Schwartz EVP and Healthcare Practice Leader Lloyd Benson takes on the question of how best to time a medical device product launch for greatest public relations impact in a new white paper. We invite you to download "Medical Device Product Launches: Issues & Answers About Timing."
Lloyd's perspective on the question of "when to launch" is informed by Schwartz's work over the years with what we believe to be the PR industry's largest portfolio of medical device clients. A small sampling of our work, which has reached patients, physicians, payors, advocacy groups, hospital management and others, includes introductions of:
- Philips Medical Systems HeartStart home defibrillator - Cyberonics VNS Therapy for pharmacoresistant epilepsy and VNS Therapy for treatment-resistant depression - NxStage System One portable home hemodialysis machine - CYTYC (now Hologic) ThinPrep Pap test - Hologic Cervista HPV test
He notes that product launches are like "one-pitch softball--you only get the one pitch to swing at. It's not going to happen again in the product's lifetime. So it behooves the healthcare PR pro to closely examine all possible alternatives in terms of timing and effectiveness." Lloyd believes that the received wisdom among many medical device executives causes them to allow that singular PR opportunity to pass them by, effectively turning what could be a chance to reach tens of millions of people into just another press release that crosses the wires unnoticed.
Take a look at the white paper, or drop the Schwartz Healthcare Practice a note if you'd like to talk more about product introductions, seeding the market before regulatory approval, raising awareness of a product already on the market or revitalizing an established brand. We look forward to talking about your company's communications needs.
The eagerly anticipated HITECH Act's final rule on "meaningful use" of Electronic Health Records (EHRs) was announced yesterday by HHS Secretary Kathleen Sebelius. It clarifies how doctors and hospitals can qualify for federal aid when they adopt EHRs. At stake: Up to $27 billion in incentives over the next ten years - $44,000 max per clinician under Medicare and $63,750 per clinician from Medicaid. Hospitals also stand to receive millions from "meaningful" EHR implementations.
Lack of definition on meaningful use had stalled many EHR implementations, especially at smaller hospitals, while leaving vendors in a painful wait-and-see position. Last January, many vendors, healthcare organizations and physicians groups like the MGMA contributed their suggestions to a definition during the public comment period, hoping to influence a ruling that didn't position them out of the stimulus-fueled market.
Yesterday's announcement outlined a definition by the Centers for Medicare & Medicaid Services (CMS) on minimum requirements that providers must meet through their use of certified EHR technology to qualify for stimulus dollars. Listed are a "core" group of requirements - like e-prescribing - that must be met, plus an a la carte "menu" of procedures from which providers may choose. This approach is meant to have teeth, but also give providers flexibility to pursue their individual needs. While certainly lowering barriers to federal dollars (and market barriers to vendors), some point out that this also dilutes quality. Many, however, are relieved – and thankful for the public comment period – as the initial “all or nothing” approach, as first outlined, meant that many organizations would likely have not even tried to qualify, fearing they couldn't possibly meet the stringent criteria needed to get funding.
In addition to the final rule on meaningful use, the U.S. Department of Health and Human Services' Office of the National Coordinator of Health Information Technology (ONC) also issued a rule identifying the standards, implementation specifications and certification criteria for EHR technology. But, as ZDNet Healthcare points out, "the companies which will do the certifying have yet to be chosen, after which vendors will have to line up to assure customers of stimulus cash." Assuming their technology is certified, many healthcare IT vendors now have the opportunity to help physicians improve the various processes outlined in the a la carte menu.
More and more, B2B companies are finding Facebook valuable for sales and marketing to facilitate communication with clients and prospects, and to help drive business forward.
About a year ago, long-standing client Margaret Mayer, marketing director of Boston Software Systems, attended one of Schwartz Communications’ seminars about social media and was intrigued as to how her company could benefit from these communications methods. Margaret decided to test the Facebook waters.
Boston Software Systems is a virtual company with 25 people, 23 of whom work in different locations. Although small, it does a big job helping hospitals and other healthcare organizations save hundreds of hours and tens of thousands of dollars through its workflow automation tools.
Margaret set up Boston Software Systems’ Facebook page and added some links and information, but wasn’t very active on it. She wondered about the value of Facebook for her company and customers.
A member of the Boston Software Systems team at Schwartz, Kristen Perry, noticed that the page wasn’t set up for maximum impact. She suggested turning it from a Profile, as an individual would use, into a Fan Page, which has a more professional appearance and functionality and is geared toward businesses. There is also the question of setting up a Group.
