PDA Universe of Pre-Filled Syringes and Injection Devices Conference 2024

PDA Universe of Pre-Filled Syringes and Injection Devices Conference 2024

Injecting Innovation into Drug Delivery

22 Oct - 23 Oct 2024
Phoenix Convention Center - South Building
Phoenix, AZ

Educational Sessions | Training Courses | Networking Opportunities | Exhibit Hall | Drug Delivery Innovation Awards

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Highlighted Presenters

Key Presenters
  • Ronald Forster, PhD

    Amgen

    Executive Director

    Read Bio
  • Phil Green, PhD

    Chesapeake Pharma

    President

    Read Bio
  • David Kang

    Halozyme Therapeutics

    Director, Drug Delivery

    Read Bio
  • 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
  • Jakob Lange, PhD

    Ypsomed AG

    VP & Head of Account and Business Development

    Read Bio
  • Alessandro Morandotti

    Stevanato Group

    Drug Containment Solutions Product Development Director

    Read Bio
  • Theresa Bankston, PhD

    Becton Dickinson

    VP Combination Products & Capabilities

    Read Bio
  • Bart Burgess

    SHL

    Global Head, Portfolio Strategy and Customer Solutions

    Read Bio
  • Jeffrey Givand, PhD

    Merck

    Executive Director, Device and Combination Product Development

    Read Bio
  • Christian Helbig

    SCHOTT Pharma

    Vice President Glass Syringe Business

    Read Bio
  • Shirish Ingawale, PhD

    Takeda

    Director, Device Development

    Read Bio
  • Laurent Jeanmart, PhD

    GSK

    Head of Technical Services

    Read Bio
  • Jakob Lange, PhD

    Ypsomed AG

    VP & Head of Account and Business Development

    Read Bio
  • Philippe Lauwers

    Terumo Pharmaceutical Solutions

    Technology Development Director

    Read Bio
  • Alessandro Morandotti

    Stevanato Group

    Drug Containment Solutions Product Development Director

    Read Bio
  • Serkan Oray, PhD

    UCB Pharma

    Vice President, Head of Devices, Artwork & Packaging

    Read Bio
  • Brigitte Reutter-Haerle

    Vetter

    Vice President Product Management & Marketing

    Read Bio
  • Galen Shi, PhD

    Eli Lilly and Company

    Vice President of Engineering - Delivery Devices

    Read Bio
  • Dominik Ziegler, MSc

    Novartis

    Executive Director Device Technology Device Technology Solution Center

    Read Bio

Schedule

Discover What's Happening Each Day
Day 122 Oct Day 223 Oct Training21-24 Oct

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 Street
Phoenix, AZ 85004, United States
Phoenix Convention Center - South Building

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 Policy
Individual 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
By Air The closest airport to the Phoenix Convention Center - South Building is the Phoenix Sky Harbor International Airport (PHX - approx. 4 miles/6 km).
By Car The Phoenix Convention Center - South Building is located at 33 S 3rd Street, Phoenix, AZ 85004.

Registration

Pricing Options

Standard Registration

Register after 28 August 2024

Member Price

$2,895

GovernmentMember Only

$995

Health AuthorityMember Only

$995

Early Career ProfessionalMember Only

$1,495

StudentMember Only

$695

AcademicMember Only

$995

Non-Member

$3,295

See Qualifying Criteria for Member Types.

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
  • Madeleine Anderson

    Matchstick LLC

    Insights Manager

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  • Lucy Baldwin

    Kinneir Dufort, a SteriPack Company

    Head of Research & Strategy

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  • Barish Banerjee, MBA

    Flex

    Senior Director, Design and Engineering, Head of Customer Success, Health Solutions

    Read Bio
  • Joseph Barakat, PhD

    Veryst Engineering

    Senior Engineer

    Read Bio
  • Robert Battista

    Modality Solutions

    Engineering Manager

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  • Dominique Bauert

    SCHOTT PHARMA AG & CO. KGAA

    Read Bio
  • Photo coming soon

    David Bonnett

    Eli Lilly and Company

    Director of Engineering - Risk Management

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  • Tommaso Borghi, PhD

    Stevanato Group

    Director Product Development - Drug Delivery Systems

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  • Kimberly Brown

    Kindeva Drug Delivery

    Director, Client Portfolio & Relationship Management

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  • Claire Brunet

    BD

    R&D Staff Scientist

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  • Nicolas Buchmann, PhD

    Resyca BV

    Chief Technology Officer

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  • Bart Burgess

    SHL Medical

    Global Head, Portfolio Strategy and Customer Solutions

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  • John Burke

    Team Consulting

    Senior Consultant

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  • Gary Calderwood

    SHL Medical

    Senior Product Manager

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  • Audrey Chardonnet, MA

    Aptar Pharma

    Global Business Development Director

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  • Katharina Clitherow, PhD

    GSK

    Principal Device Engineer

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  • Garth Conrad, MBA

    Flex

    VP Quality, Health Solutions

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  • Photo coming soon

    Desiree Crisolo

    Genentech

    Principal Regulatory Program Director

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  • Simon Dell

    Pfizer

    Senior Principal Scientist – Device Development Lead

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  • Mehul Desai, PharmD, MBA

    Enable Injections

    Vice President, Medical Affairs

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  • Maëlle Douaire, PhD

    BD

    R&D Segment Lead - Biologics

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  • Paul Draper, MEng

    DCA Design International

    Senior Sector Manager, Medical & Scientific

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  • Flora Felsovalyi, PhD

    Lonza

    Associate Director

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  • Jason Fernandez

    Moderna

    Senior Director Drug Product Development

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  • Esther Foo, PhD

    Merck & Co., Inc.

