Recent Tufts CSDD Publications


peer-reviewed publications

Cohen

Barriers to Patient Access to Orphan Drugs
Cohen, Thomas, Awatin. Expert Opinion on Orphan Drugs. November 2017

Rising Drug Costs Drives the Growth of Pharmacy Benefit Managers Exclusion Lists: Are Exclusion Decisions Value-Based? 
Cohen Joshua P., Khoury Christelle, El, Milne, Christopher-Paul, Peters, Sandra M. "Rising Drug Costs Drives the Growth of Pharmacy Benefit Managers Exclusion Lists: Are Exclusion Decisions Value-Based?" Health Services Research. October 2017

DiMasi

Assessing the Financial Benefits of Faster Development Times: The Case of Single-source Versus Multi-vendor Outsourced Biopharmaceutical Manufacturing
DiMasi, Joseph A. Smith, Zachary, Getz, Kenneth A. "Assessing the Financial Benefits of Faster Development Times: The Case of Single-source Versus Multi-vendor Outsourced Biopharmaceutical Manufacturing" Clinical Therapeutics; Volume 40, No. 6. June 2018

Assessing Pharmaceutical R&D Costs (Letter)
DiMasi, Joseph A. "Assessing Pharmaceutical R&D Costs". JAMA Internal Medicine 2018;178(4):587.

Analysis of Review Times for Recent 505(b)(2) Applications
Sakai, Sharon, DiMasi, Joseph A., Getz, Kenneth A. “Analysis of Review Times for Recent 505(b)(2) Applications.” Therapeutic Innovation & Regulatory Science  2017;51(5):651-656
doi:10.1177/2168479017703138

Innovation in the Pharmaceutical Industry: New Estimates of R&D Costs
DiMasi, Joseph A., Grabowski, Henry G., and Hansen, Ronald W. “Innovation in the Pharmaceutical Industry: New Estimates of R&D Costs". Journal of Health Economics 2016;47:20-33.

Public and Private Sector Contributions to Research & Development of the Most Transformational Drugs in the Past 25 Years: From Theory to Therapy
Chakravarthy, Ranjana, Cotter, Kristina, DiMasi, Joseph A., Milne Christopher-Paul, Wendel Nils “Public and Private Sector Contributions to Research & Development of the Most Transformational Drugs in the Past 25 Years: From Theory to Therapy.” Therapeutic Innovation & Regulatory Science 2016;50(6):759-768.

Investigating Investment in Biopharmaceutical R&D
Carter, Percy H., Berndt, Ernst R., DiMasi, Joseph A., Trusheim, Mark. “Investigating Investment in Biopharmaceutical R&D.” Nature Reviews Drug Discovery 2016;15(10):673-674.

Competitive Development in Pharmacologic Classes: Market Entry and the Timing of Development
DiMasi, Joseph A., Chakravarthy, Ranjana. “Competitive Development in Pharmacologic Classes: Market Entry and the Timing of Development.” Clinical Pharmacology & Therapeutics 2016;100(6):754-760.

Getz

Financial Value of Patient Engagement
Levitan, Bennett, Getz Kenneth A., Eisenstein, Eric, Goldberg, Michelle, Harker, Matthew, Hesterlee, Sharon, Patrick-Lake, Bray, Roberts, Jaime, DiMasi, Joseph A. “Assessing the Financial Value of Patient Engagement: A Quantitative Approach From CTTI’s Patient Groups and Clinical Trials Project.” Therapeutic Innovation & Regulatory Science 2018;52(2):220-229
doi:10.1177/2168479017716715

Baseline Assessment of a Global Clinical Investigator Landscape Poised for Structural Change
Getz KA, Brown CA, Stergiopoulos S, Beltre C.  Baseline Assessment of a Global Clinical Investigator Landscape Poised for Structural Change.  Therapeutic Innovation and Regulatory Science (30 March 2017). 
http://journals.sagepub.com/eprint/dmUTuitgfq9kN54CW2Sy/full

Kaitin

Landscape of Innovation for Cardiovascular Pharmaceuticals: From Basic Science to New Molecular Entities
Beierlein, Jennifer M., McNamee, Laura M., Walsh, Michael J., Kaitin, Kenneth I, DiMasi, Joseph A., Ledley, Fred D. "Landscape of Innovation for Cardiovascular Pharmaceuticals: From Basic Science to New Molecular Entities". Clinical Therapeutics 2017;39(7):1409-1425.

Lamberti

The Use of Real World Evidence and Data in Clinical Research and Postapproval Safety Studies
Lamberti MJ, Kubick W, Awatin J, McCormick, et al. The use of real world evidence and data in clinical research and postapproval safety studies. Therapeutic Innovation and Regulatory Science. 2018: Online publish date: March 28, 2018. https://doi.org/10.1177/216847901876466

Preparing for Precision Medicine
Lamberti MJ, Wilkinson M, Peña Y, et al. Preparing for precision medicine. Contract Pharma. 2018; 20: 52-58.

