Gerresheimer Ag · XETR:GXI
Gerresheimer — American Drug Delivery & Formulation 2023
31 slides from Gerresheimer's conference presentation, September 2023
Slide 1: Facilitating Subcutaneous Self-Administration of Biopharmaceuticals for Enhanced Patient Experience
Facilitating Subcutaneous Self-Administration of Biopharmaceuticals for Enhanced Patient Experience Dr. Reza Abedian, Senior Medical Affairs Manager
Slide 2: FDA Perspective on VOP
FDA Perspective on VOP … only patients live with their medical conditions and make daily choices regarding their health care. Their voice and perspective are critical to understanding the impact of medical devices.” https://www.fda.gov/about-fda/cdrh-patient-science-and-engagement-program/patient-pr
Slide 3: Subcutaneous drug delivery of biologics
Subcutaneous drug delivery of biologics
Slide 4: Growing need for injection of biologics
Growing need for injection of biologics In a CT with 200 patients switching to SC delivery of trastuzumab at home: → Savings of more than $2 million1 1 Tetteh, E. K. et al. Health Econ. Rev. 4, 26 (2014). 4 Facilitating Subcutaneous Self-Administration of Biopharmaceuticals for Enhanced Patient Expe
Slide 5: Switching IV to SC
Switching IV to SC Benefits of SC self administration2 − Per body weight − Fixed dose − Injection time: 30-90 min − Injection time: 1-5 min − Active HCP time: 67.6 min − Active HCP time: 13.9 min − Drug preparation at hospital pharmacy 9.8 min − No Drug preparation at hospital pharmacy 2 Bittner B.
Slide 6: Subcutaneous Self-administration
Subcutaneous Self-administration Reduces the burden on the health care sector Generally preferred over IV administration as it: − Enables at-home injection − Improves quality of life − Reduces health care costs3 3 Dychter, S.S. et al. Journal of Infusion Nursing: May/June 2012 - Volume 35 - Issue 3
Slide 7: SC Injection of Large Molecule Drugs
SC Injection of Large Molecule Drugs Gx Inbeneo® Autoinjector Gx SensAir® On-body Injector up to 3 ml Volume Up to 20 ml volume Current Solutions by Gerresheimer 7 Facilitating Subcutaneous Self-Administration of Biopharmaceuticals for Enhanced Patient Experience
Slide 8: Device Development Expectation…
Device Development Expectation… Start 8 Facilitating Subcutaneous Self-Administration of Biopharmaceuticals for Enhanced Patient Experience
Slide 9: Device Development Vs Reality…
Device Development Vs Reality… Start 9 Facilitating Subcutaneous Self-Administration of Biopharmaceuticals for Enhanced Patient Experience
Slide 10: Gx SensAir On-body Injector
Gx SensAir® On-body Injector For SC self-administration of large volume biologics
Slide 11: SensAir Device Platform
SensAir® Device Platform Re-usable and disposable concept Reusable unit (Electronics module) Non-sterile packed Glass cartridge with stopper Separate packaging (Aseptic) Disposable unit (Fluidic module) Sterile packed 11 Facilitating Subcutaneous Self-Administration of Biopharmaceuticals for Enhance
Slide 12: Ecodesign Concept
Ecodesign Concept Simple 5-step approach for home use Simply attach the reusable Remove DU from electronic module to the blister pack, take disposable module cartridge from fridge & insert into DU Eco-friendly device concept Remove liner & attach device on body 5 Remove and dispose of disposable mod
Slide 13: Early-stage PPI study
Early-stage PPI study
Slide 14: Research Method
Research Method Study Methodology and design 14 American Drug Delivery & Formulation, 18-19th Sep 2023, Boston
Slide 15: Study results and insights
Study results and insights 15 American Drug Delivery & Formulation, 18-19th Sep 2023, Boston
Slide 16: Opinions of an On-body Injector
Opinions of an On-body Injector Some Patient Testimonials − ∼68% have a positive opinion of an on-body injector instead of standard SC administration 31.5% 31.5% Unsure Love it “…I would consider it” “…but it sounds like a good idea” “That would be great – I had that for another drug and I loved it
