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

PANEL: “Industry 360° – Advancing the Efficiency and Intelligence of the Biotech 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, Big Data and analytics and emerging markets. Approaches will be discussed to achieve disruption in traditional practices through technology and collaboration for efficiency and less onerous compliance with governmental regulations.
PANELISTS:  Yashwant Aphale, Vice President, Technical Operations, Sarepta Therapeutics; Kevin Duval, Director Procurement Operations and Supply Risk, Shire; Mary Kachinsky, Vice President, Strategic Sourcing and Operations, Forma Therapeutics; Craig Morgan, VP Product Supply US, Bayer;  Iris Stammberger, CEO, Talbok Consulting; MODERATOR: Devendra Mishra, Executive Director & Co-Founder, BSMA

KEYNOTE:  “Patient-centric Supply Chain in the Disruptive Digital World of Healthcare: Seizing the Potential!”   The healthcare value chain is an extremely fragmented, multi-layered system of trading partners and intermediaries. This fragmentation makes it challenging for biopharma organizations to keep the end user, the patient, at the center of their supply chain strategies. The presentation will cover the ways supply chain and digital technologies can disrupt this fragmentation and create a more patient-centric supply chain organization.
KEYNOTE SPEAKER:  Barry Blake, Vice President, Program Director, SCM World

KEYNOTE:  “Pharmaceutical and Biotech Company Practices and Strategies that Create Efficient Global Clinical Supply Logistics”   Global clinical supply professionals are driven by a simple credo: to provide the highest possible quality clinical trial supplies in a fast and efficient manner. Tufts CSDD will present data not previously revealed from a clinical supply logistics study on key distribution metrics and strategies for success as well as improved efficiencies organizations are reporting across top pharmaceutical and biotech companies. Strategies for managing returns and the use of pooled supplies, as well as global approaches to expiry dates and temperature monitoring strategies globally will be examined as well as their impact. Organizational training and communication approaches will also be shared as well as measures that have improved training effectiveness.
KEYNOTE SPEAKER:  Mary Jo Lamberti, Senior Research Fellow, Tufts Centre for the Study of Drug Development

PANEL: “Meeting the Formidable Challenges of Strategic Sourcing for Developing a Virtual Infrastructure for Drug Development and Commercialization”   For small and medium-sized biotech companies, the tasks of procuring the services required to support drug discovery, development and commercialization are overwhelming. They are often underserved because of misaligned experience, limited resources, investment constraints, and incomplete knowledge of what options are available on the market. In this context, the role of strategic sourcing becomes vital to ensuring the success of the enterprise: meeting quality and regulatory requirements, accelerating speed to market and delivering compelling financial results. Identifying, qualifying, and establishing outsourcing relationships contributes to enterprise strategy, innovation, and collaboration. Given the rising importance of digital technology in procurement, a supplier discovery and knowledge management platform will be presented that centralizes information and instantly connects supplier capabilities with specific requirements. This dynamic session will highlight how to supplement scarce internal resources and overcome organizational constraints with the full capabilities of suppliers for synergy creating value beyond cost savings.
PANELISTS:  John Napoli, Director, Information Services, Perkin Elmer;  Stephany Lapierre, Founder and CEO, Tealbook; Matt Weinberg, Director, Strategic Sourcing and Procurement, Agios;  MODERATOR: Mary Kachinsky, Vice President, Strategic Sourcing and Operations, Forma Therapeutics

Panel: “Utilizing Big Data to Mitigate Risk in Temperature-sensitive Shipments”    How data analytics tools and IoT technologies are being utilized to effectively combat risk in temperature controlled supply chains. We will share practical methods that drive big data-style analysis and help Life Science and Healthcare companies better anticipate risk factors. We will provide information from our systems which can provide real-time risk intelligence, allowing users to make better decisions based on hundreds or even thousands of risk variables.
Speaker: David Bang, CEO LifeConEx, DHL Global Forwarding

PANEL: “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.

