Purpose of the Target Product Profile (TPP) and Target Product Label (TPL) Overview of Competitive Labeling Strategy for Clinical Development and Marketing Optimal Timeline for Development of TPP and TPL How the TPL Shapes the Phase 3 protocol Use of Labeling Intelligence in the TPL process
· Purpose of the Target Product Profile (TPP) and Target Product Label (TPL)
· Overview of Competitive Labeling Strategy for Clinical Development and Marketing
· Optimal Timeline for Development of TPP and TPL
· How the TPL Shapes the Phase 3 protocol
· Use of Labeling Intelligence in the TPL process
Ideally for those involved in:
Doors open at 5:30,
Presentation + panel Q&A program begins at 6:00 pm
Babson College
Reynolds Student Campus Center
21 Babson College Drive
Wellesley, MA 02482
Space for this event is limited and we know plans change! An email will be sent to confirm attendance after registration 2 days in advance. Room number and parking pass will be released after confirmation.
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email [email protected].




Principal Consultant, Regulatory, Opus Regulatory
Mary has more than four decades of experience in the pharmaceutical industry, beginning her career as a QC Bacteriologist, then moving to clinical development, and for the last 16 years has worked in labeling. In labeling she has worked in end-to-end labeling process development, CCDS/USPI/EU SmPC/ROW label composition, maintenance, and defense of labeling challenges from regulators at both large multinational pharmaceutical companies and small biotechs.

Principal Consultant, Labeling, Opus Regulatory
A cross-disciplinary biopharmaceutical strategist, Kshitij Thakkar brings 20+ years across medicinal chemistry, drug discovery, CMC, pharmacovigilance, U.S. Ad/Promo, and global labeling, including BLA labeling and device/IFU transitions. His expertise spans rare diseases, cardiometabolic therapeutics, oncology, immunology, and CNS, enabling him to connect scientific evidence with global regulatory and market priorities. Kshitij has built labeling functions, led global teams and governance, and guided health authority negotiations and approvals across the U.S., EU, and rest-of-world markets.

Senior Director, Head of Labeling Strategy , Moderna
Throughout her career, Halley Baker has focused on global labeling strategy across development and lifecycle management, including health authority negotiations, core and regional labeling, safety labeling, and patient-focused labeling. Her background, spanning more than 25 years in regulatory affairs, pharmacovigilance, and pharmaceutical labeling, has exposed her to a variety of biopharmaceutical companies, organizational models, and labeling challenges. She has also worked extensively in labeling process development, operational improvement, and cross-functional collaboration across a wide range of therapeutic areas. As a former ICU nurse, Halley brings a clinical and patient-centered perspective to her work and collaborations. She is passionate about advancing strategic labeling practices that support effective product development, regulatory excellence, and clear communication for patients and healthcare professionals.