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Injectable Drug Delivery
24 June - 25 June 2025
Injectable Drug Delivery

Injectable Drug Delivery is an industry focused on two overarching topics the development of the device & the interaction between drug product and device. SAE’s 2025 Injectable Drug Delivery conference brings together a complete big pharma speaker line-up providing technical updates on the relationship between drug product formulation and the device primary packaging, with considerations for formulation strategies, extractables & leachables and toxicological testing of injectable devices.


This conference brings case studies from senior big pharma representatives providing an opportunity to discuss formulation considerations in depth for parenteral packaging, this is the perfect opportunity to benchmark your drug delivery programme and optimise the development of your injectable portfolio.

 

FEATURED SPEAKERS

Clovis Pichon

Clovis Pichon

Head of Device Program Leadership, UCB Medical Devices SA
Conor O'Neill

Conor O'Neill

Head of Packaging Development and Design, GSK
Nicola Bettini

Nicola Bettini

Senior Process Engineer, Roche
Ryan Noble

Ryan Noble

Associate Director Regulatory Affairs - CMC Devices, GSK
Stephanie Greco

Stephanie Greco

Section Head in Formulation and Process Development, Sanofi

Alicja Sobantka

Head of Corporate Material Qualification, Octapharma
Alicja Sobantka

Alicja is currently employed at the Octapharma group, where she is responsible for material qualification including chemical safety assessment of polymeric processing-, packaging-, and administration materials, and extractables and leachables assessment.
Prior to joining Octapharma, Alicja had a tenured position as a researcher at the French National Institute for Agricultural Research (INRA) where she investigated possibilities to foster sustainability in the food processing industry. During her PhD, Alicja developed an entropy-based method for evaluation of material flow streams.
 

Chantal Pfaffen

Global Lead Material Qualification, CSL Behring
Chantal Pfaffen

Chantal studied chemistry at the University of Bern in Switzerland, where she also received her PhD in physical chemistry. She started her professional career at CSL Behring Bern in 2013 and had different roles in QA release and process validation. Since 2021, Chantal is the global lead for Material Qualification in the Engineering Validation Center of Excellence (CoE). She leads a small team across the CSL Behring sites in Germany and USA, focusing on extractables and leachables from in process-materials, container closure systems and combination products as well as on elemental impurities in final products.

Christian Proff

Senior Verification Engineer, Roche
Christian Proff

Dr. Christian Proff is a materials scientist with degrees from Chalmers, Gothenburg (S) and Darmstadt (D) Universities of Technology and a PhD from Grenoble (F) University (INPG) with extensive experience in materials research in Sweden (Chalmers), USA (Argonne National Laboratory) and Switzerland (Paul-Scherrer-Institut). Within Device and Packaging Development at F. Hoffmann - La Roche he is working in Verification Engineering since 2018 on improvements in CCI testing and development of new device test methods

Clovis Pichon

Head of Device Program Leadership, UCB Medical Devices SA
Clovis Pichon

Clovis Pichon is the Head of Device Program Leadership at UCB, overseeing the design, development, and lifecycle management of drug delivery systems. Previously, Clovis led a team managing the UCB portfolio of commercial medical devices. He has spearheaded innovative projects at UCB (ava® Connect and CimplyMe®) and Merck Serono (easypod™ and RebiSmart™ systems). With extensive experience in project management, risk management, and regulatory compliance, Clovis has also held managerial roles in production and logistics in the aeronautics and automotive industries. He holds an engineering degree in production systems.

Confirmed

Senior Representative, Biophorum
Confirmed

BioPhorum’s mission is to create environments where the global biopharmaceutical and device industry can collaborate and accelerate its rate of progress, for the benefit of all.

A business-to-business membership organization, BioPhorum consists of twelve phorums leading industry-changing initiatives with the help of thousands of active subject matter experts.

Conor O'Neill

Head of Packaging Development and Design, GSK
Conor O'Neill

I lead the Packaging Development & Design group in GSK R&D’s Drug Product Development department. My group is responsible for the selection of the immediate or primary contact packaging components for GSK’s portfolio of small and large molecule projects in development ensuring the suitability and safety of these components with the drug product through to regulatory filing and market launch.

I am passionate about improving the sustainability perceptions around pharmaceutical and delivery device packaging. Within GSK R&D I am leading the evaluation of novel materials and systems that will enable our corporate intent to reduce the environmental footprint of our products and packaging. I am driven by the ambition to improving the circularity of the devices and packaging we ask our patients to use.

