9th BSMA Conference – Foster City, CA 2016

Welcome Address
Speaker: Devendra Mishra, Executive Director & Co-Founder, BSMA

KEYNOTE ADDRESS: “A Study of Global Clinical Supply Logistics among Pharmaceutical, Biotech, and Provider Companies”:  Business-related findings will be presented from a research study conducted recently by gathering metrics on the impact of global clinical supply logistics among 14 biopharmaceutical, CRO, and provider companies. Critical aspects of global clinical supply logistics will be identified, such as implementing an effective distribution strategy, company strategies and practices to manage inventory, and control of waste.
Keynote Speaker: Dr. Mary Jo Lamberti, , Senior Research Fellow, Tufts Centre for the Study of Drug Development (CSDD)

PANEL: “Industry 360° – Advancing the Efficacy and Integrity of the Virtual Supply Chain”: Senior SCM executives of the bio-pharma industry will address the subjects of supplier relations development, contract manufacturing and clinical trials management, cold chain technology challenges, IT deployment, Big Data and analytics, integrity in the global supply chain, emerging markets and collaboration for efficiency. Pursuit of SCM Excellence will be the objective in terms of Issues and Answers.
PANELISTS:  Lisa Hamann, ‎Vice President and Region Head, North American Supply, Genentech ; Kevin Pegels, Vice President, Global Supply Chain USA, Illumina; Paul Seaback, Head of Global Supply Chain, Gilead Sciences; Prashant Yadav, Director of the Health Care Research Initiative, William Davidson Institute; MODERATOR: Wayne McDonnell, Principal, Pharmaceutical & Life Sciences Advisory, PwC

NETWORK BREAK

 “Product Life Cycle Management (PLM): An Opportune Solution for the Biopharma Industry”: Pharma companies employ different research and operations models to succeed in this demanding new healthcare environment. One common challenge across these models – discovery, development and launch of new products – is management of product and process data.  As companies “lean out” and speed up their development processes with new technologies, they face increasing challenges with capturing and efficiently managing data as it flows from their labs to their plants around the globe.  This is further complicated as companies leverage external development and manufacturing partnerships for speed and cost, and they face the same challenges outside the “4 walls” of their process and technology landscape.  To address this product and process data challenge, pharma companies are beginning to leverage Product Lifecycle Management processes and tools.  
Speaker: Shankar Iyer, Director, Pharmaceutical & Life Sciences Advisory, PwC ; Tim Burks, Principal, PLM Technology, PwC; Shekhar Viswanath, Director, Lilly

PANEL: “Product Lifecycle Management – From Strategy to Results”: Targeted towards current PLM implementers as well as pharmacos  considering PLM in the future this session breaks out the end to end thought process behind implementing PLM – from laying out the vision , developing the business proposition, managing the technology options to selecting an implementation approach  – all of them appropriate to the size and type of business (Innovator vs generics) – from the very companies doing it currently.  
PANELISTS:  Todd Hein, Director, Oracle; Ben Beneski, Director, Amgen; Sekhar Viswanath, Director, Lilly; Susan E. Isabell, Director, Global Regulatory Affairs Clinical Safety CMC Business Process Support, Merck; Jim LaPointe, Managing Director, Cambridge Solutions; MODERATOR: Wayne McDonnell, Principal, Pharmaceutical & Life Sciences Advisory, PwC

LUNCH NETWORK

KEYNOTE ADDRESS: “CSCMP’s State of Logistics Report: Maneuvering for Efficiency and Service”   Transportation industry trends addressed in the Annual CSCMP State of Logistics Report of 2016, sponsored by Penske Logistic and researched and authored by A.T. Kearney, will be highlighted for their impact on the overall supply chain of biopharma. Considered the premier benchmark for US logistics activity, the report includes: a focused narrative on the economic environment impacting logistics; insights from interviews with industry leaders, including shippers, carriers, and analysts; a spotlight on relevant trends; and, a strategic point of view on the state of the industry, including digitization, omnichannel, platform visibility and eCommerce. The statistics and industry insights will enable logistics professionals to meet the challenges of 2017 and beyond.
Keynote Speaker: Sean Monahan, Partner,A.T. Kearny

