Considered to be the equivalent of the Nobel Prize for the life sciences industry, the Prix Galien Award recognizes outstanding biomedical and medical technology product achievement that improves the human condition.
This year, the 2019 Annual Prix Galien USA Awards includes 17 nominees in the “Best Biotechnology Product” category, 22 nominees in the “Best Pharmaceutical Product” category, and 17 nominees in the “Best Medical Technology.”
To qualify, all nominees must have been approved for marketing by the FDA within the last five years—unless the award is for a new and innovative indication, which must have been added within the previous five years. Products with provisional approvals are not eligible.
Among this year’s nominees are the first FDA-approved drugs using RNA interference technology and targeted mutation gene therapy; the first of a new line of “tissue agnostic” cancer-fighting drugs; an entirely new class of female contraceptives, designed for use in resource-limited settings; novel inhalation devices that enhance dosing accuracy against major chronic conditions such as asthma and COPD; the first FDA-approved therapy for endometriosis pain in more than a decade; the first in a new class of anti-epileptic drugs and first prescription product derived from the cannabis plant; and the first prescription digital therapeutic to address the opioid abuse crisis through interactive engagement between patient and clinician.
“The nominees selected by our independent committee reflect how drug, device, and delivery technologies are converging to offer more options for people, especially those with untreatable conditions, along with the ability to make products more effective and convenient for those who need them most, including for the aged, children, and women,” Bruno Cohen, Chairman of the Galien Foundation, said in a statement. “In addition to all the great science, it reflects progress in the global movement for health equity, which is also central to our mission to improve the human condition.”
The committee that evaluates the nominees and selects the winners in each of the three categories is made up of 12 renowned leaders from the biomedical industry and academia. This year’s committee chair is Sue Desmond-Hellmann, MD, MPh, Chief Executive Officer of the Bill & Melinda Gates Foundation. The other members are:
- Richard Axel, MD, Nobel Laureate, Co-director, the Kavli Institute for Brain Science, Columbia University Medical Center, New York
- Michael S. Brown, MD, Nobel Laureate, Professor of Molecular Genetics and Internal Medicine, UT Southwestern Medical Center at Dallas
- Laurie Glimcher, MD, CEO and President, Dana Farber Cancer Institute, Professor of Medicine, Harvard Medical School
- Joseph Goldstein, MD, Nobel Laureate, Professor of Molecular Genetics and Internal Medicine, UT, Southwestern Medical Center at Dallas
- Robert S. Langer, MD, David H. Koch Institute Professor at MIT
- Cato T. Laurencin, MD, PhD, University Professor, University of Connecticut
- Paul A. Marks, MD, Laboratory Head of Cell Biology Memorial Sloan Kettering Cancer Center, New-York and President, Emeritus, MSKCC
- Michael Rosenblatt, MD, Chief Medical Officer of Flagship Pioneering, Cambridge, MA
- Bengt Samuelsson, MD, PhD, Nobel Laureate, Former President of Karolinska Institute and Former Chairman of the Nobel Foundation
- Marc Tessier-Lavigne, PhD, President, Stanford University
- P. Roy Vagelos, MD, Retired Chairman and CEO, Merck & Co., Inc. and Chairman of the Board, Regeneron Pharmaceuticals, Inc.
Those committee members evaluate each candidate principally based on two criteria:
- What was innovative in the course of this product’s scientific development, application, or clinical utility?
- What was learned for the future of biomedical science from this product’s introduction to the clinic?
Meanwhile, the size of the market, the size of the company, the cost of development, and the contingencies of distribution are all not considered.
The internal process for evaluating the candidates starts with a double-blind first round in which the committee scores each candidate on a 1 to 5 scale, with 1 being the best and 5 the least. After the ratings are collected and compiled, the results are shared with the committee and they hold a conference call to discuss their picks and notes. This gives members time to discuss aspects of the product or technology that they may have more knowledge about, such as the impact the manufacturing of the product could have on the environment. If a consensus is reached about which drug or product is the best in that category, then the process is completed.
