Pre-clinical DMPK and relevance to the clinic

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1 Pre-clinical DMPK and relevance to the clinic Richard Weaver Ph.D Managing Director and Founder of XenoGesis limited BioCity Nottingham Pennyfoot Street Nottingham, UK NG1 1GF 1

2 Drug Discovery & Drug Development Drug Discovery multiple compounds profiled Target Selection Hit Identification (HI) Lead Identification (LI) Lead Optimisation Candidate Drug Nomination Drug Development single compound profiled Pre-Clinical Development Phase 1 Phase 2a Phase 2b Phase 3 & Launch 2

3 Design Synthesise Test Hit Identification (HI) Lead Identification (LI) Lead Optimisation (LO) Candidate Drug Nomination (CD) Primarily in vitro DMPK and physicochemical evaluation Enable hit selection In vitro and In vivo DMPK and physicochemical evaluation Enable lead series selection In vitro and In vivo DMPK and physicochemical evaluation Further detailed profiling Dose to Man estimation Candidate drug identified with minimal DMPK risk, to progress into development CD Single compound and series rejection Compound rejection 3

4 Numbers of compounds per LO campaign Design Test Synthesise In vitro DMPK, pharmacology and safety testing In vivo DMPK testing In vivo Pharmacology testing In vivo disease hypothesis testing In vivo safety testing XenoGesis impacts through whole process. Removing poor compounds from further expensive progression & recommending good compounds, thus saving significant time and money 1 CD 4

5 DMPK / ADME(T) Drug Metabolism and Pharmacokinetics What the body does to the drug (xenobiotic) ADME(T) Absorption Distribution Metabolism Excretion Toxicity 5

6 What are we trying to achieve during drug discovery? In vitro (animal) In vitro (human) In vivo PK (animal) Predict to man In vivo PK/PD (animal) 6

7 PK / PD Pharmacokinetics What the body does to the drug Relationship between drug concentration and time Pharmacodynamics What the drug does to the body Relationship between drug concentration and effect 7

8 Plasma conc (nm) % inhibition PK / PD PK Time (hrs) concentration C t = C 0 * e -kt E = E max * C C + C 50 8

9 What dose? All things are poison and nothing is without poison, only the dose makes a thing be poison Paracelsus ( ) Over 500 years later and it s very valid 9

10 What dose? What dose should we give, whether in vitro or in vivo, to cause the desired effect without inducing a negative (toxic) response? Desired Effect Toxic Effect Effect Dose 10

11 PK/PD the correct exposure A) Dose to low: Animals die from uncontrolled tumour growth despite dosing a potent drug B) Dose too high: Animals suffer/die from administered drug, despite reduction in tumour growth C) Correct dose: Only when potency and exposure are within the right range tumour growth can be inhibited without serious side effects 11

12 Prediction of Hepatic Metabolic Clearance in Man Observed unbound intrinsic clearance Includes range of acid, neutral and basic compounds Predicted unbound intrinsic clearance Clearance of a range of marketed drugs is well predicted and thus validates this approach in discovery 12

13 Predicting Oral Dose from Simple PK concepts Target concentration (C min ) C min, ss F. Dose k V e 1 = t doses t = dosing interval Where k = = CL T 1/2 V 13

14 Influence of DMPK & Physicochemical Science on all key Discovery Disciplines Absorption Metabolism Predicted pre-clinical and human half-life DDIs (CYPs and Transporters) Potency anomalies Medicinal Chemistry Reactive metabolite mitigation Dosing regime design of safety studies Metabolite testing Predicted whole blood potencies DMPK & Phys. Chem. Reactive metabolite mitigation MIST guidelines 3Rs appropriate molecules for in vivo testing Designing appropriate dosing regimes for PD studies PK/PD relationships Biological Sciences Safety Assessment TK support Safety Margin calculations Cmax:Cmin, total / free AUC etc. Dose to Man prediction 14

15 Truly Integrated Drug Discovery Medicinal Chemistry DMPK & Physicochemical Science Biological Sciences Safety Assessment Candidate Drug Nomination Key to success core project team multi-lingual in the four key pillars of drug discovery All disciplines equally involved in integrated drug design and delivery, from HI to CD nomination 15

16 March PK / 2010 PD AstraZeneca R&D Charnwood closure announced 16

17 Now PK / what? PD Go to work for AZ at another site or other Pharma Set up my own company Luckily had 12 months to decide 17

18 Why was I thinking about setting up my own company? Disillusioned with the state of the Pharma industry Had passion for the science and a drive to do my best (and to make some money) In my latter years at AZ saw a huge shift in outsourcing Was in charge of evaluating CROs in the far east Worked with a far east company on a project Knew what they did well Knew what they didn t do well 18

19 The Landscape The traditional Large Pharma model is not working anymore Looming patent cliff $78 billion erosion of sales Spiralling R&D costs From $65 billion in 2002 to estimated $140 billion in 2014 The cost of bringing a drug to market is, on average, $1.3 billion (The Pharmaceutical Research and Manufacturers of America PhRMA) Superimposed on a near flat-level level number of FDA approvals for the last 18 years Attrition remains very high 90% from Phase 1 to launch 19

20 Site closures 18 R&D sites closed in the US ( ) 54% of the total 14 R&D sites closed in the EU ( ) UK 6 R&D site closures ( ) 19% of the total 20

21 The Landscape GC Green, The CRO Market Outlook to 2014 emerging markets, leading players and future trends, Business Insights, copyright, 2009, Datamonitor Limited reproduced with permission of Datamonitor Limited How to reduce costs and maintain (or increase) success? Outsourcing is the current trend 21

22 XenoGesis Company History XenoGesis Limited, pre-clinical DMPK/ADME CRO, launched June 2011 with Dr. Richard Weaver as the founding Director Secured private investment to kick-start the business Board of Directors Richard Weaver Ph.D (ex AstraZeneca DMPK Group Leader) Glenn Crocker Ph.D (CEO of BioCity) John Dixon Ph.D (JD International Consulting, Former VP of AstraZeneca) Number of strategic alliances completed and actively pursued e.g. Strategic alliance with XenoTech in the US Ambitious but realistic growth planned Client base: UK, Europe and US 29 companies to February 2013: Virtual companies, SMEs, mid-sized Pharma 3 academic institutions 22

23 What materials do we need to deliver? Our business model of service provision heavily focussed on in vitro data Why? 3R s initiative human tissue and extracts accessible (in theory) We can scale in vitro to in vivo What do we need to enable better delivery Access to human fresh blood, plasma, tissue Access to fresh rat and human hepatocytes Access to diseased tissue Access to animal tissue Access to specialist equipment LC/MS/MS, accurate mass MS, ultracentrifuge Can you help? 23

24 Summary The landscape of delivering new and needed drugs is changing at a pace never seen before Innovation and integrated solutions are essential for success The XenoGesis business USP relies on innovation and great science Actively looking for opportunities to work with other groups to be more successful in delivery 24

25 Acknowledgements AstraZeneca R&D staff Our team and board BioCity Nottingham 25

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