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SAE Media Group’s 9th Annual Conference
Pre-Filled Syringes East Coast
April 24- 25, 2023 | Boston, USA
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The 10th annual Pre-Filled Syringes East Coast conference will once again play host to an international audience of drug delivery, medical device and PFS experts to discuss emerging trends and offer innovative solutions to the challenges facing the pre-filled syringes industry, helping attendees to secure global success for their devices.

The past year has seen significant developments in the injectables landscape with the evolving regulatory landscape, accelerating opportunities in digitilization and simulation to improve device design efficiency, and increased opportunities for connectivity to improve the user experience.


Furthermore, with a growing need for circular economy, this year’s conference will assess case studies of sustainable approaches for device packaging and life cycle management, while panel discussions, FDA and BioPhorum addresses will evaluate current and upcoming combination product guidelines and the potential for harmonization.

As part of SAE Media Group’s leading drug delivery portfolio of events, this event will bring you the key insights you need to expand and enhance your injectable device portfolio and the opportunity to network with senior players throughout the industry.


We hope to welcome you to this must attend event in April 2023.
 

  • Discover the latest industry developments for improved large volume and high viscous delivery via advanced autoinjector and on body delivery system design 
  • Assess the growing opportunities of digitalization and simulation for improved device development efficiency and potential
  • Engage in an FDA regulatory roundup from the office of combination products, insights into EPR identification from BioPhorum and a panel discussion assessing harmonization of the regulatory landscape
  • Delve into emerging technologies in injectable device design and case studies on digital integration of medical devices for improved user experience
  • Benchmark against sustainable device packaging case studies driving the combination product industry towards circular economy
  • Drug-delivery developers
  • Medical Device Engineers
  • Primary Packaging material designers
  • Secondary packagers
  • Smart device developers
  • Training device developers
  • Device-safety solution providers
  • Drug developers

Previous attendees include:

 

Alexion Pharmaceuticals; Alnylam; Amgen; AstraZeneca; BAUMANN SPRINGS LTD; Baumann Springs USA Inc.; BD; BD Medical - Pharmaceutical Systems; Biogen; Bristol Myers Squibb; BSI; BSI Group; Celanese; Clexio Biosciences; Coherus Biosciences; Corning, Inc.; CP Pathways LLC; Credence MedSystems; Datwyler Pharma Packaging Belgium; Elcam E3d ACAL Ltd; Eli Lilly and Company / DDCS; EPiWatch; Fruh Verpackungstechnik AG; Genentech; GERRESHEIMER AG; Gerresheimer Buende GmbH; Glenmark Pharmaceuticals Inc.; Groupe Jbt; Haselmeier, Inc; Johnson & Johnson; Kaleo, Inc.; Kokoku Rubber Inc.; Kokoku Rubber, Inc.; Lyndra Therapeutics; Merck & Co., Inc; Merck / MRL Device Development; Merck and Co; Nipro PharmaPackaging Americas Corporation; Novartis; Nye Lubricants; Office of Combination Products, FDA; Owen Mumford; Pfizer; Pharmacircle; PHC Corporation; PHC Corporation of North America; Polyplastics US; RAUMEDIC, Inc.; Regeneron; Regeneron Pharmaceuticals; Rx Bandz; Sagentia Innovation; Sanofi; Sanofi US; Schott North America, Inc.; Schreiner Medipharm; SHL - Pharma; Steri-Tek; SureMed Technologies, Inc.; Takeda; Terumo Solutions; UserWise, Inc.; Vertex; W.L. Gore & Associates, Inc.; Weiss-Aug Company Inc; West Pharmaceutical Services; West Pharmaceutical Services, Inc.; Zeon Specialty Materials ; Zeon Specialty Materials Inc; Zwickroell; ZwickRoell GmbH & Co.KG;

