Regulatory Intelligence Reimagined
ix Regulatory Affairs Professionals Society
My RI Journey
Ambiguity as a Compass: Building a Career Without a Map. ........................................................................................................17
Alex May, MS
Turning Global Regulatory Complexity Into Innovations for Patients...........................................................................................37
Jeff MacDonald, PharmD, RPh
A Career Built on Curiosity, Compliance, and Continuous Learning.............................................................................................67
Elayne Kimmett, MBA, CQA, RAC-Global
Regulatory Intelligence: The Bridge Between Discovery and Delivery. ..........................................................................................83
Charity-Anne Metz Schuller, PharmD, MSCR, RAC-US
Finding My Way: Serendipity, Science, and Staying Curious. ......................................................................................................103
Linda Bowen, MS, RAC-CAN, RAC-EU, RAC-US, FRAPS
Regulatory Intelligence: It’s in My Plasma....................................................................................................................................129
Raya D. Zerger, MT(ASCP)SBB
Stay Curious and Learn as You Go. ..............................................................................................................................................153
Kirsten Messmer, PhD, RAC-US
Be Open to Discomfort and Success May Follow.........................................................................................................................173
Andrew C. Wingen, MS, RAC-Global
Chance, a Few Risks, and No Regrets. ..........................................................................................................................................205
Joshua S. Silverstein, PhD
Figures
Figure 1-1. Different Perspectives on Regulatory Intelligence......................................................................................................3
Figure 1-2. Common Components of Highly Effective RI Programs..........................................................................................5
Figure 1-3. RI Roles in a Small Organization. .............................................................................................................................6
Figure 1-4. RI Roles in a Large Organization .............................................................................................................................6
Figure 1-5. Processes Within Each Component of an RI Program..............................................................................................7
Figure 3-1. Five Key Benefits of RI to a Biopharmaceutical Company......................................................................................19
Figure 5-1. Metrics Hierarchy. ...................................................................................................................................................32
Figure 6-1. Regulatory Tool Development Process.....................................................................................................................40
Figure 13-1. Process Improvement – Manual Classification to AI-Enabled Search of Regulatory Assets ..................................89
Figure 13-2. Regulatory Intelligence Input to the Product Change Agenda................................................................................90
Figure 21-1. Comparison of Due Diligence in the Acquisition of a Pharmaceutical Asset Compared to a House Purchase. .....144
Figure 26-1. Large Language Models (LLMs) in Relation to Other AI Concepts....................................................................183
Figure 26-2. The RI Workflow and Potential Areas Where AI Can Support the Workflow......................................................184
Figure 28-1. AI-Enabled RI Workflow With Human-in-the-Loop (HITL) Gates ................................................................208
Tables
Table 3-1. Organization and Roles by Company Size...............................................................................................................21
Table 3-2. Scope and Coverage of RI Content by Company Size ............................................................................................22
Table 3-3. Categories and Examples of External Networks and Their Value to RI...................................................................24
Table 4-1. Core Activities of RI. ...............................................................................................................................................27
Table 4-2. RI Deliverables by Product Lifecycle Phase.............................................................................................................28
Table 5-1. Sample Objectives and KPIs....................................................................................................................................34
Table 11-1. The Case for Effective Communications of RI. .......................................................................................................74
Table 13-1. Sample Regulatory Metrics Dictionary....................................................................................................................89
Table 16-1. Framing Your Questions. .......................................................................................................................................109
Table 17-1. Key Profile Elements for Health Authority Meeting Participants. ........................................................................112
ix Regulatory Affairs Professionals Society
My RI Journey
Ambiguity as a Compass: Building a Career Without a Map. ........................................................................................................17
Alex May, MS
Turning Global Regulatory Complexity Into Innovations for Patients...........................................................................................37
Jeff MacDonald, PharmD, RPh
A Career Built on Curiosity, Compliance, and Continuous Learning.............................................................................................67
Elayne Kimmett, MBA, CQA, RAC-Global
Regulatory Intelligence: The Bridge Between Discovery and Delivery. ..........................................................................................83
Charity-Anne Metz Schuller, PharmD, MSCR, RAC-US
Finding My Way: Serendipity, Science, and Staying Curious. ......................................................................................................103
Linda Bowen, MS, RAC-CAN, RAC-EU, RAC-US, FRAPS
Regulatory Intelligence: It’s in My Plasma....................................................................................................................................129
Raya D. Zerger, MT(ASCP)SBB
Stay Curious and Learn as You Go. ..............................................................................................................................................153
Kirsten Messmer, PhD, RAC-US
Be Open to Discomfort and Success May Follow.........................................................................................................................173
Andrew C. Wingen, MS, RAC-Global
Chance, a Few Risks, and No Regrets. ..........................................................................................................................................205
Joshua S. Silverstein, PhD
Figures
Figure 1-1. Different Perspectives on Regulatory Intelligence......................................................................................................3
Figure 1-2. Common Components of Highly Effective RI Programs..........................................................................................5
Figure 1-3. RI Roles in a Small Organization. .............................................................................................................................6
Figure 1-4. RI Roles in a Large Organization .............................................................................................................................6
Figure 1-5. Processes Within Each Component of an RI Program..............................................................................................7
Figure 3-1. Five Key Benefits of RI to a Biopharmaceutical Company......................................................................................19
Figure 5-1. Metrics Hierarchy. ...................................................................................................................................................32
Figure 6-1. Regulatory Tool Development Process.....................................................................................................................40
Figure 13-1. Process Improvement – Manual Classification to AI-Enabled Search of Regulatory Assets ..................................89
Figure 13-2. Regulatory Intelligence Input to the Product Change Agenda................................................................................90
Figure 21-1. Comparison of Due Diligence in the Acquisition of a Pharmaceutical Asset Compared to a House Purchase. .....144
Figure 26-1. Large Language Models (LLMs) in Relation to Other AI Concepts....................................................................183
Figure 26-2. The RI Workflow and Potential Areas Where AI Can Support the Workflow......................................................184
Figure 28-1. AI-Enabled RI Workflow With Human-in-the-Loop (HITL) Gates ................................................................208
Tables
Table 3-1. Organization and Roles by Company Size...............................................................................................................21
Table 3-2. Scope and Coverage of RI Content by Company Size ............................................................................................22
Table 3-3. Categories and Examples of External Networks and Their Value to RI...................................................................24
Table 4-1. Core Activities of RI. ...............................................................................................................................................27
Table 4-2. RI Deliverables by Product Lifecycle Phase.............................................................................................................28
Table 5-1. Sample Objectives and KPIs....................................................................................................................................34
Table 11-1. The Case for Effective Communications of RI. .......................................................................................................74
Table 13-1. Sample Regulatory Metrics Dictionary....................................................................................................................89
Table 16-1. Framing Your Questions. .......................................................................................................................................109
Table 17-1. Key Profile Elements for Health Authority Meeting Participants. ........................................................................112