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Sept 5 – 7 | San Diego

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Day One
Thursday September 6, 2018

Day Two
Friday September 7, 2018

08:00
Morning Coffee & Registration

09:00
Chair’s Opening Remarks

  • James Wabby Executive Director - Regulatory Affairs, Devices & Combination Products, Allergan

Injectable Development – Capitalizing on Innovations

09:10
The Injectable Journey: From PFS to Wearable – Developing a Patient-Centric Device

  • E Guan Director, R&D, Platform Device Development, MedImmune

Synopsis

  • The evolution and shift from PFS to other injectable formats – auto-injectors
  • Designing a patient-centric device: Large volume autoinjector
  • Opportunities and challenges: from formulation to patient experience

09:40
Innovating in the Connect Care space through Design

  • Hung-Hsiang Chen Strategic Design Director, DDCS User Centered Design , Eli Lilly & Company

Synopsis

  • The challenge of designing connected products
  • Why user experience matters
  • Designing products beyond features and benefits

10:10
Stay Connected via Connected Device – The Next Big Thing in Injectables

Synopsis

  • Connected device and platform – what do they mean?
  • The questions and challenges associated with the development and maintenance of connected platforms
  • What does the regulator think?
  • Addressing cyber and data risks – cloud and security

10:40
Morning Refreshments & Networking

Quality Engineering and Flexibility

11:10
Panel Discussion: Enhancing Combination Product Usability Testing

  • Katie Hansbro CEO, Design Science Consulting Inc.
  • Nick Zampa Senior Engineer, Technical Development Human Factors & Risk Management, Biogen
  • Tracy VonBriesen Director, Human Factors, Combination Products , Fresenius Kabi
  • Sean Harper Sr. Manager Human Factors & Usability, Regeneron

Synopsis

  • How to best utilize quantitative techniques to allow for the collection of “big data”
  • How to quickly iterate your study design and study materials to obtain the most information from your participants
  • New technologies that are available to assist with your data collection

11:50
The Art of Engineering – Developing a Patient Friendly Autoinjector

  • Jessica Gwinnup Director - Mechanical Engineering, Delivery, Device & Connected Solutions , Eli Lilly & Company

Synopsis

  • How to progress smoothly from PFS to autoinjector: from device design to development timeline
  • Compatibility considerations and constraints
  • Innovations in safety features to enhance patient experience

12:20
The Challenges with Device Providers – Platform Solutions vs. Customization

  • Raihan Hossain Associate Director CH I&D Medical Device Quality, Bayer

Synopsis

  • The challenges of buying devices off-the-shelf from suppliers from a human factors perspective
  • Compatibility, customizatbility and ease of assembly
  • Selecting a platform that reflects good HFE and will meet your users’ needs

12:50
Lunch & Networking

13:55
Master Mind: Rethink Your Device Selection and Development Program

  • Scott Nunn Manager, Device Development & Clinical Packaging Engineering, Gilead

Synopsis

Speed to market and compliance are critical to patients and commercial success. With more focus placed on lifecycle management and collaboration amongst internal/ external stakeholders, how can we optimize and streamline device development programs?

This round-table session will split the audience into groups for a discussion to share their thoughts of key objectives and challenges in the following areas:

  • Getting it right from the start: which drug delivery route and device format?
  • Who to partner with: what are your vendor selection criteria?
  • Who should you collaborate with? Identifying the key functional teams you’d need to engage and map out the timeline
  • Development plan and lifecycle: parallel device development to shorten the timeline

After this session, each group will share their ideas of how to lay out a best practice plan to takeaway and implement at work with a wider device team.

14:30
A Systematic Approach to Develop a Novel E2E Stability Program for Combination Products: A Unique Product Quality Management Perspective

  • Alie Jahangir Sr. Manager, Quality Engineering & Design to Value, Janssen Pharmaceutical

Synopsis

  • Defining a unique approach to establish specific stability requirements for combination products, aligned with both drug and device guidelines, and beyond determination of expiration dating alone.
  • The critical role of Design Control process in defining the scope of E2E stability paradigm for combination products.
  • Sterility and stability concerns – from pre-filled to autoinjectors to next generation injectables

15:00
Simple as it Seems – How to Close Your Container?

  • Eugene Wu Combination Products Manager, Novavax

Synopsis

  • The different approaches to container closure systems and deterministic methodology
  • What are the parameters and considerations? Product stage, product type, container closure components and fill-finish platform
  • Enhance your CCIT confidence to assure product integrity during manufacturing, shipping, storage, and through product shelf-life
  • Lessons learned and challenges

15:30
Chair’s Closing Remarks

  • James Wabby Executive Director - Regulatory Affairs, Devices & Combination Products, Allergan

15:40
Close of Conference