobile clinical apps.

Until next time…

Good Luck and Good Job Hunting!!!!!!!

 

Over 50,000 New Healthcare IT Jobs Will be Added in the Next Few Years

Posted in BioJobBuzz

The $789 billion American Recovery and Reinvestment Act that was passed in 2009 included funding for the Health Information Technology for Economic and Clinical Health (HITECH) act to promote the adoption of electronic health record (EHR) technology in health. Beginning next year, doctors and eligible medical providers can receive Medicaid incentive payments over a five-year period if they adopt a certified EHR technology platform and adopt so-called "five goals" established by the Centers for Medicare and Medicaid Services

The act is expected to create more than 50,000 new health information technology (HIT) jobs. With many hospitals and physicians making the transition from paper charts to electronic medical records, there is a growing demand for specialists trained in the latest medical record technology. Recognizing the surging demand for HIT workers many universities including two- and four- year colleges and for profit institutions like DeVry University have created HIT certificate and degree programs.

There is no question that HIT professionals will be in high demand over the next decade or so. That said, if you have an interest in biology or medicine and like IT, HIT may be a good career choice for you! Don’t wait; act now.

Until next time…

Good Luck and Good Job Hunting!!!!!!!

 

Mobile HealthCare Applications Represent the Next Frontier in the Life Sciences Industry

Posted in Social Media

While the debate rages on over the use of social media in the life sciences industry, industry experts and insiders have largely ignored the growing importance of mobile healthcare and its use by healthcare professionals and patients. Consumers and professionals are increasingly using their mobile devices for healthcare information. They are also interacting with healthcare providers and colleagues on their mobile phones. 85% of US consumers have cell phones and growing vs. only 65% of Americans which have broadband access. Further, the divide between mobile use and broadband Internet access is increasing. According to a Manhattan Research report 70% of Physicians say PDAs/Smartphones are "essential" to their practice.

Because of the growing importance of mobile healthcare communications, the Manhattan-based Business Development Institute decided to organize a conference around this theme. The primary goal of the conference is to address the following questions:

  1. How do healthcare brands connect and interact with consumers via mobile strategies?
  2. How do healthcare brands connect and interact with healthcare professionals via mobile strategies?
  3. What are the leading technologies being used for mobile strategies?
  4. How do you deal with regulatory hurdles when implementing mobile campaigns?
  5. How do you integrate your mobile strategies into your enterprise-wide marketing, communications and social media platforms?
  6. What are the leading monitoring and measuring approaches/technologies being employed for mobile campaigns?

Person giving presentations at the meeting include:

Lance Hill, CEO, Within3
Ray Kerins, Vice President/Worldwide Communications, Pfizer Inc.
Marc Monseau, Director, Corporate Communications and Social Media, Johnson & Johnson
Todd Siesky, Public Relations Manager, Roche Diabetes Care
 
Date: Wednesday, January 19, 2011
Time: 8:00 a.m. – 1:00 p.m.
Location: The Graduate Center of The City University of NY; 365 Fifth Avenue; New York, New York 10016
Registration Fee: $195
Website:http://www.bdionline.com/mobilehealthcare.html

For more information, including registration, please click here to visit the event website. Use promo code BC for a discounted rate of $155.

Please contact Steve Etzler at setzler@bdionline.com or 212-765-8045 for additional information.

See you at the meeting!

Until next time…

Good Luck and Good Job Hunting!!!!!

 

Possible "Side Effects" of Online Patient Communities

Posted in Career Advice

I want to state at the onset of this post that I am an ardent supporter of online patient communities because I believe that the exchange of information between people who suffer from the same or similar medical conditions is vital to their health and well being. Further, I believe that social media will force physicians, the medical community and the US healthcare system to become more transparent, open and interactive. That being said, in this past Sunday’s New York Times, Natasha Singer wrote an extremely revealing article about some possible, unforeseen “side effects” associated with membership in online patient communities.

The reason why these online communities exist is for patients to commiserate with one another and exchange personal stories and medical information. While personal stories may be emotionally satisfying for patients, it is their medical information and demographic data that is extremely valuable to drug makers. To that end, many online patient communities inform their members that they reserve the right to share information and data for research purposes. And many of them do!

To be clear, I am not suggesting that the people who create or manage online patient communities have avaricious, nefarious or otherwise unsavory ulterior motives for the medical and patient demographic data that they collect. However, these communities need to generate revenue in order to stay in business and drug makers are willing to pay for access to it.

