2013: A Big Year for Genomics, Genetic Testing and...

2013 was a banner year for raising the visibility of genetic testing. The news varied. It can be argued, however, that all parties (patients, clinicians, industry and researchers) have benefited from the increased coverage. This brief snapshot of the stories about genetic testing that made it into the headlines in 2013 suggests that we are at a critical point. Patient demand, industry innovation and policies are converging. Consumers seem to embrace the technology and the opportunity to take action with the information they may receive. The law is carefully considering how to treat genetic information and the regulatory agencies continue...

FDA Social Media Guidance Removes Some Barriers

This week, the FDA issued draft social media guidance specifically focused on requirements, responsibility and process for postmarketing submission for approved drugs and biologics. While the long official title is “Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics” the document covers two primary areas: Considerations to determine when interactive media (Facebook, Twitter, blogs, forums, etc.) are subject to the FDA’s postmarketing submission requirements How firms can maintain regulatory compliance given the unique...

Flu Vaccination: Education is Imperative

Due to pervasive myths and other hurdles, many Americans do not realize the seriousness of the flu and the ways it can disrupt lives – even for healthy people. While the flu, or influenza, is often mistaken for the common cold, the flu is far worse and can lead to severe and even fatal complications, particularly in children. Last year, 167 children died due to the flu. That is the highest recorded number in a non-pandemic season. Flu vaccination is the single best preventative measure we have to protect against this highly-contagious disease and this important fact underscores the need for ongoing educational efforts to address this...

The Prognosis for Participatory Care

As “The Innovator’s Partner,” we embrace new ideas and the big impact they can have in addressing disease and improving health. We are passionately enthusiastic about the role we and our clients can play in enhancing each patient’s journey, care, and outcomes. But what do health care providers—in whose hands the fate of many of these new tools and treatments rest—think about all this innovation? Do they get as excited as we do? For some, the answer appears to be, “Not so much.” Significant numbers of docs are in fact reluctant to embrace new diagnostic methods and tools, slow to adopt electronic health...

Three Big Ideas for Extreme Productivity

Recently, author Robert C. Pozen—Senior Lecturer at Harvard Business School and Senior Fellow at the Brookings Institution—spoke at the FKH offices as part of our Great Authors Great Speakers series. His book, Extreme Productivity: Boost Your Results, Reduce Your Hours has many valuable lessons and key points that may be particularly interesting and useful for innovators and entrepreneurs, including: how to be as productive as possible; tips to develop personal skills like reading, writing, and speaking; advice on the best ways to manage your team and your boss; and overall recommendations on pursuing and living a productive life...

Evolving Challenges of Digital Health Literacy

The buzz among digital healthcare marketers over the last several years has focused primarily on emerging social technologies, mobile platforms, and the long awaited FDA social media guidance. But there is one other major digital health communications trend that is often overlooked and deserves to be a part of these conversations: digital health literacy. What do I mean? Digital health literacy is the concept of how the evolving digital landscape is impacting health disparities based on the patient’s capacity to obtain the latest health information and make educated decisions as that information increasingly moves online. If digital...

Visualizing Digital Healthcare Data

It is no surprise that communications strategies that drive meaningful changes in health outcomes need to be heavily grounded in up-to-date research. Increasingly that research focuses on digital health information as health-related queries continue to dominate Google searches and patients becoming increasingly comfortable sharing personal health information online. In many cases, we are researching everything from conversation trends to social sharing to web traffic to get a better understanding of how our clients can strategically tailor their messages. Besides using this data to inform messaging strategies, another major opportunity...

The (New) Ethics of Medical Privacy

I recently had the opportunity to attend a screening of Here.Us.Now., a documentary funded by the Ewing Marion Kauffman Foundation. It should be required viewing for anyone who touches the health care system, which includes pretty much everyone. The film tells the story of Chris and Hugh Hempel’s medical odyssey in the wake of their twin daughters’ diagnosis with a rare, incurable disease called Niemann-Pick Type C. I can’t get this film out of my head.   Why? Because it not only tells the Hempels’ story rationally and beautifully, it uses their narrative to absolutely nail the bigger issues facing any family desperately...

Creating a New Class of Vaccines

Vaccines are among the most cost-effective and successful health interventions ever developed, saving millions of lives each year. However, traditional vaccines are designed to target pathogens that live in the bloodstream. Many infectious diseases, such as herpes, chlamydia and malaria, live inside the body’s cells, leaving these serious illnesses literally beyond the reach of available technology—until now. Genocea Biosciences, an FKH client,  is working to develop the first vaccine that will trigger the body to destroy its own infected cells –something that has never before been possible, due to the volume of potential pathogen...

Here. Us. Now: Documentary Spotlights Rare Disease

Recently, members of Feinstein Kean’s Cambridge staff gathered for a screening of the documentary Here. Us. Now. The film shares the inspirational story of two parents who receive a crash course in drug development. Hugh and Chris Hempel of Reno, NV were forced into the world of rare diseases when their twin daughters, Addison and Cassidy, were diagnosed with Niemann-Pick Type C (NPC1), a terminal disease affecting only an estimated 1 in 150,000 people worldwide. NPC1 is caused by a genetic mutation involving lipid metabolism and eventually leads to fatal build-up of lipids in the brain. This causes developmental delays and leads to...