technology roadmapping external briefing pack2_v2 (1)

© BioPhorum Operations Group Ltd
BioPhorum Technology Roadmapping
Introduction
Steve Jones
March 2016

Agenda
▪ Why technology roadmapping is needed for the industry?
▪ What is the ambition, process, structure?
▪ What is the progress & plan forwards?
Technology Roadmapping Mar 2016 2

Complex industry structure has traditional held back innovation
▪ Many end users, all trying to
develop new technology in
isolation. Leading to
standardisation after the
technology is launched.
▪ Suppliers find it difficult to
innovate; have to guess end
user requirements; risk-
reward balance is poor
▪ New technology that makes it
onto commercial programs is
often removed to de-risk
▪ Everyone wants to be a fast
second
Mar 2016Technology Roadmapping 3
End Users
Suppliers

The next wave of capacity expansion cannot only use large scale facilities
▪ Extremely high cost, when capital is included, at a time when
payer & biosimilar cost pressure will be huge
▪ Long start up lead-times, meaning that forecasts will never
match real demand and time to market is slow
▪ Inflexible, yet pipeline trend is towards many more products
in lower quantity, eventually towards personalised medicine

Agenda

Audacious goal: To agree an industry technology strategy
An industry technology roadmap is – a dynamic and
evolving collaborative technology management process
for:
▪ determining pre-competitive critical needs and drivers,
▪ identifying technology and/or manufacturing targets, and
▪ assessing/modeling potential solutions
to:
▪ focus an industry community,
▪ provide direction, and
▪ resolve those critical needs for a specific timeframe by
consensus

What will the output look like?
Contents
▪ Market trends &
business drivers
• Analysis
▪ Future bio-
manufacturing
scenarios
• Assessment
▪ New technology &
enablers
• Needs
• Difficult challenges
• Potential solutions
NASA
Semiconductor
7Mar 2016Technology Roadmapping

How will the roadmap be communicated?
▪ The roadmap will be published and made freely available to all

What is the scope of the Technology Roadmapping process?
Technology Roadmapping
What it is
▪ Process to engage and align industry
stakeholders to define future needs of
the industry, difficult challenges &
potential solutions
▪ Involves cross industry, supply partner,
regulator, academia input
▪ Communication of the needs,
challenges and potential solutions to
industry stakeholders to guide
innovation
▪ Process to monitor industry progress
What it is not
▪ Actual implementation – that is the
responsibility of the industry once the
consensus on requirements is clear
▪ Focused on short term tactical needs –
the roadmap provides a long term, big
picture view of industry requirements
Mar 2016 9

Collaborating on an Industry Technology Roadmap will enable company
technology strategy
Technology Roadmapping 10
BioPhorum
Industry
Roadmap
• Collaboration of bio-pharmaceutical
companies at an industry level
engages regulators and supply
partners on common industry need /
position
Company
Strategic
Roadmap
• Adaptation to
company specific
perspectives and
business strategy
Company
Site
Roadmap(s
)
• Application of
company technology
strategy and sets
priority at the site
level
Mar 2016

Kick-off meeting Feb’15 - 19 companies contributed to a high level
industry roadmap, identifying focus topics for the technology roadmap
Technology Roadmapping
Advanced
integration of
current platform
Speed to clinic
Diversification
of product
groups
Payer pressure
on cost
In region
manufacturing
Personalised
medicine
Portable
modular
manufacturing
Human
resources &
talent
Global
regulatory
strategy
Supplier
management
Inline
monitoring
Real-time
release
Fully automated
robotic facility
Process
intensification
Knowledge
management
Continuous
processing
Modular and
mobile
Modelling data
& integration
Regulatory
harmonisation
Sensing
technology
Vendor
interaction
Multi-use and
flexible facilities
Technology
standards
Keep workforce
capable
Preparing the
next generation
capabilities
Industry Trends & Drivers
Roadmap Focus Topics
Capabilities and Enablers
Mar 2016 11

Building the industry strategic landscape

Agenda

Technology Roadmapping Steering Committee
▪ Developed a strong Steering Committee
• To make the decisions required
• To have the weight to drive the roadmap through
• To access the best experts in the industry
▪ So far have 18 companies on the Steering Committee
• We expect more to make the commitment

Technology Roadmap plan – 2016 activities
2016
D J F M A M J J A S O N D
Face to face meetings
Roadmap Team (RT) activity
Industry stakeholder
engagement in roadmapping
Roadmap content development
Communications
Publish industry roadmap
Stakeholder engagement and input to the roadmap
Chapter detailing Chapter finalising
Final approvals
Mobilise RT’s
TR03 – Roadmap team
meeting (12-14 Apr’16)
TR04 – Finalising the
roadmap (20-22 Sep’16)
Comms strategy
and channels
Comms for progress and launch of roadmap
1st Level
Map
2nd
Level Map
SC
input
Draft
due
SC
review
Press release

Substantial benefits can be gained through a cross industry collaboration
on the roadmap team topics
16
Roadmap
Team
Vision Benefit
Process
Technology
Process Intensification - Intensifying production
through highly concentrated reactants and products
and combining unit operations into single units
• Reduction in facility size
• Reduced capital investment
• Speed to market
Continuous Processing - New separation and media
technologies, coupled with advanced automation and
process control
• Flexibility for smaller patient populations
• Speed
• Reduced cost
In-line
Monitoring and
Real-time release
Process control and assurance of product quality
through advanced monitoring devices, in-direct or
multi-attribute sensors, and PAT.
• Tighter product and process control
• Reduced cost of quality
• Enables real time release
Global regulatory testing standards, advanced process
control strategies and raw material characterization.
• Eliminate $Bn’s of inventory
• Product released 1-2 days after manufacture
• Reduce quality costs
Modular and
Mobile
Manufacturing systems that are quick to configure
and assemble using ‘plug and play’ standard designs
• Scalable capacity
• Manufacturing process available in weeks
rather than years.
Fully Automated
Facility
Scale up from development to manufacturing, with a
focus on automation, equipment, and biology, results
in a fully automated facility.
• Consistent high product quality
• Reliable supply
• Reduced time to market.
Supplier
Management
Suppliers become technology development partners
for our industry, collaborating to solve problems.
• Innovative supply partners
• Industry needs delivered faster and better
Knowledge
Management
Integrated knowledge of product and process
technology across the development, manufacturing
and commercial value streams
• Speed to market
• Cross-product learning
• Efficiency throughout product lifecycle.
Mar 2016Technology Roadmapping

Next Steps
▪ The Roadmap Teams have been mobilised and will meet face to face 12th-14th
April to complete the detailed technology roadmapping
▪ Key stakeholders, including supply partners (senior R&D technology /
innovation experts), leading professors from academia, and regulators, are
being invited to contribute at the 12th-14th April meeting and throughout the
roadmapping process
▪ The Technology roadmap report will be prepared ready for a face to face
meeting 20th-22nd September, where plans for the 2017 publication and
ongoing roadmapping activities will be confirmed.

Anti Trust Statement
▪ All BioPhorum meeting 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.
▪ Antitrust violations do not require proof of a formal agreement. A violation may be alleged
based upon 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 show a price-fixing conspiracy.
▪ 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.

technology roadmapping external briefing pack2_v2 (1)

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