One of the major shortcomings of the current drug discovery and development process is the inability to bridge the gap between early stage discoveries and pre-clinical research in order to advance innovations beyond the discovery phase
DiscoverSys aims to create a drug discovery and development model, where the respective expertise of academia and industry are brought together to take promising discoveries through to proof of concept, providing a means to de-risk the drug discovery and development process
The primary screening of compounds for pharmacological activity assists in selecting candidates for further development. Our services provide valuable information in the early developmental process of the drug candidate.
By effectively using our academic collaboratons we have established several tests using different tissue culture models for early pharmacodynamic studies. This offers you the opportunity to investigate a variety of pharmacological aspects at considerably lower costs compared to clinical trials or animal studies
With proof of concept studies, early safety assessments and other IND enabling services, we are committed to providing a strong scientific foundation to enable your preclinical decisions. We successfully customize studies to meet your needs and work with you to develop unique procedures and practices to facilitate the research and development of your compounds.
Assay development is critical in identification and confirmation of "hits", lead optimization and generating drug candidates for development. GenScript offers a comprehensive functional in vitro assay platform, using fluorometry, radioactivity, electrophysiology and cell-based assays. We are equipped to perform high throughput screening of compound libraries and can customize primary assays, secondary assays and specificity assays for your drug development needs.
Our scientists are experts in the development and application of cell based assays for drug discovery projects and similar research. In addition to standard cell survival and proliferation assays, we can carry out various receipts/enzyme induction/inhibition assays
Selecting the right assay for target identification and validation, assay development, screening, hit validation, selectivity profiling, and lead optimization, represents a critical step towards identifying candidate compounds for preclinical and clinical development. Our global in vitro assays and screening scientists, with expertise across a variety of therapeutic areas, target types, assay formats, instrument and automation platforms, are dedicated to helping you identify and progress your most promising biology and chemistry forward.
Our assay development platform is focused on functional assays due to their important role to move from in-vitro to in-vivo pharmacology for a high range of drug targets. It can be directed toward the best detection technology for a given molecular target and screening objective. We can generate stable assays for a wide variety of genes including GPCRs, ion channels, proteases and kinases as well as various other enzymes, transmembrane proteins and adhesion molecules.
One of the limitations of preclinical efficacy evaluation is the lack of appropriate animal models covering important aspects of the human disease. On the other hand, humanization of drugable targets offers a valuable tool for the preclinical evaluation of human therapeutics and especially of biologics.
Through partnerships, DiscoverSys offers both large and small animal model studies to the Pharmaceutical industries. Our clients' studies are placed only at reputable CROs / academic labs that specialize in the animal model required for the specific application of the product candidate. Sample testing is completed in laboratories with appropriate expertise, again matched to product development requirements. Intimate involvement in the protocol preparation and sample retrieval process ensures that our clients' product candidates are tested appropriately
In vivo studies are crucial to the development of novel therapies
In vivo studies provide more convincing evidence of the efficacy as well as adverse health consequences of the tested drug products.
At DiscoverSys, we have expertise and developmental experience in various preclinical animal models for surgical studies, osteopenia, diabetes, inflammation, dermal toxicology, pharmacokinetics, and many other uses. Rat and / or Mouse models available to our clients include:
A standard operating procedure (SOP) is a document with detailed instructions and methodology to be followed, in order to maintain uniformity and consistency in results. The International Conference of Harmonization (ICH) defines SOP as, “detailed written instructions to achieve uniformity of the performance of a specific function.
It is the responsibility of everyone (be it pharmaceutical company, contract research organization (CRO), sponsor, investigator, or any other party) involved in the process of drug development to prepare and follow a good SOP, in order to attain highest level of safety and efficacy of performed clinical trial. Regulatory Authority should make it mandatory for all the parties involved or conducting Clinical Research and Clinical Trials to get their SOPs verified before getting a license to perform their operations or trials. Apart from this, every employee in the organization should be well trained to follow these SOPs. An organization following a standard procedure obviously has a competitive edge over those who are not following the standard operating procedure, SOP.
With our vast experience in the field and regulatory requirements we can review your SOP for compliance and efficiency. We can also write SOPs for your needs.
Our carefully designed specific study setups for testing new drug candidates according to regulatory guidelines of FDA and EMA. We also provide specially designed studies for testing biosimilars and functional foods that have less extensive regulatory requirements.
Pharmacokinetic / pharmacodynamics (PK/PD) modeling, an integral component of the drug development process, is a mathematical technique for predicting the effect and efficacy of drug dosing over time. Broadly speaking, pharmacokinetic models describe how the body reacts to a drug in terms of absorption, distribution, metabolism, and excretion. Pharmacodynamic models describe how a drug affects the body by linking the drug concentration to an efficacy (or safety) metric. A well-characterized PK/PD model is an important tool in guiding the design of future experiments and trials.
DiscoverSys team has expertise in the application and presentation of pharmacokinetic (PK) and pharmacodynamic (PD) principles for successful drug approval
Having worked in various clinical CROs and done several BA/BE studies for US-FDA and other regulatory bodies, our team offer excellent cutting edge analysis
Use of pharmacokinetic (PK) and pharmacodynamic (PD) data analysis, to better understand a drug's mechanism of action, efficacious dose size and therapeutic inde will allow us to reduce attrition rate in the pharmaceutical industry which remains high, with a Phase III failure rate of 40 to 50%.
Engaging early with experienced statisticians in support of your research, development and operational activities can bring benefits to you and your organisation that extend go beyond the generation of p-values and basic analyses. These benefits include more efficient experimental and novel trial designs, more effective data analyses and better use of data and a positive impact on your overall strategy and critical decision making.
Our statistical consultants possess decades of experience of delivering statistical advice to a wide diversity of drug discovery projects. Our team offers advice on the execution of statistical analysis; how to plan your study including what sample size you should use, protocols to follow and how to analyse your data. We can also assist with independent statistical reviews including reports, project proposal assessments, methodological review and evaluation of research methodology.
Protocol Input – our input includes clinical study design, sample size calculations and consultancy advice during the start up of a study.
Randomization/Unblinding – we offer production of randomizations including production of emergency unblinding envelopes.
Statistical Analysis Plan (SAP) and Output Shells – we optimize the use of our Consultant Statisticians to ensure innovative approaches to the statistical content of a study to increase the chances of a successful trial.
Clinical Data Interchange Standards Consortium (CDISC) – using CDISC standards ensures that the data used in the outputs produced complies with regulatory standards.
Output Production – using Quanticate standard macros within the SAS ® Programming system ensures increased efficiency when producing outputs.
PK/PD Analysis - modeling the relationship between exposure and response using nonliner models and non-linear mixed effect modeling.
Production of Statistical Report/Clinical Study Report – our statistical and medical writing teams collaborate to produce high quality reports.
Interim Analysis/Data Safety Monitoring Boards (DSMBs) – we offer unblinded statistical support and advice for Interim Analyses and DSMBs.
Meta Analysis – our expert statisticians can advise on potentials for bias during a Meta Analysis as well as on statistical methods to use.
ISS/ISE - we provide support for the integration of safety and efficacy data prior to regulatory approval.
Our team specialized in statistical analysis for the development of therapeutic agents in pre-clinical as well as clinical research