Pharma and Device Packaging and Labeling West Coast 2019
Hilton San Francisco Airport Bayfront
13th-14th November, 2019
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Pharma and Device Packaging and Labeling West Coast 2019
DAY 1|13th November 2019
DAY 2|14th November 2019
8:50 am Chair’s opening remarks

Lisa M. Kelsey
Head of Commercial Labeling, Associate Group Director
Genentech
9:00 am SPOTLIGHT ON REGULATION: Navigating Federal Regulations
- Overview of DEA Diversion Control Division
- Insight into drug diversion and connection to opioid crisis
- Exploration of federal regulations around packaging of controlled substances

Alicea Reddy
MCJ/ Diversion Outreach Coordinator, Drug Enforcement Administration (DEA), San Francisco Field Division
9:30 am PRESENTATION: Current Overview of Pharma Labeling/Listing and Medical Device UDI Reporting
The regulatory landscape for drugs, biologics/vaccines, and medical devices is ever changing. Structured data submissions of various product information is now the norm and becoming more prevalent with FDA and other regional health authorities around the world. This session will provide an overview of FDA’s use of SPL and summarize current/future global regulatory activities related to product submissions.
Attendees will learn:
- the current use of SPL by FDA for Drug Establishment Registration and Listing
- the current use of SPL by FDA for Medical Device Unique Device Identification (UDI) Reporting
- the future global regulatory requirements for product reporting

Andrew Pfeifer
Senior Account Executive
ReedTech
10:00 am KICK-OFF KEYNOTE: Augmenting Drug Discovery, Smart Packaging and Labeling
- Introduction to Artificial Intelligence (AI) and Intelligence Augmentation (IA): A brief history, trajectory, and future perspectives
- Considering future applications of Artificial Intelligence in drug discovery, package design and medicine
- Implications of AI in digital health, medical devices and wearables on packaging and labeling
- Robotics technology & its applications to drug discovery and development
- Running intelligent clinical trials using advanced analytics, machine learning, AI, smart labeling and tracking
10:45 am Morning refreshments and networking
11:15 am Exploring UDI implementation and the impact on labeling
- Examining the process of marrying textual and barcoded content to find the ideal labeling outcome
- What steps should companies be taking to ensure the workforce is fully trained on implementing and maintaining UDI requirements?
- How has the introduction of UDI enabled companies to streamline the labeling process and prepare for future changes to device data management?
- Development of new processes and procedures that ensure data is transferred correctly to the FDA

Joyce Trese
UDI Indianapolis Site Project Leader
Roche Diabetes Care
11:45 am Solutions to Optimize Your End-to-End Artwork Process
- The drivers of change in the packaging supply chain
- Controlling a global artwork process to ensure efficiency and transparency
- Implementing a GMP compliant artwork process
- Vendor selection, managing outsourcing and developing long term business partnerships
- Identifying how Asset Management and Workflow Techniques improve effectiveness

Suzanne Ivory
Chief Operating Officer
Perigord
12:15 pm Live interview on stage: Profit from prophecy in clinical trials - key considerations for accurate forecasting with maximum flexibility and cost efficiency
- Exploring the available technologies for effective packaging forecasting
- How to maximize effectiveness of prediction and overcome packaging challenges
- Practical lessons leant on cost savings and avoiding under supply and wastage -what to avoid in the future when forecasting for packaging and labeling scenarios

Danny Lee
Associate Director
Atreca
12:45 pm Lunch and networking
1:45 pm Evolving regulatory standards for medical device packaging- navigating ISO 11607 and EU MDR, its usability and ensuring compliance
- Usability for medical device packaging and its impact on packaging
- Testing and how to integrate its usability testing into design and product development processes
- How to stay fully compliant

Nirav Bhatt
R&D Manager, Package Engineering
Dexcom
2:15 pm Case study: End-to-End solution for managing labeling and packaging artwork
Forward-thinking medical device firms are implementing integrated Enterprise Labeling and Artwork Management solutions. Many are leveraging “validated sources of record” to streamline regulatory compliance, customer and marketing requirements. Integrated solutions reduce packaging revisions while improving time-to-market and ultimately reducing costs. Hear examples of how automating and centralizing labeling enhances accuracy and eliminates complex, error-prone data replication

Laura Johnson
Life Sciences Specialist
Loftware
2:45 pm Human factors design and validation of packaging and package labeling
- An industry-wide problem: Why packaging design must start earlier in the process.
- When package label differentiation comes into play.
- Package labeling faux pas: Don’t reinvent the wheel.
- When packaging matters in human factors validation studies.
- Generic packaging and package labeling: Imitation is the greatest form of flattery!

Anthony D. Andre
Adjunct Professor
San Jose State University; Principal, Interface Analysis Associates
3:15 pm Afternoon refreshments and networking
3:40 pm Innovation Lab
Opportunity to hear and learn from 3 selected companies giving a 15 min presentation/case study on the latest developments and innovation in intelligent packaging, packaging materials, labeling, use IoT platforms, blockchain and designing packaging configurations that will align with sustainable logistics
Project 1: The use of Rapid Prototyping, 3D Modeling and 3D printing for packaging design, and the benefits to project schedule and building in house expertise
Project 2: Latest innovation in human factors design

Andy Norriss
Materials Science-HTO Materials MSAT
Genentech

Anthony D. Andre
Adjunct Professor
San Jose State University; Principal, Interface Analysis Associates
4:20 pm Trust in your Label, Trust in your Brand
Managing your labelling and artwork management lifecycle effectively and efficiently is key to gaining and keeping your end customer’s trust; whether that’s a doctor, a pharmacist, or a patient. It can also be the difference between life and death. In this presentation we will explore:
- The pitfalls of a poorly managed labelling lifecycle
- The benefits of implementing an end-to-end labelling solution
- The 5 keys to success in executing a labelling management project

