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SMi's 4th Annual Conference
Pre-Filled Syringes West Coast
June 3 - 4, 2019 | San Diego

Pre-Filled Syringes West Coast will gather a global audience of medical device experts and PFS industry leaders to discuss new developments and showcase the latest and advancements, keeping you at the forefront of a booming industry.

The competitive PFS market has sparked great improvements as devices strive for higher quality, safety, and patient satisfaction. Pre-Filled Syringes West Coast is the perfect platform to strengthen knowledge in key principles such as human factors and patient centricity, connectivity and digital health, container closure integrity, the therapeutic opportunities of pre-filled, and manufacturing in the landscape of complex biologics, whilst honing in on emerging trends for parenteral devices.

 Join us in San Diego to

  • Obtain insights into the new FDA draft guidance on human factors submissions, and the European Medical Device Regulation (EU MDR)
  • Discover key innovations in digital health and how it can benefit pre-filled syringes
  • Understand how silicon is being used to enhance formulation
  • Explore the latest case studies in therapeutic opportunities
  • Highlight the emerging trends of connected health and the future of drug delivery device designs
  • Cutting edge industry insight on manufacturing processes and techniques

Executives, Directors, VPs, Heads, Principals, Managers of:

  • Pre-Filled Syringes/ PFS
  • Autoinjectors
  • Device/ Device Engineering
  • Human Factor
  • Container Closure Integrity
  • Scientist
  • CMC
  • Product
  • Injectables
  • Sterile Manufacturing
  • Packaging
  • Regulatory Affairs


or anyone who works with Pre-Filled Syringes/ Autoinjectors within pharmaceutical, biotech and solution providers.

 

Abbott Laboratories; AbbVie; Advanced Molding Technologies; Aegerion Pharmaceuticals; Ajinomoto Althea, Inc.; Allergan; Allergen Inc; Almac Group; Amgen; Antares Pharma; Aptar Pharma; Baxter Healthcare; BCM Group LLC; BioMarin; Boehringer Ingelheim; Connecticut Spring & Stamping; Credence MedSystems; Execution Metrics, Inc; Ferring Pharmaceuticals; Fresenius-Kabi; Genentech; Genentech, Inc.; Gilead Sciences; Glenmark Pharmaceuticals; Harro Höfliger; Inovio Pharmaceuticals; iO Lifesciences; Ionis Pharmaceuticals, Inc.; Matchstick; MedImmune; MedImmune Inc; MedImmune LLC; Medizap; Medtronic; Merck & Co.; Mitsubishi Gas Chemical America Inc; MITSUBISHI GAS CHEMICAL COMPANY, INC; Nemera; Nipro PharmaPackaging; NOVO Engineering, Inc.; Novo Nordisk; Novo Nordisk A/S; One World DMG; Owen Mumford; Pfenex; Pfenex Inc; Pfizer CentreOne; RAUMEDIC INC; Regeneron; Regeneron Pharmaceuticals; Regeneron Pharmaceuticals, Inc.; Shire; Smithers Rapra; Steri-Tek; Stevanato Group S.p.A; Subcuject ApS; Suttons Creek Inc; Terumo Corporation; Terumo Medical Corporation; Terumo Pharmaceutical Solutions; UserWise, Inc.; W. L. Gore & Associates, Inc.; West Pharmaceutical Services,; West Pharmaceutical Services, Inc.; West Pharmaceuticals Services Inc; Worrell; Xeris Pharmaceuticals; ZebraSCI; zebrasci inc; ZEON; ZEON CORPORATION; Zeon Specialty Materials Inc;

Conference programme

8:30 Registration & Coffee

8:50 Co-Chair's Opening Remarks

Michael Song

Michael Song, Sr. Manager, Medimmune
View Bio

Tina Rees

Tina Rees, Associate Director-Human Factors, Ferring Pharmaceuticals
View Bio

9:00 Platform approach for combination products and devices

Ronald Forster

Ronald Forster, Director Process Development, Amgen

• HFE assessment considerations
• Challenges in biocompatibility
• The balance between volume and viscosity
• The future of the platform approach for devices
 

9:35 Elastomeric Components: Supporting Next Generation Drug Delivery Systems

Douglas Cusato

Douglas Cusato, Director of Medical Rubber Business , Sumitomo Rubber
View Bio

  • How can innovation in elastomeric components support PFS & next generation drug delivery systems?
  • How can a suppliers manufacturing network support PFS & next generation drug delivery systems?
  • What can we learn from other industries and apply it to future innovations and support drug delivery innovations?
  • 10:15 Innovative Application of Computer Aided Engineering in Development of Pharmaceutical Packaging

