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MONACONadvice & investment in healthcare
Breaking up pharma´s value chain - what
can we expect
Dr. Michael C. Müller
MONACON
The healthcare world is changing more quickly than we can believe
2
 The Chinese middle class will be above 1 billion people by 2020
 India will have to treat ~75 million people with diabetes by 2025 (today 8 million in
Germany)
 At constant prices, the total costs of diabetes in India would rise to $30bn in 2020, which
equals $80bn based on US-prices [for comparison: today total drug spending in in Germany is
appr. €50bn]
 By 2050, 50% of the population in the developed world will be chronically ill
Source: Monacon research © Monacon
MONACON
If healthcare expenditure continued simply following demographics,
cost would reach 30% of total GDP
3
Projected Healthcare spend
OECD countries 2005 2030 2050 2070
US 15.3 24.9 36.7 65.0
Switzerland 11.6 18.8 27.8 49.8
France 11.1 18.0 26.6 47.6
Germany 10.7 17.4 25.6 45.9
Greece 10.1 16.4 24.2 43.3
Canada 9.8 15.9 23.5 42.0
Netherlands 9.2 14.9 22.0 39.5
Denmark 9.1 14.8 21.8 39.0
Italy 8.9 14.5 21.3 38.2
UK 8.3 13.5 19.9 35.8
Turkey 7.6 12.3 18.2 32.6
Mexico 6.4 10.4 15.3 27.5
• Need for systematic
change
• Paradigm shift required
• Traditional models in dead
end now
<10%
10-15% >25%
15-25%
Percent of GDP
Source: Extrapolation of current growth relative to OECD GDP growth
MONACON
Pharma today is investing 5 times as much in R&D as it was two
decades ago
4© Monacon
Trends in R&D expenditure, static IRR, and NME approved by the FDA
31
35 38
43
50
54
61
69
79
88
96
108
120
129 127 129
136 134 136
143
150
10.5
7.7
7.2
4.8
0
2
4
6
8
10
12
-10
10
30
50
70
90
110
130
150
1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
WorldwidepharmaR&Dspend($bio)
StaticIRR(%)
Source: CEPTON, EvaluatePharma, PWC publication
# of FDA
approved
NME
33 58 46 40 37 35 34 26 32 25 25 22 30 35 26 35 41 35 50 56
MONACON
In the past year, many Big Pharma firms have underperformed the S&P
500 while smaller, more specialized companies rose to the top
5Source: CEPTON/CRA Analysis, Onvista
-10%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Stock performance of major Big Pharma and Biotech – Nov. 17th 2013 vs. Nov. 17th 2016
Performance
Big Pharma
Biotechnology
Index
© Monacon
MONACON
In many major therapeutic areas - based on current therapeutic
approaches - innovation is coming to an end (1)
6
Hypertension
Expected innovation and market developments for Big 71 – 2010-2020 [US$bn]
Source: Decision resources 2011/2012 1) US, GER, UK, FR, IT, SP, JPN existing MoAs innovative MoAs
0
5
10
15
20
25
30
2009 2019
Renin inhib./AIIRA FDCs
CCB/RAAS inh./Diuretic FDCs
Cross Indication FDCs
Renin inhib./Diuretic FDCs
Renin inhib.
Beta blockers
Alpha blockers
Aldosterone antag.
Diuretics
CCB/RAAS inhib. FDCs
CCB
AIIRAs/Diuretic FDCs
AIIRAs
ACEIs/Diuretic FDCs
ACEIs
27 $bn
23 $bn
© Monacon
MONACON
In many major therapeutic areas - based on current therapeutic
approaches - innovation is coming to an end (2)
7
Expected innovation and market developments for Big 71 – 2010-2020 [US$bn]
Source: Decision resources 2011/2012 1) US, GER, UK, FR, IT, SP, JPN existing MoAs innovative MoAs
0
1
2
3
2010 2020
Adenosine A2A receptor ant.
Noradrenaline precursors
Antiepileptic drugs
Antipsychotic agents
Anti-dementia agents
MAO-B inhibitors
Anticholinergic agents
Antiglutamatergic agents
Dopamine agonists
Dopamine precursors
2.7 $bn 2.6 $bn
Parkinson’s Disease
© Monacon
MONACON
The classical model has come to an end – bridging needed until real
new innovation will be ready
8
The innovation cycle challenge
Modify symptoms
10
20
30
40
50
60
70
80
90
100
% Attainment
of symptomatic
unmet
medical
need Curative
approaches
10
20
30
40
50
60
70
80
90
100% Attainment
of curative
unmet
medical
need
• Symptomatic approaches
reaching saturation
• Increasing efforts required to
achieve steadily decreasing
effects
• Less and less willingness to
accept minor increments in
markets and by payors
• Real innovation
• Understanding fundamental
disease pathology
• Treating pathology to
ultimately cure the disease
Manage outcome
Treat underlying pathology
Symptomatic
approaches
Need to bridge
© Monacon
MONACONadvice & investment in healthcare
Paradigms are shifting
1. Genome sequencing and personalized medicine will revolutionize diagnostics
and treatment
2. Prevention will develop into an essential market segment, preventing
diseases from the earliest possible point on and will monitor disease progression
or rehabilitation of patients closely
3. IT and communication will become an integral part of pharma & healthcare,
allowing firms and institutions to generate and access big data and share
knowledge in real-time
4. Payors will adapt to a new paradigm, using risk shared financing and novel
infrastructure
5. The industry will break fresh grounds, turning away from the conventional
model of R&D and sales, focusing on innovations generated outside the
traditional core competences
6. Secrecy has become a dogma of the past
MONACON
Pharma´s value chain of the past was more or less fully controlled and
done in-house
10
Research Development Manufacturing
Distribution/
Logistics
Marketing Sales
Pharma
Value chain of the past
Outsourcing
Aquisition & Licensing
Partnering sharing risk and reward
© Monacon
MONACON
11
In the future, the value chain will be broken up, allowing for full
partnership with other players
Biotech
Academia
Tech Giants
Big Data
Social Media
CRO
Med Devices
Social Media
other Pharma
Pharma Digital Services
Homecare
Tech Giants
CRO/CSO
Logistics providers
Small-scale Manufacturers
Pharma service providers
Data
Value chain of the future
Research Development
Manufacturing &
Distribution/ Logistics Marketing Sales
Pharma
Outsourcing
Classical licensing
Partnering sharing risk and reward
Pharma
Tech Giants
CSO
© Monacon
MONACONadvice & investment in healthcare
Genome sequencing changing the face of healthcare
MONACON
Personalized Medicine represents a drastic departure from the
conventional treatment paradigm
13
Stratified Medicine
Personalized Medicine – the scope shifts from standardized to highly individualized solutions
„One fits all“ Personalized medicine
Gene Therapy
Heterologous Tissue Engineering
Autologous Tissue Engineering
Patient individual onco. Vaccinations
stem cell
vector+
ø

Stratified Oncological Vaccinations
Source: Cepton © Monacon
MONACON
Based on individual mutations, a drug will work in a certain patient or
not
14
Targeted therapies – anti-EGFR therapy1 and KRAS4 / HER2+ and Herceptin®
1) e.g. Cetuximab or Panitumumab 2) mCRC = metastatic colorectal carcinoma; wildtype KRAS in NSCLC (non-small-cell lung cancer) 80-90% and in head-and-neck cancer 95%
3) EGFR = epidermal growth factor receptor 4) KRAS = Kirsten rat sarcoma 2 viral oncogene homologue, a signaling protein activating among other the MAP-kinase singaling pathway
Source: CEPTON
HER2 antibodies
binding to
receptors thereby
inhibiting tumor
growth
HER21
normally
expressing cell
HER2 over-
expression
causing
increased cell
proliferation
Signal down-regulated
due to receptor
inhibition by anti-EGFR
antibody
Signal up-regulated due
to constitutive KRAS
activation
!
