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Transdermal and Microneedle Drug Delivery
11 November - 12 November 2024
Transdermal and Microneedle Drug Delivery

Have you considered that microneedle drug delivery systems could revolutionise the future of vaccine and drug administration?

Discover the future of drug delivery at SAE’s 3rd annual Transdermal and Microneedle Drug Delivery conference, where we lead the transition beyond the needle.

Collaborate with forward-thinking experts in a high-level 2-day program, discussing case studies and real-world examples in delivery R&D, vaccine application, and diversifying capabilities.

Transdermal and Microneedle Array Patches (MAPs) are revolutionizing pharmaceutical development, offering unparalleled potency, increased community access, consistent long-term delivery, and advanced diagnostic capabilities, making this technology a frontrunner in enhancing efficacy and global access to transformative products.

FEATURED SPEAKERS

Aleksandra Puton

Aleksandra Puton

Business Manager, Biotts
David Hoey

David Hoey

Chief Executive Officer, Vaxxas
Mahmoud Ameri

Mahmoud Ameri

Vice President, Emergex USA Corporation
Muhammet Avcil

Muhammet Avcil

Managing Director, Imperial BioScience
Pawel Biernat

Pawel Biernat

Chief Technology Officer and Co-Founder, Biotts
Renske Hesselink

Renske Hesselink

Director MSC Innovations, Coalition for Epidemic Preparedness Innovations (CEPI)
Sanjiv Sharma

Sanjiv Sharma

Senior Lecturer in Medical Engineering, Swansea University
Steven Damon

Steven Damon

CEO, Micron Biomedical
Tom Lake

Tom Lake

Senior Vice President, Strategic Alliances and Commercialization, Vaxxas
Waleed Faisal

Waleed Faisal

Project Manager, School of Pharmacy, University College Cork

Aleksandra Puton

Business Manager, Biotts
Aleksandra Puton

Associated with the business for over 10 years, she has competence in project management, marketing and communication supported by many years of cooperation with customers in the pharmaceutical industry. Responsible for marketing and customer acquisition for the unique MTC-Y technology. Graduate of the University of Warsaw.

Brian Pfister

Vice President, Emergex USA Corporation
Brian Pfister

Dr. Brian Pfister is a Vice President at Emergex USA where he leads US operations. Emergex USA is a wholly owned subsidiary of UK based Emergex Vaccines Holding Limited, a clinical-stage, privately held biotechnology company pioneering the development of 100% synthetic CD8+ T cell-priming immune set-point therapeutic candidates that harness and direct the body’s natural T cell immune response to destroy and to clear pathogen-infected cells in order to provide protection against some of the world’s most urgent health threats. Brian received his Ph.D. in biochemistry from Rush University and M.B.A. from the University of Notre Dame.

Clemens Gunther

Former 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.
 

Dr. Clemens Günther started his professional career in 1990 at Schering AG, Berlin-Germany. From 2007 to 2013, he was Director and Head of Global Preclinical Development at Intendis GmbH, branded later-on as Bayer Dermatology. In this position, he was responsible for Nonclinical Safety for the marketed product portfolio of Bayer Dermatology as well as the global preclinical development strategy including human DMPK for development and life cycle management projects.
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. He held this position until June 2024.
 

Dr. Clemens Günther gained about 35 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 including Transdermal Therapeutic Systems. His expertise includes also the Toxicological Risk Assessment of impurities as well as extractables and leachables.
 

Conor O Mahony

Principal Researcher, Tyndall National Institute
Conor O Mahony

Dr. Conor O’Mahony is a Principal Researcher with the Tyndall National Institute, and an Adjunct Professor at Chongqing Technology and Business University, China. He is currently leading a team focussed on the development of Micro Transdermal Interface Platforms (MicroTIPs) – high-value, wearable systems that combine elements of microneedle devices for transdermal delivery and diagnostics, self-awareness and communications capabilities. These ‘smart patches’ interact with the outermost skin layers in a minimally invasive manner, and will blur the lines between implantable medical devices and the current generation of wearable electronics.

