Dear valued member,
Welcome to Day Two of the PDA Universe!
Yesterday was a powerful opening day! The presenters represented a fusion of technical expertise, scientific research, case studies, innovation finalists, human-factor design and storytelling to an attentive international audience.
A connective thread was the high level of science-based decision-making and an understanding of the human factor in product development. As Bart Burgess, Global Head of Portfolio Strategy and Customer Solutions at SHL Medical AG said in his session, “We’re all dealing with patients who have a condition they don’t want. Our jobs are to ease the burden and make their lives easier.”
And on day one, our presenters reflected that theme with thoughtful, deliberate and expert guidance and recommendations.
Winning Teams
But first, congratulations to the Innovation Award winning team, Joel A. Gresham, Lead Engineer at Crux Product Design and Simon J. Dell, Senior Principal Scientist – Device Development Lead at Pfizer. Their innovation, 3D Imaging and Analysis of Large Volume (20mL) Viscous (25cP) Injections with Fast Delivery Rates (10mL/min) in a Porcine Model: Risks and Opportunities was inspired because during the evaluation of large volume injection devices for a plethora of new drug products, they were coming up against a common theme.
Most device manufacturers had very limited knowledge of ‘how big and fast’ the safe volumes and injection rates were. There was therefore no evidence for the safety and practicality of large volume injectables for patients. They believe their innovation help the industry because their data set a benchmark for the safe and practical design space for large-volume injectables, providing indications of required user forces, device specifications, drug-tissue interactions and bleb/wheal formation. They also evaluated the most significant device and formulation design parameters affecting these performance metrics.
And, also, congratulations to the Partnership Innovation Award teammates Duncan Paterson, MSc, MBA, Senior Director, Device Development at AstraZeneca and Michael Herd, MEng, Senior Engineering Consultant at Team Consulting. The AstraZeneca Reusable Autoinjector platform is designed to meet a key industry challenge – creating a reusable parenteral drug delivery device that is both low-cost and sustainable, while offering exceptional usability and safety.
The device, developed by AstraZeneca with support from Team Consulting, features a fully mechanical reusable mechanism that is paired with a low-cost, single-use cassette, removing the need for carbon-costly electronic components typically found in other reusable systems.
With a highly optimized user-centered design and intuitive use steps, it is set to offer a novel approach to the reusable autoinjector market. Duncan and Michael were inspired for this project by a perceived gap in the reusable autoinjector landscape for a simple, low-cost and sustainable device to meet the needs of products intended for highly competitive or low-income markets, and to minimize environmental impact.
Explore the Winners and the Finalists>
High-Level Thought Leadership
The opening plenary featured two strong presenters who advocated for innovation in a regulatory environment that may not be changing at the same speed as the industry. The challenges and frustrations of moving the industry forward with breakthrough product development and testing platforms within a slower-moving regulatory environment are real and present.
There is no better way to get an audience’s attention than by sharing a personal experience that puts the challenges of bridging science, development and the human factor into perspective. And that’s what Andrea Redd, Associate Vice-President, Global Regulatory Affairs, Drug Delivery and Combination Products at Eli Lilly and Company did in sharing her story as a Type 1 Diabetes patient and the journey she has been on since he was diagnosed at ten years old. Andrea presented the panoramic evolution of delivery systems over the past decades as a clear reflection of how the human factor is so critical in the success of any product development and delivery.
Desiree Crisolo, Sr. Director, Head of Global Regulatory CMC Policy and Intelligence at Biogen reviewed recent efforts to make platform strategies for combination products a viable option. More widely utilized in the UK, platform strategies are gaining a toehold in the US. Integral to a successful bridging strategy is a clearly defined approach for leveraging the platform with prior knowledge. Then develop a technology that supports the current and future platform. Next, testing should account for the range of potential drug products and users. And finally, be intentional with the documentation of the platform to streamline future development efforts.
The second plenary focused on three research studies on large-volume injectables. From reviewing the pipeline of new products to the myths and realities of patient pain, the panel was a fast-track canvas of three intriguing studies. Patient pain was a theme that stressed the human factor in product development and delivery. What causes pain? It’s a combination of physiological and emotional aspects, and interestingly, patients express more pain in anticipating an injection than they do when actually getting the injection.
The robust and thoughtful Q/A included a positive and optimistic Stage 4 Breast Cancer patient who weighed in on the realities of living with daily injections and therapies. As a side note, a video of a 30-second injection on a patient’s belly dramatized the large-volume injectable reality.
Field Report Selected Highlights from Afternoon Sessions
The concurrent sessions were deep dives into research, technical innovations and novel approaches.
The human factor is a hinge point to successful product research and development. Anecdotally, the human factor in product usability and design can trigger larger problems as significant as impacting the supply chain.
