Driving Innovations In Pharmaceutical Industry

<h2 style="text-align: justify;">Q1. Could you start by giving us a brief overview of your professional background, particularly focusing on your expertise in the industry?</h2>Appointments: Director – NGB Laboratories Pvt Ltd, Independent Director – Entod Pharmaceuticals Ltd, Independent Director Zodiac JRD MKJ Ltd.Consulting: Advisor with multiple leading firms and also platforms like GLG, Guidepoint, Atheneum, Knowledge ridge, etc., due to the vast range of topics being delivered regularly via personal visits, phone & video calls, surveys, and reports.Corporate strategy & transformation: Market entry, expansion, and transformation for Indian and international companiesM&A: Integration of multiple corporations, including US-based MNC, divestitures & acquisitions of sites and products.Business development: In/out-licensing, co-marketing, brand launches and life cycle management, tenders, new product development, techno-commercial marketing & sales deployment for a wide range of products & services using CRM.Legal: Patent, pricing based on product class under various statutes like DPCO, GST, royalty, transfer pricing, statutory litigations under the D & C Act, and other applicable laws. Part of the team that successfully protected US patents against infringers.Manufacturing & Procurement: Product development & tech transfer, localization, registrations, commercial supplies streamlining, KPI, efficiencies on COGS and process time, unlocking inventory value, digital & AI, IoT, ERP planning.Public platform: Engagement /speaking/ shaping policy open- and closed-door forums.Compliance: Building and sustaining strong systems and teams to deliver exceptional and sustainable results & complianceCommercial: Import, export, registrations & sourcing for a wide range of products.Due diligence: Plant, products, personnel, processes, procedures, approvals, intellectual property for banks & PE.IT: AI ML Solutions developed for diverse projects, including price discovery, tenders, training, ERP, and development.Affiliations: Ex-Member of the Technical & Supply Chain Committee – Organization of Pharmaceutical Producers of India (OPPI), current Joint Secretary of FPME, life member of Indian Pharmaceutical Association, Pharmacy Council of India, Member Institute of Directors (M.IOD), Qualified independent director by MCA, Govt. of India.Education: M.Pharm. (Pharmaceutics)- MBA (Marketing), 2017, Certified Licensing Professional (Emeritus) from CLP Inc, USA, PGP-Artificial Intelligence & Machine Learning (AI/ML) from University of Texas, Austin, USA. <h2 style="text-align: justify;">Q2. Which therapeutic areas are seeing the most AI-driven product development, and what are the market competition implications? What are the potential risks of increased AI reliance in drug development, especially regarding regulatory approvals and data security?</h2>It is well known that there is significant drug discovery-related AI deployment in therapy areas, including oncology, immunology, neurology, and rare diseases. However, I observe a higher focus on AI deployment with regard to:<ul style="text-align: justify;"><li>Target identification for objectives like Gene editing (CRISPR –Cas9), Vector design for gene delivery, Optimal CAR-T cell receptor designing</li><li>Optimal manufacturing via cell monitoring, contamination control, cycle time optimization of X-stream processes</li><li>Patient matching to the right gene/cell therapy </li></ul> The market competition is driven not only by first-mover advantages and related funding but also by big pharma companies' rapid collaborations or even M&A of smaller start-ups. Entry barriers are getting higher due to the cost of secure & internal AI infrastructure due to secrecy requirements, and also the increasing speed of IP filings of AI-generated gene-editing designs, which will be disputed due to multiple reasons. Needless to say, cybersecurity, AI biases due to unrepresented training data (one of the significant cost elements), and long-term safety steps may be skipped as the targets may not be fully revealed. Scaling up the GMP process may be a challenge as well.That brings us to the regulatory uncertainty of additional scrutiny due to AI-based designing & mapping. The guidelines for the use of AI/ML are not yet fully defined for a standardized approach. During my PGP in AI/ML, it became very clear that the evolution & evaluation will have to traverse a long path that may actually be counterproductive compared with traditional approaches in the drug commercialization framework till very clear guidelines and adopted are validated. <h2 style="text-align: justify;">Q3. How will India’s Contract Research, Development, and Manufacturing Organization (CRDMO) market, projected to reach $22-$25 billion by 2035, impact investment opportunities in contract drug manufacturing?</h2>Investments have already commenced in this space in the last few years. Be it Aurobindo with CUrateQ, TL Biopharm, collaboration, VerGO, or others. Syngene has invested in new biologics facilities and collaborations with innovators and other vaccine leaders. Laurus, Divi’s, Piramal, Jubilant, DRL, and others have taken the lead, while many smaller units in biologics have also been commissioned. <h2 style="text-align: justify;">Q4. Which Indian pharmaceutical companies are best positioned to benefit from the shift toward domestic raw material sourcing? </h2>Integrated companies with API and formulation (domestic & export) will benefit immensely. The list of APIs in the PLI scheme is one indicator of some level of import substitution; in addition, there is a significant move to synthesize at the level of N-6 or N -7 or even N – 8 or more, which is a sea change in approach for independency and profitability.Also, strategically focusing on the KSM (Key Starting Materials) has helped, but these need to be scaled up from the basic chemicals stage by the non-pharmaceutical players in the core chemical sector via government intervention. <h2 style="text-align: justify;">Q5. How will India's push to become a pharmaceutical innovation hub shape public-private partnerships, and which companies are positioned to benefit?</h2>Innovation in India is riskier compared with any other Western context or even China/Korea due to the highest cost of innovation and the severe impact of failure. One of the reasons is the high cost of finance/capital, even if there are small grants to start with, and secondly, the high cost of analytical equipment, the highest slab of 28% on simple cooling equipment used in HVAC, and so on. Nevertheless, programs involving the New Millennium Indian Technology Leadership Initiative (NMITLI) launched by the Council of Scientific and Industrial Research (CSIR), the Drugs and Pharmaceuticals Research Programme (DPRP) a program initiated by the Department of Science and Technology (DST), Biotechnology Industry Research Assistance Council (BIRAC), a public sector enterprise under the Department of Biotechnology (DBT), National Biopharma Mission a mission implemented by BIRAC are some of the premier support institutions. There are networks to utilize for each stage of the innovation roadmap. Large conglomerates like Reliance have made significant investments in biologics in 2 phases nearing half a billion US dollars, and an area of 16o acres, which is about 9-10 cricket stadiums. <h2 style="text-align: justify;">Q6. Which pharmaceutical segments (biologics, biosimilars, generics) are expected to see the highest revenue growth?</h2>Biologics overall, including biosimilar (mabs, peptides covering multiple therapies), will see the highest growths, other areas like plasma proteins, blood factors, specific small molecules in oncology and chronic therapies, and not the least vaccines and opportunities in gene therapy. <h2 style="text-align: justify;">Q7. If you were an investor looking at companies within the space, what critical question would you pose to their senior management?</h2>I would like to see the clinical trial approvals and pipelines with related ROI   <h2 style="text-align: justify;">Expert Summary</h2>Dharmesh Kharwar is a seasoned Independent Director at Entod Pharmaceuticals, bringing over 28 years of extensive cross-functional expertise and P&L responsibility primarily in the healthcare sector. His career highlights include serving as Director of Strategic Alliances at MSD Pharmaceuticals, where he was instrumental in overseeing commercial supplies, strategic sourcing, and business development initiatives. Dharmesh is known for his strategic acumen in market entry, expansion, M&A integrations, and brand lifecycle management. His roles have encompassed vast responsibilities in manufacturing, procurement, legal compliance, and corporate strategy, emphasizing product development, tech transfer, and regulatory compliance.

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