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SMi presents the Inaugural Transdermal and Microneedle Drug Delivery Conference
24th to 25th January, 2022 | London
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SMi is proud to present the Transdermal and Microneedle Drug Delivery Conference, taking place on the 24th to 25th January 2022, in London. Transdermal and Microneedle Drug Delivery Conference will explore real world applications of microneedles in drug delivery and strategies for device design while engaging in the latest innovations in device design and formulation with case studies from thought leaders.

The conference will consider key developments in the transdermal drug delivery field, including the innovations in microneedle technology for a COVID-19 vaccine and opportunities for development in cancer vaccine delivery, advances in microarray patches, and microneedle-based diagnostics. Key regulatory updates including guidance on classification of microneedle devices and considerations for ensuring quality will be presented by regulatory experts for a comprehensive outlook of this exciting and ever-growing field, and the importance of considering human factors in order to enhance the user experience will be presented by industry experts.

This two-day agenda offers you peer-to-peer networking with leaders in transdermal and microneedle delivery. We look forward to welcoming you to the conference in January.

  • Gain insight into developments in microneedles for drug delivery and diagnostics
  • Hear key regulatory updates from regulatory bodies including FDA and WHO on guidance for regulatory compliance
  • Explore new applications of microneedle technology in vaccinations
  • Discover advances in design and application of transdermal patches
  • Explore and benchmark against industry developments through case studies and real world examples in device development for microneedles
  • Drug-Delivery  Device Developers
  • Microneedle Device Developers
  • Transdermal Delivery  Developers
  • Microarray Patch Developers
  • Medical Device Engineers
  • Primary Packaging Material Designers
  • Secondary Packagers
  • Smart Device Developers
  • Training Device Developers
  • Device-Safety Solution Providers
  • Drug Developers
  • Transdermal Drug Product Developers


Previous attendees include:

AbbVie; Alnylam Pharmaceuticals; Amgen; Aptar Pharma; AstraZeneca; Bayer AG; BD Medical; Bd Medical-Pharmaceutical Systems; Becton dickinson; Becton Dickinson (BD); Bespak Europe Ltd; Boehringer Ingelheim; Boehringer Ingelheim GmbH; Boehringer Ingelheim Pharma GmbH & Co. KG; BSI; BSI Group; Cardiff University; CSL Behring AG; Eveon; F. Hoffman-La Roche Ltd.; F. Hoffmann-La Roche Ltd.; Ferring Pharmaceuiticals Pvt. Ltd.; FERRING PHARMACEUTICALS PVT LTD; Gerresheimer Buende GmbH; GlaxoSmithKline; GlaxoSmithKline (GSK); GSK; Haughton Design Ltd; Institute BCN Esthetics, S.L.; Ipsen; Ipsen Group; IPSEN Pharmsciences; Janssen; Janssen Pharmaceutica NV; Janssen Pharmaceutical Companies of Johnson and Johnson; Janssen Research and Development, LLC; Johnson & Johnson (Janssen Pharmaceutical); kaleo, Inc.; LEO Pharma A/S; Medicines & Healthcare Products Regulatory Agency (MHRA); MedinCell; Merck; MHRA; Minapharm Pharmaceuticals; Nemera; Nipro PharmaPackaging Germany; Novartis; Novartis – Global Drug Development; Novartis Pharma AG; Novartis Pharmaceuticals; Novo Nordisk; Novo Nordisk A/S; Novo Nordisk Pharma; Owen Mumford; PCI Pharma Services; Pfizer; Pfizer Inc.; Pfizer Ltd UK; Pfizer UK Limited; Pfizer, INC.; Regeneron Pharmaceuticals, Inc.; Rhein Minapharm; Roche; RSK-Solutions/ RSK Life Science Media; Sanofi; Sanofi SWI; TERUMO coeporation; Teva Ltd; Teva Pharmaceuticals; Teva UK; Teva, Combination Products; TUV SUD Japan Ltd.; UCB; UCB Pharma; W.L. Gore & Associates, Inc.; West Pharmaceutical Services; Zeon Corporation; Zeon Europe GmbH; Zeon Specialty Materials

Conference programme

8:00 Registration and Coffee

9:00 Chair's Opening Remarks

Sanjiv Sharma

Sanjiv Sharma, Senior Lecturer in Medical Engineering, Swansea University
View Bio