If, however, no consensus is reached then a second call is scheduled at a minimum of two weeks after the initial call. This provides committee members with time to do additional research or reach out to friends or colleagues for more information. Then a consensus must be agreed upon during the second call.
The winners are kept under embargo until they are announced at the Prix Galien USA Awards Ceremony on October 24, 2019 at the American Museum of Natural History in New York City. Registration to attend the 2019 Prix Galien Awards Ceremony can be accessed at http://register.prix-galien-usa.com.
The full list of this year’s nominees is:
Best Biotechnology Product:
|Aimovig® (erenumab-aooe)||Amgen Inc.|
|Andexxa®||Portola Pharmaceuticals, Inc.|
|Dupixent®||Regeneron & Sanofi|
|ELZONRIS®||Stemline Therapeutics, Inc.|
|Emgality®||Eli Lilly & Co.|
|LUXTURNA™ (voretigene neparvovec-rzyl)||Spark Therapeutics|
|Palynziq®||BioMarin Pharmaceutical Inc|
|Revcovi™||Leadiant Biosciences, Inc.|
|TREMFYA®||Janssen Research & Development, LLC|
|TAKHZYRO®||Takeda Pharmaceutical Company Limited|
|TEGSEDI®||Akcea Therapeutics and Ionis Pharmaceuticals|
|ULTOMIRIS® (ravulizumab-cwvz)||Alexion Pharmaceuticals, Inc.|
Best Pharmaceutical Product:
|EPIDIOLEX®||GW Pharmaceuticals plc/Greenwich Biosciences Inc.|
|ERLEADA®||Janssen Research & Development, LLC|
|INGREZZA® (valbenazine) capsules||Neurocrine Biosciences, Inc.|
|Jardiance®||Boehringer Ingelheim Pharmaceuticals, Inc.|
|LUMOXITI™||AstraZeneca PLC; Innate Pharma SA|
|LUTATHERA®||Advanced Accelerator Applications USA, Inc.|
|Moxidectin||Medicines Development for Global Health|
|Pifeltro™ and Delstrigo™||Merck & Co., Inc.|
|Prevymis™||Merck & Co., Inc.|
|RADICAVA®||Mitsubishi Tanabe Pharma America, Inc.|
|Rhopressa®||Aerie Pharmaceuticals, Inc.|
|TPOXX®||SIGA Technologies, Inc.|
|VABOMERE®||Melinta Therapeutics, Inc.|
|XTANDI®||Pfizer Inc. and Astellas Pharma|
|YUPELRI® (revefenacin) Inhalation Solution||Theravance Biopharma, Inc.|
|ZEJULA®||TESARO, a GSK Company|
Best Medical Technology:
|rhPDGF-BB Technology||Lynch Biologics, LLC|
|AXIOS™ Stent and Electrocautery Enhanced Delivery System||Boston Scientific Corp., Inc.|
|CUSTOMFLEX® ARTIFICIALIRIS||Clinical Research Consultants, Inc. and HumanOptics AG|
|FreeStyle® Libre 14 Day Flash Glucose Monitoring System||Abbott|
|HeartLogic™ Heart Failure Diagnostic||Boston Scientific Corp., Inc.|
|Implantable System for Remodulin®||Medtronic plc|
|INSPIRIS RESILIA Aortic Valve™||Edwards Lifesciences Corporation|
|iStent inject®||Glaukos Corporation|
|Magtrace® and Sentimag® Magnetic Localization System||Endomag|
|Medtronic DBS Therapy for Epilepsy||Medtronic Brain Modulation|
|PK Papyrus Covered Coronary Stent System||BIOTRONIK|
|ProAir® Digihaler™||Teva Pharmaceutical Industries|
|reSET® and reSET-O®||Pear Therapeutics|
|Sentinel™ Cerebral Protection System||Boston Scientific Corp., Inc.|
|Starkey Livio® AI||Starkey Hearing Technologies|
|Zephyr Endobronchial Valve System||Pulmonx|