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 Room 721-724
Conference

Authorised badge access:

Speaker badge, Conference Delegates badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

Opening remarks by the chairs
09:00 - 09:15 Room 721-724
Conference
Hospital Pharmacist
AP-HP & ANSM Expert
Executive Director
HCPC Europe

Authorised badge access:

Speaker badge, Conference Delegates badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

Digital Value Added Medicines
09:15 - 09:40 Room 721-724
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
 

Authorised badge access:

Speaker badge, Conference Delegates badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

Ensuring our digital solutions truly deliver value
09:40 - 10:05 Room 721-724
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
 

Authorised badge access:

Speaker badge, Conference Delegates badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

Break & Refreshments
10:05 - 10:30 Room 721-724
Conference

Authorised badge access:

Speaker badge, Conference Delegates badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

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 Room 721-724
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.

Authorised badge access:

Speaker badge, Conference Delegates badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

Enabling smart packaging for pharma through printable and flexible hybrid electronics – how can we make our packaging truly intelligent?
10:55 - 11:20 Room 721-724
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.

 

Authorised badge access:

Speaker badge, Conference Delegates badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

Advancing Drug Delivery – Building the Business Case and Creating the Ecosystem for Intelligent Primary Containers
11:20 - 11:45 Room 721-724
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
 

Authorised badge access:

Speaker badge, Conference Delegates badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

Risks and real-world issue with connected devices
11:45 - 12:15 Room 721-724
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
 

Authorised badge access:

Speaker badge, Conference Delegates badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

Lunch break, Exhibition visit
12:15 - 14:00 Room 721-724
Conference

Authorised badge access:

Speaker badge, Conference Delegates badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

Workshops

Impact of Medical Device Regulation on Drug/Device Combinations - are the market players ready?
09:10 - 09:50 Room 725-727
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

Authorised badge access:

Speaker badge, Workshop Delegate badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

The Wearable Injection Device Platform That Works from Clinical Trials to Lifecycle Management
10:50 - 11:30 Room 725-727
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

Authorised badge access:

Speaker badge, Workshop Delegate badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

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 Room 725-727
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

Authorised badge access:

Speaker badge, Workshop Delegate badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

Design Control and Control Strategy - How to reach a state of control for combination product manufacturing and release
12:30 - 13:10 Room 725-727
Workshops
Managing Director
Tengroth Consulting
  • Introduction to Design Control
  • Control Strategy as result of Risk Management
  • Case Study: Pre-Filled Syringe
  • Case Study: Auto-Injector
  • Takeaways

Authorised badge access:

Speaker badge, Workshop Delegate badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

Polycarbonate Innovations for Next Generation Drug Delivery Devices
14:00 - 14:40 Room 725-727
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

Authorised badge access:

Speaker badge, Workshop Delegate badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

Measuring the Value of Improved Workflow Efficiency and Safety of Drug Administration with Prefilled Syringes
14:50 - 15:30 Room 725-727
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.

Authorised badge access: Speaker badge, Workshop Delegate badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

ActiveGuard®Connect™ - A Smart Packaging Solution Driving Adherence
15:40 - 16:20 Room 725-727
Workshops

Sponsored by:

Authorised badge access:

Speaker badge, Workshop Delegate badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

Feasibility of Large Volume Drug Delivery in Subcutaneous Injections
16:30 - 17:10 Room 725-727
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.

Authorised badge access:

Speaker badge, Workshop Delegate badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

Succeeding in the Indian Pharma Market
09:10 - 09:50 Room 725-727
Workshops
Director & Practice Lead, Healthcare & Life sciences Advisory
Sathguru Management Consultants Private Limited

Sponsored by:

What’s your strategy to succeed in the East? India’s $33 billion pharma industry continues to grow north of 10%.  Opportunities abound; and winning here calls for a targeted approach.  The workshop will dive into key trends and evolving business composition in the pharma manufacturing hub crowed ‘Pharmacy of the World’ for its formidable export presence.  The industry’s growth direction is progressively evolving – the workshop will also dwell upon key growth pivots – specialty pharma foray in regulated markets, the emerging biologics opportunity et al, and implications thereof.

