ISPE LA Tour of Amgen Bioprocessing Center at KGI and Panel Discussion
You are Invited
Tour of Keck Graduate Institute's
Amgen Bioprocessing Center
Strategic Management of Biotech Assets
Wednesday, July 17, 2013
Keck Graduate Institute (KGI)
535 Watson Drive, Claremont, CA 91711
Learn how biopharmaceutical organizations manage their strategic operations assets. Corporate leaders will answer questions about how utilize and respond to initiatives like Operations Excellence, Software Tools, QbD, PAT, Inventories, Continuous Manufacturing, Single Use Systems and other Hot Industry Topics.
Diana Bartlett, Assistant Vice President, Corporate Partnerships, KGI
KGI: Matthew Croughan, PhD, Director, KGI Amgen Bioprocessing Center
ISPE LA: Paul Crissman, Principal, Biotechnical Solutions
Martin VanTrieste, Senior Vice President, Quality, Amgen
Tim Culbreth, COO, PolyPeptide Labs
Wolf Noe, PhD, Vice President, Manufacturing, Agensys
Judy Chou, PhD, Vice President, Research & Development,
La Jolla Biologics Inc. and Tanvex Biologics, Inc.
4:00 - 5:00 pm
Registration and Networking
5:00 - 6:00 pm
Tour and Dinner
6:00 - 7:00 pm
Cost to Attend
$50 ISPE Members
$70 Non-ISPE Members
$20 Non-KGI Students
$500 Event Sponsor
Free for KGI Faculty and Students
About Keck and Keck Leadership:
Keck Graduate Institute of Applied Life Sciences is dedicated to education and research aimed at translating into practice, for the benefit of society, the power and potential of the life sciences.
An excellent example of this mission in practice is KGI'sAmgen Bioprocessing Center (ABC), one of its most important teaching and research laboratories. Founded in December 2004 thanks to a $2 million gift from The Amgen Foundation, the Center serves as the basis for the bioprocessing concentration offered as part of KGI's Master of Bioscience (MBS) degree program.
The Amgen Bioprocessing Center is a state-of-the-art facility where KGI Master of Bioscience (MBS) students learn the skills necessary to become leaders in bioprocessing and operations. Bioprocessing refers to the manufacture of valuable products through the culture of living microorganisms. Products from bioprocessing include many life-saving biopharmaceuticals and antibiotics, renewable biofuels such as ethanol and biodiesel, and fermented beverages, such as wine and beer. Today, over one-third of all medical products in active development are biopharmaceuticals. Life-changing therapeutics -- such as human insulin and human growth hormone (for children with growth hormone deficiency)--have improved the quality of life for thousands of people suffering from diabetes, cancer, arthritis, cardiovascular disease and infectious diseases.
The Amgen Bioprocessing Center is run by Dr. Matthew Croughan, KGI's George B. and Joy Rathmann Professor.
Dr. Croughan joined KGI in February 2006 after a nationwide search, bringing with him more than 20 years' of experience in research, engineering, bioprocessing and manufacturing. In addition to launching the Center, Dr. Croughan has crafted the curriculum for the bioprocessing focus track, taught numerous courses in bioprocessing, advised Team Masters Project teams, and assembled the Amgen Bioprocessing Center Advisor Board (ABCAB). Consisting of scientists, engineers, academics and corporate executives, ABCAB provides support and advice to strengthen the mission of the Amgen Bioprocessing Center.
About the Speakers:
Judy Chou, PhD is the Vice President of Research & Development, La Jolla Biologics Inc. and Tanvex Biologics, Inc. (both are affiliates of ScinoPharm Taiwan). For La Jolla Biologics she manages process development of biologic products. She also manages preclinical and clinical study supply production. For Tanvex Biologics she manages R&D activities of biosimilar and biologics development, including bioprocess (cell culture and purification) development, and analytical and pharmaceutical/formulation development. She also manages preclinical studies, clinical studies and discovery phase target research and preclinical and clinical study supply production. She is responsible for regulatory affairs to interact with regulatory agencies for product applications.
