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Pre-Filled Syringes and Injectable Drug Devices West Coast
June 9 - June 10, 2025
Pre-Filled Syringes and Injectable Drug Devices West Coast

SAE Media Group’s 9th Annual Conference
Pre-Filled Syringes West Coast
9th - 10th June 2025, CA, USA
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Foster Innovation and Collaboration at the 9th Annual Pre-Filled Syringes and Injectable Drug Devices West Coast Conference!

Join us in June 2025 as SAE Media Group’s renowned West Coast event returns, bringing together biotech pioneers, pharma leaders, and device innovators to shape the future of injectable drug delivery.

This year’s conference offers an unparalleled platform to explore cutting-edge advances in combination product technology while fostering collaboration between pharma, device developers, and regulators.

Why Attend?

  • Foster Collaboration and Innovation: Engage with industry leaders such as AstraZeneca, Gilead, and Alnylam to explore new opportunities, address challenges like large-volume delivery, and stay informed about emerging technologies.
  • Stay Updated on Global Regulatory Trends: Participate in discussions on evolving EU and US regulations, including the latest digital health technology registration requirements, with insights from Merck.
  • Optimize Combination Product Manufacturing: Learn strategies from leaders like Ionis to enhance combination product manufacturing and effectively manage product lifecycles.
  • Enhance Human Factors Understanding: Gain practical knowledge from JnJ and AbbVie on best practices for human factors, including testing and validation approaches for combination products.

What You’ll Gain:

  • Actionable insights to strengthen your drug-device portfolio.
  • Opportunities to network with key players shaping the injectable drug delivery landscape.
  • A future-focused perspective on innovation, regulation, and patient-centric care.

This must-attend event is your chance to stay ahead in the rapidly evolving injectable drug delivery space. We look forward to welcoming you to the West Coast in June 2025!

FEATURED SPEAKERS

Amin Sedighiamiri

Amin Sedighiamiri

Director, Device Development, AstraZeneca
Aniket Badkar

Aniket Badkar

Director, Pharmaceutical Product Development, Vir Biotechnology
Bernie Huyghe

Bernie Huyghe

Chief Technology Officer, Candid Therapeutics
Christina Rabolli

Christina Rabolli

Principal Engineer, Device Development, Bristol Myers Squibb
Confirmed Representative

Confirmed Representative

, Gilead Sciences
Daphne King

Daphne King

Previously Associate Director, Regulatory CMC, Biomarin
EJ Brandreth

EJ Brandreth

Senior VP, Quality, Inovio
James P. Wabby

James P. Wabby

Executive Director, Head of Regulatory Strategy, emerging Technologies and Combination Products, AbbVie
Kevin Zen

Kevin Zen

Senior Director, IGM Biosciences
Kinsuk Shah

Kinsuk Shah

Sr. AD Combination Product Steward, Boehringer Ingelheim
Mitch  Zhao

Mitch Zhao

Distinguished Engineer, JnJ Innovative Medicine
Phil Estepa

Phil Estepa

Executive Director, Pharmaceutical Development, Ionis Pharmaceuticals
Ravi Kaushik

Ravi Kaushik

Vice President, Patient Integrated Care Innovation Platform, Takeda Pharmaceuticals
Sheldon Moberg

Sheldon Moberg

Senior VP Drug Delivery, Bexson Biomedical
Shiang Gwee

Shiang Gwee

Director, Drug Product Development, Altrubio, Inc.
Sujit K. Basu

Sujit K. Basu

Vice President & Head, Ionis
Tina Rees

Tina Rees

Associate Director, Human Factors, Regeneron Pharmaceuticals
Wenjing Wang

Wenjing Wang

Associate Principal Scientist in Regulatory Affairs, Merck & Co

Alasdair Young

Senior Director - Device Engineering, Gilead Sciences
Alasdair Young

Alasdair has been with Gilead for approaching two years, leading the development group as part of Device Engineering. Alasdair has spent 18yrs working on combination products for a number of pharma and biotech companies. Over the recent years he has played a pivotal role in the development and approval of a number of combination products spanning prefilled syringes, autoinjectors, and on-body delivery systems. He has also held roles in early concept development and commercial support during his career.

