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Pre Filled Syringes East Coast (Virtual Conference)
26 April - 27 April 2021

Post event on demand access to recorded presentations will be available to all attendees 5 working days from the end date of the event.

Pre Filled Syringes East Coast (Virtual Conference)

SAE Media Group are proud to announce the 8th Pre Filled Syringes East Coast virtual conference taking place on 26th and 27th April 2021 | ALL TIMINGS ARE EDT

The global pre-filled syringes market was valued at $4.9 billion in 2018 and with the rapid growth of the industry, is expected to exceed $9.7 billion by 2025. With that in mind, this event will bring together specialists within the industry to provide an exclusive insight into the sphere of regulation, new digital technology trends, human factors studies and innovative design and delivery systems within the prefilled syringe industry.

This comprehensive overview will help attendees understand the changing global market and the challenges faced within the industry. The upcoming conference will cover key topics driving the industry including: advancing development for drug delivery devices, regulatory updates including the FDA draft guidance on bridging studies, connectivity and digital health for combination products and compatibility for drug delivery systems.
 

This two-day agenda offers you peer-to-peer networking with Global Product Managers, Senior PFS Engineers, Device Testing Managers, Heads of Late-Stage PFS Development and many more.


We look forward to welcoming you to the conference in April 2021.

 

FEATURED SPEAKERS

Christine Lynn Lanning

Christine Lynn Lanning

Distinguished Scientist, Device Area Leader, Safety Assessment/Merck & Co., Inc
Courtney Jarrahian

Courtney Jarrahian

Portfolio Leader, Packaging and Delivery Technologies, PATH
Danielle Laiacona

Danielle Laiacona

Device Development Engineer, Regeneron Pharmaceuticals, Inc.
Herve Soukiassian

Herve Soukiassian

Senior program leader - Chronic therapeutics segment, Becton Dickinson (BD)
John Barr Weiner

John Barr Weiner

Associate Director for Policy and Product Classification Officer, Food and Drug Administration
Julia Frese

Julia Frese

Director, TUV SUD Japan Ltd.
Kathleen Gove

Kathleen Gove

Senior Device Development Engineer, Regeneron Pharmaceuticals
Kristina  Lauritsen

Kristina Lauritsen

Combination Products Regulatory Advisor, FDA/CDER
Krystin Meidell

Krystin Meidell

Senior Manager, Regulatory Affairs CMC Medical Devices and Combination Products, Biogen
Megan K. Doyle

Megan K. Doyle

Global Policy Lead, Combination Products, Digital Health, and Diagnostics, Amgen
Miles Buroker

Miles Buroker

Human Factors Engineer, UserWise, Inc.
Prem Ganapathy

Prem Ganapathy

Director, Head, Medical Device Test and Design Lab, Takeda
Sally Wixson

Sally Wixson

Associate Director Regulatory Affairs, CMC. Combination Products and Medical Devices, Janssen Research & Development
Susan Neadle

Susan Neadle

Executive Director, Regulatory Affairs (Devices, Combination Products, Digital Health and IVDs), Amgen
Theresa Jeary

Theresa Jeary

Technical Specialist & Scheme Manager, BSI
Tieming Ruan

Tieming Ruan

Sr. Director of Combination Products, Alexion Pharmaceuticals

Christine Lynn Lanning

Distinguished Scientist, Device Area Leader, Safety Assessment/Merck & Co., Inc
Christine Lynn Lanning

Dr. Christine Lynn Lanning is a Distinguished Scientist in Safety Assessment at Merck. In this role, she provides oversight of the biocompatibility of medical devices and medical device combination products. She has a PhD from Duke University in Pharmacology/Toxicology and is Six Sigma Green and Black Belt Certified. She has been at Merck over 20 years with experience with both drug and device development. She has authored over 200 scientific reports and over 50 regulatory submissions.

Courtney Jarrahian

Portfolio Leader, Packaging and Delivery Technologies, PATH
Courtney Jarrahian

Courtney Jarrahian oversees a portfolio of projects at PATH advancing vaccine and pharmaceutical packaging and delivery technologies and is co-leader of the Microarray Patch Center of Excellence. In collaboration with private- and public-sector partners, she implements projects to develop, assess, and introduce combination products and medical devices, with a focus on user-centered design, technical development, human factors evaluation, health economics, manufacturing, regulatory pathways, and commercialization. She also serves on the World Health Organization’s (WHO) Immunization Practices Advisory Committee (IPAC) delivery technologies working group and is a member of PATH’s Research Ethics Committee.

