Author: soumya296

In Vivo Pharmacology Services

GVK BIO has assembled a highly experienced team of scientists with strong background in drug discovery and in-depth knowledge in disease biology and expertise in In Vivo Pharmacology Models. Our scientists are well aligned with expectations from the industry regarding quality of scientific data and timeline.

Our animal facility is accredited by AAALAC and NIH for ethical treatment of animals. All the animal experiments at GVK BIO are conducted in accordance with IAEC approved protocols. GVK BIO’s rodent facility is also certified by OHSAS for strictly following all recommended rules for health and safety of our employees.

Infrastructure & Expertise

  • AAALAC accredited and OHSAS certified animal facility
  • 10 scientists including one veterinarian and four PhDs with collective 50 years of disease biology experience in CNS, pain, oncology, inflammation and metabolic disorders
  • Scientists with broad drug discovery experience from target identification/validation to IND submission
  • Extensive in-house experience of validating rodent models and providing screening support for clients in oncology, pain, inflammation, diabetes and obesity disease model
  • Our clients include large, mid-size pharma and virtual companies across globe
  • Compounds screened and characterised by our team have progressed to IND studies

To get a quote on our In Vivo Pharmacology services team, please contact us here. We will get back to you as soon as possible.

In Vivo Pharmacology

Source: GVKBIO
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Trends in Drug Discovery Outsourcing: A Perspective

Seven drugs of the current top-10 best selling drugs are biologics, the penetration of biologic drugs is expected to reach 30% by 2020 of the global pharmaceutical market and some of the key modalities include monoclonal antibodies, recombinant proteins, peptides, cell and gene therapy products.dr_subir_gvk_bio-8998                               Dr Subir Basak Chief Business Officer, GVK Biosciences

Over the last two decades, the Pharmaceutical industry has seen a radical change. The unprecedented downsizing of the internal discovery of big pharmaceuticals, patent expiration, shift towards biologics have seen a surge in the externalization and outsourcing activities. As the industry is looking for new sources of discovery and innovation with limited resources, there is a growing preference to move towards externalization and willingness to embrace the concept of outsourcing.

Seven drugs of the current top- 10 best selling drugs are biologics, the penetration of biologic drugs is expected to reach 30% by 2020 of the global pharmaceutical market and some of the key modalities include monoclonal antibodies, recombinant proteins, peptides, cell and gene therapy products. Global R&D spend in the biopharmaceutical industry is estimated to be $194 billion in 2016 and according to industry experts, 75-80% of the expenses can be outsourced. However, current penetration rate is around 58% which presents a huge opportunity for the CROs to tap the Trends in Drug Discovery Outsourcing: A Perspective market. The global pharmaceutical outsourcing market was estimated to be $113.7 billion in 2016 and out of which 49% is accounted for CROs. Among the $55.7 billion CRO market, 31.2% accounts for discovery-based service i.e. $17.4 billion in 2016 and the remaining 68.8% accounts for Preclinical and clinical services.

Biology related services segment is a high growth area with huge potential and expected to grow faster at a CAGR of 17.2% compared to the small molecules segment due to increase in budget allocations for R&D by biopharmaceutical companies.

The drug discovery CRO industry is witnessing increased consolidation. Many Asia-based companies are increasing their foothold in Europe and North America. GVK BIO, a Contract Research & Development Organization (CRDO) from India has taken over Aragen Bioscience. Aragen has early stage discovery biologics capabilities and played a leading role in oncology and fibrosis based animal models for preclinical biotechs in bay area. Similarly, ChemPartner established research facility in South San Francisco. Also, WuXi AppTec acquired HD Biosciences (HDB), a biology focused preclinical drug discovery CRO.

Advancement in drug discovery technologies such as iPS cells, automated high content screening, patch clamp, gene editing and DNAencoded libraries have expedited the drug discovery process with increased efficiency. There is an increased interest in the use of DNAencoded libraries (small molecules tagged with DNAs) by major pharma companies.Majority of the companies offering DNA-encoded library services are from US (DiCE, X-Chem, Ensemble therapeutics) and Europe (Nuevolution, Vipergen, Cominnex, Philochem). There seems to be very little competition in APAC. This trend should push some of the CROs from APAC region to acquire companies with proprietary technology in DNA-encoded libraries or to build capabilities and this seems likely to be a focus point for majority of the CROs especially from APAC.

Evolving business models including risk-based and insourcing are facilitating better collaboration between pharmaceutical companies and CROs. Some of the companies established a new business model known as insourcing which is a new sourcing for pharma where CROs work on-site at customer location in an integrated fashion. This new model provides outstanding performance with efficient cost and time.