© Monacon
MONACON
# Product Company
Phas
e
Pharmacological Class
WW 2022
Sales ($m)
NPV
($bn)
Indication
1 Ocrevus Roche Filed Anti-CD20 Mab 3,962 16,965 MS
2 Dupilumab Sanofi Ph. III Anti-interleukin-4 & interleukin-13(IL-13) Mab 3,725 12,884 Dermatitis
3 Ozanimod Celgene Ph. III Sphingosine-1-phosphate(S1P)1&5 receptor modul. 2,112 9,458 MS
4 Durvalumab AstraZeneca Ph. III Anti-programmed death-1 ligand-1(PD-L1) Mab 1,673 8,276 Oncology
5 Abemaciclib Eli Lilly Ph. III Cyclin-dependent kinase (CDK) 4 & 6 inhibitor 1,619 7,919 Oncology
6 Veliparib AbbVie Ph. III Poly (ADP-ribose) polymerase (PARP) inhibitor 1,714 7,502 Oncology
7 Semaglutide Novo Nordisk Ph. III Glucagon-like peptide 1(GLP-1) agonist 2,356 6,889 Diabetes
8 Abducanumab Biogen Ph. III Anti-beta-amyloid (Abeta) Mab 939 6,889 Alzheimer’s
9 LEE011 Novartis Ph. III Cyclin-dependet kinase (CDK) 4 & 6 inhibitor 1,410 6,370 Oncology
10 Emicizumab Roche Ph. III Anti-factor Ixa/X bispecific Mab 1,765 6,336 Hemophilia A
11 ABP 501 Amgen Filed Anti-tumour necrosis factor alpha (TNFa) Mab 810 6,273 Oncology
12 Lanadelumab Shire Ph. III Anti-plasma kallikrein Mab 1,064 5,915 HAE
13 Solanezumab Eli Lilly Ph. III Anti-beta-amyloid (Abeta) Mab 1,556 5,577 Alzheimer’s
14 Fovista Ophthotech Ph. III Anti-platelet derived growth factor (PDGF)-B aptamer 1,973 5,514 AMD4
15 Apalutamide Jonson & Jonson Ph. III Anti-androgen 1,160 5,366 Oncology
16 Bictegravir/F Gilead Sciences Ph. III
Nucleoside reverse transcriptase inhibitor (NRTI) &
HIV integrase inhibitor
3,489 5,276 Alzheimer’s
17 Verubecestat Merck & Co Ph. III Beta secretase cleaving enzyme (BACE) 1 inhibitor 1,480 5,219 Alzheimer’s
18 JCAR017 Juno Therapeutics Ph. II Anti-CD 19 chimeric antigen recept. (CAR) T cell ther. 1,086 4,836 Leukaemia
19 Mongersen Celgene Ph. III Smad7 mRNA antisense 1,205 4,719 Crohn`s
20 Sirukumab Jonson & Jonson Ph. III Anti-interleukin-6 (IL-6) MAb 1,134 4,708 Dermatitis
Looking into “most valuable pipeline” reveals new kids on the block on
almost all “is personal medicine”
15© MonaconSource: CRA / EvaluatePharma 1) Primary biliary cirrhosis 2) Dry age-related macular degeneration 3)
Chronic lymphocytic Leukaemia 4) Wet age-related macular degeneration; * Organic, In-licensed, Acquisition
Most Valuable R&D Projects
Big Pharma Biotech/Niche
MONACON
Breakthrough research suggests that pancreatic ß-cells can be grown
for transplantation
16Source: Pagliuca et al., Cell (2014; 159: 428-439)
• For the first time, fully functional ß-cells could
be grown from embryonic stem cells
• Cells are capable of sustainably secreting
insulin, controlling the blood sugar like
intrinsic ß-cells
• Stem cells could be grown individually for
each patient, minimizing autoimmune
response of the body
• Break through would make conventional
insulin therapies or complex closed loop
systems/artificial pancreas obsolete
© Monacon
MONACON
Therapeutic vaccination is not only fully personalized, it offers healing
of cancer for the first time
17Source: Bayer Innovation / Scientific American / CEPTON
Bayer’s/Icon`s plant-cloned idiotype NHL vaccine
Idiotype
production
Cloning
idiotype
gene
magnICON®
Leukine®
(GM-CSF)
Biopsy
Conjugation
to KLH
© Monacon
MONACONadvice & investment in healthcare
Prevention by “Dr. Pepper”
MONACON
Smart-phone apps and mobile devices are combined to create entire
warning systems for medical urgencies
19
Vicinity’s new Asthma monitor ‘Wheezy’ warns patients of Asthma attacks
• Small monitor is connected to the smart phone
• When patient blows into phone, device scans
the sound along 40 Asthma-related
characteristics
• Device warns patients of asthma attacks and
informs caregivers and relatives
• If risk is too high, phone automatically calls
ambulance
Source: Vicinity Health © Monacon
MONACON
Biostamps and implantable chips are a new generation of “wearable
electronics”, helping prevent diseases by non-invasive monitoring
20
Utilization of patches for non-invasive monitoring
Source: MC10 Inc., 1) VMed Publication
• Flexible “biostamps” stick directly to the skin
• Monitors temperature, hydration and strain without external
support, more accurately than under controlled conditions
• Widely used in newborns and babies to monitor them
continuously and non-invasively
• Implantable chips serve as storage device for personal
health data: patients can keep track of their health, always
having the data with them
© Monacon
MONACON
Foot mats and shoe soles can prevent diabetic foot ulcers
21
• Sensor-enabled mat, scanning feet and
collecting data about blood flow
• Automatic transmission of data to cloud
• Analyzes of changes in blood flow and
early alerts
• Surro Sense Rx – insole that collects data on
pressure patients put on feet
• Wireless transmission of data to a
wristwatch display or smartphone
• Alerts to users at pressure that can lead to
ulcers or be an early sign of ulcers
• Reduction of amputations by up to 85%
due to early alerts
Patient empowerment as a new business model to prevent secondary complications
Source: CEPTON research / Podimetrics / Orpyx © Monacon
MONACON
New, ultra-fast genomic sequencing technologies allow to prevent
genetic diseases in newborns before they manifest
22
Genomic sequencing allows to prevent rare genetic disease Phenylketoneuria
Source: Foxnews Health, Press releases
PKU is a hereditary disease, yet
just one in four children of carrier
parents develop overt PKU
• Phenylketonuria (PKU) causes severe damage to nervous
system and brain if undetected (1 in 15,000 newborns
positive)
• Immediate therapy after birth is needed to prevent disease
from manifesting, at later stages no therapy is available
• New, fast genomic sequencing technology allows to run tests
within two days, quick enough to deliver prevention in all
cases
© Monacon
MONACON
You can find out what your DNA says about you and your family!
