DRUG DISCOVERY SERVICES AT A GLANCE:
Program and Project Management Strategic and Technical Consulting
Strategic and Technical Drug Discovery Services
IDSC Consultants advise clients on various drug discovery strategies and issues. These efforts range from optimizing potency, designing analogs to improve PK and safety, to designing studies required for IND filing. IDSC Scientists have a consistent track record of solving problems to advance compounds into the clinic. They have also managed multi-disciplinary programs within several therapeutic areas, and developed project portfolios directed toward achieving unmet medical needs. The IDSC Team assists clients in optimizing their project strategies to achieve goals with the most effective timelines and resource utilization.
Program and Project Management
The IDSC Team offers seasoned expertise to support or manage clients' programs/projects and is able to effectively cover multiple drug discovery disciplines to deliver quality results in a timely and cost efficient manner.
Virtual Head of Research, Medicinal Chemistry, Pharmacology, SBDD, Outsourcing, Chemical Development
Virtual Head of Research
IDSC Colleagues provide scientific leadership and project management expertise to chart a company's path to achieving its drug discovery and development goals. The IDSC Team has extensive experience in all phases of the drug discovery process, ranging from the exploratory stages, such as target validation and lead identification, to full discovery activities including lead optimization and clinical candidate selection.
- Manage client's project initiation to rapidly begin producing data/results
- Create and manage client's chemistry and biology outsourcing programs
- Scan the landscape to evaluate potential in-licensing opportunities
- Enable founders to focus on other important aspects of the business
Virtual Head of Medicinal Chemistry
IDSC Medicinal Chemistry directors have decades of large pharmaceutical industry experience with a track record of delivering clinical candidates in all major therapeutic areas. Modern drug discovery concepts are integrated with traditional Structure Activity Relationship (SAR) analysis to simultaneously optimize potency/selectivity and suitable physiochemical and ADME properties, while minimizing safety risks (e.g. structure based toxicity, CYP450 inhibition, gene toxicity, QT prolongation).
- Assessment of the drugability of targets
Assess likelihood of success against a particular target type (e.g. enzyme, receptor, ion channel, protein-protein interaction). If feasible, use structural bioinformatics to assess binding site properties and selectivities, as well as escape mutations that can help inform decisions to pursue a particular target. Determine the availability and sourcing of relevant animal models. Formulate a hypothesis concerning therapeutic utility, and then develop an experimental strategy to test the hypothesis. - Development of lead identification strategies
Identify sources of chemical matter such as natural products, high through-put screening, virtual screening, literature sources, drug rescue, and new indications for old drugs. Propose a screening strategy and ensure availability of relevant assays to identify the best possible lead. - Assessment of chemical lead quality
The transformation of a lead into a drug requires knowledge of the compound's ADME profile. Appreciation of these properties at an early stage can increase the probability of a compound's successful entry into the clinic. In silico calculations and actual determinations of physical properties (e.g. solubility, log P, permeability, in vitro metabolism) can be used as filters in chemical lead selection to exclude non-viable candidates. The patent potential and competition are ideally evaluated at this early stage. - Development of lead optimization strategies
Design screening strategies that aim to improve physicochemical, pharmacokinetic and animal efficacy properties. Design medicinal chemistry strategies that aim to simultaneously optimize potency and PK parameters. Begin an early assessment of formulation needs with regards to salt forming potential, polymorph formation, hygroscopicity and chemical stability. Develop backup criteria. - Definition of patent strategy and map Intellectual Property space
Assess the primary and patent literature to identify competitors in the chosen area. Ensure coverage of the chemical matter, synthetic routes, method of use, salts, polymorphs, etc. Ensure patents are filed in a timely manner and consider filing defensive patents. Assess the patent landscape utilizing on-line resources. Consider patenting the target (if possible), biological assays and screening strategies as well as crystal structures and pharmacophore models.
Virtual Head of Molecular Modeling
IDSC offers a range of molecular modeling services that are contracted independently or in conjunction with a Medicinal Chemistry project. Molecular modeling can provide key insights for decision making in the laboratory.
- Evaluation of potential biomolecular targets
Apply structural bioinformatics techniques to compare and analyze the amino acid sequences of target proteins in the context of available structural information. Generate homology models to enable active-site analyses that provide insight into drugability, selectivity, and susceptibility to escape mutations. - Evaluation of prospective molecular modeling projects
Assess the potential contribution of molecular modeling to a project by examining the nature of the biochemical system being targeted, the biomolecular target, and the nature of the ligands under consideration. If the project is amenable to molecular modeling techniques, recommend the best approaches: ligand-based, structure-based, or statistical modeling. - Definition of molecular modeling and computational chemistry needs for an in-house facility
Determine what capabilities are appropriate for the research area and identify software packages that best provide those capabilities. In addition, help develop the qualification lists for the personnel to staff the facility. - Facilitation of team interactions
Work with client project teams to optimize the role of molecular modeling in their research.
Virtual Head of Pharmacological Sciences
IDSC expertise in pharmacology is provided for all aspects of the client drug discovery process, including assessment of adherence to sound in vitro and in vivo pharmacological principles. Informed IDSC decision making is applied to biological screening strategies enabling a logical and efficient path to goal.