Beth Peckover
Client Services Director
Kallik
4:50 pm LIVE DEBATE AND AUDIENCE Q&A: Innovation in the spotlight
- What is needed to create a nurturing corporate environment for innovation within your firm?
- Who is the customer/patient of the future? What do we know about them and how can we respond to their needs through smart packaging?
- How Blockchain and intelligent packaging being used and its potential to change the industry
- How will sustainability, waste management and reusability drive packaging and labeling?
- How to innovate on a small scale when you don’t have large investment behind you

Andy Norriss
Materials Science-HTO Materials MSAT
Genentech

Anthony D. Andre
Adjunct Professor
San Jose State University; Principal, Interface Analysis Associates

Swanand Kullarwar
Senior Packaging Engineer
Abbott
5:30 pm Conclusion and Key take away points

Lisa M. Kelsey
Head of Commercial Labeling, Associate Group Director
Genentech
5:45 pm Close of day 1
8:15 am Registration and refreshments
8:50 am Chair’s opening remarks

Lisa M. Kelsey
Head of Commercial Labeling, Associate Group Director
Genentech
9:00 am Think Tank Hour
Interactive Think Tank sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others. Each Think Tank session lasts for 30 minutes, and delegates may attend up to 2 think tank tables. In the end of the session each chairperson will share key findings from the discussions.
Roundtable 1: Mastering labeling and packaging in cryogenic temperatures led by led by Eric Barnitz, Senior Packaging Engineer, Kite Pharma
Roundtable 2: How to develop effective leadership skills and bring out the best in team members led by Led by: Lisa M. Kelsey, Head of Commercial Labeling, Associate Group Director, Genentech
Roundtable 3: Artwork Centralization process led by Sathyanarayanan Krishnamurthy, VP – Regulatory Operations, Freyr Solutions OR
Roundtable 4: Increased Importance of Traceability by Regulators led by Kiran Venkata Satya Chinnalla, Executive Management – Labeling services, Freyr Solutions
Roundtable 5: Errors in labeling – how to overcome these issues and what needs to be done to avoid and improve your processes led by Bruce Suknanan, Manager, Regulatory Labeling, Regeneron Pharmaceuticals

Eric Barnitz
Senior Packaging Engineer
Kite Pharma

Lisa M. Kelsey
Head of Commercial Labeling, Associate Group Director
Genentech

Bruce Suknanan
Manager, Regulatory Labeling
Regeneron Pharmaceuticals

Kiran Venkata Satya Chinnalla
Executive Management – Labeling services
Freyr Solutions
10:30 am Morning refreshments and networking
11:10 am Considerations for Shipping Category B Hazardous Materials
- Definitions and Regulations
- Packaging requirements and best practices
- Testing Requirements

Eric Barnitz
Senior Packaging Engineer
Kite Pharma
11:40 am LATEST RESEACH: Latest Research: Advancing inclusive research and ensuring trial products enhance patient participation
- Clinical development strategy – examining disparities in clinical research
- Scientific insights and personalized healthcare- optimizing clinical outcomes for all patients
- Advance external partnerships – creating a path for more representative patient populations in clinical
- research and evolving the promise of personalized healthcare for all
- Strategies for trial product packaging and supply to engage patient populations – are products reaching patient populations and encouraging patient retention?

Nicole Richie
Global Head Health Equity Science and Strategy
Genentech
12:10 pm Lunch and networking
1:10 pm PANEL DISCUSSION: Durability and product stability in pharma and medical device packaging
- The role of packaging and its impact on products longevity -what is that ideal aging of a medical device?
- How packaging can support durability in devices and how durable, lightweight materials can enhance product integrity
- Assessing the best materials and packaging for protecting products that could meet your company cost effectiveness and environmental aspects

Scott Gerondale
Director Packaging Engineering
AMGEN

Swanand Kullarwar
Senior Packaging Engineer
Abbott

David Larwood
CEO
Valley Fever Solutions
1:40 pm Enhancing internal alignment and accelerating cross functional collaboration to the next level

Joyce Trese
UDI Indianapolis Site Project Leader
Roche Diabetes Care
2:25 pm Afternoon refreshments and networking
2:55 pm FIRESIDE CHAT: Professional growth and leadership - taking charge of your future
- How to make an impact at every level to create an effective packaging and labeling
- Approaches in advancing your career progression within the pharmaceutical and medical device sector
- How to effectively recruit the best talent into pharma and device packaging and labeling

Lisa M. Kelsey
Head of Commercial Labeling, Associate Group Director
Genentech

Santiago Beltran
Principal Packaging Development Engineer
NuVasive
3:30 pm Conclusion and key take away points

Lisa M. Kelsey
Head of Commercial Labeling, Associate Group Director
Genentech
3:45 pm Close of conference
SPONSORSHIP OPPORTUNITIES
To enquire about sponsorship opportunities for the conference, please contact:
Alexander O’Leary
Senior Sponsorship Manager
T: 44 207 936 6690
E: AlexanderOLeary@arena-international.com
SPEAKING OPPORTUNITIES
The speaking faculty for 2019 is underway. If you would like to be involved, please get in touch below.
Hannah Toms
Head of Production
T: + 44 (0) 207 9366 855
E: hannah.toms@arena-international.com