WO2009111210A2

WO2009111210A2 - Data management system and method for pharmaceutical development

Info

Publication number: WO2009111210A2
Application number: PCT/US2009/034955
Authority: WO
Inventors: Theresa O'brien
Original assignee: Peak Value Sarl
Priority date: 2008-02-29
Filing date: 2009-02-24
Publication date: 2009-09-11
Also published as: WO2009111210A3

Abstract

A data management system for pharmaceutical development includes a processor and a memory operably connected to the processor. The memory is configured to store a discovery module for processing data regarding an investigation of the therapeutic value of a target molecule. The memory also is configured to store a development component for processing data regarding the creation and testing of a drug related to the target molecule. The memory also is configured to store a documentation module for capturing data regarding testing and trial results related to the drug. The memory also is configured to store a delivery module for processing data regarding the production of the drug. The memory also is configured to store a commercialization module for processing data regarding the commercialization of the drug.

Description

DATA MANAGEMENT SYSTEM AND METHOD FOR PHARMACEUTICAL DEVELOPMENT

INFORMATION ON RELATED APPLICATION

[0001] This application claims the priority benefit of U.S. Provisional Application No. 61/032,514 filed on February 29, 2008, which is hereby incorporated herein by reference.

BACKGROUND

[0002] The present disclosure relates generally to the field of pharmaceutical development. The disclosure relates more specifically to the field of data management systems and methods for pharmaceutical development.

[0003] Several complicated steps must be taken to deliver a safe, effective drug to the marketplace resulting in significant costs to drug development companies. A developer must prove that a drug is safe, effective and align research activities with future development and marketing activities.

[0004] Drug development involves several sub-processes. These processes include drug discovery, drug development, preparing the drug for marketing opportunities, delivering the drug to the marketplace and deriving revenue from the drug by exploiting various business opportunities including the sale and license of the drug. Generally, each sub-process has its own set of proprietary support tools, services and databases. These services often vary from one sub-process to another, producing a fragmented set of tools used throughout the drug development cycle. Further, these tools are often unnecessarily complex and expensive.

[0005] Existing tools are insufficient to support efficiency in discovery research due to the fragmentation of the processes, redundancy, and the incompatibility between data formats. For example, financial data must be manually input into reporting tools for presentations to Boards. Further, there is no discovery project management tool that allows an update of milestone status automatically, based on an evaluation of the quality of test results received from a contractor, there is no statistical tool that automatically generates tables in eCTD format, there is no tool for controlling versions of image output from microscopy, there is no tool for uploading image data into statistical analysis tools, there is no search tool that will allow management of scientific publications by content and there is no support for scheduling testing and trials on a critical path, with resource re-allocation among trial sites as needed.

[0006] Accordingly, a readily accessible platform of tools and services is needed. Such a platform should provide a single interface for all phases of the drug development cycle, empowering scientists to share information, make more discoveries and quickly deliver drugs to the marketplace.

SUMMARY

[0007] In one aspect, a data management system for pharmaceutical development is provided. The data management system includes a processor and a memory operably connected to the processor. The memory is configured to store a discovery module for processing data regarding an investigation of the therapeutic value of a target molecule. The memory also is configured to store a development component for processing data regarding the creation and testing of a drug related to the target molecule. The memory also is configured to store a documentation module for capturing data regarding testing and trial results related to the drug. The memory also is configured to store a delivery module for processing data regarding the production of the drug. The memory also is configured to store a commercialization module for processing data regarding the commercialization of the drug.

[0008] In another aspect, a method for managing pharmaceutical development is provided. The method includes receiving a request for data, processing data regarding an investigation of the therapeutic value of a target molecule, processing data regarding the creation and testing of a drug related to the target molecule, capturing data regarding the testing and trial results related to the drug, processing data regarding the production of the drug, processing data regarding the commercialization of the drug, and making the requested data available to a user.

[0009] In still another aspect, a computer program product embodied in a computer readable medium is provided. The computer program product includes computer code for receiving a request for data, computer code for processing data regarding an investigation of the therapeutic value of a target molecule, computer code for processing data regarding the creation and testing of a drug related to the target molecule, computer code for capturing data regarding the testing and trial results related to the drug, computer code for processing data regarding the production of the drug, computer code for processing data regarding the commercialization of the drug, and computer code for making the requested data available to a user.

