Speakers
Cassie Megna
Design Verification Lead
Merck Research Laboratories
Day One
Wednesday September 9, 2020
1:15 pm | Live Q&A - Ask Our Speakers Your Burning Questions
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
Day One
Wednesday September 9, 2020
4:00 pm | Sterility Seal Design for Prefilled Container Closure Systems & Drug Delivery Devices
4:40 pm | Panel Discussion: How to Leverage Human Factors at Every Stage of Combination Product Design
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
10:30 am | Panel Discussion: How Customer Requirements Have Changed How We Package Biologics – From PFS to Autoinjector?
Jonas Fransson
Director Drug Product Development, Technical Operations
Swedish Orphan Biovitrum AB
Day One
Wednesday September 9, 2020
10:40 am | Live Q&A - Ask Our Speakers Your Burning Questions
10:00 am | Panel Discussion: Putting Your Users in the Designers’ Seat – Enabling Users’ to Lead the Development of Safer & More User-Friendly Injection Devices
Heydy Andolz
Senior Consultant Engineer - Human Factors
Eli Lilly
Day One
Wednesday September 9, 2020
10:40 am | Live Q&A - Ask Our Speakers Your Burning Questions
10:00 am | Panel Discussion: Putting Your Users in the Designers’ Seat – Enabling Users’ to Lead the Development of Safer & More User-Friendly Injection Devices
Daniel Bonanno
Method Validation Lead
Merck
Day One
Wednesday September 9, 2020
1:15 pm | Live Q&A - Ask Our Speakers Your Burning Questions
11:45 am | The Development of a New Container Closure Integrity Test (CCIT) for Holistic Evaluation of Prefilled Syringes to Ensure Regulatory Compliance
Cecilie Anker
Senior Usability Engineering Lead
Novo Nordisk
Day One
Wednesday September 9, 2020
10:40 am | Live Q&A - Ask Our Speakers Your Burning Questions
10:00 am | Panel Discussion: Putting Your Users in the Designers’ Seat – Enabling Users’ to Lead the Development of Safer & More User-Friendly Injection Devices
Bill Welch
Chief Technology Officer
Phillips-Medisize, a Molex company
Day One
Wednesday September 9, 2020
2:20 pm | Balancing Drug Delivery Device Connectivity, Cost, Sustainability & Usability
Kevin Deane
Executive VP Front-End Innovation
Phillips-Medisize, a Molex company
Day One
Wednesday September 9, 2020
2:20 pm | Balancing Drug Delivery Device Connectivity, Cost, Sustainability & Usability
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
10:20 am | Live Q&A – Ask Our Speakers Your Burning Questions
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
3:00 pm | Live Q&A - Ask Our Speakers Your Burning Questions
2:40 pm | 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
10:30 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
1:15 pm | Live Q&A - Ask Our Speakers Your Burning Questions
12:25 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
4:40 pm | Panel Discussion: How to Leverage Human Factors at Every Stage of Combination Product Design
4:20 pm | Strategic Platforming: Leveraging Platforms for Combination Product Development
Min Wei
Former Associate Director
Janssen
Day Two
Thursday September 10, 2020
12:20 pm | Panel Discussion: Change Control to Drive QMRS & Product Progression
12:00 pm | Device Innovation & Challenges to Support Emerging Cell & Gene Therapy
Tim Quigg
Programme Development Lead
Crux Product Design Ltd
Day One
Wednesday September 9, 2020
4:40 pm | Panel Discussion: How to Leverage Human Factors at Every Stage of Combination Product Design
1:15 pm | Live Q&A - Ask Our Speakers Your Burning Questions
12:45 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
10:40 am | Live Q&A - Ask Our Speakers Your Burning Questions
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
12:20 pm | Panel Discussion: Change Control to Drive QMRS & Product Progression
11:40 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
1:15 pm | Live Q&A - Ask Our Speakers Your Burning Questions
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
3:00 pm | Live Q&A - Ask Our Speakers Your Burning Questions
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
4:40 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
3:00 pm | Live Q&A - Ask Our Speakers Your Burning Questions
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
10:30 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
10:30 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
12:20 pm | Panel Discussion: Change Control to Drive QMRS & Product Progression
Senior Representative
Philips Medisize, a molex company
Day One
Wednesday September 9, 2020
3:00 pm | Live Q&A - Ask Our Speakers Your Burning Questions
Allison Y. Strochlic
Research Director, Human Factors Research & Design
Emergo by UL
Day One
Wednesday September 9, 2020
10:40 am | Live Q&A - Ask Our Speakers Your Burning Questions
10:00 am | Panel Discussion: Putting Your Users in the Designers’ Seat – Enabling Users’ to Lead the Development of Safer & More User-Friendly Injection Devices
Sion Coulman
Senior Lecturer
Cardiff University
Day Two
Thursday September 10, 2020
3:00 pm | Live Q&A - Ask Our Speakers Your Burning Questions
2:40 pm | A Collaborative Approach to Microneedle Development
James Birchall
Deputy Head of School
Cardiff University
Day Two
Thursday September 10, 2020