    Lin Li

    Lin Li, Senior Consultant Engineer, Eli Lilly and Company Ltd
    View Bio

  • Simulation led design
  • Device mechanism optimization
  • Container closure integrity at various shipping condition
  • Injection Physiology
  • 10:50 Morning Coffee Sponsored by Zeon

    11:20 Multilayer plastic syringe with excellent oxygen and UV barrier

    Hiroki  Hasegawa

    Hiroki Hasegawa, Researcher, Mitsubishi Gas Chemical Company, Inc

    • Excellent oxygen and UV barrier contribute to stability of biologics
    • Optimized silicone-oil contributes to preventing protein aggregation
    • Extremely low levels of extractables contribute to stability of biologics
    • Development of staked needle syringes
     

    12:00 Development of user-centric requirements for prefilled syringes and injection devices

    Diane Doughty

    Diane Doughty, Senior Scientist, MedImmune
    View Bio

  • Review of user-centric device characteristics
  • Generating user-relevant design input requirements
  • Applying a platform approach to user-centric devices
     
  • 12:35 Networking Lunch

    13:35 Human Factors Guidelines for Mobile Health Applications

    Natalie Abts

    Natalie Abts, Senior Program Manager, Usability Services, MedStar Health
    View Bio

  • Background on development process
  • Guidelines content review
  • Details on development and application of usability guidelines
  • Practical ways to apply guidelines to development
     
  • 14:10 Digital Health, considerations when developing digital connectivity solutions

    Michael Song

    Michael Song, Sr. Manager, Medimmune
    View Bio

  • Explore the use of wireless communication systems beyond Bluetooth
  • Explore advantages and disadvantages between using add-on vs. add-in
  • How much data is enough data
  • Regulatory considerations and challenges

     

  • 14:45 FDA Training Decay Research Initiative – Is a 1-hour training decay long enough for summative usability testing?

    Shannon  E. Clark

    Shannon E. Clark, Principal, UserWise, Inc.
    View Bio

  • Identify differences in decay between device types
  • The effects of accelerated decay
  • Assessing the task-training decay curve profiles
  • Identify generalizable detailed training decay curves
  • 15:20 Afternoon Tea Sponsored by Zeon

    15:50 Panel Discussion: Future Regulatory Trends

    • The European Medical Device Regulation
    • The emerging market in China
    • Brexit and how it will effect the device industry
    • Regulatory strategies for wearables, software-based medical devices and integrated devices
     

    Ronald Forster

    Ronald Forster, Director Process Development, Amgen

    Natalie Abts

    Natalie Abts, Senior Program Manager, Usability Services, MedStar Health
    View Bio

    Gay Steinbrick

    Gay Steinbrick, Regulatory and Safety Expert, Managing Partner, gMedicas. Formerly, Lead, Medical Device and Combination Product, Global Safety, Merck & Co., Merck
    View Bio

    16:25 Overview of EU MDR specific to safety

  • Overview of requirements for EU MDR
  • Discuss new requirements for post-market surveillance
  • Integration of post-market surveillance activities with risk management and clinical evaluation

     

  • Gay Steinbrick

    Gay Steinbrick, Regulatory and Safety Expert, Managing Partner, gMedicas. Formerly, Lead, Medical Device and Combination Product, Global Safety, Merck & Co., Merck
    View Bio

    17:00 Chairman’s Closing Remarks and Close of Day One

    Michael Song

    Michael Song, Sr. Manager, Medimmune
    View Bio

    Tina Rees

    Tina Rees, Associate Director-Human Factors, Ferring Pharmaceuticals
    View Bio

    8:30 Registration & Coffee

    8:50 Chairman's Opening Remarks

    Michael Song

    Michael Song, Sr. Manager, Medimmune
    View Bio

    Tina Rees

    Tina Rees, Associate Director-Human Factors, Ferring Pharmaceuticals
    View Bio

    9:00 Digital health applications

    Edmond Israelski

    Edmond Israelski, Co-convenor of ISO and IEC Medical Devices Standards Committee, Abbott Laboratories
    View Bio

  • Mobile applications that support drug delivery
  • The benefits of digital health and patient compliance
  • User interface developments
  • Advances in connectivity
     
  • 9:35 Pain perception and injection devices: could pain be assessed through non-human person trials in early stage device development?

