Speakers

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Paul Roussel
Senior Director – Combination Products
Kiniksa Pharmaceuticals

Day Two

Thursday 26th September 2019

9:10 am | Timely Launch: What Does a World Class Device Engineering Team Need to Look Like & How Can We Ensure Speed-to-Patient?

Daniel Latham
Head of Device Development & LCM
Novartis

Daniel Latham is the Head of Device Development & LCM,  where he leads an organisation of around 120 associates responsible for the development and life cycle management of delivery systems of drug/device combinations for both new biologic entities, biosimilars, and new chemical entities. Over the past 12 years at Novartis, he has overseen significant device and primary packaging developments and launches and has significantly supported the growth of device development and drug/device interaction within the organisation. Prior to Novartis, he worked in a variety of roles in consumer health­care, focusing on the development of OTC medicines, transdermal patches, and medical devices. He has a Ph.D. in controlled drug delivery from Queen Mary, Uni­versity of London and a bachelor’s degree and master’s degrees in engineering from the University of Sheffield.

Day Two

Thursday 26th September 2019

9:40 am | How Should the Device Team Anticipate & Prepare for Emerging Pipeline to Accelerate Speed-to-Market with a Patient Centric Approach?

John Schalago
Executive Director, Senior GPRD
Novartis

Day One

Wednesday 25th September 2019

9:40 am | Smart Device – the FDA’s Thinking of Software as a Medical Device & The Future Ecosystem

Tycho Speaker
Director, Drug Delivery & Biomaterials
Allergan

Day Two

Thursday 26th September 2019

2:00 pm | From Device to Development – How Far Are We from a Commercial Needle-Free Injection?

Stephen Gilmore
Director of Engineering
Crux Product Design

Day One

Wednesday 25th September 2019

3:55 pm | Make vs Buy (vs Customize): Evidence-Led Device Decision-Making

Michael Song
Head of Device Functionality, Safety, Digital Connectivity
AstraZeneca

Day Two

Thursday 26th September 2019

3:30 pm | From Connected Devices to Building a Digital Ecosystem

Alasdair Young
Director, Device Engineering
Coherus Biosciences

Day Two

Thursday 26th September 2019

10:10 am | Panel Discussion: How Customer Requirements Have Changed How We Package Biologics – From PFS to Autoinjector?

Tracy Hsu
Associate Director
Ionis Pharmaceuticals

Day One

Wednesday 25th September 2019

4:25 pm | Strategic Platforming: Leveraging Platforms for Combination Product Development

Ophelia Wells
Device Development Project Lead
Merck

Day One

Wednesday 25th September 2019

2:15 pm | The Development of a New Container Closure Integrity Test (CCIT) for Holistic Evaluation of Prefilled Syringes to Ensure Regulatory Compliance

James Birchall
Deputy Head of School
Cardiff University

Day Two

Thursday 26th September 2019

1:30 pm | An Introduction to Microneedles – What, Why and Who?

Min Wei
Former Associate Director
Janssen

Day Two

Thursday 26th September 2019

12:00 pm | Device Innovation & Challenges to Support Emerging Cell & Gene Therapy

Prem Ganapathy
Head of Device Testing
Takeda

Day One

Wednesday 25th September 2019

1:45 pm | The Importance of Device Testing – And Should You Do it In-House?

Young Chun
Associate Director, Human Factors & User Research
Takeda

Day Two

Thursday 26th September 2019

4:00 pm | The Challenges of Conducting Formative Studies for Electro-Mechanical Injectable Device

Prasad Peri
Senior Director, Regulatory Affairs & CMC
Teva Pharmaceuticals

Day One

Wednesday 25th September 2019

9:10 am | Keynote: Navigating the Combination Product Regulatory Framework for an Autoinjector

Richard Featherstone
Research Director – Human Factors Research & Design
Emergo by UL

Richard Featherstone is Research Director, Human Factors Research and Design for Emergo by UL. Based in Cambridge UK, Richard has nearly 20 years of experience of usability research with a special interest in combination products such as autoinjectors and breath-actuated inhalers. Prior to his usability work, Richard worked for 20 years in a variety of roles in the pharmaceutical industry, and pioneered some of the early work on using observational data to compare outcomes for different types of pharmaceutical devices. He speaks internationally on the application of human factors to medical devices and leads Emergo’s human factors activities in Europe. Richard has more recently been instrumental in developing human factors testing methodologies for connected devices such as mobile apps and electromechanical autoinjectors for some of the world’s largest pharmaceutical and software companies.

Day One

Wednesday 25th September 2019

2:45 pm | Panel Discussion: Incorporating Your User Feedback into Your Device Design & Development to Ensure Smooth Regulatory Approval

Murat Gunay
Senior Consultant Engineer, Delivery & Device R&D
Eli Lilly

Day One

Wednesday 25th September 2019

12:15 pm | Sterility Seal Design for Prefilled Container Closure Systems & Drug Delivery Devices

Alex Weaver
Director of Engineering
PCI Pharma Services

Day Two

Thursday 26th September 2019

10:10 am | Panel Discussion: How Customer Requirements Have Changed How We Package Biologics – From PFS to Autoinjector?

Senior Representative

Philips Medisize, a molex company

Day Two

Thursday 26th September 2019

11:30 am | The Future of Electronic-Enabled Combination Drug Delivery Product

Adam Schroeder
Business Development Manager
PCI Pharma Services

Day Two

Thursday 26th September 2019

10:10 am | Panel Discussion: How Customer Requirements Have Changed How We Package Biologics – From PFS to Autoinjector?

Alan Golden
Principal
Design Quality Consultants, LLC

Joely Gardner, PhD
Professor; Chief Researcher
California State Fullerton; Human Factors Research

Sion Coulman
Senior Lecturer
Cardiff University

Day Two

Thursday 26th September 2019

2:30 pm | A Collaborative Approach to Microneedle Development