INDIAN PHARMA 10X
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Transcript of INDIAN PHARMA 10X
Pharma | Life science | Biotechnology PLB
TRENDS & OPPORTUNITIES Assessment of HIGH GROWTH , HIGH MARGIN SPACE
AJAY GOHIL CHALLENGE SEEKING FROM HARVARD & MCKINSEY
In the Quest for 10X …… STRATEGIC OPTIONS Assessment for
INDIA PHARMA cos.
EVERY THING YOU WANT TO ABOUT INDIAN PHARMA
A STORY OF INDIAN GENERICS PHARMA CO – INGNX
10 X
Strategic Options Assessment
Value Addition Specialty Inputs
Program Manager Across value chain
Platform as a service CRO/CMO as a service
Leverage the SMAC+ BIG DATA + e-commerce
M&A
Divestment
Strategic Alliances / JVs
CAPACITY Expansion
Biologics | Biosimilars | Bio enzymes
Ultra Advanced GENETICS research
Unmet medical needs | Rare diseases
Consumer sectors AN/HC/Chemicals
Anatomy of the presentation
SECTION 1 MOLE size on big canvass A mediocre performance of INGNX
PERFORMANCE ANALYSIS
SECTION 2 Why INGNX should consider
SECTION 1 seriously ?
SECTION 1
MOLE Size in a big strategic canvass….
$ 900 Bn
Global Rx Pharma Size
0.0005% INGNX market share
IF INGNX just have to play in RED SMALL ZONE…Just
operational thinking..then the fault is NOT in
EMPLOYEES but ..with SNR MNGT
Why INGNX should see this presentation?
INGNX should have been $ 10 Bn organization by now What is the problem with INGNX ?
Mole size , Mediocrity , Questionn of survival, Bullet point culture
Bullet point
Culture
INGNX can grow “10-X” How INGNX can grow 10 times … Strategic Thinking – Smart , Practical , Innovative
10 x
How to grow 10x Complete Strategic road map
How
First lets see what is wrong with INGNX
INGNX should have been $ 10 Bn organization by now What is the problem with INGNX ?
Mole size , Mediocrity , Questionn of survival, Bullet point culture
Bullet point
Culture
FIRST THING FIRST – Lets Clear some MYTHS TEMASEK …
Strategic MYTH TRUTH
Off patent means BIG opportunity for INDIAN GENERICS …
WRONG ..boss the days are gone..where the RANBAXY uses the reactors in small part of LUDHIANA and earned hefty premium on DRUGS to US Now there is very stringent FDA…mistakes and u r gone…and then there is ACCEPTABILITY
Again,… are the INDIANs the only guys who know the generics game,.. Remember not even the SUN + DRL + CIPLA is equal to MYLAN or TEVA or SANDOZ or HOSPIRA… globally + CHINESE Companies are now a FORCE to reckon with .. IN GENERICS the price erosion is so high… look what has happened to
LIPITOR…PLAVIX Furthermore ..the Global MNCs ..despite the patent loss ..have managed to stop the PLUMMET …and they have tactically used good marketing to arrest the FREE FALL…which indian Pharmas lack..
FIRST THING FIRST – Lets Clear some MYTHS TEMASEK …
Strategic MYTH TRUTH
EV/EBIDTA for INDIAN PHARMA Cos will always increase – there is cool 5-6 Exit multiples
Long term outlook depends on the Cos future s – strategic plans – the sensitivity of the capital is very high wrt the Indian stocks..INDIAN cos are highly COUPLED with GLOBAL FINANCIAL
MARKETS ..the biggest fear is QE TAPER ..if the QE shrinks
..there could be capital withdrawal..thus Investment by TEMASEK in Indian firms ..all firms..is more to do with CAPITAL GLUT than
the real bright chances …and performance – TEMASEK WOULD AGREE SHEEPISHLY
Global MNCs will be weaken by off patents…
PARTIALLY TRUE – for ex . ASTRA ZENECA ..since it is unable to replace the off patent NEXIUM ( Aripiprazole ) or SYMBICORT or TEVA worried about COPAXONE – with next phase of the Molecules ( PIPELINE DRYNESS) ..but these guys have big pockets and they can simply buy the competition …
THE GLOBAL M&As like PFIZER bought HOSPIRA , TEVA intends to buy MYLAN ( 70% market ins specialty injectiables) etc ..would imply a Lot to be done for INGNX
FIRST THING FIRST – Lets Clear some MYTHS TEMASEK …
Strategic MYTH TRUTH
Biologics means heavy investments …India Pharmas cant afford
If a WUXI APPTECH (A $ 700 MM Size small Chinese co have ambition to acquire and participate across the VALUE CHAIN ( drug
discovery to drug delivery ) … we talk about non being able to create value ..is not A TENABLE ARGUMENT …
Biologics have RAPIDLY GROWN and become BLOCKBUSTER drugs..if we analyze the PIPELINE of BIG PHARMA it is 90% MABs+ proteins + ANTIBODY DRUG CONJUGATES ( paclitexil + adalimumab) Also ..See how RITUXIMAB , AVASTIN ( bevacizumab) , HERCEPTIN ( trustuzumab) have quickly become BLOCK BUSTER ..leaving behind the small molecules XTANDI ( enzalutamide) , REVLIMID , GLEEVEC , KYPROLYS ( carflozumab etc ) … thus the BIOLOGICS are really the future …because it is based on the body's internal mechanism + IMMUNE SYSTEM and CELLS …
CAN TEMASEK DIFFER from this ?
Analysis of VARIANCE – INGNX vs. PFIZER BULLET POINT CULTURE ….JUST BULLETED the company
Lack of Meta Systemic Strategic planning ..no
HGHMLC sectors , No BIG THINKING, No strategic
real investments No strategic partnership
$ 56 Bn
PFIZER
$ 1 Bn INGNX
Lack of Eco system synergies , No High
quality R&D , No undisputed leadership in
a single area …
Lack of Excellence in Operational aspects
No MaSE , No OE, no People excellence , No real
desire to excel…
JUST BULLET POINTS CULTURE .. NEVER REALLY UNDERSTOOD THE MIND OF PEOPLE , CUSTOMER What is the MS% of INGNX amongst the key strategic
therapeutics areas ? What is the KOL brand equity ? What about advocacy ? What is the marketing strength ? What is INGNX relative performance in terms of ROCE /
ROA / ROE ?
COMPLETELY OPERATIONAL MINDSET Why INGNX has not participated in HGHMLC
..who has stopped the company ? Why INGNX is not striving for the best
benchmark..in terms of best people . Best processes ..?
Global Pharma Dynamics • Big Pharma- Consolidation
underway M&A , High performance pharma manufacturing (* Molecular biology products , Genes derived ..) ( Pfizer + Sandoz , Mylan + Teva , Actavis + B&L , Elan + Perrigo , Az + Kythera , Bayer CH + Merck CH )
• Key emerging areas – Immuno oncology
, lifestyle diseases , unmet medical needs, rare diseases…Orphan drugs can surprises too
• Key emerging markets – Low value – MENA,SEA
• High focus on R&D – pivotal around
Advanced Genomics , RNA intervention, CRSPR, Cell , Molecular biology
• Consumer / Animal HC & Nutrition , Enzymes , Anti oxidants ,
prebiotics, probiotics – High growth emerging areas – but highly competitive
• Off patent is necessary but not sufficient – has hurt Big
pharma..to extract the benefits the generics cos have to do much more ..that too in price erosion envt.
• Game is quickly shifting towards Biologics , Biosimilars can
be opportunity but requires High quality processes , unlike chemical molecules
• Compliance has become stringent - product registration
• China has massive cost advantages
Means INGNX has to really think strategically . Non linear and out of the comfort zone ….need to consider the following..
Global Value chains in PLB Opportunities are DYNAMICALLY EVOLVING
Novel MAB
discovery
Discovery Biology +
Drug screening
Cell Line Engineering + vector
constrn
Toxicology + ADME + DM PK
BioAnalytical services Mfg
Process research
Assay formulation + Process
dev
Cell banking + viral
clearance validation
Clinical Testings
Phase 1 to Phase 4
C GMP mfg
Lot release stability testing
BIOLOGICS
Synthetic Chemistry
Discovery Biology
Medicinal Chemistry
ADME + DM PK
Formulation BA/BE
Mfg Process research
Stability Toxicity
Clinical Testings Phase 1 to
Phase 4
BioAnalytical services +
Commercial Mfg
SMALL CHEMICAL MOLECULES
Animal Models
Cell source characteriz
ation
Assay develop
ment
Safety + toxicology
Process Development
+ Bioanalytical
services
Kilo lab
Scale up +
process optimiza
tion
Technology transfer + Ascetic
process validation
C GMP mfg
Lot release stability testing
CELLS
The Mergers amongst the BIG PHARMA – verticals + Cloud technology will eliminate the need for spending on CRO /CMO infrastructures + Biologics as a
Service could alleviate problems for the pharma
GENERICS ..can not save the day –cant be
sustainable game
Key Universal Truths , Observations , Prediction
Off patents are necessary
..but not sufficient for the
success in generics
Generics – needs much more than
being a generic..
Specialty pharma
can set in Biologics can grow like
INTERNET / Adv
technology platforms are must
Consumer healthcare & nutrition
+ Enzymes + Emerging Markets + AFRICA ….good but over crowded
IND Pharma would
require MUCH
SMARTER GAME PLAY
..not just GENERICS
PHARMA + BIOTECH + STEM CELLS + M&A + BIG DATA +
SMAC – can change the game on
its head
This means INGNX has to carefully select the strategic options
CRITICAL QUESTIONS for INGNX.. This will establish the
importance of STRATEGIC THINKING
US$ 900 Bn : Total Rx market
Off patent market
US$ 150 Bn
What MONEY INGNX made from the OFF PATENT molecules since 2004 ?
