Thursday September 6, 2018
08:00 Morning Coffee & Registration
09:00 Chair’s Opening Remarks
Ensuring a Regulatory Compliant Injectable Device
09:10 Opening Address: How Safe is Your Safety Device?
- Joseph Purpura Executive Director, Medical Device Safety Physician, Medical Devices, Allergan
- From Quality System Regulation (QSR) 21CFR820 to design control requirements – reassure your device’s safety and effectiveness for the intended users, uses and use environments
- Can you identify possible use errors and mitigate the associated risks?
- Re-validate legacy product and collate feedback from users’ post-launch to enhance safety features
09:40 Combination Products Regulatory Expectations from the Agencies
- Jennifer Hefele Wald Director Global Regulatory Affairs Combination Products, Pfizer
- Combination products approval guidelines – what data is required for filing?
- Updates on CRF21 Part 4 – cGMP and multi-site manufacturing oversight
10:10 Speed Networking & Morning Refreshments
The Human Touch – Developing a User-Friendly Device for Your Patients
11:30 How to Anticipate the 2020 Deadline – EU Medical Device Directive
- Gay Steinbrick Lead Medical Device & Combination Products, Global Safety, Merck
- Key changes with MEDDEV Rev 4
- Looking ahead to EU MDR
- Clinical evaluation reports for drug delivery device constituents
12:15 The New Beginning after Launch – A Device Regulatory Perspective and Journey
- Kesley Gallagher Senior Regulatory Affairs Manger, Amgen
- Post-launch regulatory considerations and executing a robust change system for device
- Regulatory affairs’ role during the evolution of injectable devices – from PFS to on-body injector
- Case study: Amgen’s success story and lesson learned
12:30 Tech-Show at Exhibition Hall
- Live demos from our technology partners to showcase how latest PFS and injectable innovations.
- Delegates will get the chance to ask questions during this interactive sessions.
12:45 Lunch & Networking
13:45 Human Factors Study – How, When, What and Who?
- Young Chun Principal Engineer – Human Factors Lead, Shire
- It’s not a check box exercise: devising a thorough design plan for your HF study
- When should you conduct and what’s the optimal sample size?
- Defining your sample pool for a meaningful study
14:15 Human Factors within the Device Design Control Paradigm
- Nick Zampa Senior Engineer, Technical Development Human Factors & Risk Management, Biogen
- How can a human factors approach enable more robust risk management?
- Knowing your intended users to make risk-based decisions about device design.
- Integrating human factors as part of the broader device development process within Pharma/Bio-Pharma
- Post-launch: role of human factors during post-market surveillance?
14:45 A Different Perspective – Biosimilars Combination Product Development Considerations and Challenges?
- Alasdair Young Associate Director - Device Engineering , Coherus BioSciences
- Biosimilars and interchangeability:
- A perspective on current human factors guideline
- The impact on technology selection
- Developing a biosimilar as a combination product
- Anticipating and addressing potential challenges with characterizing a reference product
- Differentiation – managing technology platform across products
15:15 Panel Discussion: Applying Human Factors Engineering to Platform Drug Delivery Devices – Pitfalls and Lessons Learned
- Allison Strochlic Research Director, Human Factors Engineering, UL
The panel will discuss challenges and lessons learned associated with applying HFE to platform drug delivery devices, including:
- how to select a platform device that reflects strong HFE and how to properly scale HFE work for a particular drug and indication, leveraging any prior HFE work performed on the platform
- the extent to which HFE work is performed by the platform device developer versus the pharmaceutical company responsible for drug development and combination product commercialization
- experiences with cases in which FDA and/or other regulators enabled manufacturers to “bridge” usability test data between platform devices, thereby reducing the extent of testing needed for specific products and indications
- how to scale HFE work to leverage work performed on other marketed products within the platform family
At the end of this session, delegates will also have the opportunity to fire Qs for our elite panelists.
16:00 Afternoon Refreshments & Networking
16:30 Device Development Using In-Silico Techniques within an FDA Framework
- Stephen Gilmore Engineering Director, Crux Product Design Ltd.
- Solving some of the industry’s most complex device design challenges using In-Silico (virtual) techniques
- Reporting of computational modelling within an FDA regulatory submission – FDA V&V40
- Digital evidence and the digital twin
- Acoustic design and simulation
- Will modelling and simulation ever be accepted as credible evidence of safety or clinical benefit?
17:00 Case Study: Journey of Drug-Device Integration
- Karthik Balasubramanian Associate Director, Global Device R&D Operations, Teva Pharmaceuticals
- QbD thinking and design controls
- Risk-based approach to human factors study and validation
- Parameters and considerations for generic PFS and injectables
- Looking ahead: where do opportunities and challenges lie?
17:15 Less is More – Delivering a High Volume, Highly Viscosity Drug with Precise Dosage
- Amy Wang Director Drug Delivery & Device Development, Alexion Pharma
- With trends turning towards less frequent administration and larger dosing, what does it mean to existing formulation and drug delivery options?
- Addressing the challenges of highly concentrated and highly viscous drugs during injection
- Different platform selection criteria and considerations
- Challenges to work with confined parameters and lessons learned
18:00 Downsizing: Microneedle Opportunity in Injectables
- Faz Chowdhury CEO, Nemaura
- How micro can a microneedle injectable be?
- Formulation and efficacy challenges
- Applications and opportunities – patient adherence and ease of self administration