    Severine Duband

    Severine Duband, Global Category Manager, Nemera
    View Bio

  • Pain perception key drivers during injection
  • Can a study on NHP evaluate pain associated to injection?
  • Application of NHP model on testing customization and technical improvements on injection devices to limit pain
     
  • 10:10 Human Factor considerations for pre-filled syringes

    Tina Rees

    Tina Rees, Associate Director-Human Factors, Ferring Pharmaceuticals
    View Bio

  • Human Factor considerations for pre-filled syringesNew product design and development
  • Approaching a regulatory submission
  • Advancements in human factors for pre-filled syringes
  • Considerations for patient centricity
  • 10:45 Morning Coffee Sponsored by Zeon

    11:15 Session Reserved for Kaleidoscope

    11:55 Panel Discussion: Improving patient centricity through digital health

  • Optimising user interface tools
  • How to improve patient compliance
  • Overcoming cyber security challenges
  • The benefits of digital health and patient compliance

     

  • Edmond Israelski

    Edmond Israelski, Co-convenor of ISO and IEC Medical Devices Standards Committee, Abbott Laboratories
    View Bio

    Lin Li

    Lin Li, Senior Consultant Engineer, Eli Lilly and Company Ltd
    View Bio

    Diane Doughty

    Diane Doughty, Senior Scientist, MedImmune
    View Bio

    12:30 Viscosity Challenges for Design and Development of Combination products for Subcutaneous Administration

    Swapnil Pansare

    Swapnil Pansare, Scientist, MedImmune
    View Bio

  • Combination products (i.e., accessorized prefilled syringes and autoinjector) for SC administration have different requirements for maximum viscosity to meet the device functionality (i.e. glide force & injection time) criteria
  • Protein formulations may show shear thinning behaviour (i.e. decrease in viscosity as shear rate increases), thereby impacting device functionality
  • Viscosity limit for combination products was significantly higher due to shear thinning observed for protein formulations
  • 13:05 Networking Lunch

    14:05 Technical updates in Cyclo Olefin Polymer (COP) – A Case Study

    Toshiro Katayama

    Toshiro Katayama, Product Manager, Zeon Chemicals L.P.
    View Bio

  • Key Properties of COP
  • Case study:  Biologics formulation for COP syringe optimized to eliminating use of surfactant.
  • Case study:  Study on Protein adsorption/aggregation – COP vs glass
  • Case study:  Study on delamination with glass syringe vs COP syringe
  • Leachable data on COP syringes with various chemicals
     
  • 14:45 Impact of silicone oil free polymer syringes on therapeutic proteins

    Benjamin Werner

    Benjamin Werner, Scientist, Boehringer Ingelheim

  • Advantages and disadvantages of glass and polymer syringes
  • Long-term protein stability for polymer systems
  • Oxygen permeation of polymer syringes
  • Nitrogen filled pouches for polymer syringe storage
     
  • 15:20 Afternoon Tea Sponsored by Zeon

    15:50 Drug Product Development Considerations for Subcutaneous Delivery of Proteins

    Jason Fernandez

    Jason Fernandez, Drug product formulation and process development scientist, Biogen
    View Bio

  • There are a number of considerations when developing protein drug products for subcutaneous delivery, this talk will highlight some common considerations:
  • Managing the viscosity of liquid formulations for high concentration products.
  • Drug product manufacturing parameter development for SC administered products
  • Managing subcutaneous primary container compatibility and interactions with protein formulations for SC delivery.
  • 16:25 Understanding and Controlling the Risk of Protein Aggregation in Siliconized Pre-Filled Syringes

    Lori Burton

    Lori Burton, Senior Principal Scientist, Bristol-Myers Squibb Co
    View Bio

  • Biologics products, packaged in pre-filled syringes, can sometimes show physical instability due to the silicone oil used to lubricate the syringe barrel.
  • The following will be reviewed:
  • Nature of the interaction between proteins and silicone oil
  • Common approaches for mitigating the risk of silicone oil-induced instability
     
  •  

    17:00 Chairman’s Closing Remarks and Close of Day Two

    Michael Song

    Michael Song, Sr. Manager, Medimmune
    View Bio

    Tina Rees

    Tina Rees, Associate Director-Human Factors, Ferring Pharmaceuticals
    View Bio

    +

    FEATURED SPEAKERS

    Benjamin Werner

    Benjamin Werner

    Scientist, Boehringer Ingelheim
    Diane Doughty

    Diane Doughty

    Senior Scientist, MedImmune
    Douglas Cusato

    Douglas Cusato

    Director of Medical Rubber Business , Sumitomo Rubber
    Edmond Israelski

    Edmond Israelski

    Co-convenor of ISO and IEC Medical Devices Standards Committee, Abbott Laboratories
    Gay Steinbrick

    Gay Steinbrick

    Regulatory and Safety Expert, Managing Partner, gMedicas. Formerly, Lead, Medical Device and Combination Product, Global Safety, Merck & Co., Merck
    Hiroki  Hasegawa