CROs should build capabilities to differentiate in the area of Target Identification/Target Validation on how to use human disease pathology knowledge/primary tissues from humans clubbed with Omics knowledge to further validate the concepts. As most of the CROs propose targets from literature and sponsor companies consider it as risky option to invest in such projects without substantial evidences. As a de-risking strategy some CROs are investing internally and validating the concept by siRNA, knockdown approaches and take the concept to a level-up and then approach the sponsors companies who are working in similar area. This approach would increase the sponsor confidence in the CRO program.

There is a huge demand for the novel therapeutics addressing the unmet needs, for example, there are no FDA approved drugs or any therapies for NASH treatment and there is a tremendous opportunity for CROs to work on novel targets, preclinical models and biomarker to come-up with some early stage assets for partnering. Owing to market attractiveness, there is funding provided by venture capitalists to promising players, while some investors are even launching new companies to specifically work on NASH projects. For instance in February 2017, Versant Ventures formed Jecure Therapeutics through $20 million investment for NASH program development. Similarly, Third Rock Ventures formed Pliant Therapeutics with $45 million investment for TGF-β signaling based NASH treatment. These companies could potentially outsource majority of the work to CROs in APAC region.

Asia is emerging as a preferred destination for outsourcing drug discovery activities due to the vast availability of skilled manpower, lower costs, favorable regulatory environment and quality data. In addition the local governments are focusing on development of healthcare and pharmaceutical industryby ensuring focus on high quality & compliance in terms of higher regulatory surveillance and training programs. Japan being the second largest pharmaceutical market in the world provides huge opportunity for CROs from APAC. Chinese and Indian pharmaceutical markets are one of the fastest growing in the world and are considered to be the preferred locations for drug discovery outsourcing primarily because of the end-to-end technological capabilities developed over several years. Asian CROs have strong capabilities in biologics research services and built new technology platforms for high-throughput screening, genomics and proteomics research panel screening, enzymatic, and binding assays. They are also well equipped with transgenic and disease animal models that have been developed for target validation, efficacy, and safety studies, thereby providing clients with end-to-end services. Indian CROs typically focus more on new chemical entities and offer integrated discovery services at much lower cost.

Therapeutic area gap analysis research indicates that the key contract research organizations in Asia pacific region are majorly focusing on Oncology, metabolic diseases, Inflammation and CNS. However, majority of Pharma companies in addition to the above therapeutic areas are also focusing on other areas like cardiovascular, immunology, infectious diseases. Since there is a high gap in these therapeutic areas, the CROs should increase their focus in order to tap the opportunity.

Growth in biologics research and orphan drugs, innovative technological platforms and evolving business models encourage pharma and biotech companies to outsource. Even though, big pharma is moving towards research institutions and academia to accelerate knowledge and leverage innovation and technology platforms, they lack the infrastructure to move the drugs from early stages of drug discovery. These factors are expected to enhance drug discovery outsourcing market in APAC region for the coming years.

Source: biospectrumasia

Medicinal Chemistry Services

Medicinal

GVK BIO provides Medicinal chemistry services through an experienced team of medicinal chemists augmented by synthetic chemists, computational chemists and biologists. Our focus is on making the right compounds to validate hypotheses and drive SAR/SPR by utilising appropriate assays/models to determine target mediated efficacy, differentiation and translation to clinic.

Hit generation

Hits are important starting point in a discovery program. Hits are either provided by client or generated using virtual screen, knowledge based design or HTS using client’s compound library.

Virtual Screening: Computational Chemists leverage the GVK BIO proprietary databases containing over 6 million compounds. These databases capture various properties of compounds including chemical, biological and material science properties and support discovery research for structure mining, focused library design, computational chemistry and SAR analysis.

Knowledge Based Design: GVK BIO’s discovery chemists make use of multi parameter advanced chemical analogue approaches for Hit/Lead Generation and Optimisation based on the known structures which bind to target of interest, target substrate or inhibition of protein-protein interaction.

HTS: GVK BIO does not have proprietary compound collection, but can undertake high throughput screening (HTS) on commercially available libraries or libraries provided by clients.

Hit-to-Lead activities

Qualified hits undergo ADME screening, such as, solubility, logD, CYP interaction, permeability, etc. to understand the liabilities at an early stage.

These hits are further evaluated for lead likeliness such as LiPE plot, optimisation potential (in terms of medicinal chemistry), binding and functional assay. Preliminary SAR is generated by filling the gaps with new molecules or synthesising analogues. These analogues are not only evaluated for their potency (biochemical and cell based) but also assessed for selectivity, efficacy in relevant animal models, PK and early safety. Target relevant pharmacodynamic models are developed to guide SAR development and compound prioritisation for efficacy models. End point is identification of more than one lead series.

Lead optimisation

One series is prioritised for LO and the other for backup. Apart from potency, PK and efficacy, analogues are assessed for novelty, extended selectivity, efficacy in animal models, safety pharmacology and preclinical toxicity. The goal is identification of pre-clinical candidate(s).

Source: GVK BIO