Authorised badge access:

Speaker badge, Workshop Delegate badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

New therapy request on new container solutions
10:00 - 10:40 Room 725-727
Workshops
Senior Global Director Business Development MDS
Gerresheimer AG
Chief Commercial Officer
Sensile Medical AG

Sponsored by:

The focus of the Pharma industry is highly driven by new therapies. Cell and gene, new bio molecules and orphan drugs are the new approach. On the one hand it often asks for smaller batch sizes in filling, but on the other hand the filled product is sensitive to the storage environment. The container and the application forms have to be individually adapted. In a hands-on presentation we will evaluate the pros and cons of existing and new delivery strategies. Direct interaction with the attendees will lead to a good understanding of new "containers" and will help with picking the best solution in the future.
• On and off body worn Pumps for larger volume application
• Polymer syringes for reduced container interference
• Silicon-free for glass and polymer syringes in case of sensitive drugs
• RTF vials for more flexibility
• Integrated safety device for easy and cost effective implementation of regulatory requested safety

Authorised badge access:

Speaker badge, Workshop Delegate badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

Open Innovation Model: an approach to accelerate innovation in pharma packaging
10:50 - 11:30 Room 725-727
Workshops
Head of Product Strategy and Planning
Bormioli Pharma

Sponsored by:

In this workshop we will describe Bormioli Pharma’s way of changing the standard approach to innovation. Among other topics, we will discuss:
• How to re-think an innovation model starting from scratch
• How to create a permeable environment in continuous exchange with a growing innovation ecosystem, made of research centers, universities, startups, but also customers, suppliers and final users
• How to apply different methodologies to develop new concepts: which one to choose, between design thinking, lean startup and design sprints? When? Who has to be involved?

Authorised badge access:

Speaker badge, Workshop Delegate badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

Products and Processes for Life Changing Technologies
11:40 - 12:20 Room 725-727
Workshops
Technical Manager - Healthcare & Medical Europe
Trelleborg Sealing Solutions

Sponsored by:

• How to bring combination products or drug eluting devices to market
• Benefits of smart 2C/2K solutions
• Why it is important to involve your partners in an early stage of development

Authorised badge access:

Speaker badge, Workshop Delegate badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

Ready-To-Use secondary packaging platform for flexible aseptic operations
13:40 - 14:20 Room 725-727
Workshops
Chief Innovation & Development Officer
SGD Pharma
Product Manager for Vials
Ompi, Stevanato Group

Sponsored by:

• Supply chain improvements for pharma companies when selecting ready-to-use configuration for glass primary packaging
• Benefits in using the same standardized secondary packaging presentation in pharma F&F operations

The pharmaceutical industry is experiencing a shift from blockbuster to biological drugs for more personalized treatments. This trend results in a need for manufacturing smaller batches, handling multiple products in different container presentations on the same filling line, adopting ready-to-use primary packaging. Although the technology of combi lines and RTU for small volume is well established in the market, solutions for larger sized containers, in the 50 to 250 ml volume range, are not yet fully established. To ensure manufacturing readiness, a key aspect pharma companies take into account when selecting the technology is the possibility of multiple sourcing along their supply chain. Flexibility, quality and optimized total cost of ownership are key criteria when selecting partners for fill & finish operations. This presentation illustrates how the partnership between Ompi, Stevanato Group and SGD Pharma on RTU vials has supported a real case of switching manufacturing processes from bulk to EZ-fill®. For the first time, both moulded and tubular glass primary packaging are available in the same secondary packaging, allowing multi sourcing without impacting line format change at pharma operations.
 

