Clare Simpson 21 st November Content courtesy of Steve Jones, Paul Illot, Bert Frohlich, Thomas Ryll Biopharm Services

Transcription

1 Modelling a technology roadmap for acceleration of global industry innovation Presentation to Wales Life Science Hub, Health Economics Special Interest Group Clare Simpson 21 st November 2016 Content courtesy of Steve Jones, Paul Illot, Bert Frohlich, Thomas Ryll Biopharm Services

2 Who is BioPhorum Operations Group (BPOG) Industry collaboration that brings together 33 biomanufacturers, collaborating in six phorums to accelerate the industry 2

3 6 Phorums covering all aspects of operations and accelerating biopharma industry s journey to maturity Supply Partner Phorum Drug Substance Development Group Fill Finish Information Technology Technology Road Map BPOG manages the linkages to ensure Decisions are made at the right time, at the right place by the right people Linkages are made visible to avoid redundancy Synergies are leveraged through effective coordination Drug Substance, Fill Finish, Development Group and IT Phorums Accelerate the way the industry delivers near term results making best practice development and implementation faster, cheaper and smarter Supply Partner Phorum Strategic focus on the wider supply chain needs of the industry; defining, developing & implementing solutions Focus on business processes/systems & culture The focus for this presentation Revolutionise the way the industry develops longer term transformational manufacturing and technology capabilities Focus on longer term strategy & 10+yr time horizon, defining needs, difficult challenges and potential solutions Regulatory Interactions Group Engage and align with Health Agencies in the design and adoption of advances in manufacturing 3

4 What is a Technology Road Map?! An industry technology roadmap is a dynamic and evolving collaborative technology management process For: determining precompetitive critical needs and drivers, identifying technology and/or manufacturing targets, and assessing/modeling potential solutions 4

5 Overview of Methodology for Technology Roadmap Construction 1 Evaluate Biopharmaceutical Market Trends Define Objectives 2 3 Identify Main Business Drivers & Metrics Develop Representative Scenarios 4 Define Scenario/Options Matrix and Objectives Business Scenarios (Key Drivers) vs. Biomanufacturing Facility Type Scenarios (Options) Model 5 Model Facility Types Fix: Process/Facility Type Vary: Throughput, utilization, product mix Model Business Scenarios Fix: Throughput, Product mix Vary: Process/facility design Analyze 6 7 Identify/prioritize Opportunities for Improvement Identify Potential Solutions and Alternatives Identify/prioritize Advantages / disadvantages Identify Potential Solutions and Alternatives Plan 8 Define Development Timelines and Pathways Define Development Timelines and Pathways Technology Roadmap 5

6 Developing Representative Scenarios (Step 3) Purpose of Business Scenarios To help evaluate biomanufacturing strategies and technologies that will have greatest impact for a particular set of business drivers Not all companies have the same set of Key business drivers or metrics Purpose of Biomanufacturing / Facility Type Scenarios and Options Represent today s typical facilities (current state-of-art) Many companies have existing assets that need to be utilized and even potentially expanded Serve as starting point for technology road map 6

7 Defining Objectives and Options for Modeling (Step 4) Purpose of Modeling Identify areas of opportunity for improvement within a given scenario / facility type. Compare performance between options within a scenario or between scenarios relative to a given metric o e.g. compare estimated Cost of Goods using different process formats Process parameter sensitivity analysis Identify bottlenecks in throughput and breakpoints in technology strategy/selection. To evaluate the technology improvements proposed by the roadmap teams Model developed in collaboration with Biopharm Services, using Biosolve tool Limitations of Current Models Performance estimates are not absolute. Models are not calibrated to any specific circumstance such as location or specific organizational context For relative comparisons only; Default values for base line comparison (e.g. price of raw material costs, equipment and labor, installation factors Excluded Site purchase, staffing cost and raw materials & consumables up to production Central development labs and site offices Site warehousing Black utilities 7

8 Net Present Cost: Scaling up vs. Scaling Out. Expanded or Multi-Facility 6 x 2,000L Single-use Bioreactors Conventional Six-pack Facility 6 x 15,000L Stainless Steel Bioreactors Model developed in collaboration with Biopharm Technology Services, Roadmapping using Biosolve tool Total Facility Output (kg/yr) 8