An afternoon track focused on patient-centric innovations ranging from new product packaging to comprehensive data-driven research and M&A. There are factors organizations can control and then there are other unexpected elements, all of which impact the human factor.
There is power in partnerships articulated by a team presentation with Agata Pczycka, Principal Engineer, Packaging Development & Technology at AstraZeneca and Lucy Baldwin, Head of Research & Strategy at Kinneir Dufort a SteriPack Company. The case for holistic design thinking for new packaging is amplified by gathering meaningful intelligence from patients and multidisciplinary experts.
One of the key takeaways is the value of seeing how patients use products in their own homes, and with a rich photographic library from patients, it’s clear to see how to move from Zip-Lok bags to well-designed systems.
Enrica Papi, Device Engineering Manager, Human Factors at GSK presented her innovation award entry, Quantification of User Inputs During Injection Device Use: An Anthropometric Human Factors Study with an example of how to use comprehensive data to reveal solutions for self-administered devices for patients with dexterity issues. She was inspired by her interest in combining objective evidence with patients’ feedback to find optimal solutions to meet user needs. She says that technology can enhance our understanding of human behavior and better inform current clinical practice and treatment provision.
Enrica says most industries rely on published anthropometric data to establish the appropriateness of devices yet are limited by data that are not relatable to actual device use. Her approach provides a framework to capture data over device use to fully quantify the behavior.
Esther Foo, PhD, Senior Scientist at Merck covered an often-overlooked situation of how the human factor team can play a valuable role in M&A. She offered a comprehensive diagnosis of how to make a successful product acquisition. Financial considerations aside, product acquisition integration can be a challenge with unanticipated implications.
How do you embed operational and cultural aspects? Where is the product in its life stage of product development, pre-trial or en route to commercial?
Digital simulations drive speed to market, product efficiencies, unravel complexities and deliver cost savings. The industry is making investments in digital tech to move the regulatory effort forward.
The session on tissue modeling and simulation techniques for drug formulations and injection devices presented innovative models to help build our understanding of a range of real-life pain points.
The presentations included two studies; one using simulation tools on physics-based inspection modeling based on pain metrics by Katharina Clitherow, PhD, Principal Device Engineer at GSK and Joel A. Gresham, Lead Engineer at Crux Product Design; and the other from Scott Lovald, PhD, Senior Managing Engineer at Exponent who aggregates study data to develop computational models that he describes in tech terms as “dumber and broader” to predict tissue pressure under specific situations.
Tommaso Borghi, Director of Product Development of Drug Delivery Systems at Stevanato Group recalled the impressive speed of sequencing the covid virus as inspiration on how we can apply these lessons to medical devices and drug delivery systems.
He asked, “What if we cut development times in half?” The simulation revolution from physical to digital is powered by rapid iteration and testing as building blocks. Using digital twins and simulation tools to fine-tune prototypes is a game changer for development and production.
Connections and Mementoes
The expo hall was buzzing with meetups, tech talks and poster presentations. The connections continued during the reception where attendees modeled their cowboy hats and southwestern style in a festive evening wrap-up to the day of intense presentations. Pictures and videos from last night will be posted to the on-site attendee webpage. See if your image found itself on the page.
You can get your own custom-printed, limited-edition PDA Week T-shirt at the PDA booth #918 in the exhibit hall and move fast before they are gone! You can also learn how to download PDA Technical Report No. 68 – all for free.
And don’t forget to stop by the Meet the Presenters Booth to get your questions answered after the sessions, stop by the PDA Pro Store in the lobby to review the PDA Technical Reports you need in your toolbox, visit the on-site attendee webpage, and take your selfies at our selfie spots and post to social media using the #PDAuniverse or#PDAups hashtags.
Don't forget to visit and view the conference posters online>
Sneak Preview for Today
Don’t miss today’s plenaries on Drug Delivery Platforms – Compare and Contrast Device and Pharma Perspectives.
Join us for a dynamic presentation and panel session on leveraging device platforms to accelerate development with a device manufacturing perspective contrasted with the pharma perspective.
The closing session focuses on How Cross-Industry Collaboration Can Boost Sustainability. The session will explore some of these technologies and opportunities, including portfolio choices and the interplay/conflict between cost, ergonomics, sustainability, and brand value.
Have a terrific second day throughout PDA’s Universe!
Please seek out our fellow conference committee members and offer your thanks for their hard work in putting together such an impactful and substantive conference program.
Sincerely,
Alessandro Morandotti, Stevanato Group, Drug Containment Solutions Product Development Director, Co-Chair
Jakob Lange, PhD, Ypsomed AG, VP & Head of Account and Business Development, Co-Chair
