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Change in the Pharmaceutical Industry: Aspects on Innovation, Entrepreneurship, Openness, and Decision Making
Linköping University, Department of Management and Engineering. Linköping University, The Institute of Technology.
2012 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Over the past century, the pharmaceutical industry has been a major contributor of individual and population health and societal wealth. Its products and services have contributed to longevity of large groups of patients and symptom relief from major diseases. However, during the past 2 decades, the innovative capacity of the pharmaceutical industry has lagged behind, and there have been concerns and discussions on the prevailing business model of the industry, and whether it needs to be refined and altered.

Development of a new drug is a time-consuming and complex undertaking, which involves elements of discovery as well as process development. Recently, the average cost of developing a new molecular entity (NME) was estimated to be around U$800 million for small molecules and around U$1,300 million for biologics. If post approval costs for Phase IV studies, costs to gain regulatory approval in various global markets and costs for obtaining additional label claims for new indications are included and adjusted for cost increases and inflation, the cost estimates per NME increase to U$1,754 million for small molecules and U$3,911 million for biologics. Revenue streams from global market sales are only able to offset these escalating costs to a limited extent.

The present dissertation focusses on the on-going change processes in the pharmaceutical industry (Big Pharma). An important change process is related to open information and open intellectual property (IP) platforms. The work also relates to entrepreneurial orientation, inherent project uncertainty and decision modelling. In the biomedical field, there are an increasing number of stakeholders that collaboratively develop, package and build transactions around technology. Such open innovation model differs from the classical closed innovation model when openness is structured in open networks and business consortia. This thesis provides examples of how open innovation models function in the context of the pharmaceutical industry and how Life Science companies could design their IP-strategies to optimize the value extraction potential from open innovation in general and open IP platforms in particular.

The present work also investigates perceptions of experts within the pharmaceutical industry and allied health sectors, with respect to entrepreneurial attitudes, intent and engagements during pharmaceutical innovation and new drug development. It was shown that positive attitudes and orientation towards entrepreneurship are perceived to be of high value for the early strategic selection and validation of the drug target area, for costs assessments and pharmacoeconomics, as well as for positioning and marketing of a new drug to patients and the public. Entrepreneurial traits were however judged to be less important for some major process steps during preclinical and clinical development.

Based on real scenario cases, this thesis also investigates how employees make judgments in the pharmaceutical industry and allied health care sectors. Each case study relates to go/no-go decisions taken from the various steps in drug discovery through preclinical and clinical development (IND) on to market introduction (NDA) and treatment of the target population. Results revealed that there is a major inter-individual difference between experts in their individual intuitive go/no-go/recycle decisions during the drug discovery and development process. This lack of coherence and wide variability with respect to the drug development cases selected may reflect judgment  in the real world. Accordingly, increased openness, entrepreneurial awareness and orientation towards entrepreneurial engagements and skills may help the pharmaceutical business sector to improve vital parts of its value creation processes. Also, by modelling decision-making in real cases from initial drug discovery to late development and marketing, in pharmaceutical industry R&D, we demonstrated that rational decision-making can commonly be managed by a group of 10 – 15 experts when mean group judgments over a series of decision points are clear go decisions. However, when mean group judgments from one decision point to another vary from go to stop in a specific case, i.e. involves a recycle component, there will be a need to expand R&D expert input substantially. In such cases, the drug development processes more or less takes on the form of an open innovation process. Thus, our findings may be used to construct a new model on how to plan and model the size of expert input in structured decision processes similar to those practiced in the pharmaceutical industry.

Based on the findings in this thesis, it may be concluded that high-tech innovation in the pharmaceutical and biotech sectors show signs of movement from a closed to a more open innovation paradigm. This change is driven by several factors such as the possibility of rapid and unlimited communication through the Internet, the increasing global availability of experts for complex decision-making, the international reach of innovators and entrepreneurs, the need of the venture capital market to support appropriate investment cases, as well as the increasing possibility and interest of external suppliers and interest groups to participate in new product and service development.

Abstract [sv]

Läkemedelsindustrin har under det senaste århundradet varit en viktig bidragande orsak till hälsa och välfärd i samhället. Innovativa produkter och tjänster har bidragit till att öka livslängden och att ge symtomlindring för stora grupper av patienter med allvarliga sjukdomar. Men under de senaste 2 decennierna har den innovativa kapaciteten inom  läkemedelsindustrin släpat efter, och man har diskuterat om den klassiska affärsmodellen för branschen behöver omvärderas och förbättras.

