Home
Prefilled Syringes West Coast
June 10 - June 11, 2024
Prefilled Syringes West Coast

SAE Media Group’s 8th Annual Conference
Pre-Filled Syringes West Coast
10th - 11th June 2024, CA, USA
-------------------------------------------------------------------------
SAE Media Group’s 8th Annual Pre-Filled Syringes West Coast Conference will be back for 2024 in the West Coast to bring together device developers, biotech and big pharma. This year’s conference will explore the exciting advances in the combination product drug delivery space and a future outlook exploring how pharma, device developers and regulators can work together to encourage innovation.

As part of SAE’s leading injectable drug delivery conferences this is a must attend event; not only will the conference bring you key insights to enhance your drug device portfolio, but it will also give you the opportunity to network with key industry players. We hope to welcome you in June 2024!
 

FEATURED SPEAKERS

Aaron Sundman

Aaron Sundman

Innovator in RFID Technology, Business Leader, CCL Label inc
Amin Sedighiamiri

Amin Sedighiamiri

Director, Device Development, AstraZeneca
Bidisha Nandi

Bidisha Nandi

Human Factors Engineer, Regeneron Pharmaceuticals
Frank Pillsbury

Frank Pillsbury

Technical Manager, Datwyler
Jian Liu

Jian Liu

Sr Principal Scientist, Amgen
Kinsuk Shah

Kinsuk Shah

Sr. AD Combination Product Steward, Boehringer Ingelheim
Landon Goldfarb

Landon Goldfarb

Biomedical Market Manager, Instron
Li-Chun Tsou

Li-Chun Tsou

Director, Global Device Engineering and Technologies, GSK
Liz Wellwood

Liz Wellwood

Director of Quality Services, ClariMed
Marie Printz

Marie Printz

Executive Director, Bioanalytical & Nonclinical Sciences, Halozyme Therapeutics
Mark Hassett

Mark Hassett

Vice President of Business Development, Credence MedSystems
Masashi Miura

Masashi Miura

Researcher, Mitsubishi Gas Chemical Company, Inc
Mitch  Zhao

Mitch Zhao

Engineering Fellow, JnJ Innovative Medicine
Monica Swinney

Monica Swinney

Sr. Director, New Product Planning & Drug Delivery Innovation, Gilead Sciences
Natalie Abts

Natalie Abts

Head of Human Factors Engineering, Genentech
Paul Upham

Paul Upham

Head, Smart Devices, Roche-Genentech
Phil Estepa

Phil Estepa

Executive Director, Pharmaceutical Development, Ionis Pharmaceuticals
Saher Bishara

Saher Bishara

Associate Director of Human Factors, ClariMed
Sherri Biondi

Sherri Biondi

Executive Director Device Development, AstraZeneca
Stephanie Smith

Stephanie Smith

Principal Human Factors Engineer, Genentech
Tina Rees

Tina Rees

Associate Director, Human Factors, Regeneron Pharmaceuticals
Wenjing Wang

Wenjing Wang

Associate Principal Scientist in Regulatory Affairs, Merck & Co

Aaron Sundman

Innovator in RFID Technology, Business Leader, CCL Label inc
Aaron Sundman

Aaron Sundman is a trailblazing RFID innovator with over 25 years in technology and business efficiency. Beginning as a software developer, his exploration of RFID technology led to significant industry advancements. At CCL eAgile, he merges technical expertise with business strategy, enhancing supply chains and inventory management. As a self-described techno-optimist he sees this technology as the way to help the entire world create a safer and more efficient pharmaceutical supply chain.

Amin Sedighiamiri

Director, Device Development, AstraZeneca
Amin Sedighiamiri

Amin Sedighiamiri is Director of Device Development at AstraZeneca, where he is leading cross-functional product teams to develop and bring drug-device combination products to market. Additionally, he spearheads the evaluation and integration of digital solutions for injectable biologics, with the aim of improving the overall patient experience and adherence. Before joining AstraZeneca, Amin worked in Delivery, Device and Connected Solutions organization of Eli Lilly and Company, where he led design and development of connected solutions for drug delivery devices. He also serves as a board member at the Society of Plastics Engineers – Medical Plastics Division, which aims to share technical knowledge within the scientific and engineering community regarding medical uses of plastics. Amin holds BSc, MSc and PhD in Mechanical Engineering and over 13 years of experience in product innovation and commercialization across multiple industry segments.
 

Bidisha Nandi

Human Factors Engineer, Regeneron Pharmaceuticals
Bidisha Nandi

Bidisha Nandi is a Human Factors Engineer at Regeneron where she has been working for two years on a variety of combination products. Prior to Regeneron, she completed a Master’s at Duke University in Biomedical Engineering, specializing in Medical Device Design. She was born and raised in Houston, TX until her move up to upstate New York.

Chris Muenzer

Vice President Innovation and Development, Haselmeier GmbH
Chris Muenzer

Chris Muenzer is the Vice President of Innovation and Development at Haselmeier. He leads a team of experts that create customized drug delivery systems for pharmaceutical and biotechnology companies. He has over 18 years of experience in the pharmaceutical and medical device industry, having worked at Novartis, Roche, and the Battelle Memorial Institute. During this time he has worked at all stages of device development from initial concept, engineering development, clinical trials, and launch.
Mr. Muenzer holds a BSME from Carnegie Mellon University in Pittsburgh, Pennsylvania in the US. He is also the inventor of several patents and is a frequent contributor to industry conferences and ISO standards.
 

