Author Interviews, Cancer Research, Melanoma, Nature / 21.05.2020

MedicalResearch.com Interview with: [caption id="attachment_54260" align="alignleft" width="200"]Dr. Kelly Brooks PhD Research Officer QIMR Berghofer Medical Research Institute Dr. Brooks[/caption] Dr. Kelly Brooks PhD Research Officer QIMR Berghofer Medical Research Institute     MedicalResearch.com: What is the background for this study? [caption id="attachment_54258" align="alignleft" width="200"]uveal-melanoma__DERMNet image An example of uveal melanoma
DermNet NZ image[/caption] Response: There are approximately 175 new cases a year for melanomas inside the eye called uveal melanomas. These cancers spread to other sites of the body in about half of patients. Uveal melanomas are very different to skin melanomas and so far no effective treatment have been approved to treat uveal melanoma once it has spread. We sequenced uveal melanoma tumours from over 100 different patients to look at what mutations are responsible for tumour growth and development. 
Author Interviews, Dermatology / 21.05.2020

MedicalResearch.com Interview with: [caption id="attachment_54295" align="alignleft" width="138"]Dr. Melanie D. Palm, MD, MBA Board-certified dermatologist and cosmetic surgeon San Diego, CA Clinical investigator in the Restylane Kysse phase 3 Galaderma trial Dr. Palm[/caption] Dr. Melanie D. Palm, MD, MBA Board-certified dermatologist and cosmetic surgeon San Diego, CA Clinical investigator in the Restylane Kysse phase 3 Galaderma trial Dr. Palm discusses the recent announcement that the FDA has approved Restylane® Kysse for lip augmentation and the correction of upper perioral rhytids (wrinkles)  in adults over the age of 21.   MedicalResearch.com: What is the background for this announcement?
    • Restylane® Kysse has been approved and used in Europe and Canada for several years. It is now the first FDA-approved hyaluronic acid (HA) lip filler in the U.S. formulated with XpresHAn Technology™ (pronounced ex-'spre-shan’) for smooth, natural-looking results.
    • It is FDA-approved for use not only in the lip but for improvement of upper lip lines.
    • Restylane Kysse is the third product (following Restylane Defyne and Restylane Refyne) in the Restylane family of fillers to use XpresHAn Technology™ which allows for a gel that integrates into the skin for natural expression in motion
Author Interviews, Gender Differences, JAMA, Surgical Research, University of Pittsburgh / 21.05.2020

MedicalResearch.com Interview with: [caption id="attachment_54289" align="alignleft" width="200"]Sara P. Myers, M.D., Ph.D. University of Pittsburgh School of Medicine Dr. Myers[/caption] Sara P. Myers, M.D., Ph.D. University of Pittsburgh School of Medicine  MedicalResearch.com: What is the background for this study? Response: Compared to other fields, medicine, and especially academic surgery and its subspecialties, trail with respect to gender diversity. Considering that these fields were traditionally male-dominated, two issues that may present ongoing challenges to the retention and promotion of women are pro-male bias and negative stereotypes about women. Training specific to pursuing a surgical career begins in residency, so it is important to understand how these issues affect motivation and achievement during this formative period. In our study we first evaluated the association between pro-male bias and research-related career engagement using a survey methodology, and then looked at whether evoking negative stereotypes about women was associated with reduced performance on a simulated technical skill assessment called the Fundamentals of Laparoscopic Surgery (FLS) assessment. 
Author Interviews, Cancer Research, COVID -19 Coronavirus / 19.05.2020

MedicalResearch.com Interview with: [caption id="attachment_54066" align="alignleft" width="200"]Paolo A. Ascierto, MD Melanoma. Cancer Immunotherapy and Development Therapeutics Unit Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale" Napoli - Italy Dr. Ascierto[/caption] Paolo A. Ascierto, MD Melanoma. Cancer Immunotherapy and Development Therapeutics Unit Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale" Napoli - Italy  MedicalResearch.com: What is the background for this study? What are the main findings? Response: As we know, in Covid-19 pneumonia, especially in its complication “acute respiratory distress syndrome (ARDS)”, a key role is played by the immune system. We know that when we treat a tumor with immunotherapy, it could give side effects because the stimulated immune system produces a series of substances to destroy the tumor. Sometimes, the immune system can also give side effects related to a hypersecretion of some cytokines, such as IL 6, the target of tocilizumab. This condition is called cytokine storm, or better, cytokine release syndrome (CRS).Oncologists use tocilizumab in the management of CRS that can occur following the use of bispecific antibodies, or recently, the use of CAR-T cell therapy, where such drug is approved for CRS treatment. 
Author Interviews, Cancer Research, Lancet, Nature / 19.05.2020