Groups are great for organizing on a personal level and for smaller scale interaction around a cause. Fan Pages are better for brands and businesses that want to interact with their fans/ customers without having them connected to a personal account, and that have a need to exceed Facebook’s 5,000 friend cap.
Kristen also outlined some reasons why it’s a good idea for companies to have a Facebook Fan Page: • It improves search engine results. Facebook pages now appear among the top entries in Google search results. • It’s easy for people to remember (particularly if it’s a shorter URL) and for companies to promote. • It encourages discussions. Fans of the page, by nature, are interested in the company and are more likely to engage in discussions.
Setting up the Fan Page and moving the current fans and links would take time, but Kristen was up to the challenge, and Margaret was pleased and relieved. Kristen describes the process of setting up a Fan Page:
• Before setting up a Fan Page, the administrator needs his or her own Facebook account. Designate someone who can manage the Page and add content regularly. If you also have a solid and trusting relationship with an outside communications agency or marketing consultant, you could also give that person rights as an administrator to keep tabs on the Page’s status and to ensure it has fresh content. If you happen to end your relationship with that agency or consultant, you can remove them as an administrator.
• Recently, Facebook updated one of its most business unfriendly controls by giving page administrators the ability to remove other administrators, regardless of who created the page. This was announced late last week on the Facebook Page for Facebook Pages. Previously, the creator of a page had rights above all other admins, due to the fact that they could never be removed.
• Go to the page to set up a Username and click “Set a username for your Pages.” Be sure to check the Username that you select as you cannot change it. Many companies use Facebook pages to talk about an issue or technology idea. It is a good idea to choose a username that authentically represents your business or brand. You can have it link back to your website and improve search engine optimization.
• Fill out basic company info in the Info tab, including date founded, description of the company and number of employees. You can also start building content on the wall with messages and announcements. It is important to write the company description in the little “About” box with keyword-dense prose to enhance search engine optimization. This holds true for the Info section, where you can also add high priority links.
• One important SEO strategy that should be employed on your Facebook Page whenever feasible is placing keyword-dense prose as close to the top of the Page as possible.
• After you’ve set up your Fan Page, promote it by adding the Facebook icon link to your Web site for easy access. You can also add it to your boilerplate and email signature. Consider linking your Facebook page with your company’s Twitter handle and LinkedIn page. For an extra investment, you can set up an ad, although so far we haven’t seen great value in the ads from a customer adoption perspective.
• Populate your Fan Page with links to interesting content, company news, events or industry news, and start sending messages to your fans. You can load Notes, start a discussion, add photos of people, products, company events, trade shows and screen shots. It is important to keep the information fresh, updated and give your fans a reason to visit and interact.
• Build your Fan base by contacting friends and colleagues already on Facebook. You can also send a note to the fan base from the old site and ask them to get onto the new one. Once people start becoming fans of Facebook pages, their friends will see it on their status. This offers a possibility that they too will show interest and Fan the page.
Once you have 25 or more fans, you can create a custom URL or vanity label for your Fan Page. Although not critical, it makes the page’s URL much more manageable. By adding links to their email signatures, promotional email and other outbound marketing efforts, Margaret and her team at Boston Software Systems are actively encouraging their customers to ‘Become a Fan’ of the Page.
Boston Software Systems is much happier with the company’s new Facebook Fan Page as it presents the B2B company in a more professional manner and allows easy interaction with stakeholders.
May is treating the Schwartz team well. Last week, the team was recognized with a SABRE Award in "Research for Publicity" for its work in "Research for Publicity" on behalf of Javelin Strategy & Research.
The Schwartz team and Javelin combined professional and social media to promote Javelin's annual identity fraud report, increasing media coverage 126 over previous years, and a whopping 97 percent of all articles emphasizing at least two key messages.
In addition to Javelin, some terrific clients were recognized as finalists: medical device company Bioness, antivirus and desktop security software provider ESET and boutique healthcare investment services provider Leerink Swann. Although they didn't take home trophies, it's the first time Schwartz has emerged with four finalists in the SABRES and the work remains outstanding.
There's a great case study on Schwartz's work with Bioness, including a campaign that delivered $4M in sales leads. Check it out!
The intersection of PR and SEO for B2B healthcare and technology companies is My Current Obsession. Naturally, then, I'm fascinated by how Google works. We all know it's a Google world, right, but I care in particular about Google's treatment of news releases and content generated by the media.
