Platform Technology | Novel Therapies | Advanced Digital Solutions

LIVE ONLINE 23 September 2021

CATCH UP ON DEMAND

PharmaTech Integrates 2021 Agenda

THURSDAY 23RD SEPTEMBER 2021

PANEL DISCUSSIONS AND TECHNOLOGY SHOWCASES

PLEASE NOTE: Timings may be subject to change.

SESSIONS WILL BE DIVIDED INTO 3 TRACKS PRIOR TO THE EVENT.

DELEGATES WILL BE FREE TO CHOOSE FROM TRACK 1, 2 or 3 AT ANY TIME.

THE DAY WILL START WITH OPENING REMARKS AND CONCLUDE AT 17:00

Opening

10:30 – 10:40

Welcome and Opening Remarks

DAVE TUDOR, Managing Director, Medicines Manufacturing Innovation Centre, CPI

PLATFORM TECHNOLOGY

NOVEL THERAPIES

ADVANCED DIGITAL SOLUTIONS

Session 1

10:45 – 11:35

Revolution not evolution of Biologics production

Stepping up to meet patient need and market demand…

Advanced
thinking

Tackling the development, scale up and scale out of ATMP to effectively address rare and complex diseases…

Digging into
Data

Contextualising data and modelling to deliver real time decision making and faster problem solving…

Technology Showcase 1

11:40-11:55

Technology Showcase
CMAC

Digital Twins and MicroFactories

Directors, Prof Alastair Florence and Massimo Bresciani, will present on how CMAC are working on flexible integrated manufacturing technologies to accelerate product and process development, providing greater agility, sustainability and flexibility for future medicines development and manufacture.

Technology Showcase
Brave & Heart

Turning Data Oil into Insights Gold?
Unlocking Future Science Through Real World Data Integration, Modelling & Analytics

Technology Showcase
Nanoform

Nanoformers, Particles in Disguise! – Illuminating the future of Pharma with STARMAP®

Our STARMAP® 2.0 platform leverages cutting-edge sparse-data AI to pick winners among candidate molecules that are predicted to be best amenable to CESS®-powered nanoforming and that exhibit optimal production characteristics.

12:00-12:15

Technology Showcase
Glatt

What are the benefits when using the Glatt MODCOS (MODular COntinuous System )?

An introduction and overview on Glatt’s world of continuous manufacturing for OSD-Pharma. Glatt-MODCOS offers a wide range of processing capabilities and options due to the unique modular approach.

Technology Showcase
GSK

System modelling to Accelerate Pharmaceutical Development

Technology Showcase
LEON Nanodrugs

Nanotechnology for delivery of nucleic acid payloads

A market snapshot:

bottom up technology comparisons
equipment trains
liposomes & LNPs

PLATFORM TECHNOLOGY

NOVEL THERAPIES

ADVANCED DIGITAL SOLUTIONS

Session 2

12:25-13:15

Making solid progress in Continuous Direct Compression

Building smart and dynamic collaborations that increase the adoption of continuous manufacturing principles…

New
Genes

Enabling the progression and adoption of complex DNA and RNA based technologies to tackle new therapeutic areas (oligonucleotides), to ensure rapid deployment and better outcomes for patients.

Supply Chain
Pain Relief

Deploying digital and data-driven approaches that enable demand-led pharmaceutical supply, delivering better patient supplies and productivity gains.

13:15 – 13:35

NETWORKING

Technology Showcases

Technology Showcase 3

13:40 – 13:55

Technology Showcase
CPACT

Getting value from process data in advanced pharma manufacturing
Intelligent measurement, modelling and control are at the heart of Pharma 4.0. Getting the right data and using it properly are crucial for effective digitisation of advanced manufacturing.

Technology Showcase
Booth & Welsh

The Art of the Possible with Environment 4.0

At our technology showcase we want to demonstrate there doesn’t need to be a trade-off between addressing the environment and delivering measurable business results. These drivers can go hand in hand.

