Agenda

All times displayed for Europe/Paris timezone.

Conference | Session 1: Connectivity and Patient-centricity (Connectivité et centricité du patient)

Welcome Coffee & Breakfast
08:30 - 09:00
Conference
Opening remarks by the chairs
09:00 - 09:15
Conference
Hospital Pharmacist
AP-HP & ANSM Expert
Executive Director
HCPC Europe
Digital Value Added Medicines
09:15 - 09:40
Conference
Engagement Manager, European Thought Leadership
IQVIA

• The role of devices in VAMs: Evolution of devices, how companies think of devices now, patient centricity and good product design
• Therapy areas with unmet needs: Which therapy areas lend themselves naturally to disruption from devices
• What does a digital strategy look like? How companies, from innovators to generics can implement an effective digital strategy
• Beyond digital: influencing patient behaviour: What is on the horizon? Gamification as an important element in providing value

Ensuring our digital solutions truly deliver value
09:40 - 10:05
Conference
Head, Smart Devices
Roche/ Genentech

• The lessons we have learned to date
- Separating the science from the marketing hype
- Key insights from patients, clinicians, and drug development teams
• What value propositions matter and how should we design products and services to serve them?
- The unique value of device connectivity, approaches to behavioural change and digital partnerships

Break & Refreshments
10:05 - 10:30
Conference
Packaging: Labeling setup requirements for, and experiences with, clinical trials and post-market surveillance of pharmaceuticals in relation to patient therapy compliance
10:30 - 10:55
Conference
Industrial Project Leader
Sanofi

• Clinical trial packaging design. The key points of concept, differentiation and industrialization.
• Commercial packaging VS Clinical packaging: How to combine the Regulatory Requirements, manufacturing constraints and hospital/patient centricity.
• Solutions for quick and easy identification of clinical boxes.

Enabling smart packaging for pharma through printable and flexible hybrid electronics – how can we make our packaging truly intelligent?
10:55 - 11:20
Conference
Strategic Marketing Manager
CPI

There are many benefits to the introduction of active and intelligent features to packaging. There is a multitude of technologies available from printed codes through embedded and integrated flexible electronics to complex conventional electronic solutions.
We will give an overview of the different drivers for active and intelligent packaging in pharma and will link these to the appropriate potential technological solutions highlighting the factors needed in the decision making process. We will give examples of where printed or flexible hybrid electronics provide the unique features required for the intended use and will describe what can be achieved with this emerging technology.
We will show why now is the time for smart packaging to shine and how together we can develop an intelligent packaging ecosystem of the future.

Advancing Drug Delivery – Building the Business Case and Creating the Ecosystem for Intelligent Primary Containers
11:20 - 11:45
Conference
Managing Director
SHL Group

• Smart objects in prefilled syringes that enable unit-level traceability and industry 4.0 in drug delivery manufacturing
• Open platforms as enablers for new technology throughout the drug-device ecosystem
• Technology partnerships with Pharma and suppliers to implement new technologies
• Intelligent applications to support patient benefits and digital healthcare

Risks and real-world issue with connected devices
11:45 - 12:15
Conference
Director of Drug Delivery Device Development
Springboard

We have heard much about the need for, and advantages of, connected medical devices. In this presentation, we shall cover the main risks and strategies to manage those risks using real-world case studies where possible. The types of risks and strategies that we shall cover include:
• Technical (examples include robustness, complexity, security, data breaches)
• Usability (human factors)
• Supply chain
• Business model
• Regulatory and legal

Lunch break, Exhibition visit
12:15 - 14:00
Conference

Workshops

Impact of Medical Device Regulation on Drug/Device Combinations - are the market players ready?
09:10 - 09:50
Workshops

• What is the MDR and why are Pharma products affected?
• What is new compared to before MDR
• Status on MDR implementation
• Notified body readiness
• New requirement on drug manufacturers
• Implication on combination product manufacturers / shortage of notified bodies
• Risk on drug product submissions in the EU
• EU vs US comparison on combination product regulation