Alasdair holds a Master’s degree in Manufacturing Engineering from Cambridge University and a Bachelor’s degree in Mechanical Engineering from Glasgow University.
 

Amin Sedighiamiri

Director, Device Development, AstraZeneca
Amin Sedighiamiri

Amin Sedighiamiri has a PhD in Mechanical Engineering with more than 12 years of technical leadership experience, including product innovation and commercialization across multiple industry segments, like medical device, combination product, automotive and water management in Europe and the US. Currently, he is Device Development Engineering Manager in Dosage Form Design and Development organization of AstraZeneca where he is leading combination product development as well as smart drug delivery device technology development projects.

Before joining AstraZeneca, Amin worked as Sr. Engineer in Delivery, Device and Connected Solutions Organization of Eli Lilly and Company, where he led cross-functional teams of engineers to develop connected solutions for drug delivery devices.

He is also Board Member and Technical Programming Committee Chair at Medical Plastics Division in Society of Plastics Engineers.
 

Aniket Badkar

Director, Pharmaceutical Product Development, Vir Biotechnology
Aniket Badkar

Dr. Aniket Badkar is Director, Pharmaceutical Product Development at Vir Biotechnology where he leads biologics and combination product development of Vir’s pipeline. Prior to joining Vir Biotechnology, Dr. Badkar served multiple positions of increasing responsibilities at Abbvie Inc., Zoetis, Inc. and Merck, Inc. developing biologic products for parenteral, ocular and topical delivery. He has led the technical development and / or life cycle innovation of several biologic products such as Cytopoint™, Tildrakizumab, Brazikumab and Botox®. Dr. Badkar has a Ph.D. in Pharmaceutical Sciences from Mercer University and a BS in Pharmacy from University of Mumbai, India.

Bernie Huyghe

Chief Technology Officer, Candid Therapeutics
Bernie Huyghe

Christina Rabolli

Principal Engineer, Device Development, Bristol Myers Squibb
Christina Rabolli

Christina Rabolli is a Principal Engineer within the Device Development team at Bristol Myers Squibb, where she has worked on several combination product programs, employing several different types of delivery technologies. Prior to her time at BMS, Christina spent 7 years with BD, contributing to the development of two wearable injector devices and managing relationships with pharmaceutical partners. She also spent time at Pfizer, primarily focused on sustaining engineering activities for on-market prefilled syringe products. Christina has had the enjoyable experiences during her career of working for both a device constituent supplier and a pharmaceutical company, and across the entire combination product lifecycle.

Confirmed Representative

, Gilead Sciences
Confirmed Representative

Daphne King

Previously Associate Director, Regulatory CMC, Biomarin
Daphne King

With a robust history of engagement with US, EU, and international regulatory agencies, Daphne King is a seasoned leader in the biopharmaceutical, medical device, combination products, Companion Diagnostics and digital/mobile health sectors. Daphne King possesses extensive expertise in regulatory strategy, Chemistry, Manufacturing and Controls (CMC), submissions, project management, quality systems, and biopharmaceutical regulations, including FDA, EU, and other global regulations.
Demonstrating a thorough understanding of key regulatory frameworks such as FDA 21 CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR/IVDR, Daphne King has been instrumental in driving product development and securing approvals for US, EU, and global commercialization, ensuring alignment with corporate goals and objectives.
Key achievements include:

  • Supporting product development and approval processes across various markets
  • Enhancing regulatory compliance by forming and leading effective cross-functional teams
  • Building productive external alliances with agency reviewers
  • Cultivating effective stakeholder relationships to drive regulatory compliance and project success

As an accomplished director of regulatory affairs, Daphne King combines deep regulatory knowledge with strong leadership and project management skills. Daphne King has a proven track record of managing complex projects from inception to delivery, balancing competing priorities, and leading high-performing teams. Recognized for the ability to build successful relationships with cross-functional teams, FDA, EMA, and other health agency reviewers, Daphne consistently contributes to the achievement of corporate regulatory objectives.

