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1 Analiza i strategia R&D w biotechnologii i farmacji część 2 Rafał Derlacz Zakład Regulacji Metabolizmu, Wydział Biologii, UW

2 Strategia rozwoju i funkcjonowania R&D struktura projektowa?? struktura macierzowa??

3 WYNALEZIENIE LEKU BADANIA PREKLINICZNE BADANIA KLINICZNE REJESTRACJA BADANIA NAUKOWE CZĄSTECZEK NOWY LEK DOPUSZCZONY NA RYNEK FAZA I FAZA II FAZA III LICZBA OCHOTNIKÓW LAT 6-7 LAT 0,5-2 LATA

4 Strategia rozwoju i funkcjonowania R&D struktura projektowa?? struktura macierzowa??

5 Small compound Vs Technology Large compound

6 Koszt Zasoby Czas Sukces vs Porażka

7 Patent protection for XXXX SPC Application Patent Additional Application 2010 Launch Launch Patent protection for NCE SPC

8 PST Development Program Global Development Lead Global Commercial Lead Global Regulatory Lead Global Project Manager Global Payor Lead Global Operations Lead Parallel Processes with Interdependencies Clinical Development Non- Clinical Chemistry Manufacturing and Controls

9 Development Program Aim: NDA Approval / Partnership Nonclinical Pharmacology, ADME, Toxicology Program Typical Development Plan Clinical Program Labeling Label /TPP Clinical Program Non-typical Development Plan Nonclinical Pharmacology, ADME, Toxicology Program NDA NDA / Partner

10 Risk Management Plan Basic Components of a Risk Management Plan Safety Specification Summary of important identified risks important potential risks missing information (ICH E2E) Pharmacovigilance Plan b Based on safety specification; Routine PV practices and action plan to investigate specific safety concerns (ICH E2E) Risk Minimization Activities to be taken to minimize the impact of specific safety concerns on the benefit-risk balance

11 Optimizing Benefit Risk High Unacceptable Risk Risk Manageable Risk Acceptable Risk Low Low Benefit High

12 Life cycle Risk Management Planning Model Development Risk Management Plan created First Time in Humans Candidate selection - FTIH FTIH - PoC PoC- Commit to Ph3 Phase 3 file and launch lifecycle. Candidate Selection FTIH PoC Commit to Ph3 Commit to file Approval and launch Postlaunch reviews DRMP updated with significant new data at least annually and before key development milestones Evolves into the Risk Management Plan submitted with the Marketing Application RMP continues to be updated at agreed milestones; coordination with PSUR, labelling etc

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17 Key Findings Drivers & Resistors for Pharma Key growth drivers and resistors for leading branded pharma companies between 2009 and 2014

18 Factors responsible for declining internal R&D productivity and sales The leading pharmaceutical companies are finding it increasingly difficult to maintain their revenue growth, with several key factors affect R&D productivity and product sales.

19 How are pharma companies improving R&D? Niche, specialty care markets offer Pharma the greatest growth potential In the face of traditional barriers to R&D, Pharma companies are starting to employ a number of strategies. These include, targeting niche indications and increasingly focusing on specialty markets, employing more creative lifecycle management strategies, widening the R&D bottleneck, creating satellite start-up R&D companies, and increasing utilizing CROs to cut internal R&D costs. Source: Datamonitor, PharmaVitae Company Comparator Tool, IMHC0080, January 2009

20 Two key types of restructuring are available to Pharma Restructuring Big Pharma R&D operations to increase productivity While acquiring pipeline and marketed drugs through M&A increases the acquirer s portfolio, it does not necessarily address the core issue of low productivity. However, it does buy the company time with which it can use to implement R&D restructuring; be that horizontal or vertical restructuring in order to reorganize operations, creating smaller R&D units in an effort to re-create the entrepreneurial and innovative culture found in small biotech firms. Source: Adapted from Man, 2009

