Clinical medicine in 1987

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2 Clinical medicine in 1987 Rheumatoid arthritis Crohn s disease

3 Triumph of translational medicine Cytokine-targeting antibodies Leukocyte adhesion blockers Kinase inhibitors (cancer, chronic inflammatory diseases) Immune checkpoint inhibitors (cancer) CAR T-cells Novel therapeutic platforms Monoclonal antibodies Cyclic peptides Gene therapy Gene silencing Gene editing (CRISPRs) Oncolytic viruses Cancer vaccination technologies 3

4 On the other hand... Currently available therapies address less than 10% of all diseases (my estimate) Conventional drugs cannot effectively treat all diseases

5 A common (mis)perception of translation research subsidy research therapy

6 Duur medicijn Pompe nagemaakt Er is goed nieuws voor de patiënten die lijden aan de ziekte van Pompe. Het medicijn tegen de ziekte van Pompe, een erfelijke spierziekte, is goedkoop nagemaakt. Daardoor kan er mogelijk een goedkope variant worden gemaakt. Dat middel is veel goedkoper dan het huidige medicijn, belooft Huub Schellekens, hoogleraar Farmaceutische Biotechnologie aan de Universiteit Utrecht.

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9 Scope of this presentation Suppose: You are a medical doctor with an interest in research You have improved a medical device You synthesized a novel class of anti-cancer drugs You have developed new bioinformatics tools What next?

10 First: Then: You need a plan You need money

11 The Plan discovery development clinical development drugability Medicinal chemistry manufacturing pharmacology toxicology Potency assay regulatory Academia Biotech/Pharma Financing ( m)

12 Acquires want to see: A product at a clinical stage of development Source: HBM

13 The Plan discovery development clinical development drugability Medicinal chemistry manufacturing pharmacology toxicology Potency assay regulatory What is the value proposition? Academia Biotech/Pharma Financing ( m)

14 The missing piece discovery development clinical development drugability Medicinal chemistry manufacturing pharmacology toxicology Potency assay regulatory Academia Biotech/Pharma Financing ( m)

15 The money: Let s go to the bank for financing! I need 1-2m now. But I will need 15m later. And in the end I probably will need 50m. All this time (maybe 10 years) I will only spend money. But I do want to keep a majority ownership. There will be many hurdles and for all kinds of reasons my project may fail. I have never done this before. Actually I am a scientist with no business experience, but I have a friend who worked at a pharmaceutical company and is willing to become CEO.

16 Sources of Capital Subsidies ZONMW, FP7, etc. Loans (soft or commercial) Technopartner, etc Debt securities to investors Investments (sale of shares) Informal investors (family and friends) Business angels Early stage funds Venture Capital Seed Start Series A Series B Series C

17 Government subsidy policies ( valorization, innovation ) discovery development clinical development 1-2m grant Valley of death drugability Medicinal chemistry manufacturing pharmacology toxicology Potency assay regulatory Financing ( m)

18 Large pharmaceutical companies make huge profits by selling expensive and ineffective drugs by Forbion Capital Partners

19 Drug development: Some facts Total world-wide medicinal drug revenues about $550 billion/year Total global drug R&D budget $50 billion/year Total number of NCE approvals (EMA/FDA) 25/year; less than 50% really innovative R&D costs per approved drug $50 billion/25=$2 billion More than 1000 diseases without treatment Costs of some therapies is very high (yearly $100k for cancer drugs, $300k protein replacement therapies, $15m lifetime hemophiliac, etc.) Changing demographics (aging), therefore more drugs needed Demand from new markets (China soon to be the #2 drug market in the world)

20 Drug development is extremely costly Page 20

21 What drives large pharma profitability? Page 21

22 Large Pharma problems Productivity of large pharma drug development too low and timelines too long Patent cliff: Most Western large pharmaceutical companies cannot replenish their cash flow with the current pipeline No longer possible to merge the problem away Emerging markets pharma companies have no pipeline Revenues from drugs going off patent in 2014 Page 22

23 Why is is so difficult to make new drugs? Page 23

24 DiMasi et al Tufts Center for the study of Drug Development 2014 Page 24

25 Where do large pharma blockbusters orginate? Page 25

26 Where do the new drugs come from? Currently 30-40% of all large pharma blockbusters has been sourced outside (i.e. lipitor, fosamax, cozaar, humira, remicade etc.) This is expected to increase to 70% or more Drugs are sourced from small to medium size biotech companies Virtually all these companies are financed by VC All breakthrough technologies Monoclonal antibodies Gene therapy Cancer immunotherapy Have been conceived and developed outside large pharma Therefore: Most new drugs (medical devices, diagnostics) will be developed by VC-backed small to medium size companies Page 26

27 Conclusions There are enormous opportunities for developing new drugs Improved drugs for common diseases (diabetes, hemophilia, etc.) New drugs for common diseases that have no treatment (Alzheimer, Parkinson, etc.) drugs for rare diseases that currently cannot be treated (i.e monogenetic diseases) But: We need to become much more professional TTO s Patent protection Preclinical and clinical development Financing and capital markets Page 27

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