I was interested, then, in last week's BusinessWire post on "Why Your Release Might Not Make it Into Google News." Not often, but every now and again a client doesn't find their release on Google News and they wonder what happened. Sometimes they ask us to "call Google and fix it." Tragically, we can't do that, so it's going to be easier to write the release in the first place to maximize its chances of getting picked up by Google News.
In the BusinessWire blog entry, Joseph Miller lists four reasons that releases may not be indexed by Google News: the release is too short (fewer than 125 words), too large (e.g., an earnings release with huge associated tables), appears to be fragmented into unrelated bullet points and, most important, the title is too long. Specifically, Mr. Miller says, a news release headline shouldn't exceed 22 words.
Really long press release titles should be avoided because they're clumsy, of course. Beyond that basic guideline, we've understood for some time the importance of prominently including keywords in press release headlines to improve SEO--they should appear toward the beginning of titles. It's useful to also know now that verbose headlines not only don't help SEO, they likely hurt it by causing releases to be tossed out by Google News altogether.
Say what you will about the effectiveness of conferences in the marketing mix--there are still a lot of shows that companies feel they have to attend in order to see and be seen. In the case of Schwartz client BioImagene, that conference is the annual meeting of the U.S. & Canadian Academy of Pathology (USCAP).
BioImagene is one of the companies that dominate USCAP and their PR team is working overtime to support the show presence. So it was nice for everyone to see a blog entry, "BioImagene PR Doing It The Apple Way," from New York-based pathology resident Karl Robstad, M.D.
Dr. Robstad offers, "In an industry that, at least in my opinion, lacks some of the excitement in spreading the word about their newest and best products/services, BioImagene is a real stand-out taking a page out of Apple’s handbook, by creating mystique and hype around product releases, and then following the hype up with grand spectacle unveilings."
He continues, "You can look at stuff like this and call them 'PR stunts' or whatever, but I think there is a certain amount of merit behind a good PR campaign."
We'd agree, Dr. Robstad, and thank you for noticing. It's all about generating the sort of visibility that makes the BioImagene sales team happy and that underscores how a company that was founded a few years ago is altering a century-old industry.
The BioImagene booth was hopping at USCAP last year. Here's to an even more successful 2010 event later this month.
This photo from euthman is covered by a Creative Commons license.
Following are additional impressions from HIMSS 2010, Atlanta contributed by Schwartz Communications colleagues Dave Close, Nigel Smith, Dana Conti, Mercedes Fereck…
• Bloggers vs. reporters: There is hardly a difference in the healthcare IT market. Prominent bloggers like HISTalk attract big readerships - large enough to host their own party and awards ceremony on the same night as Healthcare Informatics’ Innovators Awards Event. At a client’s press briefing, bloggers sat next to top tier outlets like Modern Healthcare, providing their own perspective and reporting on the news. Take Anthony Guerra for instance. He is the former editor of Healthcare Informatics, who is now leveraging his CIO contacts to write stories on his new site healthsystemCIO.com
• Booth Gimmicks Abound: From the aforementioned DeLorean, to a specially constructed basketball court featuring former Harlem Globetrotters to Tiki-themed lairs and Vespa giveaways, HIMSS once again featured some pretty memorable booths. I can certainly appreciate the scenery, but it seems somewhat "Mad Men" retro and a bit silly to see companies still hire beautiful young women to draw traffic into the booths. Every spokes-model in the southeast must have been at the GWC. How do you stand for seven hours on six-inch heels?
• Wither the CIO? There weren’t as many hospital CIO types roaming the show floor as in years’ past. Many we spoke with said the CIO was an “endangered species” at HIMSS and most who did attend were there as a guest of a vendor. So, HIMSS this year was mostly vendors talking to vendors, with the most likely business outcome being strategic partnerships down the road, or planting seeds for a future merger or acquisition.
• Testing The Waters: This year at HIMSS, Schwartz met with a number of general technology vendors who were there to “test the waters” of the healthcare vertical market and/or to gather information on healthcare IT certification.
When you convene a group of leading healthcare journalists, in front of a room full of healthcare PR professionals, sometimes there's no telling what you might hear. Journalists and PR folk, especially healthcare PR agency specialists, have a bit of a love hate relationship. We both need each other, for different reasons of course, and in light of the different media world we live in today, it's more critical than ever that we best understand how we can help each other. As a PR practitioner, I'm most concerned with finding creative and impactful ways for my medical device, biotech and biopharmaceutical clients to get their message out to their key target audiences. The game has changed and in fact continues to change on what often seems like a minute-to-minute basis. OK, maybe I'm exaggerating but you get the point.