9 Business drivers Driver Metric Description 5 yr Target 10 yr Target Cost Total cost to supply COGs - Labour, materials, utilities, variable costs, delivery rejects. $50/gm (mabs) $10/gm (mabs) Speed Cost of upfront investment in manufacturing Reduction of total cost to supply from 2015 values 50% 90% Total capital cost of facility to supply 1,000,000 doses / year $100M DS facility $50M DP facility $50m DS facility $25M DP facility Cost of development Start of phase 3 process analytical formulation development to launch (1st major market approval) - reduction from 2015 levels 25% 75% Time to make product (End to end Time from initiating Drug Substance Production (vial thaw) to completing speed) Drug Product Production 2 months 1 month Time from initiating Drug Substance Production (vial thaw) to completing DP Production - reduction from 2015 levels 50% 75% Time to release product (End to Time from completion of Drug Product production to full release of Drug end speed) Product 2 weeks 1 day Time to produce first GMP material for the clinic Time from DNA (molecule selection) to material available to clinic 12 months 8 months Speed to market Time from release of phase 1 material to launch 5 years 3 years Time to introduce a change to an existing process Time to introduce a process change (specifically new DS site, new resin, etc) 2 months 1 month Time to introduce a process change (eg new DS site, new resin, etc) 18 months 6 months Facility build speed Time from build decision to ready for first PPQ batch 2 years 1 year The ability to change to different platforms (eg, CHO, E. coli, yeast, gene Flexibility Number of platforms per suite therapy) within a suite. 3 >5 Titer Range in upstream that is The ability to manage higher and wider titer ranges in both fed-batch (FB) FB: 1 10g/L FB: 2-40g/L directly accommodated by and perfusion (P). P: 0.5-5g/L/day P: g/L/day downstream facility fit Facility production per unit time - Time facility in use for production (rather than product changeover, Utilization percentage cleaning, shutdown / maintenance) >85% >95% Discard rate, investigation resources. Quality Cost of Non-Quality Batch record rework. Includes RMs 10% of operating costs 2% of operating costs Assay quality Process Variability Product availability Measure of process reliability. PPK for assay for all measures (release tests, CQAs, CPPs) Inventory level >1.5 >1.8 50% reduction 2 months 90% reduction 2 weeks March

10 Conclusions and Next steps Significant progress has been made in bringing the industry together for this precompetitive collaboration A work in progress, More work to be done Will take some time and a few iterations. First time this is being done with wide industry participation Vendor and academic partner participation Technology innovation opportunities are beginning to be identified More modeling to be done to help assess value and prioritize Plan to publish completed road map before mid of

11 Thank You! Disclaimer This presentation was prepared by the BPOG Consortium. The opinions and views expressed are from the BPOG Consortium and do not reflect the views of individual member companies 11

12 Anti-Trust Compliance Statement v4.0 It is the clear policy of BioPhorum that Biophorum and its members will comply with all relevant anti-trust laws in all relevant jurisdictions All BioPhorum meetings and activities shall be conducted to strictly abide by all applicable antitrust laws. Meetings attended by BioPhorum members are not to be used to discuss prices, promotions, refusals to deal, boycotts, terms and conditions of sale, market assignments, confidential business plans or other subjects that could restrain competition. Anti-trust violations may be alleged on the basis of the mere appearance of unlawful activity. For example, discussion of a sensitive topic, such as price, followed by parallel action by those involved or present at the discussion, may be sufficient to infer pricefixing activity and thus lead to investigations by the relevant authorities.. Criminal prosecution by federal or state authorities is a very real possibility for violations of the antitrust laws. Imprisonment, fines or treble damages may ensue. BioPhorum, its members and guests must conduct themselves in a manner that avoids even the perception or slightest suspicion that antitrust laws are being violated. Whenever uncertainty exists as to the legality of conduct, obtain legal advice. If, during any meeting, you are uncomfortable with or questions arise regarding the direction of a discussion, stop the discussion, excuse yourself and then promptly consult with counsel.. The antitrust laws do not prohibit all meetings and discussions between competitors, especially when the purpose is to strengthen competition and improve the working and efficiency of the marketplace. It is in this spirit that the BioPhorum conducts its meetings and conferences. 12