Debayan Ghosh, Founder & President, Epygen Biotech PVT. LTD.

How policies for Biotech and Pharma industry should be different from one another?
As we know that biosimilars are far more complicated than the average medicine as they are produced using living cells and have a few caveats, unlike generics which are chemical-based drugs like antibiotics that can be interchangeable with branded versions. Biosimilar productsare approved by FDA on the basis of being highly similar to an already approved biological reference product, unlike a generic drug.It takes much more time, energy, and money to get a biosimilar approved, compared to a generic medicine. For example, where a generic chemical drug has to pass through a few head to head comparisons to be registserd as authentic, a recmbinant biotech biosimilar drug passes through an battery of around 50 characterization tests followed by some phases of Clinical trials, including 100s of patients. To develop a biosimilar, it could take anywhere from 5 to 10 years and can costs 100s of million dollars. In comparison, a generic drug takes at the most about two years and costs one tenth of the price compared to a biosimilar drug.

How Maharashtra has the potential to contribute to the Biotech Industry but can do better with improved facilities and regulations?
Since several decades, Maharashtra had been one of the most preferred destinations for the pharmaceutical industry, and attracted investments in Drugs and Pharmaceuticals. The state contributes about 40% of the total pharmaceutical turn over.
However, Biotechnology industry requires an Ecosystem, which will allow the state and federal governments to have a deeper understanding of this field, from the regulatory perspective. The set of rules that apply for pharmaceutica industry will not apply for biopharaecuticals. To take a leaf from Bangalore, the Centre for Cellular and Molecular Platforms (C-CAMP) in Bangalore helps in developing and establishing new high-end technologies, drives academic and Industrial Research and Development and promote entrepreneurship with strategic nucleation of biotechnology industry with an aim of developing and making available new platforms.
Just like the Bangalore Bio Cluster, there is a need to develop such platforms in every state of the country, in order to captilizethe full potential of Biosimilars. Maharashtra is one such state, where there is immense potential of developing a C-CAMP like eco-system.Apart from the core healthcare biotech, there are so many fields of biotechnology like industrial, animal, agriculture, ocean and marine biotech which can fuel such an ecosystem in this state.

About Debayan Ghosh
Debayan Ghosh Co-founded and built Epygen in the year 2006 with a vision to emerge as a leading biotech innovator enhancing human life. Having worked for leading Biotech companies in the United States and India for more than a decade prior to founding Epygen, Debayan realized the potential for biotechnology to shape tomorrow’s world as Epygen’s tagline says “building future strand by strand”. Through his education and experience, he observed how modification of proteins using the recombinant path revolutionized areas from critical healthcare to chemicals and clean energy. Leading a team of scientists, technologists and business professionals at Epygen’s labs, manufacturing facilities and offices in Dubai, India and USA, innovation for sustainable development has been his key focus.
Currently, Debayan and his team are in the process of completing the Regulatory Pathway of cardiovascular Thrombolytic Recombinant Protein drug for patients in Indian subcontinent and the underprivileged of the world. His aim is to produce this Life-Saving drug to address the mid income strata and bottom of the pyramid and his target launch date is in 2018. Unlike most Biotech drugs, this drug will be produced at an affordable cost, while maintaining highest international quality standards. He will oversee the entire operations at Epygen Biotech, leading a qualified team of scientists and research experts.
Prior to starting Epygen, Debayan served as the Regional Director at Dyadic International of Jupiter, Florida. During his seven years stint with Dyadic, he was instrumental in monetizing its recombinant technology platform through the New York Stock Exchange. Prior to this, he worked with Asia’s biotech leader Biocon for five years, developing enzyme technology and global business.