2017 ISPE Annual Meeting & Expo, 29 October - 01 November, San Diego, CA

Education to Move Your Company Forward

Explore, strategize, develop tools, and determine how to navigate organizational and regulatory complexities to advance patient therapies.

"Exciting conference with plenty to learn from all different facets of the industry!"
          ~2016 ISPE Annual Meeting & Expo Attendee

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

From clinical trials to commercialization – Managing supply chains through innovative solutions and technology  

  • 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 deliver, 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: Steven Wisniewski, Principal Compliance Consultant, Commissioning Agents, Inc. 

Meeting unique requirements for the facility design and production

  • Critical Utilities Systems and Methods: Materials and construction requirements, pharmaceutical waters sampling methods, and 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, and pros and cons of modular and/or offsite construction
  • Biotech Facilities Development Plans: Master, business, investment, and drug production, what the next manufacturing generation(s) will bring regarding construction requirements, role of biosimilars and their impact in new facilities construction and/or renovation, role of contract development and manufacturing organizations (CDMO) in new facilities construction and/or renovation, and 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?, and 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 

Driving innovation with integrity in life-science information/GAMP®

  • Data Integrity: Focus on the new electronic records and data integrity guide providing a framework for assuring data integrity in computerized systems and pragmatic experiences of addressing real-world data integrity challenges
  • Clinical/R&D Systems: A focus on the introduction and explanation of content/concepts contained within the new GAMP® Good Practice Guide on GCP Systems and Data
  • Devices in Biotech and Therapeutic Applications: Explores the challenges and pragmatic solutions arising from new and emerging technology, including mobile apps as part of clinical systems, the enablement of cloud environments and cyber security considerations
  • Serialization/Track and Trace: Experiences and findings from implementation of serialization strategies
  • Digital Health: Understanding the convergence of digital and genomic technologies, and the possibilities and/or challenges it brings to maintaining GXP compliance
  • Case Studies in Computerized Systems Validation (CSV): A 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 computerized systems validation 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
Co-Director: Anne Kantardjieff, PhD, Director, Early Stage Process Development, Biologics Process Development, Alexion Pharmaceuticals 

Navigating the current landscape of pharmaceutical research, development and manufacturing for successful innovation  

  • Emerging methods, equipment, and technologies
  • Flexible & continuous manufacturing
  • Emerging therapeutic modalities and novel medical devices
  • Sustainability - eco-friendly trends and practices
  • Knowledge management
  • Global regulatory & industry environments 

Product Development and Production Systems Track

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

Developing agile and flexible production systems for the next decade 

  • Facilities of the Future: Operational improvements, facility utilization to address changing product needs, product types, and new technologies
  • Biotechnology: New product types, new processes, and new ways of producing such as continuous processing
  • Operational Excellence: Ways to make our 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
Co-Director: Frank Montgomery, PhD, Global Head, Regulatory CMC, AstraZeneca 

Balancing regulatory opportunities and quality challenges 

  • 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

"Engagement opportunities were numerous and the social events facilitate these interactions."     
          ~2016 ISPE Annual Meeting & Expo Attendee

2017 ISPE Annual Meeting & Expo Daily Schedule

Saturday, 28 October 2017

08.00 – 17.00 Committee Meetings
17.30 – 19.00 Leadership Reception (Invitation Only)

Sunday, 29 October 2017

07.30 – 15.30 Exhibitor Move-In
08.00 – 15.30 Committee Meetings
11.00 – 13.00 Young Professionals Lunch & Orientation
13.00 – 15.15 Education Sessions
15.15 - 15.30 Networking Break
15.30 – 17.00 Opening Keynote Session
17.00 – 18.30 Exhibit Hall Open
17.00 – 18.30 Welcome Reception

Monday 30 October 2017

06.30 – 08.00 5K Charity Run/Walk
07.15 – 08.15 New Member Breakfast
08.30 – 10.00 Keynote Session
10.00 – 17.00 Committee Meetings
10.00 – 16.15 Exhibit Hall Open
10.00 – 11.00 Networking Break
11.00 – 12.30 Education Sessions
12.30 – 13.45 Lunch
13.45 – 15.15 Education Sessions
15.15 – 16.15 Networking Break
16.15 – 17.45 Education Sessions
18.00 Open Night for Sponsored Events and Exploring the City

Tuesday 31 October 2017

08.00 – 10.00 Membership Breakfast & Awards
10.00 – 15.45 Committee Meetings
10.00 – 16.00 Exhibit Hall Open
10.00 – 10.45 Networking Break
10.45 – 12.15 Education Sessions
12.15 – 13.30 Lunch
13.30 – 15.15 Regulatory Town Hall
15.15 – 16.00 Networking Break
16.00 – 18.00 Exhibitor Move-Out
16.00 – 17.15 Education Sessions
19.00 – 22.00 Tuesday Night Party

Wednesday 01 November 2017

08.00 – 16.00 Committee Meetings
08.30 – 10.45 Education Sessions
11.00– 18.00 Facility Tours
"ISPE is a great meeting. I usually go as an exhibitor but would also like the opportunity to attend educational sessions."
~2016 ISPE Annual Meeting & Expo Attendee