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Sivanandam K

Our Global Program Head – Program Management, Sivanandam highlights how Program Management has evolved since its inception in 2009.

Sivanandam k

In the PM team, initially, we were a bunch of people who came together for a common cause without limiting us to the responsibilities / role of a department to meet business and personal interests.

You were the first member of our Program Management Team, and since then you have come a long way. Tell us about your journey at Biocon.

I joined Biocon in July 2009 as the first program manager to manage biosimilar insulins developed markets portfolio and development of Phybrid molecule though Amlin-Biocon relationship. Back then program management was reporting into Business Development Head Mr. Sandeep Rao under Marketing organogram. My immediate job was to conduct and complete multiple PK/PD studies in EU and global Ph-3 clinical studies for human insulin by working closely with R&D, Clinical and Axicorp (Biocon EU subsidiary) and file marketing authorization in EU. I also managed early to mid stage development of biosimilar Glargine, Aspart and Lispro. I played a key lead role in several due diligences with multiple MNCs leading to signing the development agreement with Pfizer in Oct 2010 to take biosimilar insulins to global markets.

I was the member of JDC in Pfizer-Biocon governance. I also played a key role in signing of human insulin and insulin Glargine with Fuijifilm Pharma (FFP) for development in Japan. During 2009-12, we learnt to conduct due diligences in successful manner and learnt to partner with big companies for developing biosimilars with global ambition. This were big achievements for the small sized company based in Bangalore. We gained lot of confidence. It was one of the golden chapters in professional life for many of us.

Pfizer acquired Wyeth in mid 2011 and announced its shift in strategic focus to the development of biosimilar Mabs and discontinued the development on insulins in Feb 2012.

As a part of restructuring in 2013, program management of insulins came under Insulins BU head, Mr. Sandeep Rao (until Jan 2015) and Mr. Shreehas Tambe (from Feb 2015 to Mar 2018). In the BU structure from 2013-18, program management played a key role in completing the development of Glargine in Japan, gaining registration and launch. We also partnered with Mylan (Viatris now) for insulin analogs in this period. As part of Mylan-Biocon co-development, I played a key role in the late stage development of Glargine for US & EU, including tech transfer to Malaysia, gained registration and launched. I also played a key role in developing Glargine and gaining registration in S. Korea, Russia, Ukraine, Mexico and other key emerging markets. I also managed the development programs and relationship with BIVI, Thermo and Celerity/Baxter to expand out footprint to supply insulin drug substance for veterinary, cell culture and human infusion bag use in hospital setting, Program management was “eyes and ears” of BU head, increased its size significantly during this period.

As a part of another restructuring in Mar 2018, program management started reporting into COO, Mr. Shreehas Tambe. During 2018-21, I managed the Viatris-Biocon programs for the developed markets. During this period, I played a key role in late stage development / life cycle management of Glargine, Aspart, Trastuzumab, PEG-GCSF and Bevacizumab including filing, gaining registrations, launches, qualifying additional capacities and reducing CoGS. I also served as co-chair in the Quality Mission Force (QMF) to prepare the team for the GMP inspections of our mfg facilities by FDA & EMA at Bangalore and Malaysia. We successfully passed 3 FDA and 2 EMA inspections.

1st Mar 2021, I was elevated to the position of AVP, Global Program Head, reporting into Deputy CEO, Mr. Shreehas Tambe. Currently all the program leads managing different portfolios report into me. It has been a stellar journey with the constant support and guidance from Kiran, Arun and Shreehas.

You have been instrumental in driving the insulins and MABs Program management functions. What were the key factors that you had considered to successfully manage these projects?

The key factor from the program management perspective is timeline, budget, manage co-development partner expectations, honest business communications to senior leaders in the company and program milestones delivery without compromise. Outside of the ambit of program management, obviously the desire to develop, interactions and learnings with several regulatory agencies, file, gain registration and launch in developed markets which no one has done at scale thus far from India. We were a bunch of people who came together for a common cause without limiting us to the responsibilities / role of a department to meet business and personal interests. Lot of us remember the long meetings, long days, long debates and in the end fruitful one to remember.

 

Any particular challenging moment for you in Project Management and how did you overcome the challenge?

It is not easy to work in program management especially when you do not have a projectized structure and working on functional structure where no one reports into you but yet you will be responsible to communicate to senior leaders ‘first’ when things go wrong with immediate Plan B with no/less damage to timelines, budget and delivery. Sometimes you have thought of Plan B in advance, sometimes you don’t. Basically, you cannot develop Plan B / C for multiple scenarios in practice. No project is in the world is run with infinite time and money, it is always finite. There are always conflicts between programs for resources. Adding to complexity, we are in generics business where time is money.

I can recollect multiple challenging moments, but two in particular – first one, we were asked to repeat the process validation of Glargine drug substance by Japan Agency during NDA review, we did that in record 45 days including protocol, execution and report closure. Glargine is in Pichia platform, it takes 30 days for the upstream process alone. PV report was signed off in 48 hours after the last mfg step, no one went home. The second one – when we did not get pass the EU-GMP inspection in 2017 for fill-finish, our pen assembly unit was also affected. We had to qualify an alternate unit outside of Biocon Bangalore for pen assembly, packaging and release site in 45 days record time to save Glargine EU MAA under review by EMA. Program management was at its best working around the clock, non-stop for 45days to make it happen. It was the first of the Glargine approvals in the developed markets in Mylan-Biocon governance, we infused confidence into the relationship.

 

You have been associated with Biocon Group for XX years now. What has been your motivation?

I have been associated with Biocon for 12+ years now. I have grown from deputy manager to AVP now. My motivation to work at Biocon is:

  1. Open door culture from senior management, you are free to discuss your problems. As most of them have worked on the shop floor, it is easy to connect and explain your problems. Most of the times, you get quick solutions in few minutes connect or you will be given a new perspective to think about it for problem solving on your own
  2. People at Biocon, who have got amazing appetite to learn every single day
  3. Amazing 40 member talented PM team, led by capable and sensational PM leads. We are one of the largest program management teams in the world in the area of biosimilars. I look forward to my interaction everyday with them for constant learning while we achieve the business goals for the company at the quarter / fiscal / 5 year plan level

I look forward to my interaction everyday with our talented PM team for constant learning while we achieve the business goals for the company.

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