Frequently Asked Questions

What is biomedical research?

Succinctly, biomedical research is a scientific discipline aimed at understanding the biological and genetic causes of human disease. The success of biomedical research requires multidisciplinary collaboration between several specialized areas including biology, chemistry, in vitro, in vivo, clinical, and engineering.

The ultimate goal of biomedical research is to learn how to prevent and treat diseases to improve the human condition. Drug discovery and development rely on biomedical research.  

What are examples of biomedical research?

Biomedical research is aimed at developing novel therapeutics for disease, including pharmaceuticals, devices, and techniques such as chemotherapy, hip replacement, and tumor resection respectively. The most well-known, recent example of biomedical research is the development of the COVID-19 vaccines.

Development of these vaccines required concerted efforts across research disciplines to identify therapeutic targets and test the resulting treatments. Vaccine testing required extensive in vivo studies to delineate the most efficacious and safe compounds for use in humans. 

When vaccines were tested in humans, the compounds were deemed safe and effective, obtaining authorization for international implementation. COVID-19 vaccines are now a prophylactic measure reducing the likelihood of acquiring and transmitted the COVID-19 disease. 

What is in vivo testing?

In vivo translates to “in living”. In biomedical research, in vivo most often refers to assessing the safety and efficacy of therapeutic drug compounds or devices in a living animal model of disease and is considered “pre-clinical” research. Pre-clinical in vivo research most often begins in rodents, such as mice and rats, and progresses through higher order animals such as ungulates, dogs, and ultimately non-human primates. 

In vivo testing must adhere to strict guidelines regarding the care and safety of animals as set by the Guide for the Care and Use of Laboratory Animals (The Guide), Institutional Animal Care and Use Committee (IACUC), and The Animal Welfare Act, to name a few. If the tested therapeutic meets acceptance criteria, it is submitted to the FDA for testing in humans under the care of medical professionals in the clinic 

What is in vitro testing?

In vitro translates to “in glass” and is considered part of pre-clinical research. In vitro testing is often performed on cells that are maintained, or cultured, in a petri dish, test tube, or well plate, and are thus often referred to as “cell culture”. The cells are either derived from living organisms or a cell line.

 In biomedical research, in vitro testing refers to assessing the safety and efficacy of a therapeutic drug compound at the cellular level. If results from in vitro testing meet acceptance criteria, the next step is to perform in vivo testing, as described above. 

What's the difference between in vitro and in vivo testing?

In vitro testing identifies therapeutic targets and evaluates therapeutic efficacy and safety in cells. For example, a new anticancer drug may be tested on tumor cells cultured in a petri dish to assess its ability to induce apoptosis in the cells, thereby killing the cancerIn vivo testing identifies therapeutic targets or evaluates therapeutic efficacy and safety in whole living organisms, such as plants or animals. 

For example, if our aforementioned anticancer drug proved effective in vitro, it would be tested in a mouse model of cancer to ensure it maintained efficacy and did not cause deleterious side effects. In vitro testing offers a cost effective, simple, and high throughput method to detect cell specific effects. 

In vivo testing captures the complex interactions between cells and biological systems that impact the performance of the tested therapeutic in a model that more closely represents the human condition. 

What is the role of animals in new drug discovery and research, and why is it important?

Animal research plays a vital role in our understanding of etiopathogenesis as well as therapeutic target identification, validation, and safety. Rodent models are especially critical to the drug discovery and research process, due to their fast rate of reproduction and ageing, they allow high-throughput screening.

In addition, our deeper understanding of genetics has led to the establishment of rodent models that more accurately recapitulate human conditions, thereby increasing the translatability of this pre-clinical research to the human condition. As a result of this extensive research, therapeutics that make it to human clinical trials do so with higher efficacy, tolerability, and a lower adverse side effect profile. Taken together, researchers can reduce the pursuit of false leads and can more quickly determine if a therapeutic is effective.

Why is animal testing necessary?

Animal research has provided myriad advances to our understanding of basic biology, etiopathology, and disease progression. Many of the treatments and vaccines that humans benefit from today would be impossible without animal research.

Non-human animals have strong genetic, metabolic, and nervous system similarities with humans – known as conservation – and often naturally express human diseases, for example flu and several cancers. Animal research has offered critical insights into the understanding of basic biology, disease progression and treatment. In addition to its contribution to human health, many of these therapeutics are also used in veterinary care.  

What are the stages of drug discovery?

According to the FDA, the drug discovery process generally has 5 stages:

  1. Discovery and Development – Research for a new drug begins in the laboratory.
  2. Preclinical Research – Drugs undergo laboratory and animal testing to answer basic questions about safety.
  3. Clinical Research – Drugs are tested on people to make sure they are safe and effective.
  4. FDA Review – FDA review teams thoroughly examine all of the submitted data related to the drug or device and make a decision to approve or not to approve it.
  5. FDA Post-Market Safety Monitoring – FDA monitors all drug and device safety once products are available for use by the public.

The FDA has a great infographic detailing the different steps here.

Why are mice used for testing?

At first glance, it may seem strange to consider that research conducted using mice can be informatively applied to humans; however, mice and humans share considerable anatomy and physiology.

In addition, the genome between the two species is remarkably conserved, allowing complex genetic risk factors known to underlie human disease to be studied in mice. Furthermore, immunodeficient mice can be humanized, meaning a mouse can express a functioning human gene, cell, tissue, or organ allowing for a more accurate disease model. 

Logistically, mice are easily housed, and breed and age quickly. These characteristics allow high-throughput research and the ability to see the effects of ageing on disease etiology and progression, and therapeutic efficacy. 

What is Climb?

Climb is a cloud-based collaboration LIMS for in vivo study operations and data management. Its ease of use and configurability makes it ideal for in vivo study management for Biotechs, Pharma, Contract Research Organizations, and Academia.

Our comprehensive Climb 2.0 solution manages, tracks, and logs all aspects of in vivo research, aggregating and harmonizing data for on-demand access. 

What is LIMS?

LIMS (Laboratory Information Management System) is a type of software designed to improve lab efficiency and productivity while managing and maintaining vast amounts of data. While all LIMS systems contain data management and workflow modules, there can be significant differences in functionality across different solution providers and laboratories. 

Over the past several years, LIMS functionality has grown to include a wide range of features including data mining and analysis, assay management, electronic laboratory management, and equipment integration.  

How does LIMS work?

LIMS replace traditional, antiquated methods of laboratory and data management tools such as spreadsheets and physical notes with a comprehensive digitalized solution. Scientists, schedulers, technicians, and other team members can enter detailed, essential information relating to the samples and projects they’re working with.

Depending on the functionality of the LIMS, it can handle everything from aggregating and storing data for future access to sample, vivarium, and workflow management. LIMS are often cloud-based platforms, allowing for easy access, searchability, and audit support. By standardizing operations and maintaining workflows, LIMS improve efficiency and time to market. 

What are the advantages of LIMS software?

LIMS effectively manage the flow of samples and data, standardizing operations and improving lab efficiency, accuracy, and productivity. Some of the main benefits of LIMS software are: 

  • Enabling workflow automation, reducing human error 
  • Aggregating, harmonizing, and storing data for ease of access and searchability 
  • Supporting compliance efforts with chain of custody and audit support 
  • Standardizing workflows and vocabulary 
  • Integrating with instruments or other in-lab systems to improve lab efficiency 
  • Easy task management and resource scheduling 
  • Encouraging global real-time collaboration and decision-making 
  • Getting more science done! 

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