    Hiroki Hasegawa

    Researcher, Mitsubishi Gas Chemical Company, Inc
    Jason Fernandez

    Jason Fernandez

    Drug product formulation and process development scientist, Biogen
    Lin Li

    Lin Li

    Senior Consultant Engineer, Eli Lilly and Company Ltd
    Lori Burton

    Lori Burton

    Senior Principal Scientist, Bristol-Myers Squibb Co
    Michael Song

    Michael Song

    Sr. Manager, Medimmune
    Natalie Abts

    Natalie Abts

    Senior Program Manager, Usability Services, MedStar Health
    Severine Duband

    Severine Duband

    Global Category Manager, Nemera
    Shannon  E. Clark

    Shannon E. Clark

    Principal, UserWise, Inc.
    Swapnil Pansare

    Swapnil Pansare

    Scientist, MedImmune
    Tina Rees

    Tina Rees

    Associate Director-Human Factors, Ferring Pharmaceuticals
    Toshiro Katayama

    Toshiro Katayama

    Product Manager, Zeon Chemicals L.P.

    Benjamin Werner

    Scientist, Boehringer Ingelheim
    Benjamin Werner

    Diane Doughty

    Senior Scientist, MedImmune
    Diane Doughty

    Diane Doughty is a senior scientist in the Drug Delivery & Device Development group at MedImmune (A Member of the AstraZeneca Group). Her focus is developing combination products for the delivery of peptides and monoclonal antibodies using prefilled syringes, autoinjectors, and pen injectors. Diane has a Ph.D. in Pharmaceutical Sciences from the University of Maryland where she investigated usability of orally inhaled and nasal drug products and the effects of patient-variability on product critical quality attributes.

    Douglas Cusato

    Director of Medical Rubber Business , Sumitomo Rubber
    Douglas Cusato

    Douglas Cusato is the Director of the Medical Rubber Business for Sumitomo Rubber, North America . In this role, he is responsible for all aspects of the regional business including Strategy, R&D, Operations and Sales. Douglas has been active in the parenteral packaging industry since 2006 and has served in various technical leadership roles with focus on technology and platform development. He has chaired multiple industry tasks forces and participates in numerous groups as a subject matter expert in elastomeric components for parenteral packaging applications. Doug holds a bachelor’s degree in Chemistry from Rutgers University.

    Edmond Israelski

    Co-convenor of ISO and IEC Medical Devices Standards Committee, Abbott Laboratories
    Edmond Israelski

    Ed Israelski is a consultant and the recently retired director of Human Factors at AbbVie, a biopharmaceutical company. He joined the company in 2001, where he led a cross-company team to imbed best-practice human factors engineering HFE design methods into all of AbbVie’s products, to ensure safety and usability. He did this through hands-on design and evaluation of key new products, managing a group of HF professionals; training and mentoring internal resources, writing corporate policy and guidelines and facilitating the use of outside professional HFE resources.

    He is the co-convener for IEC and ISO Ergonomic and Usability Engineering groups in developing international Human Factors/Usability medical devices standards. Ed is also past co-chair of the AAMI Human Factors Engineering committee, which develops HF standards for medical devices. He is a certified human factors professional CHFP. He has authored fourteen book chapters and numerous articles in the area of human factors. Ed holds thirty patents. He is a fellow of the Human Factors and Ergonomics Society and a member of the National Academy of Sciences Board on Human-System Integration. He is on the editorial board for the journal Human Factors and serves as a regular reviewer for several other scientific journals.

    He has worked as a systems engineer, product manager, market researcher, industrial/organizational psychologist as well as a human factors engineer at various companies including Lucent Technologies - Bell Labs, formerly AT&T, Ameritech/SBC and Human Factors International, Ed is an adjunct instructor at Northwestern University. He received a B.S. in electrical engineering from NJIT, an M.S. in operations research from Columbia University and a Ph.D. in industrial and engineering psychology from Stevens Institute of Technology.
     

    Gay Steinbrick

    Regulatory and Safety Expert, Managing Partner, gMedicas. Formerly, Lead, Medical Device and Combination Product, Global Safety, Merck & Co., Merck
    Gay Steinbrick

    Gay Steinbrick, PharmD is a Managing Partner at gMedicas. Dr. Steinbrick has Bachelor’s Degree in Pharmacy and Doctor of Pharmacy from Massachusetts College of Pharmacy and completed her post-doctor training at the Hospital of the University of Pennsylvania.

    Dr. Steinbrick began her career as an Assistant Professor of Clinical Pharmacy at Rutgers University. She then joined Schering-Plough were she established and headed Global Drug Information Services (GDIS) for 18 years. After GDIS, Gay took a strategic role under the Chief Medical Officer focusing on Clinical and Safety Compliance and Clinical Quality Assurance. Dr. Steinbrick moved to Clinical Safety and Risk Management following merger of Schering-Plough and Merck. While at Merck, Dr Steinbrick implemented the Risk Management Process, developed the REMS program and headed the design and implementation of the EU EVMPD Program resulting in a successful best in industry on time delivery.

