Posted on Fri, Jan 20, 2012 @ 04:20 PM
Welcome to The JFK Download - JFK Communications' video blog. This inaugural edition of The JFK Download, David Patti, Senior Vice President, JFK Communications, discusses the latest FDA Guidance, "Responding to to Unsolicited Requests for Off-label Information About Prescription Drugs and Medical Devices," and what implications this guidance has on the healthcare communications industry.
Read the full FDA Guidance here.
For more information on The JFK Download, please contact Michele Beyer, mbeyer@jfkhealth.com.
We welcome your comments!
Posted on Tue, Dec 13, 2011 @ 10:47 AM
Recently, I had the opportunity to read a colleague’s article on tips for managing difficult clients and was struck by the realization of how simple conversations can seem so complex for many account managers. When you peel back all of the “issues” surrounding account management, the underlying cause of agency-client tension is often either results or budget – and they are often intrinsically linked. One could argue strategy and results (or lack thereof) are the root causes, but I believe it’s really about getting value for the money.
At its core, public relations is a relationship business -- and one of the leading causes of tension in both personal and professional relationships centers around money. In a distressed economy, this issue becomes magnified. Every dollar counts, and is counted. We are in an unprecedented time of fiscal accountability from scrutiny over how long it takes to write an article to how much a staff member paid for a cab ride. I’m sure we would all (clients and agencies) like to return to the days when securing a budget didn’t require a three month process, a vial of blood and DNA testing – but until those days return (if ever), we are stuck with the reality of today’s economy.
Learning how to communicate about money should be taught at the earliest grade levels, because it’s a communications skill that will follow you throughout life. Taking the first step and opening a dialogue about fiscal responsibility at the beginning of a client relationship will not only avoid future conflict but will serve to set boundaries between agency and client.
Understanding your professional and personal boundaries is a key aspect of account management, as it sets the tone for what is and what is not acceptable behavior and demands. It also mitigates the emphasis on money and redirects the dialogue to expectations and performance. Understanding what value means to a client and how to help them showcase that value will help smooth the road for future budget discussions.
Also, it is critical to take the time to understand your client’s experience level. We are seeing an increasing number of clients who are new to public relations or who have been asked to manage several departments, one of which is PR. For these individuals, establishing the basics at the beginning of the relationship becomes paramount, as some have limited experience with public relations agency billing practices, budgets and measurement.
At the end of the day, regardless of client experience or any other variable, it’s paramount that an agency understands what value and results mean for each individual client. Providing clear, transparent information on a weekly or monthly basis is an excellent way to achieve that goal.
The more well rounded the relationship, the less likely issues will quickly escalate to become potentially damaging to the relationship and the account.
So don’t be afraid to engage your client in tough discussions about budgets. Nor should clients hesitate to engage their public relations agencies in the same manner. Open dialogue about budgets and expectations will ensure a well-rounded relationship that can grow in the good times and weather storms in bad ones.
Do your discussions with clients about budgets look something like this?
If so, then it's time to change the conversation.
--David Patti
Posted on Fri, Dec 02, 2011 @ 11:55 AM
As we head rushing towards the end of 2011 and look ahead to 2012, a young man’s (or in my case, a relatively young-ish healthcare communications professional’s) thoughts turn reflective.
Therefore, let’s review what 2011 meant to the life sciences industry, and let’s make a wish list of some of the things we’d like to see (or never see again) next year. I know that some members of our industry would much rather drink battery acid than re-live the events of 2011, but those who fail to learn from history are doomed to repeat it. So humor me.
Here’s a quick summary of what we learned this year:
The Industry is Changing: Deal With It
If anybody thinks that the biopharmaceutical industry is somehow going to go back to what it was in the 1990’s, then a nice, comfy padded cell may be in your future. Let’s face it folks, those days are over. Too much has changed. The total number of pharma job cuts since 2009 is approaching 150,000, and approximately 300,000 pharmaceutical industry jobs have been cut since the year 2000. The majority of these job cuts were at the world’s largest pharmaceutical companies, and many of them were the result of consolidation due to M&A activity, operational cost cutting and significant sales force reductions.
An increasingly pedantic regulatory environment, lower returns than ever before on R&D investment and operating costs in Big Pharma limiting which drugs can be profitable for them are factors unlikely to change without a total transformation of the industry and the regualtory system. Also, comparative effectiveness is coming. I believe that a comparative effectiveness model similar to NICE in the UK will evolve here in the US as we continue to grapple with escalating healthcare costs and decreasing returns on healthcare investment.
