Academic CRO/Industrial collaborations in drug discovery

Academic CRO/Industrial collaborations in drug discovery provides insight into the potential synergy of basing R&D in academia while leaving drug companies to turn hits into marketable products. These assist in increasing access to cutting-edge science, equipment, and resources for both universities and biopharmaceutical companies enabling the nation’s R&D enterprise to tackle the most complex and challenging diseases and conditions. In the face of an increasingly challenging R&D environment and global competition, we are likely to witness the continuing proliferation of AMC industry partnerships.

The track will cover how to:

• Gain global perspectives on the benefits and potential issues surrounding collaborative innovation
• Ways through which industries can come together
• Learn how nonprofits are becoming the driving force behind innovation
• Read case studies of specific academia-pharma partnerships for real-life examples of successful collaboration
• Explore initiatives that help foster cooperation between industry and academia

Anti-Infectives

Anti-infective agents include antibiotics and antibacterials, antifungals, antivirals and antiprotozoals. Anti-bacterials are the largest segment of the anti-infectives market and within this segment, drugs for resistant bacteria are of most concern.

The ultimate solution to anti-infective drug resistance is prevention of infection through vaccination, and continued research and development of vaccines is an important part of any strategy to address drug resistance. The urgent need to combat drug resistance demands three major responses: conservation of existing anti-infective drugs through prudent use and investment in research and development both for new anti-infective drugs and for vaccines, which are the ultimate solution to infection and drug resistance.

Bioactive Lipids

All bioactive lipids exert their effects through binding to specific receptors, many of which have just recently been characterized. Bioactive lipids play important roles in energy homeostasis, cell proliferation, metabolic homeostasis, and regulation of inflammatory processes.

Bioactive lipids or lipids that activate specific signalling pathways are involved in the regulation and maintenance of normal bodily functions. Furthermore, bioactive lipid targets have been implicated in a number of conditions such as cancer, asthma and arthritis, all of which contain an inflammatory element. Additionally, a number of bioactive lipids are also known to target several different types of receptors. These include the cannabinoid receptors, peroxisome proliferator activated receptor alpha (PPARα) and transient receptor potential vanilloid-1 (TRPV1) ion channels.

Biologics

Biologics are isolated from a variety of natural sources - humans, animals, or microorganisms - and may be produced by biotechnology methods and other cutting-edge technologies. Gene-based and cellular biologics, for example, are often at the forefront of biomedical research, and may be used to treat a variety of medical conditions for which no other treatments are available.

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Clinical Trials and Regulatory Affairs

Regulatory affairs play critical roles throughout the lifecycle of pharmaceuticals, medical devices, biologics, veterinary medicines, pesticides, agrochemicals, cosmetics and complementary medicine and functional foods. The regulatory professional services can be utilized in research and development, clinical trials, extension of premarket approvals, manufacturing, labeling and advertising, and post-market surveillance.

Clinical trials are conducted on new drugs and this process involves the design, execution and management of clinical trials as well as quality assurance and compliance principles to enhance the development of healthcare products.

Cancer Targeted Drug Delivery

Targeted drug delivery systems can directly deliver the payload to the desired site of action without undesired interaction with normal cells. Number of targeted drug delivery systems i.e. use of microfluidics, nanoparticle-based formulations, and use of monoclonal antibodies for anticancer drugs are in the market and many more are in research phase. Successful translation (from bench to bedside) of potential cancer and gene therapies, particularly small interfering RNA (siRNA) delivery, will largely depend on targeted drug delivery strategies. In future, the advancements in these approaches may lead to significant improvements in cancer therapy procedures to avoid risks associated with chemotherapy in these methodologies.

Cardiovascular Drug Discovery & Therapy

Cardiovascular disorders are the predominant cause of death or disability in the industrialized world and increasingly prevalent in developing nations. Cardiovascular Drug Discovery & Therapy fields include heart failure, coronary artery disease, high cholesterol, plasma lumps, circulation disorders, and others.

Chemistry

The role played by chemistry in the pharmaceutical industry continues to be one of the main drivers in the drug discovery process. However, the precise nature of that role is undergoing a visible change, not only because of the new synthetic methods and technologies now available to the synthetic and medicinal chemist, but also in several key areas, particularly in drug metabolism and chemical toxicology, as chemists deal with the ever more rapid turnaround of testing data that influences their day-to-day decisions.

