PDA Universe of Pre-Filled Syringes and Injection Devices Conference 2024
Injecting Innovation into Drug Delivery
Educational Sessions | Training Courses | Networking Opportunities | Exhibit Hall | Drug Delivery Innovation Awards
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Learn about groundbreaking innovation in injectable drug delivery at the 21st edition of the annual PDA Universe of Pre-Filled Syringes and Injection Devices Conference!
The largest event on pre-filled syringes and injection devices brings together key field players to discuss the breakthroughs that are propelling the industry forward.
This conference is the top platform to hear top-notch content, exchange knowledge with other experts, and contribute to enhancing global health within the pharmaceutical and medical device sectors.
A comprehensive agenda covers critical topics, including sustainability, large-volume injections, digital health, and regulatory compliance. One key conference highlight is the interactive exhibit hall featuring 120+ vendors and service providers introducing new technologies and partnerships.
Additionally, forward-thinking poster presentations, lightning sessions, lively Q&A sessions, networking activities, and the Drug Delivery Innovation Awards make this event a must-attend.
Following the conference, join specialized training to bridge theory to practice.
Mark your calendar for an unforgettable experience at the world's leading event in drug delivery!
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Learn MoreHighlighted Presenters
Key Presenters
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Andrea Redd
Eli Lilly and Company
Associate Vice President, Global Regulatory Affairs, Drug Device Delivery
Read Bio
Conference Co-Chairs
The Minds Behind the Insights
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Alessandro Morandotti
Stevanato Group
Drug Containment Solutions Product Development Director
Read Bio
Program Planning Committee
The Team Behind the Event's Agenda
Schedule
Discover What's Happening Each Day
07:00 – 18:00
Registration Open
07:15 – 08:15
Continental Breakfast
08:15 – 10:00
P1: Regulatory Landscapes and Strategies for Combination Products
Moderator: Theresa E. Bankston, PhD, VP Combination Products & Capabilities, BD
Navigating the complex and evolving requirements for combination products is a challenging and critical undertaking for many parenteral therapeutics. In this plenary session, we will provide an update on the latest regulatory developments and guidance for combination products, discuss common pitfalls in their development and approval, and share lessons learned, best practices, and helpful strategies from case studies. The audience will also benefit from industry perspectives shared by the CPC Bridging Working Group on bridging in relation to device platforming. Join us for the integrated panel discussion/Q&A to engage in a dialogue on these and other critical regulatory topics.
08:15
Opening Remarks from Conference Co-Chairs and Awards Presentations
08:45
Evolution of Combination Product Requirements to Support Innovation
Andrea Redd, Associate Vice-President, Global Regulatory Affairs, Drug Delivery and Combination Products, Eli Lilly and Company
09:10
Bridging Strategies for Combination Products
Desiree Crisolo, Sr. Director, Head of Global Regulatory CMC Policy and Intelligence, Biogen
09:35
Q&A
10:00 – 16:30
Exhibit Hall Open
10:00 – 11:00
Networking Break, Tech Talks, and Guided Poster Walk in the Exhibit Hall
10:00 –11:00
Exhibitor Tech Talks
10:10
SHL Medical's Elexy™: Expanding True Autoinjector Versatility for the Development of Combination Products
Vince Masciopinto, Director, Customer Solutions SHL Medical
10:25
Enabling High-Volume Drug Delivery with a Platform Approach
Gurmeet Singh, MBA, Senior Director West Pharmaceutical Services
10:40
Benefits of Utilizing a Digital Validation Process for Parenteral Inspection Systems
Karen Granzow, Senior Consultant, Koerber Pharma, North America
11:00 – 12:30
P2: Current Opportunities and Challenges with Large Volume Injections – Market Overview and Delivery Options with focus on Injection Tolerability and Pain
Moderator: Jakob Lange, PhD, VP & Head of Account and Business Development, Ypsomed AG
This session will explore the emerging field of large volume injections and provide a market overview and delivery options, i.e., subcutaneous injections of volumes larger than 2 ml. We will begin with an overview of the drugs in development, presenting results of a recent detailed analysis of the clinical trial registers.