Danielle Laiacona

Device Development Engineer, Regeneron Pharmaceuticals, Inc.
Danielle Laiacona

Danielle Laiacona is a Device Development Engineer with Regeneron’s Combination Products New Technologies Management team, where she leads collaboration projects with medical device partner companies to identify innovative delivery solutions for Regeneron’s patients. Danielle earned her MS in Biomedical Engineering from Binghamton University with a focus on skin biomechanics

Herve Soukiassian

Senior program leader - Chronic therapeutics segment, Becton Dickinson (BD)
Herve Soukiassian

Hervé Soukiassian joined BD-Pharmaceutical Systems business 12 years ago and is currently the leader for Product Development pertaining to Prefillables Syringes for Chronic therapeutic segment. He has also contributed actively within the PDA – currently engaged in the PDA task force “Achieve Zero visible particles injecting into patients”- and is one of the co-author of the Technical report 73 “Prefilled Syringe User Requirements for Biotechnology Applications”. Prior to joining BD, Herve worked for 13 years at Hewlett Packard in various positions gaining experience and developing expertise in the field of process engineering – learning and applying key concepts of Total Quality Control, Design for Manufacturing, Just in Time, Single Minute Exchange of Die, Theory of constraint. He later joined the board of Directors of ActiCM, a start-up company associated with the “Commissariat a l’Energie Atomique (CEA)” and specialized in optical Coordinate Measurement Machines.
Herve graduated from the "Institut National des Sciences Appliquées" of Lyon as a mechanical & industrial engineer. He also holds a master’s degree in material sciences.
 

John Barr Weiner

Associate Director for Policy and Product Classification Officer, Food and Drug Administration
John Barr Weiner

John Weiner is the Associate Director for Policy in the Food and Drug Administration’s Office of Combination Products, which is tasked with the classification and assignment for regulation of therapeutic products (drugs, devices, biological products, and combination products), and with ensuring the sound and consistent regulation of combination products. Prior to joining OCP, Mr. Weiner was an Associate Chief Counsel in FDA’s Office of Chief Counsel, advising the agency on various issues including regulation of drugs and cross-cutting topics including the regulation of products that use nanotechnology. Before coming to FDA, Mr. Weiner was in private practice in the areas of food and drug, environmental, and related aspects of public international and trade law. He has published and lectured on topics in all three areas. Mr. Weiner received a B.A. from Princeton University and a J.D. with honors from the Columbia University School of Law.

Julia Frese

Director, TUV SUD Japan Ltd.
Julia Frese

By education biomedical engineer with a Master degree in business administration. Julia gained experience in development, regulatory approval of combination devices and ATMP products. She was further involved in the development of standards for ATMP products. Currently Julia Frese is heading the division of Medical and Health Services at TÜV SÜD Japan and is responsible for the development of article 117 service within the organisation. She is further co-chair of the Team NB working group for article 117.
 

Kathleen Gove

Senior Device Development Engineer, Regeneron Pharmaceuticals
Kathleen Gove

Kathleen Gove graduated from Clarkson University in 2012 with a BS in Mechanical Engineering and a minor in Biomedical Engineering. Kathleen completed her doctorate in biomedical engineering from Dartmouth College in 2017 and went on to work in product development in the field of Orthopedics. Kathleen then joined Regeneron in 2019 as a senior device development engineer working on clinical programs and leading platform initiatives to improve the speed to clinic for project teams.

Kristina Lauritsen

Combination Products Regulatory Advisor, FDA/CDER
Kristina  Lauritsen

Kristina Lauritsen, PhD serves as a Combination Product Policy Advisor within the Center for Drug Evaluation and Research (CDER) at the FDA. In this role, she is responsible for engaging in development of CDER's policies related to combination product review and regulation, including activities such as guidance development, facilitating coordination with the FDA's Office of Combination Products, CBER and CDRH, and representing CDER in cross-center combination product working groups. Kristina originally joined FDA in 2003 as a device reviewer in CDRH. She later joined the Office of Combination Products and spent several years there prior to joining CDER in 2014. She holds a B.S. in Biology from Shippensburg University, and a Ph.D. in tumor biology from Georgetown University.

Krystin Meidell

Senior Manager, Regulatory Affairs CMC Medical Devices and Combination Products, Biogen
Krystin Meidell

Krystin Meidell works with the Regulatory CMC Medical Devices and Combination Products group at Biogen where she has supported combination product regulatory strategy for the past two years, including digital health. Prior to joining Biogen, Krystin’s experience includes global regulatory and analytical roles in active medical devices and software, drug delivery, and diagnostics. She holds a Bachelor of Science degree in Chemical Engineering from Carnegie Mellon University.