 

EJ Brandreth

Senior VP, Quality, Inovio
EJ Brandreth

E.J. has over 35 years in life sciences including small molecules, devices, and pivotal biotechnology products, and is currently the Head of Quality for Inovio Pharmaceuticals, where he oversees QA for a combination Medical Device and DNA therapeutic platform. He was previously Sr. Vice President of Quality and Regulatory Affairs at Ajinomoto Althea Technologies, specializing in CMO biotech processing and aseptic filling. He was the Sr. Director of Quality for BioMarin where he helped design and build the commercial orphan drug facility and launched Aldurazyme® and Naglazyme®. During the startup of IDEC Pharmaceuticals he held various management positions in QA, Validation and Regulatory Affairs, and was a core team member for the development and launch of Rituxan® and Zevalin®. He is the past Chairman of the PDA Biotech Advisory Board, author of several PDA Technical Reports, UCSD Dean’s Leadership Counsel, and is the past President of ISPE, San Diego. He holds an MBA from UOP and a BA in Biology from UCSD.

James P. Wabby

Executive Director, Head of Regulatory Strategy, emerging Technologies and Combination Products, AbbVie
James P. Wabby

Kevin Zen

Senior Director, IGM Biosciences
Kevin Zen

Kevin has served leadership positions developing therapeutic biological products at AbbVie, AnaptysBio, Catalent Biopharma Solutions, IGM Biosciences, and Opthea. Kevin not only has in-depth expertise in Analytical Development but also has broad experience in Biologics CMC technical operations. In addition to developing therapeutic biological products in-house, Kevin also had extensive experience selecting and managing external CDMO and CRO. He was often invited to present seminars and offer training courses on biologics process development, manufacturing, control strategies, formulation, analytical technology, comparability, process and method validation in the international conferences. In his career, he has successfully managed many biological drug candidates from early development to commercial.

 

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.

Mitch Zhao

Distinguished Engineer, JnJ Innovative Medicine
Mitch  Zhao
  • 20 years at JNJ
    • 16 years at JNJ Innovative Medicine 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 MedTech 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

 

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.

 

Ravi Kaushik

Vice President, Patient Integrated Care Innovation Platform, Takeda Pharmaceuticals
Ravi Kaushik

Ravi joined Takeda in 2021 as the VP, Global Program Leader, PDT Integrated Care Solutions where he has formed a GPT to drive patient centered integrated care solutions with devices/digital innovations to help drive better patient outcomes while growing the PDT business (initially focusing on IG home infusion therapy).
Ravi was most recently the CEO for TransAsia Biomedical Ltd. (a large IVD company) where he led & drove the Strategy, Product Development & Launch Execution, Leadership Team Management, Business development & growth with P&L Responsibility (~ $120MM).
Earlier, Mr. Kaushik was with Medtronic as the Group Marketing Director, APAC & Country Director, India for the Diabetes business (insulin pump & CGM). He drove strategic growth for the ~$100 MM business and led innovative patient centric business models to improve solutions and services for Diabetes patients (value-based healthcare) across the APAC region.
Prior to that, Mr. Kaushik was at Baxter International (Baxalta-Shire) as Director for Strategy & Healthcare Innovation function for the Emerging Asia/India markets. He provided strategic leadership, identifying, and executing key market and patient centric innovation programs while aligning these initiatives with the global company strategic plan. He also led the commercial (P&L) of the $70MM Baxalta India when it was spun off from Baxter in 2015.
Earlier, Mr. Kaushik was at GE Healthcare as the Director of Global Upstream Marketing (Maternal Infant Care), Emerging Markets leading multiple teams of product managers for disruptive medical device product innovation, driving market creation with organic growth across Asia & Africa.
Prior to that Mr. Kaushik was with GE LED Lighting as a Global Product Marketing Manager, in Cleveland, USA leading several new product innovations in LED lighting for retail display.

