Lambda Therapeutic Research is a global clinical research organization with its headquarters in Ahmedabad. Could you please introduce Lambda to our readers?

We are a Multinational Clinical Research Organization, providing full spectrum drug development services to the global biopharmaceutical, innovator and generic drug industries. Our services include Early Phase I, First-in Human, BA/BE, DDI - Phase II to Phase IV Patient-based Clinical Trials; Bioanalytical services; Pharmacokinetics; Data Management; Medical Writing; Regulatory Affairs; Pharmacovigilance services; Large Molecule Assay services and Medical Imaging services. Our global infrastructure encompasses facilities and operations in India, Canada, Poland, the United Kingdom and the United States, employing more than 1,500 people.

Lambda most recently acquired Novum and extended its presence in North America. Could you speak about your plans in this region?

Novum Pharmaceutical Research Services is a marquee organization headquartered in Pittsburgh, Pennsylvania with operations in Fargo and Las Vegas. Established more than 40 years ago, Novum provides scientific leadership and full-service offerings to the pharmaceutical, biotechnology and medical device industries in the United States. As a stronger combined entity, we have multiple synergies to fuel our growth.

What are the advantages and challenges of conducting clinical research trials in India?

India continues to be one of top destinations for conducting clinical trials, especially the late phase, thanks to a huge treatment naïve population. The strong medical capability pool and English communication skills also play a role in its growth. Most importantly, India in particular offers a tremendous opportunity in contributing data for oncology trials due to genetic testing and high quality data generation. With the recent overhaul of the Indian regulatory guidelines, we expect the current upswing to continue for the next few years.

Based on Lambda's experience conducting operations around the globe, how do market requirements and dynamics differ?

Since 1999, Lambda has been a pioneer in setting benchmarks in global Clinical Research - expanding organically and inorganically over the years. The size of operations, huge pool of international doctors and pharmacists as well as an outstanding regulatory track record has empowered us to service every market through our various facilities.

In addition to its work in biosimilars, could you please provide insight into Lambda’s bioanalytical services?

Lambda has created a new milestone in the field of biosimilars with the launch of the first biosimilar generic product in Europe. Considering our hands-on experience in conducting trials for USFDA/EMA/DCGI, our dedicated lab in India for biosimilars testing and an upcoming one in at our Canada facility, we continue to be very optimistic in this arena.

In the domain of small molecule bioanalytical services, Lambda has one of the largest footprints with more than 50 LCMS/MS, 1000 methods validated and a capacity to analyze more than 1,25,000 samples per month. This gives our clients an added advantage in terms of timeline and flexibility.

What are the main objectives for Lambda moving forward?

While our strategies might vary with regards to business lines overall, at Lambda we shall continue to focus on the late phase oncology studies, both in new entities as well as NDDS molecules, biosimilars and of course pharmacovigilance, as we continue to consolidate our undisputed leadership in the BA/BE segment. Business sustainability will be one of the key drivers for us as we move forward. 

At Lambda, employee development is at the core. We work on a high collaboration quotient, with professional integrity and transparency, ensuring respect for individuals. These are our values, which we thrive upon and will continue to be our driving force.