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