23
DNA sequencing as offered by 23andMe
Source: 23andMe
• Patients can order DNA
sequencing online,
obtaining full insight into
their genome
• With the help of
physicians, consumers can
read the risk of
developing certain
diseases from DNA and
initiate steps to prevent
them
© Monacon
MONACON
24Source: 23andMe
Would you want to know that you will have ALS in 10 years
from now with now available treatment against it today?
Will your insurance ask you for testing?
Will employers ask for it, once data is avaibale?
Will there be different classes of men, depending on their
gene-code?
© Monacon
MONACON
23andMe analyzes patient´s genetic patterns to help Pfizer in its search
for novel drug targets
25
Patient diagnosed
with Crohn‘s disease
or ulcerative colitis
DNA-saliva kit Online survey about
IBS experience
Analysis of genetic
mutations linked to
inflammatory bowel disease
Pharma and independent genomics company cooperation
• Together, 23andMe, a Google-backed genomics firm, and Pfizer will analyze data from the genetic
information of over 10,000 patients to find genes linked to inflammatory bowel disease
• Pfizer, not currently marketing any IBD drugs, is looking for potential targets of new therapies
• Outsourcing this analysis to 23andMe who has specialized in genetic information gathering saves both
time and R&D spend for Pfizer
+
Source: 23andMe, CEPTON research © Monacon
MONACONadvice & investment in healthcare
Payors will adapt
MONACON
27© CEPTON a CRA company
MONACON
Outcome based Risk Sharing helps to gain trust with stakeholders,
thereby strengthening the own position in the market
28Source: Illustrated London News, 1895
Long history of risk-sharing
© Monacon
MONACON
Sharing risk may apply to price reductions, volume caps or even total
re-pays in case of therapy failures
29
Novartis funds the cost of its drug in cases where
patients experience an osteoporotic fracture within 1
year following drug infusion
Patients have to show clinical response every three
months (based on rheumatoid factor) in order to
continue reimbursement
If annual spending for the scheme exceed A$100
million, Pfizer covers additional costs
Criteria
No-cure, no-pay deal (Germany)
Aclasta (Novartis) Osteoporosis
DAK and Barmer Ersatzkasse
Fixed budget agreement (Australia)
Enbrel (Wyeth/Pfizer)
Rheumatoid Arthritis
Pharmaceutical Benefits
Pricing Authority (PBAC)
NHS pays for the drug only when tumor shrinks and
50% reduction in blood serum M-protein levels
within four treatment cycles is proven
Performance based payment (UK)
Velcade (Johnson & Johnson)
Multiple Myeloma
National Health Service (NHS)
Source: press research © Monacon
MONACONadvice & investment in healthcare
The industry has to break fresh grounds
MONACON
Rethinking the R&D approach means switching from a mono-
directional in-house to a highly collaborative work model
31
Yesterday: Closed innovation Tomorrow: Open innovation
70% of all Phase 1 targets today, are not generated in-house anymore!
Focused
biotech
IT
Crowd
research Gene labs
Technoloy
platforms
Universities
& Academia
Source: CEPTON © Monacon
MONACON
Setting an early example, Roche has widened its innovative reach and
discovery potential by creating research hubs with over 300 partners
32Source: CEPTON, Roche 1) Proof of concept
Diagno-
stics
Diagno-
stics
Diagno-
stics
Early research & development through POC1 Starting phase III
Independent research hubs working with numerous external
partners under various forms of collaborations
Product development
Manufacturing
Commercialization
Secure diversity
Roche
pharmaGenen-
tech
© Monacon
MONACON
33© Monacon
Big
Pharma
Partner Deal Type Rationale for deal/agreement Year
Joint Venture
Sanofi and Verily Life Sciences LL are teamed up on a $ 500 million joint venture named
Onduo to develop a comprehensive diabetes platform for the type 2 diabetes community
2016
Partnership Developing epigenetic approach to central nervous system disease, crafting small-molecule
therapies to modulate the process that governs heritable genes and how they express
themselves
2016
Partnership
Abbvie invests up to $750 million in letting Google’s biotech spinoff Calico do R&D on aging-
related neurologic diseases such as neurodegeneration
2014
Acquisition
Okairos’ platform technology is based on novel viral vectors (deliver genetic material into
cells) that are designed to stimulate immune responses, (in particular T-cells)
2013
Attempted
Acquisition
Illumina rejected an acquisition offer by Roche, making a $6.7bn bid; the offer, equalling >30
times Illumina’s EBITA and 6 times their sales, reflected Roche’s firm belief in the future of
genome sequencing in healthcare
2012
Partnership
Developing a molecular companion diagnostic test intended to identify patients most likely to
benefit from a new Bayer antibody-drug conjugate
2012
Partnership
Collaborating on the regulatory submissions of Dako's HercepTest and HER2 FISH pharmDx
as companion diagnostics for a Genentech’s trastuzumab emtansine in advanced HER2-
positive breast cancer
2012
Big Pharma is turning externally for innovation – looking for unique
partnerships in novel therapeutics and personalized medicine
Selected collaboration agreements and acquisitions in Personalized and Innovative medicine
MONACON
Scientists and pharma try to leverage crowd-sourcing for research
34