[0010] In other aspects, a computer implemented method of managing pharmaceutical development is provided. The computer implemented method involves receiving a request for data, processing data regarding an investigation of the therapeutic value of a target molecule, processing data regarding the creation and testing of a drug related to the target molecule, capturing data regarding the testing and trial results related to the drug, processing data regarding the production of the drug, processing data regarding the commercialization of the drug, and making the requested data available to a user.

[0011] In another aspect, a data management system for pharmaceutical development is provided. The data management system includes a client terminal configured to execute a user interface module for interacting with a web application, a web server, connected to the client terminal via a network, and an application server operably connected to the web server. The application server is configured to host a discovery module for processing data regarding an investigation of the therapeutic value of a target molecule, a development component for processing data regarding the creation and testing of a drug related to the target molecule, a documentation module for capturing data regarding testing and trial results related to the drug, a delivery module for processing data regarding the production of the drug, a commercialization module for processing data regarding the commercialization of the drug, and a data access module for accessing and manipulating said data. The data management system also includes a database operably connected to the application server for storing the data.

BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Figure 1 is a block diagram of an exemplary data management system, according to one embodiment.

[0013] Figure 2 is a block diagram of an exemplary web-based data management system, according to one embodiment.

[0014] Figure 3 is an exemplary technical architecture functional design, according to one embodiment.

[0015] Figure 4 is an exemplary technical architecture of two-way integration, according to one embodiment.

[0016] Figure 5 shows an exemplary process flow diagram of a method for managing pharmaceutical development within any of the data management systems of Figures 1 -4, according to one embodiment.

[0017] Figure 6 shows an exemplary screenshot of a homepage that may be used by an interface in any of the data management systems of Figures 1-4, according to one embodiment.

[0018] Figures 7-11 are schematic flow diagrams of five stages of pharmaceutical development that may be executed on any of the data management systems of Figures 1-4 according to some exemplary embodiments.

[0019] Figure 12 is a data model, according to one embodiment. [0020] Figure 13 provides one example of a process model for developing pharmaceuticals.

[0021] Figure 14 provides additional information concerning certain entities and attributes utilized in Figure 13.

DETAILED DESCRIPTION

[0022] An integrated, platform of information technology, tools and services is provided to facilitate the development of life-science products. The platform provides tools for managing the myriad of data required to commercialize a health-care product, including solutions ranging from planning and analyzing experiments to financial forecasting. The platform enables practitioners to focus on core scientific activities and thereby decreases time to market, lowers cost and increases asset value.

Definitions

[0023] 21 CFR § 11 refers to a regulation passed in 1997 in the USA that provides for the voluntary submission of parts or all of regulatory records for drug approval in electronic format without an accompanying paper copy.

[0024] Abbreviated New Drug Application (ANDA) relates to a proposal from a drug sponsor that the FDA expedite approval of a new pharmaceutical for sale in the U.S.

[0025] Active Pharmaceutical Ingredient (API) refers to a substance or compound that is intended to be used in the manufacture of a pharmaceutical product as a therapeutically active compound (ingredient).

[0026] Adverse Effects Reporting System (AERS) relates to a system for reporting drug safety issues.

[0027] Amino acid refers to a molecule that contains both amine and carboxyl functional groups. Examples include the alpha-amino acids of the general formula H₂NCHRCOOH, which represent the twenty building blocks of proteins. [0028] The term batch relates to a quantity of a compound made at the same point in time, using the same production process and same source of raw materials, identified by a number unique to the specific quantity produced.

[0029] Biologies License Application (BLA) refers to a request for approval to produce and distribute a biological product in the US.

[0030] Candidate relates to a substance or compound that will be submitted for approval to be used as a drug.

[0031] Case Report Form (CRF) refers to a part of an NDA showing results of individual patient observations from drug testing.

[0032] Case Report Tabulation (CRT) relates to a part of an NDA showing summary results of patient observations from drug testing.

[0033] Center for Biologies Evaluation and Research (CBER) refers to a US agency which reviews applications to make and distribute new biological products.

[0034] Center for Drug Evaluation and Research (CDER) relates to a US agency which reviews applications for approval to make and distribute new drug products.

[0035] Common Technical Document (CTD) refers to a standard format for submissions to the authorities and agencies responsible for regulation of pharmaceutical products in the US, Europe and Japan.

[0036] Drug Regulatory Authority (DRA) relates to a governmental agency responsible for approving drugs for use and sale in a particular country.

