Expertise

Preclinical Therapeutic Area Expertise

Infectious Disease

  • Chemistry and pharmacology experience in most major classes of antibacterials
  • Antibacterial pharmacodynamics, dose selection and safety requirements
  • Antiviral medicinal chemistry
  • In depth experience in quinolones, oxazolidinones, beta-lactams, LpxC, Fab proteins, gyrase inhibitors and HIV protease inhibitors

CNS

  • Psychiatric disorders including schizophrenia, anxiety, bipolar disease, depression, ADHD
  • Neurological and neurodegenerative disorders including Alzheimer's disease, stroke and pain

Pain

  • Fibromyalgia, neuropathic pain, and inflammatory pain associated with OA and RA

Cardiovascular

  • Development of lipid modification strategies, e.g. LDL lowering, Lp(a) lowering, triglyceride lowering and HDL elevation
  • Drugs targeting the atherosclerotic process at the artery wall. Anti-atherosclerotic drugs and drugs that stabilize atherosclerotic plaques
  • Heart failure
  • Hypertension

Inflammation

  • Development of disease modifying strategies in osteoarthritis (DMOAD's) targeting the prevention of the destruction of cartilage
  • Identification of disease modifying rheumatoid arthritis drugs (DMARD's), particularly those attacking the inflammatory, immune and destruction of bone and cartilage aspects of the disease

Dermatology

  • Drug discovery in cosmetic dermatology including hair growth, acne, and skin aging (wrinkles)
  • Wound healing, dermal scarring and antiinflammatory expertise

Oncology

  • MAP, MEK, erbB, Cdk4, and EGFr kinase inhibitors

Metabolic Diseases

  • Diabetes . Kinase and phosatase inhibitors


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Drug Discovery Expertise

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 activity/selectivity and suitable physiochemical and ADME properties, while minimizing safety risks (e.g. structure based toxicity, CYP450 inhibition, gene toxicity, QT prolongation).

IDSC Medicinal Chemistry directors drive drug discovery programs by:

  • Evaluating leads for drug potential
  • Leading medicinal chemistry strategy and SAR development
  • Design and synthesis of small targeted libraries, focused analogs
  • Outsourcing compound synthesis
  • Coordination of secondary screening (function, selectivity, ADME, safety)
  • Evaluating secondary screen results
  • Evaluating patent landscape

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.

  • Ligand-Based Design and Structure-Based Design provide medicinal chemistry projects with a framework for interpreting structure activity relationships and for selecting synthetic targets more productively.
  • Structural Bioinformatics provides project teams with analyses of drugability, target selectivity, and potential escape mutations that help inform decisions about whether to pursue a biomolecular target. It provides active-site analyses and homology models for Structure-Based Design, and construct designs for assay development and crystallography.
  • Cheminformatics provides designs for parallel medicinal chemistry libraries, filters and virtual screens for identifying candidates for testing, and clustering for organizing compounds for SAR interpretation.
  • QSAR multivariate statistics provide predictive models for ADME/Tox and for medicinal chemistry projects.

Pharmacology

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.

Pharmacokinetics

Identifying drug candidates with a desirable pharmacokinetic profile is of utmost importance in the drug discovery process. The extensive drug discovery experience of IDSC scientists in multiple therapeutic areas enables us to provide clients with guidance on important issues relating to all aspects of drug absorption, distribution, metabolism, and excretion (ADME). From the identification and optimization of early chemical leads to identification of clinical candidates, IDSC scientists assist clients in obtaining and interpreting data relating to:

  • Physicochemical properties
  • Chemical and metabolic stability
  • Permeability
  • Plasma protein binding and tissue distribution
  • Potential for drug/drug interactions
  • In vivo PK

In this way, IDSC drug discovery scientists help clients identify and progress compounds with the most favorable ADME profile, providing the highest likelihood of success. In addition, our experience provides clients with expert problem solving approaches to address identified ADME issues.

In addition, specialized PK/PD experts at IDSC have the career experience to understand the pharmacokinetic profile and data needed to progress identified clinical candidates to IND and can assist in the preparation of regulatory filings:

Assessment of drugability of a chemical series or potential clinical candidate from a pharmacokinetic perspective -

  • Assess likelihood of success based on pharmacokinetic ADME profiles (absorption, distribution, metabolism, and excretion).
  • Design in vitro and in vivo experiments to estimate extent of absorption, elimination half-life, bioavailability, protein binding, blood-brain barrier permeability, and potential of metabolism or transporter related drug-drug interaction and polymorphism.