This will be followed by a presentation covering options for hand-held, large volume injections including data from recent studies on the tolerability of such high-rate injections. Finally, we will hear results on tolerability and pain of very high-volume injections (up to 25 ml or more) using on-body and near-body delivery solutions. After the presentations, we will conclude with a panel discussion, including a patient on the challenges and opportunities in the field.
11:00
Overview of the Industry's Pipeline of SC Drugs in Development Above 2ml Injection Volume
Phil Green, PhD, President, Chesapeake Pharma
11:20
Challenges and Opportunities with Rapid Handheld Injections (> 2mL) and the Clinical Tolerability of a 10 mL High-Volume Auto-Injector
David W. Kang, Director, Innovation, Halozyme, Inc.
11:40
Pain & Tolerability of Large Volume Subcutaneous Injection
Galen Shi, PhD, Vice President of Engineering – Delivery Devices, Eli Lilly and Company
12:00
Q&A with Additional Panelist
Rana Mogannam, Patient Advocate, Patient Pavilion (Booth 1029)
12:30 – 14:00
Networking Lunch and Tech Talks in the Exhibit Hall
12:40 –13:35
Exhibitor Tech Talks
12:40
Accelerating Your Vial to PFS Pathway
Flora Felsovalyi, PhD, Associate Director, Lonza
12:55
Ypsomed's Perspective on Industry Partnering for Successful Combination Products
Philipp Richard, MSc, MBA, Account & Business Development Manager, Ypsomed AG
13:10
A New Frontier: Self-Administration of Lyophilised, Large-Volume, Subcutaneous, Biologics
Daniel Waites, Director, Research & Development, Koerber Pharma, North America
14:00 – 15:30
Concurrent Sessions
A1: Putting the User First - The Human Side of Product Development
Moderator: Bart E. Burgess, Global Head, Portfolio Strategy and Customer Solutions, SHL Medical AG
Human factors remain a source of uncertainty for combination product developers and suppliers. More than ever, careful planning is required to increase the probability of program success. This session will present new perspectives on incorporating user capability inputs, designing a product holistically, and incorporating technologies once they arrive from outside your organization.
14:00 | Holistic Design Approach for Combination Products: Patient, Product, Device, and Packaging
- Agata Pczycka, Principal Engineer, Packaging Development & Technology, AstraZeneca
- Lucy Baldwin, Head of Research & Strategy, Kinneir Dufort a SteriPack Company
14:20 | Quantification of User Inputs During Injection Device Use: An Anthropometric Human Factors Study
Enrica Papi, PhD, Human Factors Manager, GSK
14:40 | Navigating Human Factors Challenges: Lessons Learned from Combination Product Acquisitions
Esther Foo, PhD, Senior Scientist, Merck
15:00 | Q&A
B1: Autoinjector - One Size Doesn't Fit All
Moderator: Dominik Ziegler, MSc, Executive Director Device Technology Device Technology Solution Center, Novartis Pharma AG
The rising interest in high doses for subcutaneous drug delivery is fueling the development of high volume/high viscosity autoinjectors for rapid and convenient dose delivery. This session will explore the design space of autoinjectors in combination with formulations and primary packaging. Additionally, we will discuss novel solutions for primary packaging and autoinjectors, focusing on sustainability, cost, and usability.
14:00 | High-Dose Drug Delivery: How Far Can Autoinjectors Go?
Iain Simpson, PhD, Director, Global Pharma Segment, Phillips Medisize
14:20 | A Summative Report on Exploratory Studies and Collaborative Developmental Work Toward Understanding Large Volume Subcutaneous Autoinjections
- Gary Calderwood, Senior Product Manager, SHL Medical
- Robert Lindner, PhD, Global Product Manager Bulk and Sterile Cartridges, SCHOTT Pharma
14:40 | Reusability Simplified: The Journey to Develop a Sustainable, Low-Cost Reusable Autoinjector
- Duncan Paterson, Senior Director, Device Development, AstraZeneca
- Michael Herd, MEng, Senior Engineering Consultant, Team Consulting
15:00 | Q&A
C1: How to Prioritize and Optimize Quality Control
Moderator: Brigitte Reutter-Haerle, Vice President Product Management & Marketing, Vetter
Quality control is paramount in injectable manufacturing, and emerging technologies are creating new techniques to optimize it. This session reviews examples of innovative strategies that advance QC capabilities, prioritize timelines, and promote packaging integrity. The presentations will also explore AI applications for injectable manufacturing quality control and how these innovations relate to regulatory compliance in parenteral product manufacturing.
