Posted on Mon, Jul 26, 2010 @ 01:47 PM
Could the recent FDA approval of a generic version of Lovenox (enoxaparin) be the beginning of approvals of other complex molecules? We recall that the Biologics Price Competition and 
Innovation Act of 2009 found its way into the Health reform bill. The Biologics Act provides a pathway for biosimilars, however, grants biologics innovator companies 12-years patent exclusivity (http://tiny.cc/ymnj1). While biologics currently reside outside the current generics approval processes, it seems that “complex molecules” like enoxaparin do not. The developers of the generic enoxaparin, Sandoz, division of Novartis, are hoping to win approval next for a generic version of the “complex mixture” Copaxone for the treatment of multiple sclerosis. For more details on FDA’s position visit: http://tiny.cc/fvvve. For more information regarding Sanofi’s position, read their July 23 statement here: http://tiny.cc/zgib3.
Posted on Wed, Jul 14, 2010 @ 04:27 PM
As personalized medicine continues to become more of a reality, 
pharmaceutical, biotechnology and medical technology companies are finding ways to create new partnerships focused on building the future of medicine.
BioNJ's Diagnostics Committee, of which JFK Communications is a member, is hosting a free webinar keynoted by G. Steven Burrill, Chief Executive Officer, Burrill & Company.
This event is the first in a series of initiatives from BioNJ for global life sciences companies. Learn more about it, and register, by clicking here: New Jersey Gets Personalized – A series of initiatives from BioNJ to advance the Diagnostics industry and foster partnerships with biopharma companies in the State of New Jersey. How New Technologies are Changing Opportunities in the Diagnostics Industry, Creating Value and Encouraging Partnerships.
Posted on Wed, May 26, 2010 @ 11:05 AM
Personalized medicine has been a hot topic in life sciences for a while now. With
the clearly changing landscape in healthcare, and increased pressure on drug developers to maximize their returns and minimize costs, personalized medicine is more important now than ever before, and it is becoming a reality.
It is estimated that the majority of cancer drugs fail to deliver the outcomes for which they are prescribed. The promise that personalized medicine offers to patients is the potential to identify which individuals will respond to a particular drug. Think about the cost savings implications if the practice of personalized medicine can become standard operating procedure across all therapeutic areas.
There are also enormous potential benefits to full implementation of personalized medicine in clinical research and drug development. Consider the impact on clinical trial design, cost and success vs. failure rates for clinical research programs of drugs in development if the trial sponsors can screen and identify those patients most likely to respond to a potential new therapeutic at enrollment, and which patients should be excluded from the trial.
What is also very intriguing is to consider how many drugs that have "failed" using traditional clinical research models that could find new life in the era of personalized medicine. Drugs that showed promise but ultimately failed due to the inherent shortcomings of current clinical development protocols could be resurrected and ultimatley brought to market if found to be effective in specific patient populations identified using personalized medicine. Unmet needs in under served patient populations could be addressed, and investments in new therapeutic options could be justified as money well spent, rather than written off.
This is an area of great interest to me. I recently published an article in the Life Sciences Supplement to NJBIZ that explored some of these issues, and I look forward to what the future has in store.
Click here to download a copy of my article, entitled "Personalized medicine offers opportunity" published in the 2010 Life Sciences Supplement to NJBIZ.
Posted on Fri, Apr 09, 2010 @ 08:56 AM
With healthcare reform legislation signed by President Obama on March 23 2010, there's no doubt that along with changes to the US health insurance system, there will be a much greater focus on healthcare cost-containment in the years to come. Predictions on whether the impact of this legislation on the US pharmaceutical industry will be positive or negative are mixed.
What does this mean for healthcare public relations? Actually, on this issue, I'm bullish. I think there are a number of reasons why public relations has a major role to play in the changing healthcare environment, and I discuss them in a recent article I published in Communique Volume 16.
