2. (c) AKH's Bio-Innov Com SBD Exp Pres
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Transcript of 2. (c) AKH's Bio-Innov Com SBD Exp Pres
Highlights from
Commercializing Converging
Bio-µ-InfoTechnologies :
Diagnostics & Discovery Tools
Alan K. Hauser, Ph.D., CLPMy Biotools-Innovation
Commercialization Accomplishmentsalso see www.AlanKHauser.com
040301 02
© 2014 Alan K. Hauser
Soar Full
Strategic Market/Business Development (SBD)
© 2015 Alan K. Hauser
R&D SUCCESS
I2C SBD SUCCESS
I2C SBD CONSULTING SUCCESS
FUTURE
SUCCESS
*Innovation to CommercializationCatalyzing Bio-I2C*
OUTLINE:
also see www.AlanKHauser.com
© 2014 Alan K. Hauser
: the µFluidic Lab-on-a-Chip PGx-HTS , Dx
& NGS shop secured $189 M in successful IPO.
DiscoveryTools
• in-vivo tumor cell immunity methods for vaccines
• homologous DNA recombination for genetic Rx & Dx
Catalyzing Bio-I2C in Silicon Valley Ventures
Dx
As biz dev director with Pangene in
1995 & 96, executed strategic alliances & licenses to IP rights for:
As licensing dir, built strong IP portfolio enabling partnerships & private placement @
& spearheaded 1st corp product dev partnership.
02
100’s of thousands of potential biomarkers
to be explored
TM
Discovery
© 2014 Alan K. Hauser
eSensor TM
Products that Linkthe Promise of Genomicsto Practical Solutions
Life Sciences
Catalyzing Bio-I2C in a Fortune 100 Corp.
10’s of clinically relevant biomarkers
per indication
Diagnostics
02
Product offerings provide complete multiplex bioarray research solutions for gene-expression & SNP analyses
Motorola Life Sciences Life Sciences
© 2014 Alan K. Hauser
• Conducted business development, including:
✓ competitive microarray/informatic product/IP landscaping
✓ in-licensing proprietary discovery biotools & methods
✓ executing assay reagent & chemistry-supply agreements
✓ strategic MPGx, mDx & proteomic I2C roadmapping
✓ mDx prod-platform comprehensive M&A due-diligence
now
02
© 2014 Alan K. Hauser
"A 'roadmap' is an extended look at the future & communicates visions, attracts resources, stimulates investigations & monitors progress, becoming the inventory of possibilities ..."
*
Robert Galvin Science, 1998
Strategic Roadmapping @ MLSBio-I2C02
KEY
GOALS / RESULTS
PROJECTS /STRATEGIES
KEY EVENTS
PRODUCTS / SERVICES / SITES
LEARNING
PEOPLE
DATELINE
• Non-array
• Pharmaco- genomics (PGx) screening platform
Alan & Market Consultant Alan &Alan K. Hauser, Strategic Com Dev Leader@ outreach to
BIG PharmaBiotools
TIP Provider
Product Development
Roadmap
Market ValidationBusiness Development
Mini Biz-Plan
• Mkt assessment
• Pro forma P&L
• KOL w/in MLS
• Mgmt buy-in
Q2 02
Conducting market research without a product is challenging
Customer Development
License & Prod Co-Dev Negotiation
TIP Innovator
• Primary mkt research
• Refine ROI analysis
• KOL outside MLS
• Sr. mgmt buy-in
Q1 02Q4 01Q3 01Q2 01Q1 01Q4 00
Strategic Commercial
Roadmap
• Massively Parallel (MP)
• Multi-Plexed (MP)
• RT-PCR PGx assay
Good things can take some time to materialize
Prelim Proposal
IN THE BEGINNING…
Leadership by influence requires listening & selling
Business Unit
East Coast West CoastMid-West
MPGx MPGx
MPGx Concept
*Innovation to Commercialization © 2014 Alan K. Hauser
Life Sciences
Rx-Discovery & High-Content AnalysesBio-I2C Roadmap for my MPGX Initiative @ MLS: Concept to Productization
02^
eSensor™
multiplexed DNA Diagnostics
Clinical Micro Sensors (now GenMark Dx) A Caltech Spinout & Life Sciences Company
© 2014 Alan K. Hauser
^Cystic Fibrosis Genotyping Test*
^Thrombophilia Risk (Factor II, V & MTHFR) Test*
Respiratory Viral (incl H1N1) Panel*^Warfarin Sensitivity
(CYP450 2C9) Test*
^Plavix Metabolism (2C19 Genotyping) Test
^Pain/Statin Drug Mtblsm (3A4/3A5 Genotyping) Test
Colorectal Cancer (K-ras Mutation) Test
HCV Direct Test
^Breast Cancer (2D6 Tamoxifen Mtblsm) Test
* FDA-cleared IVD products^ Pursued & secured IP rights to
genetic content (bio-markers)
02
Valuation / Negotiation Success @ eSensor02
Details provided in MLS eSensor section of my LI profile.
