Experts Call for Clear FDA Guidelines for AI, ML, and RPA in Pharma Industry

Experts Call for Clear FDA Guidelines for AI, ML, and RPA in Pharma Industry

Experts Stress on the Need for Clear FDA Guidelines for AI, ML, and RPA Validation in Pharma Industry

Hyderabad: During the second edition of Next Gen LabCon, a panel discussion titled "Role of Sensors, AI, ML, and RPA in Enhancing R&D Experimentation" took place. Experts shared valuable insights on how these advanced technologies are being integrated into pharmaceutical research and development. The panel also touched upon the ethical considerations and the need for human-machine collaboration in Industry 5.0.

Panelists:

  • Tushar Zade, Chief Digital Officer and Chief Information Officer at Aurigene Pharmaceuticals Services Ltd
  • Dr. Mandar Ghatnekar, Global IT and Digital Transformation Head at Biocon Biologics
  • Chitti Babu, CIO at Aurobindo Pharma
  • Dr. Sujay Rajhans, President and Chief of Research and Development at JB Pharma
  • Moderator: Chakravarthi AVPS, Chairman of the Federation of Pharma Entrepreneurs - Telangana & Andhra Pradesh, FOPE South

Discussion Highlights:

  • India’s Role in Global Healthcare:
    • Chakravarthi AVPS highlighted the country’s significant contributions through the provision of affordable, life-saving medications.
    • He emphasized Hyderabad’s position as a major exporter of pharmaceuticals with numerous FDA-approved facilities.
    • He envisioned a future where Telangana harnesses its expertise in chemistry and digital technology to spearhead healthcare innovation.
  • Evolution of the Indian Pharmaceutical Industry:
    • Dr. Rajhans discussed the industry's evolution from a local player to a global exporter.
    • Key drivers included cost-effective manufacturing, high productivity, and adherence to quality-focused regulations.
    • The adoption of advanced technologies like process analytical tools and sensors facilitates real-time monitoring and continuous quality assurance.
  • Technological Innovations:
    • AI and Machine Learning:
      • Dr. Ghatnekar highlighted the rising importance of AI technologies, enabled by faster computing.
      • AI applications include enhancing productivity, generating new content, and performing complex tasks such as protein structure prediction.
      • Challenges include the need for high-quality data and the slow adoption of digital technologies in India.
    • Data and Computing:
      • Tushar Zade pointed out challenges like data costs, a shortage of skilled talent, and the need for precise validation in diagnostics.
    • ERP System Integration:
      • Chitti Babu recalled historical challenges like computer illiteracy and departmental silos.
      • He underscored the importance of human insight in digitalization efforts.
  • Regulatory Compliance and Ethical Concerns:
    • Dr. Rajhans emphasized the importance of human-machine cooperation in Industry 5.0.
    • He highlighted the need for AI to manage regulatory compliance autonomously.
    • There is a call for clear guidelines from regulatory agencies like the FDA for validating AI, especially self-learning models.

Conclusion: The panel discussion at Next Gen LabCon emphasized the transformative impact of AI, ML, and RPA on pharmaceutical research and development. It also highlighted the indispensable role of human expertise and the need for robust regulatory frameworks to ensure the safe and effective deployment of these technologies in the industry.