Speakers

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Cassie Megna
Design Verification Lead
Merck Research Laboratories

Day One

Wednesday September 9, 2020

11:45 am | The Development of a New Container Closure Integrity Test (CCIT) for Holistic Evaluation of Prefilled Syringes to Ensure Regulatory Compliance

Murat Günay
Senior Consultant Engineer of Delivery, Device and Connected Solutions
Eli Lilly and Company

Peter Grassl
Head of Sales & Marketing
Dividella AG

Head of Sales & Marketing and extended member of the Executive Board of Dividella AG in Grabs, Switzerland, a Körber Group company. Prior to this position, he was Deputy Head of Sales and Area Sales Manager for the USA at Seidenader in Markt Schwaben, also a Körber Group company. As Area Sales Manager at Seidenader, Peter Grassl played a significant role in the company's success in the US market and therefore an important role in the company's overall growth. His career started in the German Air Force as a Flight Officer for the Air Force, whilst also graduating Univeristy of the German Armed Forces in Munich with a Bachelor of Engineering for Air and Space Technology. After which he completed his Masters degree for Computer Aided Engineering and a degree in Computational Engineering. Last but not least he graduated with an Executive MBA in General Management at the Technical University in Munich, Germany. He lives in Landshut near to Munich, Germany, and has two beautiful children. His passions are fishing, sports and spending time with his family. Especially his open minded nature is characteristic for Peter Grassl. His strengths are professional integrity and a high level of customer-driven focus.

Day Two

Thursday September 10, 2020

10:20 am | Panel Discussion: How Customer Requirements Have Changed How We Package Biologics – From PFS to Autoinjector?

Paul Roussel
Senior Director – Combination Products
Kiniksa Pharmaceuticals

Day Two

Thursday September 10, 2020

9:40 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 September 10, 2020

10:00 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 September 9, 2020

10:00 am | Smart Device – the FDA’s Thinking of Software as a Medical Device & The Future Ecosystem

Alasdair Young
Director, Device Engineering
Coherus Biosciences

Day Two

Thursday September 10, 2020

10:20 am | Panel Discussion: How Customer Requirements Have Changed How We Package Biologics – From PFS to Autoinjector?

Prem Ganapathy
Head of Device Testing
Takeda

Day One

Wednesday September 9, 2020

12:05 pm | The Importance of Device Testing – And Should You Do it In-House?

Tracy Hsu
Associate Director
Ionis Pharmaceuticals

Day One

Wednesday September 9, 2020

4:45 pm | Strategic Platforming: Leveraging Platforms for Combination Product Development

Min Wei
Former Associate Director
Janssen

Day Two

Thursday September 10, 2020

11:50 am | Device Innovation & Challenges to Support Emerging Cell & Gene Therapy

Stephen Gilmore
Director of Engineering
Crux Product Design

Day One

Wednesday September 9, 2020

4:15 pm | Make vs Buy (vs Customize): Evidence-Led Device Decision-Making

Prasad Peri
Senior Director, Regulatory Affairs & CMC
Teva Pharmaceuticals

Day One

Wednesday September 9, 2020

9:40 am | Keynote: Navigating the Combination Product Regulatory Framework for an Autoinjector

James Leamon
Director, Biologics Device Development
Jazz Pharmaceuticals, Inc

Day Two

Thursday September 10, 2020

11:30 am | Jazz’s Journey in Developing a Novel Biologics Device – Thinking Ahead & Putting Patients’ Needs First

Ophelia Wells
Device Development Project Lead
Merck

Day One

Wednesday September 9, 2020

11:45 am | The Development of a New Container Closure Integrity Test (CCIT) for Holistic Evaluation of Prefilled Syringes to Ensure Regulatory Compliance

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

Day One

Wednesday September 9, 2020

2:00 pm | Digital Health - From Connected Devices to Building a Digital Ecosystem

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

Day One

Wednesday September 9, 2020

5:05 pm | Panel Discussion: How to Leverage Human Factors at Every Stage of Combination Product Design

Tycho Speaker
Director, Drug Delivery & Biomaterials
Allergan

Day Two

Thursday September 10, 2020

2:20 pm | From Device to Development – How Far Are We from a Commercial Needle-Free Injection?

Adam Schroeder
Business Development Manager
PCI Pharma Services

Day Two

Thursday September 10, 2020

10:20 am | Panel Discussion: How Customer Requirements Have Changed How We Package Biologics – From PFS to Autoinjector?

Alex Weaver
Director of Engineering
PCI Pharma Services

Day Two

Thursday September 10, 2020

10:20 am | Panel Discussion: How Customer Requirements Have Changed How We Package Biologics – From PFS to Autoinjector?

Alan Golden
Principal
Design Quality Consultants, LLC

Day Two

Thursday September 10, 2020

12:10 pm | Panel Discussion: Change Control to Drive QMRS & Product Progression

Senior Representative

Philips Medisize, a molex company

Day One

Wednesday September 9, 2020

2:20 pm | The Future of Electronic-Enabled Combination Drug Delivery Product

Allison Y. Strochlic
Research Director, Human Factors Research & Design
Emergo by UL

Day One

Wednesday September 9, 2020

2:50 pm | Panel Discussion: Incorporating Your User Feedback into Your Device Design & Development to Ensure Smooth Regulatory Approval

Sion Coulman
Senior Lecturer
Cardiff University

Day Two

Thursday September 10, 2020

2:40 pm | A Collaborative Approach to Microneedle Development

James Birchall
Deputy Head of School
Cardiff University

Day Two

Thursday September 10, 2020

2:00 pm | An Introduction to Microneedles – What, Why and Who?