14:00 | Unlocking the Potential of AI Visual Inspection and Data Analytics to Revolutionize Quality Control in Pharmaceutical Manufacturing
Garth Conrad, MBA, VP Quality, Health Solutions, Flex
14:20 | The Impact of Varying Concurrent Transport Hazards on Plunger Movement
Robert Battista, Engineering Manager, Modality Solutions
14:40 | New Solutions for Quality Control of Difficult-to-Inspect Parenterals
Matthias Kahl, PhD, Head of R&D and Lab Services, WILCO AG
15:00 | Q&A
15:30 – 16:30
Networking Break, Tech Talks, and Guided Poster Walk in the Exhibit Hall
15:40 –15:50
Exhibitor Tech Talks
15:40
Sterile Product Introduction and Tech Transfers in a Crowded Market
Kimberly S. Brown, Director, Client Portfolio and Relationship Management, Kindeva Drug Delivery
15:55
Pre-Filled Syringe Considerations for VHP Sterilization
Juha P. Mattlia, MEng, Senior Manager, Technical Services, STERIS Life Sciences
16:10
Integration of Primary Container Solutions with CDMO Services for Biotech Parenteral Drug Products
Jianxiu Zhao, PhD, Senior Technology Development Manager, Terumo
16:30 – 18:00
Concurrent Sessions
A2: Computational Tissue Modeling and Simulation Techniques for Drug Formulations and Injection Devices
Moderator: Philippe Lauwers, Technology Development Director, Terumo Pharmaceutical Solutions
Computational tissue models help build our understanding of injection site pain and the impact of patient, drug formulation, injection device on the overall patient experience.
These digital tools may also minimize the need for extensive clinical studies reducing patient burden and providing valuable time and cost savings to the pharmaceutical industry.
In this session, we will also discuss how simulation tools enhance the performance and reliability of complex engineering systems; ranging from primary container components and injection devices up to automated assembly equipment.
16:30 | Computational Tissue Simulation to Predict Pain, Tolerability, and Acceptability of Drug Formulations and Injection Devices
- Katharina Clitherow, PhD, Principal Device Engineer, GSK
- Joel A. Gresham, Lead Engineer, Crux Product Design
16:50 | Computational Modeling of Large Volume, High-Viscosity Subcutaneous Injections
Scott Lovald, PhD, Senior Managing Engineer, Exponent
17:10 | Application of Advanced Simulation Techniques for Drug Delivery Devices: From Micro to Macro
Tommaso Borghi, Director Product Development - Drug Delivery Systems, Stevanato Group
17:30 | Q&A
B2: Large Volume Subcutaneous Injections (LVSC) Advancements
Moderator: Christian Helbig, Vice President Glass Syringe Business, SCHOTT Pharma AG
Dive into large volume subcutaneous drug delivery advancements. This session provides valuable knowledge to enhance the patient experience, improve adherence, and drive pharmaceutical innovation.
We will focus on the benefits and challenges of permeation enhancers, how on-body injection devices can help to transform delivery larger than 2 mL, and the challenges of overcoming the subcutaneous administration of a small molecule, high viscosity long-acting HIV treatment.
