Their goal: go head to head with China while becoming less of an assistant and more of a partner for their drug industry customers. State-of-the-art facilities and top-notch teams are not compatible with offering low-cost services, he says. Founded in by Biocon, a leading Indian drug company, Syngene is one of the Indian CROs that have moved beyond the rote performance of research tasks and into fuller discovery collaborations.
Syngene established a dedicated research facility for the US drugmaker in Earlier this year, Syngene announced the addition of a 4, m 2 lab to the facility.
The partnership, Hunt says, has committed Syngene to processes and quality standards that are equal to global ones. His company has around 1, people dedicated to drug discovery. Western scientists have long been hires at companies like Syngene and Aragen. And increasingly, the top CROs are hiring outside managers with large pharmaceutical or chemical experience.
Velterop held positions with DSM and Dr. The firm has been strengthening its sales staff in key markets like the US and UK, but all its discovery and manufacturing facilities are in India. Other Indian CROs consider a site in the West necessary if they are to form more integrated relationships with their clients—especially relationships that extend beyond preclinical drug discovery and encompass the manufacturing of drug candidates that might enter clinical trials.
Hyderabad-based Sai opened a development and manufacturing site in Manchester, England, in August Despite challenges posed by the pandemic, the site was a success. Less than 6 months after opening, Sai announced plans to double its head count and expand the site to offer active pharmaceutical ingredient API production, particle science and engineering, in silico modeling, and flow chemistry.
A further expansion later this year will add a kilogram-scale lab that follows good manufacturing practice GMP standards. Last year, Sai began working with a drug industry client that has a policy of not outsourcing the synthesis of new chemical entities to India. We had been trying to get into that big pharma for several years. The plan to expand into flow chemistry in Manchester, for example, will be aided by the team in Hyderabad, where flow-chemistry experience is more readily available.
And once travel is possible again, team members will rotate between sites. Officially, the rationale was to get involved on the biologics side of the drug industry. It currently occupies 5, m 2 of laboratory space across sites in Ewing, New Jersey, near Princeton, and Richmond, Virginia. If used well, this system will allow TCG Lifesciences to engineer complex molecules at low cost, he says. Newer, smaller CROs are also taking this approach. But he also speaks highly of chemists trained in the US who bring a more innovative approach.
Diversity brings innovation. Jain also helped to launch an affiliated company, Amar Chemistry, in Mumbai, India, around the same time. Between its sites in India and NJ, the CRO specializes in bioconjugation, nucleotide chemistry, custom synthesis, biomolecular nuclear magnetic resonance, and flow chemistry. To achieve this, NJ Bio has to convince its potential clients that it is safe to entrust their intellectual property IP to a team that works partially out of India, Jain says.
Miles Congreve, chief scientific officer at the biotech firm Sosei Heptares, is an example of such a client. He is used to working with Asian CROs on drug discovery but draws the line at the manufacturing of drug candidates under GMP standards. Syngene supported chemical synthesis, enzyme inhibition screening, and characterization of pharmacokinetic properties of key compounds. UK-based Domainex and Croatia-based Fidelta contributed to assay development and screening.
The brothers geared their business to help start-up biotech companies from the get-go. Besides drug discovery services, they offer seed funding and incubation support, as well as mentoring and connections to clients in the vibrant Cambridge scene.
The advantage of doing most of its chemistry and biologics in India, he says, is the ability to scale up a project quickly.
Sosei Heptares started working with O2h in It was the first CRO the young biotech hired. Would the relationship have been this successful if O2h had only had a site in India, or only in the UK? When biotechs stopped partnering with Big Pharma firms for all their promising compounds and began taking some drugs to market themselves, Sai changed its business model to cater to them, he says.
Besides the Manchester site, Sai has placed business development representatives in Massachusetts, San Francisco, and European hubs like Barcelona. The focus on biotechs also gives CROs a chance to shake off their reputation as rote makers of compounds.
Rather than settle into the service role often expected by big drug companies, CROs can enjoy relationships that are more symbiotic, as young companies take help from experienced contract research partners to craft their strategies for drug development.
The difference may be indistinguishable, but it continues to be important. Sometimes, finding a CRO based in a country that best suits your research needs is imperative. We hope this contract research map allows you to find the right partner in the right place at the right time.
Have questions or feedback? You can find our FAQs and contact information on the Learn more page. Interested in connecting with one or more of the contract research organizations listed on this map? Once you set up a marketplace account you can start the ordering process immediately. If you are employed by one of these organizations, you can log in to get started today. If you are unsure about how to get started, you can email our team at support scientist.
As such this makes India, once again, a highly attractive destination for clinical trials. India has been conducting global studies for over 30 years. Several guidelines provide the framework for clinical trial conduct in India, such as the Indian Good Clinical Practice, the Indian Council of Medical Research ethical guidelines and clinical trial related drug laws Schedule Y and its amendments. The cost to conduct a trial in India is estimated to be 40 to 70 percent lower compared to the United States or European Union.
India has been predominately well experienced in conducting clinical trials over several decades and most recently supported the regulatory governance, becoming more transparent. There are some factors, which have made this enabling in India. So all these go a long way in making India a very promising destination for clinical trials.
George Clinical in India is basically capable of offering the entire spectrum of clinical development services, which ranges right from project management, clinical data management, project operations. I think the rapport and relationship between the CRO and the sites is going to very crucial for efficient execution and coordination for the study management and India being a culturally diverse country with multiple languages across various states, it is going to be helpful to have somebody on the ground to coordinate and being the point person on the ground to facilitate the study trials.
Also the local presence is going to help a long way in interfacing and appreciating the regulatory aspects and interactions with the regulatory bodies is also going to be very helpful with the person on the ground and that is going to be very helpful to enable the interactions and strategize the study design. Yes true.
There has been several regulatory issues in the past and these have actually kind of blocked out the clinical trials market for some time, a few years back. There is also the audio video consenting that has been introduced.
Also the ethical operations aspects has been focused on. So these are various aspects that are evaluated and the regulatory bodies are getting around providing guidelines and making it enabling. Necessary cookies are absolutely essential for the website to function properly.
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