Pharma 2020: Which Path will you take? Automation in Pharma Congress, Leiden 8 October 2009 Loic Kubitza & Arwin van der Linden

Transcription

1 Pharma 2020: Which Path will you take? Automation in Pharma Congress, Leiden 8 October 2009 Loic Kubitza & Arwin van der Linden

2 Agenda Trends and implications Potential business models Personalized medicine Impact on manufacturing 2

3 There is more power to patients. Market trends More diversity due to the emerging markets Better informed patients Bigger bill share for patients Individualization More complex care and personalized treatment models Demand for cures vs treatments Health & Healthcare The burden of and bill forchronic disease is soaring Healthcare payers are establishing treatment Budget protocols Pay-for-performance pressure on the rise Blurring boundaries between different forms of care Increasing financial constraints on payers Scientific & Technological More virtualised R&D The research base is shifting to Asia Remote Increased monitoring is improving rapidly possibilities 3

4 .so Pharma needs to deliver. Pharma to go beyond the medicine Outcomes will pay (vs. products) Outcomes data will drive healthcare policy Get paid for Higher profile for prevention what is delivered Pharma to offer medicinesplus packages of care Pharma to adopt more flexible pricing strategies R&D to go beyond the lab Pharma to access outcomes of data Pharma to work with IT vendors to virtualise R&D Pharma to Need have for a wider, more multy-disciplinary skills base Pharma to evidence extend its presence in Asia Pharma to demonstrate real value-for-money More intertwined Pharma and Healthcare value chains Pharma to work closer with regulators Pharma to collaborate with Enhanced payers and providers to perform continuous relationships trials Pharma to collaborate with numerous service providers to deliver packages of care Business models based on collaboration 4

5 The business model of today must change to one that fully embraces collaboration PRESENT centred on the securing and protection of IP leveraging scale to run widespread clinical trials and deliver an extensive sales and marketing presence. single companies, deploying a variety of contractual relationships, but seeking to secure profits on their own a profit alone model patents alone will no longer suffice profit alone model will have gone the same way as the blockbuster model. a company s ability to develop collaborative business models will dictate success in the 2020 world. Profit alone will have been replaced by profiting together by developing networks of collaboration This is a business model where you are guaranteed to lose your entire book of business every 10 to 12 years. J.P. Garnier, former chief executive of GlaxoSmithKline 5

6 The Fully Diversified Model will only be pursued by the very largest of organisations Ethical Pharmaceuticals Diagnostics & Devices Generics Consumer Health Health Management Mass-Market Primary-care products (Including patches, inhalants and controlledrelease implants) Poly-pills Specialisedmarket Biologicals Orphan Drugs Vaccines Molecular testing Clinical Biomarkers Medical Devices Branded generics Commodity generics Super-generics Follow-onbiologicals Over-the-counter medicines Consumer diagnostics Nutraceuticals Patient education Delivery and drug administration services Monitoring and counselling Physiotherapy Nutritional advice Wellness management 6

7 The Federated Model will lead to sustainable competitive advantage if implemented effectively Incentives Fixed budget/patient Improved life expectancy Improved QALYS 7

8 The Venture variant secures control and autonomy through funding mechanisms Pharmaceutical company Growth company Investors Third Party Service providers (CRO, CDO, CMO etc.,) 8

9 While the Virtual variant is a potential familiar starting point for more collaborative models 9

10 One emerging area of collaboration for the pharma industry is with diagnostics industries To support the move towards more personalised medicine, the pharma industry is seeking new, relevant tools using expertise from the diagnostics industry. 10

11 Personalised medicine What is it? Is it new? Common sense definition Fit the therapy to the patient A formal definition - A form of medicine that uses information about a person s genes, proteins, and environment to prevent, diagnose, and treat disease (US National Cancer Institute) The industry leader s perspective - Personalised healthcare is nothing new. Doctors have always tried to fit the therapy to the patient if possible. But what s happened more recently is that we ve begun to go a level deeper... We re now exploring the biology of disease and treatment at the molecular level. (Severin Schwann, CEO, Roche) 11

12 Personalised medicine is it important? Current levels of drug performance are far from satisfactory Today, the response rates vary from 20% to 75% depending on the drug and the disease. Jürgen Schwiezer, CEO, Roche Diagnostics 12

13 Accessing new tools from the diagnostics industry In-house cooperation Buy-in Fee for service Licensing 13

14 In-house cooperation The pharma business is part of a group that also includes a diagnostics division. Illustration Three obvious examples: Roche, J&J and Abbott these groups include three of the top five IVD businesses. Other cases with medium sized or emerging IVD businesses: Fujirebio, Menarini, Solvay and Novartis. - As regards Novartis, in 2006 the company added a diagnostics business through the acquisition of Chiron. More recently, it decided to develop a diagnostics division focused on molecular diagnostics. 14