Most importantly, challenges such as communicating the very real differences between cost effectiveness as opposed to price when talking about a drug, biologic, device or procedure require the development of multifaceted, nuanced arguments. And public relations, more than any other marketing discipline, is best at framing complex issues, creating and mobilizing advocates and engaging in conversations with multiple stakeholders.
For these reasons, healthcare PR is alive and well in countries where healthcare cost containment has been in place for decades. As an American who lived and worked for eight years in the United Kingdom, you need only look at the vibrant, continuously evolving and highly creative UK healthcare communications agency business to see proof of that.
There is no doubt that changes in the US healthcare system will place new pressures on the life sciences industry to communicate in different ways. I believe that as a result, healthcare public relations will become a tool that these companies will rely on more than ever before.
For a PDF of the article I published recently in Communique 16, click here.
Posted on Thu, Feb 04, 2010 @ 03:34 PM
Nearly three months have now passed since the FDA's Division for Drug Marketing Advertising and Communications (DDMAC) held its hearing entitled “Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools.” So far the response from DDMAC and direction provided to industry can be measured by the almost deafening sound of crickets coming from the direction of Washington DC.
Hopefully, before we're too far along into 2010, DDMAC will provide constructive guidance to industry on the use of social media to communicate with patients. They certainly had plenty of feedback from interested parties during those hearings.
Posted on Fri, Dec 04, 2009 @ 11:14 AM
The In Vivo Blog has a very interesting discussion about a recent Pink Sheet/CMS Summit Panel discussion that suggested that the FDA may be practicing "stealth" comparative effectiveness through an increasingly greater focus on superiority data (rather than, I presume, non-inferiority data). Read it here at In Vivo.
The blog raises a number of interesting points, not the least of which is the question that is on many people's minds, including physicians, patients and industry: "is the FDA becoming too conservative?"
I believe that this question needs to be considered as part of the overall discussion, debate and analysis of issues such as the decline in new molecular entities, fewer first action FDA approvals, and fewer treatment options available for patients who need them.
A decline in R&D productivity has contributed to these issues to be sure, but I don't believe that industry is to blame for all of it. Open and honest discussion and debate is in the best interests of everybody, especially patients.
Posted on Mon, Nov 09, 2009 @ 09:40 AM
For better or worse, on November 12 & 13, 2009, the U.S. Food and Drug
Administration and its Division for Drug Marketing Advertising and Communications (DDMAC) will convene a hearing entitled “Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools.”
Sorry, if you didn’t register by October 9, you will not be able to attend in person; however, all are welcome to participate. Healthcare communicators, especially healthcare PR folks, should submit questions and comments to: “Electronic Comments,” identified with docket number FDA-2009-N-0441, at http://www.regulations.gov. Everyone can watch and listen to this hearing for free by registering here.
The hearing will be just that. Be prepared to listen to more than 80 (that’s right, eighty) 15-minute presentations by healthcare communication leaders from industry, academia, government, media and non-profits. And, for one who has endured my fair share of FDA hearings, don’t expect any action, other than the obligatory, “We thank all of you for coming, for your time and thoughtful insights.” “We will take all of your comments under advisement and will continue to compile outside comments and reconvene in 2010.”
We can expect that FDA and DDMAC will float a straw man document for comment in 2010. And, perhaps after another hearing, they might finalize new regulations in 2010. For those of us involved in healthcare communications, healthcare PR and medical communications, these new regs will help us reduce our risk of DDMAC violations. However, it remains to be seen if these new regs will help or hinder industry communication to physicians, patients and caregivers.
Posted on Fri, Oct 23, 2009 @ 11:18 AM
Do you want to lead? Remain teachable. This is especially true for healthcare communications and marketing professionals who want to engage the digital health consumer (in other words, all of us).
Next week, we'll be participating in the e-Patient Connections Conference in Philadelphia, organized by my friend Kevin Kruse. If you want to see a Who's Who of leadership in digital healthcare communications and social media, check out the speaker line-up and the program for this event.