• Current disease studied include Malaria, Tuberculosis and Sleeping
Sickness
• GSK created Open Lab and gave complete IP on their library and
compounds away
• Detailed data from GSK‘s many clinical trials is made available online to
induce „open innovation“
• “Play to Cure™: Genes in Space is the world’s first free mobile game that
uses the collective force of players to analyse real genetic data and help
beat cancer sooner”
• The players‘ routes through the dense space field help accelerate
discovery of cancer-accelerating oncogenes
Examples of crowd-sourcing research applications
Source: CEPTON research, press releases © Monacon
MONACON
Secrecy has become a dogma of the past - pharma companies are
cooperating to share information and escalate innovation
35© CEPTON a CRA company
A data transparency and collaboration
project which grants free access to
clinical data in oncology trials
Source: Project Data Sphere
MONACON
36© CEPTON a CRA company
MONACONadvice & investment in healthcare
IT and communication will become an integral healthcare part
MONACON
Social media have become a serious healthcare player
38
Over 250,000 members share information on
• Frequency and severity of therapy side effects
• Adherence, frequency of medication intake /
dosages
• Reasons for therapy termination or switches
• Provides firms with real-time data on treatment
outcomes, disease progression, perceived
effectiveness and adherence on their product
Source: CEPTON research / PatientsLikeMe © Monacon
MONACON
Pharma partners with social media and big-data to use data for a new
kind of clinical development
39
Examples of crowd-based social media data usage
Source: Genentech, Pfizer, press releases
• 5-year commercial agreement
• Genentech can tap PatientsLikeMe’s network for focused
research projects to evaluate and develop new medical
evidence and measures
• Communicate with a huge peer group, collecting real-time
data
• Great potential also cross-sectional searches conducted
• 23andMe, a Google-backed genomics firm and Pfizer will analyze data from the
genetic information of over 10,000 patients to find genes linked to
inflammatory bowel disease
• Genetic information matched with IBS history and anamnesis from social
media query
© Monacon
MONACON
Meanwhile, other companies have collaborated with medical
technology to accurately monitor patients and better adherence levels
40
• Electronic pill bottles
• Collect and send all
adherence data (based on
time and number of pills
taken from bottle) in real-
time
• If doses are missed,
patients receive
customizable messaging
and interventions
• Sensor for the back of Respimat
inhaler, collecting and transferring
data on drug use
• Understand reasons for
nonadherence and gather data to
improve adherence levels for
asthma and COPD patients
Source: CEPTON research
• Signed an exclusive 15-year
agreement
• Genesis created a compact, ‘all-in-
one’ artificial pancreas
© Monacon
MONACON
Developing “smart pills”, monitoring administration and adherence,
Proteus is said to be one of the next healthcare IPOs
41
Increase adherence – smart pills and patient monitoring solutions
Continuous
Medication
sensing & Wireless
upload to Raisin
enabled mobile
Device
(Smartphone)
to collect data
and interact with
patient
• Patient directed
Permissions
• Web Server Interface
• RaisinRx Population
• Data Aggregation
RN/Physician/Pharmacist
Family Caregivers & Community
• Alerts
• Trends
• Support
• Wellness Index
• Summary
• Alerts
• Cross-Patient benchmarks
Informed
Clinical Communication and Support
+
Tagged drugs
(RFID, chip tag,
chemical)
Receiver
carried on
body
(patch,
watch, …)
Proteus recently secured
additional funding of >$360m
from >20 prominent investors
+ + +
Source: Proteus / press research © Monacon
MONACON
New implantable depots will be able to replace the daily pill by
releasing medication continuously for 16 years
42
Prevention without substantial patient interaction
• The implant contains a dose of a contraceptive
sufficient for 16 years
• Device releases 30 μg of the contraceptive every
day
• The drug is stored between ultra-thin layers and
realeased when a layer dissolves as a rection to
an electrical current
• Patients can turn the device on and off remotely
• The product is designed to hold any other drug to
be administred that way
Source: Microchips © Monacon
MONACON
Apple Research includes Apps which generates research data from patients
• Symptoms, courses of a disease, therapies and after care for several diseases are collected and evaluated
by researchers
• Data is collected with Apple products like the iPhone or the iWatch and Apps like the Apple Health apps
Apple Health on every iPhone generates massive research data
43Source: Apple © Monacon
MONACON
Samsung is making big moves into the healthcare arena
Source: Cepton / Bloomberg BusinessWeek / Financial Times / Fiercebiotech 44
• Strategic partnership between Samsung (90%) and Quintiles (10%)
• Provision of biopharmaceutical contract manufacturing solutions
• Samsung plans to invest more than $2bn until 2020 into new
biosimilar plant
• Production of biosimilar versions of bestselling cancer and
immunological disease at half of current western prices
• $1.8bn annual revenue expected by 2020
Products easily
shipped worldwide
from Samsung‘s
Korean facility
© Monacon
MONACON
NO YES
ELIGIBLE?