To that end, we prepared a special report with our takeaways from this session, thoughts on how the media environment is altering communications strategies and ideas on how healthcare companies can capture the right mix of influential mindshare. Is it shocking that healthcare journalists are busy (no), have fewer resources (no) and have less time to pursue feature-based stories (no)? How about the fact that several of the reporters we heard from have yet to jump on the social media bandwagon? Probably not shocking, but interesting, yes especially when the media organizations they write for are knee deep in trying to drive eyeballs to their respective Web sites via the multitude of social media tools and channels available. Check out the report and read on to uncover the good, bad and the ugly of what to expect in 2010. Feel free to opine on our blog with your thoughts and observations, we would love to hear from you.
The January 24th edition of the Sunday New York Times ran a Page One Investigative report on the perils and dire consequences on the use of radiation in medical diagnostics and cancer therapies. The lengthy report, put together by an investigative team of six people, left the reader chilled and saddened for the families of the two patients whose experiences formed the substance of the vast majority of the Times’ reporting. Indeed they suffered greatly as a result of what the Times inferred was a result of a human error and/or faults in complex technology. Rare will be the reader who will put the piece down believing as much in the safety and efficacy of radiation as when they began reading.
Yet the Report was both disconcerting and troublesome to me. As a healthcare public relations professional, I have indeed represented companies who had developed both radiation diagnostics and various types of therapies, yet even so, I found I was not biased by my professional associations. What really was disturbing to me was this quote found in the 9th paragraph of the 4 full page article.
“Without a doubt, radiation saves countless lives, and serious accidents are rare.”
OK. I get that—and I believe it. For many years radiation based protocols have been the standard of care and indeed gold standard in more procedures than I have time to list here. And this knowledge, juxtaposed with the Times reporting of yesterday is totally perplexing to me. I feel that the Times reporting was both sensationalistic and severely unbalanced. If they were to use all of that hugely expensive space in the Sunday paper detailing the potentially dangerous applications of radiation, would not a great deal larger amount of space be required to tell the stories of just some of the “countless” number of lives that the Times says radiation therapy has saved. I don’t get it.
Of course medical error and improper use of new and different technologies are serious problems. They deserve to be covered and extensively reported on. But to run such an emotional and one-sided account as the Times did, disappoints me. Not only as a healthcare PR Pro, but also as an informed potential patient. I love the Times. It is my favorite newspaper and a ‘must-read’ every day. But in this case they fell far short of their usually high journalistic standards. And in doing so, carried out an injustice to their readers by painting a picture that only tells a small, small part of the story.
Jim Weinrebe presented his perspective on the role social media is playing in crisis communications management for biotech, life science and pharmaceutical companies at the Publicity Club of New England's "Crisis Communications Preparedness" program held at Schwartz Communications.
Jim, along with his fellow panelists, weighed in on the need to plan, plan, and then plan some more as it's still at the root of any good crisis communications or reputation management plan for healthcare PR. Simply put, you can't be too careful, or too prepared in today's digital media age. It's not so much that many of the fundamentals have changed but that the SPEED, unbiquity of communication and new product applications in social media, with Google Sidewiki offered as just one recent example, have the potential to outpace the planning capabilities of some of even the most seasoned practitioners.
What's very different today in healthcare, according to Jim, is diminished ability of healthcare prescription product manufacturers to control, manage or even respond to messages that are swirling around them in the social media universe. With the prolific growth in use of Twitter, blogs, Facebook, YouTube, Flickr and other channels, social media content is not only broadly influencing people online, but also becoming a feeding ground for resource-constrained traditional media outlets that are constantly seeking audience generated content to embellish their reporting. The news vetting bar has never been set so low for provocative content that can get instantly posted and then picked up by influential traditional broadcast and print outlets in the blink of an eye.