Technology Showcase
Exonar

Unravelling the thread: A whole new way to find and use deviation management information hidden in unstructured data

Unravelling threads and finding patterns in data to understand quality deviations is a key fundamental in manufacturing productivity.

14:00 – 14:15

Technology Showcase
MMIC

Medicine Manufacturing Innovation Centre: Delivering Benefit to Industry and Patients Through Complex Technology

This presentation will outline one of our Grand Challenges (Grand Challenge 2) to demonstrate our approach to innovation and the work we have completed during our start-up phases.

Technology Showcase
Applied Materials

Advancing the digital maturity of pharma: from process development to manufacturing
How data delivers for pharma innovation

Listen in to the discussion between process development and commercial owners on how data can be uncovered, shared and applied to respond to the volatile needs for new products and market demands.

PLATFORM TECHNOLOGY

NOVEL THERAPIES

ADVANCED DIGITAL SOLUTIONS

Session 3

14:20 – 15:10

Intense thinking for API manufacture

How to drive process intensification, continuous manufacturing, and biocatalysis into API processes…

Immune
Response

Transforming vaccine manufacture to increase access to vaccinations through speed, cost and more sustainable vaccines supply chain.

Super
Simulations

Accelerating drug development through increased adoption of digital tools and applications. Introducing data twinning and digital twins into the drug development cycle…

15:10 – 15:30

NETWORKING

Fireside Chat

15:35 – 15:55

How do we align with the Regulators for new technology approvals and do it faster?

An interview with: IAN REES, Manager for the Inspectorate Strategy and Innovation Unit, MHRA
Interviewed by: CLIVE BADMAN, Executive Director, University of Strathclyde

Fireside Chat

16:00 – 16:20

Is your organisation ready for the technology revolution?

An interview with: SIR JIM McDONALD, Principal and Vice-Chancellor, University of Strathclyde
Interviewed by: TAMSIN BERRY, Director, PHP

Fireside Chat

16:25 – 16:45

What are the game changing technologies and approaches that can transform the carbon footprint from Pharma manufacturing?

An interview with: JULIETTE WHITE, Vice President – Global SHE and Sustainability, AstraZeneca
Interviewed by: ROUDIE SHAFIE, Director, OVID Health

Closing

16:50 – 17:00

Closing remarks

DAVE TUDOR, Managing Director, Medicines Manufacturing Innovation Centre, CPI

10:30 – 10:40

Welcome and Opening Remarks

DAVE TUDOR, Managing Director, Medicines Manufacturing Innovation Centre, CPI

10:45 – 11:35

Choose between Track 1, 2 or 3

Track 1: PLATFORM TECHNOLOGIES

Revolution not evolution of Biologics production

Advanced thinking

Digging into Data

Choose between
Technology Showcase 1, 2 or 3

Technology Showcase
CMAC

Technology Showcase
Brave & Heart

Turning Data Oil into Insights Gold?
Unlocking Future Science Through Real World Data Integration, Modelling & Analytics

12:00 – 12:15

Choose between
Technology Showcase 1, 2 or 3

Technology Showcase
Glatt

Technology Showcase
To Be Confirmed

Technology Showcase
Leon Nanodrugs

12:25 – 13:15

Choose between Track 1, 2 or 3

Track 1: PLATFORM TECHNOLOGIES

Making solid progress in Continuous Direct Compression

New Genes

Supply Chain – Pain Relief

Networking

13:40 – 13:55

Choose between
Technology Showcase 1, 2 or 3

Technology Showcase
CPACT

Technology Showcase
Exonar

14:00 – 14:15

Choose between
Technology Showcase 1, 2 or 3

Technology Showcase
SK biotek

Technology Showcase
MMIC

Technology Showcase
Applied Materials

14:20 – 15:10

Choose between Track 1, 2 or 3

Track 1: PLATFORM TECHNOLOGIES

Intense thinking for API manufacture

Immune Response

Super Simulations

Networking

15:35 – 15:55

Fireside Chat

How do we align with the Regulators for new technology approvals and do it faster?