Off patent is necessary but not sufficient –Means INGNX failed to identify the HGHM sectors , therapeutics to
differentiate Branded GENERICS
: US$ 100 Bn
How many brands of INGNX is UNDISPUTED MARKET LEADER ?
Branding & Marketing , Differentiation is must - company has lots ANDAs/DMFs /NDDS Approved generics ..what about
liberating potential Generics
$ 50 Bn
What is the EVA for Generics per site ? Cost advantages / manufacturing excellence / OE/ EOS /
Strategic Manufacturing / DMF advantages/ M&A is must
Formulation
$ 35 Bn
Is GENERIX leader in Innovative Drug Delivery platform, ANDA ?
Now lets analyze situation for INGNX
why INGNX needs to look at the BIGGER picture at al ? Why INGNX can not have 10% growth forever ..why break heads
High Globalization – more opportunity for BIG
PHARMA than Generics
• EM –APAC –BRIC /CIVET are coupled to the growth of Adv economies and trade dependency
• Big Pharmas deep pockets can simply acquire the co..
• Strong adv of PFIZER / SANOFI / BMS / can really stop the plans for Indian comps..even MYLAN / TEVA/ SANDOZ are at risk..of losing grounds ..
GENERICS (0) vs R&D (5)
• The BIG pharmas have already started extending the life of their off patent molecules .through multiple GTM , MaSE Brand price points ..it will be big affairs for GENERICS to match the efforts
• GENERICS will always be subjected to competition..even if WINNING a SMALL BATTLE in generics..does not protect agains the big WAR …the ultimate investments need to be in R&D or CAPACITY building
Indian Investments is nothing if the globalization effects
are ignored
• The trends of SMAC / ecommerce has virtually made it possible to AIRDROP the FACILITIES
• The GTM has changed significantly – the consumers are bestowed with choices – the quality provider even a start up can compete with the BIG GUY ..as long as he provides the quality
• INGNX – has to compete in GENERICS market – the profits are low and GENERICS will not be a guarantee of success
Why INGNX need to be concerned about STRATEGIC CANVASS
Pfizer – Spent $
250 Bn on Wyeth+ Pharmacia + Warner
Lambert
Adv R&D – Genomics + Molecular Bio + Specialty Sectors High Margin | High Barriers | Strategic
Consumer + Animal HC & Nut Mid margins + Low barriers + crowded
Plain JANE ..Generics
HOSPIRA
Bayer – Xarelto + CH
Actavis + Watson
$ 50 Bn spent
B&L + Forest
Merck Consumer
Merck kGA BMS +
Keytruda + Yervoy
SIGMA Aldrich
Sun + Ranbaxy
Mylan + TEVA
Novartis Eli Lilly
Glaxo
Danone
Nestle Zoetis
Mead Johnson
Saputo
CHINESE Cos can be every where
SABIC DUPONT
BASF
Fertilizers +
Micronutrients cos
$ 1000 Bn Global opportunity Pharma
$ 500 Bn
Global opportunity
Biologics
$ 500 Bn Global opportunity Animal Health
FOR INGNX .. The presence across the HGHMLC sectors ..need LIBERATING POTENTIAL .. Simply operating in the INDIAN context
or relying on GENERICS can shut the doors…
INGNX must DIVERSIFY into HGHMLC strategic sectors …MUST ENRICH PORTFOLIO ..create differentiation – connect to consumer -
Big opportunities requires competitive
differentiation. GENERICS too big a
risk
200 Bn$
API + HP API + formulation
Specialty APIs – High performance APIs – controlled substances – cytotoxic Target differentiated SMS – emerging therapeutics in Generics ANDAs / NDDS / Para 4 - widen the reach , Multiple mode of deliveries – FASTER Advanced FORMULATION technology ( Specialty Injectibles , Lyophilization , Liposomal ,)
Biologics + Biosimilar+
mab + genes
High margins / High process complexity / requires significant investments but competitive landscape is emerging
Strategic Alliances with Big pharma / Invest into R&Ds of selected genes – BRAF/ HLA/ cells / genes / vector – Invest into ADV GENOMICS ..cut the deals with ILLUMINA / BIORAD / CRSPR / RNA intervention technology
250 Bn$
CRO/CMO/ Custom
synthesis / Analytical chemistry
Develop expertise in specialty pharma molecules , High purity , high quality – analytic / molecular biology / HPLC/ Micro reactors / filters / high container manufacturing suites / lyophilization / Liposomal / micro/nano sphere technologies
Adv Analytical chemistry & Custom synthesis – sp chemical reactions , process development , route synthesis , label compounding
150 Bn$
Proteins / peptides / Vitamins Hormone
Invest in to PYRIDINE/ basic chemicals / vitamins/ high purity proteins / COSMETIC PEPTIDES / Collagen /FSH/ MSH / Insulin / Adrenalin / testosterone/ estrogen . M&A ( femicare ) , Opthalmic compounds – STRATEGIC ALLIANCES / LICENSING ( with Japanese companies)
Huge Market – High margins ..can be used in connecting with the CONSUMERS . Strategic synergies can be availed to consumer sector
500 Bn$
+
+
+
Consumer / Animal
Nutrition
Preferred brands in Animal / Consumer sectors – cosmetics , personal care, skin care , healthcare , nutrition drinks ., adult & child nutrition
Best benchmark with ABBOTT, MEAD JOHNSON , DANONE … or may have alliances / contract manufacture and later connect to CONSUMER
600 Bn$
+
Key strategic market sector evaluation
10x Total
addressable markets in Bn$
Why INGNX can not afford to remain in the STATUS QUO zone .,..it has to liberate potential.. IT HAS TO BE PROFESSIONAL and ULTRA HIGH PERFORMANCE COMPANY ….which is GLOBALLY COMPETITIVE
LIBERATE POTENTIAL
WHY INGNX has shrunken to a MOLE size on big canvass ? case study on lack of Strategic Planning
2 - Low Executional Rigor in HG HM LC strategic market sectors
High end strategic market sectors are ignored – INGNX has been the follower..never really strive to create SPECIALTY SEGMENT ..long term vision .. Lack of executional rigors in the strategic market sectors to really create the
market presence
1 – Lack of strategic planning – Strategic options analytics
Why INGNX did not benchmark with the GLOBAL giants – like Unilever , P&G , L'Oreal , BASF , DANONE , Nestle – why INGNX never tried to best benchmark..where is the COM VISION ..what is holding INGNX back ..…this is called STRATEGIC PLANNING ..
No JVs/ No alliances / No Big M&As due to excessive profit seeking attitude
3 – PIRAHNAs in the RED OCEAN
INGNX – Even as a completely OPERATIONAL FOCUSED co..could not become the Market leader amongst the selected categories , KOLs, no
CRM / No motivated employees , No big quality quest ..and drives… MAY I KNOW WHY ???
High Importance , Low Differentiation
Low Importance, Low differentiation
High Differentiation High Importance
High Differentiation, Low Importance
Calcium Tablets
Filgrastim
CONSUMER – Healthcare+ Nutrition +
Animal HC & N
Simple APIs
INGNX has good platforms like Marketing and Sales
distribution / brand equity –It can MAKE a GOOD strategic partner for
Advanced Products ..can make it big in CONSUMER
SECTOR too
Biotech R&D
CAR-T| RNA i| Biologics| Adv Genomics Mab| proteins & peptides |
CS+CT| HP API
INGNX never tried to create the space into High importance High diff SMS – it went after Low margin products and –
The opportunity cost of MISSING BUS is $ 10 Bn…which INGNX could have been by NOW
Can I know ? How
many products of INGNX ..have >50% MS and earns >50% gross
margin
INGNX must identify the variance of HIGH PERFORMANCE vs MEDIOCRE PERFORMANCE
HGHMLC strategic markets sectors – not present
Not having portfolio of products across the SMS – presence in low value product categories
Lack of strategic planning Lack of VISION
Marketing / Sales / CRM gaps Product Portfolio gaps Customer Mix ( Missed positioning products Channel mix – Omni channel presence ( P&G deliver +connect) Total Awareness across customer segments – conversion achieved / A&P
budget Marketing campaign ROI Strategic Markets covered Value Pricing opportunities New customer segments - No CRM New Channel penetration – No SMAC / No Big data use
$
20
Bn INGNX Could have been
$ 0.8 Bn
Strategic GAP
Big INDIAN Pharma comparison
2164 2060
1885 1830
1395
940
723
194 185
535 584
864
349 283
111 133
16 33
Rev Mn $
NI Mn $
EBIDTA Mn$
Indian Total Pharma size
50% revenue from US/EU thru GENERICS
INDIAN Cos have to be GLOBALLY competitive …china can easily crush them
INDIAN PHARMA is totally dependent on US/EU markets ..and
regulations will become stringent and there will
be 0% UNETHICS
..ever tolerated by FDA
$ 12 bn
26
4
1
11
26
13
21
19
9
14
28
30
22
11
30
15
19
30
11
14
25
28
46
19 20
DRL Lupin Sun Cipla Cadila HC
Debt/Asset RoA%
RoE% NPM %
EBIDTA %
Lets compare Margins ….Big 5 EXCEPT SUN pharma..which has a
RECORD of meaningful ( so far) M&A , strategic partnership could manage above 40%
EBIDTA …without raising any DEBT ….