AIS checks
suitability
Physician
opens AIS
file
Intermedix / Compugroup and
Pharma Partnering
Source: intermedix
Completed Merger of Equals transaction between IMS Health and
Quintiles provides evidence on future role of “data”
45
Assess real time
data
Create virtual
control arm
Use doctors
office file
Certain set of
therapies
Potential patient
for study
• Integration of pop-up windows, when the
physician opens an eligible patient file
• Individual activation of selection of studies
• Providing Case Record Form online (if required)
Clinical trials automation by Quintiles Real time evidence creation by IMS
• Collecting real time patient treatment data
globally
• Generating “virtual controll arms for clinical
studies”
• Provided to:
© Monacon
Clinical trial
patients
treatment arm
MONACON
Personalized medicine will require entirely new partners for the
manufacturing and logistics value chain
46Source: Bayer Innovation, Scientific American, CEPTON
• No “one” product any
longer
• No central manufacturing
site
• All new manufacturing
partners
• Limited number of
patients –> one patient
only
• New payment schemes
• Change of customer
landscape and profiles
• Completely different
distribution model
stem
cell
ø

vector+
Stratified Medicine
Gene Therapy
Autologous Tissue Engineering
Heterologous Tissue Engineering
Oncological Vaccinations
Therapeutic Vaccinations
© Monacon
MONACON
In the future, personalized treatment might be able to provide remote,
cheap and easy genetic sequencing and therapy anywhere in the world
47
Tuesday, November 8th 2022
“Mail us your damaged genes and we’ll
mend them and send them right back to
you”
• Future scenarios like to become
reality, once bio-replication tools are
developed that can create micro-
organisms from genetic code
• DNA-decoders will be capable of
scanning and transcribing biological
data so that it can be sent around
the world
• Changing full genetic code “in
vivo” was already successful
© Monacon
MONACON
48
Plenty of room to grow - 10% of the world population still eating up 90%
of resources
Source: Worldmapper
Global healthcare spending
© Monacon
MONACON
49
Plenty of room to grow - 10% of the world population still eating up 90%
of resources
Source: Worldmapper
Global healthcare spending
© Monacon

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"Breaking up pharma´s value chain - what can we expect", MICHAEL MÜLLER

  • 1. MONACONadvice & investment in healthcare Breaking up pharma´s value chain - what can we expect Dr. Michael C. Müller
  • 2. MONACON The healthcare world is changing more quickly than we can believe 2  The Chinese middle class will be above 1 billion people by 2020  India will have to treat ~75 million people with diabetes by 2025 (today 8 million in Germany)  At constant prices, the total costs of diabetes in India would rise to $30bn in 2020, which equals $80bn based on US-prices [for comparison: today total drug spending in in Germany is appr. €50bn]  By 2050, 50% of the population in the developed world will be chronically ill Source: Monacon research © Monacon
  • 3. MONACON If healthcare expenditure continued simply following demographics, cost would reach 30% of total GDP 3 Projected Healthcare spend OECD countries 2005 2030 2050 2070 US 15.3 24.9 36.7 65.0 Switzerland 11.6 18.8 27.8 49.8 France 11.1 18.0 26.6 47.6 Germany 10.7 17.4 25.6 45.9 Greece 10.1 16.4 24.2 43.3 Canada 9.8 15.9 23.5 42.0 Netherlands 9.2 14.9 22.0 39.5 Denmark 9.1 14.8 21.8 39.0 Italy 8.9 14.5 21.3 38.2 UK 8.3 13.5 19.9 35.8 Turkey 7.6 12.3 18.2 32.6 Mexico 6.4 10.4 15.3 27.5 • Need for systematic change • Paradigm shift required • Traditional models in dead end now <10% 10-15% >25% 15-25% Percent of GDP Source: Extrapolation of current growth relative to OECD GDP growth
  • 4. MONACON Pharma today is investing 5 times as much in R&D as it was two decades ago 4© Monacon Trends in R&D expenditure, static IRR, and NME approved by the FDA 31 35 38 43 50 54 61 69 79 88 96 108 120 129 127 129 136 134 136 143 150 10.5 7.7 7.2 4.8 0 2 4 6 8 10 12 -10 10 30 50 70 90 110 130 150 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 WorldwidepharmaR&Dspend($bio) StaticIRR(%) Source: CEPTON, EvaluatePharma, PWC publication # of FDA approved NME 33 58 46 40 37 35 34 26 32 25 25 22 30 35 26 35 41 35 50 56
  • 5. MONACON In the past year, many Big Pharma firms have underperformed the S&P 500 while smaller, more specialized companies rose to the top 5Source: CEPTON/CRA Analysis, Onvista -10% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Stock performance of major Big Pharma and Biotech – Nov. 17th 2013 vs. Nov. 17th 2016 Performance Big Pharma Biotechnology Index © Monacon
  • 6. MONACON In many major therapeutic areas - based on current therapeutic approaches - innovation is coming to an end (1) 6 Hypertension Expected innovation and market developments for Big 71 – 2010-2020 [US$bn] Source: Decision resources 2011/2012 1) US, GER, UK, FR, IT, SP, JPN existing MoAs innovative MoAs 0 5 10 15 20 25 30 2009 2019 Renin inhib./AIIRA FDCs CCB/RAAS inh./Diuretic FDCs Cross Indication FDCs Renin inhib./Diuretic FDCs Renin inhib. Beta blockers Alpha blockers Aldosterone antag. Diuretics CCB/RAAS inhib. FDCs CCB AIIRAs/Diuretic FDCs AIIRAs ACEIs/Diuretic FDCs ACEIs 27 $bn 23 $bn © Monacon
  • 7. MONACON In many major therapeutic areas - based on current therapeutic approaches - innovation is coming to an end (2) 7 Expected innovation and market developments for Big 71 – 2010-2020 [US$bn] Source: Decision resources 2011/2012 1) US, GER, UK, FR, IT, SP, JPN existing MoAs innovative MoAs 0 1 2 3 2010 2020 Adenosine A2A receptor ant. Noradrenaline precursors Antiepileptic drugs Antipsychotic agents Anti-dementia agents MAO-B inhibitors Anticholinergic agents Antiglutamatergic agents Dopamine agonists Dopamine precursors 2.7 $bn 2.6 $bn Parkinson’s Disease © Monacon
  • 8. MONACON The classical model has come to an end – bridging needed until real new innovation will be ready 8 The innovation cycle challenge Modify symptoms 10 20 30 40 50 60 70 80 90 100 % Attainment of symptomatic unmet medical need Curative approaches 10 20 30 40 50 60 70 80 90 100% Attainment of curative unmet medical need • Symptomatic approaches reaching saturation • Increasing efforts required to achieve steadily decreasing effects • Less and less willingness to accept minor increments in markets and by payors • Real innovation • Understanding fundamental disease pathology • Treating pathology to ultimately cure the disease Manage outcome Treat underlying pathology Symptomatic approaches Need to bridge © Monacon
  • 9. MONACONadvice & investment in healthcare Paradigms are shifting 1. Genome sequencing and personalized medicine will revolutionize diagnostics and treatment 2. Prevention will develop into an essential market segment, preventing diseases from the earliest possible point on and will monitor disease progression or rehabilitation of patients closely 3. IT and communication will become an integral part of pharma & healthcare, allowing firms and institutions to generate and access big data and share knowledge in real-time 4. Payors will adapt to a new paradigm, using risk shared financing and novel infrastructure 5. The industry will break fresh grounds, turning away from the conventional model of R&D and sales, focusing on innovations generated outside the traditional core competences 6. Secrecy has become a dogma of the past