Tycho Speaker

Tycho Speaker, Director, Drug Delivery and Biomaterials, AbbVie Ltd
View Bio

9:10 Prioritisation of microarray patches (MAPs) for vaccine delivery in low and middle-income countries

  • Compelling attributes of MAPs for vaccine delivery, and potential public health impact
  • MAPs, priority #1 as part of the Alliance Vaccine Innovation Prioritisation Strategy – methodology and rationale
  • The Alliance 5-year strategy and action plan for MAPs
  • Prioritisation of antigens for MAPs’ use in low and middle-income countries
  • Birgitte Giersing

    Birgitte Giersing, Team Lead, Vaccine prioritization and platforms, World Health Organization
    View Bio

    Marion Menozzi-Arnaud

    Marion Menozzi-Arnaud, Senior Specialist, Gavi
    View Bio

    9:50 PATH Microarray Patch Center of Excellence

    Courtney Jarrahian

    Courtney Jarrahian, Program Advisor, PATH
    View Bio

  • Overview and update from PATH’s Microarray Patch (MAP) Center of Excellence, an initiative to mobilize efforts to accelerate the development of MAPs for critical vaccines and essential medicines.
  • How the MAP delivery technology platform can maximize its impact by meeting global public health priorities.
  • Evaluations of user needs, human factors, cost-effectiveness modeling, and manufacturing approaches.
  • 10:30 Morning Coffee

    11:00 Advances in Vaccine Adjuvants and RNA Vaccines

    Derek O Hagan

    Derek O Hagan, Senior Advisor Vaccines, GSK
    View Bio

  • Licensed vaccines with adjuvants
  • RNA vaccines
  • Delivery systems
  • Discovery of next generation adjuvants
  • 11:40 Development of Smart Vaccine Patch for COVID19 vaccination

    Sanjiv Sharma

    Sanjiv Sharma, Senior Lecturer in Medical Engineering, Swansea University
    View Bio

  • Repurposing microneedle technology for a COVID vaccine
  • Monitoring biomarkers in the skin compartment to assess efficacy of the vaccination
  • Microneedle patches for diagnostics and drug delivery
  • Evaluating advantages of microneedle technology: allowing for lower doses of the vaccine which contributes to low-cost manufacturing
  • Beyond the pandemic: expanding research to other diseases
  • 12:20 Developing differentiated, transdermal forms of high-value drugs

    Jake Lombardo

    Jake Lombardo, Co-Founder & CEO, Anodyne Nanotech, Inc

  • How does the Hero Patch work? A technology overview
  • Current challenges in the sustained delivery of macromolecules
  • A new class of microneedle – the cutting edge technology behind improved drug loading
  • Pre-clinical data and future possibilities of the Hero Patch delivery platform
     
  • 13:00 Networking Lunch

    14:00 Considerations for Microneedle System Development: An FDA Assessor’s Perspective

    Caroline Strasinger

    Caroline Strasinger, Master Reviewer, FDA
    View Bio

  • An overview of FDA perspectives on combination products, specifically transdermal and microneedle systems
  • Considerations for the manufacturing process and ensuring product quality of microneedle systems
  • Enhancing communication to move microneedle technology to the commercial market
  • 14:40 The MAP Center of Excellence Regulatory Working Group: A collaborative approach to help define the regulatory pathway for MAPs

    Sion Coulman

    Sion Coulman, Senior Lecturer, Cardiff University
    View Bio

  • A background to the MAP Regulatory Working Group (RWG)
  • An update on the activities of the MAP RWG, to include:
  • - Laboratory Developments; Developing new standardised Test Methods for MAP critical quality attributes
  • - Guidance; Helping to define the regulatory pathway for MAP development
     
  • 15:20 Afternoon Tea

    15:50 Transdermal and Microneedle Drug Delivery – Regulatory requirements in the EU

    Janet Koenig

    Janet Koenig, German CHMP Alternate, Head of the Unit Anaesthesiology, Algesiology, Rheumatology, Pneumology, ENT, German Federal Institute for Drugs and Medical Devices (BfArM)
    View Bio