Conference programme

8:00 Registration & Coffee

9:00 Chairman's Opening Remarks

Alie Jahangir

Alie Jahangir, Sr. Principal Engineer, Janssen Pharmaceuticals
View Bio

9:10 A regulatory round up from the office of combination products

John Barr Weiner

John Barr Weiner, Associate Director for Policy and Product Classification Officer, Office of Combination Products, FDA
View Bio

  • An insight into the office of combination products current focus with regard to pre-filled syringes and injectable drug delivery devices
  • Updates and clarifications on current projects including:
  • Reliability guidance for emergency use injection systems
  • Essential performance requirements
  • Human factors studies
  • ICH Q9
  • Bridging studies guidance
  • Looking to the future, what can we expect from the office of combination products; evaluating feedback from industry and assessing needs for clarified or updated guidance
  • 9:50 Combination Product Essential Performance Requirements; Interpretation and Control Strategy Development – A BioPhorum Appraisal

  • Interpretation and classification of EPR’s along the lines of ICH Q9 
  • Challenges to define and identify EPRs during the development of a combination product
  • Applying EPR’s during device development and manufacture via control strategies. Review of an acceptable test plan or control strategy for each EPR, including evaluation of potential substitute testing and reducing burden on batch-release testing.
  • Traceability matrix demonstrating all the essential performance requirements have been adequately verified and validated 
  • Anticipated feedback in response to FDA Q1 2023 draft-guidance
  • Eric Houde

    Eric Houde, Senior Manager Combination Products, Regeneron

    Weina Lu

    Weina Lu, Staff Engineer, Takeda
    View Bio

    Ross Allen

    Ross Allen, Associate Engineering Advisor, Eli Lilly

    10:30 Panel Discussion: Evaluating the pre-filled syringes and injectables drug devices regulatory landscape

  • Delving into the FDA’s efforts towards harmonization and convergence
  • Key challenges in multi-market launches, industry examples and experiences
  • Where are we seeing challenges in consistencies across jurisdictions internationally and across the EU
  • How can the FDA and industry align to improve processes for engaging with regulatory bodies
  • John Barr Weiner

    John Barr Weiner, Associate Director for Policy and Product Classification Officer, Office of Combination Products, FDA
    View Bio

    John Schalago

    John Schalago, Executive Director, Senior Global Program Director Regulatory Affairs, Novartis
    View Bio

    Theresa Scheuble

    Theresa Scheuble, Head Enterprise Design & Innovation, Johnson & Johnson
    View Bio

    11:00 Morning Coffee

    11:40 Regulatory considerations for large volume injectors: autoinjectorscompared to on body delivery systems

    John Schalago

    John Schalago, Executive Director, Senior Global Program Director Regulatory Affairs, Novartis
    View Bio

  • Drawing on previous projects and a review of FDA approvals
  • What are the complexities that need to be addressed and the similarities and nuances between autoinjector and wearable systems
  • Perspectives from individual device development stages and how do the regulatory considerations of each impact development strategy?
  • Assessing user needs and reviewing when the preferred large volume delivery system has been different to original assumptions
  • Impacts from health authorities in the US and the EU
  • 12:20 High dose/ high volume Subcutaneous Drug Delivery Systems - Patient Preference Study (PPS)

  • High dose/ high volume subcutaneous drug delivery project objective
  • Patient Preference Study (PPS) creation and its role in achieving the project objective
  • Implementing IMI PREFER in PPS design
  • Lauren Ziegler

    Lauren Ziegler , Senior Director Medical Devices, Novartis
    View Bio

    Marie Picci

    Marie Picci, Director Science and Technology, Novartis
    View Bio

    13:20 Networking Lunch

    14:00 Session Reserved for Schreiner

    14:40 Assessing the industry landscape and growing advances for subcutaneous delivery of high-dose and high-volume biologics

    Deep S Bhattacharya

    Deep S Bhattacharya, Senior Scientist, Drug Product Development and Design, Pfizer
    View Bio

