Hill happenings, RWE, and celebrating biodiesel

Ending the week with two hearings that covered Silicon Valley Bank and Mexico’s corn ban—plus, a celebration of National Biodiesel Day (tomorrow) and what BIO’s doing about real-world evidence. (769 words, 3 minutes, 50 seconds)

Capitol Hill happenings: SVB and Mexico

Two hearings yesterday addressed critical issues for the biotech sector: the collapse of Silicon Valley Bank and Mexico’s biotech corn ban. Here’s what we learned.

What’s happening with SVB? Following the collapse of the bank—utilized by nearly half of U.S. biotech and life sciences companies—the U.S. government intervened to protect depositors, with companies reporting they had no problem obtaining needed funds.

The next steps: “The Federal Reserve is providing additional support to the banking system with the new lending facility. This will help financial institutions meet the needs of all of their depositors,” Treasury Secretary Janet Yellen told the Senate Finance Committee yesterday.

The bottom line: “I can reassure the members of the committee that our banking system is sound and that Americans can feel confident that their deposits will be there when they need them,” she said.

What’s been happening with Mexico? On March 6, the U.S. Trade Representative (USTR) requested technical consultations on Mexico’s biotech corn ban under the U.S.-Mexico-Canada Agreement (USMCA)—something BIO’s long called for.

Safety will be the focus of consultations,said Agriculture Secretary Tom Vilsack during a Senate Agriculture hearing yesterday: “At the crux of [the President of Mexico’s] decree is this issue of safety, and we have to overcome that concern.”

“This is fundamental to our whole approach to trade,”he continued. “If it’s not science-based, if you can inject culture, if you can inject non-scientific factors into trade discussions, you will have a very difficult time having global trade.”

Exclusive: How biotech is addressing sources of bias in studies using real-world evidence

Data and the growing use of technology—such as wearables—provide an opportunity to use and analyze this data to inform medical product development. But we need regulatory clarity on using this “real-world data” and “real-world evidence” for regulatory decision-making, writes BIO’s Dr. Camelia Thompson in an exclusive Bio.News piece.

Why it matters: RWE can inform medical product development—but we need to address “unmeasured confounders,” or sources of bias, which can occur “when you have an unmeasured variable that affects both the treatment and the outcome,” explains Dr. Thompson.

What BIO’s been doing: In October, BIO convened a workshop to discuss how to address unmeasured confounding in real-world evidence studies. Now, BIO will develop a white paper to consider analytical methods, discuss how they may be best leveraged in drug development, and inform regulatory decision-making and FDA guidance development.

The bottom line: “BIO believes that well-designed and appropriately conducted observational and interventional RWE studies should be accepted as supporting or providing sufficient evidence for label expansion for an approved product,” concludes Dr. Thompson—read the whole thing.

 

More Health News: 

Forbes (Opinion): Bernie doesn’t ‘get’ healthcare innovation
“If lawmakers effectively criminalize profit, then biomedical research and development will grind to a halt—and society won’t have innovative medicines for Sen. Sanders to demagogue about,” writes Sally Pipes, President of the Pacific Research Institute.

Celebrating 100+ years of biodiesel

Tomorrow is National Biodiesel Day, a day to celebrate this fuel that’s more than a century old—but is seeing new advances thanks to biotech.

As old as the engine: Rudolf Diesel, who invented the diesel engine in the 1890s, ran his demonstrator on peanut oil and said plant-based oils would someday be an important fuel source. His birthday, March 18, was declared National Biodiesel Day.

What is biodiesel? Made from vegetable oil, animal fat, and other renewable feedstocks, biodiesel can be used in regular diesel engines, but it has lower greenhouse gas emissions and, in some cases, is cheaper than traditional petroleum-based diesel.

BIO members are innovating: Gevo is making affordable diesel “from a blend of fusel oils (a waste byproduct of fermentation) and isobutanol” that has a low sulfur content and no particulates.

The government has supported biodiesel innovation—with federal subsidies, including incentives in the Inflation Reduction Act, designed to help biodiesel achieve price parity with regular diesel sooner.

But biodiesel needs more support. In yesterday’s Senate Agriculture Committee hearing, Sen. Joni Ernst (R-IA), a big biofuels backer, called for more support in the new Farm Bill, and Agriculture Secretary Tom Vilsack promoted the importance of biodiesel and USDA’s Renewable Energy for America Program, which supports biofuel infrastructure.

Read about National Biodiesel Day at Bio.News.

President Biden’s Friday: On St. Patrick’s Day, hosting H.E. Leo Varadkar, Taoiseach of Ireland, and attending the Friends of Ireland Caucus St. Patrick’s Day Luncheon before a Shamrock presentation at the White House.

What’s Happening on Capitol Hill: In yesterday’s Senate Agriculture Committee hearing, part of a series of hearings expected to lead to a vote on the Farm Bill, Agriculture Secretary Tom Vilsack promoted climate-smart agriculture, biobased products, and renewable energy (including biodiesel) and discussed next steps for consultations with Mexico on the biotech corn ban—watch here.