MedicalResearch.com Interview with: [caption id="attachment_53818" align="alignleft" width="130"]Matthew Galsky, MD Icahn School of Medicine at Mount Sinai New York, NY Dr. Galsky[/caption] Matthew Galsky, MD Icahn School of Medicine at Mount Sinai New York, NY MedicalResearch.com: What is the background for this study? Response: Standard first-line treatment for metastatic urothelial (bladder) cancer has been platinum-based chemotherapy for decades. In 2016, atezolizumab, an immunotherapy that inhibits PD-L1, received accelerated approval by the FDA for the treatment of metastatic urothelial cancer for patients progressing despite prior platinum-based chemotherapy and this was followed by approvals for 4 additional PD-1 or PD-L1 inhibitors in this setting over the next couple years. With this first new drug class approved, representing the first new drugs approved for metastatic urothelial cancer for decades, logical question arose (a) should we combine these drugs with platinum-based chemotherapy in the first-line metastatic treatment setting and (b) is there a role to replace first-line chemotherapy with atezolizumab monotherapy. The IMvigor 130 trial was designed to address these questions. The trial enrolled 1213 patients who were randomized to treatment with (a) atezolizumab plus platinum-based chemotherapy, (b) placebo + platinum-based chemotherapy, or (c) atezolizumab monotherapy. The trial employed a hierarchical analysis plan such that comparisons between arms for certain endpoints could only be formally tested if other the preceding comparisons demonstrated a significant improvement. 
ASCO, Author Interviews, Cancer Research / 19.05.2020

MedicalResearch.com Interview with: [caption id="attachment_54274" align="alignleft" width="200"]Dr. Jesus G. Berdeja, MD Director of Myeloma Research Sarah Cannon Nashville, TN Dr. Berdeja[/caption] Dr. Jesus G. Berdeja, MD Director of Myeloma Research Sarah Cannon Nashville, TN MedicalResearch.com: What is the background for this study? Response: Despite many advances in the treatment of multiple myeloma in recent years, the majority of patients will progress through all available therapies and ultimately succumb to their disease.  Thus there is still a high unmet medical need. The Phase 1b/2 CARTITUDE-1 study evaluates the safety and efficacy of JNJ-4528, an investigational BCMA-directed CAR-T therapy, in the treatment of patients with relapsed or refractory multiple myeloma. Participants in this study have already tried approved therapies, and had received a median of five prior treatment regimens and their median overall survival is less than 12 months. 
Author Interviews, JAMA, Orthopedics, Race/Ethnic Diversity, Surgical Research / 19.05.2020

MedicalResearch.com Interview with: [caption id="attachment_54220" align="alignleft" width="200"]Alyson Cavanaugh, PT, PhD Joint Doctoral Program in Epidemiology University of California, San Diego/ San Diego State University  Dr. Cavanaugh[/caption] Alyson Cavanaugh, PT, PhD Joint Doctoral Program in Epidemiology University of California, San Diego/ San Diego State University MedicalResearch.com: What is the background for this study? Response: More than 700,000 total knee replacements are performed annually in the United States, but there is a racial disparity in outcomes after the surgery. If the knee replacement procedure is considered a highly effective treatment, why don't black women present with the same outcomes as whites? Physical function when going into surgery has a large impact on the potential functional outcomes after surgery. Our hypothesis was that black women were presenting to surgery with poorer physical function, which was contributing to poorer functional outcomes after surgery.
Author Interviews, JAMA, STD / 19.05.2020