Combinatorial Chemistry

Combinatorial chemistry used to conceivably develop some of the non-biological derivatives is in itself fundamentally based on the naturally occurring processes; only these processes are systematically used to create new leads in drug discovery.

Through the rapidly evolving technology of combi-chemistry, it is now possible to produce compound libraries to screen for novel bioactivities. This new,powerfultechnology has begun to help pharmaceutical companies to find new drug candidates rapidly, saving significant costs in preclinical development, ultimately changing their fundamental approach to drug discovery.

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CNS Drug Discovery & Therapy

In this complex era of advancement in every field of life, from a single genome to complex brain neuronal system, the world is facing an augmented share of Central Nervous System diseases. One of the new advancements as therapeutic tool is the introduction of carrier-mediated transport systems to the blood–brain barrier as a supporting and protecting interface for the brain; importance for CNS drug discovery and development.

Three interacting disciplines—molecular genetics, systems neuroscience, and translational medicine—have synergistic potential in CNS drug development and therapy.

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Diabetes and Obesity Drug Discovery & Therapy

There are many promising drugs under development in life sciences companies that have just been waiting for a usable animal model. Most of the previous work was focused on the effect of genetics in altering the immune system (in T1D) and metabolic dysfunction of the liver (in T2D), much of this health care burden is caused by late-stage type 2 diabetes, where we do not have effective treatments, so we desperately need new research into novel therapeutic approaches. Given the magnitude of the challenges, highly collaborative efforts involving academia, biotech, pharma, regulatory agencies, patient advocacy groups and other key stakeholders are required to identify and advance new therapies that are substantially differentiated from current disease management.

Multiple options exist for the treatment of obesity including bariatric and metabolic surgeries, either gastric banding or procedures that involve resecting, bypassing, or transposing sections of the stomach and small intestine, that can be effective weight loss treatments for severe obesity when performed as part of a comprehensive weight management program with lifelong lifestyle support and medical monitoring.

Drug Delivery & Targeting

Drug Delivery plays a significant role in the future of pharmaceutical research. Novel drug delivery system is a method by which a drug delivered can have a significant effect on its efficacy. Topical drug delivery is through a large range including but not limited to creams, foams, gels, lotions, and ointments. Pulmonary mode of drug delivery system route is gaining much importance in the present day research field as it enables to target drug delivery directly to lung both for local and systemic treatment. Nasal drug delivery is an alternative route restricted to intravenous administration. This area has been widely investigated in recent years by academics. Vaginal drug delivery covers self-insertion creams, foams, gels, irrigations and tablets are known to reside in the vaginal cavity. Oral Drug Delivery routes reach different parts of the body via the bloodstream.

Drug Discovery in Preclinical Research

Preclinical development encompasses the activities that link drug discovery in the laboratory to initiation of human clinical trials. Preclinical studies can be designed to identify a lead candidate from several hits; develop the best procedure for new drug scale-up; select the best formulation; determine the route, frequency, and duration of exposure; and ultimately support the intended clinical trial design. Concurrent preclinical development activities include developing a clinical plan and preparing the new drug product, including associated documentation to meet stringent FDA Good Manufacturing Practices and regulatory guidelines.

Drug Metabolism

Drug metabolism is the process by which the body breaks down and converts medication into active chemical substances. It is the enzymatic conversion of one chemical compound into another. Drugs can be metabolized by oxidation, reduction, hydrolysis, hydration, conjugation, condensation, or isomerization; whatever the process, the goal is to make the drug easier to excrete. The enzymes involved in metabolism are present in many tissues but generally are more concentrated in the liver. Drug metabolism rates vary among patients. Some patients metabolize a drug so rapidly that therapeutically effective blood and tissue concentrations are not reached; in others, metabolism may be so slow that usual doses have toxic effects. Individual drug metabolism rates are influenced by genetic factors, coexisting disorders (particularly chronic liver disorders and advanced heart failure), and drug interactions (especially those involving induction or inhibition of metabolism). Overall, metabolic processes will convert the drug into a more water-soluble compound by increasing its polarity.