21 Refocusing R&D onto biologics will increase efficiency Thousands of compounds Biologics will sharpen the focus of the R&D pipeline Research Early development Late development One approved drug In addition to emulating Biotech in terms of R&D structure and culture, Pharma is also increasingly targeting niche markets served by biologic drugs, which offer higher rates of efficacy compared to small molecule drugs (albeit in smaller patient populations), command a high price, and which can be marketed by small secondary care sales specialists. Also as biologics are more insulated against generic competition (at least in the shortterm), the revenue streams of such products achieve greater longevity. Source: Ernst & Young, Beyond Borders, 2008

22 Current barriers to R&D optimization The R&D process is failing somewhere between initial innovation and market approval Despite growing pipelines in recent years, clinical trial success and approval rates have not improved. The key factors impacting Pharma s R&D capabilities and output include: increasing cost, duration and number of delays in R&D, poor candidate selection with drugs chosen on their commercial rather than their therapeutic potential, more limited financial resources with lifecycle management and indication expansion strategies prioritized, rather than for the development of novel innovative drugs.

23 R&D is expensive and carries significant risks, therefore optimizing the way it is carried out is vital The level of R&D investment is balanced by benefits resulting from carrying it out (including the economic value to both society and drug developers, and the benefits to the patient and their family) against the risks and costs (including scientific risk and the costs of development) These benefits and risks are substantial: the top selling drug of 2006 Pfizer s Lipitor (atorvastatin) generated $10.3 billion that year across the six major markets that year 1, meanwhile total R&D spend by the pharmaceutical industry in 2006 was estimated at $55.2 billion (PhRMA Pharmaceutical Industry Profile, 2007) As a result of the high level of investment and risk, strategies to improve its productivity have historically received considerable attention. Additionally, there are a number of factors that are changing the R&D environment and making drug developers increase their focus on improving productivity and be more responsive so they are better placed to capitalize on opportunities 1 : 6 major markets = France, Germany, Italy, Spain, the UK and the US; MIDAS Sales Data, IMS Health, July 2007, Copyright, reprinted with permission)

24 There is a widespread belief that Big Pharma is facing an R&D productivity crisis, however there are many who argue that this is not the case Drug development costs have soared, with estimates that the average cost to develop a successfully launched drug ranging from $ bn (Gilbert et al., 2003; Adams & Brantner, 2006) The pharmaceutical industry is an ultra slow industry, making it is very difficult to forecast future performance and assess current productivity The overall number of drug approvals have been falling over the last 15 years Big Pharma is facing a productivity crisis Big Pharma is not facing a productivity crisis The number of priority approvals has risen consistently over the last 40 years Of the drugs that are being approved, only a low percentage are truly new, innovative drugs The number of drugs entering clinical trials increased 52% from to the period (Tufts Impact Report, May/June 2006)

25 Irrespective of whether the industry is facing a R&D productivity crisis a number of factors are changing the R&D environment and making drug developers increase their focus on improving productivity, including Failing in-house R&D productivity Shorter periods of exclusivity? Increasing internal pressures Patent expiries on a number of key drugs Pressure on Big Pharma Increasing regulatory pressures An increasingly harsh P&R environment negatively impacts profitability and reduces R&D spending Renewed focus on increasing reliance on generic and drugs sourced from parallel importation in the major markets

26 Deal activity is relatively constant, but spikes slightly at the end of each year Deal activity per quarter, End-of-year deal activity spikes are caused by: Deal number Q Q Q Q Q Source: MedTRACK, April 2007, Datamonitor plc Q Q Q The keenness of drug developers to use up their budgets by the end of the year The strong interest of deal partners in getting a deal signed and completed at the end of the year and not letting it drag into the next year this is driven by the impact of deals on annual accounts and the resulting effect on the investment community

27 Leading dealmakers during During , Novartis was the leading dealmaker, followed by Bayer-Schering, Roche, J&J and GSK, with the top 6 companies responsible for 50% of all deals made by the leading 20 Pharma. Novartis was the leading dealmaker during Source: MedTRACK, September 2007, Datamonitor plc