[0037] Electronic Common Technical Document (eCTD) refers to a structured XML style sheet which allows the electronic submission of the Common Technical Document (CTD) from applicant to regulator, with ICH-compliant (harmonized) table of contents and technical solution. [0038] Financing Services relates to the activities associated with securing funding to cover costs before sales, license revenues, trade sale or IPO create revenue streams to cover costs, in sequence from Startup to Seed to Series A (first 2-10 mio CHF), Series B (next 10-20 mio CHF), and Series C (next 10-20 mio CHF).

[0039] Galenical Form refers to a pharmaceutical product prepared according to an official formula expounding the identity, quantity, purity and stability of the components.

[0040] Individual Case Safety Report (ICSR) relates to a post marketing expedited safety report.

[0041] An Initial Public Offering (IPO) relates to a first sale of stock by a company to the public. A company can raise money by issuing either debt or equity.

[0042] Intellectual Property relates to an intangible asset consisting of monetizable knowledge or information.

[0043] International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) refers to a Europe, Japan and US group to harmonize regulatory requirements for quality, safety, efficacy and multidisciplinary presentation.

[0044] Investigational New Drug (IND) relates to a status of an experimental drug after the Food and Drug Administration agrees that it can be tested in people.

[0045] The term lead refers to a compound with suspected pharmacologically-active characteristics (reactivity, binding properties, ion channel effects, aptotic induction, signaling, etc.)

[0046] License relates to a contract to use the IP of another company to produce and distribute a drug.

[0047] Marker refers to a characteristic trait of a disease that facilitates differential diagnosis, for example, a particular gene sequence linked to a hereditary disease. [0048] Mass-spectrometer relates to an instrument which measures the masses and relative concentrations of atoms and molecules used to identify compounds via measurement of magnetic force on moving charged particles.

[0049] MeDRA refers to standardized medical terminology for drug regulation.

[0050] Metabolite relates to a product of a set of chemical reactions that occur in living organisms in order to maintain life, allowing the organisms to grow and reproduce.

[0051] Microscopy (SEM, TEM) refers to a method of measuring compound activity in cells by counting phenomena in magnified images, usually electron- enhanced images to inspect specimens at the sub-cellular level (TEM=transmission electron microscope, SEM=scanning electron microscope).

[0052] Monoclonal Antibody (mAb, moAb) relates to a laboratory-produced substance (antibody) that can locate and specifically bind to particular antigens, for example on cancer cells. Such antibodies are produced by a single clone of cells (specifically, a single clone of hybridoma cells) and, therefore, represent a single pure homogeneous type of antibody.

[0053] New Chemical Element (NCE) refers to a new non-biologic compound which has not been previously approved for use in humans.

[0054] New Drug Application (NDA) relates to a proposal from drug sponsors that the FDA approve a new pharmaceutical for sale in the US. Such a proposal typically includes: what happened during animal and human trials (NDA results), the ingredients of the drug, how the drug behaves in the body, and how it is manufactured, processed, and packaged.

[0055] Oligopeptides refers to a structure formed by the linkage of a few amino acids.

[0056] Orphan Drug Application relates primarily to an application under the Orphan Drug Act of January 1983 ("ODA"), a federal law concerning rare diseases ("orphan diseases"), defined as diseases affecting fewer than 200,000 people in the United States or low prevalence is taken as prevalence of less than 5 per 10,000 in the community. Such applications also can be filed in the European Union, via a process administered by the Committee on Orphan Medicinal Products of the European Medicines Agency (EMEA).

[0057] A patent is a grant of property right by a government to an inventor to exclude others from making, using or selling an invention.

[0058] Peptide relates to a molecule composed of two or more amino acids, while larger peptides are generally referred to as polypeptides, or proteins.

[0059] Pharmacology refers to a set of activities to discover whether or not a compound or substance has benefit as a drug in humans or animals.

[0060] Pharmacopeia (Ph. Eur., DAB, USP) relates to a book describing chemicals, drugs, and other substances and how they are used as medicines prepared by a recognized authority.

[0061] Phytopharmaceutical refers to a plant or plant product used as a drug.

[0062] Proof of Concept (POC) relates to a dataset demonstrating that a hypothesis concerning the efficacy and safety of a compound proposed to ameliorate a disease is potentially feasible, and has less than 50% chance of failure in subsequent tests.

[0063] Reference substance refers to a compound subjected to analysis to be used as a comparison standard to assure the quality of chemical products and to satisfy the demands of the regulatory authorities.