Quantitative structure-PK relationship (QSPKR) and optimization of drug delivery -

  • Absorption/Excretion: Evaluate the potential involvement of transporter(s) in absorption/excretion and the correlation between physicochemical properties and ADME properties to guide structure modification for optimization of absorption, bioavailability, and dose regimen.
  • Tissue Distribution: Identify the potential involvement of transporter(s) in tissue distribution and develop a strategy (e.g. prodrug design, transporter delivery, etc) to optimize drug delivery for central nervous system, cancer therapy, etc.

Pharmacokinetic/pharmacodynamic (PK/PD) modeling, interspecies scaling and human PK projection -

  • Design in vitro and in vivo experiments, conduct and perform PK/PD modeling to estimate efficacy related dose and concentration.
  • Use interspecies scaling as a tool to extrapolate animal PK/PD data to humans to assess safety margin and to project dose range and dose-regimen for human clinical trials.

Pharmacokinetics (PK), toxicokinetics (TK) -

  • Perform PK and TK analysis to determine PK and TK parameters needed for regulatory filing
  • assess potential of dose- and time-dependent PK or TK
  • Prepare regulatory documents for IND (Investigation New Drug), IB (Investigation Brochure), NDA (New Drug Application).

Preclinical Safety

The extensive drug discovery experience of IDSC scientists enables us to provide clients with guidance on important issues relating to preclinical safety, helping clients progress compounds with the highest likelihood of success. From the identification and optimization of early chemical leads to identification of clinical candidates, IDSC scientists assist clients in obtaining and interpreting data needed to minimize potential safety risks (structure based toxicity, CYP450 inhibition, gene toxicity, QT prolongation, mechanism related toxicity). In addition, our experience with a range of molecular targets in various therapeutic areas allows us to provide guidance on studies particular to those areas.


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Preclinical Development Expertise

IDSC experts provide our clients with the broad range of expertise and services needed to advance their drug candidates to IND. Our resources in Preclinical Development span the fields of Pharmacokinetics/ADME, Drug Safety/Toxicology/Veterinary Pathology, Chemical Development/CMC, Clinical Program Design, and Regulatory. IDSC brings these resources together in a collaborative environment to implement an effective strategy from candidate identification to IND filing.

Pharmacokinetics

IDSC scientists bring the expertise needed to evaluate the pharmacokinetic ADME profiles of potential clinical candidates, optimize drug delivery and progress the candidate to IND.

  • Design of in vitro and in vivo experiments to estimate extent of absorption, elimination half-life, bioavailability, protein binding, blood-brain barrier permeability, and potential of metabolism or transporter related drug-drug interaction and polymorphism.
  • Pharmacokinetic/pharmacodynamic (PK/PD) modeling to estimate efficacy related dose and concentration
  • PK projection using interspecies scaling as a tool to extrapolate animal PK/PD data to humans to assess safety margin and to project dose range and dose-regimen for human clinical trials
  • Pharmacokinetics (PK), toxicokinetics (TK) analysis to determine PK and TK parameters needed for regulatory filing
  • Preparation of regulatory documents for IND (Investigation New Drug), IB (Investigation Brochure), NDA (New Drug Application).

Preclinical Safety

IDSC brings to the table extensive expertise in preclinical safety and veterinary pathology to assist clients in progressing their drug candidates to IND.

  • Extensive expertise in preclinical toxicology for drug candidates in a wide range of therapeutic areas including cardiovascular, anticancer, and anti-infective agents and medical devices including osteoinductive agents
    • Design of toxicology plans and work supporting safety packages
    • Coauthoring IND applications as well as safety assessments and FDA briefing documents
    • Experience includes assisting start-up companies to construct toxicology plans and summaries for small molecules and macromolecules
  • Board certified veterinary pathologist
    • Experienced in designing pathology endpoints and performing pathologic evaluation for drug candidates
    • Multiple years experience as collaborating pathologist for drug discovery

Regulatory CMC:

Expertise is available through IDSC to address a variety of client's needs in Regulatory CMC.

