Workshop on the Supply Chain for Medicines, Vaccines, PPEs During the Pandemic

Posted on August 14, 2020 by WebMaster in COVID-19 Supply Chain Initiative

August 27, 2020 3:30 pm – 5:00 pm EDT

Medicines workshop news article

Organizing Committee:

Fred Roberts, Director, CCICADA Center, Rutgers University (chair)

Alok Baveja, Rutgers University

Tamra Carpenter, Rutgers University

Weiwei Chen, Rutgers University

Dennis Egan, Assistant Director, CCICADA Center, Rutgers University

Benjamin Melamed, Rutgers University

Viswanath Narayan, Rutgers University

Program:

Introductory Remarks: Gia Harrigan, Acting Director, DHS Office of University Programs

Introductory Remarks: Fred Roberts, Director, COE COVID-19 Supply Chain Initiative, Director of CCICADA COE

Bio: Fred Roberts
FRED S. ROBERTS is a Distinguished Professor of Mathematics at Rutgers University and Director of the Command, Control, and Interoperability Center for Advanced Data Analysis (CCICADA), founded as a University Center of Excellence of DHS. He is Emeritus Director of DIMACS, one of the original National Science Foundation science and technology centers, with 14 academic and industrial partners and some 350 affiliated scientists. Among his current research interests are resilience of supply chains, challenges of disasters and pandemics, stadium and large venue security, resource allocation, maritime cyber security, and the homeland security aspects of global environmental change. Roberts has authored four books, edited 24 additional books, and authored 200 scientific articles, some translated into Russian and Chinese, included the first book on maritime cyber security. Among his awards are the Commemorative Medal of the Union of Czech Mathematicians and Physicists, the Distinguished Service Award of the Association of Computing Machinery Special Interest Group on Algorithms and Computation Theory, Fellow of the American Mathematical Society, the National Science Foundation Science and Technology Centers Pioneer Award, and an honorary doctorate from the University of Paris-Dauphine.

Panel I: Vaccines

Moderator: Fred Roberts, Director, CCICADA COE

Joe Lewis, Managing Director, Deloitte Consulting

Bio: Joe Lewis
Joe has nearly 20 years of consulting experience focused on supply chain, global business transformation, and business process improvement. For the last eleven years, Joe has been focused on the life sciences sector, and has delivered digital and analytics-led supply chain transformations, as well as integrated business planning, supply chain risk, and network optimization projects for pharmaceutical manufacturers. Joe oversees Deloitte Consulting’s supply chain and manufacturing activities for two top pharma manufacturers and is currently leading Deloitte’s US Life Sciences Supply Chain COVID response programs.

Joe holds a BE in Naval Architecture from SUNY Maritime College, and an MBA from UNC’s Kenan-Flagler Business School

Karin Shanahan, SVP of Global Biologics & Sterile Operations, Merck

Bio: Karin Shanahan Slides
Karin has nearly 25 years of experience in the pharmaceutical industry, beginning her pharma career with Bristol-Myers Squibb in their global supply chain organization. Working with a cross-functional team, Karin helped Bristol-Myers Squibb design the Product Development & Commercialization process; later leading the launch readiness for the Abilify launch. She moved into manufacturing operations to lead two manufacturing operations, first a radio-pharmaceutical operation in Billerica, MA and then the networks’ largest API and DP site in Latina, Italy. She left BMS to join Becton Dickenson as VP, Global Operations supporting their Pre-Analytical Services business unit. After a brief role with Catalent Pharmaceuticals, she moved to Teva Pharmaceutical as SVP, Americas & EU Sterile Operations where she had responsibility for 24 sites in Canada, US, Latin America and Europe. During her 5 years at Teva, Karin created the MS&T (Manufacturing, Science & Technology) organization to enhance product launch capabilities, took on responsibility for network strategy and was globally responsible for Operational Excellence. She recently joined Merck as SVP, Global Biologics and Sterile Operations where she has operational responsibility for Keytruda and an IO pipeline of products. In this role, she is also accountable to supply several vaccines, most notably Gardasil. Prior to joining the pharma industry, she held supply chain roles at Daimler Benz and the U.S. military in her hometown of Berlin, Germany. She holds a BA in Political Science & International Relations from Rutgers University and is earning her MSJ in Pharmaceutical and Device Law at Seton Hall University. She currently resides in New Jersey with her husband, Tim, and two daughters, Sarah (18) and Kathryn (17).

Bill McLaury, Rutgers School of Business (retired from Novartis)

Bio: William (Bill) McLaury Slides
Bill was the Executive Director, Pharma Supply Chain with Novartis Pharmaceuticals for over thirty years before retiring in July 2014 and joining the Rutgers Business School (RBS) faculty full time. While with Novartis, Bill held a number of supply chain management leadership positions with operational responsibility, both locally and globally, including ten years as Regional Head for North America, and two years as Global Head of Pharma Supply Chain Strategy. He also served as the Novartis representative on the Industry Advisory Board for the Center for Supply Chain Management at RBS for fourteen years, and as the Chairman of that Advisory Board for the last five.