  • General requirements for topical products in the context of a regulatory submission
  • Aspects to consider with respect to applications with Microneedle technology
  • Transdermal and Microneedle Drug Delivery Systems in paediatrics
  • 16:30 Transdermal Delivery Systems as Drug Device Combination Products - Considerations for the biocompatibility testing program

    Clemens Gunther

    Clemens Gunther, Director, Senior Expert Nonclinical Safety, Bayer AG
    View Bio

  • Insight into biocompatibility evaluations supporting regulatory submissions of DDCP
  • Evaluating biocompatibility of Transdermal Delivery Systems / Microneedling Devices 
  • How to comply with requirements on extractable and leachable testing
  • Toxicological Risk Assessment approaches for E&L
  • 17:10 Human centered design of microneedle products

    James  Birchall

    James Birchall, Professor of Pharmaceutical Sciences and Deputy Head of School, Cardiff University
    View Bio

  • User studies and human factors in microneedle product development 
  • Addressing challenges in contraception technologies in low and middle income countries
  • Evaluating the usability and acceptability of a microneedle-based contraceptive
  • 17:50 Chair's Closing Remarks and Close of Day One

    Sanjiv Sharma

    Sanjiv Sharma, Senior Lecturer in Medical Engineering, Swansea University
    View Bio

    Tycho Speaker

    Tycho Speaker, Director, Drug Delivery and Biomaterials, AbbVie Ltd
    View Bio

    8:30 Registration and Coffee

    9:00 Chair's Opening Remarks

    Sanjiv Sharma

    Sanjiv Sharma, Senior Lecturer in Medical Engineering, Swansea University
    View Bio

    Tycho Speaker

    Tycho Speaker, Director, Drug Delivery and Biomaterials, AbbVie Ltd
    View Bio

    9:10 Microneedles for oral delivery

    Ester Caffarel-Salvador

    Ester Caffarel-Salvador, Associate Director, Regenerative Medicine, LEO Pharma A/S
    View Bio

  • Challenges of delivering to the gastrointestinal tract
  • Key device features for successful oral delivery
  • The landscape for oral drug delivery and microneedles
  • Patient perceptions of microneedles in the oral mucosa
  • 9:50 Advanced microneedle patches for drug delivery

    Mark R Prausnitz

    Mark R Prausnitz, Regents Professor, Georgia Institute of Technology
    View Bio

  • Perspective on microneedle field as a whole
  • Novel microneedle patch designs
  • Case study on microneedle patch for drug delivery
  • 10:30 Morning Coffee

    11:00 Enabling More Efficacious and Accessible Vaccines with the MIMIX Patch Platform

    Michael Schrader

    Michael Schrader, CEO, Vaxess Technologies
    View Bio

  • Introduction to the biology of sustained intradermal delivery
  • Introduction to the MIMIX sustained intradermal delivery platform
  • Pre-clinical data review
  • Manufacturing and clinical trial program status
  • 11:40 Vaxxas HD-MAP Update

    Tom Lake

    Tom Lake, SVP, Strategic Alliances and Commercialization, Vaxxas
    View Bio

  • Pre-clinical and Clinical Studies
  • Insights into Vaxxas’ needle-free vaccination technology
  • Manufacturing of Vaxxas’ HD-MAP
  • 12:20 Networking Lunch

    13:20 Tissue Role in MAP Insertion Dynamics

    Tycho Speaker

    Tycho Speaker, Director, Drug Delivery and Biomaterials, AbbVie Ltd
    View Bio

  • Discussion of complex physical phenomena influencing MAP insertion
  • Tissue-specific considerations in development of a delivery system
  • Path to clinical studies and model selection
  • 14:00 Nanoengineered microneedle arrays and their applications

    14:40 Microneedle-Mediated Application and Delivery of Vaccines as a Dose-Sparing and In-Home Alternative to Traditional Administration

    Hayley Lewis

    Hayley Lewis, Senior Vice President, Zosano Pharma

  • A presentation on the formulation and delivery of vaccine candidate(s) via microneedles to demonstrate the efficiency and ease of use.
  • An outline of the program from concept to in vivo data.
  • Key points demonstrating the versatility and validity of microneedle delivery as a potential to respond to current challenges in vaccine distribution and roll out.
  • 15:20 Afternoon Tea

