Marieme Ba for CAAST-NET + 1 st stakeholder meeting Entebbe November 2014

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1 Coming together is a beginning, keeping together is progress, working together is success. - Henry Ford - Considering the clinical research industry as an area for enhanced public-private sector collaboration between the AU and the EU and an economic growth area for Africa : a personal perspective Marieme Ba for CAAST-NET + 1 st stakeholder meeting Entebbe November 2014 Pharmalys Ltd 2 Oaks Court, Warwick House Warwick Road Borehamwood,WD6 1GS United Kingdom Pharmalys SARL Résidence Mountakha Bassirou Mbacké Rue Birago Diop, Point E Dakar Sénégal

2 Sharing experience : Clinical Research Associate for Quintiles, market leader as a service provider for global clinical trials, Paris Clinical monitoring: patients rights and safety + data credibility 1999: Clinical Research Manager for GRT FR, mid-size German pharma company (penicillin in 1947, Thalidomide in 1957) Set up of the clinical research department, Paris 2005: International Project Manager, Paris, London, multi country projects 2006: Clinical Research Manager for GRT, UK & IE Very few peers from Africa; South Africa = ROW The dream was born 1

3 Sharing experience : EDCTP 1 was launched 2004: 1 st attendance to GCP training in Senegal Confidential level of clinical research activities: 6 CT funded by EDCTP 1 in Senegal across 10 years End of 2007: resignation from GRT January 2008: launch of Pharmalys in London Not a clue about how to run a company (probably no significant changes to my previous life as an employee) Own funds: no huge investments, 1 st contract from ex employer 1 st employees from ex employer 3, 5, 7, 9, 11, 13 employees Services provided: clinical monitoring, project management, regulatory affairs, quality assurance 2011: major achievement with 1 st inspection by the UK regulatory agency 2012: major achievement with accreditation by the European Commission as an SME for an FP7 multi country clinical trial 1 st step towards the dream was becoming reality 2

4 Sharing experience : continuous monitoring of CR activities in Senegal Quintiles is the only CRO showing signs of temerity and setting up regional offices in Africa, outside South Africa (Ghana, Egypt, Kenya: now 4 cardinal points) EDCTP funded activities more prominent More commercial clinical trials + other funded projects ROW, MENA, SSA May 2012: launch of Pharmalys Senegal Full scope: regional CRO + training and education in CR Reality: still only own funds but much less available Search for investors: too small/not ambitious enough to be attractive But 2 nd milestone towards the dream was achieved 3

5 Sharing experience - 4 May November 2014 Still no external funding Growing industry sponsored clinical trials Academia patiently waiting for EDCTP 2 calls Pharmalys UK operations to compensate slow uptake in Africa Pharmalys in Africa? The dream is still very much alive Question: enough energy? Question: will an African SME survive to the wave of the heavy weight CROs when they decide to focus on the African CR market? 4

6 Coming together is a beginning, keeping together is progress, working together is success. - Henry Ford - Considering the clinical research industry as an area for enhanced public-private sector collaboration between the AU and the EU and an economic growth area for Africa : a personal perspective Marieme Ba for CAAST-NET + 1 st stakeholder meeting Entebbe November 2014 Pharmalys Ltd 2 Oaks Court, Warwick House Warwick Road Borehamwood,WD6 1GS United Kingdom Pharmalys SARL Résidence Mountakha Bassirou Mbacké Rue Birago Diop, Point E Dakar Sénégal

7 Setting the scene - 1 From chemical compounds identified as potential candidates for research 250 will enter the pre-clinical phase (i.e lab and animal studies) Out of these 250 candidates, 10 will enter the clinical phase (i.e. human studies), meaning 1 in a thousand In the end, less than 1 drug will reach the pharmacy shelf, so 1 in each potential drug candidate becomes a drug It takes on average 15 years from lab to pharmacy shelf It costs on average USD 2.5 billion (Nov 2014 source by Tuft CSDD) which has doubled in just 10 years (USD 1.3 billion in 2003) Worldwide pharmaceutical market is estimated at USD 427 billions Worldwide R&D is estimated at USD billions Worldwide clinical trials market is estimated at USD 45 billion The portion of clinical trials outsourced to CROs is up 6.6% annually and projected to grow to USD 36 billion in