  • 10. MONACON Pharma´s value chain of the past was more or less fully controlled and done in-house 10 Research Development Manufacturing Distribution/ Logistics Marketing Sales Pharma Value chain of the past Outsourcing Aquisition & Licensing Partnering sharing risk and reward © Monacon
  • 11. MONACON 11 In the future, the value chain will be broken up, allowing for full partnership with other players Biotech Academia Tech Giants Big Data Social Media CRO Med Devices Social Media other Pharma Pharma Digital Services Homecare Tech Giants CRO/CSO Logistics providers Small-scale Manufacturers Pharma service providers Data Value chain of the future Research Development Manufacturing & Distribution/ Logistics Marketing Sales Pharma Outsourcing Classical licensing Partnering sharing risk and reward Pharma Tech Giants CSO © Monacon
  • 12. MONACONadvice & investment in healthcare Genome sequencing changing the face of healthcare
  • 13. MONACON Personalized Medicine represents a drastic departure from the conventional treatment paradigm 13 Stratified Medicine Personalized Medicine – the scope shifts from standardized to highly individualized solutions „One fits all“ Personalized medicine Gene Therapy Heterologous Tissue Engineering Autologous Tissue Engineering Patient individual onco. Vaccinations stem cell vector+ ø  Stratified Oncological Vaccinations Source: Cepton © Monacon
  • 14. MONACON Based on individual mutations, a drug will work in a certain patient or not 14 Targeted therapies – anti-EGFR therapy1 and KRAS4 / HER2+ and Herceptin® 1) e.g. Cetuximab or Panitumumab 2) mCRC = metastatic colorectal carcinoma; wildtype KRAS in NSCLC (non-small-cell lung cancer) 80-90% and in head-and-neck cancer 95% 3) EGFR = epidermal growth factor receptor 4) KRAS = Kirsten rat sarcoma 2 viral oncogene homologue, a signaling protein activating among other the MAP-kinase singaling pathway Source: CEPTON HER2 antibodies binding to receptors thereby inhibiting tumor growth HER21 normally expressing cell HER2 over- expression causing increased cell proliferation Signal down-regulated due to receptor inhibition by anti-EGFR antibody Signal up-regulated due to constitutive KRAS activation ! © Monacon
  • 15. MONACON # Product Company Phas e Pharmacological Class WW 2022 Sales ($m) NPV ($bn) Indication 1 Ocrevus Roche Filed Anti-CD20 Mab 3,962 16,965 MS 2 Dupilumab Sanofi Ph. III Anti-interleukin-4 & interleukin-13(IL-13) Mab 3,725 12,884 Dermatitis 3 Ozanimod Celgene Ph. III Sphingosine-1-phosphate(S1P)1&5 receptor modul. 2,112 9,458 MS 4 Durvalumab AstraZeneca Ph. III Anti-programmed death-1 ligand-1(PD-L1) Mab 1,673 8,276 Oncology 5 Abemaciclib Eli Lilly Ph. III Cyclin-dependent kinase (CDK) 4 & 6 inhibitor 1,619 7,919 Oncology 6 Veliparib AbbVie Ph. III Poly (ADP-ribose) polymerase (PARP) inhibitor 1,714 7,502 Oncology 7 Semaglutide Novo Nordisk Ph. III Glucagon-like peptide 1(GLP-1) agonist 2,356 6,889 Diabetes 8 Abducanumab Biogen Ph. III Anti-beta-amyloid (Abeta) Mab 939 6,889 Alzheimer’s 9 LEE011 Novartis Ph. III Cyclin-dependet kinase (CDK) 4 & 6 inhibitor 1,410 6,370 Oncology 10 Emicizumab Roche Ph. III Anti-factor Ixa/X bispecific Mab 1,765 6,336 Hemophilia A 11 ABP 501 Amgen Filed Anti-tumour necrosis factor alpha (TNFa) Mab 810 6,273 Oncology 12 Lanadelumab Shire Ph. III Anti-plasma kallikrein Mab 1,064 5,915 HAE 13 Solanezumab Eli Lilly Ph. III Anti-beta-amyloid (Abeta) Mab 1,556 5,577 Alzheimer’s 14 Fovista Ophthotech Ph. III Anti-platelet derived growth factor (PDGF)-B aptamer 1,973 5,514 AMD4 15 Apalutamide Jonson & Jonson Ph. III Anti-androgen 1,160 5,366 Oncology 16 Bictegravir/F Gilead Sciences Ph. III Nucleoside reverse transcriptase inhibitor (NRTI) & HIV integrase inhibitor 3,489 5,276 Alzheimer’s 17 Verubecestat Merck & Co Ph. III Beta secretase cleaving enzyme (BACE) 1 inhibitor 1,480 5,219 Alzheimer’s 18 JCAR017 Juno Therapeutics Ph. II Anti-CD 19 chimeric antigen recept. (CAR) T cell ther. 1,086 4,836 Leukaemia 19 Mongersen Celgene Ph. III Smad7 mRNA antisense 1,205 4,719 Crohn`s 20 Sirukumab Jonson & Jonson Ph. III Anti-interleukin-6 (IL-6) MAb 1,134 4,708 Dermatitis Looking into “most valuable pipeline” reveals new kids on the block on almost all “is personal medicine” 15© MonaconSource: CRA / EvaluatePharma 1) Primary biliary cirrhosis 2) Dry age-related macular degeneration 3) Chronic lymphocytic Leukaemia 4) Wet age-related macular degeneration; * Organic, In-licensed, Acquisition Most Valuable R&D Projects Big Pharma Biotech/Niche
  • 16. MONACON Breakthrough research suggests that pancreatic ß-cells can be grown for transplantation 16Source: Pagliuca et al., Cell (2014; 159: 428-439) • For the first time, fully functional ß-cells could be grown from embryonic stem cells • Cells are capable of sustainably secreting insulin, controlling the blood sugar like intrinsic ß-cells • Stem cells could be grown individually for each patient, minimizing autoimmune response of the body • Break through would make conventional insulin therapies or complex closed loop systems/artificial pancreas obsolete © Monacon
  • 17. MONACON Therapeutic vaccination is not only fully personalized, it offers healing of cancer for the first time 17Source: Bayer Innovation / Scientific American / CEPTON Bayer’s/Icon`s plant-cloned idiotype NHL vaccine Idiotype production Cloning idiotype gene magnICON® Leukine® (GM-CSF) Biopsy Conjugation to KLH © Monacon
  • 18. MONACONadvice & investment in healthcare Prevention by “Dr. Pepper”
  • 19. MONACON Smart-phone apps and mobile devices are combined to create entire warning systems for medical urgencies 19 Vicinity’s new Asthma monitor ‘Wheezy’ warns patients of Asthma attacks • Small monitor is connected to the smart phone • When patient blows into phone, device scans the sound along 40 Asthma-related characteristics • Device warns patients of asthma attacks and informs caregivers and relatives • If risk is too high, phone automatically calls ambulance Source: Vicinity Health © Monacon
  • 20. MONACON Biostamps and implantable chips are a new generation of “wearable electronics”, helping prevent diseases by non-invasive monitoring 20 Utilization of patches for non-invasive monitoring Source: MC10 Inc., 1) VMed Publication • Flexible “biostamps” stick directly to the skin • Monitors temperature, hydration and strain without external support, more accurately than under controlled conditions • Widely used in newborns and babies to monitor them continuously and non-invasively • Implantable chips serve as storage device for personal health data: patients can keep track of their health, always having the data with them © Monacon