16:30 | Expert Insights into the Development of Large Volume Subcutaneous Drugs with Permeation Enhancers: A Survey Examining Challenges, Alternatives, and Future Directions
Mehul Desai, PharmD, MBA, Vice President, Medical Affairs, Enable Injections
16:50 | Opportunities and Challenges of Large Volume Parenteral Subcutaneous Delivery and How On-Body-Injectors Enable Innovative Medicines
- Hanns-Christian Mahler, PhD, Chief Enablement Officer, ten23 health
- Reto Jost, Director, Category Lead Large Volume Injectors, Ypsomed AG
17:10 | Development of a Small Molecule, High Viscosity, High PH Injectable for HIV Treatment
Scott Nunn, MS, MBA, Director, Device Engineering, Gilead Sciences
Alasdair Young Director, Device Engineering, Gilead Sciences
17:30 | Q&A
C2: Digital Solutions for Self-Injection and Home Use
Moderator: Laurent Jeanmart, PhD, Head of Technical Services, GSK
This session explores the development of digital systems for patient self-administered injections, focusing on the challenges of dealing with regulatory requirements and multiple business partners. We will discuss the integration of combination products like autoinjectors with digital monitoring devices, mobile applications (SaMD), doctor portals, and cloud storage systems. Emphasis will be placed on the need for establishing clear regulatory strategies, QMS boundaries, and roles early in the process.
We will also address the cost considerations of adding connectivity to drug delivery devices, sharing experiences from the consumer tech industry. Additionally, usability studies and clinical feasibility results from a digital health program co-developed by Sidekick Health and Ypsomed will be presented, showcasing the program's success in providing therapy insights, patient education, and support.
Join us for insights into development practices, regulatory strategies, and the potential of digital health programs to enhance self-injection therapy management.
16:30 | Designing Cost-Effective Smart Devices: A Key Hurdle to Success
Hans Jensen, MBA, Business Development Lead, Cambridge Design Partnership
16:50 | Navigating the Complexities in Developing Digital Solutions for Home Use
- Jack Zhang, Associate Director, Digital Product Quality, Bristol-Myers Squibb
17:10 | Exploring Patient Insights: Developing a Digital Health Program for Self-Injection Therapies Through Usability Studies
Guy Shauli, Senior Director Pharma Partnerships, Sidekick Health
17:30 | Q&A
16:30 – 18:30
Mini Training Course: Pharmaceutical Elastomers and Closures
Trainer: Gabrielle Gehron, Technical and Scientific Expert, Datwyler
Pharmaceutical elastomers are commonly applied in the form of stoppers, plungers, and O-rings for parenteral drug-delivery applications. Here, good sealing is an apparent property for effective drug containment; however, there are several other critical attributes that govern the selection of an appropriate elastomeric component for safe and efficacious drug-delivery.
In this training course, you will gain insight into the fundamentals of pharmaceutical elastomers with practical considerations. Industry experts will describe component selection strategies, review manufacturing technologies, component processing and sterilization techniques. There will be a focus to understand the origin of defects and analytical tools applied for their characterization.
19:00 – 22:00
Networking Reception
06:30 – 17:30
Registration Open
07:00 – 08:30
Continental Breakfast
07:00 – 07:50
Pecha Kucha and Pastries – Lightning Sessions
Moderator: Bart E. Burgess, Global Head, Portfolio Strategy and Customer Solutions, SHL Medical AG
PDA's Lightning Presentations will use the Pecha Kucha presentation method, which calls for telling a story using images rather than reading text from slides during a PowerPoint presentation. Each presentation will have 20 slides set to automatically advance after only 20 seconds of commentary per slide for a total talk time of 6 minutes and 40 seconds.
07:00
Introduction to Sessions and Presenters
07:05
Driving Patient Engagement Through the Drug Lifecycle Journey
Adam Shain, VP, Head of Patient Solutions & Government Affairs Lead, Aptar Digital Health
07:12
Drug Delivery Devices: Too Much Innovation Can Kill Innovation
Andrew King, Manager, Design and Innovation, Kymanox
07:19
Preparing General Safety and Performance Requirements (GSPR) Checklist for Single Integral Drug-device Combinations Used in Clinical Development
Yik Kit Kwok, MBA, VPrincipal Scientist, Merck & Co., Inc.
