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We might need to redefine our approach to drug discovery and approval to be prepared for the future

Hitesh Windlass, MD, Windlas Biotech gives an overview of the changes bought by COVID-19 pandemic in the pharma industry, his organisation’s plans for future growth and more, in an interview with Lakshmpriya Nair

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What are the learnings from this pandemic that can be used to serve heretofore unmet needs?

COVID-19 pandemic is one of the greatest humanitarian challenges. The pharma and biotech industry has received this challenge with unprecedented courage and creativity. While we are all aware of the accelerated vaccine development efforts across the world, innovations around drug repurposing, immunity modulation, novel diagnostics, hospital-specific patient care-pathways, large scale disinfection methods, etc., have received tremendous investment and are being used as mainstream practices.

One of the biggest learnings from the pandemic has been that the realisation that the drug development regulations and the approval pathways need a complete overhaul. Response-time needed to tackle such exigencies is exponentially shorter than the typical drug approval pathway. We might need to redefine our approach to drug discovery and approval to be prepared for the future.

How is Windlas Biotech contributing to the fight against COVID-19?

Realising the urgency of the pandemic, Windlas introduced several adjunct products like – safe-to-use-sanitisers, novel germicidal mouthwash and nasal sprays, convenience packs for complicated multiday multi-drug therapies, etc., for the benefit of patients in India.

We also realised early on that scientists will need rapid prototyping and clinical trial competencies to bring new ideas to market. Therefore, we partnered with Oncotelic, a US-based biotechnology company, to develop an ayurvedic/nutraceutical drug against COVID-19 in India. The product known as ‘PulmoHeal’ is a formulated plant extract of the indigenous plant Artemisia. It is the first herbal drug showing promise against COVID-19 through TGF-ß inhibition and is expected to be effective through the entire infection cycle. Our open-label, randomised, multicentre, placebo-controlled clinical trial is nearing completion and we are observing highly promising and statistically significant impact on patient recovery.

Encouraged by the interim data, we are adding additional sites (including AIIMS Delhi) and extending the including criteria to sicker patients. The active component of ‘PulmoHeal’ is a highly pure and special form of artemisinin.

What is in store for India’s biotech sector in the coming year and the next decade?

In my view, our vast and rich heritage of Ayurveda – which is a rich resource of drug development using ethnobiological approaches, our modern scientific and highly competent clinical research ecosystem and the fact that we can accomplish all of this at a fraction of the cost compared to the developed nations, will place Indian biopharma sector in a leadership position in the world in the coming decade. Like in our partnership with Oncotelic, US, we have seen that modern scientific rigour when combined with the age-old traditional knowledge has the power to unleash potentially game-changing health solutions for the world.

In the past two decades, India has been a pharmacy to the world with its focus on generic and affordable medicines. The next decade will be about India’s emergence as a pharmacy to the world for research-based innovative medicines as well. PM Narendra Modi has repeatedly stressed the need for building a self-reliant India, asking us to be vocal for local. I think that the government’s administrative reforms coupled with market opportunity will unleash leap-frog thinking in the biopharma sector and bring creative, affordable and disruptive ideas to the forefront. Almost every company in the sector is thinking of multiplying their R&D investments manifold. This will inevitably result in new employment, new intellectual property creation and affordable health solutions for India and the rest of the world.

What are the new business models in biotech for emerging markets, including India?

Delivering drug therapies to patients in the near future world will require new skills, technologies and channels. Some of these technologies like artificial intelligence-based bioinformatics, novel protein synthesis, rapid development of bio-assay techniques of key target proteins are exciting, however, need to be supplemented with the required skill set to be widely adopted by the biopharma companies.

Once a drug is developed – it is still only half the battle won. Manufacturing it at a large scale while maintaining quality standards is critically important and requires special skills and capabilities.

We believe that Indian companies will come up with new business models to leverage opportunities across the spectrum. Playing a role in the early-stage research, technology scale-up and high volume manufacturing are all critical enablers and are need of the hour for research-based biopharma ecosystem. Indian companies will also take significant share in the bulk drugs industry and even intermediates industry to truly become the ‘Pharmacy of the World’. There is a significant opportunity for growing companies like Windlas to play the role of enablers while accelerating the search for new drugs for better health.

How is Windlas Biotech poised to leverage the opportunities in this sector?

Windlas Biotech has a strong Innovation Board with leading clinicians and academicians in the drug development field working on several short, medium and long-term projects. We have partnered with large multinationals and Indian pharma companies across the world to bring innovative products to market. These innovations are focused on three themes – improving patient compliance, novel drug delivery systems and reducing the cost of therapy.

What are your plans for the recent future?

Windlas is one of the leading CDMOs in India. We employ about 1500 people and ship around two billion dosages a year to various companies and patients.

We are evaluating expansion in terms of our manufacturing footprint in different dosage forms as well as our R&D infrastructure. We are backed by private equity investor Tano Capital and are looking at acquisition opportunities that help us further our mission. We plan to emerge as a leader in ethnobiology drug development, leveraging on the rich ayurvedic/homoeopathic knowledge coupled with cutting-edge clinical research and rigorous modern manufacturing practices. Our initial foray in pulmonary health will be further expanded into other areas where together with our partners, we have established first-mover advantage i.e. TGF-ß targeted therapies in collaboration with Oncotelic. The imminent launch of PulmoHeal together with a respiratory mobile app developed by Oncotelic using its AI/cluster computing platform with IBM provides personalised care that is consistent with Ayurvedic philosophies.

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