In this blog post, Lilly Stairs, Institute for Healthcare Improvement (IHI) Project Assistant and former MassBio Co-Op, shares some of her experiences and ideas for improving communication between patients and care professionals. She will serve as patient faculty for IHI’s seminar, Person- and Family-Centered Care: Transforming the Patient Experience, November 4-5, 2014.
“It’s different for everyone.”
I was sitting in yet another cold, sterile office as my doctor delivered this response. My heart sank. I had heard this comment one too many times. I was praying for answers that would give me some clarity.
At this point, I was no stranger to the health care system. Three years ago, I was a healthy, active 19-year-old woman beginning my second year of college when suddenly my life was turned upside down. I was diagnosed with Crohn’s Disease and Psoriatic Arthritis, both autoimmune diseases. The total body arthritis resulted in excruciating pain that made me completely reliant on my mother. The Crohn’s gave me bleeding ulcers in my small intestine that made even drinking water almost unbearable.
After I became ill, I was in and out of the hospital and constantly consulting with specialists. I was thankful for the doctors who were compassionate and generous with their time, and disheartened by the ones who seemed cold and uncaring. Even the kindest of them, however, consistently gave me the same answer to my questions about my prognosis: “It’s different for everyone.”
I can imagine this answer is standard for the 50 million Americans suffering from more than 100 different autoimmune diseases. The complexity of these diseases makes them difficult to properly diagnose, and it’s true that how they affect each individual patient can be unique.
The Mass Technology Leadership Council (MassTLC) is the region’s leading technology association and the premier network for tech executives, entrepreneurs, investors and policy leaders. MassTLC’s purpose is to accelerate innovation by connecting people from across the technology landscape, providing access to industry-leading content and ideas and offering a platform for visibility for member companies and their interests. Link
National Tay-Sachs & Allied Diseases Association (NTSAD) is one of the oldest patient advocacy groups in the country. We focus on funding research, supporting over 500 families and individuals worldwide, and raising awareness to prevent disease. Link
VBI Vaccines, Inc. (Nasdaq: VBIV) is a biopharmaceutical company developing novel technologies that seek to expand vaccine protection in large underserved markets. VBI’s eVLP vaccine platform allows for the design of enveloped (“e”) virus-like particle (“VLP”) vaccines that closely mimic the target virus. The company’s lead eVLP asset is a prophylactic Cytomegalovirus (CMV) vaccine; VBI has initiated work for GMP manufacturing of its CMV candidate for use in formal preclinical and Phase I trials. The company’s second platform is a thermostable technology that enables the development of vaccines and biologics that can withstand storage or shipment at constantly fluctuating temperatures. VBI has completed proof of concept thermostability studies on a number of vaccine and biologic targets. VBI is headquartered in Cambridge, MA with research facilities in Ottawa, Canada. Link
1) AbbVie board recommends against $55b merger with Shire, Boston Globe, October 16, 2014
The biopharmaceutical company AbbVie Inc. reversed course on its planned acquisition of specialty drug maker Shire PLC this week, but Shire, which has major operations in Massachusetts, will remain a strong company without the deal, analysts said. Shire was the target of the $55 billion merger, which would have been one of the largest in Massachusetts history, similar in size to Procter & Gamble Co.’s takeover of Gillette Co. in 2005. As an independent company, analysts said, Shire still has several successful drugs on the market and promising treatments under development. Link
2) Novartis psoriasis drug benefits outweighs risk-FDA staff, Reuters, October 16, 2014
The benefits of Novartis AG’s anti-inflammation drug outweighed the risks in using it to treat a type of psoriasis, staff reviewers at the U.S. Food and Drug Administration said. The injectable biologic, secukinumab, is part of an eagerly anticipated class of drugs called IL-17 inhibitors that have shown unprecedented success in plaque-psoriasis, the most common form of the painful skin condition. Link
3) J&J adds an $817M cancer drug pact with ambitious Aduro, FierceBiotech, October 16, 2014
A banner year for Berkeley, CA-based Aduro just got better. The biotech has inked its second licensing pact of the year with Johnson & Johnson, which kicked in a $30 million upfront and boosted its total milestone package to the $1 billion-plus category. Link
4) FDA moves cancer drug closer to approval for Pfizer, The Day, October 16, 2014