15 Buy in The pharma company buys an IVD business giving it full control of the IP Illustration Solvay s $256 million acquisition of Innogenetics, announced in

16 Fee for service The pharma company benefits from services provided by the IVD specialist, in exchange for a fee. IP rights in this case are not necessarily transferred. Illustration Lab21 s September 2009 agreement with AstraZeneca to provide a genetic testing service for oncologists in lung cancer. - The service funded by AstraZeneca aims to allow oncologists in the UK National Health Service to identify whether lung cancer patients have activating mutations in their tumours making them sensitive to tyrosine kinase inhibitor drugs. The genetic information gained from the service will assist oncologists in determining the most appropriate treatment choice for lung cancer patients. The genetic test will be carried out on samples of patients solid tumours at Lab21 s laboratories in Cambridge with results returned to oncologists within five working days. 16

17 Licensing The pharma company licenses some IP rights from the IVD company. The IP is with the IVD company but the pharma partner gets certain development or commercialisation rights. Illustration DxS s September 2009 collaboration agreement with Bristol-Myers Squibb and Lilly s subsidiary ImClone Systems to further develop a K-RAS companion diagnostic for Erbitux (cetuximab) in the US and Canada. 17

18 Outlook for CD deals We expect the annual number of diagnostics partnerships between pharmaceutical and diagnostic companies to increase over the next five years. A key factor will be increased pressure on pharmaceutical companies from regulators and payers to provide a diagnostic alongside pharmaceuticals to guide their use. 18

19 FDA imposes testing for 4 genomic biomarkers prior to drug prescribing 28 valid genomic biomarkers reported on FDA website (at 20 March 2009) - some biomarkers apply to several indications, e.g. EGFR expression. 4 biomarkers are required to be tested for prior to prescribing of an associated drug. The 4 Biomarkers Requiring Testing Prior to Deciding on the Drug Use Biomarker CCR5 - chemokine C-C motif receptor Epidermal growth factor receptor (EGFR) expression Her2 / neu over-expression Philadelphia chromosomepositive responders Representative Label Selzentry, in combination with other antiretroviral agents, is indicated for treatment-experienced adult patients infected with only CCR5-tropic HIV- 1 detectable, who have evidence of viral replication and HIV-1 strains resistant to multiple antiretrovira. Patients enrolled in the clinical studies were required to have immunohistochemical evidence of positive EGFR expression using the DakoCytomation EGFR pharmdx test kit. Detection of HER2 protein overexpression is necessary for selection of patients appropriate for herceptin therapy. Herceptin should be used in patients whose tumors have been evaluated with an assay validated to predict HER2 protein overexpression. Dasatinib is effective for the treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Indication Infectious Diseases (HIV) Cancer (Colorectal) Cancer (Breast) Cancer (Leukemia) Drug Selzentry (maraviroc) Erbitux (cetuximab) Herceptin (trastuzumab) Sprycel (dasatinib) Drug Marketer Pfizer Bristol-Myers Squibb Genentech Bristol-Myers Squibb Note: We show only one drug per biomarker, using the drug presented as prototype by the FDA. For each of the biomarkers reported above, there may be other drugs for which prescribing is affected in the same way as the representative drug shown above. Source: PricewaterhouseCoopers analysis using data from the FDA s website at 20 March

20 EMEA imposes biomarker testing for at least 11 drugs Eleven Drugs Requiring Biomarker Testing Prior to Deciding on Drug Use Drug Ziagen (abacavir) Epitol / Tegretol (carbamazepine) Herceptin (trastuzumab) Tasigna (nilotinib) Sprycel (dasatinib) Trisenox (arsenic trioxide) Erbitux (cetuximab) Tarceva (erlotinib) Vectibix (panitumumab) Tykerb / Tyverb (lapatinib) Iressa (gefitinib) Novartis Cephalon Amgen Drug Marketer GlaxoSmithKline Novartis Genentech/Roche Bristol-Myers Squibb Bristol-Myers Squibb, ImClone Systems, Merck Genentech/Roche GlaxoSmithKline AstraZeneca, Teva Test Requirement Screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient. Abacavir should not be used in patients known to carry the HLA-B*5701 allele, unless no other therapeutic option is available in these patients, based on the treatment history and resistance testing. Patients of Han Chinese and Thai origin should be screened for HLA-B*1502 as this allele strongly predicts the risk of severe carbamazepine-associated Stevens Johnson syndrome. Susceptibility to the therapy is determined by the analysis for HER2/neu over-expression. Patients with imatinib-resistant Ph+ chronic myeloid leukemia. Patients with imatinib-resistant Ph+ chronic myeloid leukemia. PML/RAR alpha gene+ [or t(15;17) translocation] acute promyelocyticleukemia. EGFR+ metastatic colorectal cancer after failure of irinotecan; KRAS wildtype metastatic colorectal cancer. Advanced non-small cell lung carcinoma; no clinically relevant effects demonstrated for patients with EGFR- tumours. EGFR+, non-mutated KRAS, metastatic, previously treated colorectal cancer Conditional Marketing Autorisation. In combination with capecitabinefor Her2+ breast cancer after failure of taxanesand trastuzumab Conditional Marketing Autorisation. For the treatment of patients with locally advanced or metastatic non-small cell lung carcinoma with activating mutations of EGFR-TK. Indication Infectious Diseases Neuropsychiatric Diseases Cancer Cancer Cancer Cancer Cancer Cancer Cancer Cancer Cancer Source: Data extracted from the presentation by Dr. Marisa Papaluca Amati, Deputy Head, Sector Safety and Efficacy of Medicines, EMEA, at the SGPPH Spring Conference, London, 3 June 2009 Note: This presentation of testing requirements by the EMEA is different from the FDA table as it starts with the drug for which there is a biomarker testing requirement rather than starting with the biomarker which needs to be tested for. 20