    Associate Principal Scientist

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  • Ronald Forster, PhD

    Amgen

    Executive Director

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  • Arnaud Fournier

    Aptar Pharma

    Regional Market Development Manager

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  • Patrick Gallagher, MA

    SCHOTT Pharma

    Vice President and Head of Polymer Solutions

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  • Gabrielle Gehron, MS

    Datwyler

    Technical & Scientific Expert

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  • Jeffrey Givand, PhD

    Merck

    Executive Director, Device and Combination Product Development

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  • Phil Green, PhD

    Chesapeake Pharma

    President

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  • Joel Gresham

    Crux Product Design

    Lead Engineer

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  • Matthew Hancock, PhD

    Veryst Engineering

    Principal

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  • Michael Herd, MEng

    Team Consulting

    Senior Engineering Consultant

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  • Markus Hoerburger

    Vetter Pharma International GmbH

    Product & Service Manager

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  • Ralph Howald, MSc, MBA

    SHL Medical

    Chief Technology Officer

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  • Hans Jensen, MBA

    Cambridge Design Partnership

    Business Development Lead

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  • Mary Johnson, MS

    Merck & Co., Inc.

    Associate Principal Scientist

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  • Reto Jost, MSc

    Ypsomed AG

    Director, Category Lead Large Volume Injectors

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  • Matthias Kahl

    WILCO AG

    Head of R&D and Lab Services

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  • David Kang

    Halozyme Therapeutics

    Director, Drug Delivery

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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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  • Andrew King

    Kymanox

    Manager, Design and Innovation

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  • Yik Kit Kwok, MBA

    Merck & Co., Inc.

    Principal Scientist

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  • Jakob Lange, PhD

    Ypsomed AG

    VP & Head of Account and Business Development

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  • Mitchell Lewis

    Modality Solutions

    Consulting Engineer

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  • Robert Lindner, PhD

    SCHOTT Pharma

    Global Product Manager Bulk and Sterile Cartridges

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  • Scott Lovald, PhD

    Exponent

    Senior Managing Engineer

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  • Hanns-Christian Mahler, PhD

    ten23 health

    CEO

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  • Vince Masciopinto

    SHL Medical

    Director, Customer Solutions

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  • Juha Mattila, MEng

    STERIS Life Sciences

    Senior Manager, Technical Services

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  • Thorsten Meiser, MS

    OPTIMA packaging group GmbH

    Technical Sales Manager Turnkey

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  • Scott Nunn, MS, MBA

    Gilead Sciences

    Senior Director, Packaging and Labeling Development

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  • Serkan Oray, PhD

    UCB

    Vice President, Head of Devices, Artwork & Packaging

    Read Bio
  • Enrica Papi, MSc, PhD

    GSK

    Human Factors Manager

    Read Bio
  • Duncan Paterson, MSc, MBA

    AstraZeneca

    Senior Director, Device Development

    Read Bio
  • Agata Pczycka, MSc Eng, DipPkgTech, GradIMMM

    AstraZeneca

    Principal Engineer, Packaging Development & Technology

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  • Dave Powell

    Grand River Aseptic Manufacturing

    VP of Business Development

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  • Omar Rahman, PharmD, MPH

    Enable Injections

    Medical Director, Medical Affairs

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  • Andrea Redd

    Eli Lilly and Company

    Associate Vice President, Global Regulatory Affairs, Drug Device Delivery

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  • Philipp Richard, MSc, MBA

    Ypsomed AG

    Account & Business Development Manager

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  • Jessica Rocco, MD

    Stevanato Group

    Technical Leader - Product Development DCS

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  • Mathias Romacker

    Kymanox

    Executive Advisor

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  • Andreas Schneider

    Ypsomed AG

    Head Innovation Delivery Systems

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  • Adam Shain

    Aptar Digital Health

    VP, Head of Patient Solutions & Government Affairs Lead

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  • Guy Shauli

    Sidekick Health

    Senior Director Pharma Partnerships

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  • Jiaying Shen, PhD

    Merck & Co., Inc.

    Distinguished Scientist

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  • Galen Shi, PhD

    Eli Lilly and Company

    Vice President of Engineering – Delivery Devices

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  • Iain Simpson, MBA, PhD

    Phillips Medisize

    Director, Global Pharma Segment

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  • Photo coming soon

    Gurmeet Singh, MBA

    West Pharmaceutical Services

    Senior Director

    Bio Coming Soon
  • Bjarne Sørensen

    Phillips-Medisize A/S

    Director, Front End Innovation

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  • Katsuyuki Takeuchi, MS

    Terumo Pharmaceutical Solutions

    Global Product Manager, PLAJEX

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  • Kevin Trivett

    Eli Lilly and Company

    Senior Vice President – Devices & Assembly Packaging,

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  • Rob Veasey, MSc

    DCA Design International

    Senior Sector Manager, Medical & Scientific

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  • Craig Voellmicke, MBA

    Suttons Creek

    Director of Sales

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  • Daniel Waites

    Enable Injections

    Director, Research & Development

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  • Kaitlin Wang, PhD

    Merck & Co., Inc.

    Associate Scientist – Postdoctoral Fellow

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  • Fubin Wu, MS

    GessNet

    Co-founder & President

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  • Alasdair Young, MPhil

    Gilead Sciences

    Senior Director, Device Engineering

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  • Jack Zhang

    Bristol-Myers Squibb

    Associate Director, Digital Product Quality

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  • Jianxiu Zhao, PhD

    Terumo

    Senior Technology Development Manager

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