Larry Atupem

Sr Business Development Specialist, Zeon Specialty Materials
Larry Atupem

Megan K. Doyle

Global Policy Lead, Combination Products, Digital Health, and Diagnostics, Amgen
Megan K. Doyle

Megan Doyle is an attorney with more than 10 years advising on matters pertaining to the regulation of drugs, medical devices, combination products, and in vitro diagnostics. She received her law degree from Georgetown University Law Center and her master’s in public health from Johns Hopkins University. After seven years in the medical device practice at Hogan Lovells, she joined Amgen as a Senior Counsel for Health Regulatory. For four years, she counseled Amgen on drug, device, combination product, and diagnostic matters. In particular, she advised product teams developing new, innovative delivery devices and digital health solutions. She also served as the law department companion diagnostic lead, advising on the co-development process for teams developing targeted therapies that require a companion diagnostic. Currently, she is a Director in Amgen’s Global Regulatory and R&D Policy group, where she is the Global Policy Lead for Diagnostics, Digital Health, and Combination Products.

Michael Song

Associate Director, Takeda
Michael Song

Miles Buroker

Human Factors Engineer, UserWise, Inc.
Miles Buroker

Miles first joined UserWise as an intern for the summer of 2018 and came on as a full-time consultant in mid-2019. He is experienced in

  • forming use-related risk analyses and test protocols; 
  • observing usability study sessions for formative and validation testing; 
  • preparing test reports, risk-benefit analyses and Human Factors Engineering Submission Reports for FDA;
  • providing human factors trainings and workshops;
  • and with establishing compliance documentation for IEC 62366:2007, IEC 62366-1:2015, and FDA Guidance Documents.

His focus is predominantly on combination products. Miles brings a wide range of pertinent experience from his undergraduate career, including serving as a research assistant, developing a stress-sensing wearable device and accompanying application, and participation in design studios.
 

Prem Ganapathy

Director, Head, Medical Device Test and Design Lab, Takeda
Prem Ganapathy

Prem Ganapathy currently works as the Head of the Medical Device Test and Design Lab, where he is responsible for managing and overseeing Takeda’s internal medical device testing laboratory and external testing partners .Prem has a background in Biomedical engineering and is a Medical device professional with over 17 years of combined experience in Product development, manufacturing and operations , where his experience last 10 years spans drug delivery and insulin delivery systems.

Sally Wixson

Associate Director Regulatory Affairs, CMC. Combination Products and Medical Devices, Janssen Research & Development
Sally Wixson

Sally Wixson has over 20 years’ industry experience, working for the past 7 years in Regulatory Affairs preparing and executing global regulatory strategies and submissions for medical devices, drugs, and drug-device combination products in a variety of fields including: ophthalmology, cardiovascular, metabolism, immunology, and neurology.
Sally has also held various roles in Regulatory Affairs and Preclinical R&D at Ethicon, Dr. Reddy’s Laboratories, Allergan, Integra LifeSciences, Merck, and Schering-Plough. Sally is Regulatory Affairs Certified (dual certified in drugs and medical devices), holds a MS and BS in Animal Science and Veterinary Medical Degree, and is an American College of Laboratory Animal Medicine Diplomate.
 

Susan Neadle

Executive Director, Regulatory Affairs (Devices, Combination Products, Digital Health and IVDs), Amgen
Susan Neadle

Susan Neadle recently joined Amgen as Head of Combination Products & Medical Devices Regulatory Affairs, following a very successful career of more than 25 years at Johnson & Johnson, where she held integral leadership roles in Research & Development and Quality Engineering, spanning medical devices, pharmaceuticals, consumer products and the Enterprise. In her most recent role, Sr. Director, Global Value Chain Quality Design, she served as Chair of J&J’s Design Council, advancing world-class practices in product and process design and development to drive robust, customer-centric health care solutions across J&J. She also led J&J's Combination Products Community of Practice. Among several achievements, Susan led the team that defined and implemented the globally integrated business model to meet Combination Products health authority regulations at Janssen, J&J’s Pharmaceutical sector. She was awarded the Janssen Supply Chain Inclusion Award in recognition of her global cross-functional leadership and collaboration. Susan is a Design & Process Excellence Blackbelt, and has applied those skills to drive and develop impactful new products and positive business outcomes, for which she was awarded the Johnson Medal, J&J’s highest honor for excellence in Research & Development. She holds numerous patents and publications, and frequently speaks in public venues. Susan is actively engaged in multiple industry working groups on a range of Combination Products topics, including ASTM International, CPC, EFPIA, AdvaMed, Xavier/FDA Combination Products Summit Planning Committee, DIA and PDA and ISPE. She serves as Chair of the ISPE Combination Products Community of Practice, and as Vice-Chair of the Combination Products Coalition PMSR Working Group. Susan earned an M.S. in polymer science & engineering, and a B.S. in biology/chemistry, as well as Fellowship in the American Academy of Optometry. Susan has also been very active in Workforce of the Future, collaborating with University of Maryland, FDA, and other cross-industry subject matter experts to establish and teach a curriculum in Combination Products.

