“These are exciting times for all areas of oncology.” With new advances across the oncological board, from immuno-oncology and biomarkers, it is important to keep up with and understand the latest innovations. We spoke to Raluca Budiu-Predoiu, Translational Oncology Principal Scientist at Merck, to get her insights on exciting new developments and company priorities for the R&D sector.

To discuss these innovations and more with leading experts in an informal setting, sign up to Proventa’s Clinical Operations & Oncology Strategy Meeting, held Online on 27 May 2021.

Hi Raluca, can you give us a brief introduction to your background and current activities?

Raluca Budiu-Predoiu: I have over 13 years of experience in basic, translational and clinical research, with accumulated knowledge in tumour biology, tumour immunology, cancer genomics, angiogenesis, autoimmunity and clinical biomarkers. I received my PhD in 2007 from Babes-Bolyai University in Romania. 

In 2008, I started a post-doctoral program where I conducted research on prognostic and predictive biomarkers of response/resistance to IL2-administered intraperitoneally to late-stage ovarian cancer patients; I generated a new triple transgenic mouse model for ovarian cancer and developed and tested pre-clinically a new vaccine for this disease. In 2012, I moved to New York City where I worked as a scientist at Icahn School of Medicine at Mount Sinai. There my research focused on circulating biomarkers for early diagnosis of breast and colo-rectal cancers.

At Merck, I specialised in design and implementation of biomarkers in early and late clinical trials, project outsourcing and collaborative work with contract research organisations (CROs). In my current role, I lead the biomarker strategies in early and late development studies for renal cell, colorectal and haematologic indications to help advance phase II/III studies towards registration. Another aspect of my job is working with discovery biology and bioinformatics colleagues for reverse translational studies: I use late stage clinical biomarker data to inform on future potential targets and/or combinatorial therapies.

What is the most exciting area of oncology you are currently working on?

RBP: With new advances in the immuno-oncology and biomarker space, these are exciting times for all areas of oncology. I am excited about the fact that more and more cancer patients are starting to be placed in different treatment regimens based on biomarker-driven studies; that we are making huge progress towards precision medicine; that fewer and fewer patients are exposed to unnecessary toxic therapies; and that we have achieved a huge improvement not only in the response rates but also quality of life for those cancer patients.

What have been the notable trends in the past year? What has been driving them, and where should pharma and biotech be focussing their R&D efforts in light of these?

RBP: Combinatorial treatments with check-point inhibitors are expanding dramatically. The trend now is precision medicine, and that involves combinations of targeted therapies which are specific for a particular group of patients, based on their genetic makeup.

These have been driven by advances in technology for biomarker discovery and easy access to information for patients and physicians, which drives the increase in patient consent for clinical specimen collection so more quality data can be generated.

From here, we should focus on understanding resistance mechanisms to current SOC therapies, focus more on pre-clinical models for a more reliable translational research, and reverse translation for biomarker discovery from clinical specimens.

Which innovations or new technology most excites you right now / in the near future?

RBP: As I mentioned, we live in exciting times, where technologies are evolving rapidly and becoming more and more accessible – not only for diagnostic but also for treatment, drug delivery and patients’ follow-ups. With all the new combinations, I am excited about the inventive ways biotech and pharma companies are approaching tumour-targeted and dose-specific delivery of these drugs. Thus, another step towards precision medicine.

Without giving too much away, can you give us a brief overview of what you will be looking to explore at the Oncology Strategy Meeting and why it is important for 2021?

RBP: I’d very much like to have a harmonisation between academia, biotech and pharma efforts when it comes to biomarker discovery. I’d also want to see how we use the complex datasets available to date to inform on future combinatorial studies, and what technologies are feasible to implement in a clinical trial for patient selection.

To discuss these topics further with sector experts, and to ensure you remain up-to-date on the latest in clinical development, sign up for Proventa International’s Clinical Operations & Oncology Strategy Meeting, set for 27 May 2021.