When Product Development Has to Think Beyond the Molecule
Bringing a molecule to market involves much more than formulation. Market opportunity, technical feasibility, regulatory requirements and manufacturing capability all influence whether a product is worth developing in the first place.
In this conversation, Urvee Garg, Director at HAB Pharma, discusses how companies evaluate off-patent molecules, why manufacturing needs to enter the conversation early, when differentiated dosage forms make sense, and how regulatory and commercial considerations shape development decisions.
1. When a molecule comes off patent, what makes you say, “This is worth developing”? Beyond the market opportunity, what do you look at before taking it forward?
The market opportunity is certainly where we start, but market size alone is not enough to justify a development programme.
I would first look at the disease area, the size and growth of the market, the existing standard of care and the clinical evidence supporting the molecule. It is not just about how much of the molecule is being sold today. We also need to understand why physicians are prescribing it and where the unmet need still exists.
Then comes strategic fit. We are more likely to pursue a molecule when it complements capabilities we already have. If we have an established presence in a therapeutic area such as neuropathic pain, a related molecule can build on our existing knowledge, customer relationships and commercial infrastructure. That can materially reduce the risk of entering the market.
We also look at development investment versus potential return, including formulation development, analytical development, bioequivalence or clinical studies where required, regulatory filings, technology transfer and ultimately commercial manufacturing. We have to ask whether the expected revenue and margin justify that investment and risk.
For me, the right molecule is one where the market opportunity, technical capabilities, regulatory pathway and commercial strategy align. A large market alone does not necessarily make a good product.
2. How early do you bring manufacturing into the product-development discussion? What can teams assess upfront to avoid discovering scale-up or manufacturing challenges much later?
I believe manufacturing needs to be involved very early, ideally around three years before patent expiry, particularly when the product is technically complex.
From the beginning, the development team needs to understand the physical and chemical characteristics of the molecule. Is it hygroscopic? Is it sensitive to temperature, moisture or light? Does it have poor flow properties? Does it require a particular particle size? Are there issues with degradation or compatibility with excipients?
These factors can completely change the manufacturing approach.
A formulation that works beautifully at laboratory scale may behave very differently when you move to a 100- or 200-kilogram batch. Mixing, granulation, drying, compression, coating and filling can all present scale-up challenges.
This is why I don’t see development and manufacturing as two separate departments. The manufacturing team should be thinking about commercial-scale feasibility while the formulation is still being developed.
The objective should be to make the transition to commercial manufacturing predictable rather than experimental. This is also consistent with WHO’s approach to technology transfer, which emphasises product and process knowledge, equipment suitability, gap analysis, trained personnel and documented evidence that the transferred process can be routinely reproduced.
3. When does a differentiated dosage form make real sense? How do you decide whether a new format solves a genuine patient or market need, rather than simply creating another version of an existing product?
For me, patient compliance is one of the strongest reasons to consider a differentiated dosage form. A new dosage form should solve a real problem for the patient, physician, caregiver or supply chain rather than simply be a reformulation for the sake of differentiation.
Orally disintegrating tablets, for example, can be useful where swallowing conventional tablets is difficult, while modified-release formulations can reduce dosing frequency and potentially improve adherence.
There can also be a logistical advantage. If a formulation can improve stability or reduce temperature sensitivity, it can simplify distribution and expand access to markets where maintaining a controlled supply chain is difficult.
Oral semaglutide is an interesting example of how a different route of administration can address a meaningful patient consideration. It is not simply an injectable product put into a tablet. The formulation and absorption challenges are fundamentally different.
That, to me, is the important distinction. A differentiated dosage form creates value when it addresses a genuine barrier to treatment.
4. How much can the regulatory pathway influence the product you finally choose to develop? At what stage do considerations such as bioequivalence, stability, analytical requirements and target-market approvals come into the discussion?
Regulatory considerations can make a very significant difference to whether we decide to develop a molecule. I believe they need to come into the discussion almost from day one.
One of the first things we ask is where we intend to market the product. The development strategy can be very different depending on whether we are targeting India, the US, Europe or emerging international markets.
We then look at the specific regulatory pathway: what bioequivalence study will be required, what reference product needs to be used, what analytical methods are required, what stability data will be needed, and whether there are product-specific regulatory expectations.
In the US, for example, a generic applicant generally needs to demonstrate pharmaceutical equivalence and bioequivalence to the reference product. FDA also publishes product-specific guidance for many products to help manufacturers understand the expected development approach.
There is a cost associated with higher regulatory requirements, but there can also be a strategic advantage. The more technically and regulatorily demanding a product is, the fewer companies may have the capability and appetite to develop it. That can create a higher barrier to entry and potentially a more sustainable commercial opportunity.