An interview with: IAN REES, Manager for the Inspectorate Strategy and Innovation Unit, MHRA
Interviewed by: CLIVE BADMAN, Executive Director, University of Strathclyde

16:00 – 16:20

Fireside Chat

Is your organisation ready for the technology revolution?

An interview with: SIR JIM McDONALD, Principal and Vice-Chancellor, University of Strathclyde
Interviewed by: TAMSIN BERRY, Director, PHP

16:25 – 16:45

Fireside Chat

What are the game-changing technologies and approaches that can transform the carbon footprint from Pharma manufacturing?

An interview with: JULIETTE WHITE, Vice President – Global SHE and Sustainability, Astrazeneca
Interviewed by: ROUDIE SHAFIE, Director, OVID Health

16:50 – 17:00

Closing remarks

DAVE TUDOR, Managing Director, Medicines Manufacturing Innovation Centre, CPI

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Platform Technology | Novel Therapies | Advanced Digital Solutions

LIVE ONLINE 23 September 2021

CATCH UP ON DEMAND

Revolution not evolution of Biologics production

Stepping up to meet patient need and market demand. Streamlining, enhancing and integrating upstream and downstream biological and vaccine production. Delivering more efficient and flexible production to dynamically address the demand side

FACILITATED BY

LUCY FOLEY | Director of Biologics | CPI

PANELLISTS INCLUDE

Advanced thinking

Tackling the development, scale up and scale out of ATMP to effectively address rare and complex diseases..

FACILITATED BY

JACQUELINE BARRY | Chief Clinical Officer | Cell and Gene Therapy Catapult

PANELLISTS INCLUDE

Digging into Data

Contextualising data and modelling to deliver real time decision making and faster problem solving. Using this to translate into efficiency and momentum into your business.

FACILITATED BY

SCOTT LAWSON | Partner | PwC

PANELLISTS INCLUDE

Digital Twins and MicroFactories

The combination of digital design and predictive tools; smart, adaptive workflows and data systems with instrumented MicroFactory platforms and Quality by Digital Design concepts will create new patient centric supply chain solutions and secure access to medicines for patients.

PRESENTED BY

ALASTAIR FLORENCE | Director, Continuous Manufacturing and Advanced Crystallisation (CMAC) Research Hub | University of Strathclyde
MASSIMO BRESCIANI | Industry Director, EPSRC Future Manufacturing Research Hub | CMAC

Turning Data Oil into Insights Gold?

Unlocking Future Science Through Real World Data Integration, Modelling & Analytics

The data challenge to Pharma and R&D intensive industries
How Industry 4.0 was supposed to enable our data dreams
The reality of this in 2020
How CPI are addressing this challenge
How B&H have helped them and supported unlocking - very brief examples of selected POC projects.
A) Running Agile Projects for Data,
B) Making Real World Inroads,
C) Developing Scorecards to focus efforts.
Practical takeaway steps for the audience – 2 or 3 things the audience can take away to quickly check their organisational reality vs dream

PRESENTED BY

Nanoformers, Particles in Disguise! - Illuminating the future of Pharma with STARMAP®

STARMAP® is a digital version of our CESS® technology that allows us to perform in silico experiments in large quantities and to create predictions of nanoformability. This is important since there are more potential drug molecules than particles in the known universe.

Our game-changing CESS® technology lies at the heart of our operations and offers a unique opportunity to both bring failed assets back to life again and accelerate APIs to the clinic. The STARMAP® platform can have wide applicability in drug discovery and development as well as in lifecycle management for existing marketed drugs and 505b2 like product development strategies.

DR ELISABETTA MICELOTTA | Science & Technology Team Leader | Nanoform

What are the benefits when using the Glatt MODCOS (MODular COntinuous System )?