The U.S. Food and Drug Administration has accepted an investigational Pfizer Inc. cancer medication for priority review, meaning it could be approved for marketing within the next six months. Pfizer said Monday that the FDA has accepted its new-drug application for palbociclib, already given breakthrough status by the agency as a first-line treatment for one form of breast cancer. Link
5) FDA Approves Gilead Sciences, Inc. (GILD)’s New Hepatitis C Drug Harvoni, BioSpace, October 10, 2014
The U.S. Food and Drug Administration (FDA) has approved the first once-a-day pill for the treatment of hepatitis C, the company that makes the drug, Harvoni, said this week. Gilead Sciences announced Friday, October 10, that the pill, which is a cocktail of ledipasvir and sofosbuvir (known under the brand name Sovaldi), has been cleared for use in the main subtype of hepatitis, called genotype 1, which accounts for more than two-thirds of the nation’s cases. Link
One of MassBio’s Impact 2020 report’s key recommendations is for MassBio to begin driving the conversation on defining value and reward for innovation. To start the conversation, MassBio is hosting a three-part Forum series this fall focused on value. The series kicked off earlier this month, and the next session is on November 20th. In the meantime, we’re pleased Leora Schiff was willing to share her perspective with us!
By Leora Schiff, Principal, Altius Strategy Consulting
The biotechnology and pharmaceutical industries are undergoing rapid, disruptive changes that will require rethinking of fundamental assumptions regarding the value of therapeutics and the nature of healthcare delivery. Increasingly, market power is being shifted away from physicians and payers towards patients and caregivers, professional organizations and newer stakeholders including accountable care organizations (ACOs), and pathway companies. In addition, all stakeholders are becoming more sophisticated and demanding in terms of their expectations related to the benefit-risk and benefit-cost calculations for drugs.
The price-protective nature of the US market is coming increasingly under fire. In addition to health insurers, ACOs, pathway companies and professional organizations are weighing in on the need for cost-effective treatments to improve patient outcomes and control ballooning health-care costs. Patients are also becoming more aware of the comparative price of care as they are increasingly asked to share the cost of healthcare through increased insurance premiums, large deductibles and more substantial co-payments.
As the concepts of patient-centered healthcare make their way into clinical practice, physicians are being encouraged to consider not just the patient’s clinical situation, but also the patient’s lifestyle, beliefs, financial situation and appetite for risk versus potential clinical and/or quality of life reward in selecting the best treatment choice to meet patient needs.
What does this mean for biotechnology and pharmaceutical companies?
Given these changes, it is no longer possible for biopharmaceutical companies to assess product opportunities and project future product pricing and revenues based simply on broad categories of comparable therapeutics and order of market entry. In the new era of value demonstration, drugs are being evaluated in the context of the current standard of care and the additional benefit that they provide – or not – in terms of efficacy, safety, patient quality of life and cost.
New England Controls is the leading solutions supplier of process control equipment and related services in the New England region. We participate in the Life Sciences, Power Generation, Pulp & Paper, Gas Distribution & Transmission, Water & Waste Water, and various other industries. As the local business partner for Emerson Process Management, New England Controls delivers a broad scope of products along with the engineering, training, maintenance and asset optimization services required to solve your most challenging process control needs. Link
Parabase Genomics is a molecular diagnostics company developing next generation sequencing based tests for use in neonatal and pediatric diagnostics. We are a team of innovators with expertise in genomics, pediatrics, and computational biology committed to improving the lives of children with genetic diseases. Our goal is to improve the standard of care in neonatal intensive care units (NICU) and pediatric wards by replacing hundreds of currently used single-gene-disorder tests, which require months to run and cost tens of thousands of dollars with the LifeTime NewbornDx test. Our proprietary test is a targeted sequencing panel designed by experts to simultaneously evaluate hundreds of known genetic disorders from a blood spot in 48 hours. This vast improvement in time to diagnosis leads to better therapeutic options, better patient outcomes, and lower costs due to less testing and shorter hospital stays. Link