MedSIR INSIDE OUT – Alicia Garcia

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Today we are happy to spend a brief moment with Alicia Garcia, Head of Clinical Operations at MedSIR.

MedSIR Newsletter Team (MS): Thanks, Alicia, for spending some time with us here today.

Alicia Garcia (AG): Thank you, it’s my pleasure!

MS: What brought you to MedSIR?

AG: Prior to joining MedSIR, I had been working in mid and large size pharma companies for a long time and I was looking for a company with a different model. A company where I could feel more involved and contribute directly to improving the lives of patients.

MS: Interesting. So, it seems you have extensive experience in the field of clinical trials in Big Pharma. What was that change to a small company such as MedSIR like? Was it difficult for to you to make such a big jump?

 

AG: It obviously required a change of mindset. I moved from the very structured environment of Big Pharma, where every step had a defined process, to a small and very new company… I joined MedSIR in 2014. However, this has also been the most creative part: finding alternative solutions to old or new needs when implementing clinical trials. It has been challenging but also very rewarding.

MS: Sometimes our clients request us to define exactly how we work and what makes MedSIR so unique. How would you define MedSIR to our readers?

AG: I think that the name of MedSIR really contains one of its most valuable assets. This asset is Innovation. Innovation not only in the design of new therapeutic strategies that could improve the lives of patients, but also innovation in how clinical trials are implemented. At MedSIR, we are always open to new technologies, methodologies, and ideas that could make clinical research more efficient. There is a clear goal of generating, in a better and faster way, results that could improve clinical practice in Oncology.

MS: What’s your favorite thing about your job? And the worst thing?

AG: What I like the most is that no day is similar to the previous one. It is always necessary for all of us to keep learning and keep abreast of new clinical data and technologies. I also love the very close interactions with colleagues who have expertise in other areas. I love not only listening to our oncology experts discussing the rationale of new clinical trials, but also learning from colleagues working in finance or marketing.

What I like to avoid is too much bureaucratic work, and, fortunately, there is not too much of that (laughs).

MS: As Head of Clinical Operations, what do you think about your operational team (the Operations Team?)? Should some essential skills relevant to the International Trial Lead role be highlighted?

AG: I think I am very lucky to be part of such as a great group of people. The group is made of professionals with outstanding backgrounds in Biological or Clinical Research. There is always a “we can” attitude, nothing is seen as impossible. Even the most difficult situations are taken as a team challenge, where everyone is contributing their effort and enthusiasm to achieve a goal.

Even though we are not a large group, we are a very multicultural team. We have people from different countries and cultures including China, Argentina, Venezuela, Spain, Switzerland, The Dominican, etc… we even mix Barça and Real Madrid supporters or even some not interested in football at all… This diversity really is the source for the creativity and differential opinions that make up this team.

MS: And what about your hobbies? How do you distract your mind away from MedSIR?

AG: I am the mother of three children. This is a good way to free my mind from MedSIR (chuckles)… No, seriously, there are lots of things I like such as traveling or trekking. On one hand, I consider myself very Mediterranean in that what I enjoy most is being with my family and friends and participating in the life and events of my neighborhood. But, on the other hand, I also need my down time and I enjoy reading, running, and gardening.

MS: Thanks so much, Alicia, for your time!

Post ASCO 2018

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Barely 8 weeks after visiting the city for the AACR 2018 annual meeting, MedSIR returned to Chicago for ASCO 2018! McCormick Place is the largest convention center in North America, but at MedSIR we feel we already know all its nooks and crannies!

If this year’s AACR meeting was exciting, ASCO didn’t lag behind! The results of many new trials involving immune checkpoint inhibitors were presented, indicating that immunotherapy is the queen at the ball of current oncology. Pembrolizumab, for example, continued to show impressive results in lung cancer patients, including those at an early stage of the disease.

But not everything was related to immunotherapy! A new targeted therapy against PIK3CA (taselesib) was shown to slow the growth of advanced breast cancers, and innovative ways of using chemotherapy were shown to significantly extend the lives of patients with pancreatic cancer, one of the most deadly tumours.

One of the highlights of the Congress was the presentation of the results of the study TAILORx, which used Oncotype DX gene expression assay to prove that many women with early breast cancer can avoid chemotherapy without fear of worsening their prognosis. The findings will be a game-changer in breast cancer care, since from now on the use of chemotherapy can be directed only to the patients that will actually benefit from it.

But more important than the number of steps we walked going from one results presentation to another is the number of hands we shacked with existing partners and potential new clients! We immediately got to work in building exciting relationships with both established companies and bold new players, in order to get the most out of the possibilities that all these advances offer to cancer patients worldwide! Feel free to contact us if you have an idea about the matter!