She was previously a Senior Group Leader at Genentech. Prior to working at Genentech, she was the Principal Scientist and Group Leader at Wyeth Biotech and a Senior Scientist at Abbott Bioresearch Center. She was a Research Fellow at Harvard Medical School. She received her MD from National Taiwan University Medical School and her PhD from Yale University. She speaks English, Chinese, Taiwanese and German.
Timothy Culbreth is the Site Director at PolyPeptide Laboratories. Tim has over 26 years in the pharmaceutical industry. He has worked for Merck, Roche and Johnson & Johnson. In his career he has worked on some of the key Active Pharmaceutical Ingredient (API) supply launches including the production of the first US commercial scale batches of Simvastatin (Zocor) and Omeprazole (Prilosec). He also played a very active role in the qualification of suppliers and the production of the API Oseltamivir (Tamiflu) during the bird and swine flu pandemics of recent years.
During his career Tim has worked at a range of facilities some being over 40 years old, some being grassroots facilities and some being turnaround facilities. Currently, Tim is the Site Director for PolyPeptide Laboratories in Torrance, CA. The PolyPeptide Group has six manufacturing facilities in total with three in Europe, one in Asia and two in North America. The PolyPeptide Group engages in custom peptide synthesis and in generic peptide production.
Tim's educational background includes a BS in Chemistry from the University of Florida and an MBA from Wake Forest University. Tim has been active in industry organizations and is a strong believer in continuous education. He has been a member of ISPE for 17 years, was a past member of the ISPE Guides Steering Committee and participated in the review of the initial ISPE Baseline Guide for APIs. Tim has been active in ASQ for over 10 years and is a CQT, CQA and CPQP. Tim has also been an active participant in Lean Six Sigma training at both Roche and J&J and is an Accenture Certified Green Belt.
Wolfgang Noe, PhD is Vice President of Manufacturing at Agensys.In his 28-year career in the Biotech industry, he played a leading role in cell culture process development, cell culture based manufacturing, and manufacturing alliances within various organizations. During the most recent years, Wolf was focusing on "new technologies" and "new directions for biologics". Wolf has also been involved in many scientific organizations, such as ESACT, CCE, IBC, where he played a pivotal role in the industrial cell culture society. He joined IDEC in 2001 as head of Process Sciences where he focused mainly on high titer processes in upstream and downstream on monoclonal antibodies. After the merger between Biogen and IDEC in late 2003, Wolf was promoted to the role of Vice President of Biopharmaceutical Development for Biogen-IDEC development for both east and west coast locations. Since 2009, he was in charge of Strategic Development and Technical Alliances at BIIB, focusing on disposables technology, outsourcing aspects, PAT, biosimilars strategy and technology development for biologics. Since late 2011, Wolf Noe is in charge of the "Technical Operations" division at Agensys Inc. at Santa Monica, Ca. USA, a subsidiary organization of the ASTELLAS organization.
Martin VanTrieste is the senior vice president of Quality at Amgen. He is responsible for all aspects of Quality Assurance, Quality Control, Compliance, Environment, Health and Safety along with Training at Amgen.
Prior to joining Amgen, VanTrieste was with Bayer HealthCare's Biological Products Division as vice president of Worldwide Quality and Abbott Laboratories as the vice president of Quality Assurance for the Hospital Products Division (now known as Hospira). While at Abbott, VanTrieste held various positions in Quality, Operations,
and Research and Development. He started his career at Abbott in 1983 after obtaining his Pharmacy degree from Temple University School of Pharmacy.
VanTrieste has been actively involved with various professional and trade organizations, including United States Pharmacopeia (USP), Pharmaceutical Quality Research Institute (PQRI), Pharmaceutical Research and Manufacturers of America (PhRMA), and AdvaMed, and he is a member of the Board of Directors of the Parenteral Drug Associations (PDA). He is the founder and first Chairman of Rx-360 and is currently on their Board of Directors. Rx-360 is a nonprofit international supply chain organization that will enhance patient safety by increasing the security and quality of all parts of the supply chain.
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|Where:||KGI Main Campus|
|When:||July 17, 2013, 4:00 p.m. - 7:00 p.m.|