Innovating Life Science Cold Chain Logistics
Philadelphia | October 24, 2024
Blue Bell Country Club, Normandy Farm
Blue Bell, PA
9:00am - 5:00pm
Join Leading Industry Peers at Normandy Farm
The Leading Minds Network powered by ELPRO and Cold Chain Technologies, invite you to a special collaborative learning experience bringing together your leading pharm/biopharma, biotech, life science, healthcare and logistics industry peers to network and share best practices. This day-long relaxing, retreat-style setting at the Blue Bell Country Club at Normandy Farm is your opportunity to benchmark ideas, share challenges and gain valuable insights into a variety of today's cold chain challenges. Pre-registration and confirmation is required. This event is complimentary (no fee) to industry professionals. Hotel and travel costs associated with attending this event are not included. Seating is limited--reserve your spot today!
The countdown to this event is over!
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October 24
8:45 | Registration & Coffee
9:00 | Opening Remarks & Welcome
9:15 | Building Trust in Our Medicines Requires Transparency, Quality & Security
Presenter: Vic Suarez, Colonel, US Army (Retired); Founder and Principal Growth Partner, Blu Zone Biosciences & Supply Chain Solutions
Q&A Facilitator: Geoffrey Glauser, former pharmaceutical executive (Merck, Pfizer); former SME at the Biomedical Advanced Research and Development Authority (BARDA)
10:15 | Networking Coffee Break
10:30 | PANEL: Driving Sustainability in the Cold Chain: State of the Industry
Moderator: Jessica Benoit, Senior Sustainability Consultant, Worldwide Specialist Organization, Amazon Web Services (AWS)
Panel: Chandon Trehan, Digital Supply Chain and Sustainability Lead, Bosch USA; Deb Scarpace, Director, Logistics and Trade Compliance, Kyowa Kirin
11:15 | PANEL: Challenges, Trends and Solutions in Frozen Shipping
Moderator: Bryan Cardis, Senior Director, Technical Services, Cold Chain Technologies.
Panel: Craig Vermeyen, Director, Packaging and Labeling, Kite, a Gilead Company; Chris Armstrong Vice President General Manager, McKesson Third Party Logistics; Dana Dallas, Cold Chain/Vaccine Program Manager, Defense Logistics Agency
Noon | Networking Luncheon
1:00 | PANEL: Next Gen Real-Time Monitoring & End-to-End Visibility Strategies
Patrik Senn, Head of Product Management, ELPRO; Jeff Lander, Director, Global Logistics, Moderna; Frank Obrad, Senior Packaging Engineer III, Kite, a Gilead Company; Stefan Braun, Managing Director, SmartCAE
1:45 | Cold Chain Challenges: CGT Temperature Control Strategies
Presenter: Brian Wallin, Associate Director, Cell & Gene Therapy Technical Services, Cold Chain Technologies
2:15 | PANEL: Mitigating Risk in Direct-to-Patient (Last Mile) Shipments
Moderator: Bill Beck, Director of Supply Chain, BlueRock Therapeutics
Panel: Mark Everitt, PCT Qualification Engineer, Astra Zeneca, K. Nicole Harter, Site Quality Leader, Logistics Operations, Eli Lilly; Jeff James, Vice President, Reliable Healthcare Logistics
3:00 | Networking Coffee Break
3:15 | Navigating Clinical Trial Supply Logistics Today
Presenter: Craig LaMarca, General Manager, Boston Clinical Trial Services, PCI Pharma Services
3:45 | BREAKOUT: Roundtable Sessions
Leaders: Melanie Krüger, Qualification/Validation Engineer, ELPRO GxP, Geoffrey Glauser, Government Consultant, Jeff Lander, Director, Global Logistics, Moderna, Karen K. Greene, Vice President of Client Solutions, Network Partners Group; President, Life Pack Labs
Various discussion topics assigned to groups; key insights shared from each group
4:45 | Closing Remarks - Wrap Up
Speakers & Panelists
Vic Suarez
Vic Suarez, Colonel US Army (Retired), MS, PMP, CMRP, is the Founder and Principal Growth Partner of Blu Zone Bioscience & Supply Chain Solutions, LLC. Blu Zone Bio assists biotechnology and life science supply chain organizations in accelerating growth and expanding domestic bio manufacturing through effective public and private partnerships, strategic alliances, and business development. Vic served over 27 years of active duty as a Biotechnology Advanced Developer and Health Care Supply Chain senior leader. He recently was the Senior Medical Acquisition Consultant at the U.S. Army Medical Research and Development Command’s Tech Transfer, IP/Patent, and Business Development Office at Fort Detrick, MD. He also served as the Commander of the 6th Medical Logistics Management Center, a globally deployed healthcare supply chain, information systems, and biomedical maintenance solutions organization. His unique dual background has enabled him to lead highly complex biotechnology and supply chain programs and organizations.