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Enabling Technologies

Enabling Technologies are fast developing technologies that range in various fields providing the means to increase performance and capabilities of the user, product or process.Recent developments in the green techniques in medicinal chemistry, high throughput screening and genomics are new state of art research and future developments in enabling technologies.

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Genomics

Genomics continuously redefines its own frontiers and relies on techniques that are evolving at a prodigious speed. However, with developments in speed, accuracy and effectiveness of high-throughput DNA sequencing, increasing computational speed, and reduction in cost per computation, genomics research is now entering a second revolution.
Doctors can now use DNA analysis to diagnose challenging cases, such as mysterious neurodevelopmental disorders, mitochondrial disease, or other disease or unknown origin in children. Genomics is possibly making its biggest strides in cancer medicine. Doctors can now sequence a patient’s tumor to identify the best treatments.

Green Techniques for Medicinal Chemistry

Green chemistry is a new way of looking at organic synthesis and the design of drug molecules, offering important environmental and economic advantages over traditional synthetic processes. Pharmaceutical companies are increasingly turning to the principles of green chemistry in an effort to reduce waste, reduce costs and develop environmentally benign processes.

Green Chemistry must establish a comprehensive set of design principles and interdisciplinary cooperation to move toward routine consideration of hazards as molecular properties just as malleable to chemists as solubility, melting point, or color.

High-throughput Screening & Laboratory automation

HTS is a relatively recent innovation, made feasible largely through modern advances in robotics and high-speed computer technology. Laboratory automation is a multi-disciplinary strategy to research, develop, optimize and capitalize on technologies in the laboratory that enable new and improved processes. Laboratory automation professionals are academic, commercial and government researchers, scientists and engineers who conduct research and develop new technologies to increase productivity, elevate experimental data quality, reduce lab process cycle times, or enable experimentation that otherwise would be impossible.

During the past 10 years, combinatorial chemistry and high throughput screening have profoundly influenced researchers' ability to produce and evaluate a group of chemical compounds for any number of purposes. This technology has helped to decrease the time and amount of material needed to produce and screen many chemical compounds.

Hot Topics in Drug Targets

Identifying the biological origin of a disease, and the potential targets for intervention, is the first step in the discovery of a medicine. This has been a great challenge for both academia and industry. Targeted drug delivery systems have been developed to optimize regenerative techniques. The drug delivery system is highly integrated and requires various disciplines, such as chemists, biologists, and engineers, to join forces to optimize this system.

There are different types of drug delivery vehicles, such as polymeric micelles, liposomes, lipoprotein-based drug carriers, nano-particle drug carriers, dendrimers, etc. An ideal drug delivery vehicle must be non-toxic, biocompatible, non-immunogenic, biodegradable, and must avoid recognition by the host's defense mechanisms.

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Hot Topics in HIV Research

The human immunodeficiency virus (HIV) is a lentivirus (a subgroup of retrovirus) that causes HIV infection and over time acquired immunodeficiency syndrome (AIDS). HIV is a virus that gradually attacks the immune system, which is our body’s natural defence against illness. There are many different strains of HIV – someone who is infected may carry various different strains in their body.

Hot Topics in Medicinal Chemistry

Medicinal chemistry is a stimulating field as it links many scientific disciplines and allows for collaboration with other scientists in researching and developing new drugs.

Medicinal chemistry focuses on small organic molecules—encompassing synthetic organic chemistry and aspects of natural products and computational chemistry in close combination with chemical biology, enzymology and structural biology, aiming at the discovery and development of new therapeutic agents. This field involves chemical aspects of identification, and then systematic, thorough synthetic alteration of new chemical entities to make them suitable for therapeutic use. It includes synthetic and computational aspects of the study of existing drugs and agents in development in relation to their bioactivities (biological activities and properties), i.e., understanding their structure-activity relationships (SAR). Pharmaceutical chemistry is focused on quality aspects of medicines and aims to assure fitness for medicinal products.

