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

All times displayed for Europe/Paris timezone.

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

Traduction en français disponible: https://app.interactio.io/Agenda/DirectAgenda?eventId=16701

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

Traduction en français disponible: https://app.interactio.io/Agenda/DirectAgenda?eventId=16701

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

Traduction en français disponible: https://app.interactio.io/Agenda/DirectAgenda?eventId=16701

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)

Traduction en français disponible: https://app.interactio.io/Agenda/DirectAgenda?eventId=16701

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
10:05 - 10:35 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.

Traduction en français disponible: https://app.interactio.io/Agenda/DirectAgenda?eventId=16701

Authorised badge access:

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

Break & Refreshments
10:35 - 11:10 Room 721-724
Conference

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.

Traduction en français disponible: https://app.interactio.io/Agenda/DirectAgenda?eventId=16701

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.

Traduction en français disponible: https://app.interactio.io/Agenda/DirectAgenda?eventId=16701

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

Traduction en français disponible: https://app.interactio.io/Agenda/DirectAgenda?eventId=16701

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.

Traduction en français disponible: https://app.interactio.io/Agenda/DirectAgenda?eventId=16701

Authorised badge access:

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

Lunch Break & Exhibition Visit
12:35 - 13:45 Room 721-724
Conference

Authorised badge access:

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