While one of the fundamental rules for participation in social media is to actively listen, Jim also noted that even this basic aspect of social media etiquette poses difficult challenges for healthcare prescription product manufacturers, who could be accountable to the FDA for reporting instances of adverse events that have been identified through social media monitoring. It was noted that the industry is seeking clarity from the FDA on these and other issues related to social media, which could be at least partially forthcoming in pending public hearings on this topic in mid-November. Until such guidance is established, Weinrebe noted, prescription healthcare product manufacturer participation in social media will be very modest, and for the most part resembling more of a web 1.0 than a web 2.0 format. Meanwhile, Weinrebe said that social media has more potential to create or accelerate crisis for healthcare prescription product manufacturers. Exceptions in healthcare cited by Weinrebe were organizations like the Centers for Disease Control and American Red Cross, and even individual hospitals, who have employed sophisticated uses of social media to help effectively manage and communicate messages during public health emergencies and crises.
Jim noted that in regulated industries, such as healthcare and finance, there is still a lot of work to be done in educating senior management about the need to apply authenticity in tone to social media communications, even if the communications are nothing more than stand-by statements or simple acknowledgment that a problem has occurred. Jim counseled attendees to consider social media monitoring tools as a core part of an effective public relations strategy, while at the same noting that many healthcare product manufacturers need more guidance on adverse events reporting before even that approach can be robustly implemented.
While the healthcare industry waits with suspense for the outcomes of the FDA hearings on social media, Jim noted that clarity will not be achieved in the short term, that the deliberations will continue well into 2010 and that even by that point and beyond, a certain degree of ambiguity may still be desired by regulatory agencies as a means for cultivating preemptive manufacturer caution.
Last week, I had the opportunity to speak at a panel discussion at NortheasternUniversity, "It's Time To Brand Yourself" sponsored by the Boston Alumni Networking Exchange, the College of Professional Studies and the Communications Alumni Network. The discussion, moderated by Dr. Carl Zangerl, College of Professional Studies, Northeastern University, focused on a topic that's near and dear to all communications professionals - personal brand building.
I was joined by Michael Armini, vice president of marketing and communications at Northeastern University, Ted Chaloner, president of Chaloner Associates and Lauren Libitz, president of the Yankee Chapter of the International Association of Business Communicators (IABC). It was a fantastic line-up and each panelist brought a unique and interesting perspective to the more than 70 attendees who showed up for the program. With terrific questions and comments from the studio audience, my fellow panelists and I opined on the current job outlook for communications and public relations professionals, the concept of personal branding, the importance of networking and the different social media tools available including Twitter, LinkedIn and Facebook, to create and promote a personal brand.
Whether you are currently employed or on the hunt, establishing a personal brand is important and something that bears relevance and utility to both an employee and a job seeker. The whole idea of a personal brand certainly isn't new but with the advent and popularity of social media tools it's quickly become a key buzz word in a challenging economic environment. I think building a personal brand is very similar to building a brand, and a strategy, for a company. The same rules apply. All the tools in the world won't do you any good unless you have a clear, consistent and differentiating vision to communicate. Further, coming up with the vision is just the first part of the challenge, the second part is figuring out which social media tools to employ. There are so many out there and it's challenging to know which ones to dabble with but my recommendation is to try a few at a time. Start slow, get recommendations relevant to your industry and observe others before jumping in head first. And, just remember, keep your personal and professional brand separate !
Jim Weinrebe, executive vice president and leader in our healthcare public relations practice, will join several panelists on Monday, October 26 at Schwartz Communications for a Publicity Club of New England panel program to talk about crisis communications preparedness.
As much as we try to avoid them, crises are inevitable and usually strike at the most inopportune times. The emergence of social media alone has exponentially increased the urgency and need for being prepared. When the pressure is on, it is important to get the facts in order as quickly as possible before any public communication is disseminated and determine the key target audiences that need to be addressed. The pre-determined crisis communications team should be prepared to deliver relevant information in a timely and appropriate manner to minimize the rumor mill and restore order and/or confidence. It's absolutely critical to have a crisis communications team and protocol in place before an emergency or potentially controversial situation strikes.
Jim will be joined by several leading industry executives to discuss effective crisis communications protocol and offer insight into real world case study examples. More specifically, Jim will provide insight into managing a crisis in healthcare PR. Participants will walk away with an understanding of what works, and what doesn't, when under the gun and how to best prepare an effective crisis communications plan in a time of turmoil. To register for the program, please visit www.pubclub.org. Space is limited so please reserve your spot!
Perhaps no single item in recent memory has generated as much curiosity and interest from healthcare PR Pros and marketers than has the growing phenomenon broadly titled "Social Media". Social Media can be broadly defined as a whole group of new communications channels that enable a more direct and conversational dialogue between medical device, pharmaceutical and biopharma companies and their key constituencies--including patients and clinicians.
