2008 Discoverers Award

Pharmaceutical Research and Manufacturers of America (PhRMA)
2008 Annual Meeting
Discoverers Award Dinner
March 29, 2008

Remarks by PhRMA President and CEO Billy Tauzin

Since 1987, the Discoverers Award has honored our industry’s finest scientists and their ceaseless efforts to research and develop medicines that quote “have greatly benefited human kind” and also for their dedication to improving the quality of life. The Discoverers Award winners form a unique society of men and women, who have not only been inspired with great ideas but who have also taken that idea and seen it all the way through from the laboratory all the way to the pharmacy shelf.

They also share something special that we, who are not so inspired, can only envy: the knowledge that thousands and even millions, as you will learn tonight, millions of patients – men, women and children – are alive today, tonight, living longer, healthier lives because of their work.

The Discoverers Award and the winners of this wonderful award represent the best of research science combined with the motivation to help cure and heal the sick. They also are the very best of a limited number of medicines that make it all the way from the laboratory to FDA approval for patient care.

Tens of thousands of potentially great ideas die on the drawing board. Thousands more never make it beyond initial research and early development. Some make it all the way through to clinical trials and then fail to keep their promise. It’s just a very little handful that make it all the way to approval and maybe one of those is truly a breakthrough medicine, a medicine that changes how we treat a disease and give patients renewed hope and the sense of possibility.

Tonight I learned about a clinical trial going on from a friend whose husband is enjoying the possibility and the hope that that new medicine will bring a cure. And that is essentially what we celebrate tonight. But before going any further I want to specifically recognize some previous Discoverers Award winners who are here with us this evening.

Last year’s clinical trial research recipients helped develop Zyvox, the only oral medicine approved for use against hospital-borne infections caused by MRSA and VRE, and Dr. Sharon Nachman is here. In 2005, for Prevnar, the first and only vaccine to prevent evasive pneumococcal disease caused by streptococcus pneumoniae in young children, Drs. Dace Madore and Vilupillai Puvanesarajah are here.

In 2003, Mylotarg to treat myeloid leukemia was recognized, and Dr. George Ellestad and Dr. Janis Upeslacis are here. In 2001, for Enbrel to treat rheumatoid arthritis, Dr. Raymond Goodwin and Dr. Craig Smith are here. Would everyone I named please stand tonight and be recognized for your great achievements – and all of you, thank you.

Well, we’re here tonight to celebrate the scientists who developed a terrific drug. It was originally called carvedilol. It’s known today as Coreg, a breakthrough cardiovascular medicine that has reduced the mortality of congestive heart failure and has actually changed the paradigm for treating this life-threatening and debilitating disease.

But before introducing this year’s Discoverers Award winners, it’s my great pleasure to also recognize the winners of this year’s Clinical Trial Exceptional Service Award. Now, this is the second year we’ve presented this award. Why?

Well, in so many ways this award is the perfect complement to the Discoverers Award because the clinical trial process is obviously a necessary capstone to the years of research and development that go into every single breakthrough medicine. Without great researchers overseeing those clinical trials and without the brave patients whom we sometimes forget to remember, the patients who volunteer to participate in clinical trials to test the medicines that save our lives, another new medicine would never get out of the laboratory.

Tonight’s honorees exemplify the very best in clinical trial research. This year’s Clinical Trial Exceptional Service Award winners are: Dr. Michael Bristow, Co-Director of the University of Colorado Cardiovascular Institute; Dr. Milton Packer, Director of the Center for Biostatistics and Clinical Science and Professor at the University of Texas Southwestern Medical Center; Dr. Mary Ann Lukas, Senior Director of the Cardiovascular Medicine Development Centre at GlaxoSmithKline; and Lacey Angioletti, a patient who participated in the Coreg clinical trial, a patient whose life was saved.

Lacey was only 21 years old when she was diagnosed with heart failure. In fact, her heart was twice its normal size. She was a member of the crew team in college. She agreed to participate in the Coreg clinical trial. She needed to, because she was within 24 hours of death. Today at the age of 34, she’s a beautiful actress, leading a normal live. Drs. Bristow and Packer were unable to be with us tonight, but I ask Dr. Lukas and Ms. Angioletti to please come forward to be recognized for their contribution to the development of this incredibly great medicine.

The American Heart Association had set some targets for reducing mortality, cardiovascular disease in this country – and we’re way ahead of that schedule. There are millions of people walking around today because of the work of the American Heart Association and the pharmaceutical industry working as great partners to save lives. You met one tonight and she said thank you. There are millions more out there who say thank you to all of you.

I want to thank Lacey and Mary for the inspiration they give to all of us in this business, all of the 80,000 researchers who are tonight working and praying that tomorrow they will make a great discovery.

Let me say just a few words about Coreg before I bring in tonight’s honorees. In the mid-1990s patients suffering from heart disease often didn’t have any options and the odds against them certainly were pretty large. Heart-related deaths were climbing to an all-time high and some patients simply didn’t have time on their side. That was Lacey’s case – as little as 24 hours.

Coreg is that wonderful, often unexpected medicine that almost instantly changes how medicine is practiced. Back in 1995, Coreg proved so effective in the clinical trials that the FDA Safety Board actually ended the clinical trial, stopped it. The folks working on it were deathly afraid when they heard that the clinical trials were being halted. They thought maybe patients were dying. After all, this was a beta blocker used to save heart patients. It didn’t make sense and yet it was working.

The safety panel stopped the clinical trials because the reduction in death was so high that it was simply unethical to maintain the placebo arm of the trials. They determined that you had to give this medicine to everybody in the trials because it was so effective. And from that moment forward, the treatment of cardiovascular disease and congestive heart failure, as well as the effort to prevent heart attacks by controlling blood pressure, would never be the same.

Tonight, in Thibodeaux, Louisiana, my 89-year old mom who nearly died of congestive heart failure on New Year’s Night – a three-time cancer survivor, a winner of eight gold medals in the Senior Olympics just a few years ago in javelin, discus, and shot-put – my mother is taking Coreg and my family feels that we have her loving warmth, her presence, her amazing courage, and her life to thank.

And so, like Lacey, like so many millions of people, my mother is another wonderful human life saved by this miracle drug.

Coreg was developed by scientists working for GlaxoSmithKline’s heritage company, SmithKline Beecham. And it has helped to improve the lives of more than five million patients worldwide since being approved by the FDA in 1997.

This year’s Discoverers Award winners once again embody the determination, the intelligence the patience, the patience, the patience and persistence and resistance necessary to discover and advance the science, the medicine. They’re true heroes – heroes who have helped millions battle and even beat deadly disease.

Ladies and gentlemen, I ask you to stand with me and applaud the distinguished winners of the 2008 Discoverers Award: Dr. Eliot Ohlstein, Senior Vice President and head of the Cardiovascular and Urogenital Diseases Center of Excellence for Drug Discovery at GlaxoSmithKline; Dr. Bob Ruffolo, Jr., formerly a research development executive at GlaxoSmithKline, now working as President of Research & Development at Wyeth, and Dr. Tian-Li Yue, Manager of the Department of Investigative and Cardiac Biology, Cardiovascular Urogenital Centre of Excellence and Drug Discovery at GlaxoSmithKline.

Would you please come forward and, ladies and gentlemen, let's rise in unison and thank these individuals.