  • The challenges and opportunities for subcutaneous delivery of high dose/volume biologics
  • The potential to apply novel subcutaneous technologies to several therapeutic areas through collaborations across industry
  • Summarizing key patient and HCP perceptions of high dose/volume subcutaneous delivery
  • Insights into developing subcutaneous technologies that could further facilitate high dose/volume subcutaneous administration
  • 15:20 A Glass Alternative: ZEONEX® and ZEONOR® Cyclo Olefin Polymer (COP) for Pre-Filled syringes

    Larry Atupem

    Larry Atupem, Strategic Business Development Manager, Zeon Specialty Materials
    View Bio

  • Key Benefits of COP for Medical Devices 
  • Case Study on Delamination: COP Syringe vs Glass Syringe 
  • Case Study on Protein Adsorption/Aggregation and its effect on Immunogenicity
  • 16:00 Afternoon Tea

    16:30 Use of Weibull Analysis to Estimate Time of Needle Clogging in Pre-filled Syringes Filled with Fast Drying Propensity Drug Produc

    Lynne Liao

    Lynne Liao, Sr. Engineer, Alexion Pharmaceuticals
    View Bio

  • Specific drug product formulations could have a propensity to rapidly dry, which may cause needle clogging either at the point of use (once the needle shield is removed) or upstream (during the syringe filling process).
  • This study was designed to characterize the time for prefilled syringes to clog after the needle shield was removed.
  • A Weibull analysis was used to predict the time to clog. This approach allowed for product reliability to be directionally established (and the risk of rapid drying to be assessed) with limited samples.
  • 17:10 Biocompatibility of Medical Device/Combination Product

    Christine Lynn Lanning

    Christine Lynn Lanning, Distinguished Scientist, Device Area Leader, Merck & Co., Inc
    View Bio

  • Overview of biocompatibility
  • Leveraging supplier information vs testing to satisfy ISO 10993 requirements
  • Case examples with a focus on on-body/wearable devices and connectivity
  • 17:50 Chairman’s Closing Remarks and Close of Day One

    Alie Jahangir

    Alie Jahangir, Sr. Principal Engineer, Janssen Pharmaceuticals
    View Bio

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    John Barr Weiner

    John Barr Weiner, Associate Director for Policy and Product Classification Officer, Office of Combination Products, FDA
    View Bio

    9:10 Digital Transformation’s Impact on Quality Engineering and Combination Products

    Alie Jahangir

    Alie Jahangir, Sr. Principal Engineer, Janssen Pharmaceuticals
    View Bio

  • Quality 4.0 provides an effective framework to transition from a compliance-based, reactive, error-prone, and siloed Quality Management System (QMS) to the one that is proactive, integrated, efficient, and most importantly patient centric, thanks to current digital tools.
  • Adoption of Quality Management System would result in process and systems agility, efficiency, and flexibility, while breaking the silos in product development and validation.
  • Digital transformation will improve efficiency and productivity of Combination Product's Development and Qualification
  • 9:50 Value of lab simulation for shipping qualification to "real world" studies

    Kirk Roffi

    Kirk Roffi, Senior Scientist, Pfizer
    View Bio

  • During high-altitude shipping of pre-filled syringes, pressure differentials can cause the elastomer stopper to move unintentionally
  • This motion represents a risk to container closure integrity and drug product sterility
  • We present a scale-down model utilizing laser displacement sensors and an acrylic vacuum chamber to measure stopper motion in real-time.
  • We will also present a dynamic model in MATLAB-Simulink that accounts for elastomer-glass and elastomer-silicone oil frictional contacts inherent to the lubricated interference fit
  • 10:30 Morning Coffee

    11:00 Advancements in Drug Delivery – Convergence of Drug Product Development and Medical Technology

    Theresa Scheuble

    Theresa Scheuble, Head Enterprise Design & Innovation, Johnson & Johnson
    View Bio

  • Advancements in Drug Delivery – Convergence of Drug Product Development and Medical Technology
  • Historical review of various routes of administration
  • Role of the Patient driving changes in delivery approaches
  • Convergence of Drug Development and Minimally Invasive procedures
  • Examples of Current and Future Technologies
  • 11:40 Device Development for Long Acting Injectables

