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Pre Filled Syringes Connect
September 11 - September 12, 2024

FREE FOR PHARMA AND BIOTECH*

SAE Media Group are proud to announce the inaugural Pre-Filled Syringes Connect event taking place on the 11th and 12th of September in Boston. As a new addition to SAE's leading injectable drug delivery portfolio, PFS Connect will bring together device thought-leaders from big pharma, biotech and device developers in an intimate, relaxed and engaging setting, fostering collaborations and idea exchanges crucial for driving innovation in injectable drug delivery.

The two-day agenda will bring you a series of keynote presentations and roundtable discussions facilitated by industry experts sharing their invaluable expertise and experiences around industry challenges and emerging trends allowing you to come away equipped with actionable knowledge to enhance your device development initiatives and strategic approach. Keynote presentations will also give you the chance gain insight into the latest case studies and innovations in the field. We hope to welcome you to this must attend event in September 2024!

FEATURED SPEAKERS

Adrienne Fletcher

Adrienne Fletcher

Director Packaging and Device Innovation, Johnson & Johnson Innovative Medicine
Dominick DeGrazio

Dominick DeGrazio

Early Device Project Engineering Lead, GlaxoSmithKline
E Guan

E Guan

Head of Injection Systems, Takeda
Fawziya Ali

Fawziya Ali

Senior Scientist, Pfizer Inc.
Khaudeja Bano

Khaudeja Bano

Vice President, Combination Product Quality, Amgen
Kinsuk Shah

Kinsuk Shah

Sr. AD Combination Product Steward, Boehringer Ingelheim
Lawton  Laurence

Lawton Laurence

Head of Device & Combination Product Development, Apellis
Leya Bergquist

Leya Bergquist

Associate Director, ClariMed
Manuel Sanchez-Felix

Manuel Sanchez-Felix

VP Drug Delivery Search & Evaluation, Halozyme
Michael Song

Michael Song

Expert in aseptic filling, combination product and packaging development and commercialization,
Ning Yu

Ning Yu

Executive Director, Device and Combination Product Development, Astria Therapeutics
Ram Halthore

Ram Halthore

Director of Engineering, Merck
Ravi Kaushik

Ravi Kaushik

Vice President, Patient Integrated Care Innovation Platform, Takeda Pharmaceuticals
Rebecca Engel

Rebecca Engel

Director, Regulatory CMC Strategy, Pfizer, Inc.
Renato Ravanello

Renato Ravanello

Sr. Director, Device and Packaging Development, Genentech
Robert 'Joe' Mather

Robert 'Joe' Mather

Vice President, Head of Digital Sciences and Head of Research, Development and Regulatory, Pfizer
Sarah Fairfield

Sarah Fairfield

Associate Director, RA Device and Combination Products Digital Device and Software, AbbVie
Shruti Parikh

Shruti Parikh

Director, Product Design, Takeda Pharmaceuticals
Soumen Das

Soumen Das

Medical Device Qualification Lead & Associate Scientific Fellow, Takeda Pharmaceutical Company Limited

Adrienne Fletcher

Director Packaging and Device Innovation, Johnson & Johnson Innovative Medicine
Adrienne Fletcher

Commerical Moderator to be announced

,
Commerical Moderator to be announced

Dominick DeGrazio

Early Device Project Engineering Lead, GlaxoSmithKline
Dominick DeGrazio

Dominick DeGrazio is an Early Device Project Engineering Lead in the Early Engagement and Deviceability Group at GSK. In this role, he focuses on the technical feasibility of early-stage assets intended for combination product development. With 12 years of industry experience, Dominick has held roles at PTC Therapeutics, Janssen R&D, Oncobiologics, and West Pharmaceutical Services. His expertise spans end-to-end drug product development and has partaken in the commercial launch of multiple gene therapy and biologic products including Upstaza, Darzalex Faspro, and Tremfya. Dominick graduated from Franklin and Marshall College in 2012 with a B.A. in Biochemistry & Molecular Biology and Neuroscience.

E Guan

Head of Injection Systems, Takeda
E Guan

E is a passionate leader in building device development capabilities and improving combination product development processes. He is savvy in delivery device technology assessment, combination product development, manufacture process development, commercial scale-up and life cycle management. E currently holds the position of Head of Injection Systems at Takeda. Previously he was Director of device development with AstraZeneca. He built a very strong device team and managed multiple combination product programs in the therapeutic areas of respiratory, inflammation, autoimmune, cardiovascular, renal and metabolic diseases. Prior to AstraZeneca, he was device lead with Janssen Pharmaceuticals and Becton Dickinson, where he led and launched/relaunched a few injection device or combination product programs.
E obtained his Bachelor and PhD degrees in mechanical engineering and a master’s degree in polymer physics.

