Research & Publications

For 25 years, Light Pharma’s work has been grounded in peer-reviewed science — much of it co-authored with colleagues at MIT and leaders at the U.S. FDA. A selection of that work is below.

Benefit–Risk Analysis with the FDA

Applying a structured, quantitative benefit–risk framework to more than 100 regulatory decisions across six disease areas — co-authored with FDA leadership.

Benefit–Risk Analysis for Decision-Making: An Approach

Raju, Gurumurthi, Domike · Clinical Pharmacology & Therapeutics, 2016

DOI: 10.1002/cpt.507

A Benefit–Risk Analysis Approach to Capture Regulatory Decision-Making: Non-Small Cell Lung Cancer

Raju, Gurumurthi, Domike, Kazandjian, Blumenthal, Pazdur, Woodcock · Clinical Pharmacology & Therapeutics, 2016

DOI: 10.1002/cpt.501

A Benefit–Risk Analysis Approach to Capture Regulatory Decision-Making: Multiple Myeloma

Raju, Gurumurthi, Domike, Kazandjian, Landgren, Blumenthal, Farrell, Pazdur, Woodcock · Clinical Pharmacology & Therapeutics, 2018

DOI: 10.1002/cpt.871

Using a Benefit–Risk Analysis Approach to Capture Regulatory Decision-Making: Melanoma

Raju, Gurumurthi, Domike, Theoret, Pazdur, Woodcock · Clinical Pharmacology & Therapeutics, 2019

DOI: 10.1002/cpt.1461

Using a Benefit–Risk Analysis Approach to Capture Regulatory Decision-Making: Renal Cell Carcinoma

Raju, Gurumurthi, Domike, Singh, Weinstock, Kluetz, Pazdur, Woodcock · Clinical Pharmacology & Therapeutics, 2020

DOI: 10.1002/cpt.1589

Patient-Centered Approach to Benefit–Risk Characterization Using Number Needed to Benefit and Number Needed to Harm: Advanced Non-Small-Cell Lung Cancer

Raju, Khozin, Gurumurthi, Domike, Woodcock · JCO Clinical Cancer Informatics, 2020

DOI: 10.1200/CCI.19.00103

Pharmaceutical Quality by Design & Maturity

Foundational work with the FDA and PQRI on building quality into products and processes by design.

Understanding Pharmaceutical Quality by Design

Yu, Amidon, Khan, Hoag, Polli, Raju, Woodcock · The AAPS Journal, 2014

DOI: 10.1208/s12248-014-9598-3

Advancing Product Quality: a Summary of the Inaugural FDA/PQRI Conference

Raju and co-authors · The AAPS Journal, 2015

DOI: 10.1208/s12248-015-9754-4

Advancing Product Quality: a Summary of the Second FDA/PQRI Conference

Raju and co-authors · The AAPS Journal, 2016

DOI: 10.1208/s12248-016-9874-5

Process Analytical Technology & Manufacturing Science

Early MIT research, with Professor Charles Cooney, on measuring quality as it happens rather than testing for it afterward.

Active Learning from Process Data

Raju, Cooney · AIChE Journal, 1998

DOI: 10.1002/aic.690441009

Real Time and Noninvasive Monitoring of Dry Powder Blend Homogeneity

Lai, Holt, Leung, Cooney, Raju, Hansen · AIChE Journal, 2001

DOI: 10.1002/aic.690471124

Quality Risk Management & Capable Facilities

Applying quality risk management to facilities and manufacturing performance — and the business case for building quality in.

MIT CAACB Risk Assessment Case Study: Assessing Virus Cross-Contamination Risk between Two Simultaneous Processes in an Open Biomanufacturing Facility

Koenigsberg, Fowler, Domike, Raju, et al. · PDA Journal of Pharmaceutical Science and Technology, 2023

DOI: 10.5731/pdajpst.2021.012691

ICH Q9: Attaining a Quality-Business Synergy through Quality Risk Management, ROI Analysis, and Highly Capable Facilities

Friedman, Lebo, Liberti, Raju · Pharmaceutical Technology, 2024

Read at PharmTech.com

Correlating Product Lifecycle and Manufacturing Site Characteristics with Critical-to-Quality Product Deviations

Sinskey, Macher, Barone, Domike, Springs, Stern · Pharmaceutical Technology, 2012

Read at PharmTech.com

How Capable Are Your Processes? Do You Know?

G. K. Raju · Pharma Manufacturing, 2004

Read at PharmaManufacturing.com

Regulatory Science & Patient Access

How the tools of modern regulation get effective medicines to patients faster.

Expediting Treatments in the 21st Century: Orphan Drugs and Accelerated Approvals

Domike, Raju, Sullivan, Kennedy · Orphanet Journal of Rare Diseases, 2024

DOI: 10.1186/s13023-024-03398-1