An introduction and overview on Glatt's world of continuous manufacturing for OSD-Pharma. Glatt-MODCOS offers a wide range of processing capabilities and options due to the unique modular approach. From as low as 1kg/h up to over 1'000kg/h can be processed with Glatt continuous processing equipment. Direct compression and Wet Granulation. It is not only the equipment - the comprehensive service on process development and process guidance complete the full scope approach. Come in and have a look!

PRESENTED BY

ANDREAS GOTTSCHALK | Business Development Key Technologies Pharma, MODCOS | Glatt

System modelling to Accelerate Pharmaceutical Development

The Pharma industry has undergone significant changes in recent years with many companies pursuing the development of lower risk / smaller volume products while progressing a much larger R&D pipeline. The success of this strategy is dependent on the ability to rapidly accelerate development through game changing technologies such as system modelling. This presentation will illustrate examples where the GSK simulations platform has been used to efficiently deploy system models for drug substance and drug product to support process design, control definition and verification. Other examples will illustrate the concept of a web application to facilitate the take up of modelling by not experts to assess process optimisation in a manufacturing environment, and the interplay of system modelling with machine learning and automation.

PRESENTED BY

SIMEONE ZOMER | Scientific Director – Process Analytics | GSK

Nanotechnology for delivery of nucleic acid payloads

A market snapshot:

bottom up technology comparisons
equipment trains
liposomes & LNPs

ANDREA CUSACK | Chief Executive Officer | Leon-nanodrugs

Making solid progress in Continuous Direct Compression

Building smart and dynamic collaborations that increase the adoption of continuous manufacturing principles and practice, with clear data modeling strategies, applied across the spectrum of finished dose forms.

FACILITATED BY

JON-PAUL SHERLOCK | Head of Innovative Manufacturing Technology | AstraZeneca

PANELLISTS INCLUDE

ALASTAIR FLORENCE | Director, Continuous Manufacturing and Advanced Crystallisation (CMAC) Research Hub | University of Strathclyde
MOHAN GANAPATHY | Head, Global Quality and Compliance | Merck & Company, USA
ANDREAS GOTTSCHALK | Business Development Key Technologies Pharma, MODCOS | Glatt
ALASTAIR COUPE | Senior Director, Drug Product Design, Pharmaceutical Sciences | Pfizer Ltd
FERNANDO MUZZIO | Distinguished Professor of Chemical and Biochemical Engineering | Rutgers University

New Genes

Enabling the progression and adoption of complex DNA and RNA based technologies to tackle new therapeutic areas (oligonucleotides), to ensure rapid deployment and better outcomes for patients.

FACILITATED BY

KATIE MURRAY | Technical Director at MMIC | CPI

PANELLISTS INCLUDE

Supply Chain – Pain Relief

Deploying digital and data-driven approaches that enable demand-led pharmaceutical supply, delivering better patient supplies and productivity gains.

FACILITATED BY

DAVE TUDOR | Managing Director, Medicines Manufacturing Innovation Centre | CPI

PANELLISTS INCLUDE

Getting value from process data in advanced pharma manufacturing

Intelligent measurement, modelling and control are at the heart of Pharma 4.0. Getting the right data and using it properly are crucial for effective digitisation of advanced manufacturing.

The Centre for Process Analytics and Control Technology (CPACT) is the leading “community of practice” in the development and use of advanced process monitoring and control techniques.

The CPACT Showcase will explain the CPACT ethos and illustrate how it supports scientists and engineers working in process analysis, chemometrics and statistics, and process modelling and control through unique cross-sector cooperation. If advances in these PAT areas are important to you and your teams, this Showcase will be of interest to you and your colleagues.

PRESENTED BY

DAVID LITTLEJOHN | Philips Professor of Analytical Chemistry | University of Strathclyde
MARTIN WARMAN | Associate Member | Centre for Process Analytics and Control Technology (CPACT).