Fawziya Ali

Senior Scientist, Pfizer Inc.
Fawziya Ali

Fawziya Ali is a Senior Scientist at Pfizer working in the Pharmaceutical Research and Development Group. She has 10 years of experience leading formulation, process and device development of early and late-stage biologics, including mRNA-based vaccines, in novel container closure systems. Fawziya holds a BS in Chemical and Biological Engineering from MIT and an MS in Pharmaceutical Sciences from Northeastern University. She is based in the US in Andover.
 

Khaudeja Bano

Vice President, Combination Product Quality, Amgen
Khaudeja Bano

Khaudeja is a Physician with a Masters in Clinical Research, Pharmaceutical engineering Certification, a Database Administrator and a certified Project Management Professional.

She is an Abbott President’s award winner, avid Toastmaster and Coach. Khaudeja has more than 25 years’ professional experience, including clinical practice. She has held several global medical positions at Guidant, Abbott, and AbbVie Inc. Her career includes global medical / clinical and safety leadership roles in devices, diagnostics, pharmaceuticals and combination products.

She currently serves as the chair for the Post Marketing Safety working group for the Combination Product Coalition (CPC).

 

Kinsuk Shah

Sr. AD Combination Product Steward, Boehringer Ingelheim
Kinsuk Shah

Lawton Laurence

Head of Device & Combination Product Development, Apellis
Lawton  Laurence

Mr. Laurence is Head of Combination Product Development for Apellis Pharmaceuticals, a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. Known as a results-oriented entrepreneur, with a demonstrated track record of success, Mr. Laurence provides leadership in strategic planning and execution for local and systemic drug delivery. Notably, Apellis recently achieved the first in industry approval for a 20ml On-Body Injector. Prior to joining Apellis, he held roles in Research and Technology Development at West Pharmaceutical Services and co-founded an orthopedic medical device company.

Leya Bergquist

Associate Director, ClariMed
Leya Bergquist

Leya Bergquist, Associate Director of Human Factors Engineering at UserWise, a ClariMed Company, is a dedicated leader with over 20 years of experience in the medical device industry. Her broad range of expertise includes product development, preclinical studies, human factors, clinical studies, technology transfer, risk assessment, product verification, design controls, cross-functional collaboration, project and budget planning, mentoring, and team building. For the past 8 years, Leya has focused on integrating human factors throughout the product life cycle, ensuring that devices and therapies are optimized for patient usability and safety.


As a key member of ClariMed, a best-in-class consultancy specializing in integrating human factors engineering and user experience design into medical device product development, Leya is well-versed in identifying and applying the appropriate human factors practices at each stage of product development. She regularly works with human factors submission strategies and compliance documentation for FDA Human Factors Guidance and international standards related to usability engineering (e.g., IEC 62366-1, IEC 60601-1-6, and ISO 14971) for both home and hospital use products.
 

Manuel Sanchez-Felix

VP Drug Delivery Search & Evaluation, Halozyme
Manuel Sanchez-Felix

Dr. Manuel Sanchez-Felix is the VP of the Drug Delivery Search & Evaluation Group at Halozyme. He is a scientific leader with over 20 years of experience in drug discovery and development where he co-invented products and contributed to the successful development and launch of various patient centric pharmaceutical products.

Previously he was at Novartis where he led a cross-functional group from Discovery and Development that have evaluated and implemented external Novel Delivery Technologies for many different types of modalities. He is also part of initiatives designed to promote innovation within Novartis. His previous position at Novartis involved heading a group of scientists at the interface between Research and Development, establishing physicochemical and biopharmaceutical properties, and combining this information to initiate development strategy and formulation design. Prior to joining Novartis, Manuel was at Eli Lilly & Company for 20 years.

His area of expertise includes Biopharmaceutics, drug delivery and patient-centered formulation design. Areas of drug discovery where he has developed products include CNS, infectious diseases (specifically TB), oncology, regenerative, cardiovascular and metabolic diseases.

