The Industry-Academia Bridge Builder: Dr. Samir Kulkarni on Why Biosimilars Startups Need More Than Just Funding

How two decades in biologics development shaped an unconventional academic career focused on teaching students what actually happens beyond the textbook

Most academics transition from university research into industry positions seeking bigger budgets, faster timelines, and commercial impact. Dr. Samir Kulkarni took the opposite path—and it wasn’t planned. After nearly 20 years in senior leadership roles across biologics and biosimilars development, personal circumstances brought him back to Mumbai. The University of Mumbai offered him dual directorships: Innovation, Incubation and Linkages, plus the National Centre for Nanoscience and Nanotechnology. He accepted, beginning an academic career in 2019 that would leverage his industry experience in unexpected ways.

Three years later, he moved to the Institute of Chemical Technology (ICT Mumbai) to lead the Department of Biological Sciences and Biotechnology—the same institution where he’d earned his Master’s in bioprocessing technology years earlier. Now as Tata Chemicals Darbari Seth Distinguished Professor, Dr. Kulkarni maintains dual identities: academic department head mentoring students whilst consulting for companies and running his own cell line development venture for biosimilars.

His educational background bridges multiple disciplines: Bachelor of Pharmacy from NDMVP College of Pharmacy in Nasik, Master of Science (Technology) in BioProcessing from UDCT (now ICT Mumbai), PhD in Chemical Engineering focused on bioprocessing and manufacturing, plus an Executive Business Management from IIM Bangalore completed whilst at Dr. Reddy’s. This combination—pharmacy foundations, bioprocessing expertise, chemical engineering principles, business strategy—mirrors the interdisciplinary reality of biologics development where single-discipline specialists struggle.

The industry experience he brings spans the complete biosimilars development journey: upstream cell line development, downstream purification optimisation, monoclonal antibody scale-up, regulatory strategy, commercial decision-making. He witnessed biologics sector evolution from the early 2000s when “biosimilar” wasn’t yet an established term and regulatory guidelines barely existed, through gradual knowledge accumulation globally, to today’s mature frameworks enabling quality product assessment.

This perspective—spanning guideline-free early days through current regulatory maturity—informs his teaching philosophy. Students learn scientific principles from textbooks, but understanding how different stakeholders align to convert scientific knowledge into marketed products reaching patients requires industry insight that traditional academics cannot provide. Dr. Kulkarni identified this gap as his defining contribution: teaching not just what biologics are, but how they actually get developed, approved, manufactured, and delivered.

The Reverse Journey: When Industry Experience Reshapes Academic Teaching

Career transitions usually flow from academic training into industry application. Dr. Kulkarni’s reverse path—industry leadership back to academic teaching—created unique perspective on what students need beyond textbook knowledge.

How did your transition from academia to the biologics industry begin, and were there key moments or experiences that shaped your career direction?

“actually my career has been from industry to academia, the other way around. Right after my education and my postdoc in US, I joined the biologics industry and I had been working in the industry for almost 20 odd years  eventually rising to senior leadership positions, in the biosimilars development domain. Mainly for personal reasons I had to move back to Mumbai when basically I was offered a position with University of Mumbai as the director for innovation incubation and linkages and also as the director for the National Centre for Nanoscience and Nanotechnology which I accepted and that’s how my academic career more or less started.

I was at the University for about three years or so as the director for innovation and later I got this opportunity at the Institute of Chemical Technology as the Prestigious Darbari Sheth Chair Professor to lead the Department of Biological Sciences and Biotechnology and in this role. In I have been able to reconnect with my expertise in biopharma development, particularly biosimilars development. During my work in the industry several times I would encounter issues and work around the problems finding alternative solutions. Academia has presented a unique opportunity to understand these problems and most of my research is now focussed on identifying root-causes behind real-life issues faced by the industry in development of Biosimilars.

 

I’ve continued to stay closely connected with industry through strategic and technical consulting for a couple of companies, and I also run my own venture focused on cell line development for biosimilars. So my transition from industry to academia wasn’t driven by a single defining moment — it happened more by circumstance. But once I entered academia, I quickly realized how valuable industry experience can be in an academic environment.

