The Latin
American Market

Latin America stands out as one of the main growing regions, having a market expansion that has averaged 14% per year between 2008 and 2012 and is expected to maintain an average of 12% per year through 2017. It is estimated that the region’s eight major countries — Brazil, Mexico, Argentina, Chile, Colombia, Cuba, Peru and Venezuela — represented a market retail value of $80bn in 2013. Mexico is one of the fastest growing pharmaceutical markets in the world valued at over USD 13.5 billion and growing at 9-10% annually.

Latin America has a population of more than 569 million people and only two official languages are spoken in the entire region: Spanish and Portuguese. This gives the region an advantage over Europe, especially as far as document translation, study team training and communication.
In Latin America you have access to some of the most populated cities in the world. The metropolitan areas of Mexico City (20 million), Guadalajara (5 million) and Monterrey (4 million) concentrate close to 30 million. These large concentrations of people give investigators access to thousands of possible patients that are treatment or trial naïve, which translates into high enrollment rates and subject retention.

About Drug Discovery and

Discovering and bringing a new drug or biologic to market typically costs on average more than $1 billion USD and takes an average of 10 to 15 years. EPIC's portfolio of services for clinical development, post-approval and consulting services allow us to provide end-to-end solutions.

Development stages

Researchers look for new insights to the causes of disease at a cellular, molecular, proteomic and genetic level so that they can find new targets to direct treatment to cure disease. Once a target is found, the right molecule or compound that has a possible beneficial effect against the target must be found. Many potential candidates or new ways to target the product to a specific site are tested. At this stage there may be thousands of potential compounds for development as a medical treatment, however only a few are determined to be the most promising and are further studied. It takes an average of 10 to 15 years to develop a new medicine from discovery to treating the patient population.

Pharmaceutical and biotech companies invest on the compounds that may lead to safe and effective treatments for patients. The average cost of research and development for each new medicine that reaches the market has been estimated to go from $800 million to $1 billion USD. These figures take into account all the testing for compounds that fail and the contributions of government, academic and industry research. Approximately one of every 5,000 to10,000 compounds that go into research and development receives regulatory authority approval.

The process can be summarized as follows:

  • Choose the target
  • Test and confirm the target’s role in the disease
  • Find a molecule or compound that may act on the target to alter the course of the disease.
  • Perform in vitro, in vivo or in silico Absorption, Distribution, Metabolism, Excretion and Toxicological tests (ADME-Tox).
  • Route of administration
  • Best dosage
  • How it affects and works on different groups of people (i.e. gender, ethnicity)
  • Interactions with other medications
  • Effectiveness compared with medications
  • Before testing a new compound in people, researchers have to determine its toxicity. The two types of preclinical research are in vitro and in vivo. Preclinical testing in lab animals has to comply with Good Laboratory Practice (GLP) and must provide sufficient and detailed information on dosing and toxicity levels. The findings are then reviewed and it is determined if the compound will be tested in humans. Regulatory authorities are very strict and require thorough testing prior to approving tests in human subjects.

    During this stage, researchers may optimize the compound to make it safer and more efficient and how to make large enough quantities of the compound for clinical trials has to be determined. If approved for use in the general population greater scaling of production is needed.

    Our clinical and regulatory teams experience will help you transition from clinical trial to post-approval seamlessly.

    We can offer you the solution you need with:

  • Phase IV and observational studies: In many cases in order to insure patient safety and to demonstrate effectiveness or comparative effectiveness and safety late phase studies and safety follow up are needed.
  • Observational studies and Phase IV studies can generate the needed evidence to meet long-term safety and effectiveness, as well as identify and support new indications and changes to label and prescribing information.
  • Risk management programs: Risk management plan (RMP) design, implementation and updates as well as risk evaluation and mitigation strategies (REMS) development to ensure that the benefits of your product outweigh its risks.
  • Pharmacovigilance and Technovigilance: We can help you meet all your Pharmacovigilance and Technovigilance regulatory obligations. Case receipt and processing, submission of expedited reports, safety report translations, PSURs, DSURs, annual safety reports, literature search, aggregate reporting and safety signal detection and analysis.
  • Medical Writing: Our writers will make certain that your documents are clear scientifically sound and meet all regulatory requirements.
  • We provide a full range of cost-effective flexible solutions to ensure accurate and verifiable data are provided to you on time.

    From study biostatistical design to data analysis to study report we will guarantee that you will always be provided with reliable data.

    Our data management services:

  • Database design
  • Data entry
  • Data Analysis and Review
  • Protocol design review
  • Statistical analysis plans
  • CRF design
  • Statistical consulting
  • Statistical and clinical study reports
  • Our independent QA team of experienced professionals can audit any part of the clinical development process (from early phases to post-approval) delving deep into detail to ensure that the quality you expect is met while ensuring compliance with GCP (Good Clinical Practice), GLP (Good Laboratory Practice), GMP (Good Manufacturing Practice) and 21-CFR § 11 standards.

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