Authorised badge access:

Speaker badge, Workshop Delegate badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

Conference | Session 2: Substainability (Développement durable)

Chair’s introduction
13:50 - 14:00 Room 721-724
Conference
Managing Director
Pharmacentric Solutions
HPRC(Healthcare Plastics Recycling Council): A Collaborative, Value Chain Approach to Enabling Plastic Recycling
14:00 - 14:20 Room 721-724
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
 

Authorised badge access:

Speaker badge, Conference Delegates badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

Recovering and managing waste generated by used medicines in the health and medico-social sector
14:20 - 14:40 Room 721-724
Conference
Purchasing Manager
Korian

Authorised badge access:

Speaker badge, Conference Delegates badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

Starting at the source, sustainable packaging in Merck supply chain
14:40 - 15:15 Room 721-724
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.
 

Authorised badge access:

Speaker badge, Conference Delegates badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

Break & Refreshments
15:15 - 15:30 Room 721-724
Conference

Authorised badge access:

Speaker badge, Conference Delegates badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

Implementing circular product design on the journey towards zero environmental impact
15:30 - 15:55 Room 721-724
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

Authorised badge access:

Speaker badge, Conference Delegates badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

Use of biodegradable materials for disposable drug delivery device design
15:55 - 16:20 Room 721-724
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

Authorised badge access:

Speaker badge, Conference Delegates badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

Medical blister recycling challenges: first steps into action
16:20 - 16:45 Room 721-724
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.

Authorised badge access:

Speaker badge, Conference Delegates badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

Preparing for the Black Swan: A Playbook for Exiting PVC in pharmaceutical flexible packaging
16:45 - 17:10 Room 721-724
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…

Authorised badge access:

Speaker badge, Conference Delegates badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

Panel Discussion
17:10 - 17:45 Room 721-724
Conference

Authorised badge access:

Speaker badge, Conference Delegates badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

Pharmapack Awards

Pharmapack Awards Ceremony
17:45 - 19:00 Learning Lab
Pharmapack Awards
Pharmapack Awards 2020 Winners’ Presentation
15:20 - 16:30 Learning Lab
Pharmapack Awards

Conference | Session 3: Challenges in Drug Delivery for Biologics (Défis liés à l'administration des médicaments biologiques)

Welcome Coffee & Breakfast
08:30 - 08:50 Room 721-724
Conference

Authorised badge access: 

Speaker badge, Conference Delegates badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

Chair’s introduction
08:50 - 09:00 Room 721-724
Conference
Director Primary Packaging Development Biologicals, Pharmaceutical Development Biologicals
Boehringer Ingelheim
Head of Technical and Pharmaceutical Operations
MedinCell

Authorised badge access:

Speaker badge, Conference Delegates badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

Global Outlook for Biologics and Biosimilars
09:00 - 09:15 Room 721-724
Conference
Engagement Manager, European Thought Leadership
IQVIA

• Biologics driving innovation
• How drug delivery has shaped the landscape
• Future biosimilar opportunities

Authorised badge access:

Speaker badge, Conference Delegates badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

How Formulation Triggers Device Development
09:15 - 09:40 Room 721-724
Conference
Director Primary Packaging Development Biologicals, Pharmaceutical Development Biologicals
Boehringer Ingelheim

• Complex molecule formats limit “high concentration liquid formulation (HCLF)” development
• Include device development from early stage on to tackle challenges
• Involving patients – patient centric model in drug development
• Innovative options for devices

Authorised badge access:

Speaker badge, Conference Delegates badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

The Dermal Filler market and its manufacturing challenges
09:40 - 10:05 Room 721-724
Conference

• Challenges of manufacturing a new crosslinked HA technology for aesthetic medicine.
• The surging market of injectables for Medical Aesthetics
• The new regulatory challenges (EU MDR, CFDA, MEA new regulations)
 

Authorised badge access:

Speaker badge, Conference Delegates badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

Break & Refreshments
10:05 - 10:20 Room 721-724
Conference

Authorised badge access:

Speaker badge, Conference Delegates badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

Understanding the Complexities of Delivering a Biologic Drug to the Market
10:20 - 10:45 Room 721-724
Conference
Vice President, Scientific Affairs & Technical Services
West Pharmaceutical Services, Inc.

