8:30 am – 8:45 am Welcome Address: Supply Chain Management – Why Life Depends on Us?

Co-Chairs

Devendra Mishra, Executive Director, BSMA

   Rich Kilmer, CEO, CargoSense

8:45 am – 9:25 am  SCM 360 INDUSTRY STATE OF THE UNION

Supply chain has increasingly become the backbone for the delivery of drugs to patients across the world. The exponential changes being brought about in processes, people, systems, and technology will be presented by executives of large and start up BioPharma companies. In addition, the ongoing challenges will be discussed to enable the ecosystem for furtherance of healthcare.

PANELISTS

Barbara Fitch, Head, Supply Chain, Allogene
Stuart Poll, Vice President, Global Supply Chain, Illumin
Gene Schneller, Professor of Supply Chain Management, W. P. Carey School of Business (ASU)
Franck Toussaint, Managing Director, BSMA Europe
Moderator: Robert Lamont, Partner, Clarkston Consulting

The unprecedented supply chain challenges of the rapidly evolving therapy of Cell and Gene will be addressed in a context where collaboration yields highest dividends for affordable treatment. The fundamental aspects of expanding community hospitals and clinical centers; standardization of the interface with CGT therapy companies; best industry procedures for cell collection; digital platform for planning, sourcing, manufacturing, and distribution operations; and European Regulatory compliance for labeling, packaging and shipping, will be discussed with solutions in mind.

PANELISTS

Lisa Taylor Ash, General Counsel, Shape Therapeutics
Heather Erickson, Former VP Supply Chain Management & Business Operations, Sangamo Therapeutics
Barbara Fitch, Head, Supply Chain, Allogene
Christophe Suchet, Vice President, IT, CARGO Therapeutics
Moderator: Colby Voorhees, Senior Director, Global Life Sciences, Slalom

10:05 am – 11:05 am  NETWORK BREAK & VENDOR EXHIBITION

11:05 am – 11:35 am  KEYNOTE:  MANAGING SUPPLY CHAIN RISKS & ENGAGING YOUR TEAMS: HOW TO PREVENT EXECUTIVE FAILURE?

Regardless of the methods used to identify risks to one’s end-to-end supply chain, it requires human intervention and human responsibility/accountability to ensure the right risks are mitigated. and The C-suite must not only understand the risks but also understand the impact if that risk were to occur and the costs required to mitigate it. Accountability lies squarely on the shoulders of the Head of Supply Chain and their team.  In order to reduce execution risk, an engaged workforce is key.  Your role as an executive can be done at several levels:  

1.  The Sr Executive E-mail (or ZOOM);
2.  The Sr Executive Walk Around; and
3.  The Embedded Sr. Executive.

  Robert Tenerowicz, Retired Senior Vice President of Supply Chain Operations and Engineering, BioMarin

11:35 am – 12:05 pm  MANAGING THE LOGISTICS TURBULENCE AHEAD – ECONOMIC VOLATILITY, REGULATORY CHANGES, DECARBONIZATION, LABOR STRIFE AND LITIGATION

80% of domestic freight transportation is spent on the $1 Trillion trucking market. Based on the personal experience as the co-president of Boyle Transportation and insights of the American Trucking Associations, the industry’s Washington-based advocacy organization, the presentation will describe the economic and regulatory factors that will affect your supply chain in the coming years, and strategies for navigating them successfully.

 Andrew Boyle, Chairman, The American Trucking Associations & Co-President, Boyle Transportation

12:05 pm – 12:35 pm KEYNOTE: BUILDING DATA AND AI FOUNDATION FOR RESPONSIBLE AI TO DRIVE BUSINESS ADVANTAGE

Organizations are witnessing the dawn of the data-driven, AI, and regulatory era where digital transformation of organizations is occurring at a rapid pace in order to stay relevant and pave the way to a sustainable future. The consolidation of an organization’s data into a governed, trusted, and well-managed environment that supports both AI development and production workloads is playing a crucial role in this transformation. Organizations want to take advantage of AI, but they need a trusted foundation and access to the data. Our mission is to deliver a trusted, enterprise-wide, data and AI backbone for transforming IBM into an AI Enterprise. This is helping to accelerate the infusion of data and AI in business processes and provide a fertile environment for identifying, building, and deploying responsible generative AI solutions. The resulting benefits to business are reduced time to find and consume data, reduced time to implement initiatives across business units, reduced end-to-end cycle time, and delivering insights that were previously impossible.

   Ranjan Sinha, IBM Fellow, VP, and CTO, watsonx, IBM Research AI

12:35 pm – 2:00 pm LUNCHEON NETWORK

2:00 pm – 2:30 pm  KEYNOTE:  GILEAD SCIENCES ROAD MAP FOR SUSTAINABILITY INTERTWINED WITH HUMAN INGENUITY

Creating a healthier world is not just an aspiration but a shared responsibility at Gilead Sciences. The path forward intertwines sustainability and human ingenuity, paving the way for a brighter future. As the threats posed by climate change loom larger than ever, Gilead Sciences is committed to transition to a low-carbon future, all while making a positive impact on the lives of underserved and at-risk populations.