NO OTHER …company has EBIDTA above
30%
Indian companies …can never be compared with each other… but rather they need comparison with the GLOBAL PLAYERS
Global Big Pharma vs. Big Generics Margins Comparison 2014
22 22 22
46
23
19
45
16 15
34
14
30
42
26
5 7
12
7 6
2
8 9
5
14 12
-4
6 5
18
12
28
12 13
5
26
20
13
20 22
-12
12
7
41
24
53
29
25
30
43
31 30
40
35
14
29
18
Debt/Asset RoA
NPM EBIDTA
The global generics are
finding tough to compete ..
While it is true that the OFF PATENT molecules have made BIG DENT into ASTRAZENECA margins – Nexium , SYMBICORT ..but Az has the problem of failure
of PIPELINE ..which can be corrected ..
So we have seen Something is WRONG with INGNX
We have seen – HOW INGNX has failed in… Liberating potential - due to lack of strategic planning – never participating in real
HIGH GROWTH HIGH MARGIN LESS CYCLICAL STRATEGIC MARKETS
Operations excellence - Godrej never fully exerted the EXECUTIONAL RIGOUR necessary
to bring potential to life … failures of so many JOINT VENTURES
failed to avail SYNERGIES across meta systems , Eco systems ( Pls ask Mckinsey or Wharton ) …remained only mired in ACCOUNTING …and
PROFITS – now is 15% a good profits earned – it is a LESS THAN MEDIOCRE performance
Delivering the HIGH PERFORMANCE – people have no fear – because even 1%
growth bringers are rewarded instead of criticized … is this a right culture … need redefinition,
reimagination , redeployment of the strategic progress – while the NEAREST PEERS like ZYDUS , CADILA PHARMA , TORRENT , CLARIS .all have done something…
Energizing the right spirit - For example taking only 5 Minutes of interviews
for the SENIOR ROLES – Is not this a big CORPORATE GOVERNANCE issue? - what kind of Snr management is this who spends only 5minutes for high strategic roles..
INGNX can not afford to remain in
status quo INGNX has to WORRY about the
GLOBAL PHARMA DYNAMICS
INGNX also need to relook into the strategic AGENDA ..
INGNX needs to read between the LINEs ..not just bullet point culture … DEVIL LIES IN
DETAIL..not in BULLET POINT SIR ..
So far we have seen
So What should INGNX do Now ?
Take Deep breath ..1
DHARMA YOG
Now Lets see the How INGNX can grow 10X …..
INGNX can grow “10-X” How INGNX can grow 10 times … Strategic Thinking – Smart , Practical , Innovative
10 x
As we have the GLOBAL MASSIVE OPPORTUNITIES and RISKS … INGNX has following choices …
INGNX $ 1 Bn
$ 10 Bn
10X Asset lite
Smart
Liberating $ 1.1 Bn
Profits can be at risk , Big capex
$ 50 Bn
-10%
CHOICE 3 : STATUS QUO
CHOICE 2 : 10% mindset Operations only ultra
paralytic Conservative thinking
CHOICE 1 :
Liberate Potential Global presence
Globally competitive Mega trends
This would require HIGH CALIBRE STRATEGIC PLANNING
So lets answer …
Can INGNX become $ 10 bn by 2020 ? My Answer is YES HOW ?
$ 10 bn
Ultra High Quality Strategic planning -Key strategic therapeutic areas
-Differentiation , Excellence - Big consumerism MEGA trend
SMART PLAY -Strategic options / alliances / meta
system cross sectoral synergies -- Smarter Business Development
High Performance Environment
- Faster , Smarter , Better -Passion , CAN DO approach
BY Liberating the Potential
Requires A VISION DRIVEN PROFESSIONAL HIGH PERFORMANCE APPROACH
DHARMA YOG
Achieving 10 X through RIGHT DHARMA
RIGHT VISION
Presence in High Growth High
Margin sectors
RIGHT STRATEGY
Smart , Advanced , practical resources
, systems , Ultra high performance
RIGHT CULTURE
Motivated Passionate Co
owner of vision Fearless
Portfolio Enrichment
So lets start with the RIGHT VISION …. INGNX should be recognized as FIRST CHOICE ..amongst all HIGH VALUE SEGMENTS ..
Consumer First Marketing & Sales
Excellence Transformation
GTM Operational Excellence
Smart & Specialist Sp chemicals, Pref partner,
CRAMs Strengthen position across
Specialty Consumer Sectors like HC| Nutrition/ Sp pharma
Significant Globally competitive PLAYER
Recognized for Ultra advanced high value adding products
Connect to Consumers
Ultra advanced
Example – THINK FRESH , think Godfrey Philips FRESH –
Freedom, Rejuvenation,
Energy , Smartness < Health
Portfolio Enrichment
Smart & Specialist
ECO SYSTEMS – Highest capital efficiency
Achieve the Highest ROI / RoA/ROCE / RoNW/ EVA across all HGHMLC sectors – through Strategic Portfolio management ( requires competitive differentiation, asset allocation , M&A ,
strategic vision- game shaping attitude )
RIGHT Framework for Liberating potential
Diagnostics 10 X treatment Implementation
META SYSTEMS- strategic Sustainable futuristic advantages
SYSTEMS- Highest Process People Product efficiency
Identification of HG HM LC sectors across all relevant industries ..stress test the growth assumptions ( in terms of impact
assessment of TRENDS + Risks – to evolve with robust strategic sectors for LIBERATING POTENTIAL
Excellence across Marketing & Sales , Supply chain, Production, Operations , Process , People …to liberate the
potential
10%
SYSTEMS – CENTER OF EXCELLENCE
Marketing & Sales Excellence Value pricing
Brand Repositioning KOL /CRM/ B2B/B2C /
Operations Excellence -Forecast accuracy
-BPI/Cloud migration -OneINGNX
-Supply chain distribution
People Excellence Leadership
Process Information Performance
Eco systems – Strategic MAP
30% Competitive Differentiation Strategic Alliances with Eco
system partners
Robust Strategic Planning for
Assets , ROIs for SBUs , Market intelligence ,
Capacity Planning
EVA for Each SBUs – High ROCE | Smart
Analytics Eco system
partnerships Collaborative
Planning
10 x – FRAME WORK – INGNX
Meta systems – Strategic MAP
Entry into new HGHMLC strategic sectors Strategic alliances Licensing / M&A Availing MEGA TRENDS – Synergies Risks Mitigation
API + HP API + CS + CT
Biologics + Biosimilars
HG HM LC strategic clusters
Protein / peptides / Hormones
Consumer / Animal HC &
Nutrition
CMO / CRO / Cus synthesis
R&D/ CoEs
60%
Scope of Value
addition
RIGHT performance themes
Liberate potential
MaSE – GTM, product enrichment, Key accounts , Cross sectoral synergies
Strategic Markets entry , CASPI, WIMO, PLASMET ,
High Growth , High margin, Less cyclical Auto/HA/OA OEMs,
Chemicals to Consumers
Futuristic step out
Strategic Adjacent Diversification (
Sustainable competitive advantages)
Ultra Advanced Technologies –High
performance advanced materials , Li, RE , Algae
,Fertilizers, PET/N, Sp chemicals, Oil n Gas N
Energy
Smart Play
Strategic Joint ventures, Alliances,
Asset light ( Smart & safe)
Cross Sectoral, Cross Functional , Cross SBUs synergies , cost savings, Optimal REACH OUT , CONVERGENCE GTM
RIGHT STRATEGIC THEMES Key Strategic theme
Rationale What should be done
Entry into HGHMLC strategic markets Connect
to the consumer Leverage
Market expertise
Capacity building in API /HP( High
Performance) API ( OEL Level5) /CS/CT ) - $ 500 Bn
Lucrative markets – can be leveraged in phase with the current SBUs
M&A or Seek partnership or Strategic alliances with SABIC ,
BASF, DuPont , Dow on API
Marketing expertise leverage to set up GTM / establish the direct to
consumer partnership ..
SABIC for ex can provide PYRIDINE ..create the Anti infective.
Consumer chemicals ..market it ..explore SMS in Consumer Healthcare , Nutrition,..
Explore Strategic alliances with ABBOTT + NESTLE + MEAD JOHNSON..or
new entrants
RIGHT STRATEGIC THEMES Key Strategic theme Rationale What should be done
Entry into HGHMLC strategic markets Connect to the
consumer Leverage
Market expertise
Animal & Consumer Care , Healthcare & Nutrition – Highly lucrative markets ( 30-45% margins)
Strategic partnership with Spe chemicals firms like SABIC , BASF, MOMENTIVE,
LONZA , LAND O LAKES, DUPONT , DANONE , SAPUTO ..etc to create the specialty nutrition business across CONSUMER / ANIMAL ( Cattle & Companion) sector value propositions
ENTRY into BIO ENZYMES / Specialty
Food ingredients – BIG $ 150 Bn Opportunity by 2025 ( Biofuel/ Bioplastics/ Food & beverages
Avail synergies from PEPTIDES / VITAMINS SBUs.
Advanced Processes / Tech/ products
Capacity building in Biologics , Adv genetics , proteins , peptides ,
US/EU / Japan – Otsuka , Lonza , Lanzatech , Genencor , illumina , Biorad. – Strategic
alliances with LOREAL , UNILEVER , NESTLE ..to capture entry into personal care, cosmetics, hormones market ..