In many institutions, students learn the science and the theory, but they often don’t get exposure to how that science is translated into real products, how different stakeholders collaborate, or how decisions are made in a real-world biopharma setting. I saw a clear need for someone who could bridge that gap. Bringing industry perspectives into the classroom helps students understand not just the ‘what’ of science, but the ‘how’ and ‘why’ behind product development, regulatory expectations, and the impact on patients. Recognizing this need has really been the defining realization for me after moving into academia.

Students graduate understanding molecular biology, cell culture kinetics, and purification chemistry but remain ignorant about regulatory strategy, commercial decision-making, manufacturing scale-up challenges, or partnership negotiations that determine whether scientific understanding translates into therapies reaching patients. This disconnect explains why industry struggles finding graduates who immediately contribute beyond bench-level technical work.

Dr. Kulkarni’s maintained industry connections—consulting for companies whilst running his own cell line development venture—ensure his teaching reflects current reality rather than outdated practices. This dual engagement proves difficult to sustain but provides enormous value: students learn not just historical approaches but current challenges that the industry faces, emerging solutions being implemented, and practical constraints shaping decisions.

What inspired you to specialise in bioprocessing and biologics development? Was there a particular aspect that drew you into this field?

“My academic foundation is in Pharmaceutical Sciences, and after my bachelor’s I had two clear options: continue with a master’s in the same field or pursue a master’s in Bioprocess Technology at what was then UDCT, now ICT. I chose Bioprocess Technology because I had always been drawn to biochemistry during my undergraduate studies. It was a subject I genuinely enjoyed, and I felt that moving into bioprocessing would allow me to deepen my understanding of that domain and explore its applications more meaningfully. That decision really set the direction for my career in biologics and bioprocess development”

“For my PhD, I continued working on a project that was deeply bio‑oriented and bioprocess‑focused, even though my degree was formally in Chemical Engineering. I remain deeply grateful to my PhD advisor, Prof. Aniruddha Pandit, who gave me the freedom to explore and integrate scientific understanding across disciplines, while guiding me along the way. That flexibility allowed me to build a truly interdisciplinary foundation — a bachelor’s in Pharmaceutical Sciences, a master’s in Bioprocess Technology, and a PhD in Chemical Engineering.

This combination has been instrumental in shaping my leadership approach in bioprocessing and biosimilars. It allows me to think simultaneously like a pharmaceutical scientist, a bioprocess engineer, and a chemical engineer — a perspective that is essential when guiding complex biologics from concept to clinic.

At Dr. Reddy’s, I completed a business management program at IIM Bangalore, which gave me a strong grounding in commercial strategy and decision‑making. That period marked my transition from a purely technical role into strategic and business‑focused responsibilities, allowing me to connect scientific feasibility with commercial viability.”

The educational trajectory of Dr. Kulkarni—pharmacy to bioprocessing to chemical engineering to business management—wasn’t random but created capabilities matching biologics development’s multidisciplinary requirements. Pharmacy provides drug product understanding; bioprocessing covers upstream and downstream operations; chemical engineering brings quantitative process design and optimisation; business management adds commercial and strategic perspective. This combination enables “clone to clinic” oversight that specialists trained in single disciplines may find challenging to comprehend.

The IIM Bangalore course completed whilst at Dr. Reddy’s marked transition “from the core technical domain into commercial strategic decision making”—a shift many technically trained professionals struggle making. Technical excellence alone doesn’t determine which programmes to prioritise, when to partner versus develop internally, or how to position products commercially. Business acumen enables these decisions whilst technical depth prevents strategic choices that ignore scientific reality.

 

Early Industry Challenges: Building Biologics Without Guidelines

The early 2000s biologics sector faced fundamental challenges beyond normal development risks: regulatory frameworks didn’t exist, biosimilarity wasn’t clearly defined, and convincing regulators about product quality proved difficult without established comparison standards.

Could you share major challenges you faced in your early industry career and how you navigated them?

“In the early part of my industry career, one of the biggest challenges was that the field of biologics—especially biosimilars—was still in its infancy. I started working in this domain in the early 2000s, at a time when the term ‘biosimilar’ itself wasn’t even formally defined. Regulators introduced the terminology gradually, but there were no clear expectations, and no consensus on what biosimilarity should look like.

This created fundamental uncertainty. Without regulatory frameworks, companies didn’t know what development strategy to follow. Should we focus on structural similarity, functional comparability, clinical outcomes, or all of them? What level of process variation was acceptable? Which animal studies were meaningful and which were unnecessary? There were no answers because the science and the regulatory thinking were still evolving.

As a result, many companies initially tried to apply small‑molecule generic development principles to biologics. But biologics are fundamentally different—far more complex, impossible to fully characterize, and inherently variable. So the conventional generic frameworks simply didn’t work. Both industry and regulators struggled to interpret development packages built on those assumptions.

Over time, as global experience accumulated—first in Europe, then the US, and eventually in India—the understanding of biosimilars became more robust. Early guidelines provided baseline frameworks, and subsequent refinements incorporated learnings from real submissions and approvals. Today, we have mature, well‑defined regulatory pathways, including in India, where agencies now have the expertise to rigorously evaluate biosimilar applications and ensure high‑quality products reach patients.

Looking back, the technical challenge in those early years was not just developing the product—it was figuring out how to present the science, how to justify the approach, and how to have meaningful discussions with regulators when no guidelines existed. That experience taught me how to navigate ambiguity, build scientific justification from first principles, and contribute to shaping a field that was still being defined.”

 

Startup Reality: Why Biosimilars Development Differs From Conventional Startups

Dr. Kulkarni’s dual perspective—running his own biosimilars-focused company whilst advising others and teaching students—provides grounded view on what biosimilars startups actually require versus what conventional startup support provides.

We’re seeing many new startups entering the industry. Do you think government funding is adequate for startups, and is the industry backing new ventures sufficiently?

“To be honest, the way we define startups in the biopharmaceutical sector is very different from the conventional understanding of startups, especially when compared to IT. In IT, a team can develop an algorithm or a digital solution, find customers quickly, and start generating revenue within months. The turnaround time is short, and the capital requirement is relatively modest.

Biopharmaceutical startups are fundamentally different. If you’re talking about novel biologics or even biosimilars, these ventures will not generate revenue for six or seven years—or even longer. The development timelines are long, the regulatory expectations are stringent, and the capital requirements are substantial. This is not something fresh graduates can start immediately. You need deep understanding of regulatory frameworks, manufacturing practices, analytical methodologies, and the overall market landscape. You also need a strong technical team capable of handling complex molecules.

There are, of course, startups that support the biopharma ecosystem—those working on reagents, consumables, bioreactor bags, or specialized equipment. But these are not leveraging the scientific depth of biopharmaceutical product development in the same way. When it comes to developing a novel biologic or a biosimilar, the expectations are entirely different.

The encouraging part is that government support for biopharma startups in India has been steadily improving. The Department of Pharmaceuticals recently introduced the PRIP program, which offers grants of around five crore rupees—substantial enough to enable a meaningful proof‑of‑concept. DBT and BIRAC have also played important roles. The BIG grant, for instance, provides an initiation fund of 50 lakhs. It’s not enough for full biosimilar development, but it helps teams reach an early concept stage, especially when combined with access to specialized incubation centers that provide analytical and processing infrastructure.

Beyond BIG, BIRAC offers several follow‑on grants and industry–academia partnership programs. But founders need to be very strategic—they must understand which grant to apply for at which stage, because the funding landscape is complex and each program is designed for a specific level of maturity.

What’s particularly encouraging is that the evaluation criteria for these grants have also matured. It’s no longer just about scientific merit. Reviewers now look closely at revenue models, market potential, competitive landscapes, and realistic timelines for commercialization. This shift reflects a more holistic understanding of what it takes to build a sustainable biopharma startup.

Overall, the ecosystem is evolving. The funding amounts are increasing, the evaluation frameworks are becoming more sophisticated, and the support structures are improving. But it’s still a work in progress, and it will take a few more years before the ecosystem fully matures to support biopharma startups at the scale and depth required.”

Talking about government initiatives, we recently saw the India-EU trade agreement. Do you think this will impact the biologics and biosimilar industry in India?

“From a biopharmaceutical industry perspective, a well‑structured trade agreement with the EU or US —which is expected shortly—can be highly beneficial. Our sector depends heavily on imported reactors, high‑end instrumentation, media, and specialized reagents, most of which come from these geographies. When duties on these inputs are reduced, the cost of development drops significantly. That directly improves the economics of biosimilar and biologics development, which is critical in a domain where capital intensity is already very high.

On the export side, lower duties also make it more competitive for Indian manufacturers to supply finished biologics to regulated markets. But of course, this advantage is contingent on meeting stringent regulatory expectations—quality standards for imported raw materials and full compliance for products manufactured in India. Trade agreements can reduce friction, but they don’t replace the need for scientific and regulatory excellence.

What is encouraging is that such agreements align well with India’s broader ambition to strengthen its biopharma footprint globally. Reduced import costs improve feasibility for innovators and biosimilar developers, and over time, those efficiencies can translate into more affordable therapies for patients.

In my opinion, trade deals are not just about tariff reductions—they are strategic enablers. They lower development costs, improve global competitiveness, and ultimately support greater patient access. If implemented well, they can accelerate India’s journey toward becoming a major biopharmaceutical manufacturing and innovation hub.”

 

Looking Forward: The Bioxyra Summit and Ecosystem Development

Dr. Kulkarni’s participation at the Bioxyra Summit brings perspective spanning industry leadership, academic teaching, entrepreneurial experience, and consulting across multiple companies—a breadth enabling nuanced assessment of what India’s biologics sector requires for continued advancement.

The value of gatherings like Bioxyra extends beyond formal presentations into substantive dialogue between stakeholders who rarely interact deeply. Government officials setting funding priorities benefit from understanding practical challenges companies face; industry leaders designing programmes gain insight into regulatory perspectives and academic capabilities; students and early-career professionals access mentorship and networking impossible through normal channels.

For Dr. Kulkarni, the summit represents opportunity to share hard-won lessons from two decades navigating biosimilars development whilst learning from peers tackling complementary challenges. His unique position—simultaneously academic, entrepreneur, and consultant—enables contributions spanning technical depth, strategic thinking, and practical execution that purely academic or purely industry voices cannot provide individually.

The broader ecosystem evolution he describes—gradually maturing government funding, increasingly sophisticated evaluation criteria, emerging regulatory frameworks, expanding incubation infrastructure—suggests India’s biologics sector is building foundational capabilities required for sustained growth. Yet gaps remain: funding mechanisms still imperfectly match biosimilars’ unique timelines and capital requirements; academic training inadequately prepares graduates for industry realities; infrastructure accessibility remains concentrated in major centres.

Addressing these gaps requires coordinated action across government, industry, and academia—precisely the constituencies Bioxyra convenes. Dr. Kulkarni’s message emphasises that progress demands more than increased funding: it requires appropriate funding structures matching development timelines, infrastructure positioned where startups can access it, training preparing graduates for actual industry needs, and regulatory frameworks enabling innovation whilst ensuring quality.

Dr. Samir Kulkarni will be a featured speaker at the Bioxyra Summit, where he will share insights from his journey spanning industry leadership through academic teaching, discussing what biosimilars startups actually require beyond conventional support, and exploring how trade agreements and infrastructure development can accelerate India’s biologics sector evolution.

 

The summit provides platform for dialogue advancing India’s biologics ecosystem through shared learning, strategic alignment, and collaborative problem-solving essential for translating India’s scientific talent and manufacturing capabilities into innovation leadership delivering affordable therapies to patients worldwide.