He is the creator of the Rutgers SCM Curriculum for Secondary Schools which has been adopted by the New Jersey Department of Education, and used in individual schools in 6 other states as well. He is also the author of the textbook, “Fundamentals of Supply Chain Management, A Practitioner’s Perspective” which is used both in the Introduction to Supply Chain Management course at RBS as well as for the Rutgers SCM Curriculum for Secondary Schools.

He is a member of the American Production and Inventory Control Society (APICS), the Institute for Supply Management (ISM), and the Council of Supply Chain Management Professionals (CSCMP) where he served as the Education Chair for the NJ Roundtable. He continues to be a frequent guest speaker at numerous industry and academic events.

Bill has a Bachelor of Science degree in Supply Chain Management from Bowling Green State University, a Masters Certificate in Project Management from George Washington University, and a Master of Administrative Sciences degree from Fairleigh Dickinson University.

Juergen Richt, Director CEEZAD COE

Bio: Juergen A. Richt, DVM, PhD Slides
Dr. Richt came to Kansas State University in 2008 as The Regents Distinguished Professor and Kansas Bioscience Eminent Scholar. In 2010, he became Director of the Department of Homeland Security (DHS) Center of Excellence for Emerging and Zoonotic Animal Diseases (CEEZAD) and in 2020 Director of the National Institutes of Health (NIH) Center on Emerging and Zoonotic Infectious Diseases (CEZID). He received his Doctorate in Veterinary Medicine (DVM) from the University of Munich and a PhD in Virology and Immunology from the University of Giessen, both in Germany. After coming to the United States in 1989, he completed three years of postdoctoral/residency studies at The Johns Hopkins University and later served for eight years as a Veterinary Medical Officer at the National Animal Disease Center (USDA-ARS) in Ames, Iowa. He has edited several books, published more than 250 peer-reviewed manuscripts and raised more than $50 million in grants for veterinary research.

Dr. Richt is a pioneer in veterinary science, most notably in the “One Health” field. His work on high consequence pathogens with zoonotic and transboundary potential led to strategies to identify, control and/or eradicate such agents. His basic and applied research includes studies on animal influenza viruses, animal prion diseases including bovine spongiform encephalopathy (BSE), Rift Valley Fever virus (RVFV), African Swine fever virus (ASFV) and Borna Disease virus (BDV). Dr. Richt established the first reverse genetics system for swine influenza virus (SIV), and made seminal contributions to the development of a modified live SIV vaccine now sold in the U.S. as “Ingelvac Provenza™” and to understanding the virulence of the reconstructed 1918 “Spanish Flu” virus in livestock. He identified an atypical BSE case with a causative mutation (“genetic BSE”), used gene-editing approaches to develop the first prion protein knock-out cattle which are resistant to prion infection, and provided valuable information on host range of animal prions essential for risk analysis. Dr. Richt’s RVFV work led to the development of novel domestic and wild ruminant models for RVF and a safe, efficacious, and DIVA compatible subunit vaccine which is presently undergoing USDA licensure. For ASFV, he is developing subunit and modified live virus vaccine candidates as well as Point-of- Need diagnostics (PenCheck^TM) to protect swine from this devastating disease. His recent work focused on the establishment of preclinical animal models for COVID-19 in cats, hamsters and ferrets. As founding Director of the DHS CEEZAD and the NIH CEZID Centers, he is supporting NIH, DHS and USDA in protecting public health and U.S. agricultural systems from devastating animal and zoonotic diseases.

Panel II: Supply Chain for Medicines, PPEs

Moderator: Dennis Egan, Assistant Director, CCICADA COE

Bio: Dennis Egan, Ph.D.
Dennis Egan is a Research Professor at Rutgers University and was appointed Assistant Director of CCICADA in 2015. Prior to his appointment at Rutgers, he had a thirty-six year career as a researcher and research manager at Bell Laboratories and its successor companies Bellcore, Telcordia, and Applied Communication Sciences. He retired in 2013 as Executive Director, Information Analysis and Services Research.

Since joining CCICADA, Dennis has led projects applying data science to problems of enterprise and homeland security. He is currently PI on a DHS S&T project focused on training and certification requirements in cyber forensics for DHS and State and Local law enforcement agencies. He has co-authored recent reports on large venue security for the DHS Office of SAFETY Act Implementation, on cyber security education for the DHS S&T Cyber Security Division, and on cyber security information sharing for the U.S. Coast Guard. Dennis currently represents CCICADA on the Cyber Security Subcommittee for the USCG Port of New York and New Jersey Area Maritime Security Committee (AMSC). Dennis received his M.A. in Applied Mathematics and Ph.D. in Experimental Psychology from the University of Michigan.

Eric Garvin, Head of Pharma Solutions, Chronicled, Lead of MediLedger Network

Bio: Eric Garvin Slides
Eric Garvin is the lead of the MediLedger Project, co-founder of The LinkLab, and a Pharma industry consultant with more than twenty-five years of management and project management experience in the Life Sciences industry.
Mr. Garvin has focused on business development, M&A, Supply Chain, and IT projects. He has spent the last 6 years leading serialization implementation programs, both for the US and globally, and driving the development of blockchain-based solutions with the mission of establishing the first Pharma blockchain network.