[0064] Seed Capital relates to an initial amount of money used to start-up a company.

[0065] Statistical Analysis System File (SAS, XPORT) refers to a file format for transmitting statistics created in SAS. [0066] Structured Data Set (DTD) relates to a structured XML stylesheet which allows the electronic submission of Individual Case Safety Reports from the investigator to the DRA's.

[0067] Study Tagging File (STF) refers to a structured XML stylesheet which allows for identification all of the files associated with a study. Each document typically includes: the document title, the headings under which the documents are located in the table of contents, the relationship to other documents, revision information, the location of the document, and information on the submission.

[0068] A target for drug discovery is typically a biological molecule that is involved in the molecular or biochemical pathway of the disease state of interest.

[0069] Toxicology refers to a set of activities to discover whether or not a compound or substance causes harm when used as a drug in humans or animals.

[0070] Trade sale relates to a sale of one biotech company to another as an exit strategy to realize a return on investment for discovery and early development.

[0071] Validated Target refers to a target that is proven to respond phenotypically when a compound binds to it. Typically, the proof consists of in vitro or in vivo evidence, such as when cell growth is inhibited by action of a biomolecule on a cell component such a ribosome.

[0072] Validation (GxP, GMP, GLP, GCP) relates to a process of confirming that manufacturing, laboratory, IT or clinical practices used in the discovery, development, production and distribution of drugs satisfies regulatory criteria designed to ensure drug safety and effectiveness. Such criteria can be found, for example, in the Good Manufacturing Practices or Good Laboratory Practices guidelines for the pharmaceutical industry.

Discussion

[0073] Referring to Figure 1 , a data management system 10 is configured to facilitate pharmaceutical (e.g., a drug, a medication, a supplement, etc.) development. For example, data management system 10 may be used to develop pharmaceuticals via various steps from analyzing therapeutic values of molecules to commercialization of the pharmaceutical. Data management system 10 typically includes a processor 12, a memory 14, a user interface 16, a data access module 18, and a development database 20.

[0074] Processor 12 is configured to execute machine instructions or operations to control the functions, inputs to, and outputs from memory 14, user interface 16, data access module, and development database 20, According to some exemplary embodiments, processor 12 maybe implemented using a computer processor of any past, present, or future design capable of performing instructions related to pharmaceutical development. According to another exemplary embodiment, processor 12 may be a special purpose computer processor for a pharmaceutical development system, incorporated for this or another purpose, or by a hardwired system.

[0075] Memory 14 is generally configured to store a computer program product, computer code, and/or machine instructions that may be executed on processor 12 to facilitate development of pharmaceuticals. Memory 14 typically includes computer code embodied as a discovery module 22, a development module 24, a documentation module 26, a delivery module 28, and a commercialization module 30. Memory 14 may be a local cache, a local hard disk drive, a CD-ROM, a floppy disk, a random access data source (e.g., a RAM), a read-only data source (e.g., a ROM), a remote server, or any other volatile or non- volatile memory capable of storing computer code related to pharmaceutical development. According to one embodiment, the above- mentioned modules 22, 24, 26, 28 and 30 are integrated so that data and processes shared between modules is in a consistent, standard format. Modules are integrated by continuous adherence to voluntarily agreed data standards that are starting to appear for biotech information. Groups analagous to CDISC for development-phase data standards are starting to emerge to conduct standardization of biotech data. The data management system will allow for a meta-model to maintain and update all interfaces according the latest standards. [0076] Discovery module 22 is configured to process data regarding an investigation of the therapeutic value of a target molecule, for example investigating a possible affect of the target molecule on a gene, disease, disorder, ailment, irregularity, etc. The discovery module can include a molecule miner module 32, a molecule modeling module 34, and an investigation module 36. Generally, molecule miner modules 32 are developed and used in an academic setting. Molecule miner module 32 is configured to discover molecular substructures or target molecules while molecule modeling module 34 is configured to model the discovered molecular substructures. The investigation module 36 is configured to determine what therapeutic value, if any, that the modeled molecular substructure may have.

[0077] Development module 24 is configured to process data regarding the creation and testing of a drug that is at least related to a target molecule discovered by discovery module 22. Development module 24 comprises, for example, a patent database 38, a literature database 40, a pharmokinetic database 42, and a toxicology database 44. According to one embodiment, the above-described databases are commercially available databases such as Schrδdinger, Tessella and Thomson. One or more of the databases may facilitate the development of a drug based on the target molecule to have a desired therapeutic value.