Frank Pillsbury

Technical Manager, Datwyler
Frank Pillsbury

Frank Pillsbury graduated with a BS in Mechanical Engineering from Widener University in Chester, PA. After finishing his undergraduate studies in 2000, he joined Gerresheimer Glass where he served as a Process Engineer and Project Engineer. In 2020 Frank worked for Nipro Glass as a Technical Customer Support Engineer before joining Datwyler.

Frank has over 20 years of experience in the primary parenteral packaging industry and joined Datwyler in 2022 as a Technical Key Account Manager in North America working side-by-side with Key Account and Commercial Development Managers, providing product and process support as well as technical advice concerning Datwyler’s products, services and material selection for new projects.

 

Jian Liu

Sr Principal Scientist, Amgen
Jian Liu

Jian Liu is a Sr Principal Scientist in Process Development at Amgen, where he leads a team of scientists developing and executing Extractables and Leachables strategies for process components and primary container closure systems. Jian has over 15 years of experience as an analytical scientist developing, qualifying, validating methods for both small and large molecules testing. His current roles and responsibilities also support forensics, customer complaints, NC investigations, etc. Jian holds a PhD in Analytical Chemistry from Purdue University.

Kinsuk Shah

Sr. AD Combination Product Steward, Boehringer Ingelheim
Kinsuk Shah

Kinsuk Shah is currently Sr. AD, Combination Product Steward at Boehringer Ingelheim, responsible for device lifecycle management and strategy for Cyltezo. Mr. Shah is accountable for continuing development and oversight of CP manufacturing + supply, leading an interdisciplinary team of internal SMEs (e.g., drug product, packaging, final assembly, device, quality). Prior to joining BI, Mr. Shah was Director of Device Development at Viridian Therapeutics, responsible for device strategy and development, including establishing internal and external capabilities within the device space, evaluation and selection of wearable and auto-injector devices. Mr. Shah has over 10 years of drug-device combination product experience from Janssen, West and Alexion. Prior to Viridian, Mr Shah was at Alexion, where he was responsible for Strategy and Program Management for ongoing device dependent programs. At West Mr Shah was the Business Development lead for the SmartDose and SelfDose platforms, successfully partnering with multiple pharmaceutical companies in establishing joint combination product programs for each product.

Landon Goldfarb

Biomedical Market Manager, Instron
Landon Goldfarb

Landon Goldfarb is the Biomedical Market Manager at Instron where he works with the world's leading biomedical companies to implement, improve, expand, and automate their static mechanical testing. Recently, he has been focusing on identifying the unique requirements associated with injectable devices and working to develop solutions designed to make testing simpler and more efficient.

Li-Chun Tsou

Director, Global Device Engineering and Technologies, GSK
Li-Chun Tsou

Brought 25+ years of drug delivery device experiences to lead a dynamic and growing team across geographic boundaries. Expand global commercialization footprint, stay in control via disciplined quality-by-design principles and design-control processes, ensure licensure through regulatory and quality compliance and freedom-to-operate. Most importantly, collaborate to win by building win-win alliance and partnership to get ahead of disease through data-driven influence and shoulder-to-shoulder engineering knowledge to develop the extended-release device platforms for our patients.

Liz Wellwood

Director of Quality Services, ClariMed
Liz Wellwood

Liz Wellwood is the Director of Quality Services at ClariMed, a human-centered medical device development and regulatory services company. With over 12 years of quality expertise in the medical device industry, Liz brings a wealth of knowledge and experience to her role. Her passion lies in supporting medical device startups, helping them navigate the complex landscape of quality systems, regulatory compliance, and operational efficiency.

At ClariMed, Liz plays a crucial role in implementing and maintaining robust quality systems, ensuring that products meet the highest standards of safety and effectiveness. She regularly conducts strategic planning sessions and audits, including those with notified bodies, internal teams, and suppliers, to identify areas for improvement and maintain regulatory compliance.

Throughout her career, Liz has demonstrated a strong commitment to integrating human factors engineering and user experience design into medical device product development. Her expertise and dedication to quality management make her an invaluable asset to ClariMed and its clients, as she consistently delivers solutions that prioritize patient safety and user experience while ensuring regulatory compliance.
 

Marie Printz

Executive Director, Bioanalytical & Nonclinical Sciences, Halozyme Therapeutics
Marie Printz

Marie is the Executive Director of Bioanalytical and Nonclinical Sciences at Halozyme and has 15 years of experience in the subcutaneous delivery of drugs. She supports nonclinical, clinical and commercial programs that utilize Halozyme’s Enhanze drug delivery and autoinjector technologies. A bioanalytical scientist by training, she’s authored a number of publications focused on SC drug pharmacology and immunogenicity assessment. Prior to Halozyme, she spent 2 decades in the gene therapy industry in bioanalytical and analytical/CMC roles.