MLS Business Units
Life Sciences
Catalyzing Bio-I2C Success
eSensor
❖ Molecular Dx platform & IVD panelsDx
Developed strategic roadmaps for next-generation Rx / Dx tools.
• High-density DNA microarray Rx Tools DiscoveryTools
By interacting with internal/external stakeholders, championed new productization via driving SBD deals:
acquired Caltech spinout,
CMS
My Bio-I2C SBD Acquisitions: $280 M
Won MLS BRAVO! Leadership Award for:
Creating / spearheading Gx HTS Rx-discovery init.
02
Molecular Diagnostics *Innovation to Commercialization
Client Valuation Project
03 Catalyzing I2C* @ Bio-Com International
also see www.BioCom.us
Biopharma & IVF *Innovation to Commercialization
Client Valuation Projects
03 Catalyzing I2C* @ Bio-Com International
Summaries are provided in the Bio-Com experience section of my LI profile.
also see www.BioCom.us
Next Generation Sequencing *Innovation to Commercialization
Client Valuation Project
03 Catalyzing I2C* @ Bio-Com
also see www.BioCom.us
next slide
03 A Representative I2C Valuation* Project^
* 1 of 5 I2C valuations (additional info is available) ^ 12 I2C landscaping maps for 7 clientsB3
More details provided in the Bio-Com experience section of my LI profile.
Catalyzing Bio-I2C at Northwestern
Precision Healthcare
CDx Precision Health
Technology-Market ‘Gap Analysis’
NGS* Commercial Assessment & Valuationyielded 35% IRR, 20x cash-on-cash ROI NU ventures raised $199 M in corp./PE funds in FY’11
NU’s annual licensing revenue > $150 M in FY’08-11
Helping to level the
‘financial playing field’ among key
stakeholders
22x36%
I2C
Valuation Projects
@
CDx-Stratified Medicines
Converging
03
02
RxDx
© 1996-2009
CUSTOMER NEEDS
$1 Trillion in Rx wasted annually
ECONOMIC CLIMATE
‣ Poor efficacyRx ISSUES
‣ Toxicity challenge
Rx TRENDS✓Regulatory
pressures to
address broken
Rx paradigm
A7 © 2012 Bio-Com
BIG Pharma➡ CDx-Rx co-development
Ref Labs/Hospitals/DxCo’s➡ Dx instrumentation / reagents
Physicians➡ Results w/ clinical utility
Patients➡ Right drug @ right dose @ right time
© 2014 Alan K. Hauser
yielding a significant unmet CDx demand ✓Biomarker-CDx
stratified medicines
- Biochemical imaging
- Proteomic
- Genomic (genotyping, gene expression, sequencing)
- Metabolomic
BiomarkersTECH FACTORS
✦ scientifically fascinating✦ clinically life saving ✦ commercially disruptive
where:
BOTTOM LINECDx-precision healthcare
“... clinical performance drives commercial
performance.”
90% of drugs work in only 30 to 50% of indiv.
adverse reactions kill 1 Am. every 5 min.b/c “one drug really doesn’t fit all.”
CDxCo
03 promises to meaningfully improve the quality of people's lives.
CDx rec is ion HealthP
© 1996-2009
A7 © 2012 Bio-Com © 2014 Alan K. Hauser
Value of CDx Test within Precision-Medicine Ecosystem03
More details are available upon request.
✴ compelling business-development role focusing on strategic I2C:
“If you want to go FAST, travel alone If you want to go FAR, travel together"
- Old African adage
Alan
Alan
Alan
Bio-Innovation-to-Commercialization (I2C) Leadership(I2C)
© 2014 Alan K. Hauser
Am seeking to leverage my SBD planning, prospecting & partnering experience in
✴ a compelling new Market / Biz Dev role:
04
• to move back to an -omics & mDx tools mfg & mktg concern as part of BD team
• to have more face - ‘influence’ - time w/ internal & external stakeholders
• to have further FAR-reaching impact in an IVDx ◆ discovery-I2C company.