Dr. Sanchez-Felix received his B.Sc. Honors degree and Ph.D in Chemistry from the University of Surrey, UK. He is also an Adjunct Professor in the Department of Industrial and Physical Pharmacy at Purdue University (West Lafayette, IN) and a Fellow of the Royal Society of Chemistry. Recently, he has joined the Advisory Board for the Biomedical Program at Middlesex Community College.

 

Michael Song

Expert in aseptic filling, combination product and packaging development and commercialization,
Michael Song

Ning Yu

Executive Director, Device and Combination Product Development, Astria Therapeutics
Ning Yu

Ning Yu is an Executive Director, Device and Combination product development at Astria Therapeutics, responsible for the entire Device Lifecycle from early stages of research and development to late and commercial product development and manufacturing at Contract Development and Manufacturing Organizations (CDMOs). Ning has 18 plus years of experience with medical devices and combination products, and worked in companies like Biogen, BD, Zimmer-Biomet. Ning has extensive experience with Pen injector, PFS, Auto-Injectors, On Body Injector, implanted drug delivery device, connected device and smart packaging. Ning holds a PhD in Mechanical Engineering from the University of Illinois and MBA from BU.

Ram Halthore

Director of Engineering, Merck
Ram Halthore

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.

 

Rebecca Engel

Director, Regulatory CMC Strategy, Pfizer, Inc.
Rebecca Engel

Becky Engel is a Director of Regulatory CMC Strategy at Pfizer working in the Global Regulatory Sciences Group in Medical Devices and Combination Products. She has over 23 years of combined industry experience leading device and formulation development, technology transfer of medical devices, OTC and pharmaceutical drugs, as well as global regulatory strategy development and pre- and post-market submissions for pharmaceutical drugs, medical devices and combination products. Becky holds a BS in Physics from the University of Michigan and an MS in Biomedical Engineering from the University of Akron. She is based in the US in Kalamazoo, MI.

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).
 

Robert 'Joe' Mather

Vice President, Head of Digital Sciences and Head of Research, Development and Regulatory, Pfizer
Robert 'Joe' Mather

Joe Mather is a Vice President, Head of Digital Sciences and Head of Research, Development and Regulatory | Lucira. Joe has over thirty years of pharmaceutical research and clinical development experience. Joe was part of Pfizer’s Chantix and Geodon discovery teams. After tenures with both Pfizer and AstraZeneca’s research & clinical development organizations, he rejoined Pfizer as part the foundational leadership for Digital Medicine organization. Since formation of the Digital Sciences group and now Lucira by Pfizer Diagnostic group he has focused on the development and clinical validation of software as a medical devices and in vitro diagnostics.

Sarah Fairfield

Associate Director, RA Device and Combination Products Digital Device and Software, AbbVie
Sarah Fairfield

Sarah Fairfield currently works as an Associate Director, Regulatory Affairs at AbbVie in Combination Products and Digital Devices. She began her career in the medical device industry as a Process Engineer and moved into Regulatory Affairs just over 16 years ago. Her experience includes global regulatory strategy development for medical devices and digital health technologies, pre- and post-market submissions for stand-alone devices and combination products, and regulatory compliance. She holds a Bachelor of Science degree in Biomedical Engineering from Purdue University, an MBA in Health Sector Management from Boston University, and US Regulatory Affairs Credential (RAC).

Senior Regulatory Representative to be announced

,
Senior Regulatory Representative to be announced

Shruti Parikh

Director, Product Design, Takeda Pharmaceuticals
Shruti Parikh

Shruti Parikh is the Packaging Design Lead, Takeda Pharmaceuticals based out of Massachusetts, USA, where she is leading and building Industrial Design, Sustainable Design and Patient-Centric Design capabilities across the company.
As the design lead in packaging development Shruti and her team works towards the remit to integrate design across the company’s consumer, medical device, and pharmaceuticals sectors. In addition to helping improve the lives of the patients using Takeda products every day, the Design team is also focused on improving the environmental impact by reducing the carbon footprint of Takeda packaging.
Specifically, Shruti is passionate about challenging people and organizations to think differently. She loves to dig into global macro trends and translate its potential to redesign products and systems. Impatient for action, she wants to help build an inclusive future that allows us all to thrive socially, ecologically and economically. She is an advocate for a circular economy and is constantly looking to connect with individuals who believe they too can make a positive impact in the world.
 