Overall, Ravi has 25+ years of global leadership experience in strategic product and business model innovation in various roles/industries ranging from Healthcare (MedTech & Pharma), LED Lighting, & Industrial companies globally. Ravi has proven himself as a disruptive innovator, strategic thinker, inclusive and execution driven leader in business analytics, strategic planning, global marketing, new product & business model innovation.

Over the past decade, Ravi has been recognized globally as India’s Top 20 Healthcare CEOs (Transasia) in 2020, Global transformative leader award (Medtronic) in 2018, Emerging Market Growth Leader award (Medtronic) in 2018, Healthcare Innovation speaker at World Federation of Hemophilia Congress (2016), Global CEO Award for “Imagining the possibilities” Business Model Innovation at Baxalta (Shire) (2015), CEO Award for Patient Centricity (GE Healthcare, India) in 2012

Mr. Kaushik holds an MBA from the prestigious Kellogg School of Management (Northwestern University) in Chicago. Mr. Kaushik also has graduate degrees of Masters in Mechanical Engineering from the University of Wyoming and Bachelors’ in Mechanical Engineering from MS University, Baroda, India.

 

Renato Ravanello

Sr. Director, Device and Packaging Development, Genentech
Renato Ravanello

Renato Ravanello is responsible for Late Stage Development in the Device and Packaging team at Genentech in South San Francisco, CA. Renato leads the design of new combinations products for clinical and commercial, focusing on new technologies for sub-cutaneous and ocular drug delivery.

Renato has been developing and commercializing combination products and medical devices for over 17 years, and has extensive experience in pre-filled syringes, needle safety devices, injector pens, patch injectors, auto-injectors, ocular drug delivery, and respiratory and transdermal drug delivery devices. He holds an M.S. in Aerospace Engineering from the University of Colorado (Boulder) and a Degree in Aeronautical Engineering from the Politecnico di Milano (Italy).
 

Sheldon Moberg

Senior VP Drug Delivery, Bexson Biomedical
Sheldon Moberg

Sheldon Moberg is the Sr. Vice President of Drug Delivery at Bexson Biomedical where he is responsible for drug delivery systems as part of Bexson's combination product portfolio. He was previously VP Drug Delivery at Amgen where he oversaw drug delivery strategy and development. Prior to Amgen, Sheldon held Research and Development leadership positions at Medtronic's MiniMed managing insulin drug delivery system R&D. Mr. Moberg has over 30 years of experience developing and commercializing innovative medical devices and combination products. He earned a Master's in Mechanical Engineering from Purdue University and a Bachelor's in Mechanical Engineering from California Polytechnic State University, SLO. Sheldon has been awarded 151 US patents, the majority of which are applied to commercialized products.


 

Shiang Gwee

Director, Drug Product Development, Altrubio, Inc.
Shiang Gwee

Sujit K. Basu

Vice President & Head, Ionis
Sujit K. Basu

Dr. Basu is currently the Head of Pharmaceutical Development at Ionis. Dr. Basu’s prior experiences include serving as Vice President, Pharmaceutical Sciences, and Pharmaceutical Development at Takeda/Shire where he led the Device and Combination Products Center of Excellence that was responsible for development and commercialization of delivery devices and combination products, digital health, and diagnostic solutions, as well as Vice President at Dicerna Pharmaceuticals (now part of Novo Nordisk). Dr. Basu studied Pharmaceutical Technology and Engineering (BS & MS) in Kolkata, India (Jadavpur University), Pharmaceutical Sciences (PhD) in Los Angeles (USC) and Certificate in Management in Cambridge, MA (Harvard).

