Embed Size (px)
Citation preview
SIMULATION & OPTIMISATION BASED DECISION-‐MAKING FOR CLINICAL TRIAL SUPPLY
Take the best decisions throughout your study!
SebasHen Coppe
London -‐ May, 20th
Agenda
• ForecasHng ? SimulaHon ? OpHmisaHon ?
• Take the best decisions throughout your study!
• Advantages and conclusions
2
May 15 (c) N-‐SIDE
SIMULATION & OPTIMISATION BASED DECISION-‐MAKING FOR CLINICAL TRIAL SUPPLY
3
Forecasts
PaHent demand
IMP demand
Cost savings
Risk management
IRT set-‐up
ProducHon schedule
Depot management PaHent care
Avoid any risk
DistribuHon network
Clinical decisions
Deal with chan
ges!
May 15 (c) N-‐SIDE
ForecasHng vs. SimulaHon ?
• Forecas(ng tools ≈ smart excel spreadsheets ▫ Provide average value (e.g. paHents demand) ▫ Need to (manually) enter the overage ▫ Will not esHmate the risk / opHmise
• Simula(on tools will test many study evoluHons ▫ Will esHmate the risk linked to one supply strategy
• Best simulaHon tools will allow to op(mise cost (with no risk) by finding the op.mal supply strategy
May 15 (c) N-‐SIDE
4
Take the best decisions throughout your study!
5
Study concept & protocol design Planning of the trial Monitoring the study
Cross-‐department communicaHon
-‐6 months First paHent in
Taking advantage of simulaHon and opHmisaHon benefits
May 15 (c) N-‐SIDE
Benefits of opHmisaHon: early stage
• Strategic decisions : huge impact on the supply (costs) of the study
• Important to involve the supply team early in the process
• Possible to provide quanHfied results to Clinical Directors – really helpful !
6
Early stage Before FPI Ongoing trial
CommunicaHon
May 15 (c) N-‐SIDE
Benefits of opHmisaHon: early stage
7
Baseline Scen. 2 Scen. 3 Scen. 4 Scen. 5
Enrolment rate (pat./month) 20 15 20 20 20
Home dispensing? NO NO YES NO NO
Going to South America? YES YES YES NO YES
Packaging design 1mg bodles 2mg bodles
1mg bodles 2mg bodles
1mg bodles 2mg bodles
1mg bodles 2mg bodles
1mg bo;les only
Supply Costs 10M€ +1M€ +3M€ -‐1.5M€ -‐1M€
Risk 0.01% = ì î î
Early stage Before FPI Ongoing trial
CommunicaHon
May 15 (c) N-‐SIDE
Take the best decisions throughout your study!
8
Study concept & protocol design Planning of the trial Monitoring the study
Cross-‐department communicaHon
-‐6 months First paHent in
Taking advantage of simulaHon and opHmisaHon benefits
May 15 (c) N-‐SIDE
Benefits of opHmisaHon before study starts
• Final protocol design • More informaHon available
• Agree on assumpHons (e.g. drop-‐out rate)
• ObjecHves: ▫ Set-‐up the IRT with opHmal parameters
▫ Define a robust producHon plan ▫ Choose a depot management strategy
9
Early stage Before FPI Ongoing trial
CommunicaHon
May 15 (c) N-‐SIDE
Benefits of opHmisaHon before study starts
10
COST OF SUPPLIES
RISK OF SHORTAGE
Larger buffers
Smaller buffers
Different shipping frequency
Early stage Before FPI Ongoing trial
CommunicaHon
Cost vs. Risk trade-‐off !
May 15 (c) N-‐SIDE
Benefits of opHmisaHon before study starts
11
COST OF SUPPLIES
RISK OF SHORTAGE
Cost vs. Risk trade-‐off !
Early stage Before FPI Ongoing trial
CommunicaHon
May 15 (c) N-‐SIDE
Benefits of opHmisaHon before study starts
• Case study: limited storage at site level
▫ Only one fridge. Storage capacity: 50 kits ▫ Clinical Department: “this is a constraint”!
12
1 fridge 2 fridges 3 fridges
Clinical Budget 0 k€ 150 k€ 300 k€
DistribuHon Budget 2.5 M€ 1.6 M€ 1.3 M€
Manuf. & Packaging budget 1.5 M€ 1.7 M€ 1.8 M€
Total Cost 4 M€ 3.45 M€ 3.4 M€
Early stage Before FPI Ongoing trial
CommunicaHon
May 15 (c) N-‐SIDE
Take the best decisions throughout your study!
13
Study concept & protocol design Planning of the trial Monitoring the study
Cross-‐department communicaHon
-‐6 months First paHent in
Taking advantage of simulaHon and opHmisaHon benefits
May 15 (c) N-‐SIDE
Benefits of opHmisaHon aOer “Go-‐live”
• Monitoring the study: ▫ AutomaHcally leverage historical data to improve planning (IRT connec.on)
▫ Update all parameters (e.g. drop-‐out)
▫ Increase service level / anHcipate shortages ▫ Update producHon plan ▫ Manage the distribuHon strategy
14
Early stage Before FPI Ongoing trial
CommunicaHon
May 15 (c) N-‐SIDE
Benefits of opHmisaHon aOer “Go-‐live”
• When and how to resupply your depots ?
• How long will it last ?
15
Ship to Expected Departure Date Quan(ty Will last un(l
[worst case]
Europe Depot 24-‐June-‐15 300 10-‐Feb-‐16
US Depot 28-‐May-‐15 400 25-‐Jan-‐16
Japan Depot 28-‐May-‐15 75 15-‐Feb-‐16
Early stage Before FPI Ongoing trial
CommunicaHon
May 15 (c) N-‐SIDE
Take the best decisions throughout your study!
16
Study concept & protocol design Planning of the trial Monitoring the study
Cross-‐department communicaHon
-‐6 months First paHent in
Taking advantage of simulaHon and opHmisaHon benefits
May 15 (c) N-‐SIDE
Facilitate cross-‐department communicaHon
• Cost vs. Risk trade-‐off !
• If risky strategy chosen: risk should be transparent (e.g. not more than 4 pa.ents enrolled within a week)
• Supply to be informed asap in case of big changes (e.g. three new par.cipa.ng countries in South America)
• Material costs vs. Shipping costs trade-‐off (usually different budgets/departments!)
17
Early stage Before FPI Ongoing trial
CommunicaHon
May 15 (c) N-‐SIDE
Take home messages
18
• The earlier the opHmisaHon the bigger the savings
• SimulaHon & OpHmisaHon will manage risk – decrease cost – save Hme
• SimulaHon is a great tool to facilitate cross-‐department communicaHon
May 15 (c) N-‐SIDE
Thank you!
SebasHen Coppe Head of ConsulHng Group N-‐SIDE
May 15 (c) N-‐SIDE
19
