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Conference | Session 4: New in Biologicals and Biosimilar Drug Delivery Devices

Welcome Coffee
08:30 - 09:00
Opening Address by the Chair
09:00 - 09:30
Global Head of Medical Device Business Solution
Head of Device Technologies Innovation Center
Biosimilars: Outlook and Market Trends
09:30 - 10:00
Managing Director
Tengroth Consulting

• Which biosimilars have been approved?
• Which are available on the market and how are they administered (device/PFS/vial)?
• Litigations or other obstacles preventing launch of approved products
• What lies ahead?

Bolus Formation and Injectability Characteristics of Long Acting Injectables
10:00 - 10:30
Device Development Engineer
Oval Medical Technologies

• The importance of consistent bolus formation in the performance of LAIs
• Design considerations when developing an autoinjector for LAI delivery
• The methodologies best used to understand bolus shape and position
• The impact of various delivery parameters on bolus formation

Coffee break, exhibition visit
10:30 - 11:00
How to Build Winning Biosimilar Defence Strategies Through User and Technology Mapping
11:00 - 11:30
Senior Innovation Consultant
Cambridge Design Partnership

• The market for biosimilars is growing rapidly, creating a vital but challenging need for companies to devise
robust biosimilar defence strategies to maintain their market share
• Simple user experience mapping methods will be demonstrated to show how truly original opportunities to
improve the patient and professionals' experience can be identified
• Technology mapping from these opportunities will then be used to discover how the latest technologies, from digital to
formulation, can provide unique strategic propositions to underpin a compelling biosimilar defence strategy

Panel Discussion
11:30 - 12:30
Panel Discussion
Senior Consultant, European Thought Leadership

Conference | Session 5: Awards Winners’ Presentations and Start-Up Pitching

How Patient-centric Design Packaging can improve patients’ lives
13:30 - 13:45
HCPC Europe
Executive Director
Pharmapack Awards 2019 Winners’ Presentation
13:45 - 14:15
Pharmapack Awards
Start-Up Driven Innovation & Technology in the Packaging Industry
14:15 - 14:35

• Innovation Map revealing emerging application areas in pharmaceutical packaging
• Visualizing Innovation: heatmaps of startup activity, technologies and trends
• Opportunities of working with cutting-edge start-ups

Start-Up Pitch and Open Discussion with the Advisory Board Members
14:35 - 16:00
Start-up Pitch

Technical Symposium

Sponsored by:

Flexible Hybrid Electronic Devices for Disposable Drug Delivery Devices and their Unique Design and Manufacturing Challenges
10:00 - 10:45
Technical Symposium
Flex Health Solutions
Design Program Manager

Sponsored by:

Hybrid systems are electronic devices where traditional silicon integrated circuits are embedded within functional smart substrates comprising flexible batteries, sensors, interconnects, antennae and displays and represent the only viable solution to integrate sophisticated functionalities in miniaturized systems in a cost-effective way. Such systems are the natural endpoint of the rush to ubiquitous computing and while still in their early days, are ultimately aimed to be deployed in a number of industries from logistics to medical devices, from consumer electronics to industrial sensing in mass volumes (hundreds of millions to billions per year) and usually have ultra-low target prices (few tens of cents).
The design and development of these tiny but complex devices poses tight constraints from system design to process development, and from materials selection to assembly equipment design.
In this work we present the unique challenges presented in the development of a new generation of flexible hybrid electronic devices and the critical role of such systems to unlock new applications for disposable.

Developing Innovative Processes for Complex Drug-Device Combination Product: How to Speed Product Development and Reduce Development Costs
11:00 - 11:45
Technical Symposium
Commercial Director
Trelleborg Sealing Solutions Stein am Rhein

Sponsored by:

• From the perspective of a polymer based component and device manufacturer
• On the examples of silicone based micro and 2-component parts for smart, wearable combination products to implantable
drug eluting devices
• Shoulder-to-shoulder development between drug, device and components
• From concept to serial production via scalable process development
• Design for Manufacture (DFM) and process integrated quality

Innovative drug delivery devices, MDR article 117: new challenges and business perspectives for manufacturers of medicinal products and medical devices involved in combination products
12:00 - 12:45
Technical Symposium
Voisin Consulting Life Sciences
Senior Regulatory Scientist, Medical Devices & Combination Products
Voisin Consulting Life Sciences
Associate director, Medical Devices & Combination Products

Sponsored by:

In partnership with Voisin Consulting Life Sciences.