Tina Rees

Associate Director, Human Factors, Regeneron Pharmaceuticals
Tina Rees

Tina Rees is the 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.

Wenjing Wang

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

Wenjing Wang is a seasoned regulatory affairs expert with over nine 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.

sponsors

Conference agenda

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8:00

Registration & Coffee

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8:50

Chair's Opening Remarks

Amin Sedighiamiri, Director, Device Development, AstraZeneca

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9:00

Accelerating Injectable Innovation: An overview of emerging technologies for injectable drug delivery

James P. Wabby

James P. Wabby, Executive Director, Head of Regulatory Strategy, emerging Technologies and Combination Products, AbbVie

  • Reviewing the current landscape of emerging technologies to support injectable drug delivery
  • Assessing industry challenges in the emerging technologies space and potential ways to overcome these
  • What are the current gaps in industry and what areas should be focused on to accelerate innovation?
  • Opportunities for development of more effective subcutaneous devices and digital apps
     
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    9:30

    Session Reserved for Suttons Creek

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    10:00

    Developing Large Volume Injection Devices: Enhancing Subcutaneous Drug Delivery and Patient Experience for Successful Commercial Launch

    Renato Ravanello, Sr. Director, Device and Packaging Development, Genentech

  • Designing user-centric devices for optimal delivery of novel therapeutics, including sustained release and large-volume formulations
  • Maximizing therapeutic efficacy by focusing on dose accuracy, safety, and user convenience
  • Real-world insights through a case study on the development and deployment of a successful wearable device
  • Sustainability implications of such devices and balancing trade offs
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    10:30

    Morning Coffee

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    11:00

    Session Reserved for SHL Medical

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    11:30

    Session Reserved for Gilead

    Confirmed Representative

    Confirmed Representative, , Gilead Sciences

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    12:00

    Session Reserved for Credence MedSystems

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    12:30

    Advancing Injectable Devices: Balancing Innovation, Scalability, and Sustainability

  • Emerging Trends in Injectable Devices: Exploring smart technologies, connectivity adoption, and patient-centric designs that enhance adherence and user experience
  • Large-Volume Delivery Challenges: Addressing engineering innovations and strategies to deliver high-viscosity drugs and biologics effectively and comfortably
  • Advancing Sustainability in Design and Manufacturing: Analyzing the push toward eco-friendly materials, recycling solutions, and sustainable lifecyle management practices in device production
  • Regulatory and Market Dynamics: Understanding regulatory developments from the past year such as the essential drug delivery outputs (EDDO) guidance and market response
  • Scalability: Experiences and approaches to scaling up injectable device development and manufacturing, emphasizing precision, reliability, regulatory compliance, and meeting the demand for complex drug delivery systems
  • Amin Sedighiamiri, Director, Device Development, AstraZeneca

    Alasdair Young, Senior Director - Device Engineering, Gilead Sciences

    Mitch Zhao, Distinguished Engineer, JnJ Innovative Medicine

    Phil Estepa, Executive Director, Pharmaceutical Development, Ionis Pharmaceuticals

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    13:10

    Networking Lunch

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    14:10

    Session Reserved for Haselmeier

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    14:40

    Combination Product Innovation and Alignment for Advanced Therapeutic Delivery

    Sujit K. Basu, Vice President & Head, Ionis

  • Balancing the timing and scale of innovation in combination product delivery solutions to meet patient and clinical demands
  • Exploring a case study on the journey from concept to approval, highlighting regulatory, design, and testing insights for combination products
  • Reviewing opportunities for scaling processes and fostering innovation in response to the growing demand for advanced modality drugs
  • Shaping the future of injectable delivery systems through collaboration and cross-disciplinary innovation
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    15:10

    Session Reserved for Mitsubishi Gas Chemical Company

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    15:40

    California-based Biotech Panel Discussion: Tackling injectable delivery of advanced modalities

