Speakers

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Kevin Deane
Executive Vice President, Front-End Innovation
Phillips-Medisize, LLC

Kevin Deane is the Executive Vice President, Front End Innovation for Phillips-Medisize. Originally from the US, Kevin started his career in the automotive industry after receiving his BSc in Electrical Engineering. He moved to Cambridge UK in 1994 and worked for PA Consulting as a Partner in the Technology Group. Kevin has led a number of Drug Delivery and Connected Health projects for pharmaceutical clients across Europe and the US, supporting strategic assessment through to full system implementations.

Day One

Wednesday 26 June

3:45 pm | Adding Connectivity to Combination Products - The Value Proposition

John McMichael
Associate Director, Combination Products
AstraZeneca

Day Two

Thursday 27 June

10:10 am | Panel Discussion: What Does a Good Change Control Strategy Look Like and Its Importance to Drive a Sustainable Lifecycle?

Jonathan Amaya-Hodges
Associate Director, Regulatory Affairs
Biogen

Kristina Lauritsen
Combination Products Regulatory Advisor
FDA

Day One

Wednesday 26 June

9:40 am | Panel Discussion: How to Handle Regulatory Uncertainty and What Does It Mean to Your Combination Products’ LCM?

Day Two

Thursday 27 June

9:10 am | Keynote Address: Building the Engagement and Dialogue with the FDA

Stephen Fournier
Director – Device Platform Management
Alnylam Pharmaceuticals

Day One

Wednesday 26 June

4:00 pm | Be Smart – Strategic Platforming for Your Combination Products

Eiichi “H.E.” Sengoku
Director, GRL for Medical Devices & Combination Products
UCB, Inc.

Day Two

Thursday 27 June

1:20 pm | Is Connectivity the Answer?

Suzette Roan
Director, Global Regulatory Affairs
Sanofi

Day One

Wednesday 26 June

9:40 am | Panel Discussion: How to Handle Regulatory Uncertainty and What Does It Mean to Your Combination Products’ LCM?

9:10 am | Keynote Address: Who Is in Charge? Securing Early Support from the FDA

Michael Roe
Director – Device Development & Industrialization
kaleo

Day One

Wednesday 26 June

4:30 pm | Chair’s Closing Remarks & Close of Day 1

3:15 pm | Kaleo’s Successful Injectable Story – From Concept to Product Commercialization

9:00 am | Chair’s Opening Remarks

Day Two

Thursday 27 June

1:50 pm | Chair’s Closing Remarks & Close of Conference

9:00 am | Chair’s Opening Remarks

John Schalago
Head, Global Regulatory Affairs, Devices & Applications
EMD Serono

Day Two

Thursday 27 June

12:50 pm | Catching Up on the Digitalization Trend?

Prasad Peri
Senior Director, Regulatory Affairs, CMC
Teva

Helen Kim
Associate Director, RA, Device & Combination Products
Allergan

Day One

Wednesday 26 June

9:40 am | Panel Discussion: How to Handle Regulatory Uncertainty and What Does It Mean to Your Combination Products’ LCM?

Sara Dutta
Business Consultant for the Life Sciences Industry
Dassault Systèmes

Sara Dutta is a Business Consultant for the Life Sciences Industry at Dassault Systèmes. She is based at the US headquarters in Waltham, MA. Her aim is to leverage her expertise and the strength of the Dassault Systèmes platform to help pharmaceutical and medical device companies innovate and transform their businesses.   Previously to joining Dassault Systèmes, over the last 7 years, Sara specialized in computational modelling to investigate arrhythmia mechanisms and drug effects on the heart. She worked for 3 years as an ORISE research fellow at the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), where she led work on developing computational techniques to assess cardiac safety and efficacy for the Comprehensive in Vitro Proarrhythmia Assay (CiPA) initiative. As part of a wider collaborative effort, she worked closely with experts from the FDA, academia and industry.   Prior to working at the FDA, she completed her PhD in Professor Blanca Rodriguez's multi-disciplinary research group, the Computational Cardiovascular Science Team, at the University of Oxford (UK). Sara is passionate about the strength of software and computational modelling to transform and enhance the Life Sciences industry, and eventually improve the patient’s life and experience.

Day One

Wednesday 26 June

1:45 pm | How a Greek Goddess can Demonstrate the Digital Transformation of a Combination Product

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

Day Two

Thursday 27 June

10:10 am | Panel Discussion: What Does a Good Change Control Strategy Look Like and Its Importance to Drive a Sustainable Lifecycle?

9:40 am | Case Study: How Can Quality Contribute to a Winning Product and LCM?

Will Sutton
VP Engineering & Technology
Minnetronix Medical

Day One

Wednesday 26 June

11:30 am | Innovation Talk: Leveraging Medical Device Expertise to Develop Combination Therapies

Alastair Clarke
Managing Principal
Weaver Technical Solutions

Leonel Vanegas
Quality Assurance Director, Medical Devices & Combination Products
Merck & Co.

Day One

Wednesday 26 June

11:45 am | Embedding Lifecycle Management Early On – but How Early?

Margaret Kelly
Device Manager, Device Development & Commercialization
Novartis

Day One

Wednesday 26 June

1:15 pm | Excellent Integration of Design Control throughout LCM

Naveen Agarwal
Principal & Founder
Creative Analytics Solutions

Winifred Wu
President & Principal Advisor
Strategic Regulatory Partners, LLC