    15:50 Panel Discussion: Future outlook of transdermal drug delivery systems

  • Recent advances of microneedles for biomedical applications
  • Commercial opportunities in developing transdermal delivery systems
  • Overcoming challenges in scale up of manufacturing
  • Future uses of microneedles in pandemics: what would it take to make the technology ready?
  • Is the market ready for microneedle patch technology? Weighing the benefits and costs of transdermal delivery
  • Sanjiv Sharma

    Sanjiv Sharma, Senior Lecturer in Medical Engineering, Swansea University
    View Bio

    Tycho Speaker

    Tycho Speaker, Director, Drug Delivery and Biomaterials, AbbVie Ltd
    View Bio

    Courtney Jarrahian

    Courtney Jarrahian, Program Advisor, PATH
    View Bio

    Hayley Lewis

    Hayley Lewis, Senior Vice President, Zosano Pharma

    Ester Caffarel-Salvador

    Ester Caffarel-Salvador, Associate Director, Regenerative Medicine, LEO Pharma A/S
    View Bio

    Michael Schrader

    Michael Schrader, CEO, Vaxess Technologies
    View Bio

    16:30 Delivery of macromolecules into and across the skin

    Sachin Dubey

    Sachin Dubey, Head of Drug Product and Analytical Development, Ichnos Sciences, SA
    View Bio

  • Currently available delivery options for macromolecules
  • Non-invasive and minimally invasive transdermal techniques
  • Iontophoresis for intra and transdermal delivery of proteins
  • Laser poration and its tandem use with iontophoresis
  • 17:10 Chair's Closing Remarks and Close of Day Two

    Sanjiv Sharma

    Sanjiv Sharma, Senior Lecturer in Medical Engineering, Swansea University
    View Bio

    Tycho Speaker

    Tycho Speaker, Director, Drug Delivery and Biomaterials, AbbVie Ltd
    View Bio

    +

    FEATURED SPEAKERS

    Birgitte Giersing

    Birgitte Giersing

    Team Lead, Vaccine prioritization and platforms, World Health Organization
    Caroline Strasinger

    Caroline Strasinger

    Master Reviewer, FDA
    Clemens Gunther

    Clemens Gunther

    Director, Senior Expert Nonclinical Safety, Bayer AG
    Courtney Jarrahian

    Courtney Jarrahian

    Program Advisor, PATH
    Derek O Hagan

    Derek O Hagan

    Senior Advisor Vaccines, GSK
    Ester Caffarel-Salvador

    Ester Caffarel-Salvador

    Associate Director, Regenerative Medicine, LEO Pharma A/S
    Hayley Lewis

    Hayley Lewis

    Senior Vice President, Zosano Pharma
    James  Birchall

    James Birchall

    Professor of Pharmaceutical Sciences and Deputy Head of School, Cardiff University
    Janet Koenig

    Janet Koenig

    German CHMP Alternate, Head of the Unit Anaesthesiology, Algesiology, Rheumatology, Pneumology, ENT, German Federal Institute for Drugs and Medical Devices (BfArM)
    Mark R Prausnitz

    Mark R Prausnitz

    Regents Professor, Georgia Institute of Technology
    Sachin Dubey

    Sachin Dubey

    Head of Drug Product and Analytical Development, Ichnos Sciences, SA
    Sanjiv Sharma

    Sanjiv Sharma

    Senior Lecturer in Medical Engineering, Swansea University
    Sion Coulman

    Sion Coulman

    Senior Lecturer, Cardiff University
    Tom Lake

    Tom Lake

    SVP, Strategic Alliances and Commercialization, Vaxxas
    Tycho Speaker

    Tycho Speaker

    Director, Drug Delivery and Biomaterials, AbbVie Ltd

    Birgitte Giersing

    Team Lead, Vaccine prioritization and platforms, World Health Organization
    Birgitte Giersing

    Birgitte Giersing leads the Vaccine Prioritisation and Platform work within the Product and Delivery Research Unit, in WHO’s Immunization Department. She is the secretariat for the Product Development for Vaccines Advisory Committee (PDVAC), working across a number of pathogens areas and vaccine platforms, and is the WHO focal point for the Vaccine Innovation Prioritisation Strategy (VIPS). She has approximately 20 years of vaccine product development experience, having led vaccine development programmes in the private and non-profit sector before joining WHO 6 years ago. She trained as a biochemist and performed her post-doctoral studies at the National Institutes of Health, USA in malaria vaccine development.