The Art of the Possible with Environment 4.0

At our technology showcase, we want to demonstrate there doesn’t need to be a trade-off between addressing the environment and delivering measurable business results. These drivers can go hand in hand. We will explore the next phase of Industry 4.0 which we are calling Environment 4.0. We will share accessible technology and tools that are currently delivering real results in efficiency, performance, mitigation, and waste reduction, while also delivering a positive impact on profitability across the pharmaceutical industry. This will be backed up with tangible case studies from clients across who have already made significant steps forward in their Net Zero journey and delivering on their strategy towards fulfilling the UN Sustainable Development Goals (SDGs). Join to hear more about how you can tap into the power of technology to support your own sustainability efforts.

PRESENTED BY

Unravelling the thread: A whole new way to find and use deviation management information hidden in unstructured data

Unravelling threads and finding patterns in data to understand quality deviations is a key fundamental in manufacturing productivity. Yet here’s a surprising fact: only 3% of the data associated with quality deviations is held in structured databases. That means 97% is hidden in your organisation’s unstructured data and can't be found. Finding the information and linking the reasons for deviations is hard because there’s no way to discover what’s in unstructured data at scale and in detail.

Until now! Join Life Sciences technology veteran, John Harris, at this session to hear about how exciting tech startup Exonar is solving the problem of discovering and revealing what’s in an organisation’s structured and unstructured data estate at petabyte scale to increase data management and manufacturing efficiencies and drive business value.

PRESENTED BY

JOHN HARRIS | Life Sciences Advisor | Exonar
TOM OWENS | Services Expert | Exonar

Medicine Manufacturing Innovation Centre: Delivering Benefit to Industry and Patients Through Complex Technology

The Medicines Manufacturing Innovation Centre (MMIC) is a new and unique GMP Innovation Centre whose mission is to deliver complex manufacturing technology through collaborative innovation to benefit patients and the pharmaceutical industry as a whole. This presentation will outline one of our Grand Challenges (Grand Challenge 2) to demonstrate our approach to innovation and the work we have completed during our start-up phases.

PRESENTED BY

DAVE BERRY | Grand Challenge Lead | Medicines Manufacturing Innovation Centre

Advancing the digital maturity of pharma: from process development to manufacturing
How data delivers for pharma innovation

Listen in to the discussion between process development and commercial owners on how data can be uncovered, shared and applied to respond to the volatile needs for new products and market demands. From R&D to scale-up into full production, how do modeling, ML, predictive maintenance, inspection and smart scheduling work together to deliver quantifiable progress.

PRESENTED BY

DARREN WHITAKER | Senior Engineering Consultant
LUCAS VANN | Chief Technical Officer, APG Pharma Global Solutions
STAVROS TARAVIRAS |Strategic Business Development Manager, APG Pharma Solutions

Intense thinking for API manufacture

How to drive process intensification, continuous manufacturing, and biocatalysis into API processes. Delivering improved control, efficiency and compliance whilst reducing the carbon footprint of medicines manufacture whilst enhancing national security and resilience.

FACILITATED BY

CLIVE BADMAN OBE | Executive Director | University of Strathclyde

PANELLISTS INCLUDE

Immune Response

Transforming vaccine manufacture to increase access to vaccinations through speed, cost and more sustainable vaccines supply chain.

FACILITATED BY

SARAH GOULDING | Challenge Director | UKRI Industrial Strategy Challenge Fund in Medicines Manufacturing

PANELLISTS INCLUDE

Super Simulations

Accelerating drug development through increased adoption of digital tools and applications. Introducing data twinning and digital twins into the drug development cycle: accelerating drugs to market, delivering for patients and the sector.