Utveckling av nya läkemedel är ett tidsödande och komplicerat arbete som löper under flera år i syfte att lansera en innovativ produkt på marknaden. Den genomsnittliga kostnaden för att utveckla en helt ny molekyl (new molecular entity - NME) har nyligen beräknas till cirka U$ 800 miljoner för små molekyler och runt U$ 1,300 miljoner för biologiska läkemedel. Om kostnader för sena studier, så kallade fas IV-studier, kostnader för att erhålla registrering på globala marknader, liksom kostnaderna för att erhålla godkännande för nya och tillkommande indikationer inkluderas samt justerats för kostnadsökningar och inflation, så kommer de totala uppskattade kostnaderna per NME att öka till U$ 1.754 miljoner för små molekyler och U$ 3.911 miljoner för biologiska läkemedel. Sådana kostnader för utveckling av ett nytt läkemedel kan endast med få undantag motiveras av intäkter från den globala försäljningen.

Avhandlingen använder kvalitativa och kvantitativa metoder för att studera några pågående förändringsprocesser i läkemedelsindustrin (Big Pharma) vilka drivs av öppen innovation och IPplattformar, entreprenörsanda, osäkerhet i beslutsmodeller och en hög inneboende utvecklingsrisk och finansiell risk. På det biomedicinska området finns det ett ökande antal aktörer som samarbetar för utveckla och bygga transaktioner kring olika forskningsområden. Dessa nya och öppna innovationsmodeller skiljer sig från de klassiska slutna innovations-modellerna som tidigare varit förhärskande inom läkemedelsindustrin (Big Pharma).

Avhandlingen ger exempel på hur det öppna innovationsperspektivet kan användas vid utveckling av nya läkemedel och hur Life Science-företag i framtiden kan utforma sina IP-strategier för att optimera värdet av öppna innovationsstrategier och öppna IP-plattformar. Avhandlingen berör även hur av experter inom läkemedelsindustrin och myndigheter ser på företagande och risk, och betydelsen av entreprenörskap för utveckling av nya läkemedel. Anställda inom sektorn uppfattar att positiva attityder till företagande är av stort värde för tidiga strategiska val och validering av nya läkemedels verkningsmekanismer, för kostnads-nytta bedömningar och hälsoekonomi, liksom för positionering och marknadsföring av ett nytt läkemedel till patienter och allmänhet. Entreprenöriella egenskaper bedömds dock vara mindre viktigt för ett antal rena processteg under den prekliniska och kliniska utvecklingen.

Baserat på verkliga utvecklingsscenarier har vi undersökt hur experter från läkemedelsindustri och sjukvård gör bedömningar i komplexa fall av läkemedelsutveckling. De olika fallen omfattar verkliga go/no-go beslutssituationer som illustrerar de olika stegen i läkemedelsutvecklingsprocessen från preklinisk och klinisk utveckling (IND) till marknadsintroduktion (NDA). Resultaten från studierna visade att det finns en stor interindividuell skillnad mellan hur olika experter gör sina intuitiva go/nogo/recycle beslut under tidig respektive sen läkemedelsutveckling. Denna uppenbara brist på enhetlig beslutsmodell och stora variation mellan experter avseende bedömning av risker och nytta i läkemedelsutvecklingsprocessen medför svårigheter att styra den industriella utvecklingsprocessen. När osäkerheten i industrins beslutsgrupper blir för stor ökar också risken för felaktiga beslut. Sådan osäkerhet kan i praktiken endast lösas genom att man involverar ett stort antal experter i go/nogo/recycle besluten, det vill säga genomför en mer eller mindre öppen innovationsprocess. Avhandlingens resultat kan användas för att ta fram nya modeller över hur man bäst planerar och utnyttjar olika experters kunskap och erfarenhet för att optimera strukturerade beslutsprocesser inom läkemedelsindustrin.

