Med Ad News talked to HVH Precision Analytics, a joint venture with Havas Health & You and Vencore specializing in AI and machine learning data analytics, about the company’s efforts at the forefront of rare disease work.
How the pandemic changes the health policy outlook
April 2020, Commissioner, Coronavirus Cases, Coronavirus Disease (COVID-19) Pandemic, Department of Health and Human Services (HHS), Donald Trump, Drug Price Legislation, Elections, FDA, FDA/Regulatory, Issue Archives, Jon Bigelow Column, Med Ad News, Senate, United States Department of Homeland Security, White HouseThis extraordinary March and April – marked by rising numbers of Covid-19 cases and fatalities, suffering for patients and families, courageous efforts by clinicians, restricted social interaction, business closings, massive unemployment – has battered our healthcare system and economy. Here are a few early thoughts on how the evolving pandemic has changed the outlook for health policy after the November elections.
Charles Rosenberg, a historian of medicine and science, observed that viral outbreaks often unfold like a play in three acts. Act 1 is to ignore the mounting threat until it can’t be avoided. Act 2 is a call to arms (citizens demanding an explanation). And Act 3 – the one we are in now – is the response. Act 3, according to Rosenberg, can be “as disruptive as the disease itself.” The potential disruptions from Act 3 of COVID-19 have significant short- and long-term implications. Our proactive responsiveness to those disruptions can help drive success.
Vaccination is often considered one of the greatest achievements in medicine. A series of injections that confers decades, if not a lifetime, of protection from a myriad of deadly or disabling diseases, including polio, diphtheria, measles, chicken pox, and more. In some cases, vaccines have been so effective that they wiped out the disease in question entirely. However, vaccines have become a topic of controversy.
David Fajgenbaum’s life changed forever one summer day in 2010. After experiencing fatigue, his liver, kidneys, bone marrow, heart, and lungs suddenly began to shut down. He was admitted to the intensive care unit where doctors found that he had a retinal hemorrhage that left him blind in his left eye. David drifted in and out of consciousness, was put on a feeding tube, and received blood transfusions. In weeks, the 26-year-old medical student sharply deteriorated and was given last rites.
Rare diseases affect more than 30 million Americans. According to the FDA, a rare disease is defined as a disease or condition that has a prevalence of fewer than 200,000 affected individuals in the United States. An orphan product is a drug, biologic, device or medical food used for the prevention, diagnosis, or treatment of a rare disease.
In addition to increased scrutiny on appropriate tone and message in light of social distancing and stay-at-home mandates, tactically, we’re already seeing the impact with brands like Linzess reinforcing telemedicine opportunities by shifting their tagline to “You may be able to talk to your doctor about your symptoms online.”
What are payers focusing on in the time of stay-at-home, work-from-home, yet still trying to serve patients? What do manufacturers need to understand? Med Ad News spoke with Greg Novello, executive VP, strategy at McCann Health Managed Markets; Adrian Garcia, senior VP, managed markets, at GSW; and Katherine Seay, executive VP, managing director, managed markets communications, Syneos Health.
Despite advances in technology and our understanding of the genetic and molecular underpinnings of cancer, making a meaningful impact on the survival and quality of life of patients with cancer remains a significant challenge. In fact, a recent review revealed that, among 59 cancer drugs approved by the U.S. Food and Drug Administration based on the surrogate endpoint of response rate, only six showed overall survival benefit.
You’ve just accepted the most exciting role in your career – to launch your company’s promising Phase III rare disease drug candidate. So many things race through your mind, from the clinical trial program through the launch readiness plan. And then you stop. How will you differentiate your new brand from your competition so that you can win in a competitive market? How will you position your brand to set it up for success? Everyone you talk to will have an opinion.