The good news is that in 2011 we saw a number of new drug approvals from smaller, more nimble companies.
A Life Sciences Industry Wish List for 2012
So, what would you like to see in 2012? What lessons can we take into the New Year?
1. Please Don’t Supersize Me
The supersizing of the pharmaceutical industry, which began in earnest in 2000 when Pfizer bought Warner Lambert, has contributed significantly to the industry’s decline. In other words, in a quest to satisfy the ever-increasing demands of shareholders, life sciences companies have pursued a strategy that has significantly contributed to the destruction of their own industry. Supersizing has ultimately resulted in downsizing. Metaphysically, this makes sense (what goes up, must come down), but as a business strategy, it sucks.
2. Boutiques are Beautiful
I think as we head into 2012 and beyond, the life sciences ecosystem will evolve to a much more focused, specialized “boutique” model where mid-sized and small life sciences companies will thrive. In fact, I wouldn’t be surprised to see one or two Big Pharmas restructure themselves to more closely resemble boutique specialty pharmas. The name of the game going forward is agility, flexibility and speed. These are not attributes that are typically characteristic of industry behemoths.
3. Smarter Procurement Policies = Better Value and Results
On the agency side, it has been pleasing to see that procurement philosophies have been evolving at leading life sciences companies. Just a few years ago, unless you were a supersized, big global healthcare communications agency that sent in senior VPs to pitch the business and then staffed it with fresh faced twenty-somethings who a just few months ago were playing Hacky Sack on some college campus, Big Pharma didn’t even want to talk to you. Now the tide seems to be turning, as life sciences companies are once again realizing the value that mid-sized and small independent agencies can deliver. There are always going to be assignments where only a big, global healthcare communications agency can do the job. But I would argue that there are many marketing challenges where smaller independent healthcare communications companies can provide breakthrough ideas and programming much more cost effectively than the big guys. The time has come to give us all a seat at the table, and let us compete where it makes sense for us to do so.
Looking Ahead, Hopefully
So good riddance to 2011—a learning year, and a year of realignment for many—and bring on 2012. As an eternal optimist, I believe that there will always be abundant opportunities for companies and individuals who are passionate about our industry and are open to change. Because the only thing that is certain about the years ahead is that our industry will continue to adapt and evolve. And when things change, new opportunities are created for those willing to seize them.
Happy holidays everybody. See you all next year!
--David Avitabile
Posted on Thu, Nov 03, 2011 @ 02:31 PM
I had the privilege of speaking to members of the Life Sciences committee of the New Jersey Association of Corporate Counsel at their 3rd Life Sciences Forum which took place on Wednesday, November 2, 2011. I participated on the Forum panel that covered the topic of Crisis Recalls. As a career life sciences public relations professional, I was eager to share my crisis communications and issues management experience and best-practices.
During my career I have been involved with scores of Rx, med tech and diagnostic product recalls. By the time the public relations group is alerted, the corporate decision to recall has usually already been made and the FDA has already been notified. Depending on the scope of the recall, the role of public relations will vary. Regardless of the situation, the public relations group is always working against very tight deadlines.
To reduce response cycle time, stress and potential missteps, planning is paramount. In crisis recall situations the public relations group needs to be front and center with key publics and the global media community. So, their rapid ability to protect patients, protect the corporation, and protect the recalled “asset” can translate into millions of dollars of potential savings in both sales and market value of the corporation. A company’s reputation can be far more valuable than one product.
Finally, I implored the group that planning is mandatory because when it comes to product recalls, it is not an if, it is a when. Hope for the best, but prepare for the worst. Good public relations support includes a crisis communications plan that is designed to enable nimble action in the face of a myriad of product and corporate issues and crises. These plans must designate teams, prepare media spokespersons, empower decision makers and include chains of command, among many other critical details.
While it is impossible to anticipate and prepare for every detail, it is possible to create plans that prepare corporations for the majority of the issues they can expect to encounter. These plans should be in place today and reviewed every six months and mock-drilled annually.
Product recall crises will occur. However, through team work and planning, their impact can be minimized.
Posted on Thu, Oct 27, 2011 @ 03:31 PM
I recently published an article in O'Dwyers about the growth of social media among life sciences companies and how these organizations can engage responsibly.
The good news is that Life Sciences companies are embracing social media and engaging with stakeholders. The bad news is that the FDA, despite hosting a well attended and highly publicized public hearing on social media and FDA regulated medicines in 2009, has issued no guidance to industry regarding this issue.