RIGHT Strategic Resource Allocation
INGNX
40% Biotech The Savior
20% CMO / CRO
20% GENERICS API – HP-API – Sp Injectables – NDDS
BIOSIMIALRS + Biologics + Adv Genomics + Stem cells + Adv proteins & peptides +
HP+HCMS
Capacity building – Samsung/ Lanza strategic alliances – To be recognized as HIGH QUALITY HIGH
PURITY Biologics+ P&P+ Biosimilar + Controlled substances or cytokines etc
Specialty generics areas – micro segments – KOL + ethical marketing + SMAC + customer satisfaction
20% CONSUMER
The DARK HORSE
INGNX must aim to become the UNILEVER of Consumer healthcare., nutrition, start B2B , E
commerce , Think Consumer Healthcare, Think INGNX ..use of SMAC – Compete with
ABBOTT , JOHNSHON
RIGHT CULTURAL THEMES REIMAGINE , REDEFINE, REVITALISE
Customer Delight & inspiration
Smart & Innovative Makes Life easy & comfortable
Brings best of ..everything Fresh and Salubrious Energy & health
CONNECT TO CONSUMER in every
possible manner
Creating the Platform for the next growth stage –
Globally recognized brand
Specialty chemicals
/ Agri business
INGNX has very high scope for 10x
10 X requires RIGHT VISION, RIGHT STRATEGIC PLANNING, RIGHT CULTURE
Having these RIGHT ELEMENTS ..still it needs to be implemented
So Lets look into the KARMA YOG to achieve the results..
So far we have seen
Take Deep breath ..2
NOW LETS LOOK INTO KARMA YOG
KARMA YOG
How to Achieve 10X through Right KARMA
RIGHT GTM
Right Business models (
innovative + consumer centric)
RIGHT PROCESSES
Excellence in Marketing & Sales
Operations + Supply chain
People
RIGHT IMPLEMENTATION
Advanced Projects management +
EXECUTIONAL RIGOUR ..
Now Lets see the IMPLEMENTATION PRACTICAL consideration to realize the
dream ..10x
How to grow 10x – KARMA YOG Complete Strategic road map
How
10%
SYSTEMS – CENTER OF EXCELLENCE
Marketing & Sales Excellence Value pricing
Brand Repositioning KOL /CRM/ B2B/B2C /
Operations Excellence -Forecast accuracy
-BPI/Cloud migration -OneINGNX
-Supply chain distribution
People Excellence Leadership
Process Information Performance
CONSUMERISM –convergence GTM + connect to consumer, How to leverage the cross functional , cross eco system synergies How to derisk the portfolio and achieve the Highest ROCE
INGNX GROUP 10 Bn$ 2020
Focus on core – Mfg excellence , strategic partnership , alliances + licensing API / HP API + CS+ CT
Capacity building CMO + CRO + Custom
synthesis + High Purity Mnfg + HCMS
Connecting with consumers directly
Patients Comfort +
Ecosystem Care
Consumer Healthcare Nutrition
Focus on BIOLOGICS / BIOSIMILARS Key Mab / oncology / Lifestyle genes Diabetes - Adv genetics | GCSF) / IF/
TNFa/ EGVF/PD1/CAR –T / RNA I / CRISPR – strategic Licensing/
alliances / partnership
partner ship BIOLOGICS –
Advanced GENETICS labs + Molecular Biology +
Analytic Labs + Bio fuels
Bio chemicals Bio enzymes
Specialty Therapeutics Area Strategic importance
Animal Health & Nutrients
Proteins + Peptides + Hormones + Vit +
Sp Chemicals
Specialty chemicals
RIGHT GTM
Innovative & Smart Business Models in Pharma
1 E-commerce Sell all under one roof
2 X V C Across the Value chain
3 D2D aaS
Drug Discovery to Delivery as a SERVICE
4 ADV GENOMICS
high end genomic research
Specialist input provider
Across the value chain – Program
manager
Consumer centric marketer
RIGHT GTM
The strategic options would requires strong
commitment and capability building
attitude – Pharma is now NO MORE
GENERICS …
PHARM-Emerging Markets
Case study – How BIG DATA helps Healthcare industry – Opportunity to exploit
• The system, which was developed using design thinking and agile application development, is being implemented on the SAP HANA cloud platform. Incoming patient data is analyzed in real time and predictive tools help project where the disease is likely to spread. SAP Lumira infographics are used to inform the public, and last but not least, the Ariba network is used to quickly mobilize medical suppliers in the region.
Fighting disease with data SAP has joined forces with a number of institutions including the Hasso Plattner Institute and the Helmholtz Center for Infection Research to develop SORMAS, the Surveillance and Outbreak Response Management and Analysis System to help fight the spread of diseases like Ebola. How does it work?
Risk ROI Assessment for INGNX of each model
Specialist Input Program manager Consumer centric
-High specialty business INGNX can leverage the expertise in one of the core areas – Manufacturing , CMO , Custom synthesis – - Strategic Therapeutics like ONCOLOGY , HIV , Biologics , Life style diseases can be thought of
-Strategic Alliances or own integrated services based - May risks so many business integration - very high returns - Emergence of the CLOUD platform would force the organization to comply with the new mode of business …like data migration. Data safety protocols. Accessibility to data to various regulatory offices … - Drug Discovery to Delivery as a service ..model like WUXI Apptech
-Consumer sectors such as Nutrition , healthcare , animal products are going to be ultra competitive . -Marketing warfare game - Overcrowded -Requires strong marketing brand A&P … but competition may not allow to get the desired premium
Innovative & Smart Business Models in Pharma RIGHT GTM
Competition benchmarking … Explore few established models
The competition benchmarking… would require
very high bandwidth …to
manage the ultra large scale
projects…competitive
differentiation, high projects
management , financial updates
- would really mean HIGH CAPACITY
PERFORMANCE PLANNING
CHINA – PHARMA EMERGING OPPORTUNITY FOR INGNX …please see the APPENDIX
Key opportunities Key proposal
JVs/ Strategic Alliances SINOPHARM / NEPSTAR /MINDRAY / WUXI APPTECH
Partnership with the BIG Chinese Distribution com can provide access to the $ 180 Bn market by 2020 ( CAGR 13%) + JVs with these cos may able to create the low cost strategic advantages… WuXi AppTec Partners with Fudan University and the Collaborative Innovation Center of Genetics and Development WuXi NextCODE Wins Genomics England Clinical Interpretation Tender in Both Rare Disease and Cancer
Bring Eco system together – to create
solid advantages
INGNX can play a role of managing the CRO or advanced R&D by participating with TSINGHUA Uni + ILLUMINA + WUXI APPTECH + SABIC + SINOPHARM etc Fosun Pharma, HOPU Investments, CEL Healthcare Fund, and WuXi PharmaTech to Jointly Acquire U.S. Innovative Biotechnology Company Ambrx
M&A in china INGNX can look forward to acquire small mid size coms in specialty chemicals, CRO , Consumer healthcare – Chinese cos have severe cost advantages + credibility in international markets
Launch of e-commerce / B2B /
B2C projects
Alibaba model – INGNX can be a great influencer – like WUXI APPTECH .
RIGHT PROCESSES Key process Relevance
Strategic planning process
Entry into HG HMLC strategic markets
Market Planning Process Effective GTM + Market share capture
Risk Assessment Process Avoid the BLACK SWANs , Avoidables
QPR process Ensure the strategic direction
Performance Planning & Monitoring process
No last minute surprise or unpleasant mishap or intentional failures or sabotages
Collaborative networking process
To ensure smooth redressal , no hold backs in performance ..ease of doing business and work - every body must co-own the vision of org.and feel the need for helping every person in need.
Customer centric processes Every process must kept in mind the final outcome to customer value creation .
Sharp Analytics Processes Smooth & easy flow of critical intelligence , whoever need it . Whenever need it …and strong ACTION ORIENTED INSIGHTS
Marketing & Sales Excellence – Energetic, Smart, Valued reach out , Most preferred to do
business with , Ethics
Users Customization Digital MaSE Influencers High standards of
Performance Ethics Hassle free Customer club Customer loyalty
schemes Customer Net
promotion KAM/ OEM/ CRM Most preferred
business partner
Marketing Strategies
Non users - Aware Part of the Elite list Regular reach out Trade fair, sponsorships Elite membership Demonstration of superior product
performance Active FEEDBACK system
Non users - Non Aware A&P , Good media presence , Smart image Helping hand, one ZYDEX image Instant customer responsiveness
Faster, Smarter , Better ways
Superior products
Smart REACH
OUT
Preferred Partner
CoE
Operational Excellence
KPI 1 What is the depth of Therapeutic areas ?
KPI 2 How many ANDAs | DMFs filed for each therapeutic areas ?
KPI 3 - Does INGNX have the widest range of PORTFOLIO like sun or Zydus ?
KPI 4 If INGNX has focused on specialty what is the market share
KPI 5 How many products of INGNX has > 50% Market share and > 50% profits ?
Ultra high performance across the key KPIs – increase the executional rigor, robust operations planning , minimize slack ,
systematic & smart processes
CoE
Processes excellence KPIs CoE
Participation across the HG HM LC sectors – has INGNX participated in all these sectors ….if not why .and how it can expand
KPI 1
REACH OUT penetration - FILGRASTIM – does INGNX has 50% above penetration in all key target audience and routes for FILGRASTIM
KPI 2
INFLUENCERS role – KOL recommendation / NPS – Net promoter of advocacy score – what is the Brand recall or equity for key products
KPI 3
Inventory + Distribution + Production planning + Forecasting – does INGNX have significant advantages in these processes
KPI 4
High Quality Market Intelligence – Does INGNX has all the mission critical information available within 3 clicks away from the beneficiary?