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Hot Topics in Natural Products

The isolation of novel bioactive natural products has strengthened due to the improvement in sensitive separation methods, mass spectrometry and nuclear magnetic resonance spectroscopy. Furthermore, recent advancements in comprehensive analytical platforms and emerging fields such as, metabolomics are now being integrated with NP chemistry to dereplicate and profile NP extracts efficiently. Isolating the elusive ‘needle-in-the-haystack’ or ‘magic-bullet’ appears to be an old paradigm and research seems to be shifting towards multi-target studies on NP extracts (botanicals and herbal formulations). Translational medicine, evidence based phytotherapy and new progresses in NP extract studies will provide new sources of innovation in the future.

Inflammation and Immunology

Inflammation is characterized by pain, edema, erythema, and heat. The inflammatory response is a normal and generally desirable outcome of an immune response.
Dramatic advances in immunology have led to the control of many chronic inflammatory processes and have had a paradigm shifting impact on immunotherapy of cancer. Basic scientific discoveries provided a basis for abrogating cancer promoting aspects of immunity, treating inflammatory diseases, detecting viruses, bacteria, and parasites, and the development of new vaccines and therapeutics.

Innovative Drug Discovery and Nanotechnology

Nanotechnology, a multidisciplinary scientific undertaking, involves creation and utilization of materials, devices or systems on the nanometer scale. The field of nanotechnology is currently undergoing explosive development on many fronts. The technology is expected to create innovations and play a critical role in various biomedical applications, not only in drug delivery, but also in molecular imaging, biomarkers and biosensors. Target-specific drug therapy and methods for early diagnosis of pathologies are the priority research areas where nanotechnology would play a vital role. Different nanotechnology-based drug delivery and imaging approaches, and their economic impact play essential role in pharmaceutical and biomedical industries.

In-silico Drug Design and in-silico screening

Recently, a trend towards the use of in-silico chemistry and molecular modelling for computer-aided drug design has gained significant momentum. In-silico drug design skills are used in nanotechnology, molecular biology, biochemistry, etc.

In-silico drug design can take part considerably in all stages of drug development from the preclinical discovery stage to late stage clinical development.

During the process of selection of novel drug candidates, many essential steps are taken to eliminate such compounds that have side effects and also show interaction with other drugs. In-silico drug designing softwares play an important role to design innovative proteins or drugs in biotechnology or the pharmaceutical field. The drug designing softwares and programs are used to examine molecular modelling of gene, gene expression, gene sequence analysis and 3D structure of proteins. In-silico methods have been of great importance in target identification and in prediction of novel drugs.

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Medical Imaging

Medical imaging encompasses different imaging modalities and processes to image the human body for diagnostic and treatment purposes and therefore plays an important role in initiatives to improve public health for all population groups. Furthermore, medical imaging is frequently justified in the follow-up of a disease already diagnosed and/or treated.

Over the years, different sorts of medical imaging have been developed, each with their own advantages and disadvantages. X-ray based methods of medical imaging include conventional X-ray, computed tomography (CT) and mammography. To enhance the X-ray image, contrast agents can be used for example for angiography examinations. Other types of medical imaging are magnetic resonance imaging (MRI) and ultrasound imaging. Unlike conventional X-ray, CT and Molecular Imaging, MRI and ultrasound operate without ionizing radiation. MRI uses strong magnetic fields, which produce no known irreversible biological effects in humans.

Medical imaging, especially X-ray based examinations and ultrasonography, is crucial in a variety of medical setting and at all major levels of health care.

Nutraceutical Drug Discovery & Therapy

Nutraceuticals play an increasingly important role in the treatment of various chronic diseases such as colon cancer, diabetes and Alzheimer׳s disease. Nutraceuticals are derived from various natural sources such as medicinal plants, marine organisms, vegetables and fruits.

Nutraceuticals may be used to improve health, delay the aging process, prevent chronic diseases, increase life expectancy, or support the structure or function of the body. Recent studies have shown promising results for these compounds in various pathological complications such as diabetes, atherosclerosis, cardiovascular diseases (CVDs), cancer, and neurological disorders. Nutraceuticals are considered as healthy sources of health promotion, especially for the prevention of life threatening diseases such as diabetes, infection, renal, and gastrointestinal disorders.

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Pharmaceutical Biotechnology

Pharmaceutical biotechnology has emerged as one of the major disciplines for drug discovery and development. Pharmaceutical Biotechnology contributes to the design and delivery of new therapeutic drugs, the development of diagnostic agents for medical tests, and the introduction of gene therapy for correcting the medical symptoms of hereditary diseases.