  • Electronic Common Technical Document (eCTD) for Quality Modules: training, strategies and policy
  • Authoring, coordination and review of CMC sections of investigational & registration dossiers
  • Preparation and review of NDA supplements, amendments and annual report submissions
  • Development of Regulatory CMC strategies to ensure compliance with regulatory requirements
  • Regulatory support and strategy for CMC query/response cycles during agency review
  • Prepare for and represent clients at Regulatory Agency meetings
  • Provide regulatory support during Pre-Approval Inspections
  • CTD templates and global content management strategies for Regulatory CMC documentation

Clinical Program Design & Strategy:

IDSC brings to the table expertise in clinical program design. In particular, IDSC provides experience in the following areas:

  • Production of a Clinical Development Plan
  • Discussion of Clinical Development Plan with regulatory agencies
  • Protocol development (Phases I . IV)
  • Review of Statistical Analysis Plan (SAP)
  • Review/interpretation of issues arising during conduct of studies
  • Interpretation of study results
  • Writing of clinical study reports
  • Integration of reports for regulatory submission (NDA, sNDA, MAA)
  • Interaction with regulatory agencies in support of submissions
  • Interaction/coordination with marketing groups
  • Development of publication strategy
  • Formation of, and interaction with, advisory group key opinion leader
In addition, specialized expertise is available in the antibacterial therapeutic area:
  • Evaluation of preclinical antibacterials for medical need and likelihood of technical and regulatory success; put compound in perspective relative to currently marketed compounds and those in development
  • Evaluation of compounds for various infectious indications
  • Presentation of study results at meetings (ICAAC, ECCMID, IDSA, annual Superbugs and Superdrugs conference, etc.)

Regulatory:

IDSC provides seasoned expertise in managing the regulatory environment.

  • Expertise to develop and implement an efficient and effective global regulatory strategy
    • Experience to work with clients to establish a dialogue between the Sponsor and the FDA/EMEA to ensure there is alignment regarding the understanding of the current science and the regulatory requirements
    • Ability to submit the necessary information in the required format so your development program proceeds on the defined timelines
    • Broad expertise and technical advisory board provides access to experts in all technical areas - clinical, preclinical, chemistry and compliance
  • Expertise in managing data and information
    • We create the documents and reports in the format that is required by the FDA/EMEA.
    • The information is stored in a secure environment where the data are backed up and remotely accessible 24/7.
    • We have a DocumentumTM license and all CTD templates.


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Outsourcing Expertise

IDSC excels in managing clients outsourcing needs, with the expertise and experience to identify the right CRO to fit the client's needs and to manage all aspects of their outsourcing programs from obtaining quotes for a one time service to managing external FTEs.

IDSC recommends CROs that are best suited for success. We do not broker or represent CROs, but are compensated only by our clients and do not receive fees, or kickbacks from CROs that we recommend. We work with approximately 70 CROs offering services in chemistry, in vitro and in vivo pharmacology, ADME, and safety/tox. Our recommendation of CROs to clients is driven by a business philosophy to identify the right CRO to fit the client's needs for the particular task at hand.

IDSC experts have the know-how to:

  • Identify the right CRO for a client's needs
  • Develop and implement client's outsourcing strategy
  • Get competitive quotes and award projects
  • Manage client's fee for service (FFS) projects
  • Manage client's external FTEs
    • Monitor vendor progress
      • Track metrics and advise
      • Keep the queues full
      • Prepare technical packages
      • Help CRO w/ problem Solving
      • Assist CRO w/ raw material sourcing
    • Manage communication
      • Liaise & manage between client and CRO
      • Keep client informed
      • Facilitate teleconferences
    • Manage logistics
    • Maintain client databases
    • Assure IP protection

Areas of Outsourcing Expertise Include:

Custom Synthesis (mg to kg / non-GMP, GMP)

Years of outsourcing experience has allowed the IDSC team to identify top performing contract research organizations (CROs) in North America, Europe and Asia. These companies have consistently delivered high quality medicinal chemistry and parallel medicinal chemistry analogs, intermediates, small scale-up and small scale GMP materials.

Biological assays, ADME, Toxicology

Top performing CROs also provide IDSC clients with in vitro and in vivo biological assays, ADME and toxicology studies.

Raw Material sourcing

The IDSC team has years of experience sourcing hard to find raw materials. Utilizing search engines, databases and trusted brokers, IDSC sources monomers and templates, medicinal chemistry intermediates, preclinical or phase I scale-ups, reference compounds, marketed APIs, biological tools, ligands, reagents, etc. IDSC arranges importing and drop-shipping on milligram to kilogram scale material from North America, Europe and Asia.

Tariff Code assignment

Harmonized Tariff System (HTS) codes are needed for every compound shipped into or out of the US, Europe, India, China, etc. Incorrectly assigned tariff codes can delay shipments and lead to fines for improper valuation. IDSC team members are trained and experienced in assigning HTS codes and provide 24-48 hour turnaround at a competitive rate.


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