KPI 5
• Performance is not well articulated and has not been defined properly , lacks the various end points considerations ( eg – Boss says tense, employee says tenacious)
• Performance lacks PLANNING in terms of various scenarios – Plan B , Plan C , effective outcomes ( U cant touch by climbing Mt everest)
• Performance does not incentivized the “tacit extra mile efforts “ but just enslaved by the results delivery ( employees feel uncared for)
• Performance is not properly segregated, the credits and blames must be fixed rather than applied homogeneously across the units ( somebody's non performance affect the entire chain)
• Lack of quality interaction and engagement of the senior leaders in achieving the success ( Non verbal behaviours- do u go to boss who does not even say good morning)
• Lack of REAL Strategic elements – like Quality products, effective value propositions , effective energy , enthusiasm
You cant MEASURE success, unless you able to DEFINE it … and You cant DEFINE it , unless you able to DESCRIBE it …
ROBERT KAPLAN – Strategy guru This necessitates the description of the performance in real sense ..
PEOPLE Excellence CoE
Case : Product journey from Factory to Market- Where is the PERFORMANCE BOTTLENECK and which are the mission critical elements
Strategy Marketing Sales Customer
Supply chain Production Process
Legal / Registration
HR Quality /
R&D
Performance Bottleneck occurs ,…if
everything else functions as per the
plan ..except this one
If the High Growth, High Margin sectors
not identified 3 years in advance
If the product has not created awareness
and product features are not digested by
customers
If the product are not made available to the
customers through channel and distribution
If the product are not produced OTIF – on
time, in full as per the Quality
If the cost effective RM/PM not procured
at right time
If the Processes ( Accounting, controls , risk mngt ) are not in
place
If the product registration is not obtained in time
If the PEOPLE are not fully committed to the
JOB
WHY PEOPLE excellence is Relevant to INGNX
Business drivers Potential Problems Potential Solutions My work
Growth Opportunities
What is the right vision 10X vs 10% ( Can there be full potential realization possible) – best strategic planning
10X possible – liberate potential tools, performance definition
ETHOS, SMILE, SHINE , GEM,
Performance Delivery
Are the best efforts applied in all the process, people ? – customer calls ( half hearted / has proper feedback taken/ has proper interview taken?)
Best benchmarks Talent METABOLISM High Performance environment culture
COE , Competency attached to values
Sustainability Is the performance delivery sustainable or just short term ,..is it creating long term value for the org
Strategic horizon wise competency profiling
Smart KPIs introduced .
Required TRANSFORMATION
Global Strategic canvass – WHY Transformation is MUST for INGNX
RED OCEAN PHASE OUT
BLUE OCEAN opportunities
Long range New Strategic markets – Biopharma,
API/generics , Biologics Biosimilars , animal, poultry , Household disinfectant tissue papers, hygiene, oral , vitamin, consumer healthcare line for urban customers
New Business models – online presence, digital B2C , new territories, new markets
Strategic alliances and M&A – to fill the product gaps or geographic expansion
Capacity expansion across different countries
New ways of working
TRANSFORMATION PHASE
Improved Strategic planning – vision based transformation
Improved processes and systems
Improved culture – High performance and Business focused strategic HR partnership
Center of Excellence – Pathway
Performance Excellence
Leadership Excellence
Process Excellence
Information Excellence
Business Excellence
CENTER OF EXCELLENCE
Actionable , valuable intelligence , insights
,Analytics competitive information
4
Strategic Business partnership Proactive,
Compelling values
5 Talent entry into org,
best benchmarks High Performance
genomics
1
Liberating Potential Effective
engagement Strategic vision achievement
2
0% HOLD BACKS Smooth Processes Highest quality of
results delivery
3
The Evolving Role of Strategic HR in creating High performance Environment
BEST STRATEGY AND
PLANNING
INTELLIGENCE TO ADVANTAGE
EXTERNAL RELATIONSHIP
LIBERATE POTENTIAL
HIGH PERFORMANCE SALES & PROFITS
Performance
Excellence
Leadership
Excellence
Process Excellence
Information Excellence
Business Excellenc
e
For High Sales and profits, Global
Competitiveness is MUST
Which requires value creation in terms of ….
Competency Framework
Which requires practical and relvant tools and processes
Competency
Competency Framework
Center of Excellence
EXECUTIONAL RIGOUR A Very IMPORTANT Aspect… THE LAST MILESTONE ..if u fail
here..u fail everything
HOW to PACK – The 10x into org…
Business transformation cell
Corporate Strategy Business Development
Business Leadership
Corporate Advisory & Consulting
Corporate Affairs
M&A Vision 2030 Global
expansion New entries GTM
Capital structure Market/ PE /
Existing Products /services
ECO SYSTEM Alliances Customer
acquisitions Capturing all
trends / drivers
Best benchmark Operational
Excellence
Marketing & Sales Excellence Robust Business
Planning
Mckinsey ++ advisory Highest level of
intelligence Corporate talent
management BASE CAMPING
&
CORPORATE ARBORITUM
Corporate Social responsibilities Corporate
communication Govt Relations Investor
Relations Image
management
Business As Usual
Operational Excellence
Robust Business Planning
Risks Assessed High ROI
Market intelligence
Business Transformation
Attitudinal change
Create Edge Drive results to
highest standards
Overall Strategic Campaigning Avail MACRO
drivers BIG THINKING
M&A Convergence
GTM Strategic Alliances
X>2
Operations Transformations Strategic
Consultants
AJAY GOHIL
Set ambitious Targets
Best benchmark
Create Edge Can Do attitude
Passion , Energy , Enthusiasm
Drive Performance to
the highest quality , ETHICs
Liberate Potential coaching,
Developing others
Balanced Approach STRATEGY = OPERATIONS
SYSTEMS Operations
Markets Supply chain
META SYSTEMS
Consumer Healthcare
$ 500 Bn Sp chemicals, AI
AGRI business $ 250 Bn
Sp chemicals, AI
Vitamins, Nutrition, Animal Feed, healthcare
$ 250 Bn
API / HPAI $ 150 Bn
Biologics/ Biosimilars/
rDNA $ 150 Bn
Cell culture MCC
$ 35 Bn
Formulation Specialty
Injectables
Formulation Oral , Control
release
CPFaR /OE / TQM/6
sigma/ QC
ECO SYSTEMS INGNX requires translating the bigger
mega trends of meta systems ( ie entry into HGHM markets) ….
INGNX can have strategic joint venture with SABIC , BASF , DOW to offer highest value propositions
INGNX can avail the best processes , technologies .. Quicken the entries into HGHM markets
ALL THESE REQUIRES HIGH BAND WIDTH PLAYER
HGHM requires HIGH BANDWIDTH PLAYER
with SNAPDRAGON processors … NOT JUST DO
AS DIRECTED.. “ MANUFACTURING ONLY
GUY “
SUMMARY – The REAL BULLET POINTS INGNX needs people Who
Have Ultra High bandwidth ..not just OPERATIONAL King
Can see the COMET coming light years away
Have ability to identify the HIGH PERFORMANCE GENE
SECTION 2
APPENDIX… Now this is not just for FUN …
Please GO through it to know why whatever is written earlier is
relevant
INGNX can look forward to incorporate..in strategic planning
Pharma-emerging Opportunities
China pharma
Biologics global business dynamics
M&A global dynamics
Key Emerging areas across each Pharma / Bio tech Line of business and therapeutics
Why GENERIX needs FASTER ,SMARTER, BETTER assets
READING BETWEEN THE LINE…. Something is WRONG
Biologics Growing demand for biologics The imperative to find cost-effective alternatives to biologics reflects the growing demand for these specialty drugs. Since their origins in the 1980s, biologics have prospered into a US$150 billion market (2014), fuelled by such key launches as recombinant insulins, human growth hormone (HGH), alteplase, erythropoietin's (EPOs),granulocyte colony stimulating factors (G-CSFs) and then monoclonal antibodies (MAbs), among others. Currently accounting for 16% of global pharmaceutical expenditure and significantly outpacing total branded sales, biologics will continue to out-perform the global market as more
Biosimilars – the paradigm shift in generics
Innovative products deliver new treatment options for a growing range of indications. Patent expiries driving new potential number of top-selling biologic brands, including Herceptin, Enbrel, Humalog, MabThera, Remicade and Aranesp, are due to lose product patent protection over the next five years, opening up a wealth of new possibilities for biosimilars players.
Key therapy areas such as cancer, diabetes and rheumatoid arthritis (RA) will spearhead this new wave of biosimilars, with attention focused on the real prizes of anti-TNF MAbs, MAbs for oncology, and insulins Diverse competitive landscape A diversified competitive arena for biosimilars is already emerging, with generics manufacturers, R&D-based pharma, and biotech companies
Biosimilars How fast they can be part of the mainstream uptake ..
Biosimilar snapshot
Now Lets us look at the BIG therapeutic category …where GENERIX stands ?
Oncology 2014 : 75 Bn$
2018 : 108 Bn$
Brand Molecule Company Class 2018 sales Mylan MS%
Avastin Bevacizumab Roche Anti VEGF Mab 7.5 Bn$
Revlimid Lenalidomide Celgene Immuno modulator 6.7 Bn$
Rituxan Rituximab Roche+BI Amti CD 20 Mab 6.3 Bn$
Herceptin Trastuzumab Roceh Anti HER2 Erb2 mab 5.3 Bn$
Brand Molecule Company Class 2018 sales Mylan MS%
Januvia Sitagliptin Merck DPP I 9.7 Bn$
Lantus Insulin Sanofi Insulin 5.9 Bn$
Novo Rapid Insulin Aspart NOVO Nordisk Insulin 4.9 Bn$
Victoza Liraglutide Novo nordisk GLP 1 3.6 Bn$
Anti Diabetic 2014 : 45 Bn$ 2018 : 65 Bn$
Anti Rheumatic
2014 : 40 Bn$ 2018 :50Bn$
Brand Molecule Company Class 2018 sales Mylan MS%
Humira Adalimumab Abbott / EL Anti TNF a mab 8.1 Bn$
Enbrel Etanercept Amgeni TNF a inhibitor 7.1 Bn$
Remicade Infliximab J&J Anti TNF a mab 4.9 Bn$ Is GENERIX in position to capture 30-40% market share in the off patent categories from 2014 – 2020 : Total size $ 200 Bn
What role Strategic Planner can play?