Pharmaceutical Research & Development

The pharmaceutical industry is growing with the development of new technology. Pharmaceutical products help to treat various types of diseases. Drugs are released into the market after studies and clinical testing. The FDA or the food and drug administration has the authority to decide about the administration of drugs to humans.

The products of pharmaceutical companies save life, improve the quality of life of people and also help in preventing diseases. Most of the present day diseases and epidemics can be controlled by the use of pharmaceuticals.

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Pharmacogenomics

Pharmacogenomics is a relatively new field combining pharmacology (the science of drugs) and genomics (the study of genes and their functions) to develop effective, safe medications and doses that will be tailored to a person's genetic makeup.

Pharmacogenomics may be applied to several areas of medicine, including Pain Management, Cardiology, Oncology, and Psychiatry. A place may also exist in Forensic Pathology, in which pharmacogenomics can be used to determine the cause of death in drug-related deaths where no findings emerge using autopsy.

In the future, pharmacogenomics will allow the development of tailored drugs to treat a wide range of health problems, including cardiovascular disease, Alzheimer disease, cancer, HIV/AIDS, and asthma.

Process Chemistry and Drug Manufacturing

Process chemistry cover organic chemistry, catalysis systems, analytical chemistry, process analytical technologies (PAT) and chemical/design engineering, laboratory process transfers to pilot and manufacturing with optimizations of chemical reactions which include research and process development in the pharmaceutical, fine chemicals, cosmetics, agrochemicals, dyestuffs and polymers.

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Protein and Peptide Sciences

In the past decade, great emphasis has been placed on bringing protein and peptide therapeutics to the market. Despite tremendous efforts, parenteral delivery still remains the major mode of administration for protein and peptide therapeutics. Other routes such as oral, nasal, pulmonary and buccal are considered more opportunistic rather than routine application. Improving biological half-life, stability and therapeutic efficacy is central to protein and peptide delivery.

Current advances in peptide science aims to overcome the physical barriers and technological barriers in the field of protein &peptide science and discuss forthcoming prospects in the area of synthesizing peptide drugs and vaccines, immunology aspects, diagnostics tools, nutraceutics, cosmetics, production and delivery of these molecules.

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Proteomics & Bioinformatics

Proteomics is a fundamental science in which many sciences in the world are directing their efforts. The proteins play a key role in the biological function and their studies make possible to understand the mechanisms that occur in many biological events (human or animal diseases, factor that influence plant and bacterial grown).

Bioinformatics is the application of computer technology to the management of biological information. Computers are used to gather, store, analyze and integrate biological and genetic information which can then be applied to gene-based drug discovery and development.

Pulmonary Drug Discovery & Therapy

Targeted therapy of lung cancer refers to using agents specifically designed to selectively target molecular pathways responsible forthe malignant phenotype of lung cancer cells, and as a consequence,of this (relative) selectivity, cause fewer toxic effects on normal cells. New frontiers in the field of targeted lung cancer, lung fibrosis and therapies to treat pulmonary related disorders will be focused in this session.

Recent Advances in Patient Treatment and Care

1. Palliative care focuses on providing patients with relief from the symptoms, pain, physical stress, and mental stress of a serious illness—whatever the diagnosis. The goal of such therapy is to improve the quality of life for both the patient and the family.
2. End-of-life care (or EoLC) requires a range of decisions, including questions of palliative care, patients' right to self-determination (of treatment, life), medical experimentation, the ethics and efficacy of extraordinary or hazardous medical interventions, and the ethics and efficacy even of continued routine medical interventions.
3. Ambulatory care or outpatient care is medical care provided on an outpatient basis, including diagnosis, observation, consultation, treatment, intervention, and rehabilitation services. This care can include advanced medical technology and procedures even when provided outside of hospitals.