  • Understanding the requirements for effective parenteral delivery of advanced modalities including DNA, RNA and Cell and Gene Therapies
  • Tackling challenges specific to novel modality formulations including cold storage, stability, high volume and high viscosity
  • Keeping pace with the growing demand for advanced modality drugs – scaling formulation and delivery processes
  • Looking to the future – how can the growing demand for new modality drugs drive innovation within the injectable sector
  • EJ Brandreth, Senior VP, Quality, Inovio

    Aniket Badkar, Director, Pharmaceutical Product Development, Vir Biotechnology

    Shiang Gwee

    Shiang Gwee, Director, Drug Product Development, Altrubio, Inc.

    Sujit K. Basu, Vice President & Head, Ionis

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    16:20

    Afternoon Break

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    16:50

    Regulatory registration for digital health technologies (DHTs) as part of combination products

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

  • Overview of digital health technologies and their integration into combination products, highlighting key trends and examples
  • Regulatory Framework for DHT Registration: Key considerations, global regulations, and pathways for obtaining approval for DHTs as part of combination products
  • Ensuring compliance through robust validation, cybersecurity measures, and real-world evidence for DHTs in combination products
  • Challenges and opportunities in the registration process
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    17:20

    Session Reserved for Zeon

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    17:50

    The evolving Regulatory Landscape for Drug-Device Combination Products: A CMC Perspective

    Daphne King, Previously Associate Director, Regulatory CMC, Biomarin

  • Moving to MDR: implementation timelines and new requirements
  • Replacement of IVDD with IVDR and implications on legacy devices
  • Transitioning from lab developed tests to companion diagnostics
  • Case study example of a successful transition of CMC processes in line with new regulations
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    18:20

    Chair’s Closing Remarks and Close of Day One

    Amin Sedighiamiri, Director, Device Development, AstraZeneca

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    8:15

    Registration & Coffee

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    8:50

    Chair's Opening Remarks

    Amin Sedighiamiri, Director, Device Development, AstraZeneca

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    9:00

    Integrating Drugs, Devices, and Digital Solutions: Navigating Connectivity, Usability, and Essential Innovation in Healthcare (subject to final confirmation)

    Ravi Kaushik, Vice President, Patient Integrated Care Innovation Platform, Takeda Pharmaceuticals

  • Approaches to deciding when software should be part of drug-device systems, considering factors like adherence, treatment regularity, and sensor integration
  • Enhancing adherence and safety, and exploring the role of connectivity in challenging drug delivery scenarios to improve patient outcomes and reduce risks during at-home treatments
  • Future-proofing digital ecosystems: Strategies to integrate software and app development into device design while mitigating the risks of software obsolescence
  • Looking at the road ahead in healthcare terms of in patient-centric care, partnerships, and innovations that will shape the 3D ecosystem of drugs, devices, and digital solutions

     

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    9:30

    Leveraging Platforms for Combination Product and Injection Device Development

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

  • Reviewing when delivery systems and devices are suitable for platforms and adapting these platforms to accommodate multiple drug products
  • Examining challenges in biocompatibility and balancing volume and viscosity
  • Case study and key takeaways for effectively implementing a platform approach
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    10:00

    Session Reserved for Sponsor

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    10:30

    Morning Coffee

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    11:00

    Streamlining Safety Syringe Development: A Case Study in Collaborative Design Verification

    Christina Rabolli, Principal Engineer, Device Development, Bristol Myers Squibb

  • Exploring how strategic partnerships can accelerate safety syringe design and development
  • Practical approaches to optimizing verification workflows for regulatory compliance and efficiency
  • Insights into overcoming common hurdles in safety device development programs
  • Case Study with lessons learned and best practices from a successful safety syringe program
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    11:30

    Session Reserved for Sponsor

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    12:00

    California-based Biotech Keynote: Development and commercialization of innovative medical devices and combination products