Assessing Study Start-up Practices, Performance and Perceptions Among Sponsors and Contract Research Organizations
Lamberti MJ, Wilkinson M, Harper B, Morgan C and Getz KA. Assessing study start-up practices, performance and perceptions among sponsors and contract research organizations. Therapeutic Innovation and Regulatory Science. Online publish date: January 11, 2018. https://doi.org/10.1177%2F2168479017751403

Futurists’ Outlook: Expect Vastly Different Clinical Research Enterprise
Lamberti MJ, Getz KA. Futurists’ Outlook: Expect Vastly Different Clinical Research Enterprise. Applied Clinical Trials. 2017; 26: 30-31.http://www.appliedclinicaltrialsonline.com/perspectives-past-present-and-future-clinical-trials?pageID=6

Mapping the Landscape of Patient-Centric Activities Within Clinical Research
Lamberti MJ, Awatin J. Mapping the landscape of patient-centric activities within clinical research. Journal of Clinical Therapeutics. 2017; 39:2196-2202. http://authors.elsevier.com/sd/article/S0149291817309840

Milne

Impact of Social Media on R&D for Orphan Drug Development
Milne, Ni, Smith. Clinical Therapeutics. November 2017

More Efficient Compliance with European Medicines Agency and Food and Drug Administration Regulations for Pediatric Oncology Drug Development: Problems and Solutions
Milne C.-P. More Efficient Compliance with European Medicines Agency and Food and Drug Administration Regulations for Pediatric Oncology Drug Development: Problems and Solutions. Clinical Therapeutics (Feb 2017); 39(2):238–245.

Landscape for Medical Countermeasure Development
Milne C.-P., Smith Z.P., Chakravarthy R. Landscape for medical countermeasure development. Nature Reviews Drug Discovery (July 2017);16(7):448-449.

Research and Development of Medical Countermeasures in Asia for Pandemic and Bioterror Threats
Smith Z.P., Milne C-P. Research and Development of Medical Countermeasures in Asia for Pandemic and Bioterror Threats. Pharma Focus Asia (2017); Issue 27: 28-34.

Stergiopoulos

Evaluating New Data-Driven Approaches Informing Global Investigative Site Selection.  Stergiopoulos S.  Evaluating New Data-Driven Approaches Informing Global Investigative Site Selection.Pharmaceutical Outsourcing. Volume 19 Issue 1: 32-35, January-February 2018.

Cost Drivers of a Hospital Acquired Bacterial Pneumonia and Ventilator Associated Bacterial Pneumonia
Stergiopoulos, Stella, Tenaerts Pamela, Brown, Carrie A,. Awatin, Josephine, Calvert, Sara B., Holland, Thomas L., DiMasi, Joseph A., Getz,  Kenneth A. "Cost Drivers of a Hospital Acquired Bacterial Pneumonia and Ventilator Associated Bacterial Pneumonia (HABP/VABP) Phase Three Clinical Trials". Clinical Infectious Diseases 2018;66(1):72-80
doi:10.1093/cid/cix726

#PatientVoiceMatters: How Social Media Is Bringing Patients and Biopharmaceutical Companies Together to Improve Drug Development
Stergiopoulos S, #PatientVoiceMatters: How Social Media Is Bringing Patients and Biopharmaceutical Companies Together to Improve Drug Development. Clinical Therapeutics. 2017. October 31, 2017
https://doi.org/10.1016/j.clinthera.2017.10.011

Diagnosing Protocol Amendment Experience to Drive Clinical Trial Performance
Stergiopoulos S, Getz KADiagnosing Protocol Amendment Experience to Drive Clinical Trial Performance.  Pharmaceutical Outsourcing.  Volume 18 Issue 1, January-February 2017.  http://www.pharmoutsourcing.com/Featured-Articles/333834-Diagnosing-Protocol-Amendment-Experience-to-Drive-Clinical-Trial-Performance/

Wilkinson

Baseline Assessment of the Evolving 2017 eClinical Landscape
Wilkinson, Michael, Young, Richard, Harper, Beth, Machion, Brittany, Getz, Ken. "Baseline Assessment of the Evolving 2017 eClinical Landscape" Therapeutic Innovation & Regulatory Science. April 2018
DOI: 10.1177/2168479018769292


Trade press Publications

Milne

Reaching a New Innovation Threshold
Milne C.-P.Pharma Focus Asia, March 2018

Regulation vs. Innovation for New Technologies: Finding the Balance
Milne C.-P.Pharma Focus Asia, November 2017

Use of Real World Evidence Increasing Throughout Asia
Milne C.-P., Smith Z. P. Use of Real World Evidence Increasing Throughout Asia. Pharma Focus Asia (2017); Issue 28: 14-19.