It was a great, successful, exhausting meeting, and therefore we can’t wait for ASCO 2019! See you all back next year in Sweet Home Chicago!

INTERVIEW: Oncologist of the Month – Dr. María Jesus Rubio Perez

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Today, we had the chance to sit down with Dr. Mª Jesús Rubio Pérez, Gynecological Cancer Specialist and our MedSIR Oncologist of the Month. Here’s an excerpt from our conversation:

MedSIR (MS): Thanks so much, Dr. Rubio, for being with us today. It really is a pleasure for us to interview someone of your talent and passion for the field of Medical Oncology in general and, specifically, Gynecological Cancer.

Dr. María Jesús Rubio (MJR): The pleasure is mine.

MS: Before we jump into the amazing advances currently happening in cancer research, let’s get to know you a little bit better. What brought you to Gynecologic Oncology? When did you realize that you wanted to help in this fight against cancer?

MJR: I realized that I was helping the fight against cancer in my last year of university. My dedication to gynecological oncology arose when the specialty ended. This is an orphan pathology with a lot of future research, it simply attracted me and I had the opportunity

MS: Very interesting! So, today you are currently working in the position of Gynecologic Oncologist at the Reina Sofia Hospital (Córdoba). How did you get there? What were your career steps? Who were the people who most influenced you along the way?

MJR: I was born in Córdoba, I studied at the University of Córdoba and when I was in the sixth year of medicine I decided to do a job (texina) on antiemetics, that took me to the Medical Oncology service and once there, the type of patients, the possibility to investigate…. Everything I wanted at that moment was in Oncology

MS: Your specialty is Gynecological Cancer. What are the most recent advances that have you thinking that we are close to making big steps towards even better outcomes?

MJR: Currently, the recent advances based on the knowledge of molecular biology and target treatment is changing the perspectives of these patients. The arrival of drugs such as anti-angiogenesis, iPARP and soon immunotherapy, as well as the combination of these new drugs are improving the survival of these women who a few years ago had a very poor prognosis in the very short term.

MS:Let’s focus more on the POLEN study. As this is a “phase 0” study in patients with early-stage endometrial carcinoma, what do you think is the importance and, also, the limitations of this type of study? Do you think it will help to improve the prognosis of these patients in the near future?

MJR: The importance of the Phase 0 studies and the POLEN study in particular is that with them we can detect activity of a drug with a short exposure through the molecular changes that occur in the tumor.

The limitation is that they are women with a recent diagnosis of cancer, they present at that time an important anxiety to perform the surgery as soon as possible, for them that step will initially mean ending a nightmare.

I think that the results of the POLEN study will help women diagnosed with endometrial carcinoma in the future. I think it’s good for them to have a therapeutic agent like Olaparib and more so in tumors like endometrial carcinoma that can sometimes have a hereditary origin.

MS: Following on with MedSIR, what is your impression about us and our vision of the clinical research? Has your experience been positive?

MJR:I have a good impression of MedSIR. In my opinion, they are an amazing team that helps to conduct good clinical research. I think that MedSIR is contributing to the scientific community giving a true value to clinical oncology, creating knowledge and “know how” in the development of clinical trials.

The operation team is awesome! They work hardly for the benefit of all parties included in the development and management of the clinical trials and, of course, in order to improve patient lives. They move very quickly in order to solve daily issues.

MS: What’s your opinion on how the MedSIR model is being received on the outside.

MJR: It should be obviously incredible. From the outside, MedSIR is considered one of the most innovative companies in the oncology field. People are beginning to understand that MedSIR’s model it is NOT like a CRO (Contract Research Organization). MedSIR is creating a new way to do things in clinical research and the design and management of clinical trials in oncology. People know that MedSIR is working with Oncology experts, and they are committed to extending the life of cancer’s patients.

MS: Thank you so much, Dr. Rubio, for your time. It was really an honor to spend this moment with you.

MJR: Thanks to you!

The POLEN Study

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The POLEN Study “A preoperative window-opportunity”, multicenter, pharmacokinetic-pharmacodynamic study to evaluate the inhibitory effects of single agent AZD2281 (Olaparib) in patients with early-stage endometrial carcinoma” finalized its recruitment last 7th May 2018.