So here's a Healthcare PR Blog shout-out to Kevin Kruse and his team a Kru Research for putting this meeting together.
I'm sure we'll have a few things to blog about following this conference. We look forward to seeing our friends and colleagues at this event.
Stay tuned.
Posted on Thu, Oct 01, 2009 @ 10:50 AM
With all the noise in the news lately about the healthcare reform battles being fought, there was some very positive news for the pharmaceutical, biotechnology and medical technology industries yesterday that I think may have gone unnoticed by many.
On Wednesday September 30th, President Obama announced a plan to spend $5 billion on medical and scientific research, medical supplies and upgrading laboratory capacity.
This is great news for the pharmaceutical, biotechnology and medical technology industries. Promising new treatments and technologies discovered as the result of NIH-funded research are usually developed and commercialized by private sector companies. More investment in NIH research means more opportunities for technology transfer to pharma, biotech and other companies through Cooperative Research and Development Agreements (CRADA). The list of successful pharmaceutical and biotechnology products developed as the result of CRADAs is extensive, and includes breakthrough cancer treatments such as Taxol and Velcade.
Government investment in medical research has contributed to enormous growth for the pharmaceutical, biotechnology and medical technology industries through technology transfer. Most importantly, these investments have improved the lives of millions of patients.
Posted on Fri, Sep 18, 2009 @ 05:58 PM
As a healthcare communications pro with experience in many therapeutic areas, I am always interested in how we can use our skills to improve patient's lives. In this information age, communication is power. I am excited about how, as strategic counselors, our ability to improve dissemination of information can influence companies and institutions to bring about improvements in patient care.
HIV/AIDS is a perfect example of how communications can change behavior and facilitate change. In just 25 years, what was once a diagnosis that meant almost certain death has now become for many a chronic condition that can be managed through a combination of medicines. In the history of medicine, this level of progress is unprecedented.
I don’t want to minimize the continued global threat of HIV/AIDS in many parts of the world, including inner cities and the developing world. This is an ongoing issue that demands sustained effort if progress is to be made in these areas.
But amazing progress has been made in understanding the disease and treating it, to the point where today many HIV positive people will never develop AIDS and will not end up dying of the disease.
How did this amazing progress happen in HIV/AIDS in less than 25 years, while in other areas like cancer, for example, certain diagnoses continue to mean that the patient will almost certainly die of the disease?
I’ve often thought about this, and there a number of possible answers depending upon who you ask. But I strongly believe that three key factors certainly helped speed progress in treating HIV/AIDS far faster than anything seen before.
1) A new age of patient advocacy
AIDS activists rewrote the rules on how to get everybody’s attention and how to motivate governments, regulatory bodies, NGOs and the pharmaceutical industry. Early AIDS activists were often militant, sometimes did outrageous things, and caused great upheaval in government and corporate circles. But by forging grass-roots advocacy organizations, and using information technology, especially the Internet, they got results.
2) Changes in the regulatory environment
Perhaps one of the most historic achievements of the AIDS activists was the major change in the worldwide regulatory environment. In 1992, the FDA introduced an accelerated approval process for HIV medicines in response to pressure from AIDS activists. HIV/AIDS activists also ushered in expanded access and compassionate use programs in the late 1980s. These programs offer patients with life threatening diseases access to experimental drugs before they receive regulatory approval.
3) The global communications revolution
We owe a great debt of gratitude to the early HIV/AIDS advocacy pioneers. They created a template for disease activism that represents best practice today in diseases such as cancer, diabetes and Alzheimer’s. The Internet has given birth to countless new media channels and a media environment that is nearly infinite in depth.
As healthcare communicators, we have the privilege of helping companies and organizations determine the best combination of media tools. The application of these new media tools, if orchestrated appropriately, can help improve the lives of millions of patients, families and caregivers.