28 Leading technology dealmakers Merck & Co. and Novartis performed the most technology deals during Merck & Co. and Novartis were the leading technology dealmakers in , collectively representing 24% of technology alliances made by the top 20 companies; with the leading six developers responsible for more than half (54 %) of all deals. However, replicating the falling number of drug discovery deals by the top Pharma as a whole, the average number of deals Merck & Co. and Novartis made per year has declined. Source: MedTRACK, September 2007, Datamonitor plc

29 How much should be spent on promotion? Companies with higher promotional spend in 2006 experienced a higher annual growth rate in The larger the pharmaceutical company, the more promotional spend it can afford. However, with the top 10 leading companies there is an inverse correlation between promotional spend and sales growth during 2005 and Therefore, in the face of ongoing patent expiries, combined with fewer novel products entering the market, and a declining return on investment, manufacturers are increasingly using promotion to drive drug sales

30 Key determinants driving promotional spend Source: Datamonitor

31 Earlier stage companies dominate as both source and partner in deals Earlier-stage companies are the most active deal makers from University/ research center/ government 7% Top 200 8% Top 50 12% Emerging markets 1% Earlier stage 72% CRO 2.7% Emerging markets 4.8% Top % Manufacturer 1.2% University/ research center/ government 9.0% Private equity 0.5% Technology provider 0.2% Earlier stage 47.0% Early-stage companies are the dominant source company and partner company in deals because: They play a leading role in supplying novel drugs and technologies to the market They lack the full integration of Big Pharma companies therefore, key functionalities, technologies, products and other resources are externally sourced Source Top % Partner Source: MedTRACK, April 2007, Datamonitor plc

32 Partnership focused co development deals, together with functional licensing deals are the most popular deal types, in terms of primary deal goal Co-development and licensing deals are the most common deal goals, accounting for more than two thirds of deals, Cash injection 5.6% Marketing/ distribution 6.1% Manufacturing 9.0% Formulation/ delivery 1.2% Licensing 22.0% M&A 1.0% Running clinical trials 4.6% Source: MedTRACK, April 2007, Datamonitor plc Manufacturing 0.5% Joint venture 0.2% Codevelopment 49.6% Other 0.2% Half of all deals were codevelopment deals, which are complex, partnershipfocused multi-facet deals involving a number of elements, and are widely used among earlier-stage companies, to boost the value of their product or technology Almost one quarter of deals are more functional licensing deals, which are more frequently used by top-50 and top-200 companies to buy in a specific technological expertise or product portfolio

33 Both the pipeline and the deal activity databases indicate that oncology is the dominant pipeline therapy area Oncology remains the dominant target, Other (2150) 31% AI & I (417) 6% CV & circulation (432) 6% Pipeline snapshot Infections (613) 9% Cancer (2409) 34% CNS (964) 14% CV & circulation (22) 5% Metabolic & Endo (27) 7% Source: MedTRACK, April 2007, Datamonitor plc Deal snapshot Other (143) 35% CNS (55) 13% Cancer (105) 25% Infections (61) 15% Oncology leads the therapeutic focus of pipeline development and deal activity, but patenting activity is lower than other therapeutic areas like CNS Both CNS and cardiovascular are dominant in terms of pipeline and deal focus, and in terms of patenting activity Infectious disease ranks high in terms of pipeline and deal focus, and patenting activity

34 Biologics are popular, although small molecules remain the dominant focus Reasons for these trends include: Of the biologics deals, antibodies dominate the deal focus while recombinant proteins lag behind, Cell-based therapy 1% Fusion protein 3% Nucleic acid therapeutic 11% Recombinant protein 15% Other 10% Vaccine 28% Source: MedTRACK, April 2007, Datamonitor plc Antibody 32% mabs are currently the high-growth biotech sector because of their attractiveness, because biosimilars of antibodies remain a long way away, and the expanding range of targets in the oncology and IDI markets is helping to drive the development of a wide number of antibodies The therapeutic recombinant protein sector is the mature, low-growth sector of the biologics market; most of the lowhanging fruit have already been picked, therefore deal activity has fallen

