global biological production summit

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Global Biological Production Summit

12./13. December 2016 San Diego

Timo SimmenDirector Technical OperationsParenterals PlatformJanssen Supply Chain

Environment is changing


«The world is changing»Top 10 Market Cap Companies (Public traded)

Rank 2016 2006

1 Apple Exxon

2 Alphabet GE

3 Microsoft Microsoft

4 Amazon Citigroup

5 Berkshire BP

6 Exxon Shell

7 Facebook P&G

8 JNJ HSBC

9 GE Pfizer

10 Wells Fargo Wall Mart

new

new

new

new

new

new

out

out

out

out

out

out

new

out


Healthcare is Changing

Consumers & Patients

Millions of new patients and consumers

Aging population

Personalization & commoditization

Broader accessibility

More focus on experience and outcomes

Environment

Increasing total cost of care

Increased price pressures and transparency

Heightened regulatory scrutiny

Risk sharing

Consolidation

Expanding care venues


Personalized health solutions

Better outcomes and improved experience

Serve unmet needs and disease states

Provide novel products and services

Move from “sick” care to “well” care

intersecting with

will present huge opportunities to transform healthcare.

A New World of

Technology

A New World of

Healthcare


Industrial & Technology Revolutions


The era of the digitization and the cyber-

physical interconnectivity, the confluence of

physical & digital world, that will transform the

E2E manufacturing “ecosystem” to create

enhanced customer experiences, help fulfill the

unmet needs, and establish new business

models through enhanced and new capabilities.

What is the 4th Industrial Revolution?

“


End to End Parenteral Manufacturing Platform


Incheon, Korea

Beerse, Belgium

Gurabo,Puerto Rico

Malvern

External

Internal

Schaffhausen, Switzerland

Parenterals MFG PlatformAPI & FF Sites (Internal and External)

Cork,Ireland

Leiden,Netherlands

+ strategic partners+ strategic partners


External

Internal Parenterals MFG Platform…End to End (Development –MFG - Patient)


Technology Management


External

Internal Technology Management requires alignment

Parenteral Technology

Strategy

PDMS

COE (AT, Packaging,

Device)

Parenteral Operations

Network

QualityRegulatory

Sourcing /

Procurment

Support Functions(Finance,

HR)


14

External

Internal ..Governance and Process

TECHNOLOGY SOLUTIONS & STANDARDS

Develop and govern• Compliant and need oriented technology

solutions• Innovation management• Expertise across strongholds• Platform standards

E2E accountabilityfor evaluation, development, delivery and

governance of Process,

Technology solutions and

standards

THR

OU

GH

DR

IVE

IMPLEMENT

DELIVER

BUSINESS (GOVERNANCE PROCESS) OWNERS

Own and govern• Technology Introduction process

(with stage gates)• Technology Strategy Process• Reward & Recognition Process

FUNCTIONAL STRONGHOLDS

Lead and develop• People in the strongholds• Upstream Processing• Downstream Processing• Advanced Formulation• Advanced analytics• Robotics, Modular and

Mobile

• Real time data and recipe management

• Packaging • Device

Added Value

One Aligned technology strategy from development to commercial• Reduction of risk, variability & complexity• Technology readiness for pipeline products

(staying ahead of the curve)• Capex efficiency• Avoiding duplication of efforts• The strong Technology Partner for the sites


..as well as Focus & Governance

Technology Governance Levels

Steering Team

Technology Stronghold Program Management

Technology Core Team

Stronghold Work Streams

Stronghold Champion(SHC)

Subject Matter Expert (SME)


Technology Strategy

16

- Internal Pipeline- Benchmarking Externally- Technology Evolution

- J&J Credo- JSC Vision & Objectives- Stakeholders (COEs, Site,

MTO Strategy)

Technology Strongholds and projectsthrough Governance structure and stage gates

Project action plan with milestones


Identifying Opportunities

Technology Strategy: Observe

17

Industry & outside industry

collaboration

Company Culture+ Incubators,

Innovation centers

Benchmarking

Immersion sessions


IMPLEMENTATIONPILOTFEASIBILITY

Ideas need to be processed

New Idea / Proposal

Stage Gate 1

Stop

Technical Recommendation

Theoretical Feasibility

Develop Business Case

Fast TrackIdeas

Stage Gate 1:

