3 Takeaways from the 2017 MassBio Annual Meeting

This past week I had the privilege of attending the Mass BIO Annual Meeting, a large gathering of life science professionals from around the world. Our conversations focused on the value of medical innovation, as well as the critical challenges facing the life science industry. Here are my three biggest takeaways from the meeting:

1. Cutting NIH funding will cripple our industry.

The big dark cloud hanging over the meeting was the proposed budget cuts to NIH funding. NIH invests $30 billion per year in medical research. Other states will survive the funding cuts because they have massive private sector research and development investment. In Kentucky, NIH funding makes up the majority of our research budget. Kentucky researchers receive over $100 million per year in NIH funding and cutting that funding will have devastating effects.

2. Travel bans would have a large impact on life science research.

There were noticeable absences at this year’s meeting due to fears of the travel ban. The immediate challenge with the travel ban revolves around intellectual property. Venture capital firms are reluctant to fund projects where critical team members could face travel restrictions and where intellectual property could end up on the other side of potential national security restrictions.

A director from one of the Harvard incubators put it well when he said, “Every research team at Harvard has an international component.”

3. This year’s buzzword was “convergence.”

The future of the life science industry will smear the lines of geography. The industry is discovering that cures know no boundaries or borders. This is a perfect setting for the Turnpike Partnership—the future of collaboration, mentorship and the virtual bio cluster.

Government Interference Would Jeopardize Access to Meds

Proposed changes to the Medicare Part D program are once again making the headlines. Last week, Senator Amy Klobuchar introduced an amendment to allow the federal government to interfere in drug price negotiations between Part D plans, pharmaceutical manufacturers and pharmacies. The Senate did not move forward with the amendment, which is good news for the 577,949 Kentuckians seniors who rely on the program to access their medicines.

Medicare Part D is viewed by stakeholders across the board as a successful program. This success can largely be attributed to the non-interference clause, which allows purchasers to negotiate substantial discounts and rebates directly with manufacturers, saving money for beneficiaries and taxpayers alike.

The nonpartisan Congressional Budget Office has stated that if the federal government participated in drug pricing, it “would not be able to negotiate lower prices than exist now without restricting access to medicines for beneficiaries.” Injecting government into drug negotiations would only harm the many seniors and individuals living with disabilities who rely on Medicare Part D for their health and wellbeing.

Over the past decade, Medicare Part D has proven to be a life-changing—and cost-effective—program for enrollees. Medicare Part D is linked to increased medication adherence, improved overall health outcomes and lower costs. Last year alone, nearly 200,000 Medicare beneficiaries lived at least one year longer, with an average increase in longevity of 3.3 years. These men and women are living longer because Part D gives them access to the medicines they need to be healthy.

The Kentucky Life Sciences Council thanks Senator Paul, Senator McConnell and health care advocates across the state who support keeping our successful Part D program intact.

Kyle Keeney is the Founder and Executive Director of the Kentucky Life Sciences Council.

A generic approach to biosimilar substitution won’t do

In Kentucky you don’t have to look far to find the positive impacts of health care innovation.

From preventative medicines to new cures, advances in medical technology have been the driving force behind significant improvements in patient health. But as new treatment options are introduced to the market, protecting patient safety has never been so important.

This year, the General Assembly is considering legislation that would establish a much-needed framework of regulations for biologics and biosimilars – breakthrough treatments that could help many people living with chronic diseases.

Unlike oral pills or tablets, which are made from chemically derived ingredients, biologics are complex treatments manufactured from living organisms – cells programmed to produce a desired therapeutic substance in a highly controlled, sterile environment.

While drug manufacturers are able to create chemically identical copies of pharmaceutical medicines such as oral pills – think generic versions of brand name drugs – the same isn’t true for biologics because they are made from living materials that cannot be perfectly duplicated.

Drug manufacturers can, however, create a version of a biologic that is so close to the original medicine it may be deemed a biosimilar. This could benefit many patients with chronic diseases, as biosimilars are expected to cost significantly less than biologics.

SB 134, in its originally intended form, would establish much-needed guidelines for substituting an interchangeable biosimilar to ensure patient safety. This includes ensuring that substitution would occur only when the FDA has designated a biosimilar as interchangeable; that the prescribing physician would be able to prevent substitution if he or she feels it is not in the patient’s best interest; that pharmacists would be required to communicate what product was dispensed with the prescribing physician; that the patient, or the patient’s authorized representative, would, at a minimum, be notified of the substitution; and that the pharmacist and the physician would keep records of the substitution.

Given the complex nature of biologics and the challenging medical conditions they treat, these are commonsense guidelines to ensure that doctors, patients and pharmacists are all informed about the medications that are prescribed and ultimately dispensed to the patient.

Biologic medicines are an important new tool in treating and curing disease. Biosimilars are also important for providing different and sometimes less expensive options for treatment.

But let’s be clear. Patient safety and ensuring physician involvement is far more important than helping the insurance company’s bottom line.

Legislators should pass SB 134 as it was originally intended. Common sense dictates that we make sure physicians are informed about what products their patients are using to treat their life threatening and chronic illnesses.

Kyle Keeney is the Founder and Executive Director of the Kentucky Life Sciences Council.