21 Key enabling technologies shaping the Manufacturing landscape Process Analytical Technology Organizational Network Analysis Modular Plant design Semantic Web Electronic Data Capture Simulation and Virtual Prototyping Continuous Manufacturing Concepts Cell on a chip Electronic Batch Management Disposable manufacturing technologies RFID Recipe driven manufacturing E-patient diaries E-labelling Demand driven manufacturing Condition based maintenance E-licensing Lab on a chip Master Data Management PLM Miniaturized Manufacturing Concepts SPC R&D Workflow Management 21

22 Future manufacturing scenarios Scenario 1: Scenario 2: M O D E R N I Z E L O W E R C O S T A U T O M A T I O N & I N T E G R A T I O N Scenario 3: Mass market Manufacturing Large-scale highly flexible plants, with high throughput Scenario 4: Speciality/Niche Manufacturing Small scale pilot centers, Integration of R&D and production: Small batches, 24/7 running Move to personalized medicines Clinical and patient feedback loops Continuous optimization and improvement 5 year 10 year 15 year 22

23 Short Term (within 5 years) Scenario 1: M O D E R N I Z E L O W E R C O S T What is the strategic response? Invest in existing manufacturing facilities, lower manufacturing costs, increase safety, comply to actual regulatory demands, increase quality, etc. Upgrade to a PAT/QbD state Higher degree of automation Integration of equipments and systems Introduction of new technologies SHORT TERM INVESTMENT CASE 23

24 Mid Term What is the strategic response? Scenario 2: A U T O M A T I O N I N T E G R A T I O N Shift from batch manufacturing to fully automated and integrated continuous manufacturing with integrated quality, designed into the process. Continuous Processing Real-time quality decision making Real-Time-Product-Release Just-In-Time Production MID TERM INVESTMENT CASE 24

25 Long Term Scenario 3: Mass market Manufacturing Large-scale highly flexible plants, with high throughput Scenario 4: Specialty/Niche Manufacturing Small scale pilot centers, Integration of R&D and production: Small batches, 24/7 running What is the strategic response? Moving towards personalized medicine, variations of the same product, closer integration between R&D, Manufacturing, sales and customer Increased manufacturing complexity Challenges to Manufacturing Execution Systems, Quality Systems, etc. Simultaneous engineering LONG TERM INVESTMENT CASE 25

26 Implications on manufacturing 2020 Manufacturing Operating Model Short-term Medium-term 2020 Make to stock Configure to order Make to order Customers Wholesalers Retailers & pharmacies Genetically assoc. patient groups Annual Production Output Three blockbusters 50 new drugs new drugs Demand Changes Monthly Weekly Hourly Capacity is planned Weekly Daily Continuously Outsourced production 20% 50% 80% Batch size 1 000s 100s <10s FG inventory as a % of Sales Less than 15% Less than 8% Less than 2% 26

27 Key messages Pharma and healthcare value chains are becoming more intertwined Business models must change to fully embrace collaboration Diagnostic tools are becoming available to better target treatments to the individual Pharma is increasingly accessing these new tools through collaborations Regulatory and reimbursement pressures will further drive the move towards personalised medicine These trends will raise demands on manufacturing models to adapt to smaller target markets and move from make to stock to make to order 27

28 For further information: Arwin van der Linden Partner Pharmaceuticals & Life Sciences PricewaterhouseCoopers The Netherlands [31] Loïc Kubitza Director Pharmaceuticals & Life Sciences PricewaterhouseCoopers Luxembourg [352]