Off patent is necessary condition – but not sufficient for GENERIX , again the question is what is the MS% of GENERIX
Trilipix (fenofibric acid) Cholesterol/Triglycerides AbbVie Global Sales 2012: $1.098 billion U.S. Sales 2012: $1.098 billion Expiration Date: January 2014, but generics launched July 2013
Evista (raloxifene HCI) Osteoporosis, breast cancer prevention Eli Lilly Global Sales 2012: $1.01 billion U.S. Sales 2012: $699 million Expiration Date: March 2014
Renagel/Renvela (sevelamer hydrochloride and sevelamer carbonate) Chronic Kidney Disease Sanofi Global Sales 2012: $861 million U.S. Sales 2012: $595 million Expiration Date: September 2014, March 2014 generic launch under license
Restasis (cyclosporine ophthalmic emulsion) Chronic dry eye Allergan Global Sales 2012: $792 million U.S. Sales 2012: Not reported, but ex-U.S. sales are "modest," company says Expiration Date: May 2014
Nasonex (mometasone furoate monohydrate) Respiratory Allergies Merck Global Sales 2012: $1.268 billion U.S. Sales 2012: $597 million Expiration Date: January 2014 (pediatric exclusivity)
Exforge/Exforge HCT (amlodipine/valsartan) Hypertension Novartis Global Sales 2012: $1.352 billion U.S. Sales 2012: $358 million Expiration Date: October 2014
Sandostatin LAR (octreotide acetate) Cancer Novartis Global Sales 2012: $1.512 billion U.S. Sales 2012: $649 million Expiration Date: June 2014
Micardis/Micardis HCT (telmisartan) Hypertension Boehringer Ingelheim Global Sales 2012: $2.217 billion U.S. Sales 2012: (not reported) Expiration Date: January 2014
Nexium (esomeprazole magnesium) Heartburn, Gastroesophageal Reflux Disease (GERD) AstraZeneca Global Sales 2012: $3.994 billion U.S. Sales 2012: $2,272 billion Expiration Date: May 2014
Copaxone (glatiramer acetate) Multiple Sclerosis Teva Pharmaceutical Industries Global Sales 2012: $3.996 billion U.S. Sales 2012: $2.9 billion Expiration Date: May 2014
What is the MS% of GENERIXC across the off patent
molecules in last 5 years - IS NOT IT a STRATEGIC
PLANNING ROLE.. Now this is where the META SYSTEMIC SYNERGIES of information
comes into play
Financial leverages are stressful… requires very high level of strategic planning… it is not the work of JUST DO AS DIRECTED manufacturing guy
21.2
15.19
24.74
39.98
43.98
62.14
23.3
29.79
22.12
11.53
6.37
-8.66
9.07
-14.97
5.06
-0.62
45.8
36.87
27.58
29.12
26.89
51.28
24.11
10.59
Pfizer Inc.
Sanofi SA (ADR)
Teva Pharmaceutic...
Actavis PLC
Mylan Inc
Valeant Pharmaceu...
Perrigo Company PLC
Hospira, Inc.
EBITD margin
Net profit margin
Total debt to assets
The financial stress would mean the APIs and manufacturing would require to bear the brunt of cost cutting ..this would mean MYLAN like cos. With too much risk of generics …need high QUALITY strategic planning
SNAPSHOT OF
PHARM-EMERGING MARKETS
CHINA centric strategy …a
great opportunity for INGNX ..
INGNX must grab with both hands..
INGNX also can look up to CHINA – China Pharma Snapshot
INGNX also can look up to CHINA – China Pharma Snapshot
2nd China’s Rank in Global Rx pharma market
120 China Rx Pharma Market size in Bn $ - 20% biologics + 80%
generics
400 $ Bn to be spent by CHINESE
Private and Govt on healthcare between 2015 – 2020
5 Chinese Total M&As – Inbound + Outbound
CHINA – A constantly emerging landscape ..capable to change the game
The M&A has remained one of the strong activities amongst the 7 “strategic emerging industries “- SEI ( Pharma is one of the 7s) for china
Big Pharmas like SHANGHAI pharma , Sinopharma , Harbin – the front runner in M&A deals – have significant investments in pharma R&D
Major Inbound M&A deals – such as
SCICLONE – NOVAMED , GSK – Nanjing Mei Rei Hologic – TCT Medical products Biosensor – 50% of JW Med from shandong Weigao Novartis - 85% of Zhejiang Tianjin Biopharma Wuxi – Apptech have been the key M&A deals implying strong trend in consolidation, new capacity acquisition, R&D driven deals …
China is very much into the game …
• All key emerging areas – RARE DISEASE , Orphan drugs developments, HIV /HCV/HPV , Immuno-ONCOGENES , CAR –T , TCR , Check point entry antigen binding, VIRUS LIKE PARTICLE , Gene identification for the disease , RNA intervention CRISPR etc…china is catching up much faster ..
• WUXI APPTECH , SINOPHARM , CRSG are the groups to watch out for …
• The global dynamics are changing fast..the trends are strongly in favour of BIOTECHNOLOGY and ADVANCED GENETICS …and the cell science..
Different Emerging Pharma models for value creation
cell therapy manufacturing 45,000 square-foot facility under construction in Philadelphia Collaborations on breakthrough technologies and
products such as CAR-T and cancer immunotherapy's
How Wuxi Apptech is taking the pharma world head on
.offers the compelling COLLOBORATION need.
Chemistry & Discovery includes Synthetic Chemistry, Medicinal Chemistry, Radio Chemistry, Peptide Synthesis, and others.
Laboratory Testing includes Core Analytical Services, Biology, DMPK/ADME, Bioanalytical Services, Core Analytical Development, Toxicology, and Genomics.
Biologics includes Biologics Discovery, Development, and Manufacturing.
Small-Molecule Manufacturing includes Small-Molecule Manufacturing and Formulation. • Other includes Clinical Site Management Services and Biologic Reagents.
Innovative Business Model – Participating Across the value chain , across the globe
2015 HIGHLIGHT NextCODE Health Acquisition WuXi acquired NextCODE Health for $65 million • A leading genomics and bioinformatics company • Operations in Cambridge, Massachusetts, and Reykjavik, Iceland Gene sequencing and genetic-based diagnostics are advancing rapidly The next major challenge: speed and effectiveness of medical analysis and interpretation NextCODE provides the leading gene sequence analysis platform and the most efficient database architecture Platform provides the ability to store, visualize, and analyze genetic data at base-by-base resolution, in real time, from any browser NextCODE Exchange facilitates collaboration among clinicians and researchers INGNX can significantly acquire
competitive advantages being part of the large pharma mission
If Wuxi a simple Chinese $ 800 Mn company can does ..so much so much..why cant INGNX …. This is called Strategic vision
Expansion of the Suzhou toxicology facility is underway, adding 49 animal rooms to the current 71 by the end of 2Q15 Ten Illumina HiSeq X sequencing machines are operational Collaborating with Foundation Medicine to bring best-in-class genomic testing to China to support clinical R&D and development of targeted therapies Launched Boshi360, the first online professional platform in China dedicated to rare diseases Acquired XenoBiotic Laboratories at end of third quarter
$ 38 MM …the Acquisition
made …and its well on its way to make 10x..
Assessment and Identification of
HGHMLC strategic sectors
The shifts in Pharma markets Generics / Off patent Rx drugs
Consumer Healthcare / Nutrition
Biosimilars / Biologics / Estb Mabs / CGV products
Generics Off patent Chemical molecules DMFs Easy to copy Less Process sensitive
The competitive landscape is getting over crowded Entry by GENERICS ( sun / zydus cadila/ Sandoz / teva/ mylan ) + entry by biotech ( skincare /peptides) – this guys need to be more vigilant…the entry of SOPHISTICATED PHARMA may make life miserable for Simple Consumer Marketers ..Product registration ( J&J /Unilever) – Oral care
High performance / HQHP processes, requires great preparation , BLA not yet defined High entry
barriers…Rich dividends $ 200 Bn market by 2020
Biosimilars Biologics Advanced Rare diseases Advanced Genetics , Proteins & peptides , Custom synthesis , Vitamins , Consumer healthcare, cosmetics , personal care Consumer Pharma / Biotech – skin care , SPF , collagen fibroblast builder , muscle builder , health drinks , energy drinks , nutrition The consumer
Healthcare / Nutrition advantage is with NESTLE , DANONE , MEAD JOHNSON ,ABBOTT ..can quick
Key Latest developments
M&A IPO PE Innovative Cos
GSK – Glycovaxyn Voyager – Genzyme Valeant – Dendreon Acadia – CRC Shire – Salix
SteadMED Bivarus Cidara INVITAE NEXVET
Aptalis - TPG VAXXAS PRACTO Digisight Imagine health WaVe LS Lysosomal Thera AuraSense – spherical NA – gene regulation Orig3n – Pluripotent Stem cell storage
Example only – there are so many PHARMA / BIO TECH opportunities which can be kept in mind …to incorporate into
strategic planning
Key Pharma M&As take away
RAISING THE BAR ON PERFORMANCE… Activist investors use shareholder arbitrage to force companies to “get lean.” Partnering and licensing opportunities are increasingly selective, with less margin
for error. One-time market authorization yields to periodic reevaluation through the product
life cycle. Relentless compliance scrutiny, expanding globally beyond illegal US off-label
marketing toward multibillion $ penalties for foreign corrupt practices. Pressure on industry to respond to a more diverse customer base, with multiple
engagement points beyond the physician. Operational challenges in high-potential emerging country markets: how to turn
strong revenues into sustainable profits? A bump up in patent expirations for big selling drugs in 2015, although the worst of
the “patent cliff” is over. China growth engine slows – GDP 14.2% in 2007 vs. 7.5% this year – while public
debt burden rises amidst more bias toward foreign multinationals. Greater pricing pressures in Europe amid generalized budget austerity. Pricing’s bottom line: future global profits depend on maintaining price freedom in
the US.
