Recent Tufts CSDD Publications


peer-reviewed publications
and Trade press Publications

Cohen

Cohen JP. Abuse-Deterrent Formulations of Opioid Analgesics Face Uphill Battle. InVivo 2018;36(4):18-21.

Cohen JP, Khoury CE, Milne CP, Peters SM. Rising Drug Costs Drives the Growth of Pharmacy Benefit Managers Exclusion Lists: Are Exclusion Decisions Value‐Based? Health Services Research 2018;53(S1):2758-2769.
doi:10.1111/1475-6773.12781

Cohen JP, Awatin JG. Patient access to orphan drugs. Expert Opinion on Orphan Drugs. 2017;5(12):923-932.
https://doi.org/10.1080/21678707.2017.1402676

DiMasi

DiMasi JA, Smith Z, Getz KA. Assessing the Financial Benefits of Faster Development Times: The Case of Single-source Versus Multi-vendor Outsourced Biopharmaceutical Manufacturing. Clinical Therapeutics 2018;40(6):963-972.

DiMasi JA. Assessing Pharmaceutical R&D Costs. JAMA Internal Medicine 2018;178(4):587.

Sakai S, DiMasi JA, Getz KA. Analysis of Review Times for Recent 505(b)(2) Applications. Therapeutic Innovation & Regulatory Science 2017;51(5):651-656
doi:10.1177/2168479017703138

DiMasi JA, Grabowski HG, Hansen RW. Innovation in the Pharmaceutical Industry: New Estimates of R&D Costs. Journal of Health Economics 2016;47:20-33.

Chakravarthy R, Cotter K, DiMasi JA, Milne CP, Nils W. 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.

Carter PH, Berndt ER, DiMasi JA, Trusheim M. Investigating Investment in Biopharmaceutical R&D. Nature Reviews Drug Discovery 2016;15(10):673-674.

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

Getz

Getz KA. Transitions In The Trial Landscape: What Will Drive RCTs Into The Clinic? InVivo 2018;36(05):16-22.

Getz KA. Trends driving clinical trials into large clinical care settings. Nature Reviews Drug Discovery 2018;(17):703-704.
https://doi.org/10.1038/nrd.2018.111

Levitan B, Getz KA, Eisenstein E, Goldberg M, Harker M, Hesterlee S, Patrick-Lake B, Roberts J, DiMasi JA. 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

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 2017;51(5):575-581.
http://journals.sagepub.com/eprint/dmUTuitgfq9kN54CW2Sy/full

Kaitin

Beierlein JM, McNamee LM, Walsh MJ, Kaitin KI, DiMasi JA, Ledley FD. Landscape of Innovation for Cardiovascular Pharmaceuticals: From Basic Science to New Molecular Entities. Clinical Therapeutics 2017;39(7):1409-1425.

Kaitin KI, Milne CP. Are Regulation and Innovation Priorities Serving Public Health Needs? Frontiers in Pharmacology 2019;10(144)1-6.
https://doi.org/10.3389/fphar.2019.00144

Selker HP, Eichler HG, Stockbridge NL, McElwee NE, Dere WH, Cohen T, Erban JK, Seyfert-Margolis VL, Honig PK, Kaitin KI, Oye KA, D’Agostino RB. Efficacy and effectiveness too (EE2) trials: clinical trial designs to generate evidence on efficacy and on effectiveness in wide practice. Clinical Pharmacology and Therapeutics 2019;105(4):857-866.

Xu L, Gao H, Kaitin KI, Shao L. Reforming China’s drug regulatory system. Nature Reviews: Drug Discovery 2018;17(Dec):858-859.

Selker HP, Gorman S, Kaitin KI. Efficacy-to-effectiveness clinical trials. Transactions of the American Clinical and Climatological Association 2018;129:279-300.

Beierlein JM, McNamee LM, Walsh MJ, Kaitin KI, DiMasi JA, Ledley FD. Landscape of Innovation for Cardiovascular Pharmaceuticals: From Basic Science to New Molecular Entities. Clinical Therapeutics 2017;39(7):1409-1425.

Lamberti

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

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

Lamberti MJ, Wilkinson M, Harper B, Morgan C, 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

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

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

Hossain I, Milne CP. Can Regenerative Medicine Help Close the Gap Between the Medicine Pipeline and Public Health Burden of Cardiovascular and Musculoskeletal Diseases? Clinical Therapeutics 2018;40(7):1066-1075.
https://doi.org/10.1016/j.clinthera.2018.06.007

Milne CP, Ni W. Impact of Social Media on R&D for Orphan Drug Development. Clinical Therapeutics 2017;39(11):2173-2180.
doi:10.1016/j.clinthera.2017.08.016

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

Milne CP, Smith Z, Chakravarthy R. Landscape for medical countermeasure development. Nature Reviews Drug Discovery 2017;16(7):448-449.