FACILITATED BY

ROSS MACRAE | Senior Director, Drug Product Manufacturing | Pfizer

PANELLISTS INCLUDE

LIVE ONLINE 23 September 2021

PharmaTech Integrates 2021 Agenda

THURSDAY 23RD SEPTEMBER 2021

PANEL DISCUSSIONS AND TECHNOLOGY SHOWCASES

PLEASE NOTE: Timings may be subject to change.

SESSIONS WILL BE DIVIDED INTO 3 TRACKS PRIOR TO THE EVENT.

DELEGATES WILL BE FREE TO CHOOSE FROM TRACK 1, 2 or 3 AT ANY TIME.

THE DAY WILL START WITH OPENING REMARKS AND CONCLUDE AT 17:00

Opening

10:30 – 10:40

Welcome and Opening Remarks

Session 1

10:45 – 11:35

Revolution not evolution of Biologics production

Advancedthinking

Digging intoData

Technology Showcases

Technology Showcase 1

11:40-11:55

Technology ShowcaseCMAC

Technology ShowcaseBrave & Heart

Technology ShowcaseNanoform

Technology Showcase 2

12:00-12:15

Technology ShowcaseGlatt

Technology ShowcaseGSK

Technology ShowcaseLEON Nanodrugs

Session 2

12:25-13:15

Making solid progress in Continuous Direct Compression

NewGenes

Supply ChainPain Relief

Lunch Break

13:15 – 13:35

NETWORKING

Technology Showcases

Technology Showcase 3

13:40 – 13:55

Technology Showcase CPACT

Technology Showcase Booth & Welsh

Technology ShowcaseExonar

Technology Showcase 4

14:00 – 14:15

Technology ShowcaseMMIC

Technology ShowcaseApplied Materials

Session 3

14:20 – 15:10

Intense thinking for API manufacture

ImmuneResponse

SuperSimulations

Break

15:10 – 15:30

NETWORKING

Fireside Chat

15:35 – 15:55

How do we align with the Regulators for new technology approvals and do it faster?

Fireside Chat

16:00 – 16:20

Is your organisation ready for the technology revolution?

Fireside Chat

16:25 – 16:45

What are the game changing technologies and approaches that can transform the carbon footprint from Pharma manufacturing?

Closing

16:50 – 17:00

Closing remarks

10:30 – 10:40

Welcome and Opening Remarks

10:45 – 11:35

Choose between Track 1, 2 or 3

Track 1: PLATFORM TECHNOLOGIES

Revolution not evolution of Biologics production

Track 2: NOVEL THERAPIES

Advanced thinking

Track 3 : ADVANCED DIGITAL SOLUTIONS

Digging into Data

11:40 – 11:55

Choose betweenTechnology Showcase 1, 2 or 3

Technology ShowcaseCMAC

Technology ShowcaseBrave & Heart

Technology Showcase 3Nanoform

Advanced
thinking

Digging into
Data

Technology Showcase
CMAC

Technology Showcase
Brave & Heart

Technology Showcase
Nanoform

Technology Showcase
Glatt

Technology Showcase
GSK

Technology Showcase
LEON Nanodrugs

New
Genes

Supply Chain
Pain Relief

Technology Showcase
CPACT

Technology Showcase
Booth & Welsh

Technology Showcase
Exonar

Technology Showcase
MMIC

Technology Showcase
Applied Materials

Immune
Response

Super
Simulations

Choose between
Technology Showcase 1, 2 or 3

Technology Showcase
CMAC

Technology Showcase
Brave & Heart

Technology Showcase 3
Nanoform

Choose between
Technology Showcase 1, 2 or 3

Technology Showcase
Glatt

Technology Showcase
To Be Confirmed

Technology Showcase
Leon Nanodrugs

Choose between
Technology Showcase 1, 2 or 3

Technology Showcase
CPACT

Technology Showcase
Booth & Welsh

Technology Showcase
Exonar

Choose between
Technology Showcase 1, 2 or 3

Technology Showcase
SK biotek

Technology Showcase
MMIC

Technology Showcase
Applied Materials