Mark Hassett

Vice President of Business Development, Credence MedSystems
Mark Hassett

Mark Hassett, Vice President of Business Development, Credence MedSystems, Inc.
Mr. Hassett has 30+ years’ experience in the medical device industry. In that time, he has functioned as Global VP Sales, Marketing, and Business Development for IVAC Corporation, Block Medical, Medication Delivery Devices, Safety Syringes, Venetec Int’l, Unilife Medical, and ROVI Contract Manufacturing (EU).
His responsibilities included commercialization of infusion pumps, injectable devices (PFS), wearable devices, and autoinjectors.
He has injectable device experience in multiple markets to include, acute care, alternate site, and more specifically for Pharmaceutical and Biotech the last 20 years.
He holds a BS degree from Georgia State University in Atlanta, GA.

Masashi Miura

Researcher, Mitsubishi Gas Chemical Company, Inc
Masashi Miura

Mr. Masashi Miura is a researcher of Hiratsuka Research Laboratory.
He gained a Diploma in Science in 2020 and a Master Degree of Science in 2022 from Osaka University.
In University, he majored in applied chemistry and studied crystalline porous materials.
Since April 2022 he has been working for Mitsubishi Gas Chemical Company, Inc.
Since May 2022 he has joined a development team of multilayer plastic vial & syringe for biologics.
 

Mitch Zhao

Engineering Fellow, JnJ Innovative Medicine
Mitch  Zhao
  • 19 years at JNJ
    • 15 years at Janssen as a multi-discipline drug/device combination product development team leader responsible for developing primary containers and drug delivery devices for various programs including guselkumab (Tremfya) and ustekinumab (Stelara)
    • 4 years at JNJ medical device section as technical leader on insulin pump and infusion set development
  • 6 years at two biotech companies in the bay area as team leader on developing microfluidic chips for bioanalytical applications
  • 10 issued patents and ~ 10 pending patents on drug delivery devices and microfluidics;
  • Over 20 peer-reviewed papers with total citations of > 8000
  • Ph.D in Chemistry; B.En and M. En in App. Chem.
     

Monica Swinney

Sr. Director, New Product Planning & Drug Delivery Innovation, Gilead Sciences
Monica Swinney

Dr. Swinney has more than 20 years of experience in the design and development of medical devices, pharmaceuticals, and combination products. She is currently the Sr. Director of New Product Planning and Drug Delivery Innovation for Gilead Sciences. Prior to Gilead, she held both strategic and technical leadership roles with Eli Lilly, Becton Dickinson, Johnson & Johnson, and Dexcom. Dr. Swinney holds a Ph.D. in polymer science from MIT a B.S. in chemistry from the University of Massachusetts, is the recipient of many industry awards in innovation and product development, and is an inventor on over 75 patents.

Natalie Abts

Head of Human Factors Engineering, Genentech
Natalie Abts

Natalie Abts is the Head of Human Factors Engineering at Genentech, where she manages the team that conducts all human factors activities for Genentech’s drug delivery devices. Prior to joining Genentech, Natalie worked in medical device consulting for seven years with the National Center for Human Factors in Healthcare. Natalie has specialized experience in planning and executing both formative stage usability evaluations and validation studies for medical devices and combination products on the FDA approval pathway. Natalie holds a master’s degree in industrial engineering with a focus on human factors and ergonomics from the University of Wisconsin, where she was mentored by Dr. Ben-Tzion Karsh.

Paul Upham

Head, Smart Devices, Roche-Genentech
Paul Upham

Paul is the Head of Smart Devices at Roche / Genentech. Paul has 20+ years of experience in medical device R&D, strategic marketing, product management, clinical research, and medical informatics.


Prior to Roche / Genentech, Paul was with Becton Dickinson(BD), as Worldwide Director of Strategic Marketing in their Pharmaceutical Systems business.

Paul was also the head of Product at WellDoc, Inc., where he led the product management activities for WellDoc’s portfolio of mobile health solutions. He was responsible for WellDoc’s landmark BlueStar™ product, a class II medical device and the world’s first reimbursed, prescription-only software for diabetes.

Paul’s prior experience includes 10 years in BD’s Diabetes Care business. Paul was responsible for the award-winning BD InterActiv® Diabetes Software, and was a member of the BD / Medtronic team that launched ParadigmLink®, the world’s first wireless blood glucose meter.

Paul holds four issued patents in medical software and drug delivery devices and has multiple patent applications. He is also an author of numerous peer-reviewed articles in medical informatics and diabetes. His education includes undergraduate studies in cognitive science and graduate work in health informatics and finance at the University of Minnesota and New York University.
 

Phil Estepa

Executive Director, Pharmaceutical Development, Ionis Pharmaceuticals
Phil Estepa

Phil is the Executive Director Pharmaceutical Development & Head of Devices at Ionis Pharmaceuticals. Phil has 20 years of experience in combination product R&D, Development and Manufacturing. He has been instrumentally involved in device strategy, delivery innovation, tech transfer-scale up and setting up manufacturing sites domestically and globally.


Prior to Ionis Pharmaceuticals, Phil has worked for Xeris Pharmaceuticals, Kaleo Pharma, Apricus Biosciences, Amylin-Bristol Myers Squib-AstraZeneca Alliance and Medtronic in various roles from Principal Engineer to Executive Leadership in the successful development and commercialization of 11 Combination Products.


