The journey of a decade: Patient therapies ... · Outsourcing inflection point around–consider the holdouts (Pfizer etc.) Serious price pressures beginning in the 90’s Aging facilities

Michael K O’BrienPresident & CEO NGT BioPharma Consultants

San Francisco, CA

January 30th, 2020

Transitioning Decades:The past and future of patient therapies, biopharmaceutical technologies, andfacility design concepts

Today’s Discussion Topics

Looking back: 2010 through 2019• Prominent and emerging therapies• Advances in development and manufacturing technologies• Evolution of facility design concepts

Our crystal ball: 2020 through 2029• Emerging therapies and building on the previous years• The technology ‘keepers’ and what’s on the horizon• What will be the major biopharmaceutical facility platforms in

2029?

Connecting Pharmaceutical Knowledge ISPE.org

Pre-2010 table setters:

▪ iPhone first released in 2007

▪ EMA/FDA Quality by Design FDA pilot programs 2005 forward

▪ Outsourcing inflection point around– consider the holdouts (Pfizer etc.)

▪ Serious price pressures beginning in the 90’s

▪ Aging facilities and their influence on utilization of fully appreciated assets

2010-2019 at a Glance: What Did We Observe

3

▪ Drug shortages and stock outs

▪ Advent of biologics, biosimilars, CAR T, Cell/Gene therapies, mAbs

▪ Patient focus industry mantra and push for localization

▪ Influence of disruptive Innovation / Clay Christenson – Open Innovatiom

▪ Digital and data revolution – NOTE: IBM Watson

▪ Less conservative industry mindset


2010-2019 Influencing Trends

4

Precision medicine:

Cell/Gene therapy and mAbs

New development and

manufacturing paradigms

Greater reliance on an outsourcing

model even with the largest

BioPharmaceutical companies

Open innovation and

pre-competitive

collaboration

Continuous, Modular, Podular


5

Fle

xib

ilit

y &

Ad

ap

tab

ilit

yHigh

Low

Future/EmergingCurrent State-of-the-ArtEstablished

Modularity

Portable

Skid-mounted equipment

Small autonomous POD’s

Rapid deployment & re-deployment

Off-site construction model

Multiple configurations

Rapid process/product changeover

Accept ‘next-gen’ technologies

Off-site design conceptsContinuous Processing

Variable lot size for demand based supply

Same equipment at multiple scales

Miniature

Small footprint

Reduced energy consumption

Enable modularity

Enable miniaturization

Transportability and

Transformational

Development, Manufacturing

& Distribution Models

Batch Processing

Continuous Processing

unleashed an unstoppable chain

of events

http://www.google.com/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&docid=UG5gIDYU4EXnHM&tbnid=kgFiQeg_pTS8SM:&ved=0CAUQjRw&url=http://www.themigraineblueprint.com/&ei=cvJ7U-iNE7jfsASPioCoAw&bvm=bv.67229260,d.aWw&psig=AFQjCNFCueVaYACdnq96FVV0yjvPTMxAYQ&ust=1400718276693230





2010-2019 at a Glance: Accelerated Timelines

6

➢ Technological and Informatics Innovations

➢ Responding to external factors

➢ Sustainable technological solutions

Sustainability

http://www.google.com/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&ved=0ahUKEwjmiq_S1J3LAhXLWT4KHafqAdMQjRwIBw&url=http://cliparts.co/clipart/2421217&psig=AFQjCNGL6fTrFw0K9WxXMM5QWNs_nYaBuA&ust=1456858769806245


2010-2019 at a Glance: Accelerated Timelines


▪ Continuous processing

▪ Digital and advanced analytical technologies

▪ Modularization & expanded transportability

▪ Single-Use Technologies

▪ Lyophilization vs Spray Dried Dispersion

▪ Evolving regulatory agencies mindset

▪ 3D Printing – additive manufacturing paradigms

2010-2019 at a Glance: Technologies

8


2010-2019 Trends: Technologies

9

Continuous processing API and drug product

Digital and advanced analytical technology including APC

Small footprint & modularization

Single-Use technology pros and cons


▪ ‘Stick built’ vs. modular construction

▪ Modularity and Transportability

▪ Eco-conscious – green (in spite of their being no climate change and our environment is cleaner than ever LOL)

▪ Technology advances to lead the way

▪ The rise of collaborative vs. do it all ourselves models

▪ Game changing consortiums

2010-2019 at a Glance: Facility Design Concepts

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▪ Continuous manufacturing firmly established but seems to have stalled – only 6 approvals

▪ Major healthcare shifts – precision med, patient centric approaches, new payor models, gene editing

▪ Gaps that will drive the future

▪ Are there winners and losers?

Lessons Learned

11


Future Trends and Drivers: Healthcare

12

Gene and Cell Therapies will Continue to Dominate the Next Decade


Future Trends and Drivers: Healthcare

13


Future Trends and Drivers: Technologies

14

IoT Wearables and

remote patient care

Machine learning,

predictive analytics, big data

Digital, highly automated AND

transportable equipment and facility

platforms


Future Trends and Drivers: Facility Designs

15

Celgene:

“Green Fairy” Project

▪ geothermal energy and energy recovery

▪ photovoltaic solar panels

▪ environmentally-friendly and energy-efficient utility equipment, materials, and componentsispe.org/facility-year-awards/winners/2019/sustainability

Sustainability is an Increasingly Important Driver


Future Trends and Drivers: Technologies

16

End-to-End Continuous

Manufacturing Each transfer point

should be a module

Modules should be

easily transported

and operated

independent for the

larger unit

Podularize the entire

unit – or at least the

API and DP

production units

Has Come a Long Way


Podular and Transportable Factories

17

▪ G-CON approach• Mini to project; $450K to $30M

• Pharmaceuticals to personalized medicine

• Small to large scale volume

• Adaptable scaling (e.g. cloning and mobility)

• Rapid POD construction (~10 months)

• Increased speed to market

• Highly sterile and sanitizeable

• Reusable

• Adopted by GE Healthcare


An Exercise in Imagination: Possibility #1

In the perfect near future, pharma manufacturing fully adapts to future trends of personalized medicine and biologics

• End-to-end continuous manufacturing of synthetic and biologics • Goal of zero-waste, GREEN• Units fully modular (plug and play chemistry), scalable, robotic to enable TOTAL flexibility (meet new

personalized medicine demands of ultra small batch but scalable)• Full digitization with no down time when transitioning between personalized treatment demands,

minimal human intervention• No drug burn, no supply depots• 6 sigma quality control due to advances in PAT. Inline, online and automated• Distributed, portable, drug manufacturing at your local pharmacy within an hour • Wearable technology and advanced biosensors immediately detect side effects or sub-optimal

treatment responses

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What Does this all Mean?

We don’t know what we don’t

know!!

19


Acknowledgements

Documents

The journey of a decade: Patient therapies ... · Outsourcing inflection point around–consider the holdouts (Pfizer etc.) Serious price pressures beginning in the 90’s Aging facilities