Peter Bains joined the board of Syngene, the contract research and manufacturing (CRAMs) wing of Indian biopharmaceutical firm Biocon, in 2010 and was appointed CEO last year, just before the company was spun-out into a standalone entity, raising $1.15bn (€1bn) in an IPO.
Bains is preparing to hand over the reins to Jonathan Hunt, the former President of AstraZeneca India, but found time to speak with Outsourcing-Pharma about the evolving Indian CRO and CMO landscapes:
How has Syngene changed since you became a Director in 2010?
Syngene has evolved from a pre-commercial manufacturing service provider to an integrated provider of end-to-end discovery, development and commercial manufacturing services for NMEs.
Our client base has increased from about 100 to more than 220 over the last five years and these now include 16 of the top 20 global pharma companies.
Why are there relatively few large Indian CROs, compared to say CMOs?
I think that the Indian strength in CMO’s is a reflection of India’s very strong heritage in generic development and manufacturing. The CRO industry in India started up later and is in that respect playing catch-up. India has great natural potential to grow in this space, drawing on its huge and diverse scientific talent pool as well as having structural cost advantages.
Another important difference between manufacturing (CMO) and research (CRO) is that drug research and development is a multidisciplinary activity requiring integration of complex work processes which very few companies are able to do effectively. This has been Syngene’s strength where we have developed and implemented these processes which effectively compliment the work-flows and mind-set of our partners.
What challenges currently face the Indian CRO factor?
CRO challenges are fundamentally the same irrespective of geography; life science based companies are looking for ways to do more and better science, to improve productivity and to drive innovation and of course they are budget constrained.
The CRO industry must share these challenges and find solutions that can be of added value to customers.
And what is Syngene doing to help overcome these?
We look to align our work to our customer’s goals and objectives at every step. We look to ensure that we have a customised team of scientists to match our customer’s needs. We have also put in place a world-class infrastructure that allows advanced and complex research across multiple domains thereby providing innovative and value added solutions to our customer’s requirements.
Indian regulators CDSCO issued new guidelines in 2014 covering a number of issues relating to clinical trials. Are there still issues with the regulations?
The landscape for CRO operations in India is competitive but there is room for improvement to ensure India can emerge as a leading destination for outsourced life science. We work with local and national authorities to look to improving the regulatory environment to help the industry match up to its potential.
What is Syngene doing about ongoing quality concerns in the country?
Syngene’s advantages include our excellent pool of scientific talent, world class infrastructure, an impeccable track record of quality compliance, our focus on delivering productivity and innovation in our work.
On quality and compliance we are pleased to advise that we have successfully cleared 4 USFDA audits in the last 2 years without any 483s.
Finally, what will your successor Mr Hunt directly bring to Syngene?
Mr Hunt has an extensive experience of the global pharmaceutical industry.
In his earlier assignments at Astrazeneca, he has built a track record of strong customer-centric result-oriented work, as well as demonstrating leadership in transformational change.
He has also been involved in several high profile drug development and launch programs as well as strengthening Astrazeneca’s relationships with both internal and external stakeholders.
Syngene is at a rapid and dynamic phase of growth and evolution and Mr Hunt brings a breadth and depth of experience that is very well suited to lead Syngene in its onward journey.
Peter Bains, thank you