  • 21. MONACON Foot mats and shoe soles can prevent diabetic foot ulcers 21 • Sensor-enabled mat, scanning feet and collecting data about blood flow • Automatic transmission of data to cloud • Analyzes of changes in blood flow and early alerts • Surro Sense Rx – insole that collects data on pressure patients put on feet • Wireless transmission of data to a wristwatch display or smartphone • Alerts to users at pressure that can lead to ulcers or be an early sign of ulcers • Reduction of amputations by up to 85% due to early alerts Patient empowerment as a new business model to prevent secondary complications Source: CEPTON research / Podimetrics / Orpyx © Monacon
  • 22. MONACON New, ultra-fast genomic sequencing technologies allow to prevent genetic diseases in newborns before they manifest 22 Genomic sequencing allows to prevent rare genetic disease Phenylketoneuria Source: Foxnews Health, Press releases PKU is a hereditary disease, yet just one in four children of carrier parents develop overt PKU • Phenylketonuria (PKU) causes severe damage to nervous system and brain if undetected (1 in 15,000 newborns positive) • Immediate therapy after birth is needed to prevent disease from manifesting, at later stages no therapy is available • New, fast genomic sequencing technology allows to run tests within two days, quick enough to deliver prevention in all cases © Monacon
  • 23. MONACON You can find out what your DNA says about you and your family! 23 DNA sequencing as offered by 23andMe Source: 23andMe • Patients can order DNA sequencing online, obtaining full insight into their genome • With the help of physicians, consumers can read the risk of developing certain diseases from DNA and initiate steps to prevent them © Monacon
  • 24. MONACON 24Source: 23andMe Would you want to know that you will have ALS in 10 years from now with now available treatment against it today? Will your insurance ask you for testing? Will employers ask for it, once data is avaibale? Will there be different classes of men, depending on their gene-code? © Monacon
  • 25. MONACON 23andMe analyzes patient´s genetic patterns to help Pfizer in its search for novel drug targets 25 Patient diagnosed with Crohn‘s disease or ulcerative colitis DNA-saliva kit Online survey about IBS experience Analysis of genetic mutations linked to inflammatory bowel disease Pharma and independent genomics company cooperation • Together, 23andMe, a Google-backed genomics firm, and Pfizer will analyze data from the genetic information of over 10,000 patients to find genes linked to inflammatory bowel disease • Pfizer, not currently marketing any IBD drugs, is looking for potential targets of new therapies • Outsourcing this analysis to 23andMe who has specialized in genetic information gathering saves both time and R&D spend for Pfizer + Source: 23andMe, CEPTON research © Monacon
  • 26. MONACONadvice & investment in healthcare Payors will adapt
  • 27. MONACON 27© CEPTON a CRA company
  • 28. MONACON Outcome based Risk Sharing helps to gain trust with stakeholders, thereby strengthening the own position in the market 28Source: Illustrated London News, 1895 Long history of risk-sharing © Monacon
  • 29. MONACON Sharing risk may apply to price reductions, volume caps or even total re-pays in case of therapy failures 29 Novartis funds the cost of its drug in cases where patients experience an osteoporotic fracture within 1 year following drug infusion Patients have to show clinical response every three months (based on rheumatoid factor) in order to continue reimbursement If annual spending for the scheme exceed A$100 million, Pfizer covers additional costs Criteria No-cure, no-pay deal (Germany) Aclasta (Novartis) Osteoporosis DAK and Barmer Ersatzkasse Fixed budget agreement (Australia) Enbrel (Wyeth/Pfizer) Rheumatoid Arthritis Pharmaceutical Benefits Pricing Authority (PBAC) NHS pays for the drug only when tumor shrinks and 50% reduction in blood serum M-protein levels within four treatment cycles is proven Performance based payment (UK) Velcade (Johnson & Johnson) Multiple Myeloma National Health Service (NHS) Source: press research © Monacon
  • 30. MONACONadvice & investment in healthcare The industry has to break fresh grounds
  • 31. MONACON Rethinking the R&D approach means switching from a mono- directional in-house to a highly collaborative work model 31 Yesterday: Closed innovation Tomorrow: Open innovation 70% of all Phase 1 targets today, are not generated in-house anymore! Focused biotech IT Crowd research Gene labs Technoloy platforms Universities & Academia Source: CEPTON © Monacon
  • 32. MONACON Setting an early example, Roche has widened its innovative reach and discovery potential by creating research hubs with over 300 partners 32Source: CEPTON, Roche 1) Proof of concept Diagno- stics Diagno- stics Diagno- stics Early research & development through POC1 Starting phase III Independent research hubs working with numerous external partners under various forms of collaborations Product development Manufacturing Commercialization Secure diversity Roche pharmaGenen- tech © Monacon
  • 33. MONACON 33© Monacon Big Pharma Partner Deal Type Rationale for deal/agreement Year Joint Venture Sanofi and Verily Life Sciences LL are teamed up on a $ 500 million joint venture named Onduo to develop a comprehensive diabetes platform for the type 2 diabetes community 2016 Partnership Developing epigenetic approach to central nervous system disease, crafting small-molecule therapies to modulate the process that governs heritable genes and how they express themselves 2016 Partnership Abbvie invests up to $750 million in letting Google’s biotech spinoff Calico do R&D on aging- related neurologic diseases such as neurodegeneration 2014 Acquisition Okairos’ platform technology is based on novel viral vectors (deliver genetic material into cells) that are designed to stimulate immune responses, (in particular T-cells) 2013 Attempted Acquisition Illumina rejected an acquisition offer by Roche, making a $6.7bn bid; the offer, equalling >30 times Illumina’s EBITA and 6 times their sales, reflected Roche’s firm belief in the future of genome sequencing in healthcare 2012 Partnership Developing a molecular companion diagnostic test intended to identify patients most likely to benefit from a new Bayer antibody-drug conjugate 2012 Partnership Collaborating on the regulatory submissions of Dako's HercepTest and HER2 FISH pharmDx as companion diagnostics for a Genentech’s trastuzumab emtansine in advanced HER2- positive breast cancer 2012 Big Pharma is turning externally for innovation – looking for unique partnerships in novel therapeutics and personalized medicine Selected collaboration agreements and acquisitions in Personalized and Innovative medicine
  • 34. MONACON Scientists and pharma try to leverage crowd-sourcing for research 34 • Current disease studied include Malaria, Tuberculosis and Sleeping Sickness • GSK created Open Lab and gave complete IP on their library and compounds away • Detailed data from GSK‘s many clinical trials is made available online to induce „open innovation“ • “Play to Cure™: Genes in Space is the world’s first free mobile game that uses the collective force of players to analyse real genetic data and help beat cancer sooner” • The players‘ routes through the dense space field help accelerate discovery of cancer-accelerating oncogenes Examples of crowd-sourcing research applications Source: CEPTON research, press releases © Monacon