According to Singer, the popular PatientsLikeMe community admits that it sells health and medical data gathered from member profiles (but with certain identifying information removed) to pharmaceutical companies and others for scientific and marketing research purposes. Further, a large number of unbranded “disease awareness” pages have recently begun to appear on Facebook and YouTube. In her article, Singer contends that “drug companies may pay people to moderate patient forums [in the community] or give testimonials but might not prominently display that fact to participants. Other sites collect consumer health data to help drug makers’ aim at specific kinds of consumers, using psychological cues.” At a medical communications meeting that I attended several years ago, a MySpace sales rep freely admitted to me that it allow pharmaceutical companies to mine profile data in order to develop targeted marketing campaigns. Is Facebook next?

Finally, while the Health Insurance Portability and Accountability Act of 1996 (HIPAA) restricts the way health care providers use and disseminate patients’ information, consumer health websites and online patient communities aren’t subject to its privacy provisions. In other words, there are no regulations guiding the privacy and use of medical information and data collected using social media tools! Essentially, this means that the persons who run online patient communities can do pretty much whatever they like with the medical and personal information that they collect!

As I stated at the beginning of the post, I am a social media enthusiast who subscribes to the notion that if used correctly, social media can help to better inform and improve the lives of people suffering from various disease. That said, I also believe that people who choose to participate in online communities MUST be fully informed about the potential uses of the personal information and data that they contribute. Until the Food and Drug Administration provides some regulatory guidance on the use social media to collect and disseminate medical information patients will be at the mercy of the entities that run online patient communities. Let’s hope that they see fit to “do the right thing.”

Until next time…

Good Luck and Be Careful What You Say Out There!!!!!!!!!

 

Nagging Concerns Persist About Continuing Medical Education

Posted in Career Advice

As part of their licensure requirements, all physicians and other healthcare providers (HCPs) in the US must participate in continuing medical education (CME). CME requirements are established on a state-by-state basis HCPs who fail to meet annual quotas face reprimand, censure and possibly loss of their medical licenses. As you may imagine, CME is a big business and, not surprisingly, there is no dearth of CME content developers and providers. Unfortunately, CME course development costs are high and, despite state mandated licensure requirements, no one seems to want to sponsor or underwrite the CME development programs except drug and devices companies. Obviously, this creates the potential for monumental conflicts of interest mainly because physicians and other HCPs are drug and device company primary customers.

While I don’t profess to be an expert on CME rules and regulation, I know that the rules and regulations that guide CME content development have become increasingly restrictive over the past few years. In the past, drug and devices manufacturers were able to identify relevant product-related topics within certain therapeutic areas, engage a CME provider to create a curriculum and then offer a product-focused program to physicians. Today, drug companies aren’t allowed to create CME program built around specific products. Instead, CME developers compete for grant monies from drug and device manufacturers and are asked to create CME around relevant issues in certain therapeutic areas. Of course, most of the companies that award the grants have products in those therapeutic areas; but i digress. Companies that award the grants cannot participate or influence the content that appears in the CME programs. Of course this is impossible!

For example, several years ago I was working at an agency that received a “grant” from a client that was developing a new treatment for a virus-associated metabolic syndrome. While we weren’t allowed to highlight or suggest specific treatment options we did receive in direct and subliminal guidance (through various company channels) regarding messaging around content development. To that end, while the company wasn’t directly involved in content development, its medical affairs and marketing departments were “aware” of the content that we were developing. While this was appropriate and well within regulatory guidelines, it is not difficult to see that potential conflicts of interest and bias may have existed in this instance.

Over the last year or so, questionable medical writing practices and conflict of interest concerns about CME course development have come under intense scrutiny in the US Congress. Consequently, there have been ongoing and repeated calls to prohibit industry participation in CME content development. While this may be a great idea, if drug companies no longer are allowed underwrite or sponsor CME course development, there isn’t likely to be any CME in the future. And, if there is no CME, physicians and other HCPs won’t be able meet state-mandated CME requirements to maintain their licenses to practice? What a conundrum!

One solution to the problem is to require state governments, the American Medical Association, university medical schools, hospitals and other organizations (insurance companies?) to underwrite CME development costs! After all, these are the entities that require CME for HCPs to retain their licenses. While this is a perfectly logical solution to a vexing problem, don’t expect any of them to step up to the plate anytime soon. The bottom line: drug companies support and underwrite CME because they recognize that it is a viable marketing vehicle—albeit a subtle one—that is certain to improve product awareness and ultimately sales. For example, if Pfizer sponsors a CME program on erectile dysfunction at a high end resort in some exotic locale and, its logo or mention of a grant to develop the curriculum is acknowledged, it is not unreasonable to assume that physicians attending the course may possibly choose to prescribe Viagra over a competitor’s product. To make matters worse, CME sponsors often time help to defer costs of hotel accommodations, provide support for meals, and even sponsor receptions for physicians who attend CME training programs.