• Drug delivery technologies: smart devices, selective, targeted delivery…
• Regulatory background: MDR (EU) 2017/745 new requirements for drug delivery devices and drug-devices combination medicinal products and directive 2001/83/EC amendment (scrutiny and clinical evaluation, article 117)
• Discussion on implementation issues, impact on device’s technical file and medicines MAA dossier and new challenges and business perspectives for manufacturers

Drug delivery devices are becoming increasingly complex and integrated, combining various advanced technologies (digital, coated, nanoparticles…) allowing to deliver the right dose at the right time and right location. They can be ruled as medical devices on their own, as well as device’s part of drug-device combination products regulated as medicinal products. We will explain in practical terms the regulatory requirements of the Medical Device Regulation (EU) 2017/745 (MDR) for these products (including for their digital components), with a focus on the clinical evaluation scrutiny by an expert panel prior to the placing on the market and on the article 117 which clarifies that the medical device constituent part of a medicinal product shall comply with MDR general safety and performance requirements. Finally, we will discuss the new business challenges and operational model implied by this regulation for pharma and medtech industries.

China Pharma Market Dynamics and Opportunities in Packaging and Drug Delivery Devices Development
13:30 - 16:00
Technical Symposium

Sponsored by:

• China FDA regulatory update on drug packaging & drug delivery devices and the impacts for new drug registration
• Expectations and suppliers management from Chinese pharma companies perspective
• Business opportunities and advices for China market entry

Learning Lab

Next generation packaging for next generation of biological drugs
09:30 - 10:00
Learning Lab
Schott AG
Senior Global Product Manager

Sponsored by:

Developing and bringing a biological drug to market is very expensive and involves risks in every stage of the project. Primary packaging is an integral part of the drug and selecting the right packaging components is crucial for the success of the project. Drug developers and manufacturers who do not understand the full impact of primary packaging on their drug product are taking a significant risk in terms of product stability, patient safety and regulatory scrutiny. The new biological drugs also demand innovative primary packaging solutions.

Learn about the next generation of packaging solutions for biological drugs to avoid the common pitfalls and put your biological drug on a “fast track” to success.

RayDyLyo a New Standard for Vial Capping
10:50 - 11:20
Learning Lab
Business Development Director

Sponsored by:

• An innovative answer to cGMP Annex 1 requirements on vial sealing
• Improving process efficiency by suppressing vial crimping
• Creating an integrated ecosystem to enhance adoption of RayDyLyo

Molded Glass Meets RTU
11:30 - 12:00
Learning Lab
R&D director
SGD Pharma

Sponsored by:

• Ready to Use packaging components: Market evolution
• Moulded Glass Vials RTU: why do we need them?
• The strengths of moulded and especially with new products
• Value Proposition of SGD Pharma Sterinity Platform

Facilitating True Adherence and Patient Engagement with AI-Enabled Add-On Devices and Smart Packaging
12:10 - 12:40
Learning Lab
Corporate Development Manager
Sanner / Sanner Ventures

Sponsored by:

• How artificial intelligence helps to optimize respiratory therapies by improving adherence and inhaler technique
• How to make medical information clear and improve patient engagement with connectivity and digital solutions

How can Devices Improve Compliance for Nasal Delivery Treatment?
13:50 - 14:20
Learning Lab
Global Category Manager

Sponsored by:

• Importance of compliance for treatment efficacy
• Innovative devices for nasal delivery: Advancia, new generation pump platform
• Correlating enhanced compliance and patient experience

Quality by Design for Pre-Filled Syringe Components
14:30 - 15:00
Learning Lab
Director Global Product Managment Prefilld Systems & Delivery
West Pharmaceutical Services

Sponsored by:

• How QbD process differs from traditional process in terms of focus, approach, and quality assurance
• How QbD process is needed in order to meet demands of advances in: biologic and complex small-molecule drug products, high-value treatments, stricter regulations, and self-administration systems
• How QbD process can be applied to design and manufacture of plungers, resulting not only in plungers of higher quality, but better performance.

The Value of A Robust System Integration for Advanced Drug Delivery Solutions
15:50 - 16:20
Learning Lab
R&D Associate Director

Sponsored by:

• System integration of a prefillable syringe in an autoinjector
• Safe and effective drug delivery to patients
• Benefits of system integration and lessons learned after 8 years of BD Physioject™ commercialization

Walking the line of quality control
16:30 - 17:00
Learning Lab
Account Executive

Sponsored by:

Packaging quality control is a delicate process, especially in pharma where regulatory bodies rule and customer safety comes first. Automation is proven to dramatically decrease the likelihood of text mistakes in regulatory submissions, inconsistencies in digital artwork files early in the revision process, and print defects/ typos on the printed samples before going to market. Recalls may still be a reality in this day and age, but so are tools that protect against them.