    Caroline Strasinger

    Master Reviewer, CDER/FDA
    Caroline Strasinger

    Caroline Strasinger

    Master Reviewer, FDA
    Caroline Strasinger

    Dr. Strasinger is a Master Reviewer in CDER’s Office of Pharmaceutical Quality and is Chair of the FDA’s Transdermal Drug Working Group (TDWG). As Chair she is responsible for assuring the TDWG fulfills their mission of continuously improving the scientific premises for regulating product quality as it relates to clinical performance and the public availability of transdermal drug products. She began her career at FDA in 2009 and holds a PhD in Pharmaceutics and a BS in Chemical Engineering from the University of Kentucky.

    Clemens Gunther

    Director, Senior Expert Nonclinical Safety, Bayer AG
    Clemens Gunther

    Dr. Clemens Günther received his diploma in biology and doctorate for natural sciences from the Free University, Berlin-Germany.
    He started his professional career in 1990 at Schering AG, Berlin-Germany.
    From 2007 to 2013, Dr. Clemens Günther was Director and Head of Global Preclinical Development at Intendis GmbH, branded later-on as Bayer Dermatology.
    After integration of Intendis into Bayer in 2013, he became Director Nonclinical Safety Consumer Care and later-on Senior Expert Nonclinical Safety within the Division of Bayer Pharmaceuticals.
    Meanwhile Dr. Clemens Günther has gained over 30 years experience in drug development. He has been involved in nonclinical development and regulatory toxicology of small molecules, biologics, medical devices and drug device combination products in various medical indications.

    Clemens Gunther

    Director, Senior Expert Nonclinical Safety, Bayer AG
    Clemens Gunther

    Dr. Clemens Günther received his diploma in biology and doctorate for natural sciences from the Free University, Berlin-Germany.
    He started his professional career in 1990 at Schering AG, Berlin-Germany.
    From 2007 to 2013, Dr. Clemens Günther was Director and Head of Global Preclinical Development at Intendis GmbH, branded later-on as Bayer Dermatology.
    After integration of Intendis into Bayer in 2013, he became Director Nonclinical Safety Consumer Care and later-on Senior Expert Nonclinical Safety within the Division of Bayer Pharmaceuticals.
    Meanwhile Dr. Clemens Günther has gained over 30 years experience in drug development. He has been involved in nonclinical development and regulatory toxicology of small molecules, biologics, medical devices and drug device combination products in various medical indications.
     

    Courtney Jarrahian

    Program Advisor, PATH
    Courtney Jarrahian

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

    Derek O Hagan

    Senior Advisor Vaccines, GSK
    Derek O Hagan

    I am currently a Senior Advisor in R&D in GSK Vaccines, since 2018, and a GSK Fellow, since 2019. Prior to this I was the Global Head of Discovery Support and New Technology in GSK Vaccines. Until 2015, I was the Global Head of Vaccine Chemistry and Formulation Research for Novartis Vaccines. I have extensive experience on Vaccine Adjuvants, including participation in the R&D of those included in licensed products and I was part of the Team that established the program on Self Amplifying RNA vaccines (SAM) in Novartis, Cambridge, which is now active in GSK. I served on the Board of Scientific Advisors for the Controlled Release Society and I am a Fellow of the American Association of Pharmaceutical Scientists. I was awarded the Conference Science medal of the Royal Pharmaceutical Society of Great Britain in 1997, and the Young Investigator Research Achievement Award of the Controlled Release Society in 1999. I was also named as the ‘most inventive scientist’ in Chiron in 2004 and was the lead author on the most cited paper in ‘Vaccine’ 2008-10. I served on the Board of Scientific Advisors for the Controlled Release Society and I am a Fellow of the American Association of Pharmaceutical Scientists.

    Ester Caffarel-Salvador

    Associate Director, Regenerative Medicine, LEO Pharma A/S
    Ester Caffarel-Salvador

    Dr. Ester Caffarel-Salvador is a multidisciplinary scientist with a background in biotechnology and biochemistry. She was recognized by the MIT technology review with the Innovators under 35 award in 2019 and the Nova Talent award in 2021. As a postdoc in Professor Robert Langer's laboratory at MIT, she developed a novel pill design to administer insulin and other macro-molecules via oral delivery in collaboration with Novo Nordisk.
    Dr. Caffarel-Salvador is now an Associate Director of Regenerative Medicine at LEO Pharma. She is passionate about advocating on career development for women in science and is an advisor and mentor at various academic and entrepreneurial programs, both locally and internationally.
     