PANEL: “Unleashing the Trapped Value in the Supply Chain Management Process by Starting at the Beginning of the Sourcing Process – Drug Discovery & Development CROs and CMOs”   The intrinsic nature of a biotech company has the CROs and CMOs providing extraordinary value in development and delivery of drugs under the cloud of cost efficiency, scalability and time to market. The consequent challenges of achieving total alignment of strategic objectives, seamless integration of services, capability to monitor the process and ensuring governmental regulatory compliance are enormous. The executives of small to large biotech companies will address how management, systems and technology are being deployed to maximize success of drug delivery to the market in a speedy and efficient manner.
PANELISTS: Andy Nichols, PhD. CSO, Catabasis Pharmaceuticals, Inc.; Liz O’Day,PhD, CEO & Founder, Olaris Therapeutics, Inc.; Roya Khosravi-Far, PhD, Co-Founder & Chief Scientific Officer, Biomar Therapeutics; Paul Wengender, CEO, Crow’s Nest Bio; Moderator: Michael Luther, CEO and President, Bantam Pharmaceuticals

PANEL: “Optimizing and Integrating the Fulfillment Process of the Clinical Supply Chain in the Global Territories: Technology, People and Processes”  The practical opportunities to significantly reduce cost, time and failures in Clinical Trials of drugs, while ensuring regulatory compliance, will be addressed through the deployment of automation of clinical protocol request process; a patient-centric approach to overcome logistics impediments to patient enrollment; demand planning and inventory management with drug expiry; integration of labeling, packaging, delivery and returns with governmental regulations in mind; and, enhanced integration of the IRT links based on transparency and trust. In addition, the unique opportunities in Latin America will be explored for patient enrollment.
PANELISTS:  Mary Jo Lamberti, Senior Research Fellow, Tufts Center for Drug Development; Arun Cavale, CEO, NexInfo; Sara Tylosky, President & CEO,Farmacon; MODERATOR: Jim Shuman, CEO, PDM Consulting

 PANEL:  “Are You Ready for Serialization 2017 Mandate of DSCSA?”   An interactive panel discussion will cover how to prepare for the November 2017 deadline for DSCSA serialization. Serialization can involve manufacturing implementation of unit level bar coding, case and pallet level aggregation, system management of product movement, warehousing and distribution processes to ship product. This panel will address topics such as: pharmaceutical manufacturers/CMO collaborations and integration, line management upgrades, serialization readiness, and discuss how to overcome these operational challenges while achieving compliance with the least cost, time and risk to your organization. Finally, the panel will provide an overview of global serialization requirements with first-hand experience of how support of these regulations may benefit from early lessons learned in US implementation of serialization.
PANELISTS: Brian Daleiden, VP Industry Marketing, TraceLink;  Franco Pasquale, Senior Director of Supply Chain, Technical Operations, Agios Pharmaceuticals; MODERATOR: Greg Cathcart, CEO, Excellis Health Solutions

 TRACKS: PROCESSES, TECHNOLOGY AND SYSTEMS INNOVATIONS IN BIOTECH

• “Meeting the Formidable Challenges of Strategic Sourcing for Developing a Virtual Infrastructure for Drug Development and Commercialization”
• “Overcoming the Organizational, Operational and Systems Roadblocks of Clinical Supply Through Collaboration”
• “IoT-driven Technology: Producing Disruption for Progress”
• “Integrating Planning, Packaging, Logistics and IT to Maximize Accountability and Efficiency in the Global Clinical Supply Chain”
• “Complying with DSCSA Serialization Mandate of 2017: Meeting the Operational Challenges of Readiness”
• “Achieving Visibility, Accountability and Regulatory Compliance in the Supply Chain:From Dream to Reality!”
• “Unleashing Innovation Through Data Analytics”
• “Successful Adoption of Artificial Intelligence in Supply Chain Management”
• “Temperature-Controlled and Cold Chain Supply Chain: Proven Technologies and Practices”

WRAP UP!

SCM EXCELLENCE AWARD CEREMONY

“SCM Innovation Awards” have been given since 2014 to the stakeholders of the Biotech industry – Manufacturers, Service and Material Providers, Technology Enablers, Academia, Management Consultants, Trade Associations and Governmental Regulators, in order to recognize exemplary contribution towards advancing the Global Supply Chain.

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