Med olika strategiskt anpassade öppna innovationsmodeller skulle man kunna utveckla och förvalta viktiga innovationer på ett mer konstruktivt sätt inom läkemedelsindustrin. Idag finns ett flertal exempel som illustrerar att detta är möjligt, som till exempel vid nya läkemedel för behandling av malaria (MMV - Medicines for Malaria Ventures).

denna avhandling drar jag slutsatsen att högteknologiska innovationer inom läkemedels- och bioteknikindustrin, i allt större utsträckning rör sig från en sluten till en mer öppen innovation paradigm. Denna förändring inom läkemedelssektorn drivs av flera faktorer såsom möjlighet till snabb och allt mer obegränsad kommunikation via Internet, den ökade globala tillgången på experter för komplexa beslut, liksom tillgång till allt flera oberoende innovatörer och entreprenörer, kapitalmarknadens behov att hitta lämpliga investeringar, liksom det ökande intresset från externa experter och intressegrupper att delta i komplex produkt- och tjänsteutveckling.

Place, publisher, year, edition, pages
Linköping: Linköping University Electronic Press, 2012. , 85 p.
Series
Linköping Studies in Science and Technology. Dissertations, ISSN 0345-7524 ; 1393
Keyword [en]
Pharmaceutical industry, Big Pharma, life sciences, drug discovery, drug development, R&D, business model, innovation, closed innovation, open innovation, entrepreneurship, intellectual property, multiple stakeholders, decision making, judgment, uncertainty, go/no-go, go/no-go/recycle, company, SME.
Keyword [sv]
Läkemedelsindustri, Big Pharma, biovetenskap, läkemedelsutveckling, utveckling av läkemedel, FoU, affärsmodell, innovation, stängd innovation, öppen innovation, entreprenörskap, immaterialrätt, beslutsfattande, osäkerhet, go/no-go, go/no-go/recycle, företag, små och medelstora företag
National Category
Engineering and Technology
Identifiers
URN: urn:nbn:se:liu:diva-74781ISBN: 978-91-7393-082-6 (print)OAI: oai:DiVA.org:liu-74781DiVA: diva2:492631
Public defence
2012-01-27, ACAS, Hus A, Campus Valla, Linköpings universitet, Linköping, 10:15 (English)
Opponent
Supervisors
Available from: 2012-02-08 Created: 2012-02-08 Last updated: 2016-05-04Bibliographically approved
List of papers
1. Open Innovation in the Biomedical Sector - An Alternative Approach to Organizational Value Extraction
Open this publication in new window or tab >>Open Innovation in the Biomedical Sector - An Alternative Approach to Organizational Value Extraction
2011 (English)In: World Sustainable Development Outlook 2011 / [ed] A. Ahmed and M. Busler, 2011, 31-25 p.Conference paper, Published paper (Refereed)
Abstract [en]

The concept of Open innovation is a phenomenon gaining momentum amung pharmaceutical companies, university research consortia and other for-profit and non-profit organizations in order to address increasingly complex, uncertain and changing R&D projects. In medicine, open innovation projects may provide incentives for creativity, adaptability and easier access to knowledge as well as to generate quicker and cheaper innovation cycles for defined products and services. Also, projects and products may be better adjusted to the markets and provide flexible cost structures in developed as well as developing countries. There are today growing efforts for nonprofit foundations to participate and establish co-operation in complex research and development efforts such as bringing new medical drugs or new technology to public use. Interestingly, such incentives might open up for new and creative open innovation models. In this paper, we discuss how the open innovation model differs from the classical closed innovation model in respect tOj type of project, organizing aspects and value creation and value extraction aspects. We also illustrate 3 different value extraction concepts relating to open innovation in the pharmaceutical sector, representing different strategies and degrees of openness; the Medicine for Malaria Venture (MMV); InnovationXchange; and InnoCentive. Further, we discuss how the term "openness" can be understood in levels; in terms of the extent of control a collective upholds for ownership as well as the access and utilization of platform content that is jointly aggregated, created and developed. Collective innovation can be described as; open for all (openness with little, or no, limitations); open IP groups (openness within R&D groups); open IP projects (openness within R&D collaboration projects); open IP communities (openness within certain communities); and open IP platforms (structural arenas for openness). Our case examples illustrate how open innovation networks may provide new possibilities to generate value from academic - industrial networks. However, the open innovation model builds on involvement from a variety of external sources, such as independent researchers and experts, R&D institutes, universities and contract research organizations, customers, partner companies or even competitors. In the transition from a closed to an open innovation model, the pharmaceutical industry needs to develop flexible boundaries to allow a creative exchange of knowledge and experience from the outside to the inside of their organisation.