    Scott Nunn

    Scott Nunn, Director, Device Development, Gilead Sciences, Inc
    View Bio

  • Patient Drivers for Long Acting Injectables
  • How have long-acting injectable devices evolved in recent years
  • Formulation and device considerations for long acting injectables
  • Common pitfalls and challenges in long-acting combination product design
  • 12:20 Networking Lunch

    13:20 Session Reserved for BD Medical - Pharmaceutical Systems

    14:00 Digital Integration of Medical Devices

    Ning Yu

    Ning Yu, Director, Biogen
    View Bio

  • Considering human-centred design and producing devices tailored to improve adherence
  • Case studies on the use of digital solutions
  • Challenges with regulatory guidance
  • How to capture novel opportunities in digital health
  • The future of digital systems and increasing acceptance
  • 14:40 Session Reserved for ApiJect

    15:20 Afternoon Tea

    15:50 Innovation in Drug Delivery Combining Human Factors and AI

    James Leamon

    James Leamon, Director Device Development, Device Development
    View Bio

  • New developments in Drug Delivery
  • Human Factors impact on device development and human safety
  • Artificial Intelligence and Human Factors
  • The New Needs for the next generation Delivery Device
  • 16:30 Design for Sustainability - Pharmaceutical Packaging & Medical Devices

    Shruti Parikh

    Shruti Parikh, Associate Director Product Development, Takeda Pharmaceuticals
    View Bio

  • The current landscape and industry movement towards sustainable practices
  • The role LCAs can play in strategic decision making at the corporate level
  • Design for sustainability process
  • Trends & Case Studies
  • 17:10 Finished Good Packaging Development for Device and Combination Product

  • Key packaging challenges related to device selection and impact to the supply chain
  • Case study: Sustainable Packaging as a LCM project for a commercial PFS product
  • Development of new pharma packaging standard
  • Laurent Dionet

    Laurent Dionet, Head of Packaging Development , Biogen International GmbH
    View Bio

    Katja Klenner

    Katja Klenner, Sr Engineer III, Biogen International GmbH
    View Bio

    17:50 Chairman’s Closing Remarks and Close of Day Two

    Alie Jahangir

    Alie Jahangir, Sr. Principal Engineer, Janssen Pharmaceuticals
    View Bio

    +

    FEATURED SPEAKERS

    Alie Jahangir

    Alie Jahangir

    Sr. Principal Engineer, Janssen Pharmaceuticals
    Christine Lynn Lanning

    Christine Lynn Lanning

    Distinguished Scientist, Device Area Leader, Merck & Co., Inc
    Deep S Bhattacharya

    Deep S Bhattacharya

    Senior Scientist, Drug Product Development and Design, Pfizer
    Eric Houde

    Eric Houde

    Senior Manager Combination Products, Regeneron
    James Leamon

    James Leamon

    Director Device Development, Device Development
    John Barr Weiner

    John Barr Weiner

    Associate Director for Policy and Product Classification Officer, Office of Combination Products, FDA
    John Schalago

    John Schalago

    Executive Director, Senior Global Program Director Regulatory Affairs, Novartis
    Katja Klenner

    Katja Klenner

    Sr Engineer III, Biogen International GmbH
    Kirk Roffi

    Kirk Roffi

    Senior Scientist, Pfizer
    Larry Atupem

    Larry Atupem

    Strategic Business Development Manager, Zeon Specialty Materials
    Lauren Ziegler

    Lauren Ziegler

    Senior Director Medical Devices, Novartis
    Laurent Dionet

    Laurent Dionet

    Head of Packaging Development , Biogen International GmbH
    Lynne Liao

    Lynne Liao

    Sr. Engineer, Alexion Pharmaceuticals
    Marie Picci

    Marie Picci

    Director Science and Technology, Novartis
    Ning Yu

    Ning Yu

    Director, Biogen
    Ross Allen

    Ross Allen

    Associate Engineering Advisor, Eli Lilly
    Scott Nunn

    Scott Nunn

    Director, Device Development, Gilead Sciences, Inc
    Shruti Parikh

    Shruti Parikh

    Associate Director Product Development, Takeda Pharmaceuticals
    Theresa Scheuble