Key Pharma M&As take away
RAISING THE BAR ON PERFORMANCE… Growing complexity in clinical trial requirements, including big
Phase IV population studies extending beyond the patent term.
New competitive threats from generics, CROs and adjacent industries – Google, Nestle – outside health care.
Crowding in key therapeutic categories - “counter launch” campaigns hype the marketing bill.
Social media’s disruptive effect on the patient/physician relationship and the accuracy of clinical trials – an alternative, open source information stream.
Formal patient group engagement in drug development, regulatory approval, market access.
What BIG PHARMAs up to ?
• INVESTMENT DYNAMICS NO LONGER FAVOR ORGANIC GROWTH
• Big Pharma is cash rich and asset poor.
• Productivity crisis in in-house R&D: is the model broken?
• High drug candidate failure rate, especially in costly Phase III studies.
• 60 billion+ R&D spend in 2013 for 29 FDA approved drugs, mostly for small-population biologics. •
• M&A activity is reaching all-time high, with 2014 deal volume to date at more than $250 billion.
• Big Pharma’s in-house corporate venture funds are back and in a buying mood.
• Smaller biotechs with unique, clinically differentiated assets are driving innovation.
• Big Pharma puts its stable of older off-patent medicines on the block for potential buyers outside the industry.
• Collectively, the changes promise a more diverse industry, particularly with the entry of buyers from adjacent sectors – adding many potential new customers for the B2B advertising vertical.
Pharmemerging markets India aims to introduce universal health coverage during the 12th five year plan (2012-2017), but the public health system faces massive problems with inadequate infrastructure, poor funding and inefficiency − Public health experts have recommended that the government move from 'insuring' to 'assuring' health by investing in primary care
Brazil −Plans for expansion and improvement of the public health infrastructure and more widespread provision of subsidised medicines −National List of Essential Drugs and Popular Pharmacy Programme increased the number of drugs covered under the scheme and will see further improvements over the next years
Vietnam −Plans to increase universal health insurance coverage to 75-80% population by 2015; 90% by 2020 −National Target Program for Health 2015 −Programme includes diabetes focus, increasing early diabetes detection by providing screening programmes and a nation-wide disease treatment network by 2015
Key HGHMLC strategic market sectors
Cardiovascular & Metabolic Diseases
Immuno-Oncology Immunoscience Inflammation &
Remodeling Neuroscience Oncology Pain & Sensory
Disorders Rare Disease Vaccines.
Biotechnology Platforms Biologics Product & Process
Development Biotherapeutics Discovery Clinical Innovation Drug Safety Pharmacokinetics, Dynamics &
Metabolism Precision Medicine Small Molecule Product &
Process Development Small Molecule Therapeutics
Discovery.
Key Developments Big pharmas not too shy on spending big dollars TAX savings - Redomiciling $ 385 BN deals in Life science sector Big Pharma Portfolio rationalization
Off patent molecules – have average performance
BLAs are not clearly defined
Peptides / proteins /Small molecules – emerging sector
HIGH GROWTH HIGH MARGIN opportunities – Immuno-oncology , precision medicines , gene pills, formulation tech
OTC/CH/ AN – emerging markets
• ƒVaccines for the prevention and/or treatment of infectious diseases
• ƒ Vaccines for the prevention and/or treatment
• of non-infectious diseases through the
• active elicitation of disease-modifying immune responses Adjuvant
• ƒNovel in vitro systems for assessment of vaccine immunogenicity
• ƒ Novel animal models for assessment of vaccine effectiveness
• ƒ Novel immunomodulators of the adaptive immune response
• Novel vaccine target antigen
• identification systems
• ƒ Novel vaccine delivery platforms
• ƒNovel vaccine administration systems
Licensing & JVs
ITS ALL BIOTECH High Number of deals in
Biotechnology – driven by genomics , Antibody –Protein interaction
Advanced Protein delivery technology
Precision Antigen binding
Mab+Mab | Mab+ Small molecules – Immuno-onclogy
RNA intervention , CRISPER , PTGS , siRNA
Next gen-sequencing
Potential Licensing Deals strategic areas
Cardiovascular &Metabolic Diseases • ƒ CVD (Acute Coronary Syndrome, heart
failure,
• peripheral arterial disease and atherosclerosis)
• ƒ Diabetes and related co-morbidities
• ƒ Obesity and related co-morbidities
• ƒ Renal diseases and related co-morbidities
• ƒ Prevention of cardiac remodeling
• ƒ Prevention of MACE via anti-inflammatory
• pathways
• ƒ Improvement in cardiac performance via
• protection or repair or improved vascular function
• ƒ Solute transporters and their role in metabolic
• and renal diseases
• ƒ Kidney podocyte architecture
• ƒ Insulin sensitization
Beta-cell function and survival in obesity and Diabetes ƒDysregulation of alpha-cell function ƒMetabolic adaptations to exercise which protect against or reverse diabetes Mechanisms which protect mitochondria under conditions of chronic caloric excess ƒGut and brain signals that regulate energy homeostasis and metabolism ƒThe role of sleep and circadian rhythm in regulating endocrine function and metabolism ƒCentrally-acting anorectics ƒBariatric surgery mimetics ƒModulators of beige and brown fat metabolism ƒLipid content and the development of liver fibrosis in patients with NASH / NAFLD ƒDysregulation of liver metabolism
Immuno-Oncology – Key Potential Licensing deals areas
Novel Targets for Overcoming Tumor induced Immune Resistance
Targets that promote immune response
Targets that provide Innate immune support
Targets that reduce immune suppression
ƒPlatform Technologies
Mechanisms, biomarkers, and screening approaches to identify and accelerate the most promising combination therapies
New modalities to induce immune responses:
Bi-specific mAbs, nanoparticles, oncolytic
viruses, tumor vaccines For Identification of new immunemodulating targets
Robust monitoring of anti-tumor
immune responses
Monitoring of immune-supporting andimmune-suppressing biomarkers in the tumor o Novel animal models that accurately recapitulate human tumor-immune system interactions
Immuno science ƒ Rheumatoid Arthritis ƒ Systemic Lupus Erythematosus ƒ Inflammatory GI disorders (i.e., Inflammatory Bowel Disease) ƒ Psoriasis ƒ Multiple Sclerosis
ƒ Other indications with high unmet need that are mechanistically related to those above Specific areas of interest include: ƒ Cytokines and their signaling pathways ƒ Adaptive Immunity, Lymphocyte biology including Th17 lymphocytes ƒ Regulatory cells and Tolerance induction ƒ Host-microbial interactions and micro biome
Technology platforms and products to
help understand patient segmentation in the disease
areas of interest and develop precision medicine strategies for innovative portfolio products ƒTechnology platforms and products that allow for greater tissue and cell specific delivery
Inflammation & Remodeling
ƒ Diabetic nephropathy ƒ IgA nephropathy, Lupus nephritis and membranous nephropathy ƒAutosomal dominant polycystic kidney disease ƒ Acute kidney injury (prevention and treatment) ƒ COPD ƒ Severe asthma ƒ Pulmonary hypertension and Idiopathic Pulmonary Fibrosis ƒ Other pulmonary, liver and skin fibrotic diseases
ƒ Innate immune suppressors ƒ Oxidative stress modulators ƒ Anti-fibrotics ƒ
Neuroscience Biomarkers for ƒ Alzheimer's Disease (AD) ƒ Parkinson's Disease (PD) ƒ Huntington's Disease ƒ Vascular Dementia (Cerebelar Amyloid Angiopathy) ƒ Multiple Sclerosis (MS) ƒ Cerebrovascular disease ƒ Hearing Loss ƒ Schizophrenia: positive, negative and cognitive deficits ƒ Bipolar Disorder ƒ Adjunctive treatment of Depression ƒ Addiction (opiate and alcohol) ƒ Autism spectrum disorders
Key Development Areas : Neurodegeneration / Neurological Disease: ƒNovel symptomatic agents for AD or PD (could include L-DOPA-induced dyskinesias) ƒ Agents affecting micro vascular circulation and brain metabolism with validated link to AD ƒImaging agents (e.g., tau, synuclein neurotransmitters, neuroinflammation and gliosis) ƒTranslational biomarkers – preclinical to clinical ƒBiological samples ( induced pluripotent stem cells) from well defined AD or PD patient populations ƒ Agents impacting neuroinflammation ƒConformational antibody that has cross reactivity to all “amyloids” (e.g., tau, Aß, huntingtin, δ-synuclein) ƒ Novel delivery of growth factors and other biotherapeutics (e.g., viral delivery or implanted device)
Pain & Sensory Disorders Chronic pain
Neuropathic pain
Nociceptive pain
ƒ Acute pain
Perisurgical pain management, prevention of chronic post-operative pain
ƒEpigenetic pathways
ƒ Sensory disorders Disorders involving abnormal sensations of clinical relevance (e.g., visual, auditory, vestibular, somatosensory systems) ƒ Ion channels, notably targets where there is strong human genetic evidence for a role in pain or in mechanistically-related sensory disorders (e.g., epilepsy, channelopathies) ƒ Novel targets on pathways with known relevance to pain (e.g., neurotrophins) Highly differentiated opiates with fewer side effects, including novel abuse-resistant formulations and approaches to address over-consumption ƒ Nociceptor-specific drug delivery ƒTechnology platforms and products to help understand and segment patients in pain and develop Precision Medicine strategies innovative portfolio ƒ Novel approaches to demonstrate cross-species target engagement of an ion channel-excluding fMRI, microneuography, threshold tracking, capsaicin / cinnmaldehyde flare, UVB, etc.