PANEL: “BREXIT and Global Commerce: Move it or Lose It!”:  The potential impacts of Current Event Topics and the new world order on Supply Chains today and throughout the next decade. Considerable emphasis will be placed on topics such as Brexit and if/how these are impacting or enabling the establishment of logistics hubs, manufacturing centers, or potential HQ’s and even tax shelters. Other current topics demanding attention like Industry 4.0, the age of automation, and Government 4.0 especially as it relates to business stimulation initiatives for the economy and alternatively extraction of corporate taxes. These topics are presented not to deliver answers but to facilitate exchanges of ideas amongst the panel and the audience. Expect an informative exchange of experiences and expectations from practitioners, consultants both US and abroad. Come ready to participate! 
PANELISTS:  Horacio Enriquez, Sr. Manager, Bio-Rad Laboratories;  Franck Toussaint, Managing Director, Biolog Europe;  Moderator: Sean Monahan, Partner, A.T. Kearny

 NETWORK BREAK

TRACK 1: CLINICAL SUPPLY CHAIN & COLD CHAIN

PANEL: “Reducing Waste, Maximizing Efficiency and Streamlining Your Global Clinical Supply Chain”  This panel will address how data is captured and used for managing clinical studies.  Topics covered will include forecasting, tracking shipments, managing inventory, production planning and MRP, and performing drug accountability and reconciliation.  A wide range of solutions will be discussed, ranging from manual processes, to automated ERP systems,  to hybrid solutions that reflect combining multiple tools and solutions.
PANELISTS: Malou Berdan, Senior Manager, Clinical Supply Chain, BioMarin; Renae Bentley-Gay, Team Leader Clinical Supply Optimization, Fisher Clinical Services; Ryan Mills, Associate Director, Enterey Life Sciences; Michael Dallmann, Consultant, TMD Clinical Supplies; Ravi Kiron, Managing Partner, ProPharma Strategy Advisors; Moderator: Devendra Mishra, Executive Director, BSMA

“The Missing Link: The Ups and Downs of Integrating IRT Data with Forecasting Tools” When you have better access to clinical study data, better forecasts can be made.  How do you shorten the gap between IRT event data and one’s planning tools?  Presentation will include enhanced and proven forecasting processes and outputs, as well as the challenges encountered in closing the supply planning loop through integration with IRT systems.  
Luke Moyer, Supply Chain Solutions Manager, Almac Clinical Services

“Operationalizing and Transitioning to a New Plant for Commercial and Clinical Operations – Trials and Challenges” This presentation will highlight the success story of enhancing the supply chain with a new plant for a large pharma company. The rewiring and transformation of the supply chain to achieve greater profitability, both on the commercial and the clinical side, will be examined . Insights will include managing business continuity risks, coordination across multiple functional groups, validations, warehouse challenges, and IT challenges. Transition challenges include manufacturing & packaging processes that will be spread across both plants.  
Syam Veeramachaneni, Manager Business Applications, Gilead Sciences; Arun Cavale, Managing Principal, NexInfo

“Realizing Efficiencies in the Supply Chain: Monitoring VS Controlling Debate”  Maintaining the cold supply chain demands planning, partnering and attention to detail. This presentation debates the right assessment to monitoring, controlling of clinical trial shipments or a combination of both. It gives insight into reusable shipper programs and their benefits to all parties in the Supply chain including the investigator sites.
Allex Guillen, Global Cold Chain Director, Fisher Clinical Services

NETWORK BREAK

“Advancing GDP Compliance Standards In Airline Transportation: Raising the QA Bar for Biopharma”   This session will review the development of air transport cold chain services from a quality perspective.  It will discuss methods used to assess quality, what questions to ask and how a service provider’s organization impacts service quality.  A solution for addressing an often overlooked area of compliance will also be presented.  
Chris Fore, Compliance Manager, Envirotainer

PANEL: “Cold Chain Realities: Keeping Executives Awake at Night” Technology, Business Process, Network, Regulation and Education are beginning to allay the fears of supply chain professionals delivering drugs vulnerable to damage. The stakeholders of the industry will present solutions for the successful deployment of the emerging temperature-controlled logistics and cold chain technology, manifesting from end-to-end of the supply chain. A comprehensive assessment will be made of packaging, engineering standards, business processes, information systems and monitoring mechanisms. The stakeholders will discuss the pitfalls and present a blueprint for the manufacturing, logistics and distribution of temperature-sensitive materials and finished products globally.
PANELISTS: Doug Wettegren, Global Key Account Manager, Envirotainer; Alex Guillen, Global Cold Chain Director, Fisher Clinical Services; Jim Peyton, Associate Director, Supply Chain, Gilead Science ; Wahiba Hall, Leader, Global Transportation and Cold Chain, Pharmacy Group, Bayer Health; Gary Hutchinson, CEO, Modality Solutions;  MODERATOR; Vishal Singal, Principal Real World Insights, QuintilesIMS 