    Theresa Scheuble

    Head Enterprise Design & Innovation, Johnson & Johnson
    Weina Lu

    Weina Lu

    Staff Engineer, Takeda

    Alie Jahangir

    Sr. Principal Engineer, Janssen Pharmaceuticals
    Alie Jahangir

    Dr. Jahangir is an innovative, and cross functional team leader at Janssen Pharmaceutical in charge of E2E development and execution of Quality Management Systems for complex Biologic-Device Combination Products. He has championed the development and global launch of several safe, effective and functional combination products. With a unique multidisciplinary technical background along with 15 years of experience in Quality, R&D, and Regulatory Affair, Alie’s passion lies in enablement of new emerging technologies into practical solutions with direct impact on patients’ therapeutic journey and their well-being. He is currently engaged in integrating emerging digital and advanced devices modalities, with bold mission to revamp the Pharma’s existing quality infrastructure that utilizes more digital and data analytic capabilities to address patients’ unmet needs, more efficiently. Prior to Janssen, He has led a successful R&D career, managing, developing, and commercializing advanced polymeric technologies in consumer, oil & gas, and medical devices industries. Dr. Jahangir is also an Adjunct Professor at the Department of Bioengineering at Temple University in Philadelphia. He holds a Doctorate and Master’s degree in Polymer & Biomedical Engineering from University of Toronto and Dalhousie University and completed a Post-Doctoral Fellowship at Harvard School of Public Health in Boston.

    Christine Lynn Lanning

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

    Dr. Christine Lynn Lanning is a Distinguished Scientist in Nonclinical Drug Safety at Merck. She has a PhD from Duke University in Pharmacology/Toxicology and has been at Merck over 24 years gaining experience in both nonclinical drug safety and the safety of medical device/combination products. In her current role, she oversees the biocompatibility of Merck’s medical devices/combination products in development and those on the market. She has supported a variety of drug delivery devices including prefilled syringes, inhalers, oral administration kits, auto- and onbody injectors. She has authored over 200 scientific reports and 60 regulatory submissions/Health Authority responses.

    Deep S Bhattacharya

    Senior Scientist, Drug Product Development and Design, Pfizer
    Deep S Bhattacharya

    Deep S Bhattacharya is a senior scientist working with DPDD since November 2019. He received his Ph.D. from the University of Nebraska Medical Center, College of Pharmacy in Pharmaceutical Sciences with a focus in engineering polymer-protein conjugates and polymeric nanoparticles using computational chemistry, biophysical tools, formulation developments, to in vivo characterizations in multiple animal models. After joining Pfizer, he has worked with DMD gene therapy, CD80, p40-TL1A bispecific, and currently leading CpG/Alhydrogel adjuvant program for C.Diff and Tetra-Fab LTβR programs. He is experienced in the formulation development of recombinant protein vaccines and high concentration mAbs. His areas of interest include biophysical assessment of proteins, utilizing NMR for structural determination of biologics, subcutaneous assessments of biologics, early-stage development of biologics, interfacing with early-stage discovery teams for candidate selection, and understanding business strategies for developments of biopharmaceuticals. He also is involved group functions involving CPED DPDD and new colleague recruitments efforts with the St. Louis DPDD.

    Eric Houde

    Senior Manager Combination Products, Regeneron
    Eric Houde

    James Leamon

    Director Device Development, Device Development
    James Leamon

    Jim is a medical device and drug device combination product development leader, an engineering director, and a manufacturing manager. He is experienced in working across functions and business groups in varying organizations. Jim has successfully brought new and effective products to market throughout the world and has developed and implemented new engineering, quality control and manufacturing processes. Jim has led product development, and contract engineering teams. He is highly experienced and proficient in CMC drug-device combination product leadership as well as strategic planning, design engineering, manufacturing engineering and new product and process development.

