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)


R&D SUCCESS

I2C SBD SUCCESS

I2C SBD CONSULTING SUCCESS

FUTURE

SUCCESS

*Innovation to CommercializationCatalyzing Bio-I2C*

OUTLINE:

also see www.AlanKHauser.com


: 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


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


• 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


"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


^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

D7

03 Catalyzing I2C @ Bio-Com International

xxx

More details are available upon request.

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.


Next Generation Sequencing *Innovation to Commercialization

Client Valuation Project

03 Catalyzing I2C* @ Bio-Com


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


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

Dx Test Providers: Pharma’s Potential Partners


✴ 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)


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.

Plan-ning

Partner-ing

Prospect-ing

Productiz-ing

Valuation POWERED

StrategicBusinessDevelop

-ment

also see www.AlanKHauser.com

2. (c) AKH's Bio-Innov Com SBD Exp Pres

Documents

Transcript of 2. (c) AKH's Bio-Innov Com SBD Exp Pres