Slide 17: Opinions of Home Use
Opinions of Home Use Some Patient Testimonials − Over 70% of patients are No thanks in favour of the aspect of 13% home use (n=32) Miss contact with HCP 12% Love it 44% “That would be awesome !” “that would be very convenient” Makes life “It will help reduce travel time” easier 19% Like it 12% 17 Fa
Slide 18: HF & usability evaluation
HF & usability evaluation
Slide 19: Useability Evaluation
Useability Evaluation Assembly and simulated drug administration “It's good that there aren't too many buttons” “Easy to use” “Can be done before breakfast, half asleep” “Technically very simple, even for elderly people” Participants “Lightweight and compact device” − n = 10 subjects − 6 female, 4 m
Slide 20: Observed Use Errors & Design Solutions
Observed Use Errors & Design Solutions Vital information for further design development Error: Cartridge inserted into Error: RU & DU not correctly Error: Users found it difficult RU & not clicked in assembled to track injection progress 20 Facilitating Subcutaneous Self-Administration of Biopharmac
Slide 21: Observed Use Errors & Design Solutions
Observed Use Errors & Design Solutions Vital information for further design development Solution: Design of cartridge Error: RU Design Solution: & DU not correctly change of Solution: Increased size of LED rear cap changed so no assembled RU/DU interface geometries light guide & observation window c
Slide 22: Gx Inbeneo Autoinjector
Gx Inbeneo® Autoinjector For SC self-administration of single-dose biologics In cooperation with Midas Pharma
Slide 23: Gx Inbeneo Key Device Benefits
Gx Inbeneo® Key Device Benefits 23 Facilitating Subcutaneous Self-Administration of Biopharmaceuticals for Enhanced Patient Experience
Slide 24: Key Platform Characteristics
Key Platform Characteristics To Address Therapy and Patient Needs 24 Facilitating Subcutaneous Self-Administration of Biopharmaceuticals for Enhanced Patient Experience
Slide 25: Gx Inbeneo - Formative Study
Gx Inbeneo® - Formative Study* Study Population Breakdown 24% Naive adults with 26% mild/moderate dexterity Patients with experience injecting themselves with an AI/PFS Lay caregivers who are naive to using AI/PFS 24% HCPs (4 med doctors, 5 nurses) who have 26% experience using /have been trained to
Slide 26: Patient-centric Design: Ease of Use
Patient-centric Design Ease of Use Did you monitor the injection progress? On a scale of 1 to 5, how easy was it for you to monitor (n=34) injection progress? (n=29) Very difficult 3% No 15% Doable 14% Relatively easy 21% Very easy 62% Yes 85% 26 Facilitating Subcutaneous Self-Administration of Biop
Slide 27: Patient-centric Design: User Preference
Patient-centric Design User Preference Which method did you use to monitor the injection progress? (n=29) Inspection window 34% Visual indicator 66% 27 Facilitating Subcutaneous Self-Administration of Biopharmaceuticals for Enhanced Patient Experience
Slide 28: Patient-centric Design: Visual Indicator
Patient-centric Design Visual Indicator − 75% gave a positive response How useful was the visual indicator (n=34) Not useful at all 9% Not too useful 16% Very useful 39% Quite useful 10% Visual Indicator − Partially transparent housing − Enables tracking of the injection Useful 26% progress 28 Facil
Slide 29: In Summary
In Summary Early-stage PPI and HF Studies help − Understand the unmet user needs hence, − Optimizing device design − Avoiding foreseeable use errors à Save costs and reduce time to market Cancer patients ask for a route of administration which is − Quick − Less painful − Offers more flexibility 29 2
Slide 30: Remote drug delivery
Be Wherever independent you are Remote drug delivery In the Stay comfort of connected your home
Slide 31: Gerresheimer - innovating for a better life
serresheimer innovating for a better life
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