Phil holds two issued patents in medical and drug delivery devices and has multiple patent applications. His education includes undergraduate studies Industrial Engineering Technology locally from San Diego State University, with an emphasis in plastics/polymer science. Prior to his life science career, Phil was involved in aerospace engineering in the development of the Apache Helicopter, F-18 Super Hornet, A-12 Avenger, and multiple UAV aircraft used in today’s defense strategy.
 

Saher Bishara

Associate Director of Human Factors, ClariMed
Saher Bishara

Saher Bishara is an Associate Director of Human Factors Engineering at ClariMed, a human-centered medical device development and regulatory services company. With over 20 years of experience in Human Factors Engineering across various industries, including defense, aerospace, nuclear, oil and gas, and medical devices, Saher brings a wealth of expertise to his role. His background encompasses user research, use-related risk analyses, formative evaluations, and validation testing for a wide range of medical technologies, from home-use devices to complex surgical systems.

Throughout his career, Saher has significantly contributed to commercial and governmental product design, lifecycle development and management, operations, and sustainability. His pragmatic leadership and deep understanding of Human Engineering, User Interface Design, Usability Testing, Systems Engineering, Ergonomic Design, and Risk Management have been instrumental in helping clients successfully navigate regulatory audits and approvals. Saher's expertise and dedication to human-centered design principles make him an invaluable asset to ClariMed and its clients, as he consistently delivers innovative solutions that prioritize patient safety and user experience.
 

Sherri Biondi

Executive Director Device Development, AstraZeneca
Sherri Biondi

Sherri joined AstraZeneca in 2018 and is Head of Device Development. She is responsible for parenteral drug delivery development including early-stage technology strategy, clinical device development and late stage scale-up for commercial manufacturing. Currently, her group is developing products such as prefilled syringes, autoinjectors, on-body delivery systems, and pen injectors as well as a range of new technologies to meet the AstraZeneca pipeline needs. A particular focus of her group is understanding user needs and business needs to design the right product for patients, caregivers and health care providers. Prior to working at Astra Zeneca, Sherri was Director of Device Development at Genentech and Director of Product Development at Alexza Pharmaceuticals developing both injection and inhalation products.
Sherri earned a PhD in Chemical Engineer from the University of Pennsylvania and a BS in Chemical Engineering from Rensselaer Polytechnic Institute. While in industry she has been active in various academic and industry-based organizations. She has taught several university engineering courses and publishes and presents frequently.

 

Stephanie Smith

Principal Human Factors Engineer, Genentech
Stephanie Smith

Stephanie joined Genentech in August 2020 as a human factors engineer. Before joining Genentech, Stephanie has a decade of experience working in the Medical Device and Biotechnology space with over 5 years in Human Factors. Stephanie has also worked as a Global Product Manager and product developer and completed a 2-year rotation part-time as a project manager at Genentech. Stephanie has Bachelor's degrees in Biomedical and Electrical engineering from Marquette University and an MSc from Queen Mary University in London in Biomedical engineering. Stephanie has experience in conducting ethnography, formative and validation studies, and providing user requirements.

Tina Rees

Associate Director, Human Factors, Regeneron Pharmaceuticals
Tina Rees

Tina Rees is the Associate Director of Human Factors at Regeneron, where she leads a team of human factors engineers that manage all aspects of human factors integration across the development and commercialized platforms. Prior to Regeneron, she also led Human Factors at Ferring Pharmaceuticals and was a Principal Research Scientist in Human Factors at Eli Lilly. She has experience with a wide variety of combination products and medical devices and has participated in a number of submissions resulting in approval of combination products and clearance of medical devices. She received her Ph.D. in Biomedical Research from the Mayo Clinic in Rochester, MN and was a Midwesterner until her move to the East Coast 5 years ago.

Wenjing Wang

Associate Principal Scientist in Regulatory Affairs, Merck & Co
Wenjing Wang

Wenjing Wang is a seasoned regulatory affairs expert with over eight years of industry experience in medical devices, combination products and in vitro diagnostic devices. Her latest experience includes regulatory registration for digital health technologies (DHTs) being utilized in decentralized clinical trials and DHTs being part of the combination product. Wenjing has master’s degrees in Biochemistry and Regulatory Affairs and a bachelor’s degree in biotechnology. She has extensive experience in global registrations including FDA, Health Canada, EMA, JMHW, NMPA, and other foreign agencies for various types of medical devices.

What will you gain?
  • Engage in discussions on evolving EU and US regulations as well as reviewing the latest FDA guidance on human factors and drawing insights from successful notified body opinions for streamlined regulatory compliance.
  • Gain insight into advancements in large volume drug delivery devices with a case study from Halozyme and a panel discussion assessing key considerations, benefits and barriers of such devices for stakeholders including patients, HCPs and pharma companies.
  • Delve into comprehensive strategies for maximizing combination product manufacturing and effectively managing your product’s lifecycle with key insights from GSK and Merck
  • Acquire insights into human factors best practices from AbbVie and Regeneron, and discover ways to effectively apply testing and validation approaches for combination products.
  • Explore collaborative opportunities to advance innovation in the injectables field and gain insight into the latest technology updates and challenges these pose such as leaching in electro-mechanical devices.

Who should attend?