I graduated from the University of Limerick, Ireland, as an Applied Physicist and I joined GSK’s then Device Technology Group in Inhaled Product Development in 2003. I began my career as a Device Technologist supporting and subsequently leading the design verification for the MistPro platform - used for the delivery of the Veramyst/Avamys product. During my career I have worked across the primary and secondary packaging space in both our R&D and Global Supply Chain organisations. I have supported multiple product developments and launches ranging across respiratory treatments, infectious diseases, oncology. and rare diseases.
 

Elodie Hablot

Senior Packaging Engineer, Roche
Elodie Hablot

Elodie holds a Ph.D. in Polymer Chemistry and an M.S. in Materials Science from the University of Strasbourg, France. Following her studies, she conducted postdoctoral research in the Biobased Materials Research Group at Michigan State University, USA. Elodie began her career at Dow Chemical as a research chemist, focusing on the formulation of adhesives for various applications. Since 2022, she has been working within the Device and Packaging Development at F. Hoffmann-La Roche. Her focus is on developing packaging components, particularly secondary packaging for drug products intended to be manufactured, stored, and transported at very low temperatures.

Fatima Bennai-Sanfourche

Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer AG
Fatima Bennai-Sanfourche

Dr. Fatima Bennai-Sanfourche is working currently as Senior Director of QA&RA Compliance for Medical Devices, Combinations Products, and eHealth at Bayer AG.
Previously she worked in the medical affairs and Pharmacovigilance department at Bayer as Director, Medical Device Safety Global Pharmacovigilance/Medical device Safety officer.
She has more than 15 years of experience in the quality management and Regulatory Affairs of medical devices field, and over 20 years of supervisory and leadership experience including hiring, training and performance evaluation.
In her current position by Bayer AG her focus is ensuring the regulatory compliance as well as high product quality of medical device, combination products and eHealth components of the Pharmaceuticals portfolio.
She is also responsible for Ensuring compliant use of medical devices and medical software tools in the context of clinical investigations and clinical trials, incl. accordance with medical device Good Clinical Practice (GCP).
She is also leading the project of the implementation of euMDR for PH-Bayer AG.
 

Jehanzeb Ahmed

Project Leader, Device Engineering, GSK
Jehanzeb Ahmed

Joel Richard

Chief Development Officer, Enterome
Joel Richard

 

Dr Joël Richard has 30 years of experience in biopharmaceutical R&D, including several global senior leadership positions in various Biotech and Pharma companies, such as Enterome, MedinCell, Ipsen, Merck Serono, Serono and Ethypharm, leading Drug Development Operations of these companies. He is presently Chief Development Officer in Enterome, leading CMC, Non-Clinical and Regulatory activities.
Dr Richard graduated from Ecole Normale Supérieure (Paris-Saclay, France). He has got his PhD in Materials Science/Colloids & Interface Science from University of Paris and “Habilitation à Diriger les Recherches” (HDR) in Chemistry from University of Bordeaux. He also had an entrepreneurial experience, co-funding and leading the Mainelab Company (Angers, France), a drug delivery company specialized in the discovery and development of solvent-free processes for protein delivery systems.
In the past 20 years, Dr Richard has focused his scientific activities on new formulations and drug delivery systems (such as microspheres, nanoparticles, gelling and self-assembling systems, chemically modified proteins, supercritical fluid technology . . .), especially for injectable protein and peptide formulations. Dr Richard has published 75 peer-reviewed scientific papers, 8 book chapters and 2 editorials in various fields (colloids and interfaces, drug delivery, supercritical fluids, protein and peptides formulations, sustained-release formulations…). He is the author of 140 invited international conferences, 50 international communications and 55 international patent families.
 

Kai Zwingenberger

Medical Director Global Quality, Akamema Consulting
Kai Zwingenberger

Kai is a physician holding postgraduate degrees in tropical medicine, immunology, toxicology and business administration. During three decades in the pharmaceutical industry his roles spanned R&D, medical affairs, business development and quality. Supporting quality in CSL Behring Inc Kai authored patient risk assessments including toxicological assessments of extractables/leachables for medical devices and packaging materials used for various routes of administration. An area of special expertise is the assessment of potential interaction of drug impurities with the immune system including sensitization and immunogenicity of protein biotherapeutics.
Kai lives in Basel, Switzerland.
 

Klaus Boje

Senior Scientist Primary Packaging Development, Boehringer Ingelheim
Klaus Boje

Klaus Boje studied mechanical engineering. He has been working for Vetter as a supervisor of the QC of packaging material. Since 1999 he is working for Boehringer Ingelheim, first in the pharmaceutical development of biopharmaceuticals. Since 2014 he is a Scientist in primary packaging development and responsible for early and late stage NBE and NCE projects for parenteral products.

Marion Briggs

Circular Economy Expert and Member, Alliance to Zero
Marion Briggs

Nicola Bettini

Senior Process Engineer, Roche
Nicola Bettini

Nicola works as Principal Process Engineer in Global dMSAT at Hoffman-La Roche.

After completing his master studies in pharmaceutical chemistry and technology at Ferrara University (Italy) he joined Sandoz/Novartis in 2015, where he worked until 2022 for then joining Lonza and finally Roche in 2023.
He covered various roles with increasing responsibilities such as QA compliance for device and combination products, QA operations manager for assembly and packaging, global senior expert primary packaging and senior scientist process development.

In his current role, Nicola is supporting the industrialization/scale-up activities in order to bring new innovative products to the market.
 

Ryan Noble

Associate Director Regulatory Affairs - CMC Devices, GSK
Ryan Noble

Ryan Noble is an Associate Director at GSK in the Global Regulatory Affairs Devices Team. He is currently focused on integrating device engineering and drug product development to ensure regulatory compliance with the ever-changing regulatory landscape. Ryan has been working in combination product development for 25 years and has experience in testing, formulation, manufacturing, quality systems, and regulatory processes throughout the lifecycle of both respiratory and parenteral systems.

Simon Dell

Device Development Lead, Pfizer
Simon Dell

Simon Dell is a Senior Principal Scientist at DCoE where he’s a Device Development Lead. Having served 17 years at Pfizer, he enjoys the challenges of defining needs, strategies, vendor network, team leadership on many varied device requiring projects. With special interest in emerging technologies with large volume delivery, he is active in the Large Dose CIG and champions the potential of On Body & Large volume Auto Injectors.
Prior to joining Pfizer, Simon received his BSc from Oxford Brookes University in Product Design where his dissertation was around the subject of personalized electric transport, a long time before getting his Tesla! Prior to joining Pfizer as design engineer, he worked in the military and automotive industries.
 

Soroosh Bagheriasl

Phorum Director, BioPhorum
Soroosh Bagheriasl

Stephanie Greco

Section Head in Formulation and Process Development, Sanofi
Stephanie Greco

Dr Stéphanie Greco is a section head in Formulation and Process Development (FPD), focused on the process development of injectable biologics drug product. She holds a PhD in physico-chemistry from Paris University, and an “Engineer” degree from the ESPCI Paris-Tech (Engineering school of industrial physics and chemistry).
She started her career at Sanofi in 2003 , working on the physical characterization of crystalline or amorphous drug substance during physical treatment (drying, milling…). During the last decade she has developed strong skills in the process development & scale-up, and industrial transfer of injectable biologic drug products (mAbs, bi-specific antibodies, nanobodies, ADC…). She’s now leading a 10 person’s group dedicated to this expertise.
 

Sylvestre Grizot

Research & Innovation Leader, MedinCell
Sylvestre Grizot

Dr Sylvestre Grizot is currently the Research & Innovation Leader at MedinCell (Montpellier, France), where he leads the research department with the aim of developing new technology platforms and extending the capabilities of MedinCell’s proprietary BEPO® LAI technology with a particular focus on peptide/protein formulations or local delivery. Before joining MedinCell, he worked for several companies in the field of protein engineering. He holds a Master of Bioengineering from the Ecole Centrale Paris, a Master of Science in Molecular Biophysics from University Paris VI and a PhD in Protein Biochemistry and Crystallography from the University of Grenoble, France.

Tony Haythornthwaite

Device Engineering Manager, GSK
Tony Haythornthwaite

 Why you should attend:

  • ENGAGE in discussions on the latest innovations within complex formulations including long acting and large volume injectables with leaders from Novartis, Pfizer, and Medincell.
  • GAIN insights from senior industry experts on combination product design considerations including primary packaging material choices and risk management strategies.
  • UNCOVER the robust E&L and toxicology testing strategies being employed to minimize unwanted drug-device interactions through detailed case study presentations from CSL Behring, Octapharma and Biophorum.
  • DISCUSS the future of sustainable device development with industry leaders from GSK, UCB Pharma, Roche and more, through an interactive panel discussion session.
  • BUILD your ecosystem within Injectable Drug Delivery to uncover potential collaborators and keep pace with this rapidly advancing field.
     

Who should attend:

Any company striving to optimize injectable delivery of therapies to patients in need.
If you or your company are working on or looking to break into any of the following areas, this conference is a must!

  • Combination product/parenteral drug research and development
  • Vaccine R&D
  • Combination product formulation
  • Primary packaging and container closure integrity challenges
  • Biocompatibility, extractables and leachables and toxicology testing
  • Device design for advanced modalities
  • Regulatory compliance for combination products
     

To discuss your involvement as a sponsor contact Ash Khan on +44 (0) 20 7827 6110 or ash.khan@saemediagroup.com

Conference agenda

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8:00

Registration and Coffee

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9:00

Chair's Opening Remarks

Rachel Koppelman

Rachel Koppelman, Head of Device Engineering, Sandoz

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9:10

Novel immunomodulatory peptide formulations for improved therapeutic outcomes in immuno-oncology

Joel Richard, Chief Development Officer, Enterome

  • Peptide-based Vaccines Strategies in Immuno-Oncology
  • What Key Features of Liquid Formulations improve the Delivery and Efficacy of Peptide-based Vaccines
  • Advantages and Challenges of Using Multiple Peptides: Progress in this area
  • Drug Development Challenges up to the Clinic
  • clock

    9:50

    Implications of fast, large volume delivery

    Simon Dell, Device Development Lead, Pfizer

  • Impact of large volume formulations with fast delivery rates on drug efficacy and safety
  • 3D imaging methods for testing efficacy and risk in novel formulations
  • Innovations within patient device interactions
  • clock

    10:30

    Morning Break

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    11:00

    Enabling controlled and targeted delivery of long acting injectables

    Sylvestre Grizot, Research & Innovation Leader, MedinCell

  • Medincell’s BEPO technology
  • Improving drug efficacy through use of long acting injectables
  • Case studies on overcoming challenges within long-acting injectable formulations
     
  • clock

    11:40

    Compatibility studies for a pre-filled syringe: case studies from Boehringer Ingelheim

    Klaus Boje, Senior Scientist Primary Packaging Development, Boehringer Ingelheim

  • Comparison of commercially available PFS qualities
  • Selection criteria and compatibility considerations
  • Case study: How to deal with challenges
     
  • clock

    12:20

    Networking Lunch

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    13:20

    Packaging challenges in extreme cold temperatures - from secondary packing to container closure integrity

  • Comparison standard to cryo packaging conditions
  • Labelling requirements - secondary packaging
  • Handling
  • Primary packaging - container closure integrity assurance
     
  • Elodie Hablot, Senior Packaging Engineer, Roche

    Christian Proff, Senior Verification Engineer, Roche

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    14:00

    Session reserved for GSK

    Tony Haythornthwaite

    Tony Haythornthwaite, Device Engineering Manager, GSK

    Jehanzeb Ahmed

    Jehanzeb Ahmed, Project Leader, Device Engineering, GSK

    clock

    14:40

    User-centric device design incorporating risk management strategies

    Fatima Bennai-Sanfourche, Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer AG

  • Ensuring appropriate balance of risk vs benefit for medical devices in development
  • Understanding the importance of biocompatibility, E&L and patient safety during device design
  • Impacts of the EU MDR on risk management processes for combination products
     
  • clock

    15:20

    Afternoon Break

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    15:50

    From Fill to Finish: Optimizing Filling Parameters to Improve Lyophilized Cake Appearance and Minimize Rejects

    Stephanie Greco, Section Head in Formulation and Process Development, Sanofi

  • Description of visual defects related to splashing and dripping effects during filling.
  • How to avoid these undesired filling events by playing on critical parameters: filling flow-rate, height of the filling needle, suck-back parameter.
     
  • clock

    16:30

    Panel discussion: Combination product design - challenges associated with drug-device co-development

  • Discussing the latest industry findings regarding drug-device co-development challenges
  • Mid-size pharma and biotech perspectives on the biggest challenges they face during combination product design and development
  • What solutions exist to overcome formulation challenges relating to novel and complex parenterally delivered modalities including biologics, peptides and cell and gene therapies
     
  • Joel Richard, Chief Development Officer, Enterome

    Soroosh Bagheriasl

    Soroosh Bagheriasl, Phorum Director, BioPhorum

    Alicja Sobantka, Head of Corporate Material Qualification, Octapharma

    Rachel Koppelman

    Rachel Koppelman, Head of Device Engineering, Sandoz

    clock

    17:10

    Chair's closing remarks and close of day one

    clock

    8:30

    Registration and Coffee

    clock

    9:00

    Chair's Opening Remarks

    Ryan Noble, Associate Director Regulatory Affairs - CMC Devices, GSK

    clock

    9:10

    Reviewing the latest advancements in parenteral delivery systems and technologies

    Rachel Koppelman

    Rachel Koppelman, Head of Device Engineering, Sandoz

    clock

    9:50

    Toxicological and product quality concerns during E&L testing of Injectable Drug Devices

  • Risks assessments and toxicological testing strategies for injectable drug products
  • E&L safety assessments for novel immunotherapeutic preparations
  • Dealing with unexpected occurrences during manufacturing of combination products in the context of patient risk
  • Preparing for the upcoming ICH Q3E quality guidelines, due to come into effect in 2026
  • Kai Zwingenberger

    Kai Zwingenberger, previously Medical Director Global Quality, CSL Behring UK Ltd

    Chantal Pfaffen, Global Lead Material Qualification, CSL Behring

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    10:30

    Morning Break

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    11:00

    Technical challenges and considerations for E&L testing of advanced modality injectable drug products

    Alicja Sobantka, Head of Corporate Material Qualification, Octapharma

  • Developing analytical tools for protein-reactive extractables and leachable risk assessments
  • Challenges relating to emerging technologies within E&L
  • Technical advancements within the E&L field
     
  • clock

    11:40

    Biocompatibility Challenges and considerations for Drug Delivery Devices

    Confirmed, Senior Representative, Biophorum

  • Biocompatibility Testing Across the Product Lifecycle
  • Risk Assessment Strategies and Requirements
  • Device Categorization for Cumulative Use
  • GSPR and EU MDR
     
  • clock

    12:20

    Networking Lunch

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    13:20

    Implementing device sustainability frameworks in line with regulatory variation expectations

    Ryan Noble, Associate Director Regulatory Affairs - CMC Devices, GSK

  • Assessing the impacts of updated EU variation and other regulations on injectable device sustainability initiatives
  • Considering different aspects of sustainability with respect to both existing and new injectable products
  • Opportunities for improved alignment in change management across drug-device development teams
     
  • clock

    14:00

    Industrialization of Combination Products; a final assembly perspective

    Nicola Bettini, Senior Process Engineer, Roche

  • General considerations
  • Important device features aimed to Design for Manufacturing/Design for Assembly
  • Supply chain
  • Sustainability
  • clock

    14:40

    Adoption of sustainability practices within subcutaneous drug delivery: Industry Insights

    Conor O'Neill, Head of Packaging Development and Design, GSK

  • Overview of an industry benchmarking survey to understand industry sustainability trends
  • Insights into the current state of adoption and prioritization of sustainability practices within the industry
  • Highlighting key barriers to implementation and opportunity areas for impactful change
  • Benchmarking insights and opportunities for sustainability best practices and collaboration
     
  • clock

    15:20

    Afternoon Break

    clock

    15:50

    Towards a more sustainable future – sustainability initiatives within combination product design and development

  • Discussing recent sustainability initiatives within combination product design
  • Major blockers to sustainability and circular economy within the injectable drug delivery sector
  • Addressing the reasons for industry hesitation to use of recycled materials within drug delivery devices
  • Novel and alternative methods to improve sustainability of combination products
  • Marion Briggs

    Marion Briggs, Circular Economy Expert and Member, Alliance to Zero

    Ryan Noble, Associate Director Regulatory Affairs - CMC Devices, GSK

    Conor O'Neill, Head of Packaging Development and Design, GSK

    Clovis Pichon, Head of Device Program Leadership, UCB Medical Devices SA

    clock

    16:10

    Chair's closing remarks and close of day 2


    Head of Corporate Material Qualification
    Octapharma
    Global Lead Material Qualification
    CSL Behring
    Senior Verification Engineer
    Roche
    Head of Device Program Leadership
    UCB Medical Devices SA
    Senior Representative
    Biophorum
    Head of Packaging Development and Design
    GSK
    Senior Packaging Engineer
    Roche
    Senior Director of QA & RA Compliance for Medical Devices and eHealth
    Bayer AG
    Project Leader, Device Engineering
    GSK
    Chief Development Officer
    Enterome
    Medical Director Global Quality
    Akamema Consulting
    Senior Scientist Primary Packaging Development
    Boehringer Ingelheim
    Circular Economy Expert and Member
    Alliance to Zero
    Senior Process Engineer
    Roche
    Associate Director Regulatory Affairs - CMC Devices
    GSK
    Device Development Lead
    Pfizer
    Phorum Director
    BioPhorum
    Section Head in Formulation and Process Development
    Sanofi
    Research & Innovation Leader
    MedinCell
    Device Engineering Manager
    GSK

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