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

Welcome Coffee & Breakfast
08:30 - 09:00
Global Outlook for Biologics and Biosimilars
09:00 - 09:15
Engagement Manager, European Thought Leadership

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

How Formulation Triggers Device Development
09:15 - 09:40
Director Primary Packaging Development Biologicals, Pharmaceutical Development Biologicals
oehringer 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

The Dermal Filler market and its manufacturing challenges
09:40 - 10:05

• 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)

Break & Refreshments
10:05 - 10:20
Understanding the Complexities of Delivering a Biologic Drug to the Market
10:20 - 10:45
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.

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

• 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

Primary Packaging and Injection Systems for Biopharmaceuticals: The Role of an Integrated Approach from Design to Final Device Assembly
11:10 - 11:30
Drug Delivery Systems Business Development Director

• 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.

Oxidative Stability of Biologic Formulations Packaged in Sterilized Hybrid Primary Containers
11:30 - 11:50
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.

Harmonizing Cost and Microliter Dosing Performance Requirements – Applications in Ophthalmology, Oncology, Cell & Gene Therapy
11:50 - 12:10
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

Case study on the development of a new high performance autoinjector
12:10 - 12:35
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.

Lunch Break & Exhibition Visit
12:35 - 13:30


New therapy request on new container solutions
10:00 - 10:40
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

Open Innovation Model: an approach to accelerate innovation in pharma packaging
10:50 - 11:30
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?

Products and Processes for Life Changing Technologies
11:40 - 12:20
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

Ready-To-Use secondary packaging platform for flexible aseptic operations
13:40 - 14:20
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.

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

Remarks from the chairs
13:30 - 13:40
Technology, Innovation, Process & Solution Head, Clinical Supplies R&D
Pharmacist, charge of courses, Biopharmaceutical Department
Faculty of Pharmacy, University of Clermont Auvergne
Change as a prerequisite to enhancing innovation capabilities for organizations
14:05 - 14:30
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.
Speaker bio:
Marc received his Master’s Degree in English and Biology from Ruhr-University Bochum, Germany and his Ph.D. in Pharmaceutical Technology from Heinrich-Heine-University Düsseldorf, Germany.
He started his career in the pharmaceutical industry as a Project Manager in Regulatory Affairs for Respimat® Soft Mist Inhaler with STEAG microParts GmbH, Germany in 2001. From 2004 -2011 Marc held positions of increasing responsibility in the development of inhalation devices and formulations within Boehringer Ingelheim. In 2012 he joined Boehringer Ingelheim’s Biopharma Division as Senior Manager, Technology & Innovation Delivery, before being appointed Head of Device/Combination Product Development for biopharmaceuticals in 2014. In July 2017 Marc joined Novartis Pharma AG as Head New Technologies for Device Development and Commercialisation within TRD.

Using Blockchain across the Pharmaceutical Supply Chain
14:30 - 14:55
Chief Executive Officer

• 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

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

• 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

Pharmapack Awards

Pharmapack Awards 2020 Winners’ Presentation
15:20 - 16:30
Pharmapack Awards

Learning Lab

Innovations in Glass Packaging to Increase Drug Product Quality: The Root Cause of Conventional Container Glass Issues
10:10 - 10:40
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.

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

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.

Design with the End in Mind: Patient-centric Innovations in Containment and Delivery of Parenteral Drug Products
11:30 - 12:00
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.

Packaging and Product Testing Services
12:10 - 12:40
Learning Lab
Technical Advisor - Packaging

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

Digitisation of the Packaging Supply Chain
12:50 - 13:20
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

Best Plastic Vial & Syringe for Oxygen Sensitive Drugs
13:50 - 14:20
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

Protecting Health vs. Sustainable Packaging - Dream or reality?
14:30 - 15:00
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?

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

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

Sterigenics Session
15:50 - 16:20
Learning Lab

Sponsored by: