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SAE Media Group’s 7th Annual Conference
Pre-Filled Syringes West Coast
June 12 - 13, 2023 | San Diego, CA, USA
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SAE Media Group’s 7th Annual Pre-Filled Syringes West Coast Conference will be back for 2023 in San Diego to bring together the device developers, innovative biotech and big pharma. This year’s conference will explore the exciting advances in the combination product drug delivery space and a future outlook exploring how pharma, device developers and regulators can work together to encourage innovation.


With the injectable drug delivery industry rapidly advancing year-to-year, administration using pre-filled syringes, auto-injectors, and pen-injectors are increasingly common. Innovations in device technology, such as connected devices are leading the way in device design in addition to injectable delivery devices for novel and large volume drugs. With the need for self-administration growing, there is an enhanced demand for on-body injectors and digitalised health as well as patient centricity. We are beginning to see environmental sustainability being incorporated into aspects of device lifecycle from design to manufacturing and the use of the device. This year’s conference looks to address these hot topics through case studies and industry insights.


As part of SAE’s leading injectable drug delivery conferences this is a must attend event; not only will the conference bring you key insights to enhance your drug device portfolio, but it will also give you the opportunity to network with key industry players. We hope to welcome you in June 2023!
 

  • Engage with industry representatives about the latest technologies and advances within the injectable device market and directions to take to advance your device portfolio
  • Gain insight into new technologies for wearable injectors he delivery of novel and large volume drugs
  • Understand the latest regulatory requirements and guidance to ensure your combination products are compliant such as meeting essential performance requirements
  • Delve into aspects of primary packaging such as material components to consider during device design to ensure drug stability and safety
  • Explore how digital technologies such as companion apps are being incorporated into drug delivery devices to improve user-centricity

 

 

Directors, Heads of Departments and Managers for the following areas:

  • Device Development
  • Device Engineering
  • Combination Product Development
  • Drug Delivery Devices
  • Primary Packaging Development
  • Digital Health
  • Large Volume Drug Delivery
  • Novel Drug Product Formulation
  • Regulatory Affairs
     

AbbVie; Amgen; AnaptysBio; AstraZeneca; BCM Group LLC; BD; Bexson Biomedical; Biogen; Biomarin Pharmaceutical; BioMarin Pharmaceutical, Inc.; BioPhorum; Boston Analytical; Cambridge Design Partnership; Corning; Credence MedSystems; Datwyler Pharma Packaging USA; Elcam E3d ACAL Ltd; Genentech; Halozyme Therapeutics; Haselmeier; Heron Therapeutics ; Immunovant; Ionis Pharmaceuticals; Janssen Pharmaceuticals; Johnson & Johnson; Kymanox; MACH32 Inc; Medical Design Briefs; My Green Lab ; NEMERA; Nemera services; Noble International; Noble International Inc.; Owen Mumford; PHC Corporation; PHC Corporation of North America; Raumedic; Raumedic AG; Regeneron Pharmaceuticals; Sagentia Ltd; Sanofi US; Scherdel Medtec North America; Schott North America; Semigator GmbH; SureMed Technologies; Takeda Pharmaceuticals; Terumo Pharmaceutical Solutions; Teva Pharmaceuticals; UserWise; Zeon Specialty Materials ; ZwickRoell;

Conference programme

8:00 Registration & Coffee

9:00 Co-Chair Opening Remarks

Scott Nunn

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

Natalie Abts

Natalie Abts, Head of Human Factors Engineering, Genentech
View Bio

9:10 New Alternatives for Subcutaneous Drug Delivery and Human Factors Implications

Tina Rees

Tina Rees, Associate Director, Human Factors, Regeneron Pharmaceuticals
View Bio

  • Reviewing the current landscape of emerging technologies to support parenteral drug delivery
  • Assessing industry challenges in the emerging technologies space and potential ways to overcome these
  • Assessing the impact of new technologies on human factors testing
  • Special considerations and developing a successful human factors strategy
  • 9:50 Successful Collaboration for a Strategic Combination Product Devcelopment

    Mark Howansky

    Mark Howansky, Director, Device Development, Bristol Myers Squibb
    View Bio

  • Partnering with internal cross-functional teams to interpret and apply evolving global regulations and guidance documents towards combination product development
  • Key considerations for a collaborative development process across inter-departmental teams
  • Meeting essential performance requirements: challenges to define and identify essential performance requirement (EPR) during the development of a combination product
  • Strategies for meeting the needs of the device constituent as well as the drug constituent
  • 10:30 Morning Coffee

    11:00 Taking a Platform Approach for Combination Product and Injection Device Development

    Nicholas Mandala

    Nicholas Mandala, Senior Director, Combination Products and Device Engineering, Pfizer
    View Bio

  • What delivery systems and devices are suitable for platforms and tailoring for a range of delivery volumes
  • How can platforms be used to maximise product success: a case study
  • What is the impact of regulations: looking at ISO11608 and updates
  • Strategies for advancing and implementing a platform approach
  • 11:40 Sustainability Implications in Electro-Mechanical Devices

    Karthik Vaideeswaran

    Karthik Vaideeswaran, Associate Vice President, Eli Lilly And Company
    View Bio

  • Discussing the shadow effect of incorporating connectivity into injection devices
  • Assessing electro-mechanical device production to final use and end of life, and areas to be reviewed
  • Examining secondary packaging and opportunities for reducing plastic use
  • How can the pharma industry and other stakeholders collaborate to overcome challenges and advance sustainability?
  • 12:20 Successfully Implementing Effective Post Market Surveillance Processes for Injectable Devices

    Khaudeja Bano

    Khaudeja Bano, Vice President, Combination Product Quality, Amgen
    View Bio

  • Discussion of key PMS and medical device vigilance concepts and requirements
  • Guidance on compiling PMS reports and periodic safety update reports for combination products
  • Case studies on effective approaches for efficient report maintaining for injection devices
  • Insight into utilising surveillance feedback to identify areas of continuous improvement
  • 13:00 Networking Lunch

    14:00 Delivering Large Volume at Home with a Sustainable Wearable Injector Platform

    Cecile Gross

    Cecile Gross, Category Manager Parenteral, Nemera
    View Bio

  • Challenges of large volume drugs for the industry
  • Addressing chronic diseases with large volume drugs
  • Challenges for delivering large volume injections at home
  • Drivers for designing a sustainable platform to address all these challenges
  • Necessity of a patient-centric approach
  • 14:30 Device Development Strategies for Long Acting Injectables

    Scott Nunn

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

  • Review of how HIV treatment has evolved over time
  • Key considerations for development of long-acting formulations
  • Challenges to establishing effective delivery devices for long acting injectables
  • 15:10 Session Reserved for Zeon

    15:40 Afternoon tea

    16:10 Making a Material Choice: Polymer vs Glass

    Yusuf Oni

    Yusuf Oni, Associate Director, Bristol Myers Squibb
    View Bio

  • Assessing the current landscape of primary packaging material for pre-filled syringes and injectable drug delivery devices
  • Comparison of glass and polymer materials
  • Exploring the challenges for drug stability and safety: permeation behaviour, difference regarding their break resistance and siliconization
  • What should be considered when selecting polymer vials?
  • 16:50 Session Reserved for Mitsubishi

    17:20 Assessment of the Impact of X-ray Screening on Product Quality for Biotherapeutic Products

    Aslin M. Rodriguez Nassif

    Aslin M. Rodriguez Nassif, Senior Scientist, Pfizer, Inc.
    View Bio

  • Evaluation of the risk of exposure of biological products to X-ray radiation during transportation
  • Evaluation of the impact of potential X-ray exposure to different biotherapeutic modalities
  • Quality Attributes assessment after X-ray radiation
  • 18:00 Co-Chair Closing Remarks and Close of Day One

    Scott Nunn

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

    Natalie Abts

    Natalie Abts, Head of Human Factors Engineering, Genentech
    View Bio

    8:30 Registration & Coffee

    9:00 Co-Chair Opening Remarks

    Scott Nunn

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

    Natalie Abts

    Natalie Abts, Head of Human Factors Engineering, Genentech
    View Bio

    9:10 Successful Digital Integration of Medical Devices and Life Cycle Management

    David Morra

    David Morra, Director, Devices and Digital Health, Merck, Sharpe, & Dohme
    View Bio

  • Reviewing developments in connected combination products over the past year and looking forward: How to capture novel opportunities in digital health
  • Optimising human-centred design and strategies for producing devices tailored to improve adherence
  • Regulatory considerations for the integration of digital components and ensuring compliance
  • What is the future for digital systems and increasing acceptance?
  • 9:50 Using Patient Centric Design to Develop a Connected Digital Device Solution

    Daniel Branco

    Daniel Branco, Digital Health in Omnichannel, Ionis Pharmaceuticals

  • Optimising digital strategies to deliver successful smart devices and connected platforms
  • Key patient and user considerations for the design of digital devices and connected platforms
  • Addressing the challenges in development and review of connected combination products and other digital health products
  • Outlook on the future of connectivity and wearable devices: how can more connected combination products be approved?
  • 10:30 Morning Coffee

    11:00 Meaningfully CONNECTING with Patients for Home Infusion Therapy!

    Ravi Kaushik

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

  • As patients manage their home infusion therapy with combination devices– we need to strive to make digital companion apps and voice enabled (hands free) – become part of their daily routine
  • We can share the progress we are making on these efforts and learnings we have
  • 11:40 Panel Discussion: Promise, Challenges and Considerations for Developing Smart Injectables for Clinical and Commerical Operations

  • How can we generate value from connected devices? Examining what additional benefits connectivity brings
  • How can we utilise connectivity to decentralise healthcare, disease management and more?
  • Does the patient really benefit from connected health or is it a push by payers and device manufacturers? Identifying the connected features that provide beneficial user guidance and patient adherence
  • How does connected devices and digital health fi t to user needs?
  • Amin Sedighiamiri

    Amin Sedighiamiri, Associate Director Device Development, AstraZeneca
    View Bio

    Ravi Kaushik

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

    Jeanne Greathouse

    Jeanne Greathouse, Global Director Healthcare, BSI Group
    View Bio

    Karthik Vaideeswaran

    Karthik Vaideeswaran, Associate Vice President, Eli Lilly And Company
    View Bio

    12:20 IoMT Wearables in Digital Health

    Jeanne Greathouse

    Jeanne Greathouse, Global Director Healthcare, BSI Group
    View Bio

  • Security aspects to maintain protected health information (PHI)
  • Strategies to successfully manage PHI
  • Ensuring compliance in Digital Health ecosystem
  • Exploring important security considerations and steps that should be taken to protect patients
  • 13:00 Networking Lunch

    14:00 Formulating Design Inputs to Develop the Right Device for the Right Patients

    Alex Baker

    Alex Baker, Senior Engineer II, Biogen
    View Bio

  • Synthesizing user research and task analyses to formulate validation-ready user needs
  • Crafting Use Cases to define features, align stakeholders, and drive lower-level requirements
  • Balancing must-have and nice-to-have requirements and planning for future generations of product
  • Choosing the right device platform for a specific drug and patient population
  • 14:40 Session Reserved for Haselmeier

    15:10 Incorporating Patient Centricity into Product Design

    Angela Muriset

    Angela Muriset, Director, Human Factors - Combination Product Development, AbbVie
    View Bio

  • Carrying out human factors and usability studies to understand patient needs and preference
  • Strategies for successfully implementing patient centric design into device development
  • Assessing the impact of patient centricity on dosage form design and lifecycle improvements
  • Reviewing user needs, technical requirements, commercial requirements, and development requirements for key decision criteria
  • 15:50 Afternoon Tea

    16:20 A Meta-Analysis of Shipping Simulation of Elastomeric Plungers for Syringe and Cartridge Barrels

    Gabrielle Gehron

    Gabrielle Gehron, Scientific Support Manager, Datwyler
    View Bio

  • Evaluation of shipping simulations on plungers in various conditions
  • Variety of factors can affect success during shipping simulations, including:
  • Component dimensions
  • Storage conditions
  • Elevation
  • Number of pressure cycles
  • Glean important lessons about performance testing through meta-analysis
  •  

    16:50 Adaptable Human Factors Studies

    Natalie Abts

    Natalie Abts, Head of Human Factors Engineering, Genentech
    View Bio

  • Choosing the type of human factors assessment to meet your development goals
  • Novel methods for early stage studies
  • Combining efforts across projects to streamline development
  • Adapting study designs to address the unexpected
  • 17:30 Insights & Implications from U.S. FDA-UserWise Training Decay

    Shrikar Tatapudi

    Shrikar Tatapudi, Human Factors Engineer, UserWise
    View Bio

  • An overview of Training Decay and why it matters
  • What does the FDA say about Training Decay
  • Insights and revelations from UserWise’s FDA-backed training decay research study
  • How could our findings affect future regulatory policy
  • 18:10 Co-Chair Closing Remarks and Close of Day Two

    Natalie Abts

    Natalie Abts, Head of Human Factors Engineering, Genentech
    View Bio

    Scott Nunn

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

    +

    FEATURED SPEAKERS

    Alex Baker

    Alex Baker

    Senior Engineer II, Biogen
    Amin Sedighiamiri

    Amin Sedighiamiri

    Associate Director Device Development, AstraZeneca
    Angela Muriset

    Angela Muriset

    Director, Human Factors - Combination Product Development, AbbVie
    Aslin M. Rodriguez Nassif

    Aslin M. Rodriguez Nassif

    Senior Scientist, Pfizer, Inc.
    Cecile Gross

    Cecile Gross

    Category Manager Parenteral, Nemera
    Daniel Branco

    Daniel Branco

    Digital Health in Omnichannel, Ionis Pharmaceuticals
    David Morra

    David Morra

    Director, Devices and Digital Health, Merck, Sharpe, & Dohme
    Gabrielle Gehron

    Gabrielle Gehron

    Scientific Support Manager, Datwyler
    Jeanne Greathouse

    Jeanne Greathouse

    Global Director Healthcare, BSI Group
    Karthik Vaideeswaran

    Karthik Vaideeswaran

    Associate Vice President, Eli Lilly And Company
    Khaudeja Bano

    Khaudeja Bano

    Vice President, Combination Product Quality, Amgen
    Mark Howansky

    Mark Howansky

    Director, Device Development, Bristol Myers Squibb
    Natalie Abts

    Natalie Abts

    Head of Human Factors Engineering, Genentech
    Nicholas Mandala

    Nicholas Mandala

    Senior Director, Combination Products and Device Engineering, Pfizer
    Ravi Kaushik

    Ravi Kaushik

    Vice President, Patient Integrated Care Innovation Platform, Takeda Pharmaceuticals
    Scott Nunn

    Scott Nunn

    Director, Device Development, Gilead Sciences, Inc
    Shrikar Tatapudi

    Shrikar Tatapudi

    Human Factors Engineer, UserWise
    Tina Rees

    Tina Rees

    Associate Director, Human Factors, Regeneron Pharmaceuticals
    Yusuf Oni

    Yusuf Oni

    Associate Director, Bristol Myers Squibb

    Alex Baker

    Senior Engineer II, Biogen
    Alex Baker

    Alex Baker works in Biogen’s Device Development group as a Senior Engineer II, Technical Lead based in Cambridge, MA. Alex previously worked at Veranex (formerly Ximedica), a medical device consulting company, where he was a Senior Product Development Engineer developing capital medical equipment, leading the launch of two class II medical devices, and contributing to technical deliverables for other projects. Prior to Veranex, Alex was a Senior Systems Engineer at Eli Lilly and Company, leading technical development for an electro-mechanical, mobile app, and cloud-based system. Alex has additional experience with autoinjectors, insulin pens, requirements/risk management, and Design Verification and Validation.

    Amin Sedighiamiri

    Associate Director Device Development, AstraZeneca
    Amin Sedighiamiri

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

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

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

     

    Angela Muriset

    Director, Human Factors - Combination Product Development, AbbVie
    Angela Muriset

    Angela joined AbbVie, a global biopharmaceutical company, as Director of Human Factors in 2022. At Abbvie, she shares leadership responsibilities for the human factors team as well as contributes to on-going pipeline work as a human factors project lead. Prior to AbbVie, Angela led the Evanston, IL office of Design Science Group, a consulting firm that specializes in optimizing the usability of medical products. Prior to Design Science, Angela worked for over a decade in medical device and combination product development. She holds a BS in Psychology and an MS in Human Factors from the University of Illinois at Urbana-Champaign.

    Aslin M. Rodriguez Nassif

    Senior Scientist, Pfizer, Inc.
    Aslin M. Rodriguez Nassif

    Aslin started at Pfizer as a Senior Scientist in January 2020. She has been part of the formulation team from the beginning, contributing to the process development for various modalities. Aslin has been an integral member of the gene therapy group and has been working toward understanding the impact of X-ray radiation on AAVs and LNP products. In addition to gene therapies, she has also supported particle characterization and further optimization studies for the formulation of mAB-like molecules.

    Prior to joining Pfizer, Aslin completed her post-doctoral studies at Vanderbilt University and has a background in biophysics and protein interactions.

     

    Cecile Gross

    Category Manager Parenteral, Nemera
    Cecile Gross

    Cécile Gross is Marketing Global Category Manager at Nemera, focusing on Parenteral Devices. She oversees the product portfolio strategy, development and life-cycle for safety system, pen injector and on-body injector platforms. She has an experience of more than two decades in the Medical Device Industry, marketing BtoB technological products and implementing product lifecycle management for various kinds of devices. Graduated in International Business, she completed her initial training with a master’s degree in Marketing and Management in the Healthcare Industry at IMIS Institute, Lyon France.

    Daniel Branco

    Digital Health in Omnichannel, Ionis Pharmaceuticals
    Daniel Branco

    Daniel Branco is a Digital Therapeutics expert with 20+ years of experience developing patient-facing digital tools and technologies. His first projects, still in the 90’s, included the very first medical website in Brazil, an Atlas of Human Histology; and Medicinal, the first Q&A portal to connect doctors and patients online in Brazil. A neurologist and PhD in neuroscience, Daniel developed brain mapping techniques for epilepsy and brain tumor surgery planning at Harvard’s Brigham & Women’s Hospital. A Wharton MBA, Daniel founded Medicinia, a Digital Biomarkers & Therapeutics company that develops projects with pharmaceutical companies such as Novartis and Ionis Pharmaceuticals.

    David Morra

    Director, Devices and Digital Health, Merck, Sharpe, & Dohme
    David Morra

    David comes with over a decade of experience developing complex combination products and home use digital solutions within large, medium, and start-up organizations. David has led R&D, Regulatory, and Quality organizations through development, clinical testing, FDA approval and clearance, and ultimately commercialization of these solutions in a variety of disease states and risk profiles.

    During this presentation, David plans to share his experience and lessons learned across these various programs to explain where connected delivery has been, and where it is going in the future. Come to learn about common watch outs and understand the network of groups needed to bring connected delivery systems to the market.
     

    Gabrielle Gehron

    Scientific Support Manager, Datwyler
    Gabrielle Gehron

    Gabrielle is a Philadelphia-based Scientific Support Manager who joined Datwyler Pharma Packaging in 2022. From 2015 to 2019, she attended Widener University and completed her Bachelors' and Masters' degrees in Biomedical Engineering. She has since worked in the pharmaceutical packaging industry, helping major drug companies determine how to safely and effectively package their drug products. Gabrielle has taken a special interest in many related topics, including the process of PERFECTing delivery systems, as well as the benefits of increased degrees of automation in the manufacturing process.

    Jeanne Greathouse

    Global Director Healthcare, BSI Group
    Jeanne Greathouse

    Paving the way for healthy futures through scaling digital trust solutions across the globe, Jeanne is passionate to work with key clients and industry partners to develop holistic solutions, strategies, and programs in digital health. She has worked with the MedTech and Life Sciences industry for over 15 years to accelerate client and healthcare ecosystem innovation, with the goal of improving patients’ and consumers’ quality of life.

    Karthik Vaideeswaran

    Associate Vice President, Eli Lilly And Company
    Karthik Vaideeswaran

    Dr. Karthik Vaideeswaran is an Associate Vice President of R&D in the Delivery, Device and Connected Solutions organization of Eli Lilly and Company. He leads an integrated science, technology and commercialization team comprising of surface, analytical and polymer scientists, biomedical, materials, mechanical and chemical engineers as well as experienced project management professionals who collaborate internally/externally to (a) develop and deliver the container closure systems and delivery device solutions for all the molecules in the Eli Lilly product portfolio, (b) pursue next-generation delivery device platforms including connected solutions for Lilly’s emerging delivery & device needs and (c) probe and understand the science & physiology of drug delivery and the underlying surface & interface phenomenon at a mechanistic level.

    Khaudeja Bano

    Vice President, Combination Product Quality, Amgen
    Khaudeja Bano

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

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

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

    Mark Howansky

    Director, Device Development, Bristol Myers Squibb
    Mark Howansky

    Mark Howansky is a dynamic leader with a 25-year history of developing medical devices and combination products. Currently, Mark serves the Director of Device Development at Bristol Myers Squibb, where he oversees the development of the device constituent of combination products as well as early drug delivery innovation programs and human factors engineering.
    Mark holds a Bachelors degree in Engineering Sciences from Harvard University and a MBA from Stern School of Business, New York University. He has previously developed devices for U.S. Surgical Corporation, Cardio Technologies, Stryker Orthopaedics, Johnson & Johnson and Caliber Therapeutics.
     