The Wearable Injection Device Platform That Works from Clinical Trials to Lifecycle Management
10:50 - 11:30
Workshops
Business Development Manager
Sonceboz SA

Sponsored by:

• What defines a true wearable device platform?
• Importance of container flexibility
• What is possible beyond large volume?
• DFM/DTC approach in drug delivery
• What defines a true wearable device platform?
• Importance of container flexibility
• What is possible beyond large volume?
• DFM/DTC approach in drug delivery

From Big Data to Smart Data: Extracting, Processing and Analyzing Manufacturing Data for a New Approach to OEE and Business Intelligence
11:40 - 12:20
Workshops
Product Manager
Antares Vision

Sponsored by:

• Monitoring real-time production lines efficiency
• Optimizing performances and OEE
• Connecting serialization lines and any other equipment
• Improving resource planning and maintenance

Polycarbonate Innovations for Next Generation Drug Delivery Devices
14:00 - 14:40
Workshops
Global Technology Lead, Healthcare
Covestro Deutschland AG

Sponsored by:

Drug delivery devices have taken on increasing sophistication to meet the needs of increasingly tech savvy patients. At the same time, more and more regulatory requirements such as recent revisions to USP661.1 have raised the bar for suppliers in this increasingly competitive arena. This presentation will outline and present examples of how Covestro, a polycarbonate supplier to healthcare for over 50 years, innovates its materials portfolio for healthcare to meet these challenges.
• Key Polycarbonate material properties for new Drug Delivery Devices
• Changing needs and requirements for Drug Delivery Devices (e.g. USP661.1)
• Polycarbonate innovations for Global Drug Delivery Device Manufacturers
• Orienting Drug Delivery Materials toward Circular Economies and New Sustainability Requirements

Measuring the Value of Improved Workflow Efficiency and Safety of Drug Administration with Prefilled Syringes
14:50 - 15:30
Workshops
Global Portfolio Lead
Becton Dickinson & Co

Sponsored by:

Understanding hospital and care center’s unmet needs is vital for providing them with impactful solutions. In the healthcare setting, patient safety concerns exist across the entire drug delivery spectrum. Specifically, in an acute care setting where decisions are often made quickly or under stress, error rates can be at their highest.
In a healthcare setting, medication errors can result from human factors, work-arounds etc. and may be linked with the type of primary container being used in medication preparation and administration. Collectively, drug delivery mistakes create challenges in maintaining optimal patient safety, healthcare worker safety, and can negatively impact the end user’s bottom line. Through the workshop, we will address how differences in primary container options for injectable drugs can add value by offering care centers configurations that address universal pain points.

ActiveGuard®Connect™ - A Smart Packaging Solution Driving Adherence
15:40 - 16:20
Workshops

Sponsored by:

Feasibility of Large Volume Drug Delivery in Subcutaneous Injections
16:30 - 17:10
Workshops
Associate Director, Parenteral Sciences COE
Becton Dickinson Technologies & Innovation

Sponsored by:

Current treatment of chronic diseases requires patients to undergo traditional clinical intravenous (IV) administration. The shift of IV to subcutaneous (SC) delivery may provide patients the convenience of in-home self-administration but will require formulations with higher viscosities and volumes. Delivery of higher volumes and viscosities have raised questions about the feasibility of subcutaneous delivery. BD has conducted a series of pre-clinical and clinical trials to demonstrate feasibility of 2-10 mL biologic injections into subcutaneous tissue and characterize the tissue response to those injections in human and animal subjects. This presentation will share the latest results of select studies.