Rare Disease • ƒHematology (non-
malignant) • Hemophilia • Coagulation factors
with extended duration of activity and/or improved delivery
• Oral agents to treat hemophilia
• Immune tolerance • Novel approaches
(including gene therapy)to treat hemophilia patients
Other rare hematologic (non-malignant)
Indications Sickle cell anemia, & beta-Thalassemia Hemostasis (systemic and topical) ƒ
Neuromuscular Diseases Duchenne / Becker muscular dystrophy and other muscular dystrophies, disease modifying therapies Spinal Muscular Atrophy Friedreich’s ataxia: Upregulate frataxiexpression, inhibition of degradation or frataxin pathway bypass Amyotrophic lateral sclerosis: Proteinmisfolding approaches FABRY – LYSOZOMAL SUBSTRATE DISEASE – LSD / can think of M&A
Biologics Product & Process Development
KEY EMERGING AREAS • ƒNext generation of microbial
and mammalian cell protein production systems
• ƒ Next generation process and manufacturing technologies
• ƒSystems and Synthetic Biology
• Technologies to design and influence host cell performance and product quality
• Novel expression systems with alternative post-translational modifications(e.g., glycosylation)
• Automated methods for mammalian cell line for biotherapeutics
Tissue specific delivery ƒ Alternative routes of delivery (transdermal, transmucosal) ƒAnalytics (biophysics) to predict stability ƒ Advanced formulations (improved stability, high dose delivery)
screening, selection and scale up Next generation cell culture process technologies Next generation purification process technologies – Harvesting technologies (e.g., smart polymer, automation)
High throughput analytics for product quality attributes
Advanced analytics for glycoconjugates and antibody drug conjugates Flexible and adaptive manufacturing technologies
Biotherapeutics Discovery Transformational technologies to design, construct, and optimize biotherapeutics o Informed protein design optimizes molecular properties resulting in superior efficacy, pharmacokinetics, pharmacodynamics, safety, manufacturability and differentions ƒ
Antibody drug conjugate technologies
Novel ADC platforms, novel payloads, linkers, conjugation sites Bioconjugation technologies Combinatorial biologics such as bi-specific and multi-functional platforms with promising biophysical and manufacturing properties ƒ Structure-based and computational design of Therapeutics Novel technologies to rationally design antibody, protein and peptide therapeutics that display superior pharmaceutical properties (including selectivity, half-life extension, stability, formulatability) ƒ Technologies that enhance multi-transmembrane protein target expression / presentation for antibody generation and screening
Technologies and patient sample access for
antibody discovery from human
antibody responses Targeted delivery technologies that address /overcome cell membrane penetration, cross blood brain barrier ƒ Technologies that can significantly enhance general protein expression, purification, stability for discovery ƒ Integrated service providers to support early discovery activities for development of therapeutics Broadly applicable platforms to enhance speed / quality of antibody generation Novel biologics, combination
therapies, an "biobetters"
Clinical Innovation
ƒPatient Engagement – Raising awareness
and supporting patient recruitment & retention for clinical trials, enhancing patient participation, improving generation of patient insights into study design, sharing data & information with trial participants
Real World Data – Leveraging diverse data sources and analytics tools to enhance study design and protocol optimization, capture clinical trial data more efficiently
Mobile & Digital Tools – Supporting the
informed and engaged patient during studies, improving study access and convenience, and enabling robust data capture whether reported
by the patient or leveraging novel sensors
ƒBiospecimen Management –
Enabling robust acquisition, innovative consent approaches, and advanced tracking and storage capabilities to enable ready access to human clinical specimens
to advance both traditional and precision medicine R&D ƒ
Innovative Partnerships –
Partnerships spanning other biopharma companies, others in healthcare, technology partners and beyond to stimulate new approaches to rapidly understanding the efficacy and safety of medicines in development
Drug Safety – Key emerging areas • Mechanisms,
biomarkers, and screening
• approaches related to target organ toxicity
• Cardiovascular safety
• Liver injury
• Hypersensitivity
• Nephrotoxicity – esp., glomerular
• Skeletal and cardiac muscle toxicity Ocular safety
• Screening for abuse potential
Bio therapeutics-related analytical technologies Immunogenicity and other safety-relevant assays Deeper knowledge of targets and pathways
Knock-in, knock-out technologies Novel technologies and increased throughput for target localization studies Safety biomarker technologies Platforms
multiplex; analytical approaches; validated reagents
Pharmacokinetics, Dynamics & Metabolism (PKDM)
Translational research o Translational modeling
and simulation approaches, systems pharmacology / PK-PD, integrated with quantitative biomeasures; deepen knowledge of targets and pathways;
Systems models of specific areas of toxicity, e.g., cardiovascular toxicity and application of PKPD to safety biomarker technologies to increase confidence in safety
Understand and de-risk the influence of hepatic and renal uptake and clearance on
toxicology in these organs – focus on disorders of bile production and bile acid transport ƒ
Quantitative Bioanalytics, Biomarkers, Biomeasures, and Immunogenicity (ADA) Assays – large and small molecule efforts Novel LC-MS/MS large molecule bioanalysis and automation techniques
Flow cytometry, cellular imaging techniques (Amnis) for biomarkers and biomeasures , and
highly multiparametric single cell analysis using mass cytometry (CyTOF) Development of a universal platform for Cell-based neutralizing antibody assays Biosimilars / Biocomparability: identification of critical attributes influencing PK and disposition Key vendor development for biotherapeutics bioanalytical capabilities PLATFORMS - mass spectrometry-based,ligand-binding assays, flow cytometry) cross various modalities, Quantitative biomarker capabilities in support of biomarker/ biome sure studies, •Regulated toxicology and clinical sample analyses • Next-generation of advanced intelligent •high-throughput automation platforms •for bioanalysis
Precision Medicine
ƒPatient cohorts with high quality longitudinal molecular and phenotypic data and/or DNA and appropriately-consented, IRB-approved tissue samples o clinical trials o data mining o biomarker studies o genetic and pharmaco-genomic studies ƒ Systems Biology/Pharmacology o Databases with high quality treatment and disease outcomes associated with genetic, as well as molecular (metabolomic, proteomic, transcriptomic, epigenetic, clinical chemistry markers) or functional measures in particular imaging data
o Databases of searchable eQTLs, pQTLs across tissues o Disease biology guided combination therapy design platforms o Systems biology approaches and proven in silico tools to evaluate pharmacological perturbation and elucidate mechanisms of in vivo toxicity
o Mining of data for correlation and understanding of causality ƒ Breakthrough diagnostic technologies that also are highly quantitative, require minimal specimen/ tissue, offer quick turnaround time and can be multiplexed. This will include but not limited to: o Near-patient Point-of-Care technologies o Next Generation Sequencing technologies o Circulating cells o Circulating and urinary cell-free nucleic acids o Antigen receptor sequencing o Microbiome, including virome characterization ƒ In vivo imaging technologies (including MRI, PET, CT, optical imaging technologies, imaging agents, genetically encoded tags,
Imaging agents for small and large molecule compound distribution studies o Imaging agents monitoring physiology mechanisms and disease o Analytical tools and technologies ƒ Biospecimen Analysis o Circulating tumor cell and Nucleic Acid quantification and analysis o Multiplexed flow cytometry for leukocyte analysis o Automated IHC for tissue analysis (cancer, safety) o Advanced ADME – related genotyping o 3D cell models for safety and efficacy assessment that ideally incorporate genetic diversity ƒ Physiological Biomarkers o Technologies adding precision to pain management and treatment in pre-clinical and clinical studies o EEG-based biomarker for assessment of central pharmacology ƒ iPS cell resources and technologies to generate iPS cells that may be used to enable Precision Medicine strategies o Validated cell differentiation protocols o iPS cells derived from sub populations with specific genotypic / phenotypic data
Cell therapies Imaging agents for small and large molecule compound distribution studies Imaging agents monitoring physiology mechanisms and disease Analytical tools and technologies Biospecimen Analysis Circulating tumor cell and Nucleic Acid quantification and analysis Multiplexed flow cytometry for leukocyte analysis Automated IHC for tissue analysis (cancer, safety) Advanced ADME – related genotyping 3D cell models for safety and efficacy assessment that ideally incorporate genetic
diversity Physiological Biomarkers Technologies adding precision to pain management and treatment in pre-clinical and
clinical studies EEG-based biomarker for assessment of central pharmacology ƒ iPS cell resources and technologies to generate iPS cells that may be used to enable
Precision Medicine strategies Validated cell differentiation protocols iPS cells derived from sub populations with specific genotypic / phenotypic data Technology to create iPS cells in a rapid and reproducible fashion without
insertional approaches