07:26
Revolutionizing Efficiency: AI-Powered Automation as a Tool to Enhance Operational Performance
Patrick Gallagher, Vice President and Head of Polymer Solutions, SCHOTT Pharma
07:33
Sustainability at the Heart of Parenteral Packaging Development and Manufacturing
Audrey Chardonnet, MA, Global Business Development Director, Aptar Pharma
07:40
Using a Statistical Approach for Measurement and Control of Stopper Insertion Depth of Pre-Filled Syringes
Mary A. Johnson, MS, Associate Principal Scientist, Merck & Co., Inc.
08:00 – 09:15
P3: Drug Delivery Platforms – Compare and Contrast Device and Pharma Perspectives
Moderator: Shirish Ingawale, PhD, Director, Device Development, Takeda
Join us for a dynamic presentation and panel session on leveraging device platforms to accelerate development. Hear viewpoints and experiences from both device manufacturers and pharmaceutical industry experts as they discuss strategies, benefits, and challenges in deploying standardized delivery device platforms across multiple drug products. Gain insights into both the challenges encountered and efficiencies gained from such strategies. Learn about the facets of platform development where there are strong synergies between the device and pharma manufacturers, as well as where some potential conflicting drivers may exist.
08:00
Device Manufacturer Perspective
- Jakob Lange, PhD, VP & Head of Account and Business Development, Ypsomed AG
- Bart E. Burgess, Global Head, Portfolio Strategy and Customer Solutions, SHL Medical AG
08:25
Pharma Perspective
- Ronald Forster, PhD, Executive Director, Amgen Inc.
- Jeffrey Givand, PhD, Executive Director, Device and Combination Product Development, Merck
08:50
Q&A
09:15 – 15:45
Exhibit Hall Open
09:15 – 10:15
Networking Break, Tech Talks, and Guided Poster Walk in the Exhibit Hall
09:25 –10:05
Exhibitor Tech Talks
09:25
Flow Beyond Limits: BD Neopak™ XtraFlow™ Glass PFS
Maëlle Douaire, PhD, R&D Segment Lead - Biologics, BD
09:40
When Are Springs the Right Choice? Considerations for Developing Drug Delivery Devices
Paul Draper, MEng, Senior Sector Manager, Medical & Scientific, DCA Design International
09:55
Reference Technology Platforms to Advance Drug Delivery
Barish Banerjee, MBA, Senior Director, Design and Engineering, Head of Customer Success, Health Solutions, Flex
10:15 – 11:45
Concurrent Sessions
A3: Integrated Approaches in Drug-Device Combination Products
Moderator: Shirish Ingawale, PhD, Director, Device Development, Takeda
Integrated approaches in drug-device combination products enhance patient centricity, optimize design and manufacturing, and streamline lifecycle processes. This session explores the integration of Quality by Design, design controls, and risk management, featuring insights from industry experts on ensuring drug-device compatibility. Gain valuable knowledge on innovation, risk management, and ensuring safety and efficacy in pharmaceutical products.
10:15 | Integrating Quality by Design, Design Controls, and Risk Management to Advance Drug-Device Combination Product Development
- Fubin Wu, MS, Co-founder & President, GessNet
- Jiaying Shen, PhD, Distinguished Scientist, Merck, Inc.
10:45 | The Journey of Pioneering a MRNA Vaccine in a PFS
Jason Fernandez, Senior Director Drug Product Development, Moderna
11:15 | Q&A
B3: Unlocking Large Volume Drug Delivery
Moderator: Serkan Oray, PhD, Vice President, Head of Device, Packaging, and Wearable Technologies, UCB Pharma
This session addresses the industry view on Large Volume subcutaneous delivery from multiple perspectives. It challenges the conventional beliefs of pharmaceutical industry professionals on topics such as the balance between delivery volume, speed, and ease of use. Two preclinical modeling approaches illustrate how to overcome preconceptions about large volume delivery. The first covers large volume, viscous, and high-speed administration. The second discusses using a high-volume autoinjector with a permeability enhancer and predicts the impact on clinical injection times.