[0078] Patent database 38 generally stores patent application templates and completed patent applications relating to, for example, the target molecules, therapeutic methods, and/or disorders of interest. Development module 24 may use patent database 38 to facilitate the drafting of patent applications related to the target molecules, therapeutic methods, and/or disorders of interest.

[0079] Literature database 40 generally stores literature or documentation templates that may relate to target molecules, desired therapeutic methods, or disorders of interest. Development module 24 may use literature database 40 to facilitate the drafting of literature or publications related to the target molecules, therapeutic methods, and/or disorders of interest. [0080] Pharmokinetic database 42 generally stores pharmokinetic or pharmacokinetic information or templates that may relate to discovered absorption, distribution, metabolism, and excretion of target molecules. Development module 24 may use pharmokinetic database 42 to facilitate the documentation of discovered absorption, distribution, metabolism, and excretion of target molecules.

[0081] Toxicology database 44 generally stores information or templates related to the toxicology of target molecules, for example symptoms, mechanisms, treatments, and detection of toxic substances or reactions. Development module 24 may use toxicology database 44 to facilitate the documentation of discovered symptoms, mechanisms, treatments, and detection of toxic substances or reactions.

[0082] Documentation module 26 is configured to capture data regarding testing and trial results related to the developed drug. Documentation module 26 includes a formatting module 46, a public release module 48, a processing module 50, and a document creation module 52. According to one embodiment, the above-described modules are implemented using software-as-service applications such as Documentum and SAP. Formatting module 46 is generally configured to format data generated by discovery module 22 and development module 24 for regulatory submission, for example for submission of the development data to the Unites States Food and Drug Administration (FDA) for approval of clinical trials. Public release module 48 is configured to organize the collected data and facilitate the release of at least a portion of the data to the public. Processing module 50 is configured to process data related to a patent application, for example to examine the patentability, novelty, or patent clearance of the developed drug in view of the patent landscape. Document creation module 52 is configured to create documents for clinical trials, for example clinical trial guidelines.

[0083] Delivery module 28 is configured to process data regarding the production of the developed drug (i.e., samples for tests and trials for production). Delivery module 28 can include a services module 54 and a finance module 56. According to one embodiment, the above-described modules are implemented using software-as-service applications such as Documentum and SAP. Services module 54 is configured to process data regarding bioinformatics (e.g., computational biology; systems biology; sequence, gene, or protein alignment, assembly, or prediction; etc.), protocol design (e.g., FDA protocols), and/or trial insurance (e.g., risk assessment, recommended insurance coverage, etc.) and how the data may relate to the developed drug. Finance module 56 is configured to process data regarding order tracking; overhead, clinical, and development costs; and revenues or potential revenues that may be related to the drug.

[0084] Commercialization module 30 is configured to process data regarding the commercialization of the developed drug. The commercialization module 30 may facilitate project tracking, financial valuation and financial reporting. In addition, the commercialization module 30 may process data regarding the sale, contracting, and/or licensing of the drug, for example potential buyers or licensees, a cost structure, marketing materials, etc.

[0085] User interface 16 is coupled to processor 12 and is configured process user input (e.g., via a keyboard, mouse, integrated buttons, another tactile device, an oral command, etc.) and provide user output (e.g., on a display, a printer, an audio prompt, etc.). The user interface may receive commands from the user to direct or manage the development of a pharmaceutical and/or provide reports or status updates to the user on pharmaceutical development.

[0086] Data access module 18 is generally configured to provide processor 12 access to development database 20. Figure 12 illustrates a data model Development database 20 is configured to store information that may facilitate development of pharmaceuticals via execution of the computer code and data stored in memory 14. For example, development database 20 may include information related to previously developed drugs, published or patented works of others, known information on medical disorders and treatments, etc.

[0087] Referring to Figure 2, a data management system 58 is configured to facilitate pharmaceutical development in a manner similar to data management system 10, except that user interface module 16 is located in a remote location. Data management system 58 includes an application server 60, a database 62, a web server 64, a network 66, and a client terminal 68.