    Natalie Abts

    Head of Human Factors Engineering, Genentech
    Natalie Abts

    Natalie Abts is the Head of Human Factors Engineering at Genentech, where she manages the team that conducts all human factors activities for Genentech’s drug delivery devices. Prior to joining Genentech, Natalie worked in medical device consulting for seven years with the National Center for Human Factors in Healthcare. 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.

    Nicholas Mandala

    Senior Director, Combination Products and Device Engineering, Pfizer
    Nicholas Mandala

    Nick has spent more than 20 years in cross functional roles in the device and combination products industry including systems development, clinical manufacturing, manufacturing and process engineering, validation, and combination products quality assurance. He joined Pfizer in 2017 and currently leads the team responsible for lifecycle management of drug delivery devices, implantables, SaMDs, connected devices, and IVDs. His organization’s responsibilities include device strategy, design and development of medical devices and combination products, post market surveillance, and post market innovation and sustainability. He holds a B.S. in mechanical engineering from Cornell University.

    Ravi Kaushik

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

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

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

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

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

     

    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.


     

    Shrikar Tatapudi

    Human Factors Engineer, UserWise
    Shrikar Tatapudi

    Shrikar is a Human Factors Engineer and a project lead at UserWise. He is involved in designing human factors/UX research studies, study protocols, moderating study sessions, and assisting with human factors strategy. He is experienced in working on a diverse set of research problems ranging from ergonomic capability assessments to designing smart human-machine interfaces (HMIs). As a UserWise consultant, Shrikar brings his out-of-the-box thinking and a strong work ethic to further human-centered design efforts, making medical products safe and easy to use.

    Tina Rees

    Associate Director, Human Factors, Regeneron Pharmaceuticals
    Tina Rees

    Tina Rees is the Associate Director of Human Factors at Regeneron, where she leads a team of human factors engineers that manage all aspects of human factors integration across the development and commercialized platforms. Prior to Regeneron, she also led Human Factors at Ferring Pharmaceuticals and was a Principal Research Scientist in Human Factors at Eli Lilly. She has experience with a wide variety of combination products and medical devices and has participated in a number of submissions resulting in approval of combination products and clearance of medical devices. She received her Ph.D. in Biomedical Research from the Mayo Clinic in Rochester, MN and was a Midwesterner until her move to the East Coast 5 years ago.

    Yusuf Oni

    Associate Director, Bristol Myers Squibb
    Yusuf Oni

    Dr. Yusuf Oni is an Associate Director at Bristol Myers Squibb where he is involved in all aspects of primary packaging & device development in the parenteral product development space. Prior to joining BMS, Yusuf was a Senior Engineer with the Materials Science and Technology group at BD Medical. There, he led the design and development of material solutions for various medical products and packaging applications. Yusuf is also involved in academic instruction. He currently serves as an Adjunct Faculty in the Biomedical Engineering department at New Jersey Institute of Technology. Yusuf holds a BSc degree in Chemical Engineering from New Mexico Institute of Mining and Technology and a PhD in Mechanical and Aerospace Engineering (with a concentration in Materials Science) from Princeton University.

    Sponsors

    Exhibitors

    VENUE

    Horton Grand Hotel

    San Diego, 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


    Datwyler

    Sponsors
    https://datwyler.com/healthcare

    Datwyler provides high-quality, system-critical elastomer components and has a leading position in the global healthcare market. Within the healthcare solutions business area, Datwyler develops, designs, and manufactures solutions for injectable packaging and drug delivery systems to facilitate customers to create a safer medical environment of tomorrow. Looking back onto more than 100 years of history, Datwyler is a reliable partner, now and in the future!



    Haselmeier

    Sponsors
    https://haselmeier.com/en/

    o Haselmeier, the drug delivery device business of medmix, designs, develops and manufactures advanced drug delivery systems such as pen injection systems and autoinjectors. Patient comfort and customers’ needs are always at the heart of the company’s practices. With its broad portfolio of technologies and services, Haselmeier delivers user-friendly injection systems that enable patients to self-administer their medication reliably and accurately. Haselmeier is known for its excellent and long-standing track record in providing these innovative drug delivery devices based on its proprietary IP business model. The company collaborates closely with its customers in the pharmaceutical and biopharmaceutical industries. Medmix, with its precision injection molding capabilities and expertise in liquid micro-dosing plus financial strength and global footprint, helps Haselmeier accelerate innovation in healthcare. With more than 100 years of expertise in the development and manufacture of drug delivery devices, our global footprint, nearly 250 distinguished and motivated experts, more than 200 patents granted, and numerous patents pending, Haselmeier remains committed to developing innovative solutions that support our customers and help improve the health of millions of people worldwide.