Theresa Jeary

Technical Specialist & Scheme Manager, BSI
Theresa Jeary

Theresa Jeary holds a master’s degree in Pharmaceutical Science from the Royal College of Surgeons, Ireland and is eligible to be a Pharmaceutical Qualified Person.

Theresa has over 30 years’ experience working in both the Pharmaceutical and Medical Device industries and has worked in a variety of roles across the full development cycle from product concept and early stage development, process transfer, validation and regulatory departments.

In addition to her product development and global regulatory expertise, Theresa has over 12 years Notified Body experience, first at BSI as a technical expert for devices with ancillary medicinal substance and borderline classifications moving then to LRQA where she held the role of Head of Notified Body for several years.

More recently Theresa has worked as a consultant to the Medtech sector assisting Manufacturers in their product development and supporting them in navigating their legal requirements and changes to the Medical Device Regulations and re-joined BSI in August 2020, working as a technical specialist in the Medicinal and Biologics Team.

Theresa is a regular presenter on combination products and Article 117 and regularly contributes to various scientific publications and regulatory guidance and has extensive experience of interacting with EU Competent Authorities.

Tieming Ruan

Sr. Director of Combination Products, Alexion Pharmaceuticals
Tieming Ruan

sponsors

Conference agenda

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8:30

Chair's Opening Remarks

Susan Neadle, Executive Director, Regulatory Affairs (Devices, Combination Products, Digital Health and IVDs), Amgen

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8:40

Combination Products Risk Management

Susan Neadle, Executive Director, Regulatory Affairs (Devices, Combination Products, Digital Health and IVDs), Amgen

  • Risk is everywhere! Risk management forms the foundation for effective product development and lifecycle management.
  • In this talk we review risk management for medical devices, drugs and combination products, including regulatory highlights, integrated risk management, and essential performance requirements (EPRs)
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    9:30

    A holistic overview of the injector system development process

    Michael Song

    Michael Song, Associate Director, Takeda

  • An insight into the key stages of device development for pre-filled syringes and combination products
  • How a better understanding of cross functional activities beyond device development can allow for a more integrated approach
  • Considerations in device development strategy
  • A future outlook of pre-filled syringes development and guidance for a more integrated device portfolio strategy 
  •  

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    10:10

    Morning Break and Virtual Exhibitor Hall Open

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    11:20

    Optimizing development for pre-filled syringes platforms

    Kathleen Gove, Senior Device Development Engineer, Regeneron Pharmaceuticals

  • An industry outlook on platforms for pre-filled syringes
  • Documentation creation and management strategies, challenges, and considerations throughout life of program
  • User population definitions and human factors studies as a one-size-fits-all approach
  • Use of characterization and DV&V to support the platform program and project teams
  • Challenges and limitations of testing and potential solutions

     

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    12:00

    Global health priorities for prefilled delivery devices

    Courtney Jarrahian, Portfolio Leader, Packaging and Delivery Technologies, PATH

  • Use of prefilled delivery devices to meet public health priorities in low- and middle-income countries
  • Opportunities and value proposition for prefilled vaccines and essential medicines
  • Pathways to introduction of new compact, prefilled, autodisable devices in low-resource settings
  • Novel combination product technologies, including dual-chamber delivery devices and microarray patches
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    12:40

    Networking Break and Virtual Exhibitor Hall Open

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    13:40

    Improving subcutaneous injection for chronic care settings – Working together to innovate for impact

  • Understand how early collaboration enables us to build the right product the first time by designing around needs first rather than existing technology and its constraints
  • Explore how the default use of ½” staked needle prefilled syringes has impeded combination product innovation and imposed unnecessary constraints on drug manufacturers
  • Examine how an 8 mm staked needle prefilled syringe addresses the industry’s unmet needs:
  • Increase injection device design space, focusing on solutions with high viscosities and volumes
  • Reduce the injection/needle-related anxiety
  • Reduce the risk of accidental intramuscular injection (important consideration for risk management planning)
  • Maintain acceptable injection force and time for high-volume and high-viscosity drugs
  • Maintain needle mechanical resistance (needle bending and buckling)
  • Simplify user injection technique
  • Herve Soukiassian, Senior program leader - Chronic therapeutics segment, Becton Dickinson (BD)

    Danielle Laiacona, Device Development Engineer, Regeneron Pharmaceuticals, Inc.