Keyword
Open Innovation, Pharmaceutical Industry, Biomedicine, Open Capital, Drug Discovery, Drug Development, Business Model
National Category
Engineering and Technology
Identifiers
urn:nbn:se:liu:diva-74774 (URN)978-1-907106-12-5 (ISBN)
Conference
Ninth International Conference, Atlantic City USA
Available from: 2012-02-08 Created: 2012-02-08 Last updated: 2016-05-04Bibliographically approved
2. The impact of open IP platforms on IP-strategy norms in Life Sciences
Open this publication in new window or tab >>The impact of open IP platforms on IP-strategy norms in Life Sciences
(English)Manuscript (preprint) (Other academic)
Abstract [en]

In the biomedical field multiple stakeholders may collaboratively develop, package and build transactions around technology. This mode of distributed innovation activity is often referred to as open innovation, open biotechnology or open source R&D. When such phenomena include both commercial and non-profit actors the most commonly used term is public-private partnership (PPP). In this paper we focus on the structured systems - that enable knowledge transactions - per se in PPPs and other collaborative platforms. Phenomena we refer to as open IP platforms. In spite of the important role that intellectual property (IP) and IP rights play in the value creation on such platforms - little research has previously assessed the impact that norms of open IP platforms exert on corporate IP-strategies. A case study on three open IP platforms was therefore performed to understand this better. To understand some of the norms of in the medical field the Innovative Medicines Initiative (IMI) was included, while CAMBIA Biological Open Source (BiOS) served as a comparison of the plant technology field and the Medicines for Malaria Venture (MMV) as a case study of development suited for the third world. Our study creates a holistic elucidation of the norms on the investigated open IP platforms that Life Science companies must relate to, in order to maximize value extraction potential. Value is thus provided for IP-strategy decisions concerning open innovation in general, but open IP platforms in particular. Our results thus impact managerial decision-makers at pharmaceutical, biotech and agriscience companies contemplating to implement corporate open innovation strategies.

Keyword
Intellectual property, intellectual property strategy, open intellectual property platform, open innovation, open biotechnology, open source R&D, life sciences, multiple stakeholders, company
National Category
Engineering and Technology
Identifiers
urn:nbn:se:liu:diva-74775 (URN)
Available from: 2012-02-08 Created: 2012-02-08 Last updated: 2012-02-08Bibliographically approved
3. The changing structure of the pharmaceutical industry: perceptions on entrepreneurship and openness
Open this publication in new window or tab >>The changing structure of the pharmaceutical industry: perceptions on entrepreneurship and openness
Show others...
2011 (English)In: Entrepreneurship And Technological Change / [ed] Lucio Cassia, Tommaso Minola and Stefano Paleari, Edward Elgar Publishing, 2011, 73-94 p.Chapter in book (Refereed)
Abstract [en]

The cost for radical innovation in the pharmaceutical industry, that is the development of a completely new molecular entity (NME), was recently estimated to be in the range of US$800 million (DiMasi et aI., 2003) and for a novel biologic it was calculated to be more than US$1300 million (DiMasi and Grabowski, 2007). These cost estimates were based on conventional discovery and process development programs in the pharmaceutical industry up to the point of registration and marketing authorization of an NME. However, there are additional costs stretching beyond the development program relating to the regulatory requirements to perform post-approval studies after introduction into the market. Such regulatory costs may include obtaining marketing approval in a variety of countries, costs for extended indications for new formulations as well as new patents (Gamier, 2008). In earlier estimates provided (DiMasi et aI., 2003; DiMasi and Grabowski, 2007), the authors assumed an average success rate for an NME emerging from clinical trials to be 21.5 per cent. Recent research has adjusted this estimate downwards to 11.5 per cent and the initial cost estimates of drug development have been adjusted upwards to more than US$1700 million per new NME. If further adjustment is made for additional cost increases over time and inflation, the true cost per NME is probably in the range of US$4000 million (Munos, 2009).