Directors, Heads of Departments and Managers for the following areas:

Device Development
Device Engineering
Combination Product Development
Drug Delivery Devices
Primary Packaging Development
Digital Health
Large Volume Drug Delivery
Novel Drug Product Formulation
Regulatory Affairs

sponsors

Conference agenda

clock

8:00

Registration & Coffee

clock

8:50

Co-Chairs' Opening Remarks

Natalie Abts, Head of Human Factors Engineering, Genentech

Amin Sedighiamiri, Director, Device Development, AstraZeneca

clock

9:00

US and EU regulations on drug delivery methods being part of combination products

Wenjing Wang, Associate Principal Scientist in Regulatory Affairs, Merck & Co

clock

9:30

The Game Changer

  • Authentication: One tap by the end-user generates a cryptographic digital signature and verifies the authenticity of the medication.
  • Safety Check: The same simple tap will verify if a drug is recalled or expired and can create direct access to the pharmaceutical company.
  • Guidance: Users learn proper drug administration through intuitive interfaces.
  • Impact: This solution disrupts the status quo, creating an asymmetric advantage against counterfeit drug distributors. It empowers users with knowledge and confidence.
  • Join us for a live demo as we unveil the future of pharmaceuticals—one tap at a time.
     
  • Aaron Sundman, Innovator in RFID Technology, Business Leader, CCL Label inc

    clock

    10:00

    Successfully Gaining Combination Product Notified Body Opinion

    Mitch Zhao, Engineering Fellow, JnJ Innovative Medicine

    clock

    10:30

    Morning Coffee

    clock

    11:00

    Leveraging Mechanical Testing to Optimize Insights of Autoinjector Performance

    Landon Goldfarb, Biomedical Market Manager, Instron

    clock

    11:30

    Updates on the Regulatory Landscape for Human Factors in Combination Product Development

    Natalie Abts, Head of Human Factors Engineering, Genentech

    clock

    12:00

    Solutions for Emerging Challenges to Drug Delivery

    Mark Hassett, Vice President of Business Development, Credence MedSystems

    clock

    12:30

    Networking Lunch

    clock

    13:30

    Going Big: Devices for Pharma’s increased interest in obesity and other prevalent diseases

    Chris Muenzer, Vice President Innovation and Development, Haselmeier GmbH

  • The shift from personalized medicine to global populations
  • Trends in the device landscape
  • Haselmeier's solutions for patient needs
  • Importance of sustainability and useability
  • Room to grow: Our new site in the Peach State
     
  • clock

    14:00

    Panel Discussion: Challenges and opportunities of high-dose, large volume drug delivery

  • Benefits and barriers of large-volume delivery devices from the perspectives of patients, HCPs and pharmaceutical companies
  • On-body, near-body or handheld: The potential of each delivery method in meeting the diverse needs and preferences of patients
  • Patient-filled, patient-loaded or pre-filled/pre-loaded? strategies for balancing safety, technical complexity and usability
  • The current landscape of large-volume delivery systems in terms of sustainability and areas for further innovation
  • Amin Sedighiamiri, Director, Device Development, AstraZeneca

    Marie Printz, Executive Director, Bioanalytical & Nonclinical Sciences, Halozyme Therapeutics

    Kinsuk Shah, Sr. AD Combination Product Steward, Boehringer Ingelheim

    Stephanie Smith, Principal Human Factors Engineer, Genentech

    clock

    14:30

    Container Closure Integrity & Carbon Dioxide Barrier of OXYCAPT Vial at Deep Cold Storage with Dry Ice

    Masashi Miura, Researcher, Mitsubishi Gas Chemical Company, Inc

    clock

    15:00

    Afternoon Break

    clock

    15:30

    Implementing Behaviour Design into Connected Device Development

    Paul Upham, Head, Smart Devices, Roche-Genentech

    clock

    16:00

    Facilitating Rapid High Volume Subcutaneous (SC) Drug Delivery

    Marie Printz, Executive Director, Bioanalytical & Nonclinical Sciences, Halozyme Therapeutics

    clock

    16:30

    Co-Chairs' Closing Remarks and Close of Day One

    Amin Sedighiamiri, Director, Device Development, AstraZeneca

    Natalie Abts, Head of Human Factors Engineering, Genentech

    clock

    16:40

    End of Day One Networking Reception

    clock

    8:15

    Registration & Coffee

    clock

    9:00

    Co-Chairs' Opening Remarks

    Amin Sedighiamiri, Director, Device Development, AstraZeneca

    Natalie Abts, Head of Human Factors Engineering, Genentech

    clock

    9:10

    Fireside Chat: Insights for Advancing Partnerships and Device Development

  • Successfully leveraging partnerships and what do pharma look for when looking for a development partner
  • Current needs to advance device development strategies to meet evolving portfolio needs

     

  • Sherri Biondi, Executive Director Device Development, AstraZeneca

    Phil Estepa, Executive Director, Pharmaceutical Development, Ionis Pharmaceuticals

    Amin Sedighiamiri, Director, Device Development, AstraZeneca

    clock

    9:50

    Device Life Cycle Strategies for Drug Delivery and Combination Products

    Li-Chun Tsou, Director, Global Device Engineering and Technologies, GSK

  • Expand Global Footprint: multiple indications, proper formulations, differentiated devices
  • Enhance Patient Access: broaden therapeutic area, patient-centric design, robust training
  • Enable Novel Device Design: ergonomic considerations, appropriate dosing, sustained release
  • clock