The interest in Social Media is being driven by a confluence of two factors. First--dramatic changes in the more traditional media channels typically used by healthcare companies. Print. Broadcast. Radio. The economic downturn has reduced both the number of outlets that healthcare companies have used to reach key audiences as well as the sheer time allocated to healthcare stories. Second is the advent of rapidly emerging technologies that enable a shift from the "one-way" nature of traditional media to a more conversational or cocktail party approach to engaging audiences.
Together, these two factors are stimulating whole new areas of opportunity for the healthcare or medical public relations professional and the companies they work for. But there are challenges as well.
Recently Schwartz Communications held a Webinar that provided an overview of the types of Social media programs available for medical device companies, but it is applicable to all types of healthcare companies as well.
Over the weekend, I saw a Tweet (http://tinyurl.com/ljjwla) that the Heart and Diabetes Center NRW in Bad Oeynhausen, Germany, performed the 800th implant of the SynCardia CardioWest™ temporary Total Artificial Heart (TAH‑t). Congratulations SynCardia! Back in October 2004, in my capacity as PR counsel to Syncardia, I was at the FDA Panel Meeting when it approved SynCardia’s CardioWest temporary Total Artificial Heart as a bridge-to-transplantation in cardiac transplant-eligible candidates at risk of imminent death from non-reversible biventricular failure. What an exciting time for not only the company who spent years and years working on and perfecting the device but also for physicians and patients whose lives were greatly changed—and saved—by this amazing device. I spoke with numerous patients including a cyclist who is an award winning member of the Transplant Olympic teams who had a second chance of life after being implanted with the CardioWest device. I am thrilled that more than 800 patients have since benefited from this device.
While this was the pre-Twitter, Facebook era, SynCardia made headlines news—from cover stories in its local Tucson papers to the New York Times to the Wall Street Journal to the Associated Press. This was one of the most exciting, heartwarming (excuse the pun) launches I ever worked on and will stay with me forever.
We spoke with Bjarte Reve, CEO of Oslo Cancer Cluster. The Norwegian cluster is a collaboration between pharma, biotech, research institutions and hospitals, patient groups and other organizations committed to making a difference for cancer patients.
Check out what Bjarte had to say about their initiative.
This year’s Massachusetts Biotechnology Council Annual Meeting provided a sober look at the state of the Massachusetts biotech industry and what the cluster must do to succeed in the years to come. Our world-class teaching hospitals and academic institutions, our talented scientists, physicians and researchers coupled with a vibrant VC community has resulted in Massachusetts being a world leader in the industry, but according to the council, other states and even countries are fast on our heals of potentially claiming the “super cluster” position. While Massachusetts has enjoyed being the launch pad for exciting companies like Genyzme and Biogen, today’s “rising stars” and even companies that are not yet formed but are a glimmer of hope in a scientist’s eye based on a patent or piece of IP, now face new, bigger challenges due to today’s economic conditions. The key theme of the day’s presentations was the importance of greater collaboration among industry, academia and venture capitalists. In order for the Commonwealth to not only survive today’s economic landscape but more importantly, prosper and maintain our leadership position, it will be key for these organizations to work together.
According to the MBC’s 2015 Strategic Report which was released at the conference, scientific collaboration and innovation is a critical linchpin to the success of the state’s biotech industry. The report discusses the need to better align the academic community with industry to improve collaboration and to address technology transfer processes taking innovation from the bench top to industry. Unlike other biotech powerhouse cities like San Francisco and San Diego, tech transfer doesn’t happen as seamlessly in Massachusetts. One of the calls to action was development of a consortium of academia and industry, so that the gene discovery and validation process that occurs in the academic setting can then be developed by companies with the funds and means to build accurate models and implement clinical trials. Without this technology transfer, we won’t see progress.
While it may seem ironic to say that I found the Economic Outlook session uplifting, it provided some clarity on where the industry is heading and it’s not all bad! Moderated by Xconomy Founder, CEO and Editor-in-Chief Robert Buderi, the session discussed on how the recession actually presents us with a tremendous opportunity. While pharma generally bets the bank on a blockbuster drug, nimble-minded biotech companies should focus on a “niche-buster” and be creative and adaptive in clinical trials. It is these companies who will come out standing—many of whom get their start here in the Bay State.
The MBC continues to host interesting, thought-provoking meetings that provide valuable forums for discussion, networking, collaboration and innovation.