• Governance: Stronghold Team• Description of idea• Documented reasons for accepting or

rejecting idea• Linkage of idea with stronghold

roadmap

Stage Gate 2

Stop

Select site

Operational project team selection

Develop Test Plan

Execute test and prepare report

Recommendation to proceed

Stage Gate 2:

• Governance: Core Team, Steering Committee

• Stronghold recommendation / narrative for proposed idea

• Impact of “new” technology on existing system

• High level business case• Resource requirement• High level timeline for Pilot

Stage Gate 3

Develop Implementation Plan

On -hold

Project Execution

Closed with lesson’s learned

Stage Gate 3:

• Governance: Steering Committee• Executive Summary of pilot tests and

Stronghold recommendation narrative• Impact of introducing “new” technology

on existing network• Business Case• Resource requirement• Detailed timeline for implementation

Stop

IDEA


Trend vs. Last UpdateIncreaseDecreaseEqual

Highlights• Overall, a noteworthy increase in Feasibility as teams focus on evaluating theoretical feasibility, determining technical requirements, and drafting a

business case.

Bluesky

Stage Gate 1

Feasibility

Stage Gate 2

Pilot

Stage Gate 3Active Idea Tracking (Current = 62) 13 29 17

(Prior Report = 55) 23 17 15

In-progress Stop Approve In-progress Stop Approve In-progress Stopped Complete

API LM Upstream 1 [1] 5

API LM Downstream 6 [5] [2] 3 1

Advanced Formulation [2] 7 6

Advanced Analytics 3 [1] 10 5

Real Time Data and Recipe Mgmt 1 1 1

Robotics, Modular & Mobile 1 [1] [3] 2 [1] [3] 3

Packaging and technologies [2] [1] 1

Device & Technologies 1 1 2 1

Subtotal (Current) 13 [8] [10] 29 [1] [3] 17 [0] 3

(Prior Report) 23 [1] [7] 17 [1] [2] 15 [0] 1

Note: [ ] Not in active project total

Processes need to be measured


At the end it is about people


Innovation Management Training to all levels

Empower the lowest levels

Establish reward and Recognition program forTECHNOLOGY Innovation

Establish a momentum

Prepare your workforce for required capabilities

Automation, Data Analytics, PAT, RTR

Robotics

New Materials

New Processes

Technology Strategy


Technology Megatrends important forParenterals Platform

Modularity & Flexibilty

Robotics, Automation

New Materials (Glas, plastics, ..)

Unique Identification & Traceability

Smart Sensing / Sensors

3D Printing

Natural ressources, alternative energy& sustainability


Modelling, Control, Inline release, PAT, Real Time release

Process Intensivation – continuous processing

Miniaturization

Big data, traceability

Customer adherance (Self dose, ..)

Suppliers move to service providers

Augmented Reality


Technology Megatrends important forParenterals Platform cont.

High level Technology Benchmarking resultsand relation to E to E MFG process


Parenteral Platform Technology Roadmap


Strategic Intent Develop an innovative Parenteral manufacturing network that delivers technological competitiveness for a multi-modalpipeline of products

Drivers

• New product modalities in the pipeline require new technologies and processes• Demand for high and low volume products requires flexible manufacturing footprint with more efficient production• Industry leading performance, reliability, and control strategies require Process Analytical Technology & Real Time Release Testing• Cost competitiveness required and enabled by minimizing human labor and incorporating quality during design

Timeframe 2016 2017-2020 2020-2025

Strategic Direction

Batch to semi-continuous unit operationsSingle product to multi-product facilitiesHigh and Low volume productsMabs to Multi-Modal Products

High density innoculation with continuous bioreactor feed and downstream processing; New technology integration

Parenteral Manufacturing of the Future –Innovative, Modular, agile E2E manufacturing with minimal human intervention