He earned his B.S. from the University of Notre Dame.

Rory Yanchek, VP Government Markets, 3M

Bio: Rory Yanchek Slides
Rory J. Yanchek is the Vice President and General Manager of 3M Government Markets. In this enterprise level role he is responsible for the strategic and operational leadership of 3M’s United States Government focused business.

Previously, He was the Vice President and General Manager of 3M’s Aerospace and Commercial Transportation Division. His team designed, manufactured and marketed an innovative portfolio of engineered material science solutions for the aerospace and commercial transportation industries.

From 2012 to 2014 he was the Vice President and General Manager of 3M Defense Markets Division. This cross-3M division organization was chartered to bring 3M’s broad technology capabilities and product solutions to the global defense industry. Rory led 3M’s Track and Trace Solutions Division as General Manager from 2008 to 2012.

Prior to the Track and Trace assignment, Rory was responsible for Government sales and marketing for 3M’s Occupational Health business. He was the key architect behind the successful development and successful launch of the world’s first powered air purifying respirator used for the protection of First Responders.

Before joining 3M, he served in leadership positions with international health care and medical device companies. At Racal Health & Safety Inc., he was Director of Government Sales and Marketing responsible for respiratory protection devices and before that, he spent a decade with Schein Pharmaceutical and Allergan Pharmaceuticals in various U.S. and global sales, sales management and marketing management roles.

Rory holds a Master of Business Administration from The University of St Thomas (Minnesota) and a Bachelor of Arts in Political Science from East Stroudsburg University (Pennsylvania). He served over ten years in the active and reserve components of the United State Army as an Airborne Ranger Qualified Infantry Officer.

He is active in business, professional and civic organizations including Board membership of the Alliance to Save Energy, membership in the Business Executives for National Security (BENS), past Chairman of the Board of Aearo Technologies, llc,, Board of Governors member of the Aerospace Industries Association, past Board of Trustees member at Hill Murray High School, and past Board of Director’s member of Eagle’s Turf.

He resides in Great Falls, Virginia with his wife Diane and two children.

Viswanath Narayan, Rutgers School of Business (retired from Pfizer)

Bio: Viswanath Narayan Slides
Part-Time Lecturer Viswanath Narayan brings more than 30 years of experience to bear when teaching in the Master of Supply Chain Analytics program at Rutgers Business School. He retired from Pfizer where he was director of supply chain analytics business technology. He is an experienced professional with Automotive and Pharmaceutical experience with data analytics and Supply chain. Mr. Narayan has an undergraduate degree from Birla Institute of Technology and an MS in Industrial Engineering from ASU and an MS in BIA from Stevens Institute of Technology.

Daniel Gerstein, RAND Corporation, Homeland Security Operational Analysis Center

Bio: Daniel M. Gerstein Slides
Daniel M. Gerstein is a senior policy researcher at the RAND Corporation. Previously, he served at the U.S. Department of Homeland Security (DHS) as Under Secretary (Acting) and Deputy Under Secretary in the Science & Technology Directorate. He has extensive experience in security and defense while serving as a Senior Executive Service (SES) government civilian, in uniform, and in industry. He is also an adjunct professor at American University in Washington, D.C. In DHS S&T, he managed the directorate’s $1-billion budget and spearheaded several cross-departmental efforts in big data, cybersecurity, and biodefense. Gerstein began his professional career in the U.S. Army, serving on four continents, participating in combat, peacekeeping, humanitarian assistance, counterterrorism, and homeland security. Following retirement from active duty, he joined L-3 Corporation as Vice President for Homeland Security Services. Before joining DHS, Gerstein was the Principal Director for Countering WMD in OSD (Policy). He also served on the Holbrooke Delegation that negotiated the peace settlement in Bosnia, established SOUTHCOM’s cybersecurity facility following 9/11, developed a biosurveillance system for DoD, and led the Army’s most comprehensive restructuring since WWII. He has been awarded many foreign, military, and civilian awards, including the U.S. Army Soldiers Medal for heroism. He has published many books and articles on national security topics and is a member of the Council on Foreign Relations. Gerstein graduated from West Point and has master’s degrees from Georgia Tech, National Defense University, and Army Command & General Staff College, and a Ph.D. from George Mason University.

Brian Weinhaus, ICE-HSI, Operation Stolen Promise – COVID-19 Fraud

Bio: Brian Weinhaus Slides
Brian Weinhaus is a Unit Chief with the Homeland Security Investigations (HSI) led Intellectual Property Rights Coordination Center (IPRC). Brian has 25 years of law enforcement experience with four law enforcement agencies. Brian arrived at the IPRC in February 2020 from his most recent tour as a group supervisor for the HSI Detroit field office. Brian now oversees all the national intellectual property (IP) investigative operations which concentrate on sectors such as automotive, pharmaceuticals, health and beauty products, consumer electronics, clothing and sports merchandise, tobacco, and government and DOD supply chain security.