8 Setting the scene - 2 Massive shift in the destinations of global clinical trials in the past 20 years -2% in the US, -1% for Europe = old destinations Positive double digit growth in many countries in Asia and Latin America = new/exotic destinations What happened? First: clinical research saturation in the old destinations 2 nd : increasing costs for conducting CT = creative alternatives to bring them down 3 rd : increasing needs for more patients and more treatment naïve patients Last but not least: clinical trials industry increasingly viewed as an economic growth area in new destinations and more financial support dedicated to it 7

9 Case study #1 the UK Acknowledgment by government that CT make a significant contribution to the UK economy + important means of accessing innovative new treatments for patients Steep decline in CR activities In 2000: UK = #3 country with 6% market shares In 2006: UK = #9 country with 1.5% market shares The decline has since continued due to expensive running costs, slow set-up, unreliable patient recruitment Which actions were taken (to try) to rectify? Health Research Authority created in 2011 to streamline the process and promote and protect the interest of patients and the public in health research Harmonisation, standardisation: IRAS UK-wide E-submission, mctas, mcias, micras, commercial costing template Support to research sites: NIHR clinical research networks, study feasibility, research nurse support Tax incentives: R&D tax credit 52 million investment in new and emerging talent Sciences Industrial Partnership: 7800 education opportunities May never recapture 6% market share 8

10 Case study #2 Asia Main attractive features of Asia: Hosts 60% of the world population Population density is high in cities Growing educated middle class Chronic and lifestyle diseases are common Increasing pool of talents and large hospital infrastructures Facilitation of clinical trials operations via aligned regulations, strategies and incentives without necessarily compromising on the country s priorities India and China as the top 2 countries, followed by South Korea, Singapore, Taiwan, Thailand, Philippines Sustained growth always backed by clear strategies: 9

11 Case study #2 Asia China: low cost environment, Gvt accredits CR sites, Gvt to invest 1.5 billion between 2011 & 2016 although up to 18months approval turnaround compensated by fast recruitment South Korea: quickly becoming a hub. 750 CT in 2013 (only 20 less than China despite much smaller population) helped by Gvt focus on health, a strong medical infrastructure, strategic partnerships with top CROs to set up high standards, parallel submissions, high ICH/GCP compliance, few months for approval, etc. Singapore: IP protection and incentive programs Philippines: low cost country and country is massively investing to become attractive in health research Taiwan: cost effective India: Just few years ago: projected 15% of global trials to go to India by 2010 In 2010, 500 trials registered Today: clinical research industry in troubled waters due to changing regulations (not industry friendly), IP issues and possibly quality of data In 2012, only 262 trials registered Summer2013 : NIH cancelled 40 studies In October 2013: Quintiles closed a phase I unit 10

12 Case study #3 Africa When will Africa be able to compete internationally for this dynamic business with many job opportunities? Low costs? Sufficient and skilled workforce? Talent retention? Regulatory and legal framework Infrastructure Research centres (equipment + training) Logistics: local depots, laboratories, sample transportation Technologies: CTMS, etmf, all e-tools Accreditation schemes and support for SMEs Fiscal incentives In parallel to building the infrastructure Knowledge transfer in running CT with Africa raw materials, traditional medicinal plants Running Investigators Initiated Clinical trials based on local priorities 11

13 Excellence is not a skill. It is an attitude. - Ralph Marston - Disclaimer Pharmalys Ltd 2014 The content of this presentation is the copyright of Pharmalys Ltd. You may store and use the content for your own personal use and research or that of your firm or company. You may not republish, retransmit, redistribute or otherwise make the content available to any other party, website, online service or on any other media without the express prior written consent of Pharmalys Ltd. Pharmalys Ltd 2 Oaks Court, Warwick House Warwick Road Borehamwood,WD6 1GS United Kingdom Pharmalys SARL Résidence Mountakha Bassirou Mbacké Rue Birago Diop, Point E Dakar Sénégal