    Jim is also a community leader in social justice and feeding the hungry. As treasurer of a non-profit organization, he has used his strategic planning and financial management skills to help people in need. This correlates well with his career drive to improve the lives of cancer patients and those with other life threatening diseases.
     

    John Barr Weiner

    Associate Director for Policy and Product Classification Officer, Office of Combination Products, FDA
    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.

    John Schalago

    Executive Director, Senior Global Program Director Regulatory Affairs, Novartis
    John Schalago

    John is Regulatory/Quality/Clinical professional with over 30 years of experience in research & development, quality assurance/control, clinical affairs, regulatory affairs and executive management. John has extensive experience with global health authorities as well as with CDRH, CBER, and CDER managing submission strategies, HA interactions and submissions. John has a diverse background which includes expertise in combination products, software-controlled medical device submissions including, sensors (implantable, minimally invasive and in-vitro diagnostics, and software as a medical device, including, mobile applications and web-based clinical decision software.

    Katja Klenner

    Sr Engineer III, Biogen International GmbH
    Katja Klenner

    Katja Klenner works as Senior Engineer III in the Global Packaging Development team at Biogen, based in Baar (CH). After completing studies in packaging engineering at the Berlin University of Applied Sciences, she held several positions in the cosmetics industry focusing on customer-centric and cost-effective packaging solutions for almost 20 years. Taking a fresh start in her career, Katja joined Biogen 3 years ago and has since taken on responsibility for several packaging development projects, both for new projects and life cycle projects for biologics. and combination products.

    Kirk Roffi

    Senior Scientist, Pfizer
    Kirk Roffi

    As a senior scientist at Pfizer, Kirk contributes to packaging and process development for injectable biologics. Kirk's background is in Chemical Engineering and he is currently a graduate student at the University of Massachusetts Lowell. Recent scientific interests include modelling of drug delivery systems and process equipment.

    Larry Atupem

    Strategic Business Development Manager, Zeon Specialty Materials
    Larry Atupem

    Larry Atupem is the Business Development Manager at Zeon Specialty materials with responsibility of Cyclic Olefin Polymer business in North America. He also assists with ZEON’s strategic interests in the region looking for new opportunities in the diagnostic space. He has over decade of experience in multiple industries spanning from pharmaceutical science, thermal packaging, and thermoplastics. He holds a B.S. in Chemical & Biological Engineering from Tufts University and MBA from Boston University.

    Lauren Ziegler

    Senior Director Medical Devices, Novartis
    Lauren Ziegler

    Lauren Ziegler is Senior Director, Medical Devices, leading strategic projects in Regulatory Affairs at Novartis. During the past 7 years at Novartis, she has experience working on Combination Products, novel drug delivery devices and Software as a Medical Device (SaMD), including digital therapeutics and AI/ML-based clinical decision support software. She has a B.S.M.E. degree in Mechanical Engineering and an M.B.A in Pharmaceutical Marketing and has over 20 years of industry experience.

    Laurent Dionet

    Head of Packaging Development , Biogen International GmbH
    Laurent Dionet

    Laurent Dionet leads the Global Packaging Development team at Biogen based in Baar (CH). He started his career as a formulation chemist at DuPont in the Agro-pharmaceutical sector. The interaction of drug products with plastic packaging and their environmental impact interested him early on and inspired him to join packaging development. He gained broad experience in different positions in different companies (Dow-Agrosciences, Novartis and Roche). 3 years ago, Laurent joined Biogen where he initiated packaging projects with a focus on innovation and sustainability. He is also part of Biogen’s Initiative “Healthy Climate, Healthy Life®”. His motto: Develop for the benefit of the Patient and the Environment.