- Validate therapeutic targets through a thorough understanding of molecular biology, biochemistry, physiology, pharmacology and clinical relevance
- Design in vitro assays to assess potency and selectivity
- Design in vivo animal models to assess efficacy and pharmacodynamics
Virtual Head of Chemical Development
IDSC expertise in drug development accumulated by advancing multiple compounds into clinical trials.
- Chemical process optimization
Assess the potential of the discovery synthetic route for producing clinical supplies. Refine the route and optimize yields and minimize safety hazards. - Pre-formulation and biopharmaceutics strategies
Begin an early assessment of formulation needs with regards to salt forming potential, polymorph formation, hygroscopicity and chemical stability.
Virtual Head of Outsourcing
IDSC's leadership pioneered the art of developing and managing high performing vendors in North America, Europe and Asia. Capabilities of the CROs that IDSC recommend span the disciplines of chemistry, pharmacology (in vitro screening and in vivo efficacy), ADME, safety, etc. IDSC partners clients from small biotech companies to large pharmaceutical companies with vendors that have consistently delivered the highest quality services. Managing a clients outsourcing efforts allows the clients to devote more time to the innovative aspects of drug discovery and development.
- Identify high quality vendors
- Provide metrics on the efficiency of vendors
- Develop outsourcing strategy - solicit competitive quotes from dependable vendors
- Manage client/vendor relationship -- monitor vendor progress, arrange teleconferences, provide updates / documents
- Sourcing difficult to find raw materials
- Prepare technical packages
- Import/Export expertise - properly completed forms, identification of best couriers and brokers, assignment of Harmonized Tariff System (HTS) codes, proper valuation of shipments, customs
- Maintain client database
Interim Management (for startup and virtual biotechs)
IDSC's experienced scientific leaders are offered on a contract basis to serve in an interim management role for a start-up biopharmaceutical company. A contract can be long or short term, allowing the client time to identify a permanent management team, while minimizing a client's costs, capital investment and overhead.
Interim Head of:
The IDSC team offers experienced interim management, with a proven track record. They provide the advantage of decades of experience to know what programs and compounds have the highest probability for success, and a history of delivering compounds to the clinic in all major therapeutic areas. IDSC's track record for integrating high value CROs into a program allows clients faster startup times.
Membership on client project teams
The IDSC team offers expertise (e.g., medicinal chemistry, pharmacology, toxicology) to complement or complete membership on client project teams. Ensures specialized knowledge is available at relevant and critical junctures in client's drug discovery process.
- The availability of IDSC experts allows the client to complete a well rounded drug discovery team without the commitment/cost of hiring FTEs with specialized knowledge
- IDSC experts offer that "second look" to validate/support strategic decisions of the project team before they are implemented, potentially saving the client time, resources, and money
Full Discovery Collaboration
Some clients are in the position of having multiple projects, leads or ideas that compete for resources with their primary project. Often these clients would prefer to move the backup projects forward, yet are restricted by their limited resources. IDSC's experts enhance client's business strategies by fully managing one or more of the backup projects in a collaborative arrangement. The client is responsible for establishing goals and milestones, and IDSC oversees their realization. The IDSC team performs the iterative design, synthesis, and testing using its full experience of turning leads into drugs. The result is that the client, without ever losing primary focus, successfully advances additional projects to key decision points. The client effectively increases capacity and productivity without impacting primary goals or timelines.
Strategic and Technical Consulting
Evaluation of Investment and In-licensing Opportunities
From biotechs to the biggest pharma, there are generally more opportunities for spending than the budget usually allows. IDSC scientists expertly craft TA strategies, blending advanced leads with new approaches and in-license compounds. The IDSC team reviews client's large or small portfolio to determine the proper balance of investment in in-license opportunities relative to stated goals. The IDSC team thoroughly understands the dynamics of attrition, project timelines, and required resources in great detail. Our clients tell us that our seasoned therapeutic area experience in ever-changing and competitive environments have benefited their investment strategy.
SWOT Analysis
Evaluation of Strengths, Weaknesses, Opportunities, Threats
Writing and Evaluating Patents and Intellectual Property Space
- Evaluate competitor patents and identify opportunities
- Identify existing IP space from competitors patents
- Develop strategy for expanding client's IP space
- Help draft client's patents
ChemoInformatics:
Design and implementation of databases for chemical structures and experimental (assay) data.
Many chemical research projects can benefit from the careful design of database tables to store structures and experimental or biological assay data. Rather than maintain a collection of spreadsheet files, a properly designed relational database offers many advantages such as data integrity checks, multi-user access, easy backup and efficient search methods.
Design and implementation of web-based applications to search chemical structures and data.
Web-based applications are an easy and familiar way to access information stored in a database. A web-based approach allows one central server to keep track of all data and programs without the need to update files and software on each user's desktop.
Evaluation of available software suited to particular research needs.
There are many commercial software systems available that may meet the needs of a research project. IDSC experts can help you analyze your projects' software needs, suggest possible software solutions and help evaluate combinations of software products.
Integration of new and existing software products within a research or IT department.
Some commercial products perfectly fit a project, but some may only offer a partial solution or may need to be integrated into existing software systems.
Production of computer graphics for scientific publications, company lobby displays.
Complex molecular systems are more easily explained with the use of computer graphics, for example proteins, protein-ligand interactions, molecular surfaces, and molecular interactions. These may appear in scientific publications or as artwork in a company lobby as a way of highlighting on-going research projects to visitors.