What happens when a patient meets the people who helped save her life?

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Ginger's voice was her lifeblood. For over 35 years, Ginger was a professional singer in the Chicago area, but everything changed the day she was diagnosed with Stage IV non-small cell lung cancer (NSCLC).

TAGRISSOTM is specifically designed to treat patients like Ginger with metastatic EGFR T790M mutation-positive non-small cell lung cancer who progressed on or after EGFR TKI therapy.

TAGRISSOTM was brought to market in November 2015 and granted Fast Track, Breakthrough Therapy, Priority Review and Accelerated Approval status by the FDA—progressing through clinical trials to market in about 2.5 years.

This personalized lung cancer therapeutic is designed to treat patients like Ginger with metastatic EGFR T790M mutation-positive non-small cell lung cancer who progressed on or after EGFR TKI therapy.

It was brought to market in November 2015 and granted Fast Track, Breakthrough Therapy, Priority Review and Accelerated Approval status by the FDA—progressing from clinical trials to market in ~2.5 years.

Safety Assessment is a critical step along the drug discovery and development continuum. Between 2013 and 2015, Charles River performed toxicology studies on TAGRISSOTM to meet an accelerated FDA timeline. Charles River's work in preclinical development and clinical support was vital to ensuring the drug's dosage levels were safe for patients like Ginger.

Safety Assessment is a critical step along the drug discovery and development continuum. Between 2013 and 2015, Charles River performed toxicology studies on a personalized lung cancer therapeutic to meet an accelerated FDA timeline. Charles River's work in preclinical development and clinical support was vital to ensuring the drug's dosage levels were safe for patients like Ginger.

Oncology is one of eight Therapeutic Areas that Charles River specializes in. There are expected to be over 23 million people diagnosed with cancer in the next 20 years.3

Charles River’s work in oncology drug development spans from target identification to IND. In 2015, Charles River acquired Oncotest to expand its expertise in oncology drug discovery.

AstraZeneca (AZ) is a global biopharmaceutical company whose innovative medicines are used by millions of patients worldwide.

AstraZeneca and Charles River extended our initial three-year partnership into 2020. The new agreement solidifies Charles River as AZ's preferred strategic partner for outsourced regulated safety assessment and development DMPK (drug metabolism and pharmacokinetics).

Driven by the pursuit of excellent science and a strong sense of purpose, Charles River is a leading global contract research organization (CRO), offering services that span the entire drug discovery and development pipeline. We are celebrating our 70th anniversary in 2017.

Basic Research is the first step along the drug discovery and development continuum. With a global footprint of commercial breeding facilities, rigorous biosecurity and genetic standards, and research support services such as surgery and preconditioning, Charles River provides models to meet a variety of research needs.

Drug Discovery is a critical step along the drug discovery and development continuum. Using the latest technologies and platforms, Charles River supports clients’ discovery programs across all major therapeutic areas, from hit ID to IND. In the past 15 years, our scientists have generated over 300 patents for our partners.

Clinical Support is a key part of the drug discovery and development continuum. It's essential that assays and testing methods used in the nonclinical lab transition easily to the clinical phase. As clinical trials begin, further in vitro and in vivo nonclinical studies performed at our global network of facilities provide additional information to support the continuation of clinical trials.

Manufacturing is the last step along the drug discovery and development continuum. Charles River works to ensure the safe production and release of its clients' manufactured products.

From biologics to small molecule drugs, medical devices and personal care products, Charles River can design manufacturing and testing programs that promote the optimum use of resources.

It takes an average of 15 years of research and development for a new drug to reach the market. Charles River strives to provide the highest quality service, science, and regulatory support to accelerate the development of novel therapeutics in reaching patients who need them most.

Our Eureka blog allows scientists to share ideas on cutting-edge bench science driving drug discovery and development.

Cardiovascular is one of eight Therapeutic Areas that Charles River specializes in. Heart disease is the leading cause of death in the US for both women and men.4

We support our partners through the entire cardiovascular research process. We also offer preclinical cardiac risk assessment services—from GLP hERG and ADP assays to a comprehensive survey of cardiac ion channels and cardiomyocyte assays.

Central Nervous System is one of eight Therapeutic Areas that Charles River specializes in. We offer expertise in all the major neurodegenerative diseases and neurological indications.

