ReaGene Biosciences Pvt Ltd and Humane Society International have signed a collaboration memorandum of understanding (MoU) to advance non-animal testing and research infrastructures in India as part of the overall BioMed21 strategy. Toward this end, the organizations have agreed to cooperate in the following areas:
- Building a network of Indian scientists to share information and cooperate in promoting a shift in research focus and funding in India
- Supporting continuing education for Indian authorities to support confidence and accelerated acceptance of non-animal approaches for regulatory use
- Offering continuing education and hands-on training on OECD-validated non-animal technologies for young scientists in India via an internship program
Internship Curriculum
The pilot phase of the internship program will support the training of three students, each for a period of six months, in the latest human-relevant approaches to safety assessment relevant to product sectors ranging from drug discovery and development to cosmetics, chemicals, nutraceuticals, and agrochemicals. Interns will receive in-depth, hands-on experience in applying the following globally recognized models and guidance:
Non-Testing Strategies
- OECD Guidance 237: Considerations for Waiving or Bridging of Mammalian Acute Toxicity Tests
- OECD (Q)SAR Guidance
In Vitro Skin Corrosion and Irritation
- OECD 431: In vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method
- OECD 435: In vitro Membrane Barrier Test Method for Skin Corrosion
- OECD 439: In vitro Skin Irritation: Reconstructed Human Epidermis Test Method
- OECD Guidance 203: An Integrated Approach on Testing and Assessment (IATA) for Skin Corrosion and Irritation
In Vitro Eye Irritation
- OECD 492: Reconstructed human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage
- OECD Guidance 203: An Integrated Approach on Testing and Assessment (IATA) for Serious Eye Damage and Eye Irritation
In Vitro/In Chemico Skin Sensitization
- OECD 442C: In chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA)
- OECD 442D: In vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method
- OECD 442E: In vitro Skin Sensitisation: human Cell Line Activation Test (h-CLAT)
- OECD Guidance 256: Reporting of Defined Approaches and Individual Information Sources to be Used Within Integrated Approaches to Testing and Assessment (IATA) for Skin Sensitisation
In Vitro Phototoxicity
- OECD 432: In Vitro 3T3 NRU Phototoxicity Test
In Vitro Estrogen and Androgen Assays
- OECD 455: Performance-Based Test Guideline for Stably Transfected Transactivation In Vitro Assays to Detect Estrogen Receptor Agonists and Antagonists
- OECD 458: Stably Transfected Human Androgen Receptor Transcriptional Activation Assay for Detection of Androgenic Agonist and Antagonist Activity of Chemicals
In Vitro Genetic Toxicology Assays Using Mammalian Cells (no in-lab training, but an introduction will be made as part of the program)
- OECD 473: In Vitro Mammalian Chromosomal Aberration Test
- OECD 476: In Vitro Mammalian Cell Gene Mutation Tests Using the Hprt and xprt Genes
- OECD 487: In Vitro Mammalian Cell Micronucleus Test
- OECD 490: In Vitro Mammalian Cell Gene Mutation Tests Using the Thymidine Kinase Gene
In Vitro Metabolism- and Transporter-Mediated Drug-Drug Interaction Studies (US FDA Draft guidance October 2017)
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- Determining if the investigational drug is a substrate of drug metabolizing enzymes
- Determining if the investigational drug is an inhibitor of drug metabolizing enzymes
- Determining if the investigational drug is an inducer of drug metabolizing enzymes
- Determining if the investigational drug is a substrate of transporters pGP and BCRP
- Determining if the investigational drug is a substrate of hepatic transporters OATP1B1 and OATB1B3
- Determining if the investigational drug is a substrate of renal transporters OAT, OCT and MATE
- Determining if the investigational drug is an inhibitor of transporter
- Determining if the investigational drug is an inducer of transporter
Internship Application
Indian students who meet the following qualifications are invited to contact ReaGene CEO, Dr. Subrahmanyam (Mani) Vangala, at mani.vangala@reagenebiosciences.com.
- Masters in Life Science or Pharmacy or an MTech in Biotechnology
- Interest in development and promotion of non – animal alternative models
- Strong project management and organizational skills and experience
- Excellent written and verbal communication skills, including public speaking and negotiation
- Ability to quickly absorb and communicate complex subject matter to a variety of audiencesAbility to multi-task, take initiative, and work effectively as part of a team or independently
- Outgoing and personable manner
- Ability to work patiently and astutely with different stakeholder groups and in multicultural and multilingual environment
- Experience in preparing content, specifically, the ability to extract key messages and information and compress them into prose that fits the requirements of various digital/social formats