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Week 9
Alzeca Bio is developing a platform technology to providea more accurate, lower cost diagnostic technology forAlzheimer’s Disease. The platform is also being utilized toreformulate Alzheimer’s therapies in order to be moreeffective and less toxic.
Team
- Alzeca CEO and Co-Founder
- Previous start-up/life science, VC, I-Banking experience
- Internal Medicine- Health Services
Researcher- UCSF Faculty
- Mentor- R&D Consultant- Ph.D & Post-Doc, UCSF
- Senior development process engineer
- PharmaConsultant
- Molecular Oncologist
- VC experience- MBA, Stanford
Lic ensedfrom businessm odelgenerat ion.c om underaCreat iveCom m onsAt t r ibut ion-ShareAl ike3.0Unport edLic ense
LaunchPadCentral
Ke yPartne rs
Ph a rma ce ut ica l
Co mpa n ie s
FDA
Co nt ra st Age nt
M a n ufa ct u re rs
Ima g in gEq u ip me n t
M a n ufa ct u re rs
Aca d e micla b sa n d
ph a rma comp a n ie st o
re fo rmula t e AD
t he ra p ie s
CROs
Ke yActivit ie s
Va lida t e t h e
d ia gn ost ict e ch no lo g y
ininvivoa n ima l
st u d ie sa n dh uma n
st u d ie s.
Sho w high
re so lu t io n ima g ing a n d
ma ke q ua nt it a t ive
Value Proposit ions
(Dx)To o lt oe va lu a t e
e n dp o in t inclin ica l
t r ia ls
(Dx)Accu ra t e ly
se le ct ing p a t ie n t sfo r
clin ica lt r ia ls
(Dx)Provid in ge a rly
d ia g no sist o suspe ct e d
Alz h e ime r 'sp a t ie n t s
(Dx)Ea sie ra cce ss
fo rpa t ie n t s
(Rx)Pro vid in gmore
e ffe ct ive t he ra p e u t ics
t oAlz h e ime r 'sp a t ie n t s
Custome r
Re lationships
Custome rSe gme nts
In st it u t io ns
con du ct ing clin ica l
t r ia ls
Ph a rma ce ut ica l
Co mpa n ie s
Co nt ra st Age nt
M a n ufa ct ure rs
Alz h e ime r 'sPa t ie n t s
Ho sp it a ls
CRO s
Ke yRe source s
Ca p it a l
Exclusive rig h t st o
in t e lle ct ua lp ro pe rt y
a nd kno w le d ge o f
t ra de se cre t s
R&DPe rso nn e l
Re se a rch Fa cilit ie s
Channe ls
(Dx)Dire ct t o
p ha rma grou ps
ru nn in gclin ica lt r ia ls
(Rx)Lice n sing t o
p ha rma grou psfo r
t h e ra pe u t ic
re fo rmu la t ion
(Dx)Co nt ra st Ag e n tCostStructure
R&D/Op e ra t ion a lPe rso nn e l
In t e lle ct ua lProp e rt y
Co nsuma b le s(ma t e r ia lst oma ke p rod uct s)
Re se a rchAn ima ls
Re se a rchFa cilit ie s
M isce lla ne ou s(Accou nt ing ,Tra ve l,Con fe re n ce s)
Re ve nue Stre ams
Too lfo rq u a n t it a t ive b io ma rke rme a sure me n t t o me a su re
t h e ra pe u t ice ffica cy
Too lfo rp a t ie n t se le ct io ninclin ica lt r ia ls
Se lling The ra p e ut icst o Alz he ime r 'sPa t ie n t s
Se lling d ia g no st ica g e n t t osu sp e ct e d Alz . p a t ie n t s
Lice n sing de live ryp la t fo rmt op ha rma co mpa n ie s
d e ve lop ing Alz . d ru gs
What We Thought (Rx) : Failed compounds can be reborn
PharmaInformal Partners
What We Did
What We Learned: Just Because You Can Does Not Mean You should
What we Thought (Dx)
PharmaInformal Partners
What We Did
Imaging
What We Learned
What’s Next
• Focus on Dx opportunities (tau in addition to amyloid)
• Better understand reimbursement
Next Steps…
• Review our recent preclinical data with KOLs, pharma, and imaging companies to determine additional needs
• Elucidate inflection points for them to endorse, invest, and partner in early stage clinical studies
• establish budget for each
• Assess other AD diagnostics and treatments in development
• Clarify and disseminate competitive advantages of ADx
Partnering/Customers Lay of the Lands (Populate this)
(Novel) Drug reformulationPatient Stratification for clinical trials
Pre-clinical research tool
Rodent PoC
Primate PoC
Phase 1 PoC
Randomized phase 2
Randomized phase 3
Lessons Learned about Cost, Key Resources, and Activities
Hypothesis Experiments Results
Cost Affordable to patients Talk to KOL, CMS consultants
1) ADx would be affordable and some patients would self pay.
2) CMS covers MRI w/o contrast agent.
Key Resources
Capital, patents, R&D personnel, facilities, development partners.
Talk to pharmacompanies, KOL, patent lawyers
1) True. 2) CMS consultant.3) FDA is a key
partner/resource.
Activities Validate technology, prove safety in humans, regulatory pathway, demonstrate high resolution.
Talk to pharmacompanies, CROs, KOLs, Regulatory
1) True.2) Each company has its own
unique criteria.
What is best route to your destination?
Go out and talk to people!
It is about working your network
Every customer is unique
Attend Conferences
What do experts think?
Will people invest now?
Find the minimum viable product
Can you get there on your own?
Who is that strategic partner?
How do get to the deal?
Does your MVP work?
Is it going to be too expensive for the patient?
Not only lower cost, Higher Resolution
Use it in pre-clinical testing first
That miracle drug!