Reaching a New Innovation Threshold: How Can We Make It Happen?
Milne C.-P. Reaching a New Innovation Threshold: How Can We Make It Happen? Pharma Focus Asia (2018); Issue 30:26-28.


commentaries and editorials

Getz

The Need and Opportunity for a New Paradigm in Clinical Trial Execution
Getz, Kenneth A. "The Need and Opportunity for a New Paradigm in Clinical Trial Execution" Applied Clinical Trials. Volume 27, Issue 6. June 2018.

Kaitin

Developing New Medicines for Pediatric Oncology: Assessing Needs and Overcoming Challenges
Kaitin KI.  Guest Editor. (Includes: Kaitin KI, editorial. Developing new medicines for pediatric oncology: assessing needs and overcoming challenges; pp 236-237) Clinical Therapeutics 2017;39(2).

China’s National Reimbursement Drug List 2017
Xu L, Kaitin KI, Shao L.  China’s National Reimbursement Drug List 2017. DIA Global Forum, July 2017.

Milne

Challenge and Change at the Forefront of Regenerative Medicine
Milne C.-P., Kaitin KI. "Challenge and Change at the Forefront of Regenerative Medicine" Clinical Therapeutics. June 2018.
https://doi.org/10.1016/j.clinthera.2018.06.008

A Prescription for Change: Looming Crisis in Drug Development By Michael Kinch
Milne C.-P. Drug Industry in Peril, Book Review (A Prescription for Change: Looming Crisis in Drug Development By Michael Kinch). Health Affairs (May 2017);36(5):958.

The Use of Social Media in Orphan Drug Development
Milne C.-P., Ni, Wendi. Commentary: The Use of Social Media in Orphan Drug Development. Clinical Therapeutics (Nov 2017);39(11):2173-2179. 

Regulation vs. Innovation: Are We Getting It Right?
Milne C.-P. Regulation vs. Innovation: Are We Getting It Right? Asian Hospital & Healthcare Management (2017); Issue 38: Cover Page Editorial.


books and chapters

Cohen

Decision Making in a World of Comparative Effectiveness Research: A Practical Guide
Cohen, Joshua P., DiMasi, Joseph A., Kaitin, Kenneth I.  “CER’s Impact on Drug Development Strategy and Innovation.” Decision Making in a World of Comparative Effectiveness Research: A Practical Guide, eds. Birnbaum, Howard G., Greenberg, Paul E., Adis (Springer):Singapore 2017;ch 6:63-73.


tufts csdd impact reports (by subscription)

2017-2018

Patent-to-Launch Time for Orphan Drugs is 2.3 Years Longer vs. Other Drugs
May/June 2018, Vol. 20, No.3

Clinical Site Initiation Process Remains Lengthy and Highly Inefficient
March/April 2018, Vol. 20 No. 2

eClinical Data Volume and Diversity Pose Increasing Challenges and Delays
January/February 2018, Vol. 20 No. 1

Real World Evidence Use in Clinical & Post-Approval Research Set to Expand
November/December 2017, Vol. 19 No.6

Cardiovascular Drug Approval Rate in the U.S. Fell as Development Time Rose
September/October 2017, Vol. 19 No.5

Abuse-Deterrent Opioid Development and Uptake Are Tied to Efficacy and Regulatory/Payer Policies
July/August 2017, Vol. 19 No. 4

Biotech Products Accounted for 35% of All New FDA Approvals in 2000-16
May/June 2017, Vol. 19 No. 3

Approval Time for 505(b)(2) Drugs is Nearly Five Months Longer Than for NMEs
March/April 2017, Vol. 19 No. 2

Poor Physician and Nurse Engagement Driving Low Patient Recruitment
January/February 2017, Vol. 19 No. 1


white papers

DiMasi

Assessing the Economics of Single-Source Vs. Multi-Vendor Manufacturing
This report examines the impact on development costs and net returns for drug developers if clinical development cycle times are reduced, which has implications for development efficiency, innovation incentives, and earlier access by patients to new therapies. The analysis is conducted in the context of estimated differences in development times between single-source and multi-source outsourced contract manufacturing. The full study has been submitted for peer-reviewed publication.

Kaitin

Manufacturing strategy for diverse biologic pipelines of the future
Baaj A, Kaitin KI, Serebrov M. White Paper. Manufacturing strategy for diverse biologic pipelines of the future. Tufts Center for the Study of Drug Development, Tufts University School of Medicine, Boston MA, October 2015. (Updated 2017)

Milne

Challenges to Orphan Drug Development
Milne C.-P., Smith Z. P., Ni W. Challenges to Orphan Drug Development, Tufts CSDD White Paper (Nov 2017).