In 2016, Charles River expanded our partnership with The Michael J. Fox Foundation for Parkinson's Research. Together, we are investigating mutations in LRRK2—the greatest known genetic causes of Parkinson’s disease.

Inflammation is one of eight Therapeutic Areas that Charles River specializes in. We offer a full portfolio of products and services in support of millions affected by conditions like rheumatoid arthritis and psoriasis.

We are proud to have worked on an arthritis biosimilar with Boehringer Ingelheim, which was accepted for regulatory review by the European Medicines Agency and the US FDA in January 2017.

Musculoskeletal Disease is one of eight Therapeutic Areas that Charles River specializes in. Millions of people are affected by osteoporosis, arthritis, and other musculoskeletal diseases.

Charles River offers services in the area of musculoskeletal research that combine established discovery and preclinical program development expertise with a host of novel bone research technologies.

Metabolic Disease is one of eight Therapeutic Areas that Charles River specializes in. Millions of people are at risk of increased heart disease, stroke, and diabetes.

Charles River's expertise includes the progression and analysis of compounds and agents targeting a range of conditions such as diabetes, obesity, bone disease, thyroid disease, and cholesterol and lipid disorders.

Respiratory Disease is one of eight Therapeutic Areas that Charles River specializes in. Asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis, and tuberculosis affect millions of people around the world.

In 2016 Charles River sponsored the Great Strides® walk supporting the Cystic Fibrosis Foundation; over 950 participants raised more than $27,000 to support research.

Ophthalmology is one of eight Therapeutic Areas that Charles River specializes in. Charles River offers an integrated approach to ophthalmology research.

Compounds or implantable devices intended for ocular treatment can be assessed for efficacy, safety, and toxicity in multiple species. Ocular effects of compounds administered by other routes, such as oral, can also be characterized.

Charles River strives to immerse itself in niche markets, stay abreast of regulatory changes, and keep up with new technologies in order to support the specific testing and manufacturing requirements of all product types, including biosimilars, vaccines, and cell and gene therapies.

As the world's population rises, so does the need for innovative new drugs and therapies to help the millions of people fighting diseases and chronic conditions. Charles River, along with its industry partners, is committed to improving the health and well-being of patients everywhere by continuing to push drug discovery and development advancements forward.

Charles River is proud to work with the world's leading pharmaceutical companies, providing expertise along the entire drug discovery and development continuum. Charles River is a customer-focused organization committed to advancing science and helping clients reach their goals.

More than 30% of Charles River's total work is represented by strategic relationships where we work closely with clients.

Every Step Of The Way: Network Diagram

This network diagram starts with Ginger’s story but expands to reveal how Charles River is working in every area along the drug discovery and development continuum toward bringing life-saving drugs to patients. We invite you to start exploring the diagram by clicking on any node. For additional instructions click "Need Help" below, or click in the white space to return to the diagram in full view.

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References

  1. “Key Statistics for Lung Cancer,” American Cancer Society, accessed March 2, 2017, http://www.cancer.org/cancer/lungcancer-non-smallcell/detailedguide/non-small-cell-lung-cancer-key-statistics
  2. Julian R. Molina, MD, PhD, Ping Yang, MD, PhD, Stephen D. Cassivi, MD, Steven E. Schild, MD, and Alex A. Adjei, MD, PhD, "Non–Small Cell Lung Cancer: Epidemiology, Risk Factors, Treatment, and Survivorship," Mayo Clinc Proceedings 83(5) (2008): 584–594, accessed March 3, 2017, doi: 10.4065/83.5.584
  3. "FDA approves first blood test to detect gene mutation associated with non-small cell lung cancer," U.S. Food & Drug Administration, accessed June 1, 2016, https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm504488.htm
  4. “Cancer,” World Health Organization, accessed March 2, 2017, http://www.who.int/mediacentre/factsheets/fs297/en/
  5. "Heart Disease Facts," Centers for Disease Control and Prevention," accessed March 3, 2017, https://www.cdc.gov/heartdisease/facts.htm
  6. "U.S. and World Population Clock," United States Census Bureau, accessed March 3, 2017, http://www.census.gov/popclock/
  7. "Medicines in Development," PhRMA, accessed March 3, 2017, http://phrma.org/science/in-the-pipeline/medicines-in-development
  8. "Chronic diseases and health promotion," World Health Organization, accessed March 3, 2017, http://www.who.int/chp/en/
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