    10:30

    Morning Coffee

    clock

    11:00

    Opportunities for Innovation with Biosimilars

    Kinsuk Shah, Sr. AD Combination Product Steward, Boehringer Ingelheim

    clock

    11:40

    PANEL DISCUSSION: Accelerating Injectable Innovation: Emerging technologies and future opportunities for injectable drug delivery

  • Reviewing the current landscape of emerging technologies to support injectable drug delivery and opportunities for development of more effective subcutaneous devices
  • What are the current gaps in industry and what areas should be focused on to accelerate innovation?
  • How can collaboration and partnerships throughout industry and device development be enhanced?
  • Sharing challenges in regulatory submissions and examples of industry experiences to help you overcome these
  • Mitch Zhao, Engineering Fellow, JnJ Innovative Medicine

    Wenjing Wang, Associate Principal Scientist in Regulatory Affairs, Merck & Co

    Li-Chun Tsou, Director, Global Device Engineering and Technologies, GSK

    Monica Swinney, Sr. Director, New Product Planning & Drug Delivery Innovation, Gilead Sciences

    clock

    12:20

    Networking Lunch

    clock

    13:20

    NeoFlex™ Coated Plungers, The Ideal Healthcare Packaging Solution

    Frank Pillsbury, Technical Manager, Datwyler

    clock

    14:00

    Bridging Human Factors Studies for Injectable Devices

  • Exploring bridging strategies to enable efficient human factors work
  • Successfully leveraging human factors data in new development programs
  • Insight into patient population considerations
  • Reviewing experiences of when leveraging isn’t appropriate
  • Tina Rees, Associate Director, Human Factors, Regeneron Pharmaceuticals

    Bidisha Nandi, Human Factors Engineer, Regeneron Pharmaceuticals

    clock

    14:40

    Cultivating Success: The Art of Post-Market Surveillance in MedTech

    Saher Bishara, Associate Director of Human Factors, ClariMed

    clock

    15:20

    Afternoon Tea

    clock

    15:50

    Extractables and Leachables in Injectable Devices:A Case Study

    Jian Liu, Sr Principal Scientist, Amgen

    clock

    16:30

    User-Centered Quality Management Systems: Balancing User Needs and Regulatory Compliance

    Liz Wellwood, Director of Quality Services, ClariMed

    clock

    17:10

    Co-Chairs' Closing Remarks and Close of Day Two

    Amin Sedighiamiri, Director, Device Development, AstraZeneca

    Natalie Abts, Head of Human Factors Engineering, Genentech


    Innovator in RFID Technology, Business Leader
    CCL Label inc
    Director, Device Development
    AstraZeneca
    Human Factors Engineer
    Regeneron Pharmaceuticals
    Vice President Innovation and Development
    Haselmeier GmbH
    Technical Manager
    Datwyler
    Sr Principal Scientist
    Amgen
    Sr. AD Combination Product Steward
    Boehringer Ingelheim
    Biomedical Market Manager
    Instron
    Director, Global Device Engineering and Technologies
    GSK
    Director of Quality Services
    ClariMed
    Executive Director, Bioanalytical & Nonclinical Sciences
    Halozyme Therapeutics
    Vice President of Business Development
    Credence MedSystems
    Researcher
    Mitsubishi Gas Chemical Company, Inc
    Engineering Fellow
    JnJ Innovative Medicine
    Sr. Director, New Product Planning & Drug Delivery Innovation
    Gilead Sciences
    Head of Human Factors Engineering
    Genentech
    Head, Smart Devices
    Roche-Genentech
    Executive Director, Pharmaceutical Development
    Ionis Pharmaceuticals
    Associate Director of Human Factors
    ClariMed
    Executive Director Device Development
    AstraZeneca
    Principal Human Factors Engineer
    Genentech
    Associate Director, Human Factors
    Regeneron Pharmaceuticals
    Associate Principal Scientist in Regulatory Affairs
    Merck & Co

    Gold Sponsor

    Sponsors

    Exhibitors

    Official Media Partner

    Past presentation - Biogen

    Download

    Past presentation - Regeneron

    Download

    2023 Past attendees

    Download

    5 Minutes with Wenjing Wang, Associate Principal Scientist in Regulatory Affairs at Merck & Co

    Download

    5 minutes with Amin Sedighiamiri, Director, Device Development at AstraZeneca

    Download

    60 seconds with Lin-Chun Tsou, GSK

    Download

    Sponsors and Exhibitors


    CCL Healthcare

    Gold Sponsor
    https://cclhealthcare.com/

    CCL Healthcare excels in pharmaceutical labeling for injectables for vials, syringes, prefilled syringes, and autoinjectors. Our expertise covers labels, cartons, patient instructions, and smart labeling solutions, enhancing patient experience and adherence. With our high-speed RFID packaging line management, we enable encoding with speeds of 700 injectable items per minute, ensuring peak performance for hard-to-tag items through custom RFID product design. Contact us to discuss how we can enhance your injectable solutions with smart labels and packaging.