MedicalResearch.com Interview with: [caption id="attachment_54214" align="alignleft" width="154"]Barbara Van Der Pol, PhD, MPH President, American STD Association President-Elect, International Society fo STD Research Professor of Medicine & Public Health Director, STD Diagnostics Lab Director, UAB STD Clinical Research Organization University of Alabama at Birmingham Birmingham, AL  35294 Dr. Van der Pol[/caption] Barbara Van Der Pol, PhD, MPH President, American STD Association President-Elect, International Society fo STD Research Professor of Medicine & Public Health Director, STD Diagnostics Lab Director, UAB STD Clinical Research Organization University of Alabama at Birmingham Birmingham, AL  35294 MedicalResearch.com: What is the background for this study? Response: For many decades, public health programs focused on control and prevention of sexually transmitted infections (STI) have relied on lab based tests that required a 1-day to 1-week wait for test results.  Efforts to shorten the duration of infection lead to treating at the time of the clinic visit based on the association between certain clinical signs or symptoms and the likelihood of infection. Unfortunately, more than ½ of infected persons do not have signs or symptoms so they receive no treatment until test results are available. Thus, a test that could be performed at the clinical site with a limited wait time would improve the accuracy of treatment and shorten the duration of infection. Such a strategy will hopefully reduce the number of return clinic visits, the possibility of transmission, and the potential for consequences of untreated infection such as infertility. 
Author Interviews, Cost of Health Care, JAMA / 19.05.2020

MedicalResearch.com Interview with: [caption id="attachment_54268" align="alignleft" width="142"]James D. Chambers, PhD, MPharm, MSc Associate Professor of Medicine Tufts Medical Center Institute for Clinical Research and Health Policy Studies Dr. Chambers[/caption] James D. Chambers, PhD, MPharm, MSc Associate Professor of Medicine Tufts Medical Center Institute for Clinical Research and Health Policy Studies MedicalResearch.com: What is the background for this study? Response: We know that biosimilars have not had the same uptake in the US as they have had elsewhere. We know that this is in part due to reference product manufacturer tactics to delay biosimilar market entry and patent disputes. In this study we examined whether lack of preferred coverage by commercial health insurers may also play a role.
Author Interviews, Cost of Health Care, JAMA, Primary Care / 19.05.2020

MedicalResearch.com Interview with: [caption id="attachment_54263" align="alignleft" width="168"]Sara Martin, MD, MSc Santa Rosa Family Medicine Residency Program Santa Rosa, California Dr. Martin[/caption] Sara Martin, MD, MSc Santa Rosa Family Medicine Residency Program Santa Rosa, California MedicalResearch.com: What is the background for this study? Response: To improve access to comprehensive primary care, we need to understand how much is being spent on primary care. Until recently, the United States lacked any data-based estimate of primary care expenditure.  This study utilizes Medical Expenditure Panel Survey (MEPS)data from 2002 – 2016 to estimate the percentage of healthcare expenditures that was spent on primary care. Most discussions around health care expenditure in the U.S. focus on the fact that we spend more than any other country and do not have the corresponding outcomes to match that investment.  This paper focuses the conversation around the distribution of the expenditure.
Author Interviews, JAMA, Pediatrics, Social Issues, Technology / 18.05.2020

MedicalResearch.com Interview with: [caption id="attachment_54246" align="alignleft" width="200"]Pooja S. Tandon, MD, MPH Center for Child Health, Behavior and Development Seattle Children's Research Institute Dr. Tandon[/caption] Pooja S. Tandon, MD, MPH Center for Child Health, Behavior and Development Seattle Children's Research Institute MedicalResearch.com: What is the background for this study? Response: Cell phone use is common among middle and high school students, yet we do not have an understanding of school cell phone policies and practices in the U.S. We conducted a survey of public schools serving grades 6-12. The survey sent to over 1,100 school principals, representing a national sample of schools across the U.S., asked questions about the presence of a cell phone policy for students and staff and restrictions on phone use. Additional questions addressed consequences of policy violation, the use of cell phones for curricular activities and principals’ attitudes toward cell phone policies.
Author Interviews, Cannabis, CDC, JAMA, Pediatrics, Tobacco Research / 18.05.2020