So I would not look at regulation as something that comes after the product has been selected. It is part of deciding which products are worth developing in the first place.
5. What changes when the same product has to be developed for India as well as international markets? How do differences in regulatory requirements and market needs affect the way you approach product development?
When a product is intended for India as well as international markets, I think the development strategy has to be much more deliberate from the beginning.
Historically, India was viewed as a relatively accessible market for Indian pharmaceutical companies. The regulatory environment has evolved considerably, and the emphasis on quality, documentation, stability, bioequivalence and patient safety has increased. I see this as a positive development because it pushes manufacturers towards stronger systems and more consistent standards.
At the same time, every market has its own requirements. A product that is straightforward to develop for one country may require additional studies, documentation, analytical work or stability data for another.
The commercial requirements can be just as different. In one market, the key requirement may be price and pack size; in another, it may be a particular dosage strength, presentation, shelf life or regulatory certification.
For that reason, when we develop a product for multiple markets, we try to build the international requirements into the development strategy from the beginning rather than develop for India first and adapt the product later. India’s regulatory framework itself now has a formal framework for new-drug approvals, including requirements under the New Drugs and Clinical Trials Rules, 2019.
It may increase the initial development effort, but it can prevent expensive redevelopment later.
6. In a CDMO project, how do you know whether a product is a good fit for the manufacturer’s existing capabilities? What do you assess before taking the project from development into commercial manufacturing?
For me, the first question in a CDMO project is whether the product fits the manufacturer’s capabilities, not whether the manufacturer can somehow make the product fit.
I would look at the dosage form, batch size, equipment, containment requirements, environmental conditions, analytical capabilities and the experience of the technical team. A conventional tablet is very different from a sterile injectable, an aerosol or a highly potent product. The facility, equipment, quality systems and personnel all need to be appropriate for the product.
The process itself also needs to stand up at scale. A process that works at development scale but has not been demonstrated at commercial scale is still a risk.
This is where the technology-transfer stage becomes particularly important. We want to understand the critical process parameters, critical quality attributes, analytical methods, raw-material specifications, stability data and the history of the development work before taking responsibility for commercial production.
Capacity and operational flexibility are another part of the assessment. A project may technically fit the facility but still be commercially unsuitable if it requires equipment that is already operating at full capacity or creates significant scheduling constraints.
So a successful CDMO relationship is not just about having the right machines. It requires the right combination of technology, people, quality systems, capacity and process knowledge. WHO’s technology-transfer guidance similarly emphasises gap analysis, equipment and facility suitability, personnel capability, documentation, validation and the ability of the receiving site to reproducibly execute the transferred process.
7. As more women move into technical and business leadership in pharma, how is the role evolving in decisions around R&D, manufacturing, and partnerships? What still needs to change?
I think the role of women in pharma has evolved significantly, particularly as the industry has become more multidisciplinary. Leadership today is not only about commercial decision-making. It increasingly requires an understanding of R&D, regulatory affairs, manufacturing, quality and international markets.
Women are increasingly participating directly in decisions around which molecules to develop, where to invest in manufacturing capacity, which technology partners to work with and which international markets to enter.
From my own perspective, I also think there is a natural advantage in having different perspectives around the decision-making table. Pharmaceutical development ultimately comes back to patients, and understanding how a product will actually be used, whether by a patient, caregiver or healthcare professional, can influence everything from dosage form to packaging and compliance.
But there is still work to do. I think the industry needs to move away from treating women in leadership as an exception or a diversity initiative. Technical competence and commercial judgement should be the basis on which people are given responsibility.
There is also a need to create more pathways for women into traditionally male-dominated areas of pharma, particularly manufacturing, plant operations, engineering and technical leadership. It is one thing to have women in corporate or support functions; it is another to see women leading factories, R&D programmes, quality organisations and major commercial decisions.
The next stage, in my view, is not simply having more women entering pharma. It is having more women with genuine decision-making authority across the entire pharmaceutical value chain, from molecule selection and formulation development all the way through manufacturing, regulatory strategy and international business.
About the Guest
Urvee Garg is Director at HAB Pharma, where she is involved in product development, strategic marketing and business development across India and emerging markets. Her experience also includes pharmaceutical partnerships and key account management at AstraZeneca. With a background in pharmacy, her perspective brings together product development, commercial strategy and pharmaceutical business.
Disclaimer: The opinions expressed are those of the interviewee and do not necessarily represent the views of Hello Pharma. Technical and regulatory references are presented in the context of the interview and should be independently verified where required.