    Instron

    Gold Sponsor
    https://www.instron.com/en-gb/

    Instron® brings a wealth of knowledge to the biomedical industry, serving as a strategic partner to companies of all sizes. Our equipment and services are primed to help you investigate new technologies and ensure product quality, all while maintaining the highest levels of data integrity and security. Instron has been embedded in the biomedical industry for more than 75 years, and the technological, regulatory, and manufacturing challenges facing our customers have driven us to develop products and services to address their needs. These developments include specialized fixturing, compliant software, and automation capabilities. Our most valuable asset is our extensive customer network, which represents a wide range of medical device and pharmaceutical manufacturers, CDMOs, universities, test houses, and startups.


    Sponsors


    Credence MedSystems

    Sponsors
    http://www.credencemed.com

    Credence MedSystems is an innovator in injectable drug delivery devices. Credence’s philosophy of Innovation Without Change results in products that impress and protect end-users while preserving pharma’s existing processes, sourcing strategies and preferred primary package components. The Companion® family of syringe systems includes proprietary needle-retraction technology, reuse prevention and other critical safety and usability features in Staked and Luer needle formats. The Dual Chamber platform offers single-step mixing and injection for drugs requiring reconstitution at the time of delivery. Additional products such as metered dose devices, multi-length staked needles and other novel devices address the needs of specific therapeutic markets.


    Datwyler

    Sponsors
    https://healthcare.datwyler.com/

    Datwyler provides high-quality, system-critical elastomer components and has a leading position in the global healthcare market. Within the healthcare solutions business area, Datwyler develops, designs, and manufactures solutions for injectable packaging and drug delivery systems to facilitate customers to create a safer medical environment of tomorrow. Looking back onto more than 100 years of history, Datwyler is a reliable partner, now and in the future!


    Haselmeier

    Sponsors
    https://haselmeier.com/en/

    o Haselmeier, the drug delivery device business of medmix, designs, develops and manufactures advanced drug delivery systems such as pen injection systems and autoinjectors. Patient comfort and customers’ needs are always at the heart of the company’s practices. With its broad portfolio of technologies and services, Haselmeier delivers user-friendly injection systems that enable patients to self-administer their medication reliably and accurately. Haselmeier is known for its excellent and long-standing track record in providing these innovative drug delivery devices based on its proprietary IP business model. The company collaborates closely with its customers in the pharmaceutical and biopharmaceutical industries. Medmix, with its precision injection molding capabilities and expertise in liquid micro-dosing plus financial strength and global footprint, helps Haselmeier accelerate innovation in healthcare. With more than 100 years of expertise in the development and manufacture of drug delivery devices, our global footprint, nearly 250 distinguished and motivated experts, more than 200 patents granted, and numerous patents pending, Haselmeier remains committed to developing innovative solutions that support our customers and help improve the health of millions of people worldwide.



    Mitsubishi Gas Chemical

    Sponsors
    https://www.mgc.co.jp/eng/products/abd/oxycapt.html

    Mitsubishi Gas Chemical is a leading company in the field of oxygen barrier and absorbing technologies. Based on these technologies and experiences, we have successfully developed multilayer plastic vial and syringe having excellent oxygen, ultra violet and water vapor barrier. The products make it possible to replace glass with plastic for injectable drugs.


    ZEON

    Sponsors
    https://www.zeon.eu/

    o ZEON’s Zeonex® and Zeonor® cyclo olefin polymer (COP) allow for advanced, break-resistant syringes, vials and lyophilization containers for protein-based biopharmaceuticals, high viscosity drugs, and contrast media. They also offer high purity, “glass-like” transparency, sterilization, low water absorption, and superior moldability, as well as overcome protein adsorption and ph shift concerns. Please visit our booth and discover why COP is an excellent choice for drug storage and pre filled syringes.


    Exhibitors


    KORU

    Exhibitors
    https://www.korumedical.com/

    KORU is, first and foremost, a patient-centric organization that will go the extra mile for our customers, providers, and partners who depend on our devices. We are a world-class manufacturer of subcutaneous infusion devices that deliver life-saving immunoglobulin therapies to patients with chronic illnesses such as Primary Immunodeficiencies (PIDD) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).



    Kymanox

    Exhibitors
    https://www.kymanox.com/

    Kymanox® is your life science solutions partner with a diverse team of experts who know how to connect the dots and make sure you have the right end-to-end solutions for your modern medicine development & commercialization challenges.

    We are experts in providing our clients in the combination products, biologics, pharmaceutical, and medical device industries with support from early development to post-market. We help bring products from bench to patient.



    Lyophilization Technology

    Exhibitors
    https://lyotechnology.com/

    Lyophilization Technology, Inc. (LTI) is a Contract Development & Manufacturing Organization (CDMO) focused on all aspects of lyophilization for preparation of health care products.

    Clients leverage our abilities for bringing new products to the clinic and implementing improvements for current products. LTI is recognized as an industry leader with unparalleled capabilities in product development, process engineering, clinical manufacturing, and technical support.

    To the benefit of our clients, LTI has provided Development and Clinical Trial Material Manufacturing services to more than 500 biotechnology and pharmaceutical organizations spanning virtual companies to large multi-national corporations for over 25 years. Our proven track record of performance comes from successfully developing formulations, manufacturing processes, and prepared material for clinical trials for over 900 diverse products.

    A talented and dedicated staff, skilled with over 300 years of combined experience, enjoys the reputation of providing innovative solutions, achieving desired results, and exceeding client expectations.

