Sustainable biotech innovation from an entrepreneur s perspective

Transcription

1 Sustainable biotech innovation from an entrepreneur s perspective Mauritz Venter Co-founder & CEO BIOSAFETY SYMPOSIUM 1 February 2018

2 The Biotech Dream GENETICS: THE MONEY RUSH IS ON The final decoding of the secrets of life is opening a new era in the treatment of disease and has set drug giants rushing for alliances with biotech startups. Magazine 30 May 1994

3 Getting Started 4 Entrepreneurs with different strengths Feb 2003

4 B I O T E C H P A S S I O N R E A L I Z E D

5 Plant genetic engineering Synthetic biology AzarGen s Strategy Use plants as bioreactors to produce biological drugs B I O T E C H P A S S I O N R E A L I Z E D

6 BIOLOGICALS B I O T E C H P A S S I O N R E A L I Z E D

7 The Biotech Dream Entrepreneurship Pro s Con s Remembering that you are going to die is the best way I know to avoid the trap of thinking you have something to lose. You are already naked. There is no reason not to follow your heart. Steve Jobs

8 B I O T E C H P A S S I O N R E A L I Z E D

9 Biotech Start-up Model

10 Biotech is RISKY START Discovery / R&D / Proof-of-Concept TRIALS Product Release Registration Marketing Distribution INFLECTION POINT INFLECTION POINT INFLECTION POINT B I O T E C H P A S S I O N R E A L I Z E D

11 B I O T E C H P A S S I O N R E A L I Z E D

12 Osawa and Miyazaki, 2006 B I O T E C H P A S S I O N R E A L I Z E D

13 B I O T E C H P A S S I O N R E A L I Z E D

14 Screw it, let s do it Richard Branson

15 Founders + Advisory Board (Regulatory/Business) + Investors Outsourced Activities CROs IP / Regulatory CMOs

16 Getting Money Friends Venture Capitalists Government Round-1 Round-2 Round-3 B I O T E C H P A S S I O N R E A L I Z E D

17 Networking leads to potential collaboration

18 CMO

19 Regulatory Compliance TRIALS Product Release B I O T E C H P A S S I O N R E A L I Z E D

20 The Biotech Dream Passion (Science) + Business (Making $) + Tolerate Uncertainty Biotech Entrepreneur

21 Entrepreneurial Efficiency Indeed, innovation is the work of knowing rather than doing. Peter F. Drucker B I O T E C H P A S S I O N R E A L I Z E D

22 Entrepreneurial Efficiency Identify business opportunity Start here! Investors Regulators CROs / CMOs Product Development & Release Specific territory Market demand Consumer acceptance Socio-economic benefit Policy & Regulatory frameworks IP / Freedom to Operate Economics + Community + Environment B I O T E C H P A S S I O N R E A L I Z E D

23 B I O T E C H P A S S I O N R E A L I Z E D

24 BIOTECH. PASSION. REALIZED.

25 B I O T E C H P A S S I O N R E A L I Z E D

26 Originator off-patent BIOSIMILARS DEFINITION FDA EMA WHO MCC...high similarity in terms of quality, safety and efficacy to an already licensed reference/originator product... B I O T E C H P A S S I O N R E A L I Z E D

27 $ Profit Loss TIME

28 Market introduction successfully responding to consumer needs and communicating benefits in a believable persuasive manner Business feasibility South African due diligence with investors Understanding of business (idea and related technology) education to investors and consumers Probability for success / feasibility Time / Cost / Risk Entrepreneurial efficiency Innovation ecosystem Acceleration Optimize process Stakeholder integration Transparency Regulatory compliance Awareness + revised strategy (value added)

29 Biotech is RISKY Profit Loss Profit Loss B I O T E C H P A S S I O N R E A L I Z E D

30 Factor Management Ability to adapt Timing Location Cash Science Strategy Build a team that shares an ambitious common vision, intellectual honesty and an entrepreneurial culture in which the driving founders have a long-term commitment Stick to your vision, but be prepared for your original business plan to change Where is the market going to be in seven years' time? You should know the answer Choose somewhere accessible that will raise your equity value Attract venture capitalists from day one Make sure your science is world class, but remember: science alone does not make a successful company