35 A number of factors underlie the therapeutic trends of deal activity and the industry s pipeline Approval times are quickest for infectious disease and oncology/idi drugs (Tufts Impact Report, May/June 2006) Both probability of progression through development and development speed are optimal for oncology, IDI and infectious disease drugs (Adams & Brantner, 2006; Tufts Impact Report, May/June 2006) Specific characteristics of therapy areas make some more attractive to drug developers for example, therapeutic areas such as oncology and IDI are characterized by a high unmet need in niche markets; therefore, by targeting these markets, drug developers can charge high prices, reduce sales and marketing spending by targeting a small number of specialist physicians, and obtain higher pricing and reimbursement levels Cost of drug development is lowest for infectious disease drugs such as HIV/AIDS medications, compared to other therapeutic areas such as respiratory (Adams & Brantner, 2006)

36 The R&D model can be optimized using a number of improvements Optimize R&D process Optimize macro drug development strategy Optimize outsourcing strategy (especially CROs) Better utilize licensing & M&A to support R&D Drive up access to earlystage research R&D strategy recommendations Optimize R&D model R&D tools

37 A range of factors are driving the use of CROs The opportunity to offset the capital outlay the company needs to make to build the capability up from scratch To boost staff resources in drug development companies, allowing them to focus on their core competencies The opportunity to save cash, based on increased productivity, leveraging economies of scale; and making savings related to the location where the work is carried out CRO usage The scope to quickly access expertise in a specific area CRO projects have a greater R&D productivity To help drug developers combat the increasing complexity and size of clinical trials The greater number of non fully integrated drug discovery companies in the marketplace who need to contract out clinical research program management

38 CRO activity is moving away from Europe and the US for a number of reasons advantages and disadvantages of using emerging market CROs include

39 Optimize CRO strategies: India benefits and issues Possible concerns that early-stage nature of scientific advancement in the omics fields compared to the major Western markets High level of patient consent Strong chemistry history Compliance and service levels vary widely Cultural issues: e.g. communication of bad news, plus importance of timelines Historically weak IP protection Corruption remains a problem Negatives with using Indian CROs Positives with using Indian CROs Talent pool of highquality and enthusiastic medical staff, researchers and investigators with strong work ethics Rapidly rising salaries for highly skilled workers & saturated quality manufacturing and R&D capacity A range of governmental initiatives have improved the environment & reduced the risks associated with carrying out R&D (including improving the IP environment)

40 Optimize CRO strategies: China benefits and issues Political issues (including political uncertainty, governmental expectations of expertise, investment and commitment, plus issues over the Foreign Corrupt Practices Act) Ethics issues (including concerns over animal welfare, weak privacy protection and the fact that investigators are not used to gaining informed consent) Increasingly strong IP protection Availability of non-human primates Increasingly harmonized regulatory process High numbers of professionals Complicated regulations with different interpretations Concerns over animal quality Shallow senior management pool Negatives with using Chinese CROs Positives with using Chinese CROs

41 A range of strategies can optimize the CRO experience Ensure that communication between the CRO and the drug developer is strong, and that the right information is communicated: Set up a team to co-ordinate decision making Ensure that each party understands their roles & responsibilities & clearly explain expectations Be aware of the CRO s concerns, and address them Ensure there is honesty in what can and cannot be done Make significant commitments in the relationship with the CRO: Keep senior management high-profile Dedicate significant resources to monitor and manage the relationship Enable effective know-how transfer and use this to build trust Ensure that the way that staff are used is optimal Aim to keep turnover low Invest significantly in finding the right higher-grade staff Drug developers should try to remain appropriately cautious and not take unnecessary risks with the CRO relationship

