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Driving Innovation to Advance Patient Therapies

Technical Solutions  •  Innovative Approaches  •  Emerging Trends  •  Targeted Technical Sessions  •  In-Depth Workshops

Annual Meeting Track Directors are seeking submissions that address the following topics.

End-to-End Supply Chain Management Track

Track Director: Niranjan Kulkarni, PhD, Operations Specialist, CRB
Co-Director: Neal Gordon, Director, Director MRL Logistics, Global Clinical Supplies, Merck, Sharp & Dohme Corporation

  • Current status and trends in serialization / track & trace methods
  • Supply chain responsiveness during unforeseen events, e.g. during an epidemic or outbreak
  • Supply chain / cold chain: Best practices, metrics, and trends
  • Scaling up supply chains from clinical through commercialization: Challenges and solutions
  • Innovation and adopting technology to manage supply chains and patient safety, e.g., micro needles for drug delivery, stem cell therapies, “digital pill,” etc.
  • Internet of Things (loT) applications in supply chain
  • Data mining and data analysis applications
  • Operational excellence in supply chains
  • Understanding mobile health trends and its transformation on clinical trials

Facilities and Equipment Track

Track Director: Michelle M. Gonzalez, Engineering Director (Retired) AMGEN, Inc., BioPharm Engineering Consultant
Co-Director: Gary Knight, Project Director, Commissioning Agents, Inc.

  • Critical Utilities: Systems and Methods – materials and construction requirements; pharmaceutical waters sampling methods; worldwide regulatory systems requirements
  • Facility Maintenance: Preventative maintenance; reduction and/or elimination of shutdowns
  • Facilities of the Future: Creating more efficient laboratories; effects of academia and/or innovative R&D on GMP critical facilities; pros and cons of modular and/or offsite construction
  • Biotech Facilities: Development plans – master; business; investment; drug production – what the next manufacturing generation(s) will bring regarding construction requirements; the role of biosimilars and their impact in new facilities construction and/or renovation; the role of contract development and manufacturing organizations (CDMO) in new facilities construction and/or renovation; hybrid, stainless steel/single-use technology impact on biotech facility design
  • International Facilities: Applicable building codes and GMP regulations in planning, design, and construction of new biopharmaceutical facilities
  • Sustainability: Water conservation in times of drought; waste water – recovery and recycle?; solar power – usage to support regular utility power

Information Systems Track

Track Director: Eric Staib, Executive Director, Quality Assurance, PRA Health Sciences
Co-Director: Sam Brooks, Principal Consultant, Brooks Information Integrity Innovations

  • Data Integrity: Strategies for assuring data integrity in computerized systems, pragmatic experiences of addressing real-world data integrity challenges
  • Clinical/R&D Systems: Concepts and strategies for the validation of a “clinical platform” and ensuring compliance/data integrity of multiple systems and their inter-related interactions throughout a clinical study
  • Devices in Biotech and Therapeutic Applications: Challenges and pragmatic solutions arising from new and emerging technology, including mobile apps as part of clinical systems, enabling cloud environments, and cyber security considerations
  • Serialization/ Track and Trace: Experiences and lessons learned from implementation of serialization strategies
  • Digital Health: Convergence of digital and genomic technologies, and the possibilities and challenges that it brings to maintaining GXP compliance
  • Case Studies in Computerized Systems Validation: Back-to-basics for those new to the computer validation field and young professionals, to gain practical “hands-on” experiences in the application of risk-based validation strategies while exploring how the basics of CSV may be changing

Innovation Forum

Track Director: Michael O'Brien, PhD, Vice President Technology & Innovation, Pfizer Inc.
Regulatory Track Director: Sau (Larry) Lee, PhD, Associate Director for Science, FDA/CDER/OPQ, Invited

  • Innovative strategies that have delivered value in the biopharmaceutical industry
  • Processes and technologies successfully implemented in biopharmaceutical industry
  • Novel medical devices
  • Digital technology innovation
  • Future facility design and/or operations concepts
  • Product development innovation
  • Production systems of the future
  • Quality systems
  • Supply chain paradigms of the future
  • Operational excellence
  • Drug delivery innovations

Product Development and Production Systems Track

Track Director: Steven R. Miller, CPIP, Director, AstraZeneca
Co-Director: Robert Perks, Vice President, Operations, Werum IT Solutions

  • Facilities of the Future: Operational improvements, facility utilization to address changing product needs, product types, and new technologies
  • Biotechnology: New product types, new processes, new ways of producing such as continuous processing
  • Operational Excellence: Strategies and technologies to make facilities more flexible & agile
  • Quality and Performance: Real-time release pathway, real-time process monitoring, continuous process verification, managing deviations in a continuous process, maximizing collection of critical processing data, the analysis and use of that data, and data integrity

Quality Systems and Regulatory Track

Track Director: Christine Moore, PhD, Global Head & Executive Director, GRACS CMC-Regulatory Policy & Compendial Affairs, Merck, Sharp & Dohme Corporation
Regulatory Track Director: Robert Iser, Director (Acting), Office of Process & Facilities, FDA/CDER/OPQ/OPF, Invited
Co-Director: Frank Montgomery, PhD, Global Head, Regulatory CMC, AstraZeneca

  • Biotechnology: Comprehensive control strategies and quality systems, including those needed for new technologies for products or manufacturing
  • ICH Q12: Anticipated regulatory opportunities and quality challenges, including quality system enablers such as knowledge management
  • Continuous Manufacturing: Status of international acceptability of new technology and quality system considerations for success
  • Quality Metrics and Process Capability: Utilization for continual improvement
  • Quality Systems: Challenges for integration from mergers/acquisitions and/or CMO interfaces

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