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    14:20

    Evolving PFS and combination product regulations beyond the US

    Sally Wixson, Associate Director Regulatory Affairs, CMC. Combination Products and Medical Devices, Janssen Research & Development

  • An update on the EU MDR: How has industry been adapting, considerations for dossier revisions and challenges around notified body opinion
  • Evolving international expectations beyond EU for combination products
  • Considerations for co-packaged combination products with stand-alone elements
  • Guidance on harmonizing documentation for international requirements
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    15:00

    Afternoon Break and Virtual Exhibitor Hall Open

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    15:30

    Lifecycle Management for Combination Products - An Industry Perspective

    Krystin Meidell, Senior Manager, Regulatory Affairs CMC Medical Devices and Combination Products, Biogen

  • Overview of regulatory change assessments
  • Requirements and guidance in the US and upcoming rules in the EU
  • Case Study Example
  • Key considerations when conducting lifecycle management changes

     

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    16:10

    Combination Products Bridging Study Landscape and a Case Study

    Tieming Ruan

    Tieming Ruan, Sr. Director of Combination Products, Alexion Pharmaceuticals

  • Industry strategies to ensure correct bridging of clinical trials
  • Foreseeable effects of FDA draft guidance on bridging studies
  • A Case Study of combination products bridging study
  • clock

    16:50

    Chair’s Closing Remarks and Close of Day One

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    8:30

    Chair's Opening Remarks

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    8:40

    Notified body perspective on platform approaches and European recognition of platforms

    Julia Frese, Director, TUV SUD Japan Ltd.

  • How has the pre-filled syringes and combination products industry evolved in the use of platforms
  • Current notified body guidance and requirements for combination product platforms
  • Where do European regulations stand on recognition of platforms

     

  • clock

    9:20

    Panel Discussion: Convergence opportunities for combination products

  • Key differences and similarities between international regulations, standards and guidance for combination products
  • Explore opportunities and strategies for convergence in the combination products space, amidst ongoing efforts of convergence for devices, drugs and biologics across jurisdictions
  • Regulatory Implications of a digital future
  • Susan Neadle, Executive Director, Regulatory Affairs (Devices, Combination Products, Digital Health and IVDs), Amgen

    Theresa Jeary, Technical Specialist & Scheme Manager, BSI

    Julia Frese, Director, TUV SUD Japan Ltd.

    Kristina Lauritsen, Combination Products Regulatory Advisor, FDA/CDER

    John Barr Weiner, Associate Director for Policy and Product Classification Officer, Food and Drug Administration

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    10:00

    Morning Break and Virtual Exhibitor Hall Open

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    10:30

    EU MDR and Article 117 Lessons Learned

    Theresa Jeary, Technical Specialist & Scheme Manager, BSI

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    11:10

    The acceleration towards connectivity for pre-filled syringes and combination products

    Kristina Lauritsen, Combination Products Regulatory Advisor, FDA/CDER

  • The pre-filled syringes industry’s continued growth and commitment in advancing the use of technology, software and wearables
  • A review of current regulatory guidance for PFS and combination products
  • A review of current guidance for connected devices and FDA’s new digital health center of excellence
  • The future of digital health in the PFS industry; what has changed in the past year and the key regulations to be considered
  • clock

    11:50

    Networking Break and Virtual Exhibitor Hall Open

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    12:50

    Connected Combination Products: The Industry Perspective

    Megan K. Doyle, Global Policy Lead, Combination Products, Digital Health, and Diagnostics, Amgen

  • The industry is moving to incorporate digital components into combination products to improve the patient experience.
  • Connected Combination Products are one way to accomplish this, but few have been approved to date.
  • This presentation will address challenges in the development and review of connected combination products and other digital health priorities, from the industry perspective
  • clock

    13:30

    Technical Overview of COP for Prefilled Syringes

    Larry Atupem

    Larry Atupem, Sr Business Development Specialist, Zeon Specialty Materials

  • Key properties of COP
  • Case Study (New): 
  • Protein Adsorption of Abatacept – COP vs Glass
  • Immunogenicity test of the aggregates
  • Case Study: Protein Adsorption of Humira, Embrel, Remicade – COP vs Glass
  • Case Study: Protein Adsorption with/without Polysorbate (Surfactant) – COP vs Glass
  • Leachable data on COP syringes
  • clock

    14:10

    Afternoon Break and Virtual Exhibitor Hall Open

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    14:40

    Biocompatibility of a Medical Device Combination Product: Prefilled Syringe as a Foundation for Other Delivery Devices

    Christine Lynn Lanning, Distinguished Scientist, Device Area Leader, Safety Assessment/Merck & Co., Inc

  • Foundational principles of biocompatibility of medical device/combination products
  • Regulatory expectations for biocompatibility 
  • Biocompatibility of a prefilled syringe
  • Biocompatibility of other delivery devices using the prefilled syringe as a foundational element
  • clock

    15:20

    A Holistic Industry Outlook of Testing and Development for Pre-Filled Syringes

    Prem Ganapathy, Director, Head, Medical Device Test and Design Lab, Takeda

  • Takeda’s current portfolio of pre-filled syringes
  • Current device testing processes throughout the pre-filled syringes landscape
  • How can we improve current processes to ensure optimized PFS device testing and development?