42 There are a range of recommendations for optimizing licensing strategies and making licensing more efficient, from both a time saving and a cost saving perspective Deal-selection recommendations Deal-execution execution recommendations Companies must proactively seek licensing opportunities rather than waiting for companies to approach them Ensure that external and internal projects are judged equally Successfully identify suitable deals that are consistent with corporate strategy Ensure strong communication Boost transparency of process Enhance understanding of critical issues Carry out effective due diligence Optimize team infrastructure Securing deals by being a partner of choice

43 in addition to these recommendations, there are a range of factors that restrict a licensing deal, which are to be avoided Weak commitment Ignoring key issues Merger/acquisitions change priority Incompatible objectives Budget limitations Factors restricting licensing deals Unrealistic timing Lack of flexibility Poor leadership & ineffective governance Drastic changes in business environment, or changes in senior management Inconsistencies in decision making & slow decision making

44 Big Pharma can use four strategies to gain access to early stage research Greater collaborations with universities/ research institutes/ governments Set up private equity funds Use more open-source research for precommercial work Set up incubators

45 There are four key ways to optimize macro drug development strategies Determine what weight should be placed on developing follow-on drugs compared to first-in-class innovative drugs Broaden range of targets being targeted but in a therapeutic focus-targeted way Ways to optimize macro drug development strategy Tighten therapeutic focus Implement effective portfolio management

46 Improvements to the way that R&D tools are used can also help to optimize the R&D model Optimize R&D process R&D strategy recommendations Optimize R&D model R&D tools Optimize the use of biomarkers to segment the market to drive future market growth Identify potential opportunities for better use and implementation of IT

47 Biomarkers are used in a range of functions To create a targeted therapy based on a logical target choice, which is designed to improve safety and efficacy of treatment To reduce the government expenditure on unnecessary medicines Increased biomarker usage To better define or even reclassify a disease, and to identify the disease at an earlier stage To reduce the costs of clinical trials and improve the chance of approval To use in clinical trials as surrogate endpoints

48 Factors driving the evolution of biomarkers Factors restricting the evolution of biomarkers The movement from detection/screening to therapy monitoring The increasingly wide use of diagnostics in the clinical setting Evolution of technology Relative ease of development Evolution of use and integration of biomarkers into Big Pharma R&D strategy Alliances formed by diagnostics companies Increased use of biomarkers with imaging Adequately assessing new biomarkers Low profit and reimbursement for biomarker developer, if biomarkers are developed independently from the drug developer Lack of ROI from genomics investments Issues with the IP Issues with new technologies Slow uptake and development of new biomarkers The biomarker field is becoming increasingly complex

49 There are many roles for increased IT usage Handling data accumulated with target identification/ validation Improving lead identification/ optimization with technologies such as in silico modeling Increased IT usage Clinical trial modeling and simulation Managing clinical trial data Improved communication Optimized computer models used across the whole drug development process Text searching, mining and analysis

50 A range of strategies that can be used to improve R&D processes Develop robust strategies to reduce attrition Improve patient enrollment Build up close relationship with KOLs Improve the way clinical trials are carried out in-house Optimize safety assessment in preclinical trials Optimize R&D process Optimize interaction with regulators Introduce greater P&R input into R&D process R&D strategy recommendations Optimize R&D model

51 There are two strategies to improve the way that safety testing is carried out in the preclinical setting: Using better safety assessment tools Adopting a more rigorous safety testing program, based on the following safety goals Use Phase Zero/microdosing and expinds Define the toxicological profile in lab animals Identify toxicity biomarkers to to be used in human testing Produce a preclinical data package for all necessary stakeholders Safety goals Select the right animal model (based on factors such as previous drug experience, similar pharmacology on target), carry out test ing and then determine the difference between animal models and human models, in terms of metabolism and pharmacokinetics

52 Strategia rozwoju i funkcjonowania R&D struktura projektowa struktura macierzowa

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