[0088] Application server 60 is similar to processor 12 in that it executes computer or application code embodied as discovery module 22, development module 24, documentation module 26, delivery module 28, commercialization module 30, and data access module 18. Application server 60 communicates with database 62 (e.g., development database 20) to allow data management system 58 to perform functions at least similar to that of data management system 10. According to various exemplary embodiments, application server 60 may be implemented using a server or computer processor of any past, present, or future design capable of performing instructions related to pharmaceutical development. According to another exemplary embodiment, application server 60 may include a special purpose computer processor for a pharmaceutical development system, incorporated for this or another purpose, or by a hardwired system.

[0089] Web server 64 is configured to facilitate access to application server 60 via network 66 from one or more client terminals 68. Web server 66 may be any computer or computer code that is configured to accept HTTP requests from client terminal 68 and serve HTTP responses and any associated data (e.g., web pages, HTML documents, images, other linked objects, etc.) back to client terminal 68.

[0090] Network 66 is configured to carry communication signals between web server 64 and client terminal 68. According to various exemplary embodiments, network 66 may be a local area network (LAN), a wireless area network (WAN), the Internet, or any other wired or wireless network capable of carrying data between web server 64 and client terminal 68. Client terminal 68 is configured to allow user access to application server 60 via network 66 using user interface 16. Client terminal 68 may be either a locally connected terminal or computer or a remotely connected computer. [0091] Referring to Figures 3 and 4, further characterizations of data management systems similar to data management systems 10 and 58 of Figures. 1 and 2 are illustrated. An interface provided on a website over the Internet provides access to the pharmaceutical development functionality described above. Both internal and externally hosted software packages may facilitate the management of pharmaceutical development.

[0092] Referring to Figure 5, a method 100 for managing pharmaceutical development is illustrated. Method 100 may be performed on any of the data management systems of Figures 1-4 or another similar system capable of managing pharmaceutical development.

[0093] At a step 102, the data management system (e.g., data management system 10 or 58) receives a request for data. For example, a user may request data via user interface 16 that is related to: molecules that may have an affect on a specific disorder, documentation related to previously developed drugs, commercialization efforts, clinical trials, or any other information that the data management system is capable of providing.

[0094] At a step 104, the data management system processes data regarding an investigation of the therapeutic value of a target molecule, for example as described above in relation to discovery module 22.

[0095] At a step 106, the data management system processes data regarding the creation and testing of a drug related to the target module, for example as described above in relation to development module 24.

[0096] At a step 108, the data management system captures data regarding the testing and trial results related to the drug, for example as described above in relation to documentation module 26.

[0097] At a step 110, the data management system processes data regarding the production of the drug, for example as described above in relation to delivery module 28. [0098] At a step 112, the data management system processes data regarding commercialization of the drug, for example as described above in relation to commercialization module 30.

[0099] At a step 114, the data management system makes the requested data available to a user, for example as an output via user interface 16, as described above.

[0100] Referring to Figure 6, according to one exemplary embodiment, a screenshot 120 illustrates a homepage that can be displayed by user interface 16 for user interaction in managing the development of pharmaceuticals. A user may have the ability to directly manage the discovery, development, documentation, delivery, and commercialization modules via the homepage. Various functions of the homepage may require that the user login to verify access privileges. By logging in, the user also may be provided with customized information or management options, for example related to drugs the user is developing. The homepage also may provide search functions to search the data management system for information, documentation, statuses, or other information related to pharmaceutical development as it pertains to a specific molecule, disorder, user, document, etc. The homepage also may provide options to subscribe and receive updates on further developments, for example of a drug or disorder of interest. The user also may have the option of upgrading their access or the homepage client installed on their computer. A blog or forum may be further provided for discussion related to any specific or general aspects of pharmaceutical development. The homepage may further include advertisements that may be of interest to the user, for example from biotech providers, or based on the habits of a logged-in user.

[0101] Referring to Figures 7-1 1 , an exemplary process model for developing pharmaceuticals includes five stages: a discovery or pre-clinical stage, a development stage, a documentation stage, a delivery stage, and a deal or commercialization stage. Figure 13 lists the processes for carrying out the five stages in detail. Entities and attributes used and referred to in the process are described further in Figure 14. For example, the table sets forth the purpose of each process, the information used and created by the process and several process sub steps.

[0102] Table 1 , set forth below, includes processor profiles which set forth the people who are responsible, accountable, consulted and/or informed about the processes involved in each of the five stages or pharmaceutical development.