However, it still remains a complex issue to accurately estimate the costs of NMEs since research and development (R&D) expenses are typically invested over decades and should be depreciated over a longer period. In real life the true duration of this life cycle cost is highly variable and has probably increased over time. Experts are not able to agree how to evaluate capitalization and depreciation of drug R&D for large pharmaceutical companies (Big Pharma). Therefore, providing simple and accurate cost estimates of NME development in Big Pharma is likely to remain a major difficulty. The ability to predict success for an NME and calculate return on investment is further complicated by the nature of the drug discovery R&D model which has recently been under extensive review and question.

Place, publisher, year, edition, pages
Edward Elgar Publishing, 2011
National Category
Engineering and Technology
Identifiers
urn:nbn:se:liu:diva-74776 (URN)978-1-84980-747-0 (ISBN)978-1-78100-201-8 (ISBN)
Available from: 2012-02-08 Created: 2012-02-08 Last updated: 2016-05-04Bibliographically approved
4. Decision-making in the pharmaceutical industry: analysis of entrepreneurial risk and attitude using uncertain information
Open this publication in new window or tab >>Decision-making in the pharmaceutical industry: analysis of entrepreneurial risk and attitude using uncertain information
Show others...
2011 (English)In: R &D Management, ISSN 0033-6807, E-ISSN 1467-9310, Vol. 41, no 4, 321-336 p.Article in journal (Refereed) Published
Abstract [en]

The main purpose of this study was to investigate judgments made by employees from the pharmaceutical industry and allied health-care sectors in a set of four different drug discovery and development cases derived from real scenarios. Each case study related to go/no-go decisions taken from various steps in drug discovery through preclinical and clinical development (investigational new drug) on to market introduction (new drug application) and treatment of the target population. Using a web-based questionnaire, 52 respondents made five sets of judgment within each drug case whether to continue or halt further project development. For each case, additional details of the developmental scenario were disclosed to the respondent after completion of each judgment response. We also assessed to what extent the individual judgments given by the respondents were influenced by work experience and functional role, education, or their perceived entrepreneurial character. Our study demonstrates that health-care employees differ substantially in their individual intuitive judgments of benefit and risk in go/no-go decisions during the drug discovery and development process. This lack of coherence and wide variability with respect to the drug development cases selected may reflect judgment in the real world. Such judgments are usually taken from incomplete information, and individual decision-making rules vary substantially between experts in the field. Further knowledge about this inherent human functional judgment variability may be helpful to form a better understanding of individual decision-making in relation to inherent uncertainties. Additional research may also clarify how personal experience within drug discovery and development influences judgment and help to optimize decision outcomes in the drug development sector. Importantly, a deeper insight of the fundamentals and rules that shape individual and group decision-making of everyday drug discovery and development may help to optimize the decision processes in the pharmaceutical industry.

Place, publisher, year, edition, pages
Blackwell Publishing, 2011
National Category
Engineering and Technology
Identifiers
urn:nbn:se:liu:diva-71106 (URN)10.1111/j.1467-9310.2011.00649.x (DOI)000294742300001 ()
Available from: 2011-09-30 Created: 2011-09-30 Last updated: 2017-12-08
5. Impact of Uncertainty on Drug Development Decision Making in the Pharmaceutical Industry
Open this publication in new window or tab >>Impact of Uncertainty on Drug Development Decision Making in the Pharmaceutical Industry
(English)Manuscript (preprint) (Other academic)
Abstract [en]

In the pharmaceutical industry, the process of developing a new medicinal entity (NME) is associated with considerable risk and uncertainty. The present paper investigates how variability in the decision making process in pharmaceutical industry research and development (R&D) projects influences the expert group size needed to take informed go/nodecisions. In other words, we wanted to investigate how go/no go decision process is influenced by the degree of inherent project uncertainty. Since the information gap during the early as well as late phases of the R&D process of an NME is commonly prominent, we made a statistical forecasting of the impact of individual variations in go/no-go judgments and decision making. In respect to inherent project uncertainty, throughout the discovery/development process of 8 – 10 formal go/no-go steps, we then simulated the size of the expert group size needed to take a meaningful and coherent group decision based on individual real expert judgments.