     

  • clock

    16:00

    Chair’s Closing Remarks and Close of Day Two


    Distinguished Scientist, Device Area Leader
    Safety Assessment/Merck & Co., Inc
    Portfolio Leader, Packaging and Delivery Technologies
    PATH
    Device Development Engineer
    Regeneron Pharmaceuticals, Inc.
    Senior program leader - Chronic therapeutics segment
    Becton Dickinson (BD)
    Associate Director for Policy and Product Classification Officer
    Food and Drug Administration
    Director
    TUV SUD Japan Ltd.
    Senior Device Development Engineer
    Regeneron Pharmaceuticals
    Combination Products Regulatory Advisor
    FDA/CDER
    Senior Manager, Regulatory Affairs CMC Medical Devices and Combination Products
    Biogen
    Sr Business Development Specialist
    Zeon Specialty Materials
    Global Policy Lead, Combination Products, Digital Health, and Diagnostics
    Amgen
    Associate Director
    Takeda
    Human Factors Engineer
    UserWise, Inc.
    Director, Head, Medical Device Test and Design Lab
    Takeda
    Associate Director Regulatory Affairs, CMC. Combination Products and Medical Devices
    Janssen Research & Development
    Executive Director, Regulatory Affairs (Devices, Combination Products, Digital Health and IVDs)
    Amgen
    Technical Specialist & Scheme Manager
    BSI
    Sr. Director of Combination Products
    Alexion Pharmaceuticals

    Sponsors

    Exhibitors

    Official Media Partner

    Supporting Media Partners

    Pre-Filled Syringes East Coast - Full Programme 2021

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    Preliminary Attendees List 2021

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    Speaker interview with Megan Doyle, Amgen

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    Speaker interview with Krystin Meidell, Biogen

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    Speaker interview with Julia Frese, TÜV SÜD

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    Speaker interview with Courtney Jarrahian, PATH

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    Post Conference Report

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    Speaker Interview Tieming Ruan, Alexion Pharmaceuticals

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    Speaker interview with conference chair Susan Neadle, Amgen

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    Chair Letter 2021

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    Speaker line-up & Bios 2021

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    Past Attendee List 2020

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    Pre-Filled Syringes East Coast - Short Programme 2021

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    PAST PRESENTATION BY Juha Mattila, STERIS Life Sciences

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    PAST PRESENTATION BY Alie Jahangir, Janssen

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    PAST PRESENTATION BY Heather Guerin, Janssen

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    PAST PRESENTATION BY Khaudeja Bano

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    PAST PRESENTATION BY Rajiv Gupta, Takeda

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    PAST PRESENTATION BY Megan Heft, AstraZeneca

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    PAST PRESENTATION BY Tina Kiang, FDA

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    PAST PRESENTATION BY Theresa Jeary, BSi

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    Sponsors


    BD Medical - Pharmaceutical Systems

    Sponsors
    http://drugdeliverysystems.bd.com

    As a partner of choice for the pharmaceutical and biotech companies across the globe, BD Medical - Pharmaceutical Systems provides a broad range of ready-to-use drug delivery systems including glass and plastic prefillable syringes, safety and shielding systems, self-injection systems and connected solutions that ensure smooth delivery, regardless of drug complexity, viscosity and dosing volume. We offer our expertise and resources to support their product launch and life cycle management through consultative, analytical and clinical services to help ensure drug compatibility and seamless systems integration, while accelerating time-to-market and reducing risk.

    More information available @ drugdeliverysystems.bd.com

    Contact us @ drugdeliverysystems.bd.com/contact-us



    ZEON

    Sponsors
    http://www.zeonex.com

    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.

    Exhibitors


    Almac Group

    Exhibitors
    http://www.almacgroup.com

    Almac is an established contract development and manufacturing organization that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. From our Audubon, PA facilities, Almac provides innovative commercial packaging solutions built upon quality & flexibility to support all your packing needs, from niche/orphan drug launches to high volume products. Our specialized packaging solutions for all biopharmaceutical dosage forms (vials, ampoules, pre-filled syringes, auto-injector pens) includes:
    • - Pack design and prototype generation
    • - Labeling, assembly and secondary packaging
    • - Complex kit assembly
    • - Temperature sensitive storage
    • - Serialization
    Our wide range of services and flexibility to handle projects of any size, makes us your preferred US packaging partner.