The majority of biologic drugs are delivered in a combination product format to ease self-administration and patient delivery. It is important in all cases to “start with the end in mind” when building an understanding to support the regulatory application. Combining the challenges of drug development and device development while meeting regulatory needs is a significant learning curve for the industry. The highlights of a representative injectable combination product are presented. Lifecycle management, as defined in ICH Q12, will also be discussed. A review of concepts to simplify the journey in addressing these global challenges will be presented.

Authorised badge access:

Speaker badge, Conference Delegates badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

From Primary Container to Device Development – pitfalls and ways to maximize efficiency
10:45 - 11:10 Room 721-724
Conference
Senior Manager, Biopharmaceutical Development, Dosage Form Design & Development
AstraZeneca

• Explore how early drug products - primary container characterizations can help with device development and overall program success.
• Vendor – Pharma relationships and how a successful partnership can help maximize efficiency
• Early development steps and activities to avoid development pitfalls
• Why control strategies should be considered earlier rather than later

Authorised badge access:

Speaker badge, Conference Delegates badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

Primary Packaging and Injection Systems for Biopharmaceuticals: The Role of an Integrated Approach from Design to Final Device Assembly
11:10 - 11:30 Room 721-724
Conference
Vice President of Drug Delivery Systems
STEVANATO GROUP

• From Patient Experience to Device Technology: observing market trends and human factors to drive design selections
• Combining glass primary packaging with drug delivery devices: points to consider and best practices
• The need of a multi-dimensional structure of competences to expedite time-to-market, especially for complex drug delivery devices, and to reduce risks for the bio-pharma entity
• The container-closure system: a key element of parenteral delivery manufacturing readiness: some aspects of the “downstream processes” for complex devices.

Authorised badge access:

Speaker badge, Conference Delegates badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

Oxidative Stability of Biologic Formulations Packaged in Sterilized Hybrid Primary Containers
11:30 - 11:50 Room 721-724
Conference
Chief Scientist
SiO2 Medical Products, Inc.

• SiO2 Medical Products developed coated plastic primary containers that can be e-beam or gamma sterilized without the running the risk of oxidizing the product.
• Ordinary plastic containers are vulnerable to radiation sterilization, which produces free radicals in the polymer that reacts with oxygen and forms oxidative species.
• The dense coating on the inside of the containers prevents oxidative species from migrating into the drug formulation, oxidizing the active drug and affecting its efficacy.

Biologic APIs are highly susceptible to many different degradation pathways compared to small molecule APIs. Primary container materials-of-construction play a crucial role in API preservation. While borosilicate glass is still prevalent, its vulnerability to breakage, chemical attack, and delamination has spawned the development of plastic alternatives. Ordinary plastics, for example, were marked as inadequate for primary containers after electron-beam, gamma and ethylene oxide sterilization. The combination of high gas permeability and sterilization-induced free-radical generation in plastics have been shown to increase the risk of oxidation damage to sensitive biologic drugs. Primary containers, manufactured by SiO2 Medical Products, Inc. (SMP) and composed of a hybrid of cyclic olefin polymer and glass-like coating materials, were shown to overcome both problems. Specifically, oxygen permeation is much lower than ordinary plastics and approaches glass. Furthermore, two biologic drug solutions stored in gamma and electron-beam sterilized SMP vials did not show elevated oxidation compared to either glass or unsterilized control vials. The culmination of these findings demonstrates that SMP’s hybrid primary containers are attractive for storing sensitive biologic drugs.