Soumen Das

Medical Device Qualification Lead & Associate Scientific Fellow, Takeda Pharmaceutical Company Limited
Soumen Das

Soumen Das is an experienced professional in the field of product development within the medical device industry, with a track record spanning over nine years. For the past five years, Soumen has dedicated his efforts to ensuring the biocompatibility of medical devices for the FDA, EU, and PMDA regulatory submissions. His expertise ranges from in-vitro diagnostics to implantable medical devices. His Ph.D. and postdoctoral work focused on material and nanoparticle compatibility with biology, including systemic and organ toxicity. His extensive research has resulted in over fifty peer-reviewed international journal publications showcasing his commitment to advancing the field. He holds eight patents alongside his publications, demonstrating his innovative and creative problem-solving abilities. Recognized for his achievements, Soumen has been honored with several prestigious awards, including the Young Investigator Award 2016 and the 2014 at Gordon Conference in Radiation Chemistry. Additionally, he received the University of Central Florida Innovator Award in 2014.

sponsors

Conference agenda

The two-day agenda will bring you 20+ roundtable discussions to choose from, led by thought leaders from big pharma and biotech, as well device developers, manufacturers and service providers. These discussions will be complimented by presentations in the mornings and afternoon of day one.
At each given round table session, you will have the option to choose from four parallel round tables.
 

See the full agenda here: View Brochure

Or for the summarised agenda, view the below...

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8:00

Registration & Coffee

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8:50

Chair's Opening Remarks

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

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9:00

Opening Keynote Address: Post market safety reporting for combination products and injectable devices

Khaudeja Bano, Vice President, Combination Product Quality, Amgen

  • How have we seen industry adapting to meet evolving regulations through effective compliance strategies
  • Current guidance for industry on postmarket safety reporting for combination products
  • Case study examples for effective approaches to efficiently maintain global reporting compliance for combination products and injectable devices
  • Looking to the future how can we expect the global regulatory landscape to evolve for combination product reporting and recommendation to be best prepared
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    9:30

    Session reserved for Sponsor

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    10:00

    Panel Discussion: Pharmaceutical and Biotech Industry Perspectives on Optimizing Patient Experience and Treatment Adherence Through Subcutaneous Drug Delivery Design

  • Busting myths around subcutaneous delivery
  • Reviewing device features that optimize patient experience
  • Opportunities for technology innovation for enhanced subcutaneous administration
  • Adrienne Fletcher

    Adrienne Fletcher, Director Packaging and Device Innovation, Johnson & Johnson Innovative Medicine

    E Guan, Head of Injection Systems, Takeda

    Dominick DeGrazio, Early Device Project Engineering Lead, GlaxoSmithKline

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    10:30

    Morning Coffee

    Day 1 Roundtables will be taking place from 11.00. There are 4 roundtables at each timeslot, click the roundtable icons below to navigate between all four round table options for each time slot.
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    11:00

    Device Technologies for Novel Drug Products

    Dominick DeGrazio, Early Device Project Engineering Lead, GlaxoSmithKline

  • Innovative device technologies to facilitate SC and IM delivery of novel drug products
  • Technical challenges associated with novel drug product modalities that necessitate need for innovative device solutions
  • Current state and opportunities to advance device technologies to support self-administration of novel drug products
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    12:30

    Networking Lunch

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    13:30

    Utilizing digital health technologies and connected devices in clinical trials

  • Utilising qualified novel digital endpoints and strategies for expanding decentralized trial capabilities normalising remote monitoring in clinical trails
  • Impact of changing regulatory landscape post pandemic and approach to clinical trials
  • Making these technologies impactful in clinical trials and financially viable for post market real world evidence studies
  • Robert 'Joe' Mather, Vice President, Head of Digital Sciences and Head of Research, Development and Regulatory, Pfizer

    Sarah Fairfield, Associate Director, RA Device and Combination Products Digital Device and Software, AbbVie

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    11:00

    Overcoming manufacturing and scale up challenges for injectable drug delivery systems

    Ram Halthore

    Ram Halthore, Director of Engineering, Merck

  • Importance of considering manufacturing in design - how do we build a bridge between manufacturing and design
  • Approaches and considerations for enabling scalability
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    12:30

    Networking Lunch

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    13:30

    Defining an effective biocompatibility strategy for clinical/regulatory success

    Soumen Das, Medical Device Qualification Lead & Associate Scientific Fellow, Takeda Pharmaceutical Company Limited

  • Lifecyle considerations
  • Risk assessments
  • Experiences with successful submissions
  • clock

    11:00

    As innovation in industry accelerates complex products are being designed and developed, how do members of the industry and various regulatory agencies keep up?