In the study, we used data from 52 experts in the pharmaceutical industry and allied sectors, making a series of go/no-go judgements in 4 different drug R&D case scenarios derived from real R&D cases from the pharmaceutical industry. The 4 case-scenarios related to go/no-go judgment decisions over phases of drug discovery (early) as well as development (late) ranging from target selection/pharmacology, toxicology, biopharmacy/galenics to clinical development/market introduction.

Based on the intrinsic variability found in the real go/no-go (or go/no-go and recycle) judgments made by the experts, as each of the 4 cases gradually evolved, we modelled the impact of the real intrinsic judgment variability found, on a fictive R&D decision chain based on 10000 bootstrap samples involving between 5 -20 different major go/no-go decisions. We found, that when serial mean judgements were expressed as clear go or stop, some 10 – 15 experts were needed in order to arrive at a coherent go or stop group decision. However, when both go and stop (recycle) mean decisions were encountered at any step in the process development, the number of experts needed in a group to arrive at a decisive go or no-go judgment tended to be very large. In spite of the fact that large groups were involved, there was a substantial inherent uncertainty that remained in the decision chain.

We conclude that in pharmaceutical industry R&D, rational decision making from initial drug discovery to late development and marketing, can commonly be managed by a group of 10 – 15 experts when mean group judgements over a series of decision points are clear go decisions. However, when mean group judgements from one decision point to another varies from go to stop in a specific case, i.e. involves a recycle component, there will be a need to expand R&D expert input substantially. In such cases the drug development process more or less takes on the form of an open innovation process. The present research findings may be used to construct a new model on how to plan and model the size of expert input in structured decision processes similar to those practised in the pharmaceutical industry.

Keyword
Drug R&D, discovery; development; pharmaceutical industry; decision making; uncertainty; innovation; entrepreneurship; go/no-go, go-no-go/recycle; closed innovation; open innovation
National Category
Engineering and Technology
Identifiers
urn:nbn:se:liu:diva-74778 (URN)
Available from: 2012-02-08 Created: 2012-02-08 Last updated: 2016-05-04Bibliographically approved
6. Emerging Open Models and Concepts of Innovation in the Pharmaceutical Sector
Open this publication in new window or tab >>Emerging Open Models and Concepts of Innovation in the Pharmaceutical Sector
2011 (English)In: Asia Pacific Journal of Innovation and Entrepreneurship, ISSN 2071-1395, Vol. 5, no 1, 5-18 p.Article in journal (Refereed) Published
Abstract [en]

High-tech innovation in a number of emerging and rapidly changing areas such as the pharmaceutical and bio-tech sectors, show signs of a movement from a closed to a more open innovation paradigm. This is primarily due to the possibility of rapid and unlimited communication through the Internet and the www, the increasing global availability of experts, the international reach of the venture capital market, as well as the increasing possibility and interest of external suppliers and interest groups to participate in new product and service development. As a result of this, novel forms of multisource open and user innovation models such as crowd-sourcing and crowd-casting are currently emerging. These new innovation concepts are based on global open innovation and development communities have emerged in several fields of science and business, such as e.g. in the information technologies and bio-medicine. Crowd sourcing and crowd casting are innovation concepts that are based on loosely formed groups of customers, users, scientific communities, or groups of experts who form and collectively shape product or process innovations within a specific innovation field or sector. These open platforms are altering and reforming previously closed innovation concepts to become more open, capable, innovative and cost-effective by using the "wisdom-of-crowds" concept.

This paper describes different formats and potential ways by which emerging open multisource innovation paradigms may alter the pharmaceutical innovation and value creation process in the future. The paper is focusing on how the involvement of a variety of market actors, such as academics, innovators and entrepreneurs, pharmaceutical industry employees, patient advocacy groups, medical professional organizations, hospitals and insurance companies, will influence the common biomedical innovation process and product - market platform. The paper will also introduce a range of new innovation concepts and paradigms by discussing various emerging models of multi-source and open innovator platforms.

Place, publisher, year, edition, pages
AABI, 2011
Keyword
Open Innovation, Multiple Communities, User Innovation, Crowd-Sourcing, Crowd-Casting, Biomedicine, Pharmaceutical Industry
National Category
Engineering and Technology
Identifiers
urn:nbn:se:liu:diva-74779 (URN)
Available from: 2012-02-08 Created: 2012-02-08 Last updated: 2017-01-03Bibliographically approved

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