 

Authorised badge access:

Speaker badge, Conference Delegates badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

Harmonizing Cost and Microliter Dosing Performance Requirements – Applications in Ophthalmology, Oncology, Cell & Gene Therapy
11:50 - 12:10 Room 721-724
Conference
CEO
Congruence Medical Solutions LLC

• Share technical challenges associated with standard pharmaceutical fill-finish & delivery systems for accurate, precise microliter dosing in applications for Ophthalmology, Cell & Gene therapy and Oncology
• Quantify cost challenges due to sub-optimal delivery systems and materials
• Explain how clinical trial and commercialization costs can be reduced, illustrating direct impact of improved solutions for accurate, precise microliter dosing

Authorised badge access:

Speaker badge, Conference Delegates badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

Case study on the development of a new high performance autoinjector
12:10 - 12:35 Room 721-724
Conference
Director Corporate Project Management
Midas Pharma GmbH

• Case study describing how a pharma company has worked with a device development company to develop an autoinjector with fundamentally higher performance and simpler design, and how we “translated” between the pharma and device development worlds.
 Use physics to explain why high viscosity and high volume injections are more likely to lead to device failures and recalls, and why an acceptable injection time is challenging.
• Show experimental results from autoinjector tests that verify the physics model.  Introduce a form of Monte Carlo simulation to predict the maximum injection time, even allowing for manufacturing tolerances and drug variation. Springboard has open-sourced the underlying computer code for others to use.
 

Authorised badge access:

Speaker badge, Conference Delegates badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

Lunch Break & Exhibition Visit
12:35 - 13:30 Room 721-724
Conference

Authorised badge access:

Speaker badge, Conference Delegates badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

Conference | Session 4: New Horizons in Innovation (Nouveaux horizons en matière d’innovation)

Remarks from the chairs
13:30 - 13:40 Room 721-724
Conference
Technology, Innovation, Process & Solution Head, Clinical Supplies R&D
Sanofi
Pharmacist, charge of courses, Biopharmaceutical Department
Faculty of Pharmacy, University of Clermont Auvergne

Authorised badge access:

Speaker badge, Conference Delegates badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

Change as a prerequisite to enhancing innovation capabilities for organizations
14:05 - 14:30 Room 721-724
Conference
Head New Technologies, Device Development and Commercialisation
Novartis AG

This presentation discusses the main, new challenges faced by companies operating in highly regulated business sectors – such as e.g. Biopharmaceuticals - when engaging in innovation. It is proposed that there are fundamental challenges such as:
• increased depth of multidisciplinary working demanded due to increasingly complicated therapeutic systems
• insufficient attention paid to non-technical skills (softer, psychological, aspects)
• low probability of success through implementing a top-down or bottom-up approach, rather than both at once
• a feeling of being a small part of a big system, with little empowerment or control
• innovation change programs taking a generic approach, not optimized to the national culture, corporate culture, local team and individual-specific orientations • excessive focus on a top-down scheme addressing the organization at a concept level, rather than demonstrating successful innovation deliverables within functional teams
• lack of on-going individual and team coaching to ensure permanent, embedded, change. It will be discussed that organizations in highly regulated industries seeking greater innovation can benefit from an approach tailored to and taking into consideration a culture change program that covers the discussed challenges.

Authorised badge access:

Speaker badge, Conference Delegates badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

Using Blockchain across the Pharmaceutical Supply Chain
14:30 - 14:55 Room 721-724
Conference
Chief Executive Officer
Veratrak

• Present an overview of how blockchain is being used by contract packaging organisations in the pharma supply chain currently
• present two customer case studies from Tjoapack and Central Pharma
• Discuss the future of the industry and how companies can start exploring new technologies such as blockchain

Authorised badge access:

Speaker badge, Conference Delegates badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

Big Data in pharma cold chain logistics: the key to mitigate risks and reduce cost
14:55 - 15:20 Room 721-724
Conference

• Full control based on relevant data available in real-time
• Lane risk assessment through real-life data
• Best practice: Collecting data, making data available to the client and tamper-proof collection and storage of data

Authorised badge access:

Speaker badge, Conference Delegates badge, Exhibitor Delegate badge, Premium Delegate badge, VIP badge, Press badge

Learning Lab

Changing Regulatory Requirements for Extractables & Leachables Testing on Pharmaceutical Packaging Systems
10:10 - 10:40 Stand L30
Learning Lab
Director E&L Services
Nelson Labs Europe

Sponsored by:

• Key success factors of any given E&L project on pharmaceutical packaging systems will be highlighted.
• Requirements that global regulators (EMEA and FDA regulators) are expecting of an E&L study design for submission.