[0103] According to various exemplary embodiments, Figures 7-11 provide a number of operations that may be executed by the data management system during each stage of pharmaceutical development. It is noted that while the illustrated embodiments, describe five stages of development, according to other exemplary embodiments more or fewer than five stages of pharmaceutical development may be executed by the data management system. Further, while specific operations are described in the FIGURES for execution by a data management system, according to other exemplary embodiments, more or fewer than the illustrated operations may be executed.

[0104] Figure 7 is an overall illustration of the tasks that can be performed using the data management system. For example, as shown in Figure 8, the discovery module 22 allows a user to perform tasks critical to pre-clinical pharmaceutical development from the screening of molecules to the regulatory approval of a drug. The development module 24 and documentation module 26 are configured to assist a user in performing the tasks shown in Figures 9(a)-(b). These tasks include tracking and documenting the testing of a drug. Further, the documentation module 26 can be used to generate documentation needed for regulatory approval of the drug. The delivery module 28 is configured, as shown in Figure 10, to assist in the pre-production, manufacturing, sales and distribution of a drug. This includes packaging design, obtaining raw materials and planning manufacture, accepting orders and making deliveries. Figure 11 illustrates tasks that may be performed using the commercialization module 30. Tasks facilitated by the commercialization module 30 include business plan creation, obtaining funding, performance tracking, business related report generation, payment collection and licensing.

[0105] According to one embodiment, the discovery 22, development 24, documentation 26, delivery 28 and commercialization 30 modules are tightly integrated which allow a user to proceed from one stage of drug development to the next without migrating data or repeating conventional setup procedures. Modules are integrated by continuous adherence to voluntarily agreed data standards that are starting to appear for biotech information. Groups analagous to CDISC for development-phase data standards are starting to emerge to conduct standardization of biotech data. The data management system will allow for a meta-model to maintain and update all interfaces according the latest standards. Further, the above-mentioned modules can be customized over time to fit the needs of its users to further streamline the drug development process. Further, due to the integration of each module, a user may perform tasks in a non-linear fashion. For example, a user can create a business plan using the commercialization module 30 and then use the relevant data generated by the commercialization module 30 in conjunction with the discovery module 22 to identify a drug based on the pre-existing business plan.

[0106] Since the above-mentioned modules are integrated, data generated across each module can be easily shared. The data stored by the development database 20 can be used in subsequent phases of drug development without the need for reformatting or other cumbersome modification. In addition, the development database 20 allows users to create proprietary taxonomies. Further, the integrated development database 20 reduces the occurrence of duplicate data.

[0107] While the exemplary embodiments illustrated in the Figures and described above are presently preferred, it should be understood that these embodiments are offered by way of example only. Accordingly, the present disclosure is not limited to a particular embodiment, but extends to various modifications that nevertheless fall within the scope of the appended claims. The order or sequence of any processes or method steps may be varied or re-sequenced according to alternative embodiments.

[0108] Describing the embodiments with Figures should not be construed as imposing on the disclosure any limitations that may be present in the Figures. The present disclosure contemplates methods, systems and program products on any machine-readable media for accomplishing its operations. The embodiments of the present disclosure may be implemented using any existing computer processors, or by a special purpose computer processor for an appropriate pharmaceutical development system, incorporated for this or another purpose or by a hardwired system.

[0109] As noted above, embodiments within the scope of the present disclosure include program products comprising machine-readable media for carrying or having machine-executable instructions or data structures stored thereon. Such machine- readable media can be any available media which can be accessed by a general purpose or special purpose computer or other machine with a processor. By way of example, such machine-readable media can comprise RAM, ROM, EPROM, EEPROM, CD-ROM or other optical disk storage, magnetic disk storage or other magnetic storage devices, or any other medium which can be used to carry or store desired program code in the form of machine-executable instructions or data structures and which can be accessed by a general purpose or special purpose computer or other machine with a processor. When information is transferred or provided over a network or another communications connection (either hardwired, wireless, or a combination of hardwired or wireless) to a machine, the machine properly views the connection as a machine-readable medium. Thus, any such connection is properly termed a machine-readable medium. Combinations of the above also are included within the scope of machine-readable media. Machine- executable instructions comprise, for example, instructions and data which cause a general purpose computer, special purpose computer, or special purpose processing machines to perform a certain function or group of functions.