  • 35. MONACON Secrecy has become a dogma of the past - pharma companies are cooperating to share information and escalate innovation 35© CEPTON a CRA company A data transparency and collaboration project which grants free access to clinical data in oncology trials Source: Project Data Sphere
  • 36. MONACON 36© CEPTON a CRA company
  • 37. MONACONadvice & investment in healthcare IT and communication will become an integral healthcare part
  • 38. MONACON Social media have become a serious healthcare player 38 Over 250,000 members share information on • Frequency and severity of therapy side effects • Adherence, frequency of medication intake / dosages • Reasons for therapy termination or switches • Provides firms with real-time data on treatment outcomes, disease progression, perceived effectiveness and adherence on their product Source: CEPTON research / PatientsLikeMe © Monacon
  • 39. MONACON Pharma partners with social media and big-data to use data for a new kind of clinical development 39 Examples of crowd-based social media data usage Source: Genentech, Pfizer, press releases • 5-year commercial agreement • Genentech can tap PatientsLikeMe’s network for focused research projects to evaluate and develop new medical evidence and measures • Communicate with a huge peer group, collecting real-time data • Great potential also cross-sectional searches conducted • 23andMe, a Google-backed genomics firm and Pfizer will analyze data from the genetic information of over 10,000 patients to find genes linked to inflammatory bowel disease • Genetic information matched with IBS history and anamnesis from social media query © Monacon
  • 40. MONACON Meanwhile, other companies have collaborated with medical technology to accurately monitor patients and better adherence levels 40 • Electronic pill bottles • Collect and send all adherence data (based on time and number of pills taken from bottle) in real- time • If doses are missed, patients receive customizable messaging and interventions • Sensor for the back of Respimat inhaler, collecting and transferring data on drug use • Understand reasons for nonadherence and gather data to improve adherence levels for asthma and COPD patients Source: CEPTON research • Signed an exclusive 15-year agreement • Genesis created a compact, ‘all-in- one’ artificial pancreas © Monacon
  • 41. MONACON Developing “smart pills”, monitoring administration and adherence, Proteus is said to be one of the next healthcare IPOs 41 Increase adherence – smart pills and patient monitoring solutions Continuous Medication sensing & Wireless upload to Raisin enabled mobile Device (Smartphone) to collect data and interact with patient • Patient directed Permissions • Web Server Interface • RaisinRx Population • Data Aggregation RN/Physician/Pharmacist Family Caregivers & Community • Alerts • Trends • Support • Wellness Index • Summary • Alerts • Cross-Patient benchmarks Informed Clinical Communication and Support + Tagged drugs (RFID, chip tag, chemical) Receiver carried on body (patch, watch, …) Proteus recently secured additional funding of >$360m from >20 prominent investors + + + Source: Proteus / press research © Monacon
  • 42. MONACON New implantable depots will be able to replace the daily pill by releasing medication continuously for 16 years 42 Prevention without substantial patient interaction • The implant contains a dose of a contraceptive sufficient for 16 years • Device releases 30 μg of the contraceptive every day • The drug is stored between ultra-thin layers and realeased when a layer dissolves as a rection to an electrical current • Patients can turn the device on and off remotely • The product is designed to hold any other drug to be administred that way Source: Microchips © Monacon
  • 43. MONACON Apple Research includes Apps which generates research data from patients • Symptoms, courses of a disease, therapies and after care for several diseases are collected and evaluated by researchers • Data is collected with Apple products like the iPhone or the iWatch and Apps like the Apple Health apps Apple Health on every iPhone generates massive research data 43Source: Apple © Monacon
  • 44. MONACON Samsung is making big moves into the healthcare arena Source: Cepton / Bloomberg BusinessWeek / Financial Times / Fiercebiotech 44 • Strategic partnership between Samsung (90%) and Quintiles (10%) • Provision of biopharmaceutical contract manufacturing solutions • Samsung plans to invest more than $2bn until 2020 into new biosimilar plant • Production of biosimilar versions of bestselling cancer and immunological disease at half of current western prices • $1.8bn annual revenue expected by 2020 Products easily shipped worldwide from Samsung‘s Korean facility © Monacon
  • 45. MONACON NO YES ELIGIBLE? AIS checks suitability Physician opens AIS file Intermedix / Compugroup and Pharma Partnering Source: intermedix Completed Merger of Equals transaction between IMS Health and Quintiles provides evidence on future role of “data” 45 Assess real time data Create virtual control arm Use doctors office file Certain set of therapies Potential patient for study • Integration of pop-up windows, when the physician opens an eligible patient file • Individual activation of selection of studies • Providing Case Record Form online (if required) Clinical trials automation by Quintiles Real time evidence creation by IMS • Collecting real time patient treatment data globally • Generating “virtual controll arms for clinical studies” • Provided to: © Monacon Clinical trial patients treatment arm
  • 46. MONACON Personalized medicine will require entirely new partners for the manufacturing and logistics value chain 46Source: Bayer Innovation, Scientific American, CEPTON • No “one” product any longer • No central manufacturing site • All new manufacturing partners • Limited number of patients –> one patient only • New payment schemes • Change of customer landscape and profiles • Completely different distribution model stem cell ø  vector+ Stratified Medicine Gene Therapy Autologous Tissue Engineering Heterologous Tissue Engineering Oncological Vaccinations Therapeutic Vaccinations © Monacon
  • 47. MONACON In the future, personalized treatment might be able to provide remote, cheap and easy genetic sequencing and therapy anywhere in the world 47 Tuesday, November 8th 2022 “Mail us your damaged genes and we’ll mend them and send them right back to you” • Future scenarios like to become reality, once bio-replication tools are developed that can create micro- organisms from genetic code • DNA-decoders will be capable of scanning and transcribing biological data so that it can be sent around the world • Changing full genetic code “in vivo” was already successful © Monacon
  • 48. MONACON 48 Plenty of room to grow - 10% of the world population still eating up 90% of resources Source: Worldmapper Global healthcare spending © Monacon
  • 49. MONACON 49 Plenty of room to grow - 10% of the world population still eating up 90% of resources Source: Worldmapper Global healthcare spending © Monacon