Agenda

All times displayed for Europe/Paris timezone.

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.

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:

Graphic West Session
12:10 - 12:40
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.

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.

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.

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

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