    Adrienne Fletcher

    Adrienne Fletcher, Director Packaging and Device Innovation, Johnson & Johnson Innovative Medicine

  • Exploring industry experiences
  • Approaches for mitigating challenges
  • clock

    12:30

    Networking Lunch

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    13:30

    Addressing critical human factors considerations through the connected product life cycle

  • Reviewing key considerations from early-stage development to post-market monitoring
  • Leya Bergquist, Associate Director, ClariMed

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

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    11:00

    Accelerating PFS Development

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

  • Experiences in PFS development and learnings from challenges encountered
  • Improving development efficiency for an accelerated product development
  • Deliberate partner selection for optimizing time to market
  • clock

    12:30

    Networking Lunch

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    13:30

    Effectively taking a platform approach

    Kinsuk Shah

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

  • Implications
  • Technicalities
  • Regulatory perspectives
  • clock

    11:00

    Roundtable Reserved for Gerresheimer

    Commerical Moderator to be announced

    Commerical Moderator to be announced, ,

  • Points to be confirmed
  • clock

    12:30

    Networking Lunch

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    13:30

    Reserved for Sponsor

    Commerical Moderator to be announced

    Commerical Moderator to be announced, ,

  • Points to be confirmed
     
  • clock

    15:00

    Afternoon Tea

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    15:30

    Maximising Patient Centricity in PFS Design

    Shruti Parikh, Director, Product Design, Takeda Pharmaceuticals

  • Defining accessible patient centric design
  • Executing human factors and usability studies to understand patient needs and preference and successfully implementing this in PFS design
  • Strategies and factors to consider for balancing requirements (e.g. technical, commercial, user needs)
  • Case studies and trends in patient centricity
  • clock

    16:00

    Technical Considerations for the Development of a Biologic from a Frozen Vial to a Liquid Pre-filled Pen

    Fawziya Ali, Senior Scientist, Pfizer Inc.

  • The presentation will highlight the development history of a biologic going from asingle-dose frozen vial to a multi-dose liquid pre-filled pen.
  • Topics covered will include:
  • Formulation selection
  • Manufacturing considerations
  • Approaches for the development of a pre-filled pen presentation
  • clock

    16:30

    Chair's Closing Remarks and Close of Day One

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

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    8:15

    Registration & Coffee

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    8:50

    Chair's Opening Remarks

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

    clock

    9:00

    Opening Keynote Address: Developing wearable injection devices: Facilitating effective drug delivery

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

  • Insight into developing user centric devices for effective delivery of novel therapeutic products: sustained release, large volume
  • Optimising the therapeutic effect of injection devices: considering dose accuracy and more
  • Case study on wearable device development
  • Successful strategies for producing and commercialising of a portfolio of device and combination products
  • clock

    9:30

    Session reserved for sponsor

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    10:00

    Notified Body Opinion (NBO): Submissions and Evolving Trends

  • Preparedness is Key
  • Aligning Submission Structure with EU MDR
  • Submission Experience: Expectations are Evolving
     
  • Rebecca Engel, Director, Regulatory CMC Strategy, Pfizer, Inc.

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    10:30

    Morning Coffee

    Day 2 Roundtables will be taking place from 11.00. There are 4 roundtables at each timeslot, click the roundtable icons below to navigate between all four round table options for each time slot.
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    11:00

    On-body delivery device technical and regulatory challenges

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

  • Best practices to implement in development to work towards gaining regulatory approval
  • Overcoming device technology challenges
  • clock

    11:00

    Successfully integrating combination product development with wider drug product development

    Michael Song

    Michael Song, Expert in aseptic filling, combination product and packaging development and commercialization,

  •  Collaboration across device and drug development to ensure speed to clinic
  • Key factors to take into consideration
  • clock

    11:00

    Successful strategies for combination product risk management

    Ning Yu, Executive Director, Device and Combination Product Development, Astria Therapeutics

  • Ensuring understanding
  • Drug vs device methodologies
  • clock

    11:00

    Ensuring medical devices are cybersecure in an evolving environment

  • Cybersecurity risks surrounding medical devices and role of global regulators in reducing these risks
  • Guidance on implementing regulations and steps to be taken to protect patients
  • Senior Regulatory Representative to be announced

