Shripad engaged in a conversation with the India Pharma Outlook magazine in order to answer queries on the future of biotech in drug discovery. He is working for two decades in an MNC environment with a plethora of opportunities and challenges that have been immensely enriching and fulfilling. Lessons from professional and personal life have fed into each other and helped him navigate any situation over the years.
How has the landscape for biotech driven drug discovery developed and what are the changes it has undergone over the last decade?
Biotech driven drug discovery continues to be one of the fastest growing markets globally. The advancement in technology has enabled researchers to accelerate the time to market, while continuing to optimize the costs.
Post COVID, renewed focus on R&D has been underway, across vaccine manufacturing and new modality development, increasing digitalization and government investment, which is establishing India as a significant player in drug discovery. More initiatives are being seen for collaborative approaches between government, academia and industry, while recognizing that investment is key to sustained growth of the industry. The opportunities for CROs/CDMOs for discovery and drug development projects are expected to see an increase, driven by macro-economic factors. We are also anticipating a rise in traditional drug discovery/testing along with NGS and phenotypic research. Emphasis and demand on pre-clinical testing have also surged in the last 5-6 years. The emergence of organized cluster for life sciences R&D with world class infrastructure like the one at Genome Valley Hyderabad augurs well for the long-term growth of the industry.
There are also several government initiatives towards infrastructure and policies that will benefit the industry in the long term. Today there are nine DBT (Dept. of Biotechnology) and 60 BIRAC (Biotechnology Industry Research Assistance Council) supported bio-incubators. The DBT also has been allotted significant funds towards infrastructure enhancement.
In terms of policy support, National Biopharma Mission has been set up with an ambitious goal “to enable and nurture an ecosystem for preparing India’s technological and product development capabilities on biopharmaceuticals to a level that will be globally competitive over the next decade and transform the health standards of the Indian population.”
In what ways have the modern technology innovations like AI been incorporated into biotechnology operations and what effect did that have on the outcomes?
Artificial intelligence-integrated drug discovery and development has the potential to accelerate the growth of the pharmaceutical sector and can drive a revolutionary change in the pharma industry. AI facilitates drug designing by filtering datasets for relevant compounds and advanced lead modification. Computer-aided drug design (CADD) and informatics capabilities provide effective solutions for AI model prediction. Also, target proteins are easily identified using AI, which improves the efficiency of the designed drug/assay development. Using AI technology in drug design decreases potential side effects in preclinical trials and is very cost-effective. Similar applications along with machine learning are being incorporated in technologies like high content screening and deep genomics AI-driven platforms that could be used for predicting new drug targets.
How have the incorporation of technologies significantly reduced cost and startup timeframes for new manufacturing systems and facilities?
The process of discovering and developing a drug can take over a decade and costs billions of dollars on average. Even then, nine out of ten therapeutic molecules fail phase II clinical trials. Algorithms, such as PhenoLOGIC™ machine learning, nearest-neighbor classifiers, RF, SVMs, and deep neural networks (DNNs), are used for virtual screening based on synthesis feasibility and can also predict in vitro / in vivo activity and toxicity. Several biopharmaceutical companies, such as Bayer, Roche, and Pfizer, have teamed up with IT companies to develop a platform for the discovery of therapies in areas such as immuno-oncology and cardiovascular diseases.
Revvity has and continues to develop differentiated platform solutions to enable various workflows across drug discovery and development to support target identification and validation, lead identification and screening, as well as preclinical evaluation for greater efficacy and safety. The solutions represent a broad array of instruments, reagents, data analysis and bioinformatics tools (Revvity Signals), as well as custom services with high level of technical competence.
What changes have emerged in the regulatory landscape for biotech driven drug discovery over the last decade?
The intersection of innovative biotechnological advancements and stringent regulatory requirements demands a careful balance. Biotech companies have to navigate intricate local and international regulations, introducing challenges in research, preclinical development, and commercialization. Non-compliance risks can cause delays, fines, and market entry prohibitions. Other parameters and challenges include data privacy and security, clinical trial compliance, intellectual property protection, good manufacturing practice (GMP), ethical concerns in genetic research, supply chain management, post-market surveillance, international collaboration and standards. The changes, ranging from amendments in FDA regulations to updates in EMA guidelines, have far-reaching implications for professionals in the field.
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