    In 2013, Dr. Steinbrick was asked to establish the medical device and combination product discipline within Merck Global Clinical Safety and PV organization. She also co-Lead the regulatory initiative for the US and EU drug device combination regulation implementation. Dr. Steinbrick has vast experience in compliance and regulatory agency inspections.

    Dr. Steinbrick also mentors high school and college students and is a youth advisor to the US Congressional Award Program.

    Dr. Steinbrick has Bachelor’s Degree in Pharmacy and Doctor of Pharmacy from Massachusetts College of Pharmacy. She completed her post-doctor training at the Hospital of the University of Pennsylvania.
     

    Hiroki Hasegawa

    Researcher, Mitsubishi Gas Chemical Company, Inc
    Hiroki  Hasegawa

    Jason Fernandez

    Drug product formulation and process development scientist, Biogen
    Jason Fernandez

    Jason Fernandez is a Senior Scientist in the Protein Pharmaceutical Development group at Biogen. He is responsible for the formulation, manufacturing process development, tech transfer and container development of liquid parenteral dosage forms. Jason has over 18 years of experience focused on therapeutic protein drug product development over multiple companies.

    Lin Li

    Senior Consultant Engineer, Eli Lilly and Company Ltd
    Lin Li

    Dr. Lin Li is a Senior Consultant Engineer currently working at the Delivery Devices and Connected Solutions team in Eli Lilly and Company. He has gotten his Bachelor’s degree from McMaster University (Canada) and his Ph.D from University of Tennessee in the field of Materials Science and Engineering. He joined Lilly in 2015 and has been part of Lilly’s research on the effort of developing innovative pharmaceutical packaging and devices ever since.

    Lori Burton

    Senior Principal Scientist, Bristol-Myers Squibb Co
    Lori Burton

    Lori received her B.S. in Pharmacy from the University of North Carolina at Chapel Hill in 1990 and her Ph.D. in Pharmaceutical Chemistry from the University of Kansas in 1996. She is currently a Senior Principal Scientist in the Parenteral Science and Technology group at Bristol-Myers Squibb and has over 20 years of experience in the development of drug product formulations for proteins, peptides, and small molecules from early through commercial phase.

    Michael Song

    Sr. Manager, Medimmune
    Michael Song

    Michael Song leads the Device Functionality, Safety and Digital Connectivity group at MedImmune, a Member of the AstraZeneca Group. In his current role, he oversees device functionality; primary container science and technology; biocompatibility; container closure integrity testing; and digital connectivity. Prior to his current role, Michael was head of Device and Package Engineering at Adello Biologics, a member of Amneal Pharmaceutical. He also has held key engineering lead and toxicology SME positions at Stryker, Kavlico, and other companies. Michael holds a BS in Electrical Engineering from Purdue University and PhD in Neuroscience and Toxicology from Iowa State University.

    Natalie Abts

    Senior Program Manager, Usability Services, MedStar Health
    Natalie Abts

    As the Senior Program Manager for the Usability Services team at the National Center for Human Factors in Healthcare, Natalie Abts consults with national and international clients in the medical device industry and leads a team that conducts human factors evaluations for a wide range of medical products. Natalie has specialized experience in planning and executing both formative stage usability evaluations and validation studies for medical devices and combination products on the FDA approval pathway. Natalie holds a master’s degree in industrial engineering with a focus on human factors and ergonomics from the University of Wisconsin, where she was mentored by Dr. Ben-Tzion Karsh.

     

    Severine Duband

    Global Category Manager, Nemera
    Severine Duband

    Séverine DUBAND has joined Nemera in 2018 as Global Category Manager of the parenteral segment. She is responsible for developing the parenteral products, including the passive safety systems Safe’n’Sound®, the innovative autoinjector Safelia®, as well as several other projects.
    Graduated from EM Lyon Business School in 2004, Séverine worked 10 years for FMCG in the chemical industry as International Category Manager, supervising strategic planning, NPD launches, project management and brand communication.

    With regards to the presentation title and details, it is still work in progress and very linked to a study we are conducting at the moment and for which we do not have the full results yet – we should have those by end of January. If the results are not good, we may need to adapt our presentation subject accordingly, so just wanted to give you a heads-up on this.
    I’ll keep you posted of course,
     

    Shannon E. Clark

    Principal, UserWise, Inc.
    Shannon  E. Clark

    Shannon E. Clark is founder and CEO of UserWise, a consultancy that helps medical device manufacturers and start-ups to design safe and easy-to-use medical devices. The consultants at UserWise conduct usability testing for a variety of medical devices ranging from surgical robots to home-use injection platforms. UserWise consultants also perform safety assessments to comply with U.S. and international regulations related to Human Factors.