Conference | Session 2: Substainability (Développement durable)

HPRC(Healthcare Plastics Recycling Council): A Collaborative, Value Chain Approach to Enabling Plastic Recycling
14:00 - 14:20
Conference
Technical Marketing Specialist
DuPont™ Tyvek® Healthcare Packaging

The Healthcare Plastics Recycling Council (HPRC) is a private, technical consortium of industry peers across the healthcare, recycling, and waste management industries seeking to improve the recyclability of plastic products and packaging within healthcare. Founded in 2010, and made up of globally recognized members, HPRC engages in pioneering projects designed to help boost plastics recycling efforts in clinical settings of hospitals. Committed to continuous dialogue, HPRC explores ways to enhance the economics, efficiency, and ultimately the quality and quantity of healthcare plastics collected for recycling. In this presentation, you’ll hear about:
• The collaborative approach of HPRC
• Examples of HPRC project work
• Opportunities to get involved with HPRC in Europe

Recovering and managing waste generated by used medicines in the health and medico-social sector
14:20 - 14:40
Conference
Purchasing Manager
Korian
Starting at the source, sustainable packaging in Merck supply chain
14:40 - 15:15
Conference
Associate Director, Head of Sourcing Glass
Merck Healthcare
Global Manager, Product and Packaging Sustainability
Merck Life Sciences

From locating potential issues and monitoring vendors impact, to developing packaging that is easily recyclable, and made using less energy, space or material, this presentation will show how Merck is currently improving packaging sustainability in its supply chain by working in close partnership with its suppliers.

Break & Refreshments
15:15 - 15:30
Conference
Implementing circular product design on the journey towards zero environmental impact
15:30 - 15:55
Conference
Project Lead, Corporate Environmental Strategy
Novo Nordisk A/S

With the Circular for Zero strategy, Novo Nordisk aims for zero environmental impact by implementing a circular mindset across the organisation. This presentation introduces the Circular for Zero strategy and dives into the Design for circularity track, in which Novo Nordisk has set up a framework for circular design of their products. You will learn how Novo Nordisk has:
• selected indicators to measure progress on circularity
• translated circular economy into a company-specific circular design guideline
• educated employees
• integrated circularity into decision processes in product development

Use of biodegradable materials for disposable drug delivery device design
15:55 - 16:20
Conference
Medical Device Innovation Lead
PA Consulting

The single use auto-injectors are disposed of in a sharps bin as medical waste, which is
then incinerated. However, only the syringe is technically considered to be medical waste.
Therefore more of the device than necessary is being discarded as medical waste, wasting
resources and affecting the environment.
PA has developed an eco-friendly concept by :
• Replacing standard materials with biocompatible/ biodegradable materials
• Separating auto-injectors into medical and non-medical waste could make recycling an
option

Medical blister recycling challenges: first steps into action
16:20 - 16:45
Conference
Eco-design services Manager
Adelphe

Blister packs are made primarily of aluminum and PVC, and bring the following end-of-life challenges in France. PVC packaging does not have a recycling stream in France, and mixed plastic/metal packaging is not recyclable in the plastic packaging stream. Moreover, PVC is not welcome as Refuse Derived Fuel. The road to a new recyclable blister to become the standard in the market is long, but will start with cooperation and communication. Only 67% of the public knows how to separate a blister pack for recycling.

Preparing for the Black Swan: A Playbook for Exiting PVC in pharmaceutical flexible packaging
16:45 - 17:10
Conference
Managing Director & Co-Founder
Montesino Associates, LLC

According to Investopedia, “A black swan is an extremely rare event with severe consequences. It cannot be predicted beforehand, though many claim it should be predictable after the fact.”
According to Accenture, a playbook includes “process workflows, standard operating procedures, and cultural values that shape a consistent response—the play. A playbook reflects a plan,an approach or strategy defining predetermined responses worked out ahead of time.” In short, a playbook shows maneuvers that form the pieces and parts to getting something done – in this case, exiting PVC. Key strategic factors covered in this playbook: cost, time, regulatory risk.
• Banning PVC: A “Black Swan” event for pharmaceutical flexible packaging
• Machinery Play – maneuvers required for modifying or replacing packaging equipment for non-PVC materials
• Operations Play – maneuvers required at the operational level, including efficiency
• Regulatory Play – maneuvers of what has to be done to establish equivalence
• User Interface Play – maneuvers required to manage the impact of non-PVC structures on the user experience
• Observations for the future…

