Aurigene Pharmaceutical Services Limited (APSL), based in Hyderabad, India, is a contract development and manufacturing organization (CDMO) offering services from drug discovery, clinical research and development to manufacturing active pharmaceutical ingredients (APIs) and formulation at commercial scales. A wholly-owned subsidiary of Dr Reddy’s Laboratories, APSL offers discovery and development services from R&D centers situated in India. The CDMO has development laboratories from discovery to clinical phase III for NCEs/NBEs and cGMP manufacturing facilities spread across the UK, Mexico and the U.S.

Akhil Ravi has been appointed new CEO for APSL effective February 1, 2022. He comes with rich experience from the parent company working as head of strategy for services and APIs. He also headed the sales of APIs in Europe. In addition, Ravi served as plant head for a brief period. He joined Dr Reddy’s in 2018 from McKinsey & Company.

Ravi tells Contract Pharma that one of his priorities, as the new CEO, will be building newer capabilities in biologics discovery and CDMO services to cater to the growing demand of the large molecule outsourcing space. While emphasizing the need for carving a niche in select spaces, he comments that for players with end-to-end scientific and manufacturing capabilities the transition from discovery to the clinic is easier.

Contract Pharma: Aurigene has capabilities in peptidomimetics as well, along with small molecules and peptides. How does it differentiate your service offerings?

Akhil Ravi: Aurigene has capabilities in complex peptides and peptidomimetics synthesis. Only a few contract research, development and manufacturing organizations (CRDMO) can design and convert these peptides into peptidomimetics, making these molecules more stable and orally bioavailable. We have the capability and experience to not only develop but also manufacture peptidomimetics at scale ranging from non-GMP supplies to commercial scale in our FDA-approved manufacturing plants. The instability of intermediates can be quite tricky and being able to address those challenges in the development and manufacturing is very critical. In addition, APSL can develop all kinds of APIs in the small molecule spaces such as steroids, prostaglandins, or cytotoxics.

Our integrated services across API and formulation can give customers the confidence that we can take the projects forward to formulation development and manufacturing of the final drug product. Our service offering is complemented by our analytical labs and regulatory expertise to support our clients with all necessary documentation for regulatory filings. Finally, clients also value our IP model, which guarantees that the IP rights stay with them for any work that we do in discovery or development.

CP: In what ways does Aurigene’s integrated drug discovery approach aid in overcoming the challenges inherent in drug discovery?

Ravi: One of the challenges in drug discovery is to generate leads in a cost-effective and time-bound way. The Integrated Drug Discovery (IDD) team consists of chemists, biologists, pharmacologists and toxicologists, all with extensive experience in delivering development candidates for pharma and biotech companies. Our team starts with multiple series and applies computational science to fast-track and advance leads. We also work on finding backup series while optimizing for various parameters iteratively to get to a clinical candidate faster. We are also investing in new technologies and automation to improve our productivity to enable our customers to get to the lead molecule faster.

CP: The pandemic has led to the advancement of several technologies such as mRNA warranting CDMOs to acquire capabilities in these novel modalities. As a CDMO, how equipped is Aurigene?

Ravi: At Aurigene, we are always committed to acquiring capabilities in novel modalities and responding to the demands of our customers. During the pandemic, we launched our new biological entity (NBE) discovery services in ADC, CAR-T and mRNA and are working to scale these services further. In addition, we are now scaling up our biologics CDMO services to cater to the growing biologics outsourcing market.

CP: Aurigene has developed several drug candidates to address infectious diseases and cancer over the years. Do you see Aurigene expanding its service offering to other therapeutic segments in the near future?

Ravi: You are right. Historically our discovery services have a strong focus on infectious diseases and cancer—that’s where we come from. However, we also have capabilities and expertise in other therapy areas as well such as immune-oncology, cardiovascular, pain or metabolic disorders. Especially, when it comes to scaling up and development, we have broad development and manufacturing capabilities and a strong track record of working on multiple customer projects across various therapy areas.

CP: Outsourcing in the drug discovery process phase is growing rapidly. In what ways do India-based end-to-end service CDMOs stand to gain from this trend?

Ravi: India-based contract research, development and manufacturing organizations were always known for their cost advantage. However, over the last few years, they have invested in advanced technologies across a range of services and are now benchmarked to many leading companies globally, especially in the small molecule space. For players with end-to-end scientific and manufacturing capabilities such as small molecule NCE, NBE, oligos, ADC, peptides, PROTACs (proteolysis targeting chimera) or other modalities in drug discovery, the transition from discovery to the clinic is easier and hence customers will consider working with the same partner across the whole life cycle of the drug.

CP: As the new CEO with proven credentials in sales and strategy, how would you like to position Aurigene in the next 3-5 years?

Ravi: Our purpose is to accelerate access to affordable and innovative medicines to help patients lead healthier lives. Through our integrated CRDMO services to global innovative pharmaceutical companies, we will measure ourselves on the number of patients we are able to positively impact by bringing innovative drugs to market.

The CDMO industry is highly fragmented and thus Aurigene will need to carve out a niche in select spaces such as integrated drug discovery services and drug substance contract development and manufacturing. To achieve this goal, we will focus our efforts on select scientific capabilities and tailor an integrated proposition from discovery to clinical and commercial manufacturing. To address the growing demand in the large molecule outsourcing space, we will build on our capabilities in biologics discovery and CDMO services.

Science and innovation will drive our growth and Aurigene must be a preferred choice for scientific talents. We offer our people not only the possibility to work on exciting discovery and research products, but we also invest to provide learning and growth opportunities.