MedicalResearch.com Interview with: Susan Hocevar Adkins, MD Lead Author, Senior Medical Officer, and Commander United States Public Health Service CDC MedicalResearch.com: What is the background for this study? Response: Since August 2019, the Centers for Disease Control and Prevention (CDC), the US Food and Drug Administration (FDA), and state, local, and territorial health departments have been investigating a national outbreak of e-cigarette, or vaping, product use-associated lung injury (EVALI). Although clinical presentation and outcomes of EVALI patients generally have been reported, data on adolescent patients are more limited. This article fills this gap by using data from national EVALI surveillance at CDC to examine demographic, substance use, and clinical characteristics of adolescent EVALI patients relative to young adult and adult EVALI patients.
Author Interviews, Infections, OBGYNE / 16.05.2020

MedicalResearch.com Interview with: SCYNEXIS IncMarco Taglietti, M.D. President and Chief Executive Officer SCYNEXIS Inc Dr. Taglietti discusses SCYNEXIS’ announcement of positive results from its second Phase 3 study investigating the safety and efficacy of oral ibrexafungerp as a treatment for vaginal yeast infection.  [caption id="attachment_54239" align="alignleft" width="200"]Marco Taglietti, M.D. President and Chief Executive Officer SCYNEXIS Inc Dr. Taglietti[/caption] MedicalResearch.com: What is the background for this study? Response:  The VANISH-306 study is one of two Phase 3 randomized, double-blind, placebo-controlled, multi-center studies designed to demonstrate the superiority of oral ibrexafungerp to placebo as a treatment of vaginal yeast infections, also known as vulvovaginal candidiasis. Ibrexafungerp is a novel oral/intraveneous broad-spectrum antifungal in late stage development for multiple indications, from the treatment and prevention of vaginal yeast infections to life-threatening invasive fungal infections in the hospital setting. The VANISH-306 study was conducted in 42 centers in the US and EU and enrolled 449 patients. Patients were randomized to oral ibrexafungerp (two doses of 300mg taken 12 hours apart for one day) or placebo in a 2:1 ratio The primary endpoints included clinical cure rate, defined as the complete resolution of all signs and symptoms at the test-of-cure visit (Day-10) and secondary endpoints included mycological eradication and change in signs and symptoms scores compared to baseline at both day 10 and follow-up visit (Day-25). The VANISH-306 study reported positive topline data which showed that 63.3% of ibrexafungerp-treated patients saw a complete resolution of signs and symptoms 10 days following a single day dose of ibrexafungerp. The first study in the VANISH program was VANISH-303, a US-based study, had an identical design to the VANISH-306 study. The VANISH-303 study reported positive topline data in November 2019 which showed that 50.5% of ibrexafungerp-treated patients saw a complete resolution of signs and symptoms 10 days following a single day dose of ibrexafungerp. Both VANISH studies showed a highly significant statistical difference in the primary and secondary efficacy endpoints. The product was well tolerated.
Author Interviews, JAMA, Surgical Research, Weight Research / 16.05.2020

MedicalResearch.com Interview with: [caption id="attachment_44215" align="alignleft" width="130"]Wei Bao, MD, PhD Assistant Professor, Epidemiology College of Public Health University of Iowa Dr. Wei Bao[/caption] Wei Bao, MD, PhD Assistant Professor Department of Epidemiology, College of Public Health, University of Iowa, Iowa City, IA 52242 and [caption id="attachment_50383" align="alignleft" width="128"]Yangbo Sun  MD, PhD Department of Epidemiology University of Iowa Dr. Yangbo Sun[/caption] Dr. Yangbo Sun, PhD (Former postdoc research scholar at University of Iowa) Tenure-track Assistant Professor The University of Tennessee Health Science Center.   MedicalResearch.com: What is the background for this study? Response: Obesity is a rising epidemic in the United States and worldwide. Bariatric surgery has been shown to be the most effective and durable treatment for clinically morbid obesity which is difficult to reverse through traditional approaches such as lifestyle intervention. There has been long-standing uncertainty and debate regarding the value of pre-operative weight loss as a requirement for bariatric surgery. Meanwhile, one of the major indicators for surgery outcomes is 30-day mortality after surgery, which is especially important for bariatric surgery because the vast majority of the patients undergoing bariatric surgery are voluntary and if the surgery were not performed, they are not supposed to die in short term. So far, the association of pre-operative weight loss with 30-day mortality after bariatric surgery remains unclear. Therefore, in this study, we examined the associations of pre-operative BMI and weight loss with 30-day mortality following bariatric surgery using a large database among ~500,000 patients who underwent bariatric surgery in the United States and Canada.
Author Interviews, Diabetes, Genetic Research, Pancreatic / 15.05.2020