In 2020-2021, he served as the lead Vaccine Program Manager for the Moderna COVID-19 Vaccine at Operation Warp Speed/BARDA and has served in the U.S. Army for nearly three decades in worldwide operational, healthcare supply chain, acquisition, and product development roles, including two combat tours in the Middle East as a medical company and battalion commander.
Vic is a former Chief of Staff of the Walter Reed Army Institute of Research (WRAIR), DOD’s largest biomedical research laboratory headquartered in Silver Spring, MD, and was the Joint Product Manager of the Joint Vaccine Acquisition Program (JVAP). In this biodefense advanced development vaccine program, he played critical roles in the advanced development and delivery of the FDA-licensed Ebola and MPOX vaccines. In 2016-2017, Vic was an Army War College Fellow at the Milken Institute School of Public Health at George Washington University in Washington, DC.
He is a globally and nationally sought-after keynote and panel speaker at life science, supply chain, and national security conferences. He is often asked to chair tracks or moderate high-level panel discussions from highly technical life science areas to global trade and security matters. He has been featured in Bloomberg News, on National Public Radio, Yahoo! News, Military Times, and multiple podcasts.
Vic has testified as an expert witness in the U.S. Senate and has advised many C-Suite leaders, high-level policymakers, and Congressional and White House staff on critical healthcare supply chain, biosecurity, and pharmaceutical policy matters.
He is also a visiting Senior Fellow at the Council on Strategic Risks, a DC-based, non-partisan national security-focused think tank. Vic is a board advisor for several life science, technology commercialization, and healthcare supply chain organizations. He is a Certified Materials & Resource Professional (CMRP®) and Project Management Professional (PMP) and holds a BS and MS from UCLA and Central Michigan University, respectively.
Jeff Lander
![Eblast_Jeff_Lander_400x400_round-1](https://www.leading-minds-network.com/hubfs/Leading%20Minds%20Network/LMN_Seminars/Philadelphia%20-%202024/Eblast_Jeff_Lander_400x400_round-1.png)
Jeff has over a decade of experience in cold chain distribution within the pharmaceutical industry and is currently the Director of Global Logistics Engineering at Moderna.
During his time at Moderna, Jeff has been instrumental in supporting the commercial distribution of over a billion doses of the Moderna Spikevax COVID-19 vaccine worldwide. Some areas of specialization for him include the creation of a global shipping validation framework, cold chain stability design for finished products, temperature monitoring / shipment visibility and serving as an SME during regulatory inspections and audits for cold chain distribution topics.
Prior to Moderna, Jeff was a senior consultant at Lean Biologix and Cold Chain Manager at Accutech Packaging, where he was responsible for the life cycle management and implementation of cold chain packaging across global CMO/3PL sites.
Mark Everitt
![Mark Everitt](https://www.leading-minds-network.com/hubfs/Mark%20Everitt.jpg)
K. Nicole Harter
Nicole Harter is a distinguished quality assurance professional of 30 years in the pharmaceutical industry, specializing in global logistics, quality risk management and quality systems development that align with Lilly’s corporate mission and values.
At Lilly, Harter has made significant contributions by creating global standards and Critical Quality Parameters for distribution compliance. She led the modernization of container qualification and shipping risk assessment processes, enhancing quality while reducing costs. Notably, Harter developed Lilly's global product withdrawal process, successfully implemented for Xigris, earning recognition from top executives.
In her role overseeing North American Logistics Operations, Harter redesigned the quality system and QA team, aligning them with business needs and regulatory requirements. She also led the Global Logistics Quality Leadership Team and Lilly Distribution QA Forum.
Harter's leadership in creating agile quality systems and her emphasis building and managing cross-functional have consistently resulted in zero-observation external inspections. Known for her collaboration, communication, mentoring, and diversity skills by her peers and leaders, Harter is also a dedicated mentor and facilitator of career growth for team members. She is a passionate advocate for special needs children, a volunteer at a food pantry, a half-marathon runner and a master gardener.
Craig Vermeyen
Craig was born and spent his childhood in San Diego. He remained nearby for undergrad (Bachelor’s in Mechanical Engineering 2009) and graduate school (Master’s in Mechanical Engineering 2010) at the University of California, San Diego.