    Lynne Liao

    Sr. Engineer, Alexion Pharmaceuticals
    Lynne Liao

    Lynne Liao is a Sr. Engineer in Device Development at Alexion, AstraZeneca Rare Disease Unit. She is responsible for characterizing drug delivery devices and combination products from early stage technology selection to product development and commercialization. She has 6 years of R&D and Product Development experience in the medical device industry with the focus on test method development, device characterization and process development.

    Marie Picci

    Director Science and Technology, Novartis
    Marie Picci

    Marie Picci is Director, Science and Technology, leading novel solutions and technologies strategic projects in Technical Research and Development at Novartis. During the past 16 years at Novartis, she has held several positions as Director Delivery Systems Strategy, Portfolio Group Head and project leadership for the development of medical devices towards the successful global submissions and launches of drug-device combination products. She has an MBA, M.S. Degree in Chemical Engineering and holds a diploma in Pharmaceutical Medicine and has over 20 years of industry experience.

    Ning Yu

    Director, Biogen
    Ning Yu

    Ning Yu is Director, Product and Technology at Biogen, leading the device design and development team. Ning has been working in the field of drug delivery device for the past twelve years, with broad experience on syringes, auto injectors, pen injectors, needle safety, wearable pumps, IV kit, and monitoring devices. Ning has worked on combination products from both the medical device and biopharma sides. Prior to entering the drug delivery device world, Ning worked on orthopedic implants and computer hard drives. Ning has a BS in Mechanical and Electrical Engineering, MS and PhD in Mechanical Engineering from University of Illinois at Urbana-Champaign. Ning is currently a member of the ISO/TC 84 working groups.

    Ross Allen

    Associate Engineering Advisor, Eli Lilly
    Ross Allen

    Scott Nunn

    Director, Device Development, Gilead Sciences, Inc
    Scott Nunn

    Scott Nunn is responsible for Device Engineering at Gilead Sciences in Foster City, CA. Scott is passionate about developing products to improve patient’s lives. Gilead’s combination product portfolio includes both development and commercial combination products developed to treat grievous illnesses.

    Scott has been working in the pharmaceutical industry for 16 years and has experience in development of various parenteral drug delivery devices. In his free time, Scott enjoys spending time with his family, working on home renovation projects and spending time outdoors.

    Shruti Parikh

    Associate Director Product Development, 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.

    Theresa Scheuble

    Head Enterprise Design & Innovation, Johnson & Johnson
    Theresa Scheuble

    Theresa Scheuble is Head of Design & Innovation for Johnson & Johnson. She is an expert on combination product requirements and considerations supporting all segments of Johnson & Johnson.
    Prior to her current role, Theresa was Head of the Combination Product Drug Delivery Systems Development for the East Coast team in Janssen, a Johnson & Johnson Company. While at Janssen, Theresa was responsible for Combination Product Device development and led cross-sector initiatives. Theresa has been with Johnson & Johnson for greater than 25 years, working in all Segments of Johnson & Johnson with 18 years specifically in the Medical Device Segment. She was the project lead and technical lead for greater than 20 portfolio enhancing products by Johnson & Johnson companies. She also has experience in the Automotive and Aerospace industries.

    Weina Lu

    Staff Engineer, Takeda
    Weina Lu

    Weina Lu is a Device Engineer in the Dosage Form Design & Development group within Biopharmaceutical Department at AstraZeneca. She is the device technical lead and device responsible person for combination product development from the beginning till commercial launch in the parenteral biologic world.
    Weina received her Master’s degree in Mechanical Engineering from Worcester Polytechnic Institute. Prior to joining AstraZeneca, Weina worked at Massachusetts General Hospital, focusing on catheter-based optical medical device development.

    Sponsors

    Exhibitors

    Official Media Partner

    VENUE

    Hyatt Regency 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

    Sponsors


    ApiJect™

    Sponsors
    http://www.apiject.com

    ApiJect™ is a medical technology company creating the future of medical injections.

    ApiJect™ is a medical technology company creating the future of medical injections. ApiJect products are designed to provide the advantages of prefilled syringes (quality, convenience, safety) at the cost-efficiency of multi-dose formats, regardless of manufacturing volume.