    Senior Regulatory Representative to be announced, ,

    Sarah Fairfield, Associate Director, RA Device and Combination Products Digital Device and Software, AbbVie

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    11:00

    Impact of ISO 11608-1 2022 version: industry’s response and pain points

    E Guan, Head of Injection Systems, Takeda

  • Discussing industry’s response
  • Current pain points and overcoming these
  • clock

    11:00

    Reserved for Sponsor

    Commerical Moderator to be announced

    Commerical Moderator to be announced, ,

  • Points to be confirmed
  • clock

    12:30

    Chair’s Closing Remarks and Networking Lunch

    clock

    13:30

    Early Finish


    Director Packaging and Device Innovation
    Johnson & Johnson Innovative Medicine
    Early Device Project Engineering Lead
    GlaxoSmithKline
    Head of Injection Systems
    Takeda
    Senior Scientist
    Pfizer Inc.
    Vice President, Combination Product Quality
    Amgen
    Sr. AD Combination Product Steward
    Boehringer Ingelheim
    Head of Device & Combination Product Development
    Apellis
    Associate Director
    ClariMed
    VP Drug Delivery Search & Evaluation
    Halozyme
    Expert in aseptic filling, combination product and packaging development and commercialization
    Executive Director, Device and Combination Product Development
    Astria Therapeutics
    Director of Engineering
    Merck
    Vice President, Patient Integrated Care Innovation Platform
    Takeda Pharmaceuticals
    Director, Regulatory CMC Strategy
    Pfizer, Inc.
    Sr. Director, Device and Packaging Development
    Genentech
    Vice President, Head of Digital Sciences and Head of Research, Development and Regulatory
    Pfizer
    Associate Director, RA Device and Combination Products Digital Device and Software
    AbbVie
    Director, Product Design
    Takeda Pharmaceuticals
    Medical Device Qualification Lead & Associate Scientific Fellow
    Takeda Pharmaceutical Company Limited

    Sponsors

    Official Media Partner

    Start networking early

    Taking place from the start of the week at the same venue:

    Join your peers at the Wearable Injectors and Connected Devices USA Conference where you will gain high-quality, key insights on the latest advancements in on-body device development and integration of connected applications needed to enhance your wearable devices and connected product portfolios.

    Wearable Injectors and Connected Devices USA

    Wearable Injectors and Connected Devices USA

    Courtyard by Marriott Boston Downtown
    September 9 - September 10, 2024
    , USA

    VENUE

    Courtyard by Marriott Boston Downtown

    Boston, USA

    A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
    HOTEL BOOKING FORM

    Event Brochure

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    Sponsorship Prospectus

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    Agenda at a Glance

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    About the Conference

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    Portfolio Attendees

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    Chair Letter

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    Sponsors


    Gerresheimer

    Sponsors
    http://www.gerresheimer.com

    Gerresheimer is the innovative system and solution provider and global partner for the pharma and biotech industry. The company offers a comprehensive portfolio of pharmaceutical containment solutions, drug delivery systems and medical devices as well as solutions for the health and cosmetics industry. The product range includes digital solutions for therapy support, medication pumps, syringes, pens, auto-injectors and inhalers as well as vials, ampoules, tablet containers, dropper bottles, other bottles and more. Gerresheimer ensures the safe delivery and administration of drugs to the patient. With 36 production sites in 16 countries in Europe, America and Asia, Gerresheimer has a global presence and produces locally for the regional markets. With over 11,000 employees, the company generated revenues of around €1.82bn in 2022. Gerresheimer AG is listed in the MDAX on the Frankfurt Stock Exchange (ISIN: DE000A0LD6E6).

    Media Partners


    ONdrugDelivery Magazine

    Official Media Partner
    http://ondrugdelivery.com

    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.


    Drug Delivery Leader

    Official Media Partner
    https://www.drugdeliveryleader.com/

    Drug Delivery Leader focuses on the people, technologies, and processes responsible for optimizing the therapeutic delivery of pharmaceutical compounds. The community highlights best practices and advancements throughout the development process with respect to drug delivery, from drug formulation to the design/development and, ultimately, procurement of drug delivery solutions. Scientific and engineering professionals will gain insights into addressing the biggest challenges related to drug delivery – via injectable, oral solid dose, inhalation, infusion, transdermal, and ocular routes of administration.


    pharmaphorum

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

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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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    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




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