   Joydeep Ganguly, Senior Vice President, Corporate Operations, Chief Sustainability Officer and Board Member, Gilead Foundation

2:30 pm – 3:00 pm MANAGING COST AND ACCOUNTABILITY OF PARCEL SHIPMENTS: A PARADIGM SHIFT FOR THE BIO-PHARMA INDUSTRY

Parcel shipments to healthcare providers, pharmacies and homes represent 20% of shipment volume but may account for as much as 70% of the total transportation spend of a BioPharma company and a dis-proportionate amount of delivery failures. Commercial, Clinical, Personalized Medicines and Direct To Patients deliveries face formidable challenges of Timely Delivery of Temperature -Sensitive products, Safety/Security/Reliability, and the Last Mile. A Merck-led global study, in conjunction with technology platform company CargoSense, Sustainable Packaging Company AeroSafe and the Global Parcel Delivery Network has yielded a unique opportunity for industry to collaborate to significantly reduce cost, lower carbon footprint, provide product state visibility and improve customer service.

Timothy Elliott, Executive Director, Global Transportation, Merck
Richard Kilmer, CEO, CargoSense

3:00 pm – 3:45 pm  DIGITAL TRANSFORMATION INITIATIVES FROM DRUG DEVELOPMENT TO PATIENT CARE 

The mechanism to reduce the life-threatening vulnerability of the supply chain of healthcare after the COVID-19 Pandemic was and still is digitalization. Fundamentally, digitalization accelerates the change required exponentially. While it’s argued that data, not digitalization, transforms the post pandemic supply chain, the reality is they are inextricably linked. This panel will present case studies that demonstrate this linkage between data and digitalization from the perspective of thought leaders in the areas of Clinical Operations Planning, Digital Cold Chain, Supply Chain Control Towers for Visibility and Early Warning Systems,  Panelists will explain the practicality of how embracing digitalization and advancing long a digital journey can reduce costs, lead times, and supply chain pain points.

PANELISTS

Stefan Braun, CEO, SmartCAE
Bharath Sundararaman, General Manager, Supply Network Orchestration, TraceLink.
Antonio Menendez, Vice President, Commercial Supply Chain, Exelixis
Neeraj Shah, Founder & Managing Partner, Boston Insights
Moderator: Randy Bradley, Associate Professor, Supply Chain and Information Systems, University of Tennessee

3:45 pm – 4:45 pm  NETWORK BREAK & VENDOR EXHIBITION

4:45 pm – 5:30 pm INNOVATIONS IN TRANSPORTATION & LOGISTICS: FROM ACHIEVING VISIBILITY TO CARBON FOOTPRINT REDUCTION

Meeting the challenges of delivering pharmaceutical products globally with demands of stringent temperature-control, visibility from end to end, unique packaging reconfigurations, returns management and sustainability is becoming the new norm for drug distribution. Technology-driven services available today for Cold Chain, Containerization, IoT driven platforms, Control Towers and Real Time decision-making will be presented. The economic impact of reducing waste, delays and defects will be addressed in addition to building an early global warning system for resilience of supply of materials and services.

PANELISTS

John Hoyt, Managing Director, DW Morgan
Marco Quiros, Head of Sales, SkyCell
Robert Stradford, Account Executive, Specialty Products Sales, United Cargo
Jeff Tucker, CEO, Tucker Company Worldwide
Alison Crawley, Global Sustainability Manager, Sonoco ThermoSafe
Moderator: Kumar Ayyagari, Principal, Global Supply Chain, Slalom

5:30 pm – 6:30 pm  VENDOR SHOWCASE  

6:30 pm – 11:00 pm  SOCIAL EXTRAVAGANZA

[ROOM: Crowne Plaza Suites Bistro & Lounge]

8:30 am – 8:45 am Welcome Address

  Bill Coakley, Executive Vice President, BSMA

8:45 am – 9:30 am ART VS SCIENCE:  CLINICAL SUPPLY PLANNING STRATEGIES

Learn from industry experts the challenges and opportunities around clinical supply planning for drug substance and drug product.  Is it more art than science?  We will consider strategies for CMO commitments, budget constraints, building the right relationship with clinical development, and how to ensure supply chain gets involved early in the clinical process. 

PANELISTS

Ryan Mills, Sr. Director, Supply Chain, Denali Therapeutics
Brittney Elko, Director, Technical Operations and Supply Chain, Aligos
Matt Blume, Vice President, Business Transformation, Catalent
Mike Ragone, Senior Director, Supply Chain, Vir Biotechnology
Deborah Knoll, Director, Commercial Excelleration, Thermo Fisher
Moderator: Stacey Erickson, Director Life Sciences, Clarkston Consulting

9:30 am – 10:15 am WAGING A WAR ON CLINICAL SUPPLY WASTE

Industry reports confirm that over 60% of products and supplies in Clinical Trials are wasted. These warriors will analyze the reasons for the waste which boil down to business processes, systems driving supply chain, assumptions and the collaboration among the stakeholders, organizational structures and communication networks. Analysis of War Stories will lead to strategies and specific steps that can be taken by practitioners.

