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

http://www.nasa.gov/offices/oct/home/roadmaps/index.html

http://www.itrs.net/ITRS 1999-2014 Mtgs, Presentations & Links/2013ITRS/Summary2013.htm


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

& integrationRegulatory

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 strategyand channels

Comms for progress and launch of roadmap

1st Level Map

2nd

Level MapSC

input

Draftdue

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.


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technology roadmapping external briefing pack2_v2 (1)

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