  • The importance of treating a combination product as a system and initiating the development effort early in the program
  • Understanding key device constituent part selection criteria to meet the combination product Target Product Profile (TTP)
  • The benefit of wearable infusion pumps to support a shift from in-clinic IV administration to home subcutaneous therapy administration
  • Criticality of drug/device integration including contact material assessment, fill/finish processing, drug properties, and primary container handling
  • Sheldon Moberg, Senior VP Drug Delivery, Bexson Biomedical

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    12:30

    Session Reserved for Gilead

    Confirmed Representative

    Confirmed Representative, , Gilead Sciences

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    13:00

    Networking Lunch

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    14:00

    Session Reserved for EdgeOne Medical

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    14:30

    Device Usability and Tolerability Assessment from Clinical Trials

    Mitch Zhao, Distinguished Engineer, JnJ Innovative Medicine

  • Analyzing how usability and tolerability differ across diverse patient populations in clinical trials
  • Key influences on User Experience: Exploring design, training, and demographic factors affecting outcomes
  • Strategies to align device design with real-world patient needs and feedback
  • Leveraging trial data to improve device performance and patient adherence
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    15:00

    Assessing human factors testing and validation approaches for combination product platforms

    Tina Rees, Associate Director, Human Factors, Regeneron Pharmaceuticals

  • Ways to generate high-value results to engage constructive design and development decision making
  • Best practices on platform human factors formative and validation protocol development
  • Factors to consider for balancing requirements (e.g. technical, commercial, user needs)
     
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    15:30

    Afternoon Break

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    16:00

    Session Reserved for Sponsor

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    16:30

    Afternoon Keynote: Enabling Fast Scale-Up and Successful Design Transfer for Injectables

    Phil Estepa, Executive Director, Pharmaceutical Development, Ionis Pharmaceuticals

  • Development of a transferable manufacture process to allow for quick scale up post-approval
  • Supplier selection and management considerations in device development to assist in-built scalability and transferability
  • Building a bridge between design and manufacturing
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    17:00

    California-based Biotech Panel Discussion: Partnering with biotech’s: Fostering innovation through collaboration

  • What makes a successful partnership? Identifying key criteria for successful collaboration between biotechs and big pharma or suppliers to aid parenteral delivery of novel therapeutics
  • Challenges in developing delivery systems for drug candidates as they progress through critical R&D stages
  • Uncovering the power strategic partnerships have to accelerate combination products through pre-clinical and clinical development, on to the shelf
  • Case studies showcasing partnership success stories
  • Kevin Zen, Senior Director, IGM Biosciences

    Sheldon Moberg, Senior VP Drug Delivery, Bexson Biomedical

    Bernie Huyghe

    Bernie Huyghe, Chief Technology Officer, Candid Therapeutics

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    17:40

    Chair’s Closing Remarks and Close of Day Two

    Amin Sedighiamiri, Director, Device Development, AstraZeneca


    Senior Director - Device Engineering
    Gilead Sciences
    Director, Device Development
    AstraZeneca
    Director, Pharmaceutical Product Development
    Vir Biotechnology
    Chief Technology Officer
    Candid Therapeutics
    Principal Engineer, Device Development
    Bristol Myers Squibb
    Gilead Sciences
    Previously Associate Director, Regulatory CMC
    Biomarin
    Senior VP, Quality
    Inovio
    Executive Director, Head of Regulatory Strategy, emerging Technologies and Combination Products
    AbbVie
    Senior Director
    IGM Biosciences
    Sr. AD Combination Product Steward
    Boehringer Ingelheim
    Distinguished Engineer
    JnJ Innovative Medicine
    Executive Director, Pharmaceutical Development
    Ionis Pharmaceuticals
    Vice President, Patient Integrated Care Innovation Platform
    Takeda Pharmaceuticals
    Sr. Director, Device and Packaging Development
    Genentech
    Senior VP Drug Delivery
    Bexson Biomedical
    Director, Drug Product Development
    Altrubio, Inc.
    Vice President & Head
    Ionis
    Associate Director, Human Factors
    Regeneron Pharmaceuticals
    Associate Principal Scientist in Regulatory Affairs
    Merck & Co