    Mitsubishi Gas Chemical

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

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


    Nemera

    Sponsors
    http://www.nemera.net

    As a world-leading drug delivery device solutions provider, our purpose of putting patients first enables us to design and manufacture devices that maximize treatment efficacy. We are a holistic partner and help our customers succeed in the sprint to market of their combination products. From early device strategy to state-of-the-art manufacturing, we’re committed to the highest quality standards. Agile and open-minded, we work with our customers as colleagues. Together, we go the extra mile to fulfill our mission.



    ZEON

    Sponsors
    https://www.zeon.eu/

    o ZEON’s Zeonex® and Zeonor® cyclo olefin polymer (COP) allow for advanced, break-resistant syringes, vials and lyophilization containers for protein-based biopharmaceuticals, high viscosity drugs, and contrast media. They also offer high purity, “glass-like” transparency, sterilization, low water absorption, and superior moldability, as well as overcome protein adsorption and ph shift concerns. Please visit our booth and discover why COP is an excellent choice for drug storage and pre filled syringes.


    Exhibitors


    Credence MedSystems

    Exhibitors
    http://www.credencemed.com

    Credence MedSystems is an innovator in injectable drug delivery devices. Credence’s philosophy of Innovation Without Change results in products that impress and protect end-users while preserving pharma’s existing processes, sourcing strategies and preferred primary package components. The Companion® family of syringe systems includes proprietary needle-retraction technology, reuse prevention and other critical safety and usability features in Staked and Luer needle formats. The Dual Chamber platform offers single-step mixing and injection for drugs requiring reconstitution at the time of delivery. Additional products such as metered dose devices, multi-length staked needles and other novel devices address the needs of specific therapeutic markets.


    Kymanox

    Exhibitors
    http://www.kymanox.com

    Kymanox is a life science professional services organization that offers engineering, scientific, project management, quality, and regulatory support to companies exclusively in the biotechnology, pharmaceutical, medical device, and combination product industries. With its diverse team of experts, Kymanox helps clients navigate commercialization challenges that arise throughout a product’s life cycle – from early development to post-market – with optimized safety, quality, efficacy, and accessibility. Kymanox was founded in 2004 and is headquartered in Morrisville, North Carolina USA. For more information, please visit www.kymanox.com.



    Noble

    Exhibitors
    http://www.gonoble.com

    Noble and Metaphase an Aptar pharma company, provide expertise and the “voice of the patient” in product design, user-experience research, human factors, along with tailored training & on-boarding solutions to help our clients Ideate, Validate, and Educate throughout the product development process. In addition, Noble manufactures and commercializes training devices. These devices mimic the exact feel, force, and function of drug delivery devices such as autoinjectors, prefilled syringes, onbody, nasal and pulmonary devices in order to increase patient adherence and confidence and decrease usage errors. Noble was founded in 1994 and is based in Orlando, Florida. For more information, visit www.gonoble.com.



    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/



    SCHERDEL Medtec

    Exhibitors
    https://medtec.scherdel.com/

    At SCHERDEL Medtec, we don’t just provide solutions, we provide care. Making components for the medical industry offers the unique privilege to our employees and the community.

    We’re proud to provide crucial, essential medical components to the people who need them. Scherdel employees understand that we manufacture more than just springs, we manufacture pieces of hope and health to individuals in need. At SCHERDEL Medtec, we believe that healthcare consists of two equal parts health and care.,

    The focus of our expertise is in the drug delivery device market sector. We supply 100’s of millions of springs and precision stampings for peninjectors, autoinjectors, syringe needle safety systems and other drug delivery devices. In addition to manufacturing these essential components, Scherdel also offers world class product development tools and expertise in numerical simulation and best in class engineering software tools.

    SCHERDEL Medtec, is part of the SCHERDEL Group. With about 5,800 employees at 32 locations world wide, the SCHERDEL Group is a family-owned, leading company in the field of metal-forming with core competence in the production of engineering springs, stamping parts and assemblies for the pharmaceutical market as well as of vehicle components.


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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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