One of the more interesting recent medical stories to hit the mainstream media was the news that for the first time, the FDA has cleared the use of embryonic stem cells in human clinical trials. This particular trial will use a stem cell line developed by Geron, Inc. of Menlo Park, CA and will be implanted in people who have suffered acute spinal cord injury. As somebody who has actually seen the Geron-developed video of the stem cell’s affect on paralyzed mice walking and running after having been implanted with the Geron cells, the raw potential of the therapy is breathtaking. Of course, it will take many years of rigorous scientific testing in people to determine both safety and efficacy. This first small 10-patient trial however is an important first step.
What is curious and thought provoking about this news is its timing. The public debate over embryonic stem cells has been raging for many years now. Embryonic stem cells, as their name suggests, are derived from embryos. Specifically from embryos that develop from eggs that have been fertilized in vitro and then donated for research purposes, with the informed consent of the donors. The debate became a political ‘hot button’ issue when in 2001, the former Bush administration precluded public funding of additional stem cell research beyond 31 specific stem cell lines—ironically of which the Geron cell line was one. The Geron cell line was developed without public funding using instead the private capital markets. The public funding issue was largely perceived as a political gesture toward conservative supporters of President Bush as well as an extension of former President Bush’s own religious beliefs. To which of course, he is certainly entitled as are we all.
During the course of applying to the FDA for clearance of this trial, Geron submitted a 21,000 page Investigational New Drug (IND) application to the FDA, believed to be the largest and most thoroughly documented science that the FDA has reviewed in its history. The company says that the application detailed more than 24 separate animal studies of its product that established both safety and efficacy in animals. A lot of this scientific data had appeared in peer-reviewed publications over the years of development, including a study published seven years ago that showed efficacy in rats. As the FDA laboriously poured over the data during the years of the Bush Administration’s tenure, more people suffered from acute paralysis and investors bounced Geron’s stock up and down.
Then on January 21st, only ONE day after the Obama Administration took office, the FDA, suddenly and without warning, announced clearance of the Geron trial. While much of the news reporting on the clearance focused specifically on the scientific importance of the trial, a few intrepid reporters openly speculated that the change in the White House had immediate impact on FDA policy. This is a topic worthy of discussion. Was the timing simply a coincidence? Or did the Bush administration tacitly impose its own political and/or ethical views on the FDA? The job of the FDA is difficult. It must ensure that the safety of the public is held paramount and at the same time carefully guide new products and technologies through a process that allows new therapies to get to the marketplace after appropriate review. To add a layer of “politicization” to this process does not serve the public or the government. The science of medicine is after all transparent to personal belief or religious conviction—and politics.
The American Heart Association's Annual Scientific Sessions wrapped up in New Orleans last week and for the first time in two years, there was no embargo-gate debate.
Maybe the AHA took a page from the "No Drama Obama" campaign.
What's the fuss all about? For publically-traded healthcare companies, presenting data at a prestigious medical conference like the AHA is mostly a blessing----major stakeholders including clinicians, investors and the media are all focused on news from the conference.
Yet navigating conflicting embargo policies can be a real challenge. For example, consider a Company that has highly-anticipated trial results in hand weeks before it's scheduled to present at a "Late Breaking" session.
One on hand, SEC Reg FD rule encourages companies to announce material news almost immediately. Yet conference organizers have strict policies about releasing data prior to the conference. If the data is being simultaneously published in a medical journal like JAMA or NEJM (as the JUPITER study was this year), add another layer of complexity.
Often times, companies are forced to announce top-line data prior to the conference, without being able to paint the full picture. After weeks of market speculation, the embargo is lifted.
During last year's AHA meeting, this predicament prompted Eli Lilly's CEO to write a WSJ Op-Ed entitled, "The Media on Drugs." He explained "NEJM and AHA asked for promises from Lilly and its partners, and we agreed, not to disclose any of the results prior to Nov. 4. Such guarantees of exclusivity are not only common, but also appropriate, in focusing expert attention on important research." In 2006, the AHA pulled Pfizer from the Scientific Session agenda for pre-releasing data. CNBC Reporter Mike Huckman blogged about an embargo-gate episode at the 2007 ACC conference.
What's a company to do? There is no clear cut answer. The data results, size of company and the anticipated impact of the stock all play factors in deciding the best course of action.
In the next post, we'll outline a few recommendations for a company in this situation.