David Hoey

Chief Executive Officer, Vaxxas
David Hoey

David Hoey brings more than 30 years of executive-level experience in business development, licensing, strategic planning, and financing for technology companies. His experience spans the preclincal development of small molecule and biologic therapeutics, molecular diagnostic assays and platforms, and analytical instrumentation. David has completed over $400 million in corporate partnering transactions and equity financings in the United States, Europe and Japan and has secured extensive contracts for US Government sponsored research. David has been President and CEO and a member of the Board of Directors of Vaxxas since he joined the company in 2012.

James Birchall

Deputy Head, School of Pharmacy and Pharmaceutical Sciences, College of Biomedical and Life Sciences , 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.
 

Lakshmi Jayashankar

Biologist, Influenza & Emerging Infectious Diseases, ASPR/BARDA, U.S. Department of Health and Human Services (HHS)
Lakshmi Jayashankar

Mahmoud Ameri

Vice President, Emergex USA Corporation
Mahmoud Ameri

Dr. Mahmoud Ameri currently VP at Emergex USA, spearheads microneedle research and operational initiatives at the Fremont site in California. He brings over two decades of expertise in drug delivery, preclinical and clinical development of combination products. A co-founder of Zosano Pharma he played a crucial role in the development of the microneedle technology. Prior to that he was a key innovator at Alza/J&J co-inventing the microneedle transdermal system. Dr. Ameri earned his PhD from the University of Manchester, School of Pharmacy in the United Kingdom.

Mateusz Hasso-Agopsowicz

Technical Officer, World Health Organization
Mateusz Hasso-Agopsowicz

Dr Mateusz Hasso-Agopsowicz is a Technical Officer in the Department of Immunization, Vaccines and Biologicals (IVB) at the World Health Organization (WHO). He holds a PhD in Vaccine Immunology from the London School of Hygiene and Tropical Medicine (LSHTM). Dr Mateusz leads theme areas on the role of vaccines in reducing antimicrobial resistance (AMR), prioritisation of vaccines for research and development, and supporting the development of vaccine-microarray patches (MAPs). MAPs are priority innovation for WHO and together with partners WHO is developing tools and technical products to advance development of MAPs.

Muhammet Avcil

Managing Director, Imperial BioScience
Muhammet Avcil

Dr Muhammet Avcil gained his honours degree in Chemistry and an MSc in Molecular Synthesis (Organic Syntheses) from the University of Sussex. After his MSc, He worked as a Research Assistant at the University of Sussex. He conducted his PhD research at the University of Sussex and Imperial College London. He has over 19 years of experience in biotechnology, drug discovery and development, working at universities and senior management positions in various institutions. He is a key figure in the management and strategic development of Imperial Bioscience and continues to get involved in the research and development of the company.
 

Niraj Vasisht

Chief Technology Officer, Corium International
Niraj Vasisht

Nuria Puigmal Dominguez

Founder, LybraBio
Nuria Puigmal Dominguez

Núria Puigmal, PhD, is a cross-disciplinary bioengineer and the co-founder and acting CEO of Lybra Bio, an MIT/Harvard spin out reshaping the treatment of autoimmune skin diseases using microneedle-enabled therapies. Dr. Puigmal conducted her doctoral and post-doctoral research at Harvard Medical School and the Institute for Medical Engineering and Science (IMES) at MIT, working at the intersection between biomaterials and immunology with a focus on transdermal drug delivery systems. Dr. Puigmal was also recently appointed as a Blavatnik Fellow in Life Sciences and Entrepreneurship at the Harvard Business School.

Pawel Biernat

Chief Technology Officer and Co-Founder, Biotts
Pawel Biernat

Co-founder and patent co-author at Biotts, with a PhD in Pharmacy from the Medical University of Wroclaw. A seasoned pharmaceutical technologist with over two decades of experience, specializing in the design of drug active ingredient nanocarriers, transdermal systems, and sterile, non-oral drug formulations. Renowned for contributions to numerous domestic and international scientific publications. At Biotts, excels in creating proprietary formulations and patents for innovative solutions.

Renske Hesselink

Director MSC Innovations, Coalition for Epidemic Preparedness Innovations (CEPI)
Renske Hesselink

Dr Renske Hesselink is a biochemist with a background in the vaccine industry, who is currently working as CMC Technology Lead at CEPI, the Coalition for Epidemic Preparedness Innovations. At CEPI, she works on technology innovations that enable the rapid development and suitably scaled manufacturing of equitably accessible vaccines for outbreak response.


Prior to joining CEPI, Renske worked in the pharmaceutical industry for over 10 years, mainly in formulation, analytical, and drug product development for various vaccines and biologics. She contributed to the Ebola vaccine developed by Janssen during the outbreak in West-Africa, scaling up the process and making vaccine doses available as soon as possible for clinical trials and containment of the epidemic. She also worked on the stabilization of protein- and viral vector-based vaccines against e.g., RSV and HIV. Renske holds an MSc degree in Molecular Sciences from Wageningen University, the Netherlands, and a PhD in Membrane Biology from the University of Leeds, UK.
 

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.
 

Sebastien Henry

EVP of Technical Operations, Micron Biomedical
Sebastien Henry

Speaker to be confirmed

, Crux Product Design Ltd
Speaker to be confirmed

Steven Damon

CEO, Micron Biomedical
Steven Damon

Mr. Damon is an industry veteran who has over 30 years of experience with various business roles in the medical device and pharmaceutical industries. He served as the CEO and President of 4P Therapeutics, a company he founded in 2011 and sold to Nutriband Inc. in 2018. He served as Chairman and President of Absorbable Polymers International, a company he founded in 2003 as a wholly owned subsidiary of DURECT corporation. Steve has held Executive positions in Mergers & Acquisitions, Business Development and Commercial Development for several companies including Femasys, Altea Therapeutics, DURECT and Kimberly-Clark Health Care.
In addition to his role with Micron, Steve serves on the Board of Directors for Temple Therapeutics. He is a long-time member of Georgia Bio and serves on its Board of Directors.
 

Tom Lake

Senior Vice President, Strategic Alliances and Commercialization, Vaxxas
Tom Lake

Tom Lake supports new businesses that improve access to immunizations. He brings vaccine industry experience in Product Development, Manufacturing, and Commercialization.

Waleed Faisal

Project Manager, School of Pharmacy, University College Cork
Waleed Faisal

CEO and founder of ArrayPatch Ltd. Dr. Faisal led several Enterprise Projects, contributing significantly to commercialization strategies, leading to the formation of ArrayPatch Ltd. With over 16 years of experience in multidisciplinary Pharmaceutics projects, he holds a PhD in Pharmaceutics, and was recognized among Ireland’s top 100 healthcare achievers.

Highlights include:

  • Successes in clinical data and vaccine delivery
  • Innovative capabilities and applications of transdermal and microneedle patches
  • Manufacturing challenges and progress
  • Insights and Q&A opportunities with key regulators

sponsors

Conference agenda

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8:00

Registration & Coffee

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9:00

Co-Chairs' Opening Remarks

Sanjiv Sharma, Senior Lecturer in Medical Engineering, Swansea University

Mahmoud Ameri, Vice President, Emergex USA Corporation

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9:10

Dissolving Microneedle Technology for Drug and Vaccine Administration: Closing the Commercialization Gap

Sebastien Henry

Sebastien Henry, EVP of Technical Operations, Micron Biomedical

  • Preclinical and clinical development update
  • Regulatory considerations and strategy
  • Steps towards commercialization including commercial manufacturing scale up

     

  • clock

    9:50

    Modern Strategies Of Topical And Transdermal Drug Delivery

    Clemens Gunther, Former Senior Expert Nonclinical Safety, Bayer AG

  • The physiological perspective: Understanding the difference between local, regional, systemic, and targeted drug delivery
  • Microneedles as current area of interest for transdermal drug delivery
  • Bioequivalence concepts for systemic and topical therapy
     

     

  • clock

    10:30

    Morning Break

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    11:00

    Session reserved for Crux Product Design Ltd

    Speaker to be confirmed

    Speaker to be confirmed, , Crux Product Design Ltd

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    11:30

    Non-Invasive Transdermal Drug Delivery of Peptides and Proteins

  • Expanding the window of transdermal opportunity: delivery of larger molecules like Semaglutide and Insulin
  • Update of pre-clinical results
  • Pawel Biernat, Chief Technology Officer and Co-Founder, Biotts

    Aleksandra Puton, Business Manager, Biotts

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    12:10

    Applying the Biomedical Catalyst 2023 Grant to Further Develop Microneedle Patch Technology (MPT)

    Muhammet Avcil, Managing Director, Imperial BioScience

  • Assessing the key advantages of ‘dissolving microstructure’ MPTs
  • Applying cutting-edge technology to transition into clinical stage in the development of MPT medicinal products
  • Reviewing the application of MPT technology to both therapeutic and cosmetic purposes
  • clock

    12:50

    Networking Lunch

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    13:50

    Transforming Therapeutics through Transdermal and Microneedle Delivery: Accelerating and Innovating Treatments

    Niraj Vasisht

    Niraj Vasisht, Chief Technology Officer, Corium International

  • Clinical development and gaining regulatory approval for the Adlarity patch 
  • Innovative solutions in our Corplex® transdermal platform
  • Applying intradermal delivery to new molecules and body systems
  • Corium’s MicroCOR® Microneedle Technology – Asset Licensing Opportunity
     
  • clock

    14:30

    Closing the Chapter: Reflecting on Zosano’s Legacy

    Mahmoud Ameri, Vice President, Emergex USA Corporation

  • Industry Leadership: Zosano played a pivotal role in shaping the industry landscape and influencing competitors
  • Innovation and pioneering: increasing the delivered dose from mg to mg
  • Core values: A culture of continuous innovation, encouraging employees to think creatively and take calculated risks
  • clock

    15:10

    Afternoon Break

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    15:40

    De-risking Development of Transdermal and Microneedle Drug and Vaccine Delivery Technologies

    Lakshmi Jayashankar

    Lakshmi Jayashankar, Biologist, Influenza & Emerging Infectious Diseases, ASPR/BARDA, U.S. Department of Health and Human Services (HHS)

  • Continued challenges with MAP development
  • Adjuvants for MAP vaccine products
  • Regulatory considerations
  • clock

    16:20

    Academic Panel: Applying Lessons from Vaccination Progress to the Next Generation of Transdermal and Microneedle Delivery

  • Drawing lessons from progress in vaccination trials and development
  • Overviewing key academic avenues of research - expanding the boundaries of drug delivery
  • Commercialising academic progress
  • Sanjiv Sharma, Senior Lecturer in Medical Engineering, Swansea University

    James Birchall, Deputy Head, School of Pharmacy and Pharmaceutical Sciences, College of Biomedical and Life Sciences , Cardiff University

    Waleed Faisal, Project Manager, School of Pharmacy, University College Cork

    Conor O Mahony, Principal Researcher, Tyndall National Institute

    clock

    17:00

    Co-Chairs' Closing Remarks and Close of Day One

    Sanjiv Sharma, Senior Lecturer in Medical Engineering, Swansea University

    Mahmoud Ameri, Vice President, Emergex USA Corporation

    clock

    8:30

    Registration & Coffee

    clock

    9:00

    Co-Chairs' Opening Remarks

    Sanjiv Sharma, Senior Lecturer in Medical Engineering, Swansea University

    Mahmoud Ameri, Vice President, Emergex USA Corporation

    clock

    9:10

    Exploring important attributes, the potential use-cases and feasibility of introduction of measles and rubella microarray patches (MR-MAPs): insights from nine countries

    Mateusz Hasso-Agopsowicz, Technical Officer, World Health Organization

  • How would this innovation be perceived in different countries?
  • What are the potential uses of MAP’s in different areas?
  • What are the benefits of new innovation?
  • What are the pathways for introduction? What data would we need to implement this?
     
  • clock

    9:50

    Microneedles For Immuno-Regulation And Beyond

  • Discuss the use of microneedles for local modulation of the skin immune system
  • Consider the impact of microneedles toward immune tolerance
  • Applying these findings for the treatment of autoimmune skin diseases
     
  • Nuria Puigmal Dominguez, Founder, LybraBio

    clock

    10:30

    Morning Break

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    11:00

    Joint Session: Creating MAPs for use in Low- and Middle-Income Countries (LMICs)

  • How to create MAPs suitable for use in LMICs
  • Scaling up MAP manufacturing: Challenges and successes
  • What other antigens should be pursued after Measles-Rubella (MR) MAPS?
  • Steven Damon, CEO, Micron Biomedical

    Tom Lake, Senior Vice President, Strategic Alliances and Commercialization, Vaxxas

    clock

    11:40

    The Role of Vaccine Microarray Patches in CEPI’s 100-Days Mission

    Renske Hesselink, Director MSC Innovations, Coalition for Epidemic Preparedness Innovations (CEPI)

  • Vaccine Microarray Patches (MAPs) and other needle-free delivery technologies can make vaccines more equitably accessible in epidemic and pandemic response situations 
  • Platform technology development is critical for preparedness
  • Speed of development as well as scalability of manufacturing are key to rapid response and equitable access
  • clock

    12:20

    Networking Lunch

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    13:20

    Progressing Next-Generation Vaccines using Hollow Microneedle Delivery – Results from the Emergex Vaccines naNO-Dengue and naNO-COVID Phase I Clinical Trial

    Brian Pfister, Vice President, Emergex USA Corporation

  • Demonstrating successful coating and stability of COVID-19 vaccine on MNP
  • Positive Phase 1 data of DengueTcP treatment
  • Novel proprietary MNP delivery platform
  • clock

    14:00

    Achieving Next Generation Needle-Free Vaccine Administration

    Tom Lake, Senior Vice President, Strategic Alliances and Commercialization, Vaxxas

  • Maturing HD-MAP technology for vaccine administration
  • Analysing results from recent usability and accessibility studies
  • Evaluating the potential of needle-free vaccine delivery
  • clock

    14:40

    Afternoon Break

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    15:10

    Industry Panel: Approaching and Resolving Practical and Logistical Challenges in Microneedle Delivery Maturation

  • Universal challenges when commercialising research
  • Drawing lessons from previous successes and failures
  • Achieving cost-effective manufacturing at scale
  • Sanjiv Sharma, Senior Lecturer in Medical Engineering, Swansea University

    Brian Pfister, Vice President, Emergex USA Corporation

    Sebastien Henry

    Sebastien Henry, EVP of Technical Operations, Micron Biomedical

    clock

    16:00

    Co-Chairs' Closing Remarks and Close of Day Two

    Sanjiv Sharma, Senior Lecturer in Medical Engineering, Swansea University

    Mahmoud Ameri, Vice President, Emergex USA Corporation


    Business Manager
    Biotts
    Vice President
    Emergex USA Corporation
    Former Senior Expert Nonclinical Safety
    Bayer AG
    Principal Researcher
    Tyndall National Institute
    Chief Executive Officer
    Vaxxas
    Deputy Head, School of Pharmacy and Pharmaceutical Sciences, College of Biomedical and Life Sciences
    Cardiff University
    Biologist, Influenza & Emerging Infectious Diseases
    ASPR/BARDA, U.S. Department of Health and Human Services (HHS)
    Vice President
    Emergex USA Corporation
    Technical Officer
    World Health Organization
    Managing Director
    Imperial BioScience
    Chief Technology Officer
    Corium International
    Founder
    LybraBio
    Chief Technology Officer and Co-Founder
    Biotts
    Director MSC Innovations
    Coalition for Epidemic Preparedness Innovations (CEPI)
    Senior Lecturer in Medical Engineering
    Swansea University
    EVP of Technical Operations
    Micron Biomedical
    Crux Product Design Ltd
    CEO
    Micron Biomedical
    Senior Vice President, Strategic Alliances and Commercialization
    Vaxxas
    Project Manager, School of Pharmacy
    University College Cork

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    Crux

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    Crux was founded to address challenging technical briefs and deliver compelling solutions for the drug delivery and medical device sectors. Based in Bristol, United Kingdom, our technical team champion evidence-based problem solving, coupling world-class equipment, software and facilities with a scientific approach to maximise success. Be it discovering unmet user needs, developing novel products or deploying new technologies, our team are dedicated to solving our client’s biggest problems..


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    Nemaura Pharma

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    https://nemaura.co.uk/

    Nemaura Pharma was founded in 2005 and specialises in skin drug delivery. The company has a number of drug delivery technologies for topical, transdermal and injectable drug delivery, and an in-house GMP IMP suite as well as ISO13485 accreditation for the design, development and manufacture of medical devices and injectable systems. The company is based in Loughborough, UK.


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