Outcome Metrics

Titer Time to releaseDS, DP Cost to supply(Cycle Time, RFT, Capex, Tech TRF Time)

Titer Time to releaseDS, DP Cost to supply

TiterTime to releaseDS, DP cost to supply

Tech

no

logy

In

vest

men

ts

IncrementalChange

BreakthroughTechnology

Simplified Parenteral Technology Roadmap

Robotic Aseptic filler with minimal human intervention

Media Improvement / process intensivation

Conventional ComboProducts: Agile Devices Platforms at Any Scale

Patient adherence packaging

Continuous Lyophilization

RT storage for biologics

Self buffering formulations

100% CCIT & Automatic Visual Inspection

Implementation of J4.0

Buffer on demand

PAT and RTRTE2E Process Modeling

New and Optimizaed Cell LInes

Leading Academia Technology Partnerships

Disposables & Single Use

Innovative ComboProducts: New Devices Platforms at Any Scale

Scale Up/Out Capability

Fast Tech Tranfers


Parenteral Platform Stronghold Structure


Lead Technology Strategy and Robotics, Modular-Mobile Champion- Drive Parenteral technology

strategy program- Global Business Process

Owner technology introduction

- Own robotics, modular & mobile stronghold

- Align with all stakeholders- Communication strategy- Training

Head technology strategy & Standardization and Advanced Analytics Champion- Leads E2E Network for

Analytics - PAT and associated

modeling- Review new ideas- Support core team and

steering committee in taking right investment decision

API LM Upstream Champion (PDMS)- Leads upstream

stronghold- Review all ideas in field of

upstream SH- Support core team and


- Training on technology introduction

API LM Downstream Champion- Leads Network for

downstream processing SH

- Support core team and steering committee in taking right investment decision


Advanced Formulation Champion (PDMS)- Leads Network for

Advanced Formulation SH



Device andTechnology Champion (COE Device)- Leads Network for

Device and technology SH



Packaging andTechnology Champion (COE Packaging)- Leads Network for Packaging

and technology SH- Support core team and



Real Time Data andRecipeManagement Champion- Leads Network for real time

data and recipe management SH



TOPDMSCOE-PackagingCOE - Device

Parenteral Stronghold exampleAdvanced Analytics


Factory of the Future


BPOG Industry Roadmap on I4

1st Industry Roadmap in development Mayor Big Pharma

will drive I4 TOGETHER !


Problems to solve in Up- and Downstream

Suboptimal Platforms

• Low titers <5 g/L

• Prolong Cell Culture harvest cycle time

• Limited in-line fast analytics tools (e.g. to measure generic CQAs e.g. HMW, DNA, host cell proteins)

• Expensive chromatography resins

• Extensive cleaning and changeover processes

• Large preparation and hold tanks for buffers

• Multiple filtration steps

• Labor intensive driven by multiples small handling steps

• Limited robotic applications in API mfg.

Typical API Up/Down streams unit operations are inefficient by design


Source: ZVEI following PwC

SmartProducts

SmartServices

Industry 4.0 will significantly Impact the Way Companies Operate and Transform Businesses

Smart Factory

Smart Plant


OrganizationDesign | Structure | Culture | Talent

Infl

ue

nc

er

s

Regulatory

Legal

Commercial

Policy Makers

Pa

rtn

er

sh

ips

R&DICs

Vendors, External Partners

HR, Quality, Plan, Deliver

Sourcing, IT, VCM

Foundational Enablement

EHS Proactive

Quality

Technology Systems Process

CustomerPersonalization | Solutions & Outcomes | Lower Cost | Agility | Access

People: Skills & Capabilities

Essential Resources

3D Printing

Augmented Reality

Robotics

Systems Integration

Big Data & Analytics

Smart Sensing

Manufacturing Digitization (J4.0)

Disruptive Technology, Materials & Services

Services

MaterialsInnovation

TechnologyNatural Resources, Alternative Energy & Sustainability


Collaboration needed betweenSuppliers – Industry – Regulators

and many more

Framework


Thank you..

Questions ?


global biological production summit

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