I suspect that some of you may be wondering why I am ranting and raving about CME today. Well, there was an article in today’s New York Times about Stanford Medical School receiving an unrestricted, three-year $3.0 million grant from Pfizer to develop unspecified new CME curricula for physicians. Philip Pizzo, MD, dean of Stanford’s medical school lauds this as the beginning of a new age in CME and suggests that Pfizer will have no say on how the grant monies will be spent. 

Dr. Pizzo contends that the “no-strings-attached” provisions of the grant will insure that the new curricula will be devoid of drug industry influence that has permeated CME courses in the past. Stanford plans to set up “unbiased programs” of postgraduate education on the Stanford campus rather than the industry-selected topics of the past that have been presented to rooms full of doctors at hotels and resorts.” While the new grant sounds promising, I wonder whether or not Stanford is going to disclose the amount of research funding it annually receives from Pfizer. Further, will faculty members who receive or previously have received research monies from Pfizer be prohibited from contributing to content development?  The point I want to make is that, despite Stanford’s good intentions and assertions to the contrary, there is no way to insure that there will be no bias or conflicts of interest in the new curriculum that is developed. 

Finally, I don’t think that there is any question that CME is essential to insure that Americans receive the latest and best possible medical treatments that are available. However, to insure farness and no bias, drug makers and device manufacturers should not be allowed to underwrite or participate in CME content development. This activity should be in the purview of not-for-profit entities (that don’t receive drug industry money) and state government agencies. Like it or not, we live in a quid pro quo society and drug and devices companies (like all “for profit” companies) don’t make investments unless there is an anticipated or guaranteed return on the investment!

Until next time…

Good Luck and Good Job Hunting!!!!!!!!

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Antibiotic Resistance and Healthcare: A Telling Statistic

Posted in Career Advice

I have refrained from commenting on healthcare reform until now because there wasn’t much I could add to the debate. That said, while reading an article in a local paper on bacterial antibiotic resistance and how to minimize it, the author—an infectious disease doc—offered a telling statistic that identified the root problem with our current healthcare system. According to the article, 65% of the time, physicians will prescribe antibiotics to patients suffering from upper respiratory tract infections who demand them, whether or not they are warranted. In marked contrast, 12% of patients with upper respiratory tract infections who don’t ask for antibiotics receive antibiotic prescriptions. The bottom line: physicians give patients the drugs and treatment they demand because they are afraid of losing them as customers knowing full well the patients will go to another physician who will give them what they want! After all, physicians are in business and to stay in business they need to make enough money to cover their overhead and make a profit. However, over prescribing antibiotics is one of the main reasons why we are in the midst of an epidemic of infections caused by multiple drug resistant bacteria. In my opinion, business outcomes should never supersede or trump medical or public health outcomes.

Don’t get me wrong, I am an entrepreneur and believe that people with good ideas ought to be rewarded for their efforts and make as much money as they can. However, in my opinion, for profit business practices and healthcare haven’t historically worked well for the American healthcare system. Removing profit incentives from healthcare would be an important first step to begin to repair our broken healthcare system. Can anybody say public option?

Until next time…

Good Luck and Support the Public Option!!!!

 

The Annual Biomedical Research Conference for Minority Students Rocks!

Posted in BioJobBuzz

I just returned from the Annual Biomedical Research Conference for Minority Students (ABRCMS) that was held in Orlando from November 5-8, 2008. The annual meeting, which is configured like most life sciences conferences with plenary oral sessions and poster presentations, is primarily intended to expose minority students to possible career opportunities in the life and biomedical sciences. I was at the meeting working for FASEB Careers as a career development and resume critiquing consultant.  

I have to say that this year’s  ABRCMS was one of the most exciting and motivational meetings that I have attended in my career as a scientist and educator. Part of  the excitement and upbeat feeling at the meeting may have been a direct  result of last Tuesday’s historic election of Barack Obama (who wasn’t excited?).  Nevertheless, I met countless numbers of bright,  highly motivated and talented minority students who want to pursue careers in science, medicine and sometimes both! I was pleasantly surprised to learn that many of the undergraduate students who attend this meeting are actively engaged in basic research in laboratories at their institutions. Further, unlike many of their non-minority counterparts, most of the students who I chatted with were well informed about their intended careers and had divined well thought out strategies to help them realize their career goals and aspirations.

Kudos to the conference organizers and their sponsors! I look forward to attending next year’s conference in Phoenix, AZ.

Until next time…

Good Luck and Good Job Hunting!!!!!