    Our Platform achieves this by bringing together two globally trusted manufacturing technologies: Blow-Fill-Seal (BFS) aseptic filling and high precision injection molding. Our Platform’s simple, compact supply chain uses widely-available raw materials, ensuring reliability and resilience. And in the future, the Platform will include dose-level validation technology on every device to screen out counterfeits and expired medicines.



    BD Medical

    Sponsors
    http://www.bd.com

    As a partner of choice for pharmaceutical and biotech companies across the globe, BD Medical - Pharmaceutical Systems provides a broad range of parenteral drug delivery systems including glass and plastic prefillable syringes, safety and shielding systems as well as advanced drug delivery solutions that help ensure pharma meets its drug delivery goals while considering drug complexity, viscosity and dosing volume.

    With an emphasis on patient-centered innovations and strong technical expertise, BD Medical - Pharmaceutical Systems partners with pharmaceutical and biotechnology companies to help them achieve their combination product commercialization goals. We support product launch and life cycle management through a comprehensive set of services and solutions that help to de-risk the combination product development process.

    More information available @ drugdeliverysystems.bd.com Contact us @ drugdeliverysystems.bd.com/contact-us



    Schreiner MediPharm

    Sponsors
    http://www.schreiner-medipharm.com

    Schreiner MediPharm is a leader in the development and manufacture of innovative specialty labels with value-added benefits for the pharmaceutical industry. The product portfolio includes labels with integrated hangers, with detachable parts and multi-page labels. Additionally, the company offers syringe labels with integrated needle protection, anti-tampering and counterfeiting protection solutions as well as NFC/RFID labels. These products simplify dispensing and administering of pharmaceuticals, enhance drug safety and clearly reduce process costs. Thanks to its strong solutions expertise and specialized know-how Schreiner MediPharm has established itself worldwide as a highly capable development partner and reliable quality supplier to leading pharmaceutical companies.


    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


    Owen Mumford

    Exhibitors
    http://www.owenmumford.com

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

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


    Media Partners


    Pharmaceutical Technology

    Official Media Partner
    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.


    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.


    pharmaphorum

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

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


    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.


    On Drug Delivery

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

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


    World Pharma News

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



    Pharmaceutical Outsourcing

    Official Media Partner
    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.


    Gene Therapy Net

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

    Gene Therapy Net is the information resource for basic and clinical research in gene therapy, and the site serves as a network in the exchange of gene therapy information and breaking news items. Visitors can keep track of the latest scientific papers, conference announcements, gene therapy jobs, regulations and guidelines


    ASD MEDIA

    Official Media Partner
    http://www.asd-network.com

    Professionals in the Aerospace & Defence market use the ASD Media internet platforms to:
    • Be informed on the latest market developments; www.asd-network.com
    • Find the latest business news; www.asd-network.com
    • Find the upcoming events; www.asd-network.com
    • Find companies and organizations; www.asdsource.com
    • Distribute news globally. www.asdwire.com
    The ASD Media platforms are well known and used intensively, your company is able to benefit from these large numbers of users. Be informed with ASD-Network; Create exposure for your company with ASDSource, distribute your news with ASDWire or advertise with us, build your brand and increase traffic to your company’s website.

    For more detailed information please contact with: ASD MEDIA
    Stefan.koopman@asdmedia.nl


    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


    Drug Discovery Today

    Official Media Partner
    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.


    evvnt Ltd

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

    evvnt enables people all over the world to fill their events utilising the most effective event listing sites on the web. Every minute, with little more than a click, more events and conferences appear in listings, in search engines and on mobile - discoverable by both category and location. With next to no effort customers of evvnt get better attendance, while consumers find events they previously had no idea existed. To date customers in 70 countries worldwide have submitted over 500,000 thousand event listings, created over 300,000 live links, and generated 1 million clicks to ticketing and registration pages. Learn more at www.evvnt.com


    Pharmiweb

    Official Media Partner
    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.

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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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