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    Sponsors and Exhibitors


    SHL Medical

    Gold Sponsors
    http://www.shl-medical.com

    SHL Medical is a pioneering leader in self-injection solutions, such as autoinjectors. Driven by our purpose of “enabling patients’ independence”, we partner with leading pharma and biotech companies to develop self-injection systems and digital solutions that enhance patients’ treatment experience and quality of life. Our customers benefit from our proven track record and scalable, global manufacturing excellence, with locations in Switzerland, USA, Sweden, and Taiwan. By focusing on innovation, we challenge the status quo and shape the future of state-of-the-art drug delivery. We cover the entire drug delivery value chain, providing piece of mind through our end-to-end services, from design, development, to final assembly, labeling, and packaging.


    Suttons Creek

    Gold Sponsors
    http://www.suttonscreek.com

    Suttons Creek is pharma’s device team. Any company adopting combination product technology needs an experienced combination products team working alongside their drug team, including specialists in areas like quality, regulatory, vendor selection and management, systems engineering, risk management, clinical development, and commercialization. Suttons Creek has over 650 years of combined experience and 120+ combination product projects under its belt, with a talent pool of subject matter experts that specialize in all aspects of combination product development from strategic planning through device development to launch and postmarket activities. We can be any or all things combination product to a client, consulting hour by hour or engaging in strategic partnerships to achieve milestones, lift roadblocks, fill knowledge gaps, and drive program success.


    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!


    EdgeOne Medical

    Sponsors
    http://www.edgeonemedical.com/

    EdgeOne Medical is a leading global Contract Device Development Organization, serving as the trusted testing and device development partner for 11 of the top 20 global pharmaceutical companies. As experts in compliant device development from benchtop to commercialization, we leverage our extensive industry knowledge, advanced in-house laboratory, and ISO 13485 certified Quality Management System to accelerate and derisk the development journey for our clients. EdgeOne Medical’s ability to get it “Right First Time” has made us the preferred partner for many key players in emerging pharma and big pharma. Our track record includes supporting the device development programs of newly acquired emerging pharmaceutical companies such as Carmot, Chinook, Dicerna, Horizon Therapeutics, and cell therapy innovator Miromatrix.



    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


    Gerresheimer

    Exhibitors
    http://www.gerresheimer.com

    Gerresheimer is an innovative systems and solutions provider and a global partner for the pharma, biotech and cosmetic industries. The company offers a comprehensive portfolio of pharmaceutical primary packaging, drug delivery systems and digital solutions. Gerresheimer ensures that medicines reach patients safely and can be administered reliably. With around 12,000 employees and 35 production sites in 16 countries in Europe, America and Asia, Gerresheimer has a global presence and produces locally for the regional markets with a focus on the pharma industry.



    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/



    Terumo

    Exhibitors
    https://www.terumopharmaceuticalsolutions.com/en-EMEA

    As Part of Terumo Medical Care Solutions, the Pharmaceutical Solutions Division develops patient-oriented parenteral delivery solutions for therapeutic performance and safety.

    Globally trusted for quality and precision, we offer pharmaceutical and medical device manufacturers around the world comprehensive product design and development services.

    We have decades of experience collaborating with pharmaceutical companies from the earliest phases of drug development to product commercialization to optimize critical aspects of parenteral drug delivery.

    Innovation and creativity are central to our value proposition. Our expert teams lead the industry in developing and manufacturing advanced, high-performing infusion and injection technologies, including CDMO services for all parenteral applications.

    We listen. We question. We deliver.


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    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

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    Opening Hours: 9.00 - 17.30 (local time)
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