    Before founding UserWise in 2015, Shannon was a Human Factors Engineer at Intuitive Surgical and Abbott Laboratories.

    Shannon graduated from UCLA with a B.S. in Mechanical Engineering and a technical breadth in Technology Management. Shannon is additionally a Certified Processional Industrial Engineer, holds two patents, and has written and published three books.
     

    Shannon E. Clark

    Principal, UserWise, Inc.
    Shannon  E. Clark

    Swapnil Pansare

    Scientist, MedImmune
    Swapnil Pansare

    Mr. Swapnil Pansare is Scientist at Medimmune and in his current role, Mr. Pansare is responsible for Drug Product fill finish and process development for liquid and freeze-dried biologics. He is a key member of Process Engineering and Packaging team currently supporting tech transfer of commercial products to commercial site. In his previous role, Mr. Pansare was responsible for developing protein formulations suitable for combination products. He received his MS in pharmaceutical sciences from northeastern university. Mr. Pansare’s research interests include process development, scale up and tech transfer and formulation development for Drug Products (including combination products).

    Tina Rees

    Associate Director-Human Factors, Ferring Pharmaceuticals
    Tina Rees

    Tina Rees is the Associate Director of Human Factors at Ferring Pharmaceuticals, where she is responsible for the development and implementation of Human Factors and Usability Engineering processes into the overall product development process. Prior to her move to Ferring, she was a Principal Research Scientist in Human Factors at Eli Lilly, focusing on human factors usability within the diabetes division. She has conducted many formative and summative usability studies and has participated in a number of submissions to regulatory authorities resulting in clearance of medical devices and approval of combination products. She received her Ph.D. in Biomedical Research from the Mayo Clinic in Rochester, MN. She is a strong proponent of human centered design processes and incorporating human factors early into the device development process.

    Toshiro Katayama

    Product Manager, Zeon Chemicals L.P.
    Toshiro Katayama

    Toshiro Katayama is the product manager, at Zeon Specialty Materials Inc and responsible in development of Cyclic Olefin Polymer business in the USA. He has over 35 years of various commercial experience, general management, sales and market management, strategic planning, merger and acquisition and purchasing at Gets Bros. & Co Inc (Marmon Group), Union Carbide Corp and Itoh-Chu. He holds Bachelor of Science degree in Mechanical Engineering and Master of Science degree in Structural Engineering from Polytechnic Institute of Brooklyn.

    Sponsors and Exhibitors

    Official Media Partner

    Supporters

    Workshops

    VENUE

    Hyatt Regency Mission Bay

    1441 Quivira Road, San Diego, California, USA

    Experience the epitome of California coastal chic at Hyatt Regency Mission Bay Spa and Marina San Diego vacation resort near SeaWorld San Diego. Expect the best at this remarkable San Diego vacation resort offering incredible ocean views, waterfront dining, a contemporary poolside lounge, eco-friendly spa, and redesigned hotel rooms and suites and meeting rooms. The only resort hotel in San Diego with multiple water slides, you'll delight in a water playground with three new pools, waterfront health club, and a full-service marina with jet skis, sailboats, kayaks, sportfishing and whale excursions.

    An unparalleled choice for discerning travelers, you’ll find everything you could wish for at our premier Mission Bay hotel near famous San Diego,CA attractions such as SeaWorld San Diego.

    HOTEL BOOKING FORM

    Interview with DOUGLAS CUSATO, Sumitomo Rubber

    Download

    Development of Pre-Filled Syringe Packaging - Plastic Ingenuity

    Download

    Development Guide for Automated Healthcare Packaging - Plastic Ingenuity

    Download

    2019 Speaker Biographies

    Download

    2018 Attendees

    Download

    Interview with NATALIE ABTS, MedStar Health

    Download

    Workshop programme

    Download

    CHAIR LETTER

    Download

    2019 PROGRAMME

    Download

    Past Attendee Breakdown - INFOGRAPHICS

    Download

    Presentation by Veneza Yuzon, Amgen

    Download

    Presentation by Michael Song, MedImmune

    Download

    Presentation by Paul Upham, Roche

    Download

    Presentation by Larry Atupem, Zeon

    Download

    Presentation by David Post, Abbvie

    Download

    Presentation by KALBERMATTEN FRANZESE, Terumo

    Download

    Presentation by Shota Arakawa, Mitsubishi Gas Chemical

    Download

    Sponsors and Exhibitors


    Almac Group

    Sponsors and 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.