10:15 | Exploring Clinical Development, Medical Affairs, and Commercial Function Perspectives on Large Volume Subcutaneous Drug Delivery: Insights into Perceptions, Preferences, and Decision-making Drivers
Mehul Desai, PharmD, MBA, Vice President, Medical Affairs, Enable Injections
10:35 | 3D Imaging and Analysis of Large Volume (20ml) Viscous (25cp) Injections with Fast Delivery Rates (10ml/Min) in a Porcine Model: Risks and Opportunities
- Joel A. Gresham, Lead Engineer, Crux Product Design
- Simon J. Dell, Senior Principal Scientist – Device Development Lead, Pfizer R&D UK Ltd
10:55 | Miniature Pig as a Preclinical Model to Predict the Clinical Injection Times of a 10 mL High-Volume Autoinjector (HVAI) with Recombinant Human Hyaluronidase (rHuPH20)
David W. Kang, Director, Innovation, Halozyme, Inc.
11:15 | Q&A
C3: Sustainability as a Key Driver for Medical Device Design, Manufacturing, and Supply Chain
Moderator: Alessandro Morandotti, Director, Products, Proposals, and Technical Account Management, Stevanato Group
Many sustainability practices drive key decision-making on existing and new products. The benefits of sustainability go beyond the lab and extend to the population at large.
This session will review how medical device design, development, manufacturing, and supply chain are interconnected in a sustainable network. Our experts will highlight best practices for reducing unnecessary waste, improving recyclability, and managing resources to leverage sustainable efficiencies.
10:15 | Hidden in Plain Sight? Stored Waste with Large Volume Subcutaneous Infusions and Sustainability Implications
- Madeleine Anderson, Insights Manager, Matchstick
- Ralph Howald, MSc, MBA, Chief Technology Officer, SHL Medical
10:45 | Electronic Labeling: A Leap Forward in Operational Efficiency, Patient Benefit, and Sustainability
Eva M. Garcia, Senior Advisor Global Packaging & Robotics, Eli Lilly and Company
11:15 | Q&A
11:45 – 13:15
Networking Lunch and Tech Talks in the Exhibit Hall
11:55 –13:05
Exhibitor Tech Talks
11:55
From Optional to Essential: Sustainable Secondary Packaging Goals Will Change Manufacturing Requirements
Markus Hoerburger, Product & Service Manager, Vetter Pharma International GmbH
12:10
Electromechanical Autoinjectors – A Flexible and Sustainable Solution for High Viscosity and Large Volume Applications
Bjarne Sørensen, Director, Front End Innpvation, Phillips-Medisize A/S
12:25
Critical Challenges and Proven Strategies: From Vial to Combination Product
Craig Voellmicke, MBA, Director of Sales, Suttons Creek
12:40
Targeted Drug Delivery – A Journey to Precise, Repeatable, and Personalized Drug Delivery
John Burke, Senior Consultant, Team Consulting
12:55
Annex 1 and Advanced Parenteral Closure Solutions
Arnaud Fournier, Regional Market Development Manager, Aptar Pharma
13:15 – 14:45
Concurrent Sessions
A4: Disruptive Obesity Drugs and the Delivery Landscape
Moderator: Galen Shi, PhD, Vice President of Delivery Devices, Eli Lilly and Company
Join us for a glimpse into the future of obesity treatment. The surge in the adoption of injectable obesity treatments is transforming science and society, with 15 million US adults expected to be on such medications by 2030. This session explores current injection devices and the diversified pharmaceutical pipeline. Speakers will also discuss the importance of understanding patient perceptions and device preferences. Initial findings from a recent obesity patients' device preferences study will be shared, revealing insights that drive adherence and treatment outcomes. Discover how innovations in drug delivery devices can meet the needs of diverse patient populations and potentially disrupt the market.
13:15 | Decoding the Obesity Revolution: Mapping Device Needs and Patient Preferences for Emerging Injectable Obesity Therapies
Andreas Schneider, PhD, Head Innovation Delivery Systems, Ypsomed
13:45 | The Disruption Potential of New Injectable Anti-Obesity Therapies on Drug Delivery and Beyond
Mathias J. Romacker, Executive Advisor, Kymanox
14:15 | Q&A
B4: Innovative Drug Delivery: Ocular, Reconstitution, and Intranasal
Moderator: Jeffrey Givand, PhD, Executive Director, Device and Combination Product Development, Merck & Co., Inc.