Authorised badge access:

All types of badge

Connected Pen Injectors: Creating a Real Value in Clinical Trials
10:50 - 12:00 Stand L30
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.

Authorised badge access:

All types of badge

Graphic West Session
12:10 - 12:40 Stand L30
Learning Lab

Sponsored by:

Authorised badge access:

All types of badge

PCI Session
12:50 - 13:20 Stand L30
Learning Lab

Sponsored by:

Rethinking DPI Packaging: New Solutions to Old Challenges
13:50 - 14:20 Stand L30
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.
 

Authorised badge access:

All types of badge

Accelerating and de-risking your drug development journey
14:30 - 15:00 Stand L30
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.

Authorised badge access:

All types of badge

Inhaler Devices and the Environment: Going Green Needn’t Cost the Earth
15:10 - 15:40 Stand L30
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.

Authorised badge access:

All types of badge

Diabetes & Respiratory: ready for device connectivity
15:50 - 16:20 Stand L30
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
 

Authorised badge access:

All types of badge

Innovations in Glass Packaging to Increase Drug Product Quality: The Root Cause of Conventional Container Glass Issues
10:10 - 10:40 Stand L30
Learning Lab
Applications Engineering Manager
Corning Pharmaceutical Technologies, Corning, Inc.

• Lyophilization processes can be limited by lengthy cycle times and low yields due to glass vial breakage issues.
• The economic implications of vial breakage are significant due to direct loss of product, indirect loss of product due to potential particulate contamination, lengthy clean-up procedures, etc.
• New glass packaging technology is available that reduces damage and breakage to vials and may reduce cycle times.
• Performance data on this enhanced vial will be provided and compared to conventional vial options.

A number of challenges face the manufacturers of freeze-dried products. Glass vial failures, specifically breakage, lensing, and cracks, are a source of product loss and process cost in the freeze-thaw, cryogenic preservation, and lyophilization of pharmaceutical products. Lyophilization is a common method for the preparation of freeze-dried pharmaceutical products, which requires low temperature processing to avoid product damage or decomposition. Because process times are long and lyophilization is regarded as an expensive process, considerable research has focused on improving lyophilization rates to reduce costs. One contributing factor to cost is the failure of glass vials during the lyophilization cycle, which includes freezing, annealing, and drying process steps. This vial breakage results in higher process costs, delays due to destruction of product, and lead to possible drug shortages. New glass vial options specifically designed to meet the needs of the pharmaceutical industry, dramatically reduces breakage and enables lower cost lyophilization compared to conventional glass vials.

Authorised badge access:

All types of badge

Holistic design approach for an hybrid auto- and bolus-injector platform
10:50 - 11:20 Stand L30
Learning Lab
Head of Strategic Product Management
Haselmeier

Sponsored by:

Flexible medical device platforms are getting more and more important serving the needs of different kinds of drugs in various indications. Putting the patient in the center of all considerations in combination with intensive market analysis contributes to a solid product definition and medical device system architecture for numerous treatments. Insights of the patient journey in several indications are fundamental for the development of a strong medical device platform which suits the patients’ needs and creates market acceptance. Based on the holistic design approach a hybrid auto- and bolus injector core technology for subcutaneous self- injection has been designed which reflects the idea of a modular tech-platform paired with convenient usage for various therapies.