TRACK 2: MOLECULAR DIAGNOSTICS & TECHNOLOGY

 PANEL: “Meeting the Operational Challenges of the Emerging Molecular Diagnostics Business”: Stakeholders of the molecular diagnostics industry will address supply chain issues concerning collaboration for efficiency, quality assurance, customer service and risk mitigation. Executives will discuss best practices, organizational interfaces, information sharing and system connectivity for common good. Opportunities to enhance the goals of the rapidly growing industry will be presented.  
PANELISTS: Rohit Saini, Head of Supply Chain, Guardant Health;  Susan Jiang, Manager, Supply Chain, Illumina; MODERATOR:  Mike Crowell, Director Regional Ops, Illumina;

 PANEL: Meeting the Serialization Regulation of 2017 DSCSA”: A workshop-like environment will cover how to prepare for the November 2017 deadline for DSCSA serialization. Serialization requires manufacturing implementation of unit level bar coding, case and pallet level aggregation, system management of product movement, warehousing and distribution processes to ship product. The operational issues of CMO Integration, Line Management, Readiness, and Upgrades will be addressed, while achieving compliance with Least Cost, Time and Risk. Early lessons learned from Pharma Company-CMO Collaborations will be leveraged. Finally, understanding of global requirements and first-hand experience of how this might support and/or interfere with US implementation will be discussed.
PANELISTS: Scott L. West, Associate Director, Head of Small Molecule External Mfg Operations, North America, Genentech; Basil Pais, Sr. Account Executive, North American Sales, , TraceLink;  MODERATOR: Susanne Somerville, Founder and Principal, TheLinkLab

“Will Artificial Intelligence Remold the Logistics World?”  This insightful, technology-driven talk will explore how machine learning algorithms and artificial intelligence are being deployed today to identify specific patterns from environmental sensor data such as light, pressure, humidity, shock and temperature to visually segment supply chain shipments into their parts (truck, warehouse, tarmac, flight, rail, boat).  When combining these insights on a global scale, it is possible to generate highly accurate handling and excursion benchmarks for airports, shippers, lanes, and seasons.  From these benchmarks, pharmaceutical companies can quickly and accurately project the optimal shipping method to minimize risk, reduce product damage, and cut transportation costs. The capabilities emerging from the game-changing IoT will be presented. 
Rich Kilmer, CEO, CargoSense

PANEL: “Achieving Visibility, Accountability and Regulatory Compliance in the Supply Chain: From Dream to Reality!”  To advance end-to-end supply chain visibility and accountability for product integrity in the global marketplace requires the collaborative efforts of drug manufacturers, distributors, technology solution enablers, logistics service providers and regulatory agencies. Presentation will address an IOT-driven platform and network, where data can be analyzed to provide conformance to operating standards mandated (CFR 21 part 11 and the EU Good Distribution Practice), optimization of logistics processes and cost reduction associated with product packaging (active versus passive containers), accountability of transportation carriers’ performance and other key metrics of the supply chain. Affordable environmental sensors that record temperature, humidity, shock, light, tilt and pressure events provide data to data loggers. Beacons yield the physical location of the events. The resultant benefits of reduced costs, improved compliance and causal analysis for forensics and process improvement will be discussed along with investments required.
PANELISTS: Richard Kilmer, CEO of CargoSense;  François Leclercq, Director, Global Logistics Operations, Shire Pharmaceuticals; Bob Koplowitz, Executive Director, Vertical Industries, Expeditors International;  Jeff Tucker, CEO, Tucker Company Worldwide; Moderator: Dave Malenfant, Executive Vice President, Industry Liaison & Talent Development, BSMA

“Commercial Considerations in the Clinical Laboratory Space”  Reimbursement drives demand swings for a particular test and thus directly impacts the supply chain. Presentation will address issues, such as, “Is it CMS or other payors? Or is the patient who benefits from the diagnostic test? Or is it the MDs who write the prescription for the test? Is it colleagues within the company? Or is it the independent lab?
Shalini Chander, Sr. Project Manager, Illumina

WRAP UP!

SCM EXCELLENCE AWARD CEREMONY

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