He spent the first 6 years of his professional career with Baxter BioScience, serving in a variety of roles with increasing scope and responsibility in engineering, manufacturing supervision, and packaging across Baxter’s sites in Los Angeles, Thousand Oaks, Hayward, and Westlake Village, California. In late 2016, he joined Kite as the first member of the Packaging Engineering team and built the function up to now include eight engineers. He then took on further responsibilities in addition to packaging, expanding his purview to include functions such as warehousing, logistics, trade compliance and most recently, labeling.
In his free time, Craig enjoys traveling and trying new food with his wife Lindsay, and daughter Avery.
Jessica Benoit
Bill Beck
Bill brings 19 years of Biotech industry experience with recent emphasis on operations and logistics in the autologous CAR-T space. He has worked in operations, project management and different areas of supply chain management, currently leading the supply chain team at BlueRock Therapeutics. Previously he worked for Carisma Therapeutics establishing supply chain/logistics capabilities in support of 2 FIH cell therapy clinical trials, and Celgene/Bristol Myers Squibb where he supported multiple projects including the global launches of Abemca and Breyanzi.
Deb Scarpace
![Deborah_Scarpace](https://www.leading-minds-network.com/hubfs/Deb_Scarpace.jpg)
Deborah Scarpace is a seasoned end-to-end supply chain talent with over 30 years of experience in consumer goods and pharmaceuticals. Her career spans across Fortune 100 size companies, startups, and private equity-backed firms. Currently, Deborah serves as Director of Logistics & Trade Compliance at Kyowa Kirin (KK), a global specialty Japan based pharmaceutical company, at the North America headquarters in Princeton, New Jersey. In this role, she oversees regional and global operations in transportation, warehousing, and import/export compliance.
Deborah is currently engaged in an enterprise risk management assessment project to build a more resilient supply chain for KK’s patients. She is also part of the project team establishing the greenfield site for KK’s first-ever US-based manufacturing plant.
She holds a Business degree from Northeastern University-Boston and an MBA from New Jersey State University-Rutgers. Deborah is also a Certified Supply Chain Professional (CSCP). Beyond her formal education, she values the practical lessons learned from growing up in a family business, often referring to this experience as her education at the “School of Hard Knocks.”
Craig LaMarca
Craig first joined PCI in 2015 as a Business Development Executive, supporting New England clients. Craig left PCI to take a global leadership role with Caligor RX and re-joined PCI in 2018 in a Business Development Executive role in the Tri-State. During that time, Craig worked cross-functionally across departments and drove substantial incremental growth in the North East Clinical business. In March of ‘22 Craig accepted the opportunity as GM of PCI’s new Boston Centre of Excellence.
In Craig’s current role, he reports into the SVP, Clinical Trial Services, assuming responsibility for the site, providing leadership, support and a point of client escalation. Craig was the foundational member of the PCI Boston facility and was instrumental in preparing the facility for launch, overseeing final construction development and business process readiness. As a site leader, Craig delivers site commitments, drives functional excellence and ensure effective and appropriate linkages across the organization. Craig has a keen focus on providing support to leaders and employees and continuously strives for operational excellence, One PCI Culture, and continuous improvement to further enhance the site’s performance toward short and long term goals.
Craig holds a Bachelor of Science and a Masters of Animal Science from the University of New Hampshire. Following graduate school, and a stint in research and development, Craig has spent the entirety of his career in various business development roles at leading CDMOs within both the large and small molecule space. Through this experience, he has developed a unique, holistic perspective in clinical drug development from molecule conception through commercialization.
Bryan Cardis
Bryan Cardis is responsible for the development and execution of CCT’s Customer Optimization and Implementation Services and Commercial Management. Bryan has over 24 years of packaging industry experience in Food (Nestle, USA) and Pharmaceutical (Pharmacia/Pfizer & Eli Lilly & Company) focusing on secondary/tertiary packaging, distribution, logistics, and cold chain/temperature-controlled packaging design experience. Most recently, Bryan worked at Eli Lilly and Company as the Sr. Advisor for the Temperature-Controlled Center of Excellence (COE) and Global Packaging subject matter expert. Bryan received his Bachelor of Science degree in Packaging from Michigan State University (Go Green). Additionally, he is a founding member, vice-chair, and co-author of various ISTA Pharma Committee industry technical documents.
