A Serial Entrepreneur’s Journey from Concept to Customers George Jackowski, Ph.D., KCTJ October 19...
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![Page 1: A Serial Entrepreneur’s Journey from Concept to Customers George Jackowski, Ph.D., KCTJ October 19 th, 2015 “Maintaining the Heartbeat” Chairman of NAVA.](https://reader035.fdocuments.us/reader035/viewer/2022062222/5697bfa71a28abf838c98ab6/html5/thumbnails/1.jpg)
A Serial Entrepreneur’s Journey from Concept
to Customers
George Jackowski, Ph.D., KCTJ
October 19th, 2015
“Maintaining the Heartbeat”
Chairman of NAVA Corp.
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BIOGRAPHY
Academic Appointments Held:
• University of California, San Francisco (USA)
• Cardiovascular Research Institute, San Francisco (USA)
• University of Toronto, Department of Laboratory Medicine & Pathobiology (Canada)
• Research Institute, Hospital for Sick Children (Toronto, Ontario, Canada)
• Florida Atlantic University, The Centre for Molecular Biology & Biotechnology (Boca Raton, Florida, USA)
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HISTORY
• Over the last 35 years in the Healthcare/Biotech sector raised over $150 Million from the public capital markets
• Federal Government support (IRAP): approximately $2 Million
• Over 170 US Patents issued and filed
• Created over 1,000 jobs in a hard-to-fund sector
• Created numerous new biotech companies with company valuations in the range of millions to $500 Million
• Over 25 products cleared through the United States Food & Drug Administration (FDA) and commercialized globally
• >$100 Million in transactions with Big Pharma→ Baxter, Dade, J&J, Ortho, Roche, Abbott, Fisher, Becton-Dickenson,
Genzyme, Nanogen, Schering-Plough
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COMMERCIAL FOCUS OF COMPANIES CREATED
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Commercial Focus
Cardiac Panel PCR Diagnostics/ Therapeutics
Biomarker, Proteomics, Diagnostics Pain Therapeutics
BioWrap Oral DNA Therapy
Cancer Antibodies Reprofiling
Biogenerics Stroke Diagnostics
Blood Purification Alzheimer’s Disease
Biological Chips/Wireless transmission/
Safety ProfilesHeart Failure Diagnostic
Point-of-Care DeviceSpecialty Pharma – Omega-3 Therapies
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COMMERCIAL POTENTIAL
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Need to know how to identify and when to go forward with basic laboratory discoveries that have potential for commercial development.
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CURRENT STATE OF DRUG DISCOVERY
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• The worldwide pharmaceutical market is tracking to come in at US $1,100 Billion (Growth of 3-6% over the last five years)
• By 2020 ~ $3 Trillion US
• To achieve this growth pharma needs fundamentally new drugs to market – blockbusters
• Dependent:
– Identifying novel drug targets
– Embracing new technologies
• Genomics & Proteomics based drug discovery• Screening unique cell lines• Vaccines• Hormone based cancer therapies• Immunotherapies
– Propelling the related therapeutics to market
• Changing market conditions – previously only Phase II or greater deals, now looking at preclinical data
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Cancer Therapeutics (1970 – 80’s):
• EGF/Receptor
• TGF/Receptor
• VEGF/Receptor
• Nuclear lamins
• cis and trans acting factors
• Ribonucleoprotein
• Heat shock proteins
• Erythropoietin (Epogen)
• Herceptin
• Neupogen/Neulasta
FOR OUR CURRENT DRUGS AND DIAGNOSTICS THE BASIC SCIENCE COMMERCIALIZED GOES BACK APPROXIMATELY 30 YEARS
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FOR OUR CURRENT DRUGS AND DIAGNOSTICS THE BASIC SCIENCE COMMERCIALIZED GOES BACK APPROXIMATELY 30 YEARS
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Cardiovascular (1970-80’s):
• Histone acetylase – PPARS (glitazones)
• Protein kinase C (Calcium channel blockers)
• Brain natriuretic peptides
• Lipid regulators – cholesterol-lowering statin drug
• Cardiac enzymesSource: https://thernhangout.wordpress.com/
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FOR OUR CURRENT DRUGS AND DIAGNOSTICS THE BASIC SCIENCE COMMERCIALIZED GOES BACK APPROXIMATELY 30 YEARS
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Proteomics:
• Mass spectrophotometers – chemist in the 70’s
• Gels: Laemmli (1970) Nature
O’Farrell (1975) J. Biol. Chem
Genetics (1990-2000’s):
• Cancer phenotypes and mutated genes (BRAC1 & BRAC2)
Source: http://www.surgery.hku.hk/images/br01.jpg
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WHY?