PANELISTS

Cat Hall, Head, GXP Quality, Egnyte
JP Kappelle, Vice President, Clinical Services, Inceptua
Deborah Knoll, Director, Commercial Excelleration, Thermo Fisher
Dawn Wright, Head, Global Clinical Supply Chain, Incyte
Moderator: Allen Jacques, Industry Thought Leader, Kinaxis

10:15 am – 11:15 am  NETWORK BREAK & VENDOR EXHIBITION

11:15 am – 12:00 pm  NAVIGATING THROUGH THE COMPLEXITIES OF GOOD DISTRIBUTION PRACTICES IN A  GLOBAL SUPPLY CHAIN

The links of the supply chain for Clinical Trials must comply with the regulatory and business requirements for functional integrity, best practices, standards, security and patient care across companies and countries. The Good Distribution Practice covers all activities connected with the distribution of products and supplies for a Clinical Trial from end to end. A primary requirement in the pharmaceutical industry is to assure the quality of the products throughout its entire lifecycle, beginning with using the correct quality of raw materials up to the final delivery of the medicinal product to the patient in the study. SMEs will present how Good Distribution Practices ensure the best outcome, maximum efficacy, optimal cost and minimum risk.

PANELISTS

Aparna Seksaria, Industry Solutions Sr. Manager, Life Science, SAP
Des Charlery, Associate Director Global Transportation, Allogene
Sonia Jaykell, Sr. Manager Global Trade Compliance, BioMarin
Bill Kappler, Business Development Manager, World Courier
Moderator: Sascha Sonnenberg, Vice President, Global Business Development & Country Head Germany, Sanaclis

12:00 pm – 1:00 pm LUNCHEON NETWORK

1:00 pm – 1:45 pm  THE FINAL COUNTDOWN:  NAVIGATING A SUCCESSFUL STUDY CLOSE-OUT

The activities performed upon completion of a Clinical Trial study have significant ramifications for its success as well as the subsequent commercialization for profit. In addition to delivering final FDA requirements, institutionalizing the learnings and study revisions, the business imperative is to create a vital link with the commercial business in terms of Master Data Management, Planning, Procurement, Manufacturing and QA. Avoiding unintended negative consequences will be discussed.

PANELISTS

Donna Lucero, Manager, Clinical Systems Analytical Reporting (IRT), Amgen
Francesco Santo, Associate Director, Clinical Supply Chain Lead, Exelixis
Janet Ho, Sr Manager, Clinical Supply Chain Management, Gilead Sciences
Diana Vazquez, Vice President, Supply Chain, Pliant
Moderator: Cat Hall, Head, GXP Quality, Egnyte

1:45 pm – 2:30 pm  Debate: SHOULD A COMPANY HAVE 1 COMBINED OR 2 SEPARATE SUPPLY CHAIN DEPARTMENTS FOR SUPPORTING COMMERCIAL AND CLINICAL PRODUCTS?

As organizations mature and its products achieve commercialization, decisions about department infrastructure, tools & technologies, and processes such as S&OP need to be considered.  While it is recognized that the business processes and systems for Clinical are a forebearer of the Commercial requirements, the R&D nature of Clinical Trials makes it innovation-centric and not mass production. A Debate will rage to explore what makes sense for a business at its level of maturity. Does one size fit all or is it a hybrid?

PANELISTS

Mike Ragone, Sr. Director Supply Chain, Vir Biotechnology
Matt Donnelly, Vice President, Head, Supply Chain, Arcus BioScience
Allen Jacques, Industry Thought Leader, Kinaxis
Moderator: Mike Dallmann, Sr. Director, Supply Chain, Avidity

2:30 pm – 3:15 pm  OVERCOMING THE ACHILLES HEEL VALUATING PRODUCTS FOR IMPORTERS AND EXPORTERS

Establishing the elements of Valuation for raw materials, ancillary supplies, intermediates, and final product is cumbersome and failure-prone because of the disparate nature of multi-functional reality, both internal and external to a company engaged in global drug approval and subsequent distribution. The US Customs and Border Protection pose a major challenge which is ill understood leading to risks of delays, cost and fines. The demands of multi-country, governmental compliance requirements make it very complex, particularly in the context of stringent GDP requirements. Experts will sort out the issues and provide clarity for action.   

PANELISTS

Jeff Bernia, Sr. Manager, Shipping/Export Compliance Officer, Bayer
Aaron Lee, Associate Director, Global Supply Chain, Vir Biotechnology
Chad Eastman, Director, Globl Statistics, Dermavant Sciences, Inc.
Moderator: Dan Bell, Sr. Vice President, Innovation & Strategic Operations, Marken

3:15 pm – 5:00 pm 

VENDOR SHOWCASE & NETWORK BREAK

SUPPLY CHAIN MANAGEMENT EXCELLENCE AWARDS

COCKTAIL RECEPTION

[ROOM: Vendor Showcase]