FDA Principal Deputy Commissioner Joins Keynote Line-Up for the 2019 ISPE Annual Meeting & Expo


Amy Abernethy, MD, PhD, Principal Deputy Commissioner, FDA

The International Society for Pharmaceutical Engineering (ISPE) announced Amy Abernethy, MD, PhD, Principal Deputy Commissioner, FDA, as a newly-confirmed keynote speaker for the 2019 ISPE Annual Meeting & Expo, taking place 27–30 October 2019 in Las Vegas, Nevada USA.

Dr. Abernethy, a hematologist/oncologist and palliative medicine physician, is an internationally recognized clinical data expert and clinical researcher. She helps oversee the FDA’s day-to-day functioning and directs special and high-priority initiatives that cut across offices overseeing the agency’s regulation of drugs, medical devices, tobacco, and food. As acting Chief Information Officer, she oversees FDA’s data and technical vision, and its execution.

In a “fireside chat” with Frances Zipp, President & CEO, Lachman Consultant Services, Inc., incoming 2019–2020 ISPE Board Chair, Dr. Abernethy will be answering key questions regarding current FDA initiatives.

Dr. Abernethy joins a dynamic keynote line-up that includes some of the most prominent names in the pharmaceutical industry. These senior-level presentations are rounded out by a compelling patient keynote speaker.

Additional Keynote Presenters Include:

Lou Kennedy, CEO and Owner, Nephron Pharmaceuticals

Training Tomorrow’s Workforce

John Crowley, Chairman, Chief Executive Officer, and Co-Founder Amicus Therapeutics

When Drug Research is Personal: A Lifetime Journey to Discover, Create and Manufacture Medicines for Rare Diseases

William Anderson, Chief Executive Officer, Roche Pharmaceuticals

Every Patient Matters — Transforming to Deliver Breakthroughs Faster

Pierre-Alain Ruffieux, PhD, Head of Global Pharma Technical Operations, Roche Pharmaceuticals

Transforming Big Pharma Manufacturing: Dream or Reality?

Alberto Santagostino, Senior Vice President, Head of Cell & Gene Technologies, Lonza AG

How to Achieve Industrialization and Bring Curative Therapies to the Masses

Jessica H., Patient Presenter

Thriving in My New Normal

To learn more about this event and to register, visit http://www.ISPE.org/AM19.

About ISPE

The International Society for Pharmaceutical Engineering (ISPE) is the world’s largest not-for-profit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical lifecycle. The 18,500 members of ISPE are building solutions in the development and manufacture of safe, effective pharmaceutical and biologic medicines, and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in North Bethesda, Maryland USA, and its operations center in Tampa, Florida USA. Visit http://www.ISPE.org for more information.

For more information, contact:

Amy Henry

International Society for Pharmaceutical Engineering (ISPE)

Tel: +1- 813-960-2105 Ext. 277

Email: ahenry@ispe.org

http://www.ISPE.org

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