    Owen Mumford

    Exhibitors
    http://www.ompharmaservices.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.

    Media Partners


    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.


    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.


    American Pharmaceutical Review

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

    Start receiving your free copy today. American Pharmaceutical Review is a review of the drug pipeline from the late discovery phase through manufacturing. American Pharmaceutical Review prides itself on having the most relevant, unbiased and informative editorial in the industry. You will find that all of our editorial is highly technical and written by government agencies, consultants, academics, and large pharmaceuticals companies. American Pharmaceutical Review covers several key topics that are important to drug production:Separations and purification, Drug Delivery, Biopharmaceutical Processing, Biopharmaceutical Development, Formulation development, Manufacturing, Microbiology, Instrumentation, Spectroscopy


    Medical Design Briefs

    Official Media Partner
    http://WWW.TECHBRIEFS.COM/SUBSCRIBE/MDB/SMIEAST21

    Medical Design Briefs (MDB) is the only publication for the medical OEM market dedicated to medical product design engineers and managers. We offer timely, accurate, quality content and editorial, and we report on engineering-related topics that are at the core of the latest medical technologies. From materials to manufacturing, we dive into the technical side of bringing medical devices to market. From biosensors to cybersecurity, we keep our fingers on the pulse of the hottest trends and topics that may augment or disrupt medical technology.

    Media Partners


    Gate2Biotech

    Supporting Media Partners
    http://www.gate2biotech.com

    Gate2Biotech is a portal that unites biotechnological community in Central Europe. It covers all the news in the field of biotechnology. Thanks to the the portal the companies engaged in the field can easily search for research institutions and other partners to solve technical problems they are facing and here they can also present their services offer to potential partners from the Czech Republic and abroad. Gate2Biotech portal serves as a bridge connecting scientific and commercial sector. It incorporates offices and support organizations dedicated to promoting transfer of innovative technologies into a unified communication platform of Czech and international biotechnologies. As a mediator of information it draws attention to biotechnologies and support of their application and transfer into practice. It also functions as a tool for encouraging non-professionals (especially scientists and students) towards innovative business or applied research.


    Pharmaceutical Outsourcing

    Supporting Media Partners
    http://www.pharmoutsourcing.com

    Pharmaceutical Outsourcing, the journal dedicated to pharmaceutical and biopharmaceutical contract services. With regular sections on contract manufacturing, contract research, contract packaging, formulation/development services, contract analytical testing, APIs, stability testing, clinical research and other areas, we bring the most complete coverage of trends and issues in the industry to our 15,000 readers in North America.


    pharmanews hq

    Supporting Media Partners
    http://http://pharmanewshq.com

    MedChemNet provides a unique and unparalleled platform for the medicinal chemistry community to share insights, discuss the latest research, and help move the field forward. MedChemNet covers all aspects of the drug discovery pipeline, from target identification and validation, through computer aided drug design (CADD), synthesis, screening and other biophysical techniques, to development of novel lead compounds and pre-clinical in vivo proof of concept. We also cover the design of synthetic drug delivery carriers and ADME/toxicology studies, as well as intellectual property and economic related issues. Website: Welcome to Pharma News HQ, the journal dedicated to the pharmaceutical and biopharmaceutical contract services. With regular sections on contract manufacturing, contract research, contract packaging, formulation/development services, contract analytical testing, APIs, stability testing, clinical research and other areas, we bring the most complete coverage of trends and issues in the industry. Pharmanewshq.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production.


    Technology Networks

    Supporting Media Partners
    http://go.technologynetworks.com/subscribe-to-newsletters

    Founded in 2000, Technology Networks is established as the leading news provider for life science and drug discovery professionals. In addition, we provide unique content including webcasts, videos, application notes and posters from recent conferences. Our portfolio now includes around 30 focussed scientific communities, all of which are accessible free of charge within TechnologyNetworks.com


    Pharmaceutical Technology

    Supporting Media Partners
    http://www.pharmaceutical-technology.com

    Pharmaceutical-technology.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production. Pharmaceutical-technology.com brings you the latest in industry projects and updates, along with the news, views and trends that leading professionals – from senior executives to manufacturing managers and heads of procurement – require to stay on top of their field.