Melanie Krüger
Patrik Senn
Patrik Senn is currently serving as the Head of Product Management at ELPRO, a position he has held since September 2023. With nearly three years of experience at the company, Patrik is responsible to drive product strategy and innovation. Prior to his current role, he spent almost two years as a Product Manager, focusing on various aspects of product development and market analysis.
During his tenure is Product Manager, Patrik played a crucial role in bridging the gap between global sales and development teams. His responsibilities included analyzing sales data, profit margins, and market share trends to inform strategic decisions. Patrik also coordinated product launches and discontinuations, implemented sales promotion initiatives, and developed brand-specific approval documents. His expertise in these areas has contributed significantly to ELPRO’ global product success and market positioning. Patrik is based in Switzerland.
Jeff James
A self-declared “logistics professional with a cold chain problem,” Jeff James has evolved 20+ years facilitating excellence in time and temperature-sensitive pharmaceutical distribution through a vita of experiences with Merck & Co., Janssen Pharmaceuticals, J&J, Pfizer, Sonoco ThermoSafe, Langham Logistics, Accenture, and Uline. Since 2017, Jeff has been providing professional consultative services to private equity and investor groups seeking opportunities in the life science logistics space, as well as to top industry suppliers of innovative solutions in cold chain. Jeff’s specialty is designing, developing, and delivering world-class temperature-controlled product storage and distribution operations with an extensive background in cGMP facility design; refrigerated and frozen storage environment validation; and implementing cold chain network strategy.
Brian Wallin
![Brian_Wallin_2024](https://www.leading-minds-network.com/hubfs/Brian_Wallin_2024.png)
Customer Optimization and Implementation Services and Commercial Management
focused on the Cell and Gene Therapy Industry.
Brian has over 22 years of packaging industry experience focused on cold chain
packaging, distribution, and logistics within food (FreshRealm) and Pharmaceutical (Amgen, Modality Solutions, and Kite Pharma) Most recently, Brian worked at Kite
Pharma a Gilead Company, as the Associate Director of Packaging Engineering leading
Kites Global Packaging Engineering team.
Brian received his Bachelor of Science in Packaging Engineering from the University of
Wisconsin Stout. Brian has been a member of both the International Safe Transit
Association (ISTA) Pharma Committee, and a member of the Parental Drug Association
(PDA) Pharmaceutical Cold Chain Interest Group (PCCIG) where he has co-authored
ISTA standards, and guidance documents, along with PDA Technical Report 39 and
several other Cold Chain related publications.
Chris Armstrong
Dana Dallas
![Dallas D_0964](https://www.leading-minds-network.com/hubfs/Leading%20Minds%20Network/LMN_Seminars/Philadelphia%20-%202024/Dallas%20D_0964.jpg)
Ms. Dallas began serving her country as a United States Air Force Academy graduate, using her Biology/Pre-Medicine degree as a Healthcare Administrator and Medical Logistician with the United States Air Force. She recently retired as a Lieutenant Colonel with the 914th Aeromedical Evacuation Squadron. While with the Air Force, her experiences led her to develop skills in Managed Care, Patient Administration, Resource Management, Medical Logistics, Facility Management, and Marketing. She was active in a Humanitarian Deployment to Haiti in support of Operation Uphold Democracy in 1999; a deployment in support of Operation Enduring Freedom to Bagram, Afghanistan in 2010-2011; and another deployment in support of Operation Inherent Resolve to Al Udeid, Qatar in 2018.
Joining the Defense Logistics Agency in 2000, Dana worked at length with vendors and beneficiaries alike in support of the National Mail Order Pharmacy program. There she focused on information systems, data analysis, beneficiary eligibility, and customer support. Joining the Pharmaceutical Technical/Quality branch in 2003, Dana very quickly took over program management for DLA’s Cold Chain Management Program. In this role she was active in the Department of Defense Seasonal and Pandemic Influenza programs. She also served as a technical representative for the Pharmaceutical and Medical-Surgical Prime Vendor programs and was instrumental in DoD COVID-19 Vaccine Operations packaging/distribution for overseas and US Navy Fleet assets. She established DLA Troop Support Medical as an industry benchmark for Cold Chain and is highly regarded as a Department of Defense subject matter expert in Cold Chain Management.
Chandan Trehan
Chandan leads the digital supply chain and logistics service line for Bosch, where he is responsible to build sustainable, resilient, and efficient supply chain solutions harnessing the power of “Digital.” He is recognized as a Top 50 global thought leader at Thinkers 360. His insights have been highlighted in prominent publications such as NASSCOM, Data quest, Efficient Manufacturing, Toolbox.com, among others, where he explores the role of technology in addressing practical logistics and supply chain problems.