    Aptar Pharma

    Sponsors and Exhibitors
    http://www.aptar.com/pharma

    Aptar Pharma is a leading provider of innovative drug delivery systems to pharmaceutical, consumer healthcare and biotech customers worldwide, enabling safe, convenient and compliant medication delivery. Trusted partner of the pharmaceutical community, we provide our customers with a large range of specialized drug delivery devices, components and analytical services backed by decades of proven expertise. We have broad therapeutic expertise in Nasal, Pulmonary, Injectables, Eye Care and Dermal delivery routes, among others. Our global manufacturing footprint of sites in Argentina, China, France, Germany, India, Switzerland and the U.S. provides security of supply and local support to our customers. For more information visit: www.aptar.com/pharma


    Harro Höfliger

    Sponsors and Exhibitors
    http://www.hoefliger.com

    Harro Höfliger is located in Southern Germany with over 1250 employees. With an extensive portfolio of technical platforms, Harro Höfliger offers customer specific, special solutions for growing market segments, innovative products and new drug delivery systems. Its technology platforms and turnkey system solutions are always precisely tailored to the needs of the customer. This 100% customer focus and a high level of innovation have earned the company a leading market position. With a worldwide sales and service network. A member of Excellence United.


    Kaleidoscope Innovation

    Sponsors and Exhibitors
    http://www.kascope.com

    Founded in 1989, Kaleidoscope Innovation is a full-service, insights, design and development firm. Offering consultancy-style and onsite services, Kaleidoscope Innovation helps business partners solve challenges through: Insights & Human Factors, Industrial Design & User Experience, Engineering, Visualization and Software Development. Kaleidoscope Innovation has ISO 13485:2016 certification and IEC 60601 compliant.


    Lonstroff

    Sponsors and Exhibitors
    http://www.lonstroff.com

    Lonstroff is a partner that offers all services related to elastomeric solutions from a single source. We advise our customers not only in the new development and optimization of materials, but also in their applications and in value analysis. Thanks to our experience, we are also able to provide valuable support with the registration and approval of the products.


    Mitsubishi Gas Chemical

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

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


    Nemera

    Sponsors and Exhibitors
    http://www.nemera.net

    Nemera is a world leader in the design, development and manufacturing of drug delivery devices for the pharmaceutical, biotechnology & generics industries. Nemera always puts patients first, providing services and products for several key delivery routes: Parenteral, Ophthalmic, Nasal, Buccal, Auricular, Inhalation, Dermal/Transdermal. Nemera leverages decades of experience in the parenteral device segment from full development to pure contract manufacturing, through customized solutions. Nemera developed: - Safe’n’Sound®, a fully passive safety device for prefilled syringes to avoid accidental needle-sticks. - Safelia®, a new generation of 2-steps auto-injector for fluid and viscous formulations.


    PHC Corporation

    Sponsors and Exhibitors
    http://www.phchd.com/global/

    PHC Corporation of North America is a subsidiary of PHC Holdings Corporation, Tokyo, Japan, a global leader in Medical Devices, Healthcare IT and Life Sciences. With drug delivery devices, ultra-low temperature freezers, biomedical refrigerators and incubators, PHC offers technologies and solutions for pharmaceutical, life science and biotechnology applications across industries.


    Plastic Ingenuity

    Sponsors and Exhibitors
    http://www.plasticingenuity.com

    Plastic Ingenuity is a custom thermoformer that provides packaging for the drug delivery and pharmaceutical markets. We specialize in creating secondary packaging for pharmaceutical combination products and automation trays that integrate into high volume assembly equipment for our drug delivery partners. These parts run flawlessly on highly complex automated equipment.


    Sumitomo Rubber Industries

    Sponsors and Exhibitors
    http://hybrid.srigroup.co.jp/en/products/cleanrubber/

    Since our founding in 1909 as the first modern rubber factory in Japan, we at Sumitomo Rubber Industries have strived to produce advanced, environmentally friendly products based on the latest innovations in rubber technology. Within the medical rubber group, we are focused on providing the highest quality products, and ultimately dedicated to improving the lives of people around the world. Utilizing the latest in material and process innovations and our global manufacturing footprint, our team members work diligently to ensure we deliver consistent high performing products and provide strong assurance of supply.


    WILCO

    Sponsors and Exhibitors
    http://www.wilco.com

    WILCO provides in-line, off-line and laboratory machines with non-destructive and data-driven testing methods for monitoring the gas concentration in the head space and container closure integrity (CCI) simultaneously. Our patented leak detection methods based on the process analytical technologies (PAT) offer the opportunity for monitoring the finishing processes as well.


