Executive Perspectives Pharmaceutical Industry Panel Discussion & International Networking Breakfast
This distinctive symposium provides local pharmaceutical and biotechnology innovators direct access to industry leaders with experience in preparing companies for the scientific, logistical, manufacturing and commercial challenges of taking a promising therapy from lab to the patient. Whether your ultimate goal is securing a partnership or successfully navigating your way through the clinical drug development process on your way to achieving commercial success, this symposium is for you. This interactive symposium features clinical drug development and commercial industry experts that will discuss the challenges of making medicines here in the US for distribution overseas, and the increasing attention being given to manufacturing products outside the United States.
• Listen to fascinating anecdotes about supplying the flu vaccine during the 2009 pandemic and lessons learned for current pandemics
• Learn how pharmaceutical companies, small and large, deal with making products for China, Brazil, and Africa
• Learn how the FDA’s standards are leveraged by many countries while at the same time other countries often have a distinctly different view regarding quality standards
• Learn how companies who discover new therapies often do not always know how to construct a manufacturing facility that meets regulatory requirements — and how our panelists helped bring those drugs out of the laboratory into the hands of patients
Meet Our Panel Members
Key Note Speaker: Jane Griffiths
Company Group Chairman, Europe Middle East and Africa EMEA
Completing her PhD in Biochemistry at the University of Aberystwyth, UK in 1982, Jane Griffiths has worked her way up the Johnson & Johnson career ladder, starting as a sales representative. The straight-talking Brit is now the first female Company Group Chairman of Janssen in EMEA, the pharmaceutical division of the Johnson & Johnson family. She is responsible for this business across the entire region. Her personal approach focuses on sustainability, accountability, openness and collaboration, and she is leading Janssen EMEA to live these values. Jane has held a number of senior sales, marketing and R&D positions including International VP for Western Europe and South Africa, and Head of Market Access for Janssen EMEA. As a senior female executive, Jane acknowledges the tension between family and work. She is a sponsor for the Women’s Leadership Initiative in Janssen and a Senior Advisory Board member of the EMEA Healthcare Businesswomen’s Association (HBA). Other industry roles include Chairwoman of the EFPIA Executive Committee and member of the EFPIA Board. A passionate conservationist, Jane is the founding chair and Executive Sponsor of the Janssen Global Citizenship and Sustainability Council. Jane is also Chair of the Johnson & Johnson Corporate Citizenship Trust in EMEA and a Board member.
Director, Engineering Biologics Genzyme
Allison joined Genzyme’s Framingham Biologics Manufacturing site as the Director of Engineering in August 2012. She has restructured the department to support both upstream cell culture and purification activities. She added key leaders to her management team to support the 25% capacity increase for cell culture and subsequently supporting an $80 million purification expansion to support the future growth of Fabrazyme. Allison has direct oversight of Process Engineering, Utilities Engineering, and Commissioning/Qualification teams that support both project and site initiatives for Framingham Biologics which includes manufacturing of both Fabrazyme and Thyrogen.
Allison has been employed by Sanofi since 2001 in various positions of increased responsibility. She began her career with Sanofi at the former Aventis Pasteur vaccines facility in Swiftwater, PA as a Technical Services Associate performing qualification and validation of bacterial vaccine manufacturing processes and equipment. In 2003 she acted as project leader for a pharmaceutical renovations project from feasibility through licensure. Beginning with its inception in 2005, she worked in the Process Design Engineering and Equipment Technology group, where she assisted its director in creating the Operations Engineering Support platform which supplied resources to the existing licensed facilities while the main focus of the organization was to launch three major capital investments in Swiftwater.
In 2008 Allison was appointed Deputy Director Equipment Engineering and given responsibility for Engineering of Filling, Packaging, and Sterilization Equipment, Motion Control and Machine Design. She led the Engineering oversight of the startup of the vial filling line during the 2009 flu pandemic. From 2011-2012 she successfully led the implementation of the Right First Time initiative for Engineering Efficiency and Effectiveness for the Sanofi Pasteur Americas Region.Prior to her career at Sanofi Pasteur, Allison was a consultant to the plastics and specialty chemicals industry.
Allison is a graduate of Lehigh University in Bethlehem, PA with a BS in Chemical Engineering and MBA in Management. Allison resides in Northborough, Massachusetts with her husband, Pete, and their son, Anthony.
Vice President, Operations
Enteris BioPharma, Inc.
Dr. Paul Shields, Vice President of Operations, joined the Company in July 2013. He brings more than 24 years of experience in the biopharmaceutical industry, focusing on Chemistry, Manufacturing and Controls (CMC) for a variety of products.
Dr. Shields previously served as the Vice President, Manufacturing Operations for Unigene Laboratories from 2005 to 2013, where he managed commercial CMC operations for recombinant active ingredients, and clinical and commercial supplies of nasal spray and solid dose products. Prior to that, he served as Unigene’s Director of Plant Operations from 2001 through 2005, as Plant Manager from 1995 through 2001, and in various other capacities with Unigene from 1989 through 1995.
Dr. Shields holds a Ph.D. in biochemistry from the University of Pennsylvania and a B.S. in chemical engineering from the University of Michigan.
Moderator: Malcolm Burgess
Executive Vice President
ICON Clinical Research
Thank you to Our Event Sponsors