    Gain the benefits of our experience and capabilities for creating solutions for the unique needs of your lyophilized product.



    Nipro PharmaPackaging

    Exhibitors
    http://www.nipro-group.com

    Nipro PharmaPackaging is specialized in developing and manufacturing advanced pharma packaging products and complete packaging solutions for early development drugs or the enhancement of packaging solutions for existing drugs. With a worldwide manufacturing footprint of 19 plants, multiple sales offices, and lab services, Nipro offers an exceptional service platform. Through our personnel, products, and services, Nipro PharmaPackaging enables you to provide a safer and healthier administration to your customers. Nipro PharmaPackaging is part of Nipro Corporation Japan, established in 1954. As a leading global healthcare company with over 35,000 employees worldwide, Nipro serves the Pharmaceutical, Medical Device, and Pharmaceutical Packaging industries.


    Owen Mumford

    Exhibitors
    http://www.owenmumford.com

    Owen Mumford Pharmaceutical Services is a specialist in the design, development and manufacture of injectable drug delivery systems for the pharmaceutical, biotech & generics industries. These include single dose and multidose reusable and disposable auto-injectors, pens and syringes for subcutaneous and intramuscular administration. Our innovative products are designed to meet both the need of our pharmaceutical partners and their patients by facilitating ease of use and improving safety and patient compliance. Our devices are also designed with aim of reducing complexity and risk for the pharmaceutical & biotech industry in the development of their combination products.

    For more information please visit https://www.ompharmaservices.com/


    Media Partners


    On Drug Delivery

    Official Media Partner
    http://www.ondrugdelivery.com/subscribe

    ONdrugDelivery provides 30,000 readers throughout global pharma/biopharma, with the latest, most pertinent industry information and intelligence about the drug delivery-related ideas, technologies, services and products the sector is developing. Established in 2004, and trusted throughout the industry for its high quality contributions from leading drug delivery experts, ONdrugDelivery is a must for pharma / biotech industry professionals who need to know what’s going on in drug delivery. Subscribe online today to the print or free digital edition: www.ondrugdelivery.com/subscribe.


    pharmaphorum

    Official Media Partner
    http://www.pharmaphorum.com

    pharmaphorum drives innovation within the pharmaceutical industry, by bringing healthcare together through a suite of media services that help produce and disseminate thought leadership, combined with an online platform for communicating messages to a global audience.Visit www.pharmaphorum.com


    The Medicine Maker

    Official Media Partner
    https://themedicinemaker.com/?utm_source=media_partner_24&utm_medium=event&utm_campaign=sae_media_logo

    The Medicine Maker is a print and digital publication as well as a weekly newsletter. At The Medicine Maker, we bring people into the limelight, showcasing the industry’s success stories and examining its biggest points of contention. Engaging content covers the entire spectrum of drug development, keeping all medicine makers up to date with the most pressing topics, trends and technologies driving the pharma industry forward. Register for your FREE print or digital magazine or subscribe to our newsletter here! https://themedicinemaker.com/?utm_source=media_partner_24&utm_medium=event&utm_campaign=sae_media_logo


    Pharma Journalist

    Official Media Partner
    http://www.pharmajournalist.com

    Pharma Journalist is a product of Kellen Media. Pharma Journalist is one of the leading website covering the need of global Pharmaceutical Industry. Articles like latest news, trends, analysis, market report, press releases, whitepapers, case studies, etc. published on pharmajournalist.com helps Industry professionals and decision makers to stay on the top of this fast-paced industry. Pharma Journalist aims of providing fast and informative articles to its readers and subscribers.

    San Diego Marriott La Jolla

    4240 La Jolla Village Drive
    La Jolla
    San Diego 92037
    USA

    San Diego Marriott La Jolla

    HOTEL BOOKING FORM

    Title

    SubTitle
    speaker image

    Content


    Title


    Description

    Download

    Title


    Description

    Download

    Title


    Description


    Download


    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@saemediagroup.com

    Event Title

    Headline

    Text
    Read More

    I would like to speak at an event

    I would like to attend an event

    Group Booking

    Please complete the below form and a member of SAE Media Group’s booking team will be in contact within 24 hours

    I would like to sponsor/exhibit at an event

    SIGN UP OR LOGIN

    Sign up
    Forgotten Password?

    Contact SAE Media Group

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SAE Media Group , Ground Floor, India House, 45 Curlew Street, London, SE1 2ND, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smgconferences.com Email: events@saemediagroup.com
    Registered in England - SMi Group Ltd trading as SAE Media Group




    Forgotten Password

    Please enter the email address you registered with. We will email you a new password.

    Thank you for visiting our event

    If you would like to receive further information about our events, please fill out the information below.

    By ticking above you are consenting to receive information by email from SAE Media Group.
    Full details of our privacy policy can be found here https://www.smgconferences.com/privacy-legals/privacy-policy/.
    Should you wish to update your contact preferences at any time you can contact us at data.privacy@smgconferences.com.
    Should you wish to be removed from any future mailing lists please click on the following link http://www.smgconferences.com/opt-out

    Fill in your details to download the brochure

    By submitting this form you agree to our privacy policy and consent to receiving communications, you may opt out at any time.