[0110] It should be noted that although the diagrams herein may show a specific order of method steps, it is understood that the order of these steps may differ from what is depicted. Also, two or more steps may be performed concurrently or with partial concurrence. Such variation will depend on the software and hardware systems chosen and on designer choice. It is understood that all such variations are within the scope of the disclosure. Likewise, software implementations of the present disclosure could be accomplished with standard programming techniques with rule based logic and other logic to accomplish the various connection steps, processing steps, comparison steps and decision steps.

[0111] The foregoing description of embodiments of the disclosure has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the disclosure to the precise form disclosed, and modifications and variations are possible in light of the above teachings or may be acquired from practice of the disclosed embodiments. The embodiments were chosen and described in order to explain the principals of the disclosure and its practical application to enable one skilled in the art to utilize the disclosure in various embodiments and with various modifications as are suited to the particular use contemplated.

Claims

WE CLAIM:

1. A data management system for pharmaceutical development, comprising: a processor; and a memory, operably connected to the processor, configured to store: a discovery module for processing data regarding an investigation of the therapeutic value of a target molecule; a development module for processing data regarding the creation and testing of a drug related to the target molecule; a documentation module for capturing data regarding testing and trial results related to the drug; a delivery module for processing data regarding the production of the drug; and a commercialization module for processing data regarding the commercialization of the drug.

2. A data management system for pharmaceutical development, as claimed in claim 1, further comprising a user interface module for processing user input.

3. A data management system for pharmaceutical development, as claimed in claim 1 , further comprising a development database for storing said data.

4. A data management system for pharmaceutical development, as claimed in claim 1, further comprising a data access module for accessing and manipulating said data.

5. A data management system for pharmaceutical development, as claimed in claim 1 , wherein the discovery module is configured for processing data regarding an investigation of the therapeutic value of the target molecule on a gene.

6. A data management system for pharmaceutical development, as claimed in claim 1, wherein the discovery module further comprises: a molecule miner module for discovering molecular substructures; and a molecule modeling module for modeling the molecular substructures.

7. A data management system for pharmaceutical development, as claimed in claim 1, wherein the development module further comprises: a patent database; a literature database; a pharmokinetic database; and a toxicology database.

8. A data management system for pharmaceutical development, as claimed in claim 1 , wherein the documentation module is further configured for: formatting data for regulatory submission; releasing data to the public; processing data related to a patent application; and creating documents for clinical trials.

9. A data management system for pharmaceutical development, as claimed in claim 1, wherein the delivery module further comprises a services module for processing data regarding bioinformatics, protocol design and trial insurance.

10. A data management system for pharmaceutical development, as claimed in claim 1 , wherein the delivery module further comprises a finance module for processing data regarding order tracking, costs and revenues related to the drug.

11. A data management system for pharmaceutical development, as claimed in claim 1 , wherein the commercialization module is further configured for processing data regarding the sale or licensing of the drug.

12. A method for managing pharmaceutical development, comprising: receiving a request for data; processing data regarding an investigation of the therapeutic value of a target molecule; processing data regarding the creation and testing of a drug related to the target molecule; capturing data regarding the testing and trial results related to the drug; processing data regarding the production of the drug; processing data regarding the commercialization of the drug; and making the requested data available to a user.

13. A computer program product, embodied in a computer readable medium, comprising: computer code for receiving a request for data; computer code for processing data regarding an investigation of the therapeutic value of a target molecule; computer code for processing data regarding the creation and testing of a drug related to the target molecule; computer code for capturing data regarding the testing and trial results related to the drug; computer code for processing data regarding the production of the drug; computer code for processing data regarding the commercialization of the drug; and computer code for making the requested data available to a user.

14. A computer implemented method of managing pharmaceutical development, comprising the steps of: receiving a request for data; processing data regarding an investigation of the therapeutic value of a target molecule; processing data regarding the creation and testing of a drug related to the target molecule; capturing data regarding the testing and trial results related to the drug; processing data regarding the production of the drug; processing data regarding the commercialization of the drug; and making the requested data available to a user.

15. A data management system for pharmaceutical development, comprising: a client terminal configured to execute a user interface module for interacting with a web application; a web server, connected to the client terminal via a network; an application server operably connected to the web server configured to host: a discovery module for processing data regarding an investigation of the therapeutic value of a target molecule; a development component for processing data regarding the creation and testing of a drug related to the target molecule; a documentation module for capturing data regarding testing and trial results related to the drug; a delivery module for processing data regarding the production of the drug; a commercialization module for processing data regarding the commercialization of the drug; and a data access module for accessing and manipulating said data; and a database, operably connected to the application server, for storing said data.