Discover innovative solutions in drug delivery for challenging routes of administration and complex formulations. This session will delve into the design requirements for intravitreal injections, highlighting novel primary containers and their development challenges. Learn how computational fluid dynamics (CFD) simulations optimize the reconstitution process in autoinjectors for accurate dosing. Additionally, explore the burgeoning field of inhaled drug delivery, particularly soft-mist nasal sprays, as a promising alternative for biologics and mRNA-LNP vaccines. Gain insights from case studies on container characterization, product stability, and manufacturing, and understand the latest advancements in drug delivery technologies.
13:15 |Novel Polymeric Syringes for Intravitreal Syringes for Intravitreal Injections: Challenges and Learnings
- Yuki Takeuchi, MS, Global Product Manager, PLAJEX Terumo Europe nv
- Hanns-Christian Mahler, PhD, CEO, ten23 health
13:35 | Computational Fluid Dynamics Investigation of Lyophilized Drug Product Reconstitution within Dual-Chamber Autoinjectors: Optimizing Device Performance through Simulation
- Matthew J. Hancock, PhD, Principal, Veryst Engineering
- Joseph M. Barakat, PhD, Senior Engineer, Veryst Engineering
13:55 | Next-Generation Pre-Filled Syringe Soft Mist Inhaler: Exploring Potential and Benefits for Delivering Sensitive Biologics and mRNA Vaccines via the Intranasal Route
- Nicolas Buchmann, Chief Technology Officer, Resyca BV
- Jessica Rocco, Product Developer DCS, Stevanato Group
14:15 | Q&A
C4: Transforming Drug Delivery Characterization
Moderator: Christian Helbig, Vice President Glass Syringe Business, SCHOTT Pharma AG
This session covers the transformation of the cartridge filling process from conventional BULK to high-speed RTU filling lines, emphasizing the precision of plunger positioning for multidose applications like GLP1 and insulin. Based on recent study findings, understand the benefits of silicone oil-free pre-filled syringes in maintaining protein stability and device functionality. Additionally, you will gain insights into developing mRNA LNP vaccines using an early-phase, iterative process for delivery system selection, highlighting the collaborative efforts required to ensure formulation readiness and successful product development.
13:15 | Achieve High Precision Filling Accuracy and Plunger Positioning for RTU Cartridges Flex Fillers with an Innovative Technical Concept Tailored for the Rising GLP1 (Insulin) Market
- Dominique P. Bauert, Head of Business Development, SCHOTT Pharma
- Thorsten Meiser, Technical Sales Manager Turnkey, OPTIMA Packaging Group GmbH
13:35 | Silicone Oil Free Pre-Filled Syringe as a New Type of Primary Container with Various Modalities/Formulations for Combination Product
Kaitlin Wang, PhD, Associate Scientist - Postdoctoral Fellow, Merck & Co., Inc.
13:55 | Advancing sa-mRNA-LNP Vaccine Development: A Collaborative Approach to Drug-Device Combination Product Development
Claire Brunet, PhD, R&D Innovation Leader, Becton Dickinson
14:15 | Q&A
14:45 – 15:45
Networking Break, Tech Talks, and Guided Poster Walk in the Exhibit Hall
14:55 –15:20
Exhibitor Tech Talks
14:55
A Systems Engineering Approach to Combination Product Development for Successful Commercialization
Kayla Kaspar, MS, Director of Combination Products Technology Development and Site Operations, ZebraSci, BD Medical - Pharmaceutical Systems
15:10
Why Next-Generation Syringe Fill Technology Matters for Your Product
Dave Powell, VP of Business Development, Grand River Aseptic Manufacturing
15:45 – 17:10
P4: How Cross-Industry Collaboration Can Boost Sustainability
Moderator: Alessandro Morandotti, Drug Containment Solutions Product Development Director Stevanato Group
Multiple tools, technologies, and partnerships deliver sustainable solutions for developing new products and managing a portfolio of legacy products in the pharmaceutical sector. This session explores some of these technologies and opportunities, including portfolio choices and the interplay/conflict between cost, ergonomics, sustainability, and brand value.