Authorised badge access: All types of badges

Design with the End in Mind: Patient-centric Innovations in Containment and Delivery of Parenteral Drug Products
11:30 - 12:00 Stand L30
Learning Lab
Director Global Product Management (Polymer Prefilled Systems and Vial Containment),
West Pharmaceutical Services

Sponsored by:

• Review of real life case studies of innovations designed with the end in mind.
• A focus on user needs and unique demands drives valuable innovation in the development of novel technologies for primary packaging and delivery of medicines.
• Underpinned by Quality by Design, a new state-of-the-art elastomer platform being introduced.
• Challenges with Biotech products for stability and functional performance. Prefillable syringe innovations, for intravitreal injections and for larger volume autoinjector applications, are now available to help improve usability and drive patient benefit in this rapidly expanding field.

Authorised badge access:

All types of badge

Packaging and Product Testing Services
12:10 - 12:40 Stand L30
Learning Lab
Technical Advisor - Packaging
STERIS AST

Sponsored by:

This presentation will demonstrate the importance of packaging with particular emphasis on sterile barrier packaging, and across numerous packaging levels and functions with particular emphasis on the following:
• ISO 11607 test requirements for complete sterile medical device packages including
• Transportation / distribution testing
• Integrity testing
• Strength testing
• Product testing overview

Authorised badge access:

All types of badge

Digitisation of the Packaging Supply Chain
12:50 - 13:20 Stand L30
Learning Lab
President and Managing Partner
August Faller GmbH & Co. KG

Sponsored by:

• End-to-End digital production of folding cartons with small orders and short lead times
• Managing the supply chain process between customers and suppliers digitally
• New applications for smart packaging

Authorised badge access:

All types of badge

Best Plastic Vial & Syringe for Oxygen Sensitive Drugs
13:50 - 14:20 Stand L30
Learning Lab
Research Manager
Mitsubishi Gas Chemical Company, Inc.

Sponsored by:

• Multilayer Plastic Vial & Syringe
• Excellent oxygen & UV barrier
• Container Closure Integrity
• Storage at Cryogenic Temperature

Authorised badge access:

All types of badge

Protecting Health vs. Sustainable Packaging - Dream or reality?
14:30 - 15:00 Stand L30
Learning Lab
Director Research & Development
Sanner GmbH

Sponsored by:

• How could sustainability in practice affect the healthcare packaging industry?
• How does the European Environmental Policy impact healthcare packaging?
• How could bioplastics contribute to meet the challenges in sustainable healthcare packaging?
• How could a holistic sustainability approach to healthcare packaging look?

Authorised badge access:

All types of badge

Pharmaceutical labelling for prefilled syringes - providing more than just information
15:10 - 15:40 Stand L30
Learning Lab
Manager Innovation and Strategic Partnerships Healthcare
Schreiner MediPharm
Global Product Manager, Polymer Platform
Schott

Sponsored by:

Prefilled syringes (PFS) are continuously gaining market share as they offer a convenient way to administer drugs. Especially PFS made of high-quality polymer, such as Cyclic Olefin Co-polymer (COC), have become a well-established alternative as they offer greater design flexibility while reducing the breakage rate throughout the value chain. Due to its properties and manufacturing process, COC is heavy metal and tungsten free and also features low or no siliconization. This makes it an attractive choice for a number of different applications. Yet, polymer also has a different extractables & leachables (E&L) profile and a lower oxygen and gas barrier threshold than borosilicate glass, increasing the potential for drug interaction. These barrier properties are of concern when it comes to labeling. Labels are an approved and established way to provide the demanded information about the pharmaceutical product directly on the primary packaging. However, as the labels are glued directly onto the container, there is a potential risk of glue migration into the polymer. This can be overcome by using functional labels, which even have the potential to enhance the primary packaging by adding specific material properties – reaching from overt or covert as well as analog and digital security features to providing a strong first opening indication through UV-protection or improved gas barrier properties.

In our speech you will learn more about the following topics that were evaluated:
• Combining a low migration label with COC syringes
• Adding oxygen barrier to COC syringes
• Adding UV-protection to COC syringes
• Adding a first opening indication to COC syringes

Authorised badge access:

All types of badge

Sterigenics Session
15:50 - 16:20 Stand L30
Learning Lab

Sponsored by:

Authorised badge access:

All types of badge