    Hayley Lewis

    Senior Vice President, Zosano Pharma
    Hayley Lewis

    Jake Lombardo

    Co-Founder & CEO, Anodyne Nanotech, Inc
    Jake Lombardo

    James Birchall

    Professor of Pharmaceutical Sciences and Deputy Head of School, Cardiff University
    James  Birchall

    James Birchall is Professor of Pharmaceutical Sciences and Deputy Head of the School of Pharmacy and Pharmaceutical Sciences, Cardiff University. Professor Birchall graduated from Bath University in 1993 and completed his PhD researching drug and DNA delivery systems in 1998 (Cardiff University). Current research includes pulmonary drug delivery and microneedle delivery of molecules, macromolecules, vaccines, auto-antigens and cells into skin for therapeutic, immunisation or immunotherapy applications.

    Professor Birchall has acted as Associate Editor of Critical Reviews in Therapeutic Drug Carrier Systems, a member of the Editorial Board of Expert Review of Medical Devices, a temporary advisor to the WHO and an expert advisor to the British Pharmacopoeia and conducted research funded by the EU, DFID, Bill and Melinda Gates Foundation, NIH, Wellcome Trust, EPSRC, MRC, Welsh Government, Royal Society, Innovate UK and various charities and pharmaceutical companies.

    Janet Koenig

    German CHMP Alternate, Head of the Unit Anaesthesiology, Algesiology, Rheumatology, Pneumology, ENT, German Federal Institute for Drugs and Medical Devices (BfArM)
    Janet Koenig

    Janet Koenig is the Head of Unit Anaesthesiology, Algesiology, Rheumatology, Pulmonology, ENT in the Division Licensing at the German Federal Institute for Drugs and Medical Devices (BfArM). Mrs. Koenig is also the German alternate member of the Committee for Medicinal Products for Human Use (CHMP) She received her M.D. at University of Goettingen Germany (1998) and her Board Certificate in Surgery at University Hospital of Bonn, Germany.

    Marion Menozzi-Arnaud

    Senior Specialist, Gavi
    Marion Menozzi-Arnaud

    Within the Gavi Secretariat and Market Shaping team, Marion is leading strategic cross portfolio projects in support of defining and/or accomplishing Gavi market shaping objectives. Especially, Marion is responsible for vaccine product innovation within the Secretariat as part of the Gavi Innovation Strategy, including leading the Vaccine Innovation Prioritisation Strategy (VIPS) - a partnership between the Gavi Secretariat, WHO, UNICEF, BMGF and PATH to drive vaccine product innovation. Prior to that, Marion was the Head of Pricing and Market Access, Biosimilars at Merck, and before that she was Principal in a boutique management consulting companies specialised in the pharmaceutical industry.

    Mark R Prausnitz

    Regents Professor, Georgia Institute of Technology
    Mark R Prausnitz

    Mark Prausnitz is Regents’ Professor and J. Erskine Love, Jr. Chair of Chemical & Biomolecular Engineering at the Georgia Institute of Technology. He earned a BS degree from Stanford University and PhD degree from MIT, both in chemical engineering. Dr. Prausnitz and colleagues carry out research on drug delivery using microneedles, lasers, ionic liquids and other microdevices for transdermal, ocular and intracellular delivery of drugs and vaccines. Dr. Prausnitz teaches courses on engineering calculations and pharmaceuticals. He has published almost 300 journal articles and has co-founded five start-up companies including Micron Biomedical and Clearside Biomedical.

    Michael Schrader

    CEO, Vaxess Technologies
    Michael Schrader

    Michael Schrader is the CEO of Vaxess, an NIH and VC-backed company bringing vaccines out of the clinic and into patients’ lives with the MIMIX Smart Release platform. MIMIX combines ease of administration with efficacy enhancements enabled by the "mimicry" of natural infections. The company has a pipeline of vaccines under development, including a world-first COVID + Influenza vaccine. Prior to Vaxess, Michael spent time at Google and Honda where he helped bring a range of products to market and earned more than fifteen patents. Michael received his B.S. in Mechanical Engineering from Purdue University and his M.B.A. from Harvard.

