Research at MBiotech

 Find out about novel research from MBiotech students.

The MBiotech Program actively participates in research, offering several opportunities for its graduate students to become involved in the research activities of our associated Faculty. Here is our latest contribution to the healthcare research community, hot off the press!


Siddhi
Siddhi Manjrekar
Class of 2021

Luqmaan Mohamed, Siddhi Manjrekar, Derek P Ng, Alec Walsh, Gilberto Lopes, Jayson L Parker

The Effect of Biomarker Use on the Speed and Duration of Clinical Trials for Cancer Drugs

The Oncologist, 2022, XX(XX), 1-8
 10.1093/oncolo/oyac130

Impact Factor: 5·8

Luqmaan
Luqmaan Mohamed ♟︎
Class of 2021

‘Having taken courses on pharmaceutical industry innovation - providing life-saving medication to patients as fast and equitably as possible, as well as the importance of having a competitive advantage, this sparked our interest in researching whether biomarkers have an impact on the speed and/or duration of clinical trials. This project was a large undertaking, screening over 8630 clinical trials across 4 indications to develop a novel visualization method to assess and compare the length and duration of trials by phases. This research provided us with many learnings to apply within our industry work and gain a deeper understanding of the complexities of the industry from research & development all the way to commercialization. Learnings from the MBiotech program and continuous support by the program and faculty (in particular Dr. Parker) allowed us to succeed in this research.’

Application relevance: The study showcased a novel visualization method to assess and compare whether biomarkers have an impact on the speed and duration of oncology clinical trials (across 4 indications). The novel visualization method revealed longer gaps between trial phases, later clinical trial start times, and shorter periods of concurrently run trials for drugs that used biomarkers. The study, therefore, highlights that biomarker-driven trials may impact drug approval timelines, and so these and other findings allow clinical researchers to carefully consider biomarker inclusion in their clinical development plans in oncology.


Biomarkers students group picture
A pre-COVID photo of some of the students involved in the study. From right: Rohan Tangri, Ashini Weerasinghe, Zain Shah, Kirill Pereverzev and Stephen Mac.

Parker JL, Kuzulugil SS, Pereverzev K, Mac S, Lopes G, Shah Z, Weerasinghe A, Rubinger D, Falconi A, Bener A, Caglayan B, Tangri R & Mitsakakis N

Does Biomarker Use in Oncology Improve Clinical Trial Failure Risk? A Large‐scale Analysis.

Cancer Medicine, 2021; 10(6):1955-1963
 10.1002/cam4.3732

Impact Factor: 3·4

Zain Shah Headshot
Zain Shah, Class of 2017.

‘This ROP (research opportunity program) was one of the most fundamental experiences I had as an undergraduate student. Not only did it give me the opportunity to get involved in original research, but expanded my skill set by learning new research methodologies, while acquiring domain specific knowledge. This study helps quantify the impact of biomarker use on clinical trial risk (i.e., the likelihood of a clinical trial progressing to the next stage in a drug development program) in oncology across four major disease conditions. The potential benefits of biomarker use include but are not limited to, diminishing costs of development by better patient selection, more cost-effective use of anti-cancer drugs, predicting a patient's response to therapy with more precision, and ultimately, leading to improvements in personalized medicine for the patient.’

Application relevance: This study provides the first systematic statistical evidence that biomarkers clearly increase clinical trial success rates in three different indications in oncology. Also, exploratory biomarkers, long before they are properly validated, appear to improve success rates in oncology. This study supports early and aggressive adoption of biomarkers in oncology clinical trials.


Headshot Jasper Dhanraj
Jasper Dhanraj ♙ co-author, Class of 2021
Headshot Alice
Alice Li ♙ lead author, Class of 2021

Li AJ, Dhanraj JP, Lopes G, Parker JL.

Clinical Trial Risk in Leukæmia: Biomarkers and Trial Design.

Hematological Oncology, 2021; 39(1):105-113.  10.1002/hon.2818

Impact factor: 2·8

‘The courses I took as part of the MBiotech curriculum sparked my interest in clinical trial designs and risks, and inspired me to pursue this research opportunity. This project helped me further understand the complexities of clinical trials, as well as the many multifaceted factors physicians must consider when prioritising clinical trials for patients. This research topic complemented the learnings from the MBiotech program, and continuous support by the program and faculty (in particular Dr. Parker) allowed us to succeed in this research, thanks MBiotech!’

Application relevance: The study explored clinical trial design and biomarker choices that may improve clinical trial testing success rates of new medicines in leukæmia. The use of biomarkers dramatically improved success rates ranging from 3- to 7-fold depending upon the indication. These and other findings allow oncologists to prioritise oncology trials in which to enrol their patients.

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