Market surveys clearly indicate that Brazil is one of the fastest growing pharmaceutical markets globally, with its huge population of more than 200 million, an investment friendly environment, an effective patent protection regime and a relatively low incidence of spurious drugs. The pharmaceutical market of Latin America’s largest economy is projected to reach sales of up to $46 billion by 2018, growing at a CAGR of 12%.

By establishing offices and operations in Brazil, contract research organization (CRO) Accutest is helping to shape the potential of the Latin American CRO market.

The global CRO performs clinical and BA/BE studies for submissions in all key regulated markets.

Of its strong regulatory track record of 80+ accreditations/approvals from global regulatory agencies, 12 are from ANVISA, the regulatory body that oversees the registration, production and sale of drugs in Brazil.

Speaking on the expansion, founder and chief executive officer Satish Sawant said, “Opening offices in emerging countries to support drug development is a key element of our expansion strategy. We have identified seven emerging countries to develop operational capabilities, and by opening offices in Brazil, Malaysia and Taiwan we have completed our current expansion phase.”
According to Dr. Sawant, superior quality, adherence to timelines and competitive costs are the three pillars of a successful CRO. During a preceding expansion phase, Accutest opened offices in the U.S. and in the Netherlands. By adding emerging countries, especially in Latin America and in Asia, Accutest will gain additional benefits.

Contract Pharma had the chance to discuss the move into Brazil and other broader trends with Andreas Amrein, president of Accutest International.                 —TW

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Contract Pharma: Why move into Brazil now? Any plans for further expansion in other Latin American countries?

Andreas Amrein, president, Accutest International: Accutest has been operating in Brazil for several years already, successfully partnering on clinical studies with 9 of the top 10 players. The great results and close affinity with the local industry and regulatory bodies have driven our effort to invest and expand even more.

CP: What is unique about the Brazilian/Latin American drug development market compared to the more established markets in the U.S. and Western Europe?

Amrein: Every regulatory body has the same objective of approving drugs with a good efficacy and safety profile. The differences across the countries are the processes, the detailed requirements and the formats to be use. To successfully work together with pharmaceutical companies and to enable them to submit dossiers that will be approved, it is key that the CRO fully understands and embraces all requirements of the regulatory authority. Having performed hundreds of studies for ANVISA and having been successfully inspected by ANVISA 12 times over the years, Accutest is in a unique position to offer exactly what companies present in Brazil need.

CP: What are some of the latest drug development trends and how are they impacting CROs?

Amrein: Quality, speed and cost continue to be key. Recent media attention focuses a lot on quality, which is expressed in the rigor and compliance of how a study is conducted. Accutest has been consistently over the years in processes, training, SOPs, and systems that are paying off, allowing the company to clearly differentiate itself in terms of quality. The impressive track record of regulatory inspections speaks for itself. Commercially speaking speed of execution and competitive pricing are key elements for every sponsor evaluating CROs to partner with. Recently again, with its team of 700, Accutest has been setting new benchmarks in speed, for example through FTF (First To File) studies for the U.S. FDA.

CP: What service areas are you seeing an increased demand for and from what sectors? Where do you think the biggest opportunities lie?

Amrein: The generics markets continue to grow strongly around the world due to the incessant demand for cost effective medicines for all segments of the population. Companies engaging with Accutest launch generic drugs improving access to medicines especially where affordability is a hurdle. We are proud to participate in this effort. On the other side we also see increased effort on biosimilars, where significant investments, know how and equipment for testing is required. We are also active in this fast-growing segment of the market.

CP: With the first biosimilar approval in the U.S., and additional approvals set to rise, what sort of activity are you seeing and what do you anticipate for CROs in this area in the future?

Amrein: We observe increased activities on biosimilars, which some of the regulations are still being defined. The stakes are huge—and so will be the impact on patients, once biosimilars are launched. This is a highly specialized field, which requires highly experienced scientists having access to sophisticated equipment. Only a minority of CROs will be able to successfully participate.

CP: What efforts are being made to streamline drug development within Sponsor/CRO partnership models?

Amrein: The forms of collaborations are quite established and standard. Progress is being made on a case by case basis, when the collaboration between sponsor and CROs has been successfully tested over the many projects, allowing for a swifter communication and faster solving of challenges thanks to better understanding of the clients needs and internal processes.
Accutest does not see oversight as a challenge. Having the sponsor on site during the study is an excellent opportunity to share the data, to have the client participate and add value to the project while fostering trust and strengthening the relationship, key to have seamless alignment on quality standards and results. For many of our sponsors Accutest is not a third party, but an extended arm of their development organization.

CP: To what extent are e-clinical solutions impacting clinical trials, services and partnerships?

Amrein: e-clinical solutions are excellent tools to improve efficiency, increase transparency of communication and reliably ensure QA. In most cases e-clinical solutions are still optional, as paper-based solutions are widely accepted. Increasingly we see enquiries by clients to go paperless, and possibly one day this will also come from the regulatory bodies.

CP: In addition to Latin America, what geographic markets do you see the most growth and investment?

Amrein: In addition to Latin America the U.S. and Europe continue to be attractive markets for CROs with operations in emerging markets such as Accutest, offering the same or better quality of service, at the same or faster speed, and definitely at a more competitive price. In China increasingly we see demand for our services to conduct studies for submissions overseas.

CP: With respect to establishing global standards (i.e. site accreditation and standards for sustainability and best practices), what progress is being made? Where are greater efficiencies needed?

Amrein: Accreditation standards and strict enforcement of QA are essential especially in light of recent quality issues highlighted by regulatory bodies and media. We welcome all action aimed to improve the credibility of the industry. Currently many decisions are still based on the reputation of the CROs, where we find ourselves in an excellent position thanks to a stellar track record of thousands of executed studies, also expressed in virtually all sponsors being and becoming repeat customers. We are honoured to work with many of the best companies around the globe, and we know that this is the result of years of hard work and quality standards that have become the DNA of the company. The market as a whole can become more efficient by moving more and more studies to companies such as Accutest: global best standards executed at competitive prices through operational execution in emerging markets combined with lean overheads.