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

Milne CP. Reaching a New Innovation Threshold. Pharma Focus Asia. Published Online. https://www.pharmafocusasia.com/research-development/reaching-new-innovation-threshold

Milne CP. Regulation vs. Innovation for New Technologies: Finding the Balance. Published Online: November 2017.
https://www.pharmafocusasia.com/research-development/reaching-new-innovation-threshold

Milne CP, Smith Z. Use of Real World Evidence Increasing Throughout Asia. Pharma Focus Asia 2017;28:14-19.

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

Stergiopoulos

Stergiopoulos S, Getz KA, Blazynski C. Evaluating the Completeness of ClinicalTrials.gov. Therapeutic Innovation & Regulatory Science. Published Online: July 2018. 
https://doi.org/10.1177/2168479018782885

Stergiopoulos S.  Evaluating New Data-Driven Approaches Informing Global Investigative Site Selection. Pharmaceutical Outsourcing. 2018;19(1):32-35.

Stergiopoulos S, Tenaerts P, Brown CA. Awatin JG, Calvert SB, Holland TL, DiMasi JA, Getz KA. 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

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

Stergiopoulos S, Getz KA. Diagnosing Protocol Amendment Experience to Drive Clinical Trial Performance. Pharmaceutical Outsourcing 2017;18(1).
http://www.pharmoutsourcing.com/Featured-Articles/333834-Diagnosing-Protocol-Amendment-Experience-to-Drive-Clinical-Trial-Performance/

Wilkinson

Wilkinson M, Harper B, Peacock J, Morrison R, Getz, K. Assessing Outsourcing Oversight Practices and Performance. Therapeutic Innovation & Regulatory Science. Published Online: January 2019.
https://doi.org/10.1177/2168479018820880

Wilkinson M, Young R, Harper B, Machion B, Getz KA. Baseline Assessment of the Evolving 2017 eClinical Landscape. Therapeutic Innovation & Regulatory Science 2018;53(1):71-80.
doi: 10.1177/2168479018769292


commentaries, editorials & Chapters in books

Cohen

Cohen JP, DiMasi JA, Kaitin KI. CER’s Impact on Drug Development Strategy and Innovation - Decision Making in a World of Comparative Effectiveness Research: A Practical Guide. Editors: Birnbaum HG, Greenberg PE. Adis:Springer. Singapore 2017;6:63-73.

Getz

Getz KA. The Need and Opportunity for a New Paradigm in Clinical Trial Execution. Applied Clinical Trials 2018;27(6).

Kaitin

Kaitin KI, Milne CP. Challenge and Change at the Forefront of Regenerative Medicine. Clinical Therapeutics 2018;40(7).
https://doi.org/10.1016/j.clinthera.2018.06.008

Kaitin KI, editor. Developing new medicines for pediatric oncology: assessing needs and overcoming challenges. Clinical Therapeutics 2017;39(2):236-237.

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

Milne

Milne CP, Kaitin KI. Challenge and Change at the Forefront of Regenerative Medicine. Clinical Therapeutics 2018;40(7):1056-1058.
https://doi.org/10.1016/j.clinthera.2018.06.008

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

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

Milne CP. Editorial: Regulation vs. Innovation: Are We Getting It Right? Asian Hospital & Healthcare Management 2017;38.


tufts csdd impact reports (by subscription)

2019

Outsourcing outpaces internal spending but remains tactical and reactive
March/April 2019, Vol. 21 No. 2

U.S. continues to lead new drug R&D, but Asia-Pacific is starting to rise
January/February 2019, Vol. 21 No. 1

2018

Global Biotech Product Development Continues its Multi-Decade Surge
November/December 2018, Vol. 20 No. 6

CNS Drugs Take 20% Longer to Develop and to Approve vs. Non-CNS Drugs

September/October 2018, Vol. 20 No. 5

Rising Protocol Complexity is Hindering Study Performance, Cost, and Efficiency
July/August 2018, Vol. 20, No.4

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


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 CP, Smith Z, Ni W. Challenges to Orphan Drug Development. Tufts CSDD Whitepaper. Published: November 2017.