Recent Advances in Spectroscopy

Spectroscopic techniques have been applied in virtually all technical fields of science and technology. Radio-frequency spectroscopy of nuclei in a magnetic field has been employed in a medical technique called magnetic resonance imaging (MRI) to visualize the internal soft tissue of the body with unprecedented resolution. Microwave spectroscopy is used to discover the so-called three-degree blackbody radiation, the remnant of the big bang (i.e., the primeval explosion) from which the universe is thought to have originated (see below Survey of optical spectroscopy: General principles: Applications). The internal structure of the proton and neutron and the state of the early universe up to the first thousandth of a second of its existence is being unraveled with spectroscopic techniques utilizing high-energy particle accelerators. The constituents of distant stars, intergalactic molecules, and even the primordial abundance of the elements before the formation of the first stars can be determined by optical, radio, and X-ray spectroscopy. Optical spectroscopy is used routinely to identify the chemical composition of matter and to determine its physical structure.

Regenerative Medicine

Regenerative medicine deals with recent advances and current challenges in tissue engineering and regenerative medicine, from the understanding of the cellular microenvironment, to the design, making, and monitoring of scaffold materials and engineered tissues, and more so to the healing of body tissues and organs.

The scientific program of the conference will be divided into different sessions such as stem cells; gene therapy; tissue engineering; cell based therapy and cell cultivation

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Stereoselective Synthesis of Bioactive Compounds

The invention of new methods for the stereoselective chemical synthesis of chiral organic molecules is a critical objective in modern organic chemistry because it is essential for the efficient manufacture of pharmaceutical agents. The stereoselective synthesis of difficult- to-access cyclic and polycyclic molecular frameworks is found in important bioactive molecules.

Identifying bioactive compounds and establishing their health effects are active areas of scientific inquiry. There are exciting prospects that select bioactive compounds will reduce the risk of many diseases, including chronic diseases such as cardiovascular disease. Recent findings have established that cardiovascular disease is a disease of inflammation, and consequently is amenable to intervention via molecules that have anti-inflammatory effects. The discovery of novel health effects of bioactive compounds will provide the scientific basis for future efforts to use biotechnology to modify/fortify foods and food components as a means to improve public health.

Structural Biology

Structural biology seeks to provide a complete and coherent picture of biological phenomena at the molecular and atomic level. The goals of structural biology include developing a comprehensive understanding of the molecular shapes and forms embraced by biological macromolecules and extending this knowledge to understand how different molecular architectures are used to perform the chemical reactions that are central to life.

In addition, structural biologists are interested in understanding related processes such as protein folding, protein dynamics, molecular modeling, drug design, and computational biology. Central tools used in this research include X-ray diffraction, NMR, electron microscopy, other spectroscopies and biophysical methods, protein expression, bio-physical and bio-organic chemistry, computer science and bioengineering.

Systems Biology in Drug Design

Systems biology aims to describe and understand the operation of complex biological systems and ultimately to develop predictive models of human disease. Large-scale gene, protein and metabolite measurements ('omics') dramatically accelerate hypothesis generation and testing in disease models. Computer simulations integrating knowledge of organ and system-level responses help prioritize targets and design clinical trials. Automation of complex primary human cell-based assay systems designed to capture emergent properties can now integrate a broad range of disease-relevant human biology into the drug discovery process, informing target and compound validation, lead optimization, and clinical indication selection. These systems biology approaches promise to improve decision making in pharmaceutical development.

Traditional Chinese Medicine

Traditional Chinese Medicine (TCM) is a system of primary health care that includes acupuncture, Chinese herbal medicine, remedial massage (anmo tuina), exercise and breathing therapy (such as qigong), and diet and lifestyle advice. Traditional Chinese Medicine has an uninterrupted history of development in China and other parts of East Asia dating back thousands of years. The primary feature of modern TCM is the premise that good health relies on the restoration and maintenance of harmony, balance and order of the individual.

Translational Medicine

Translational medicine is a rapidly growing discipline in biomedical research and aims to expedite the discovery of new diagnostic tools and treatments by using a multi-disciplinary, highly collaborative, "bench-to-bedside" approach. Within public health, translational medicine is focused on ensuring that proven strategies for disease treatment and prevention are actually implemented within the community.

Women’s Health Drug Discovery & Therapy

Modern drug discovery involves the drug development of steroidal and nonsteroidal drugs in numerous preclinical and clinical trials, with promising results in oncology and women’s health, including endometriosis, ovarian and endometrial cancer, breast cancer and conditions that affect elderly women, including frailty.