Panel Discussion
17:10 - 17:45
Conference

Pharmapack Awards

Pharmapack Awards Ceremony
17:45 - 19:00 Learning Lab
Pharmapack Awards

Learning Lab

Nelson Lab Session
10:10 - 10:40
Learning Lab

Sponsored by:

Connected Pen Injectors: Creating a Real Value in Clinical Trials
10:50 - 12:00
Learning Lab
Chief Innovation Officer
Haselmeier

Sponsored by:

Two topics have been constantly keeping our medical device community busy, in particular in the drug injection field: how to offer a true device platform, usable across different drug families and therapeutic areas, combined with the discussion around value of data generated by connected devices. It is broadly accepted that a true device platform should enable to reduce development time and overall time-to-market, regulatory risk, costs and Capex. We believe that such platform should also be able to accompany a drug throughout its entire lifecycle, from early-stage clinical trial to lifecycle management of a mature drug product. In addition, gearing up such device platform with connectivity, sill today raises the question of the value of the generated data. The “lots-of-data-makes-it-all” approach may be an approach worth to try but does still not answer the question of the real value of generating data and information. We believe that focusing a connected solution, generating data, on a simple use case, such as clinical trials, may provide a faster response for a sustainable and proven value proposition for connected device solutions.

Graphic West Session
11:30 - 12:00
Learning Lab

Sponsored by:

Rethinking DPI Packaging: New Solutions to Old Challenges
13:50 - 14:20
Learning Lab
Vice President, Commercial Operations
Aptar CSP Technologies

Sponsored by:

Dry Powder Inhalers (DPIs) have long faced challenges in terms of the robustness of management of active packaging. Active pharmaceutical ingredients (API) delivered in capsule-based DPIs can be subject to moisture and oxygen causing degradation of the API and ultimately impacting patient therapeutic efficacy. Three-phase polymer technology offers unique protection from residual moisture and ingress through the package.
This presentation will explore the application of Aptar’s proprietary three-phase polymer™ technology in managing headspace, moisture and oxygen. It will also review a case study on a reservoir DPI, utilizing all three-phase polymers.

Accelerating and de-risking your drug development journey
14:30 - 15:00
Learning Lab
President
Next Breath, an Aptar Pharma Company

Sponsored by:

We are witnessing an escalation in the complexity of the registration process and a heightened focus on device technology and patient safety from regulatory bodies. Many of these initiatives are driven by FDA’s Combination Drug Product Guidances. This coupled with the limited technical skills expertise in pharma companies, has resulted in a gap in the analytical capabilities required to accelerate and de-risk drug development. To address these gaps, Aptar Pharma Services builds on Aptar’s established credentials together with the expertise of Nanopharm, Next Breath and Gateway Analytical, to support customers during the entire life cycle of the drug product and deliver them a complete solution.

Inhaler Devices and the Environment: Going Green Needn’t Cost the Earth
15:10 - 15:40
Learning Lab
Director Business Development, Prescription Sales and Operations Europe
Aptar Pharma

Sponsored by:

The noise generated around reducing the carbon footprint of industrial products has grown from a local whisper to a global symphony, this growing commitment to our environment could now impact the future of our medicinal products. Inhaler devices have been subject to close environmental scrutiny before, resulting in the transition from CFC to HFA propellants in 2008 to combat the threat of ozone depletion. Today we face a new challenge of global warming. So, where are we today? Where do we need to be tomorrow? We will explore where next for MDIs & HFA propellants, review the alternatives available and discuss the opportunities and solutions for the future.

Diabetes & Respiratory: ready for device connectivity
15:50 - 16:20
Learning Lab
Business Development Director
BIOCORP

Sponsored by:

• Quick introduction on connected drug delivery devices: categories, benefits, trends, key applications
• Zoom on 2 markets with very mature ecosystems, ready to welcome connected drug delivery devices: diabetes and respiratory