I believe that healthcare communications companies, and in particular healthcare public relations companies, can play a crucial role in helping life sciences companies harness the power of social media. Public relations, at its heart, has always been about connecting with stakeholders in ways that are authentic, creating context and building dialogue.
You can check out my O'Dwyers article by clicking here.
Posted on Wed, Oct 19, 2011 @ 03:39 PM
I was invited to present at the Social Media Summit held at Harrisburg University of Science & Technology on September 14, 2011. My talk, which took place within the “Life Sciences” track of the summit, focused on the role of social media in the Rx pharmaceutical industry.
My primary message is that pharmaceutical companies, despite lack of clear direction from FDA, can and should engage its constituents through social media channels. However, social media engagement must be implemented responsibly, as part of an overall digital strategy and should be an ongoing endeavor.
JFK Communications is at the forefront of digital communication services for the life sciences industry. Our expertise spans across various digital and social media platforms such as Facebook, Youtube, Twitter and Linked In. We also support a diverse group of life sciences categories including pharmaceutical, biotechnology, medical devices, medical diagnostics, as well as key life sciences service providers such as CROs, CMOs and payers.
My presentation is here, and you can view the presentation videos here.
Posted on Thu, Sep 29, 2011 @ 02:20 PM
Reuters has an interesting story about a revolutionary new approach to drug development that could lead to the emergence of an entirely new R&D model for the life sciences industry.
Looking for ways to improve R&D productivity, some pharmaceutical companies are pooling their resources and embarking on an open source, patent free approach to drug development. Similar to the model that brought us the Linux operating system and the Firefox web browser, leading life sciences companies including Eli Lilly, Pfizer, GSK and Novartis have invested in the international Structural Genomics Consortium (SGC), a public-private partnership dedicated to the discovery of new medicines through open access research. The group has secured $49 million in new funding so far.
With all research findings made available to scientists all over the world without restriction, at least through to Phase II in clinical development, life sciences companies are hoping that an open source model will uncover new directions in research that can lead to innovative new treatments for cancer, neurodegenerative diseases and more. The hope is that individual pharmaceutical and biotechnology companies will be able to build on the open access research to develop products of their own. One of the key benefits of the open source model is in cutting out wasted time on the wrong molecules and duplication of effort, because everybody will have access to the same research.
This bold step raises a lot of questions, particularly about how life sciences companies will navigate IP issues, where the business opportunities will be for individual companies, and how they can be leveraged. But I think this is exactly the kind of creative, out of the box thinking that is necessary for a new model to emerge that will allow life sciences companies to thrive again. It also creates new opportunities for smaller companies. Open access to the same data and resources as everybody else results in a much more level playing field.
I salute the leadership of companies participating in this initiative for taking the risk, jumping into the unknown and trying to do something completely different. It is refreshing to see.
Posted on Wed, Jul 27, 2011 @ 02:53 PM
I read a very interesting and thought-provoking article in the July 25th issue of The Wall Street Journal about the importance of regulatory reform to the success of personalized medicine.
The authors of the article, one an economist and the other a professor of medicine from Washington University, argue for major changes in how the FDA reviews and approves drugs. As I read this article, my initial thought was how very radical and extreme their ideas sounded; yet the more I thought about it, the more sense their recommendations started to make.
The current regulatory system requires drug companies to provide ample evidence of both safety and efficacy for FDA approval. Under the current system, estimated costs to bring a new treatment to market are between $1 and $1.5 billion. The largest portion of those costs goes towards clinical trials establishing efficacy. These costs have increased significantly over the past 20 years. Meanwhile, drug company spending on R&D has reached an historic high of $67 billion while providing consistently decreasing ROI in terms of new drugs being approved. At least part of the reason for this, I believe, is that our current regulatory system is arthritic and antiquated.
The current regulatory system in the United States has created an economic model that only supports new drugs capable of generating more than $1 billion in sales, and provides little incentive for innovators developing niche products targeting specific patient types and disease targets. In other words, exactly the kind of treatments and technologies required to truly be able to deliver on the promises of personalized medicine--which can be summarized as providing the right treatment, for the right patient, at the right time.
Michele Boldrin and Joshua Swamidass, who authored The Wall Street Journal article, propose the adoption of a "progressive" regulatory approach, initially for drugs to treat rare diseases and then, if successful, implemented across the board. They propose a system whereby the FDA can approve a drug once a company has established that it is safe for humans. The company will then be allowed to sell the drug at a predetermined price until further research is completed that establishes its efficacy--at which point the company will then be able to sell the drug at market prices.