The primary objective of this study is to identify, the antitumoral biological efficacy, by measuring in human tumor samples, biomarker changes associated to short exposure to AZD2281 as potential predictors of activity in Endometrial Carcinoma (EC). This is an exploratory study with a biological primary endpoint. 10 Spanish sites have participated and a total of 49 patients have been recruited (36 treated and 13 Screening Failure) since February 2016. It’s been a long journey with many difficulties but the perseverance and effort of the site investigators and collaborators from the Oncology, Gynecology and Pathological Anatomy Services have been key to achieve it.

Thank you very much to all of them and specially to the H. Reina Sofia de Córdoba (Dr. Mª Jesús Rubio), H. Ramón y Cajal (Dr. Eva Guerra and Dr Alfonso Cortés), Instituto Valenciano de Oncología (Dr. Ignacio Romero) and H. Clínico San Carlos (Dr. Casado) as top recruiters. The research team was supported by an unrestricted fellowship from Astra Zeneca. From now on, we will focus in the analysis of the results with an expected database lock by end of July 2018 and Final Study Report by end of October 2018.

Clinical research in complementary Oncology

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Integrative oncology intends to improve the overall wellbeing of people with cancer. This implies dealing with physical, emotional, mental, social, spiritual, and environmental factors, and demands the coordinated combination of conventional and complementary approaches. Therefore, integrative oncology is not to be confused with alternative medical care: the later intends to be applied in place of conventional medicine, while the former is to be used together with it. Integrative oncology has the potential to directly improve the overall welfare of cancer patients and survivors, and therefore the attention generated by this novel field has increased steadily in the last decade. Interestingly, quality of life improvements can also result in additional indirect benefits, such as decreased dose-reductions of conventional drugs and increased adherence to physician’s recommendations.

Most of the complementary approaches that can be coordinated with conventional oncology fall into two different broad categories: Natural Products (including herbs, mushrooms, vitamins, minerals, or probiotics) and Mind and Body Practices (like yoga, meditation, acupuncture, or osteopathy). Around 50% of patients with cancer in the US reported that they started taking new natural dietary supplements after being given their diagnosis, highlighting the wide spread of complementary health approaches in cancer patients and survivors.

Oncologists are often questioned about the effectiveness and safety of different complementary approaches, but usually lack the clinical evidence needed to provide solid advice. Absence of patient protection for complementary health solutions means that providers cannot afford the high costs associated with the development of clinical studies. Consequently, clinical research on these programs is in its early stages, although some studies have already shown promising results in managing symptoms and side effects of patients receiving conventional cancer treatment. Acupuncture may reduce treatment-related joint pain for breast cancer patients, mindfulness practice can reduce cortisol blunting during chemotherapy, and integrative medicine programs can improve the gastro-intestinal concerns and quality of life in patients with breast and gynecologic cancer, among other examples.

In MedSIR, we believe the generation of scientifically-robust clinical evidence on integrative oncology approaches is an unavoidable necessity, and a field that will experience significant growth in the near future. The design and development of strategic clinical trials in this area, even if they need to be supported by alternative sources of funding, will pave the road for the mainstream implementation of the integrative approaches that demonstrate potential to improve the lives of cancer patients and survivors.

Roldan Cortés, MedSIR.

References:

«Acupuncture May Reduce Joint Pain Caused by Breast Cancer Therapy», National Cancer Institute. [En línea]. Disponible en: https://www.cancer.gov/news-events/cancer-currents-blog/2018/acupuncture-aromatase-inhibitor-joint-pain. [Accedido: 24-abr-2018].
 
D. S. Black, C. Peng, A. G. Sleight, N. Nguyen, H.-J. Lenz, y J. C. Figueiredo, «Mindfulness practice reduces cortisol blunting during chemotherapy: A randomized controlled study of colorectal cancer patients», Cancer, vol. 123, n.o 16, pp. 3088-3096, ago. 2017.
 
M. Domnick, M. Domnick, K.-R. Wiebelitz, y A.-M. Beer, «Evaluation of the Effectiveness of a Multimodal Complementary Medicine Program for Improving the Quality of Life of Cancer Patients during Adjuvant Radiotherapy and/or Chemotherapy or Outpatient Aftercare», OCL, vol. 93, n.o 2, pp. 83-91, 2017.
 
I. Shalom-Sharabi et al., «Effect of a patient-tailored integrative medicine program on gastro-intestinal concerns and quality of life in patients with breast and gynecologic cancer», J Cancer Res Clin Oncol, vol. 143, n.o 7, pp. 1243-1254, jul. 2017.
 
C. J. Paller, S. R. Denmeade, y M. A. Carducci, «Challenges of conducting clinical trials of natural products to combat cancer», Clin Adv Hematol Oncol, vol. 14, n.o 6, pp. 447-455, jun. 2016.

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