    Sachin Dubey

    Head of Drug Product and Analytical Development, Ichnos Sciences, SA
    Sachin Dubey

    I am presently working with Ichnos Sciences, Switzerland (A part of Glenmark Pharmaceuticals SA, Switzerland) and heading three major functions for the company – formulation, analytical, and drug product development groups. I have more than 15 years of experience in this area with > 9 years in an industrial setting (with previous global experience with Novozymes A/S Denmark and Glenmark Pharmaceutical SA Switzerland). Twelve products developed by me and my team are currently in clinical trials. These products are in different markets including the USA, EU, and Asia – this gave us very rich hands-on experience. In addition, I have 18 PCT patents, 24 publications in high-impact journals like Trends in Biotechnology, Journal of Controlled Release, Molecular Pharmaceutics, etc., 7 book chapters, and have been invited speaker on the topic in several international conferences (> 50). Industry and academia have equally recognized my contribution with 20 research awards including prestigious industry awards from Glenmark (Best innovation team – won twice), Merck (Innovation cup), Novartis (International bio camp), and the Swiss Society of Pharmaceutical Sciences (Best publication).

    Sanjiv Sharma

    Senior Lecturer in Medical Engineering, Swansea University
    Sanjiv Sharma

    Dr Sanjiv Sharma received his PhD on the development of analytical methods for determination of certain pharmaceuticals and their metabolites using miniaturised separation system in 2001. On completion of his fellowship he joined the Institute of Biomedical Engineering, Imperial College London to work with Professor Tony Cass in the area of Bionanotechnology and Biosensors. Here he developed minimally invasive microneedles, from photolithographic fabrication to high throughput fabrication, taking these microneedles from the lab to the clinic . Sanjiv was involved in a NIHR (i4i) funded research project involving clinical studies in healthy volunteers and participants with T1D with renowned Endocrinologist Clinicians; Professor Desmond Johnston and Professor Nick Oliver. He has published over 50 research articles and has patents filed in Germany, UK and the United States.
    Sanjiv is currently a Senior Lecturer in Medical Engineering in the College of Engineering at Swansea University. At Swansea, he is working on therapeutic drug delivery and diagnostic (theranostic) applications of polymeric microneedles.

    Sion Coulman

    Senior Lecturer, Cardiff University
    Sion Coulman

    Sion is based at Cardiff University and has worked on microneedle-based delivery systems since 2002. He has been involved in the development of microneedle-based systems for both novel and established therapeutic candidates and is particularly interested in translation of the technology from laboratory prototypes to clinically useful products. He is a highly collaborative researcher with expertise that bridges the engineering, pharmaceutical science and medical research disciplines, and enjoys working in international multi-disciplinary teams. He has technical experience in both laboratory and end-user research and has parallel research interests in 3D bio-printing and capsule-based dry powder inhalers (DPIs).

    Tom Lake

    SVP, Strategic Alliances and Commercialization, Vaxxas
    Tom Lake

    Tom Lake, Senior Vice President, Strategic Alliances & Commercialization, Vaxxas. Tom Lake supports new businesses that improve access to immunizations. He brings vaccine industry experience in Product Development, Manufacturing, and Commercialization.

    Tom Lake

    SVP, Vaxxas
    Tom Lake

    Tycho Speaker

    Director, Drug Delivery and Biomaterials, AbbVie Ltd
    Tycho Speaker

    Tycho Speaker is currently Director, Drug Delivery and Biomaterials at AbbVie. He holds a doctorate in physical chemistry, which is the basis for a career spanning a variety of manufacturing and formulation roles. Work toward treatment of a rare skin disorder (Pachyonychia Congenita) included the development of a novel dissolvable microneedle technology, among a range of other patents and innovations in various stages of commercialization.

    Workshops

    Beyond the Needle - (Division of Research, Innovation, and Ventures DRIVe)
    Workshop

    Beyond the Needle - (Division of Research, Innovation, and Ventures DRIVe)

    Venue To Be Confirmed
    26th January 2022
    London, United Kingdom

    VENUE

    Venue To Be Confirmed

    London, United Kingdom

    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.
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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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