People suffering from rare diseases for which there are limited treatments want access to as many new treatment options as possible. The regulatory reforms proposed by Boldrin and Swamidass could help make this possible by lowering drug development costs while providing strong incentives for life sciences companies to conduct further research to provide evidence of efficacy in order to maximize their ROI.
Personalized medicine is in many ways the antithesis of the blockbuster model of drug development, which most industry observers have long agreed is now well and truly dead. The blockbuster model of drug development was a logical response by industry to a regulatory environment that has driven drug development costs into the billions. If it costs you $1.5 billion to develop a new drug, you'd better be sure that drug has the sales and lifecycle potential to justify your investment.
For the promise of personalized medicine to be achieved, companies developing targeted therapies that will benefit a select group of patients suffering from a specific disease need to be able to afford to innovate and bring these new treatments to market. And to do that, the regulatory requirements for companies to get drugs FDA approved will need serious reform.
Posted on Wed, Jul 20, 2011 @ 03:34 PM
Never before have the risks associated with drug development been higher. According to PhRMA, the cost of bringing a new drug to market, approximately $1.3 billion, has increased 60% between 2000 and 2005. Further, according to recently published statistics, it can take up to 15 years for a new chemical entity (NCE) to progress from discovery to a marketed drug in the U.S. And a study released by the Biotechnology Industry Organization (BIO) in February 2011 revealed that the country's overall success rates in bringing a new drug to market are now almost as low as one in ten. This figure applies to new medicines moving through clinical trials to US approval between late 2003 and the end of 2010.
So, as FDA drug approval rates go down and regulatory pressures increase, innovative drug companies must ensure flawless execution of their drug development processes. Consequently, a practice that might have been considered heresy as little as five years ago has become one of the hottest trends in pharmaceutical development -- outsourced manufacturing partners.
When time is money (one day of delay in drug development can cost from $1 million to $4 million in lost downstream revenue), life sciences innovators are turning to formulation, manufacturing, packaging and supply chain solutions partners. Ideal partners can accelerate development timelines, reduce cost, reduce waste and mistakes and ideally become a seamless member of the drug sponsor’s development team.
Strategic partnerships with solutions providers can offer life sciences companies:
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Full service drug development, formulation, manufacturing, packaging and supply chain project management
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Methodological and technical competencies
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Best in class scientific expertise
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A variety of standardized processes and protocols
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A positive track record for working with regulatory agencies
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Infrastructure and capacity to produce a variety of drugs and delivery methods
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Highly trained technical personnel
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Improved efficiency and productivity
As drug development costs increase and regulatory requirements tighten, we expect to see pharma companies continue to move toward a more “virtual” model and increase the degree to which they partner and the openess of those partnerships. Keep an eye on the outsourced drug development and manufacturing industry to grow and expand its offerings from traditional services to include a variety of specialized niche technologies.
--John F. Kouten
Posted on Thu, Jun 16, 2011 @ 02:04 PM
A recent post from the June 14 Healthcare Blog is definitely worth a close read. Grace Marie-Turner outlines the dire challenges facing Medicare, and the contrasting views on how to change the program so that it becomes sustainable.
As both Democrats and Republicans do everything in their power to politicize this issue and demonize each other, it is worth taking a step back and looking at some of the realities underscoring why Medicare reform needs to happen, regardless of what side of the political fence you are on.
House Energy and Commerce chairman Fred Upton recently explained, “last year, Medicare expenditures reached $523 billion, but the income was only $486 billion — leaving a $37 billion deficit in just one year. And with 10,000 new individuals becoming eligible each day, it’s only going to get worse.”
Senator Marco Rubio (R-FL) captured it best in a new video, saying, “Medicare will go broke in as little as nine years … and anyone who is in favor of doing nothing to deal with this fact is in favor of bankrupting it.”
Currently the Medicare reform proposal attracting the most attention comes from House Budget chairman Paul Ryan. Ryan’s plan gives baby boomers the option of private coverage in a plan that works much like the one members of Congress have today.
Under Ryan’s plan, beginning in 2022 beneficiaries would be guaranteed a choice among Medicare-approved private health options. As the Congressional Budget Office notes, plans would have to issue insurance to all people eligible for Medicare who applied.
Without a serious course adjustment, Medicare is at risk of becoming a third-rate, price-controlled program that rations a lower quality of care through waiting lines and other restrictions. If the current model isn’t reformed, then we will either need to continue to pour deficit-funded dollars into the program or raise taxes to levels that would topple the economy as millions of baby boomers hit retirement.
Albeit painful, these facts are real and will not simply go away with time.
--John F. Kouten