    Pharmiweb

    Supporting Media Partners
    http://www.pharmiweb.com

    Established in October 2003, PharmiWeb Solutions is an energetic, innovative provider of web-based solutions for the pharmaceutical sector, with customers such as AstraZeneca, Roche, Servier Laboratories, and Merck With solutions in three key areas: Online Publishing, e-Business and Mobile Computing, we deliver connectivity – between people and applications – unlocking islands of data and knowledge. We own some of the sector’s most innovative Online Publications: PharmiWeb.com, HospitalPharma.com and Detail-Direct.com. We are actively developing solutions for Mobile Computing platforms. For example, our PharmiTabTM e-pharmacy solution runs real-time patient data and prescribing transactions in a busy hospital environment, on a TabletPC, wireless client/server platform. e-Business solutions range from e-Detailing, to Online Market Research, all designed to increase reach, increase sales, and to reduce administration and costs.


    Pharmacircle

    Supporting Media Partners
    http://www.pharmacircle.com

    PharmaCircle is an innovative knowledge management company serving the current and future global leaders in the Pharmaceutical and Biotechnology related industries. PharmaCircle is a one stop information and analysis source for pipeline, products, clinical trials, drug delivery technologies, deals and acquisitions, company financials, venture capital investments, product sales, pharmaceutical services, news, patents and more….


    Pharma network magazine

    Supporting Media Partners
    https://www.pharmanetwork.digital

    PHARMAnetwork is a company specialized in publishing for the pharmaceutical industry. PHARMAnetwork has developed publications for CMO, CDMO and professionals working in the life sciences. PHARMAnetwork designs specialized studies for pharmaceutical companies, contract service providers and investment firms. PHARMAnetwork magazine covers, every aspect of pharmaceutical value chain, the change and developments in the intersection between pharmaceutical industry and outsourcing industry. We perform interviews and write articles whose thematic strategies, organizations, mergers and acquisitions, regulatory, innovation in the pharmaceutical development and contract manufacturing. https://www.pharmanetwork.digital


    pharmaphorum

    Supporting Media Partners
    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


    Pharmalicensing

    Supporting Media Partners
    http://www.pharmalicensing.com

    Pharmalicensing (www.pharmalicensing.com) is the premier biopharmaceutical Open Innovation resource designed for professionals involved with partnering, licensing and business development worldwide. Actively supporting all forms of partnering and in- and out-licensing activities, Pharmalicensing utilizes the unique online Showcase Profiling & Discover services, as well as its renowned Partnering Search service leveraging its global network of industry experts, to enable companies to identify and engage with appropriate partners around the world. Pharmalicensing is actively utilized by many tens of thousands of industry professionals each month. Pharmalicensing is a division of Cognis Group, Inc.


    Farmavita

    Supporting Media Partners
    https://farmavitar.com

    FarmavitaR+ is the professional network of experts and service providers. Network is gathering local consultants from 90 countries in Europe, Asia, North America, Latin America, Australia and Africa. Management of international, multi-centre projects is our core competence. FarmavitaR+ is providing solutions related to pharmaceutical, medical device, food supplement and cosmetic products. Scope of services is related to solutions for product development, quality assurance, clinical trials, product registration, portfolio analysis, lifecycle management, vigilance/risk management, pricing/reimbursing, market access and promotional compliance. FarmavitaR+ is brand name of Farmavita Regulanet Ltd. Visit https://farmavitar.com for more information. Outsource anything you can think of!


    World Pharma Today

    Supporting Media Partners
    http://www.worldpharmatoday.com



    Biocompare

    Supporting Media Partners
    http://www.biocompare.com

    Biocompare.com is the leading resource for up-to-date product information, product reviews, and new technologies for life scientists. Biocompare combines an in-depth knowledge of life science products and new technologies with the power of the Internet to offer scientists the most dynamic, relevant, and innovative media-based marketplace for life science information.


    World Pharma News

    Supporting Media Partners
    http://www.worldpharmanews.com/



    Mednous

    Supporting Media Partners
    http://www.MedNous.com

    MedNous is a print publication and website about medical innovation in Europe. It carries exclusive interviews with companies that are at the forefront of medical technology, as well as contributor articles from prominent practitioners. Our mission is to identify significant advances in medicine and to explain how this innovation is being commercialised. In doing so, we talk to venture capitalists about what products and platforms they are supporting. We report on how regulators cope with the accelerating pace of innovation. And we regularly cover the latest developments in the discovery and development of new medical concepts in the area of antibodies, vaccines, small molecules, regenerative medicine and nanomedicines. MedNous combines the English word for medicine with the Greek word for intellect. And those with nous are readers of our publication. Visit our website: www.mednous.com


    Drug Discovery Today

    Supporting Media Partners
    http://www.drugdiscoverytoday.com/

    Drug Discovery Today covers the whole of the preclinical drug discovery process. The reviews are cutting edge, written by experts in their respective fields and cover all aspects of drug discovery from genomic and proteomic approaches, computational drug design, medicinal chemistry and the translation of these sciences to therapies.

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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
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