***2017 Speakers will be announced soon.
Check out our 2016 speakers in the meantime!***
Plenary Session & Keynote Speakers
A highlight of the ISPE Product Show, the plenary session and keynotes bring together all attendees to hear from some of the most inspiring thought leaders who influence our field and our future.
2016 Plenary Session Keynote Speakers
Immediate Past Chairman of the Board, ISPE
Vice President, Global Quality Compliance and External Collaboration, Genentech/Roche, Pharma Technical Operations
Joseph Famulare is Vice President – Global Quality Compliance and External Collaboration at Genentech/Roche, Pharma Technical Operations. He is active in aligning industry and international regulatory authorities around policy and harmonization, and also heads the company’s inspection readiness, GMP auditing and is integral to determining the company’s compliance strategies, among other duties. Mr. Famulare joined Genentech in 2009 as the Senior Director of Genentech’s Quality and Compliance External Collaboration function after a 32-year career at FDA. He is the former Deputy Director, CDER Office of Compliance, FDA, where he led an extensive team heading GMP, GCP, and GLP Compliance programs. He was a founding member and served on the Council of Pharmaceutical Quality. He also held a number of progressive roles at FDA throughout years of public service. As a Member of ISPE for more than 15 years, he served as Industry Co-Chair of the ISPE/FDA/PQRI Quality Manufacturing Conference, and has led ISPE’s PQLI® Initiative, serves on the Regulatory Compliance Committee and Drug Shortages and Quality Metrics Initiatives. He is active in ISPE global activities as a speaker and panelist and chaired the 2013 ISPE Pharmaceutical Quality System (ICH Q10) Conference in China and has co-chaired successive ISPE/FDA co-sponsored conference over the past 5 years. Joe Famulare has actively participated on the International Leadership Forum (ILF), now the Global Manufacturing Leadership Forum (GPLMF). He recently co-led the publication of PQLI®‘s Quality System Guideline on Process Performance and Product Quality Monitoring. He was elected to the ISPE International Board of Directors in 2010 and has served 2015 as Chairman of the Board and is now Past Chair. Mr. Famulare has a BS in Biology and Environmental Studies from St. John’s University and extensive training in manufacturing, microbiology and chemistry, regulatory risk management and leadership.
The Honorable Richard E. Neal
House of Representatives, First District, Massachusetts
Congressman Richard E. Neal represents the First Congressional District of Massachusetts in the United States Congress. Richard Neal was born in Worcester, Massachusetts on February 14, 1949 and was raised and educated in the City of Springfield. He is a 1972 graduate of American International College, where he received his Bachelor’s Degree in Political Science and was a member of the National Honor Society. He received his Masters Degree in Public Administration from the Barney School of Business and Public Administration at the University of Hartford in 1976.
Richard Neal was first elected to the United States House of Representatives in 1988. He is a senior member of the tax-writing Ways and Means Committee and the Ranking Member of the Subcommittee on Select Revenue Measures. He also serves on the Ways and Means Subcommittee on Trade.
Congressman Neal is the dean of both the Massachusetts Delegation and the New England Congressional Delegation. He is a long-time guest lecturer at the University of Massachusetts in Amherst, and a Trustee at Mount Holyoke College. He is a National Trustee of John F. Kennedy Library in Boston. He served as the Mayor of the City of Springfield from 1984 to 1988, and was highlighted in Newsweek Magazine for his many accomplishments as mayor.
Congressman Neal has been a lead sponsor of legislation to prevent American companies from moving offshore to avoid paying U.S. taxes. He has sponsored legislation that would increase the national savings rate by encouraging the use of individual retirement accounts, and has worked to make health care and tuition expenses tax deductible for middle class people. He successfully led the charge to eliminate the Alternative Minimum Tax (AMT) for middle-class families in America. He has a long legislative history of fighting to preserve and protect Medicare and Social Security.
Congressman Neal is an At-Large Whip for the House Democrats. He is a co-chairman of the New England Congressional Caucus, where he advocates for the unique regional interests of the six New England States. Congressman Neal is the Democratic Leader of the Friends of Ireland Caucus.