Leveraging Agentic AI for the Construct and Maintenance of Target Product Profiles

How Small to Mid-Size Biotechnology and Drug Development Companies Can Benefit from Agentic AI.

A TPP defines the intended attributes of a new drug or biologic, aligning product development with regulatory, clinical, and market goals. For smaller companies, drafting a TPP upfront is critical: it sets direction, harmonizes cross-functional priorities, and anchors all downstream decisions. Essential TPP components include:^[1][2]

• Approved indication and patient type

• Safety and efficacy goals

• Dosage specifications

• Clinical endpoints

• Differentiators from available therapies

Agentic AI can free up your team to focus on high value-add, strategic activities, leaving the intellectually mundane tasks to Agentic AI.

Building this initial TPP traditionally required labor-intensive research, manual data collection, and alignment meetings. By deploying agentic AI, teams can expedite baseline TPP construction—accessing previously approved product profiles, mining regulatory databases, and extracting competitor benchmarks with autonomous agents.^[2][1]

Automating TPP Maintenance with Agentic AI

Once the TPP is in place, maintaining its accuracy as science, clinical data, regulations, or market conditions change is critical. Agentic AI excels here, utilizing continuous monitoring and autonomous data integration:

• Clinical Trial Monitoring Agents: These review internal and public registries, update TPP endpoints as new safety or efficacy data emerges, and flag deviations from development plans.^[3][1]

• Regulatory Intelligence Agents: They scan FDA/EMA guidance shifts, automate risk assessments, and adapt TPP formats to reflect evolving submission requirements.^[4][5][2]

• Competitive Intelligence Agents: These autonomously track new drug launches, label changes, and strategic moves by large pharma in real-time, triggering TPP modifications where needed.^[6][1]

• Audit Trail Agents: Every TPP change is logged, ensuring compliance and enabling backtracking if issues arise—a vital capability for regulatory inspections and investor due diligence.^[3]

This automation transforms the TPP from a static deliverable to a living asset, continuously fed by real-world evidence and regulatory intelligence.

Agentic AI Workflow Examples

Agentic workflows can be customized to fit diverse TPP management tasks:[7][8][9]

• Trial Monitoring: AI agents analyze trial enrollment and results, instantly updating TPP

sections—such as endpoints, risk profiles, or safety signals—as public or internal data

changes.[1]

• Label Reimbursement Intelligence: Agents scan payer formularies, reimbursement guidelines, and health technology assessments, aligning TPP cost-effectiveness claims with real-world market access barriers.

• Submission Document Automation: AI self-generates TPP-aligned regulatory submissions—clinical study reports, marketing authorization applications, or health authority Q&A—reducing turnaround time and inconsistency.[2][1]

• Stakeholder Collaboration: Multi-agent orchestration enables real-time editing, alerts for key updates, and role-based access, so medical, regulatory, and commercial teams stay in sync without extensive meetings.[9][7]

These agentic workflows elevate small company operations, ensuring the TPP is current, actionable, and ready for external review or internal strategy pivots.

Strategic Value for Small Pharma/Biotech

By automating TPP creation and maintenance, agentic AI delivers:

• Faster iterations and fewer manual bottlenecks.[7][1]

• More rigorous compliance and lower regulatory risk.[4][2]

• Greater transparency for partners and investors.

• Scalable expertise, letting small teams operate at the sophistication of larger competitors.

Agentic AI turns the TPP from a one-time deliverable into a continuously optimized, business-driving asset, empowering small companies for success at every stage of biopharma development.[7][1][3]

For more information on how to integrate Agentic AI into your Strategic Business Plan and mission critical workflows for 2026, please feel free to reach out to terry@performtransform.com or call us at (828) 808-2955.

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Sources & Resources

1. https://www.salesforce.com/healthcare-life-sciences/life-sciences-artificial-intelligence/agentic-ai-in-pharma/

2. https://www.baselifescience.com/genai-for-regulatory-compliance-in-pharma-and-biotech/

3. https://www.mahalo.health/insights/how-ai-is-automating-compliance-in-clinical-research

4. https://ioni.ai/post/ai-is-revolutionizing-automated-regulatory-intelligence-ari-heres-how-you-can-keep-up

5. https://www.vistaar.ai/blog/regulatory-intelligence-auto-impacts-with-ai/

6. https://www.alpha-sense.com/resources/product-articles/workflow-agents/

7. https://www.acceldata.io/blog/how-do-agentic-ai-workflows-work

8. https://weaviate.io/blog/what-are-agentic-workflows

9. https://www.chatbase.co/blog/agentic-ai-workflows

10. https://www.salesforce.com/agentforce/agentic-workflows/

11. https://www.publicissapient.com/insights/agentic-ai-workflows

12. https://www.triplewhale.com/blog/agentic-workflows

13. https://www.upskillist.com/blog/top-ai-agents-use-case-for-healthcare-in-2025/

14. https://www.uipath.com/ai/agentic-workflows

15. https://springsapps.com/knowledge/artificial-intelligence-in-pharmacy-use-cases-examples-challenges

16. https://www.matillion.com/blog/a-guide-to-agentic-ai-workflows

17. https://medicalfuturist.com/top-companies-using-a-i-in-drug-discovery-and-development/

18. https://www.coherentsolutions.com/insights/artificial-intelligence-in-pharmaceuticals-and-biotechnology-current-trends-and-innovations

19. https://www.creolestudios.com/real-world-ai-agent-case-studies/

20. https://www.warmly.ai/p/blog/agentic-automation