Geoffrey Glauser
![20240821_Geoff_Glauser_2024](https://www.leading-minds-network.com/hubfs/20240821_Geoff_Glauser_2024.jpg)
Most recently, Geoffrey Glauser worked as an SME at the Biomedical Advanced Research and Development Authority (BARDA) where he worked on the design and implementation of vaccine and pharmaceutical supply chain management solutions involving research and development programs, and product throughput by working on contracts for the manufacture and delivery of vaccines, antivirals, therapeutics, diagnostics and medical countermeasures for the U.S. Government, requiring expertise in supply chain, logistics, packaging, sterile operations, regulatory, quality systems, technical bulk manufacturing, filling, warehousing, packaging operations, and product cold chain. Prior to that he had worked for 30 years in the pharmaceutical industry at Merck, Pfizer and in clinical services. Highlights include working with government agencies, vaccine introductions, a clinical trial for the Ebola vaccine, and COVID-19 vaccine response (Operation Warp Speed).
Stefan Braun
![Eblast_Stefan_Braun_400x400_round](https://www.leading-minds-network.com/hubfs/Eblast_Stefan_Braun_400x400_round.png)
Stefan is managing director of SmartCAE, where he works in the field of mathematical modeling of technical systems. His expertise is in thermal modeling and his company's software SmartCAEThermalpackaging, SmartCAETemperatureProfils, and SmartCAELaneRisk are used for risk-based simulation of cold chain.
Frank Obrad
Frank Obrad is a highly experienced packaging engineer specializing in cell and gene therapy cryogenic shipping and cold chain logistics. With extensive expertise in condition monitoring, telemetry, and cellular communication integration, Obrad is recognized as an industry subject matter expert. His work focuses on innovation, engineering development, and testing of secondary packaging and racking designs to support cold chain transportation.
Obrad's proficiency extends to ensuring compliance with various international regulations and standards, including IATA, ISO, and WHO requirements. He develops specifications, conducts technical assessments, and manages risk for cold chain shipping systems. His responsibilities also encompass overseeing qualification and validation processes for transportation equipment.
With a diverse background spanning aerospace, military, and pharmaceutical industries, he brings a wealth of experience in conceptual design, manufacturing, and quality engineering. His skill set and deep understanding of complex regulatory landscapes make him an invaluable asset in advancing cell and gene therapy logistics.
Karen K. Greene, CPPL
Karen is Vice President Client Solutions, Network Partners Group, a professional services firm and President and Owner of Life Pack Labs, an ISO 17025 accredited, packaging testing laboratory. She has been a life sciences packaging engineering industry professional for over 38 years. She is an IoPP certified packaging professional, CPP, lifetime, a past board member of the IoPP Medical Device Packaging Technical Committee and a member of the ISTA Pharma committee and ISTA Board of Directors. Karen is also a member of the ASTM F02, Flexible Barrier Packaging committee. She is an ISTA 7E (thermal design and validation) certified auditor.
Karen brings packaging testing, compliance, quality systems, design and validation and broad medtech and pharma industry expertise to her role as Vice President, Client Solutions at Network Partners Group and President of Life Pack Labs. She leverages this expertise to help clients bring lifesaving products to patients through these two professional services organizations. Karen is a graduate of Holy Cross College, Worcester, MA and holds a certificate in engineering management from University of California, San Diego.
Seminar Location
Blue Bell Country Club
Normandy Farm
1800 Tournament Dr, Blue Bell, PA 19422
(215) 616-8100
Accommodations:
Normandy Farm Hotel & Conference Center
1401 Morris Rd, Blue Bell, PA 19422
(215) 616-8500
www.normandyfarm.com
Hotel and travel costs associated with attending this event are not included.
![Blue Bell Country Club](https://www.leading-minds-network.com/hs-fs/hubfs/Blue%20Bell%20Country%20Club.jpg?width=597&height=398&name=Blue%20Bell%20Country%20Club.jpg)
The Leading Minds Network powered by ELPRO and Cold Chain Technologies is a collaborative learning experience that brings together industry peers and thought leaders to share challenges, solutions and best practices, so that knowledge can be shared for the greater good: providing safe and effective medications and therapies to patients. Through events, articles and conferences, Leading Minds Network explores emerging trends, technologies, and strategies that shape the future of temperature-control in the pharmaceutical, life science, healthcare and logistics industries. Join the community for free today at www.leading-minds-network.com.