Driving CMC development operations as a competitive advantage
The Bio/Pharmaceutical industry is observing a welcoming improvement in the drug discovery and selection phase augmented by digital and artificial intelligence (AI) technologies, leading to more informed and risk mitigated investments into early research candidates/ assets. However, moving some of these assets from pre-clinical stage to clinical development/ Phase 1/ first in human (FIH) can become a significant challenge to the organization and a potential bottleneck in advancing the assets further into the development pipeline.
My work aims to build and lead purpose-driven chemistry, manufacturing and controls (CMC) development teams to innovate, solve complex problems, develop and bring medicines for unmet clinical needs to the patients. With experience in all aspects of drug development operations, I help develop, implement and manage phase-appropriate CMC development strategies across the portfolio while identifying opportunities for efficiency improvements, cost optimization, risk management and setting up or expanding internal capabilities. Understanding the scope and investment requirements of CMC development for the organization’s portfolio can be helpful in building sound business unit strategy that can enable the team in advancing the drug products into the clinics. I have helped develop products in the oncology, hematology, neurology, ophthalmology, hospital and critical care medicine, including rare disease categories.
As a CMC leader, I also collaborate with the global program development teams to set, align and support the goals, budgets, resources and timelines to move the assets ahead in the different development phases. Therefore, an early and structured investment into CMC development can enable the organization for success in bringing innovative therapies for unmet clinical needs to the market, adding value to the patients, healthcare providers (HCPs) and the healthcare system.
Areas of Expertise
CMC Development Strategy
Enabling companies to take their lead candidates/ assets from pre-clinical stage/ Phase 1 to commercialization by developing and implementing Quality-by-Design (QbD) based phase-appropriate CMC development teams and strategy cross functionally, which includes, drug substance, drug product, analytical sciences, device development, clinical manufacturing, packaging & supplies, regulatory and quality teams to better position the organization and teams for bringing their innovations to the patients.
Operations
Global clinical and commercial operations management by optimizing manufacturing strategy (internal and external networks), supply chain, product lifecycle management to help bring the medicines to the patients quickly and efficiently.
Product/ Portfolio Management
Resource and budget allocations for the assets as they move form research into development space taking into consideration the disease/ therapy area, size and design of the clinical studies. Prioritizing the assets for development to maximize value creation potential for the organization and the patients.
Risk Management
Risk management for drugs/assets under clinical development to ensure developability stage gates and continuous clinical supplies to the patients. Risk management consists of proactive risk identification, assessment, mitigation and contingency plans that encompasses across the CMC development work streams.
Regulatory CMC
CMC Module 3 for investigational new drug (IND), investigational medicinal product dossier (IMPD), new drug applications (NDA) and abbreviated new drug applications (ANDA). Response strategy to the information requests from the regulatory agencies.
Quality and Compliance
Building a culture on quality principles and integrating it cross functionally throughout the organization is a competitive advantage, where teams are empowered and encouraged to design and develop products that keep raising the quality bar.