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• Medical progress tends to move along at a slow and steady pace
• Impact of big advances on the art and practice of medicine is usually incremental
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E.G. CHOLESTEROL-LOWERING STATIN DRUG (HMG-COA REDUCTASE INHIBITORS)
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• Discovered by Prof. Akira Endo ~1971 seeking a natural substance to block crucial enzyme involved in the body’s production of cholesterol
• At the time, many scientists were skeptical about the safety of lowering the amount of cholesterol
• Merck &Co. was the first to commercially market statins (Lovastatin – beginning research in 1976)
• 1980 demonstrated that statin lowered LDL or “bad” cholesterol levels
• Lovastatin was approved by the US FDA in 1987
• Many players have entered the market – E.g. AstraZeneca, Bristol-Myers Squibb, Novartis, Pfizer
• Merck loses patent protection in 2006
• Most widely prescribed drug for the prevention of heart attacks and stroke – approximately $30 Billion per year
• Prof. Akira Endo was awarded Japan Prize (2006) for his work on the development of statins and the Lasker Foundation Prize (2008)
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CREATING AN EDGE FOR COMMERCIALIZATION IN REAL-TIME
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Intellectual Property:
• Patents: US patents vs. National
• Freedom-to-Operate
• Invalidation
• Patent Strategy
• Pioneer patents and picket fence
• Sleeper/Submarine patents
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CREATING AN EDGE FOR COMMERCIALIZATION IN REAL-TIME
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The Inventor, The Science:
Breakthrough (Revolutionary Advances) vs. Innovated
• Paradigm shifts
• Simple application of technology that has worked
• Me too
Source: The Economist, Aug. 8, 2015
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CREATING AN EDGE FOR COMMERCIALIZATION IN REAL-TIME
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The Product:
• True market
• Competition
• Cost of manufacturing
• Regulatory hurdles – strategy
• Distribution channels
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CREATING AN EDGE FOR COMMERCIALIZATION IN REAL-TIME
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The Structure of the Company:
• Funding and Taxes
The Exit Strategy:
• Valuations and Making Money
The Team:
• Beyond the Inventor
• Different people for the different stages of the Company
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CREATING AN EDGE FOR COMMERCIALIZATION IN REAL-TIME
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Regulatory, Preclinical and Clinical Trials:
• Contract Research Organization
• Contract Manufacturing
• Contract Trial Organizations
• Marketing and Commercialization
• Payor Strategy
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CREATING AN EDGE FOR COMMERCIALIZATION IN REAL-TIME
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Key Elements:
• Dramatic result in a well characterized population of patients
• Dramatic results with well defined endpoints
• Tissue specific biomolecules
• Collaborate (Preclinical models, contract manufacturing/
development)
• Don’t fall in love with your technology or approach to
commercialization
• Go as far as you can within the academic research
environment
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TECHNIQUES TO EXPEDITE THE CLINICAL IMPACT OF DISCOVERY
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• Antisense
• iRNA
• Proteomics – protein – protein interaction – pathway elucidation
• Patient profiling
• Genomics
• Knock outs/in
• Models mimicking man
• Laser scanning microscopy:
– receptor interaction - pathway delineation
• Clinical samples, biopsies, serum
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IMPACT OF BASIC RESEARCH
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Fundamental Discovery• Decades to commercialization• Protein pathways, new concept, cutting edge
E.g. Nanotechnology, Statins
Applied Discovery• Decade to commercialization• Disease related biomolecules
E.g. Cardiac Panel CK-MB, Myoglobin and Troponin
Platform• Years to commercialization• Screening drugs against series of protein targets
E.g. Bioactivity Assay
ACCEPTANCE
STANDARD OF CARE
FACILITATE DRUG SCREENING
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YOUR MOTIVATION FOR GOING DOWN THE COMMERCIAL ROAD
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• Notoriety for the discovery – “Golden Hand Cuffs”
• Seeing your discovery (product) in the market and people benefiting from it
• Money – Short-term or long-term
• Control/willing to share
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QUESTIONS TO BE ASKED BY YOU
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1. Can a patent portfolio be built around the technology?
2. Is the technology robust with well defined endpoints?
3. Can it be manufactured at a low cost of goods?
4. Regulatory strategy for commercialization?
5. Does a market exist or does it have to be created?
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KEY TO COMMERCIAL DEVELOPMENT
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• Network, Network, Network – Collaborate
• Move the discovery forward as quickly as possible
Commercialization
R & D$
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Thank you
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