    ZEON

    Sponsors and Exhibitors
    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.


    ZwickRoell

    Sponsors and Exhibitors
    http://www.zwickroell.com

    With over 160 years of expertise in materials and components testing, ZwickRoell delivers intelligent materials testing solutions for the medical industry, including drug delivery testing systems for syringes and cartridges, autoinjectors, and pen injectors. Our qualification services help ensure compliance to your industry’s stringent testing requirements.

    Media Partners


    ONdrugDelivery Magazine

    Official Media Partner
    http://ondrugdelivery.com

    ONdrugDelivery Magazine is the highly regarded, world-leading series of sponsored themed drug delivery publications. Uniquely, each issue focuses tightly on one topic within the field of drug delivery. With a truly global readership already in excess of 40,000, and with contributions and loyal support from many of the most important companies in the drug delivery business - from among the largest to the smallest - ONdrugDelivery Magazine is a must for those in the industry who need to know what's going on in drug delivery.

    Media Partners


    Drug Discovery Today

    Supporters
    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.


    IPI

    Supporters
    http://www.ipimediaworld.com

    IPI – International Pharmaceutical Industry Established by professionals with over 30 years experience in the Pharmaceutical and Life sciences publishing sectors. We have identified the needs of these dynamic industries, and have listened carefully to our readers and advertisers. With strong collaboration between Pharmaceutical and Life sciences Industry Associations we have created a global distribution network. We give you a promise to become a reliable extension of your marketing and communication arm. If necessary we will integrate our expertise with your needs. Incorporating new and innovative communication methods we will help to highlight your expertise.


    Pharma Journalist

    Supporters
    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.


    Pharmaceutical Outsourcing

    Supporters
    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.


    Mednous

    Supporters
    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


    Pharmalicensing

    Supporters
    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


    Pharmiweb

    Supporters
    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.


    PharmaVOICE

    Supporters
    http://www.pharmavoice.com

    PharmaVOICE magazine, and its supporting VIEW publications, provide commentary about the challenges and trends impacting the life-sciences industry, covering a range of issues from molecule through market. PharmaVOICE's more than 41,000 U.S.-based subscribers are also kept abreast of the latest trends through additional media resources, including WebSeminars, Podcasts, Videocasts, and White Papers.


    Pharmaceutical Technology

    Supporters
    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.


    Pharmacircle

    Supporters
    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….


    Farmavita

    Supporters
    http://www.farmavita.net/

    Farmavita Net is professional community and network of pharmaceutical licensing and business development executives, innovators and researchers
    Farmavita.Net is the pharmaceutical licensing, technology transfer and regulatory affairs network. We are managing the marketplace of offers and demand for pharmaceutical Dossiers, know-how and technologies. Members of Farmavita.Net network usually find a number of attractive solutions for business development, alliances, joint ventures, co-development and co-marketing of pharmaceutical products. Farmavita.Net is not just a pure Internet portal. We manage a number of regional associates. We are connecting the dynamic network of few hundreds members / pharmaceutical companies interested in license-in and license-out opportunities.


    Gate2Biotech

    Supporters
    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.


    World Pharma News

    Supporters
    http://www.worldpharmanews.com/



    Biocompare

    Supporters
    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.


    CanBiotech

    Supporters
    http://www.canbiotech.com

    CanBiotech - A Portal and B2B Outsourcing Marketplace for the Biotech and Pharmaceutical Industry. The Marketplace features the Outsourcing Services Showcase; the Portal features our biopharmaceutical and venture capital directories and databases. Publications include the BioMedical Outsourcing Report and the Bio Outsourcing Asia© Publication.


    American Pharmaceutical Review

    Supporters
    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 Development Technology

    Supporters
    http://www.drugdevelopment-technology.com

    Drugdevelopment-technology.com covers every aspect of the drug development and research process, from conception to pre-FDA approval. Our global network of journalists updates the site with the latest and most significant industry developments. This coverage allows us to provide everyone - from senior management through to research and QA staff – with in-depth reviews of the latest projects, advance notice of new product releases and analysis of the latest procedural and legislative developments.


    Pharmavision

    Supporters
    http://www.pharmavision.co.uk

    PharmaVision offers a consultancy service providing independent pharmaceutical thematic research to the healthcare industry, the investment community and competitive intelligence specialists. We perform due diligence research and provide expert commentary in healthcare. Our reports combine scientific analysis in drug delivery, R&D technologies and pharmaceutical products including patient modelling, product/technology forecasts and market trends evaluation.


    pharmaphorum

    Supporters
    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


    pharmanews hq

    Supporters
    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

    Supporters
    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

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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, SMI 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@smi-online.co.uk

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    Contact SMi GROUP LTD

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
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