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Management Tracks

Lisa Raines: An appreciation

At the twentieth anniversary of 9/11, BioCentury pays tribute to a leader who helped build the biopharma industry’s regulatory and policy framework

At the twentieth anniversary of 9/11, BioCentury pays tribute to Lisa Raines, who helped build the biopharma industry’s regulatory and policy framework.

Sep 13, 2021 | 9:04 PM GMT

As part of a package commemorating the twentieth anniversary of 9/11, BioCentury pays tribute to Lisa Raines, who helped build the biopharma industry’s regulatory and policy framework. BioCentury’s Sept. 17, 2001 appreciation of Raines follows. BioCentury has also republished its September 2001 commentary “Attack on the Future.”

As biotech has grown, there are now many new faces in the industry who may not recognize the immense contributions of Lisa Raines to advancing the regulatory and political framework that surrounds and supports the industry. For those of us who have been around longer, Lisa’s murder in the hijacking and crash into the Pentagon of American Airlines Flight 77 last week forces us to remember other, more personal recollections that go beyond her professional accomplishments.

While we cannot catalog all the comments of her friends and colleagues, here are a few observances from BioCentury’s perspective.

The basic facts are these: At the time of her death, Lisa, 42, was senior vice president of government relations at Genzyme Corp. But she had been closely involved with virtually every important public policy issue that established the contours of the U.S. biomedical legal and regulatory map since the mid-1980s. In 1986, she joined the Industrial Biotechnology Association, which merged with the Association of Biotechnology Companies to form the Biotechnology Industry Organization (Editor’s note: now known as the Biotechnology Innovation Organization).

As director of government relations and vice president at the IBA and BIO, Raines helped enact the Drug Export Amendments Act of 1986, the Process Patent Amendments Act of 1988, and the Prescription Drug User Fee Act of 1992.

Lisa joined Genzyme in 1993, where she was responsible for federal legislative and regulatory policy issues. Working for Genzyme, she saw herself, and was perceived by her peers, as a proponent for the entire industry. During political firestorms over issues such as human subject protections or efforts to impose drug price controls, she was on the telephone throughout each day with representatives of BIO and PhRMA, plotting strategy.

She worked closely with members of Congress, congressional staff, and the biotech and pharmaceutical industries on the FDA Modernization Act of 1997. Her grasp of complex legislative and regulatory issues and tenacious advocacy for policies that would help the biotech industry get breakthrough therapies to patients won support and respect from across the political spectrum. When Lisa conceived FDAMA’s "fast track" review provisions and circulated the idea, few in industry or on Capitol Hill thought it could be enacted. But she ultimately was largely responsible for persuading key members of Congress to include fast track in the final version of FDAMA.

In like fashion, she worked closely with FDA on the development of its regulatory structure for cellular therapies, which was released in 1997.

Lisa’s views were sought and respected by influential politicians from across the political spectrum, from Sen. Edward Kennedy (D-Mass.) to Sen. Orrin Hatch (R-Utah).

Just as Lisa was a master of Washington politics, she also was a master at the art of being a source, doling out a clue here and there, leaving room for a reporter to figure out what actually lay between the lines. Lisa was willing, even eager, to spend an hour on the phone with a reporter discussing the legislative history and potential impacts of a bill, the finer points of patent law or Medicare reimbursement policies, all with the understanding that the conversation was “on background,” meaning that her name wouldn’t appear in print.

Thus Lisa knew how to be involved in a story without being “involved.” Although those from outside the media or analyst communities may find this obtuse, it is high praise from those of us who jostle daily to extract, exchange and communicate information. In some hands, these relationships can be combative and hostile. Lisa knew how to play the game in a fair, professional way, and we always appreciated that.

We knew Lisa for more than a decade and are heartbroken by her death. She was as much a fixture of the biotech industry as the double helix, and it is hard to comprehend that she is gone. She leaves a hole in the industry’s relationship with the outside world that will be difficult to fill.

Post Script

I remember exactly where I was when I heard that Lisa was murdered. I had gone out for the day to a small town called St.-Paul-de-Vence with some friends who, like me, couldn’t get back to the U.S. The alternative was to sit in our hotel and watch the horrific footage of people jumping from the twin towers over and over again. I had bought a small painting that I still call my 9/11 painting. It was late in the day, and we were just getting ready to go to dinner. My phone rang, and I walked away from the group to answer it. It was Dave, telling me that Lisa was dead. I stood by the medieval wall overlooking the city and cried. I didn’t want to ruin everyone’s day with more awful news, so I turned around, put on my best face, and said, let’s go eat. Lisa, you are not forgotten. — Karen Bernstein

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