Considering the circular economy and cross-industry collaboration, our discussion will also cover the critical need for cross-sector partnerships (e.g., pharma and device industry). Speakers will address the imperative for standardization to facilitate circularity and strategies to expedite the industry's sustainable transformation. They will also chart a course towards patient-centric products that align with environmental stewardship.
15:45
A Journey Toward Sustainability for a Mid-Cap Pharma
Serkan Oray, PhD, Vice President, Head of Devices, Artwork & Packaging, UCB Pharma
16:10
Approaches to Injection Device Design and Manufacture That Can Simultaneously Improve Both Device Sustainability and Supply Chain Robustness
Rob Veasey, MSc, Senior Manager, Medical & Scientific, DCA Design International
16:35
Q&A
17:00
Closing Remarks from Conference Co-Chairs
Location and Travel
Venue Details and Accommodations
PLEASE READ PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.
Conference Venue & Hotel Accommodations
Phoenix Convention Center - South Building
33 S 3rd StreetPhoenix, AZ 85004, United States
In Greater Phoenix, innovation is a way of life. Since ancient times, the Sonoran Desert has evoked inspiration, adaptation, collaboration, and innovation. This spirit is an indelible part of the identity and inspires the approach to agriculture, technology, sustainability, hospitality, education, medicine, business and so many other aspects that continue to shape Phoenix's future.
The result? Business is booming in the nation’s fifth-largest city. Technological and software companies are putting down roots at a rapid pace. Leading minds in energy, medicine, transportation, and other industries see Phoenix as a landscape for turning cutting-edge ideas into tools and products that the world benefits from!
Additional Hotel Information
Renaissance Phoenix Downtown (HQ)
Westin Downtown Phoenix
Residence Inn Phoenix Downtown
Courtyard Phoenix Downtown
All hotels are currently SOLD OUT at the group rate. For additional availability, please reach out to each hotel directly.
Cancellation PolicyIndividual reservations cancelled within seventy-two (72) hours prior to arrival will forfeit one night's room deposit. Individuals will be responsible for payment of their own cancellation fees.
How to Get Here
Registration
Pricing Options
Standard Registration
Register after 28 August 2024
Member Price
$2,895GovernmentMember Only
$995
Health AuthorityMember Only
$995
Early Career ProfessionalMember Only
$1,495
StudentMember Only
$695
AcademicMember Only
$995
Non-Member
$3,295
GROUP REGISTRATION DISCOUNT: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.
GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.
CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].
Presenters
Meet Our Presenters
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Barish Banerjee, MBA
Flex
Senior Director, Design and Engineering, Head of Customer Success, Health Solutions
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Kayla Kaspar, MS
ZebraSci, BD Medical – Pharmaceutical Systems
Director of Combination Products Technology Development and Site Operations
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Agata Pczycka, MSc Eng, DipPkgTech, GradIMMM
AstraZeneca
Principal Engineer, Packaging Development & Technology
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Andrea Redd
Eli Lilly and Company
Associate Vice President, Global Regulatory Affairs, Drug Device Delivery
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Promotion and Press
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Diamond
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Media Partners
Become a Sponsor and/or Exhibitor
Amplify Your Presence and Reach Your Customers!
Drive innovation and connect with a targeted audience of industry leaders at the world's premier pre-filled syringe and injection device conference. Sponsorship opportunities offer unparalleled brand visibility, networking with key decision-makers, and the chance to position your company at the forefront of this dynamic field.
Become a SponsorPut your cutting-edge technologies and solutions in front of a global audience of Drug Delivery professionals. The conference's interactive exhibit hall provides the perfect platform to connect with potential customers, generate leads, and forge valuable partnerships. Don't miss this opportunity to showcase your expertise and propel your business forward.
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