MedicalResearch.com Interview with: [caption id="attachment_54230" align="alignleft" width="200"]Dr. Núria Malats, MD PhD, Head of the Genetic and Molecular Epidemiology Group Spanish National Cancer Research Centre (CNIO)  Dr. Malats[/caption] Dr. Núria Malats, MD PhD, Head of the Genetic and Molecular Epidemiology Group Spanish National Cancer Research Centre (CNIO)  MedicalResearch.com: What is the background for this study? Response: The high mortality of pancreatic cancer is a consequence of late diagnosis because of the absence of symptoms in the earliest stages, and defining risk populations is therefore crucial to be able to carry out diagnostic tests that reveal the presence of the tumour as early as possible. Diabetes and pancreatic cancer are connected because the pancreas secretes insulin; in diabetic people, this does not occur in a normal way. It is estimated that around 50% of patients with pancreatic cancer presents diabetes. But it is an outstanding challenge for researchers to figure out which is the cause and which is the consequence.  To conduct the study, the team used data from more than 3,500 persons from PanGenEU, a large European study involving centres from six countries, including Spain, and led by Malats, to analyse the relationship between multiple risk factors and pancreatic cancer.
Author Interviews, Cancer Research, COVID -19 Coronavirus / 14.05.2020

MedicalResearch.com Interview with: AVM BiotechologyTheresa A. Deisher, Ph.D Founder and CEO Chariman of Board AVM Biotechnology Dr. Deisher discusses AVM Biotechnology’s plan to study the immune stimulator AVM0703, developed for it’s anti-tumor effects,  as a potential agent to combat COVID-19.  MedicalResearch.com: What is the background for this study? What is AVM0703 currently being studied to treat?   Response: Our lead small molecule, AVM0703, is a novel, patent-pending repurposed formulation of an active pharmaceutical ingredient that has been U.S. Food and Drug Administration (FDA)-approved since 1961. AVM0703 works by supercharging and mobilizing immune cells, including a novel natural killer T-cell (NKT), novel cytotoxic T lymphocytes and a CD11b very high dendritic cell, which invade and destroy tumors more effectively than untreated immune cells. AVM Biotechnology has received clinical trial approval from the FDA to begin Phase I/II trials to characterize the safety, tolerability, pharmacokinetics, and antitumor activity of AVM0703 administered as a single intravenous infusion to pediatric and adult patients (≥12 years old) with terminal, no-option lymphoid malignancies. In addition, we are planning to study AVM0703 in Phase I/II trials in patients with severe or life-threatening COVID-19 infection. The proposed study is a randomized, double-blind, placebo-controlled, single-ascending dose study of AVM0703 administered as a single intravenous infusion. The study’s objective is to evaluate the safety and efficacy of AVM0703 in patients with COVID-19, as well as assess pharmacokinetics and dosing, including the maximum tolerated dose and the recommended Phase II dose. We hope to begin recruiting patients next month (June 2020).
Author Interviews, Cancer Research, Genetic Research, JAMA / 14.05.2020

MedicalResearch.com Interview with:
  • Sung Jun Ma, MD, resident physician in Radiation Medicine at Roswell Park Comprehensive Cancer Center (first author)
  • Oluwadamilola T. Oladeru, MD, a resident physician at Massachusetts General Hospital Cancer Center
MedicalResearch.com: What is the background for this study? Response: More than 40% of women with hormone receptor-positive, HER2-negative early-stage breast cancer have high recurrence scores (RS) of 26-30. Optimal adjuvant systemic therapy in this subgroup remains unclear, and national guidelines currently recommend either chemoendocrine therapy or endocrine therapy alone. In addition, the difference in overall survival of a patient with a RS 26-30 versus RS >30 is unclear.
Author Interviews, Brigham & Women's - Harvard, Cost of Health Care, Heart Disease, Race/Ethnic Diversity, Statins / 14.05.2020

MedicalResearch.com Interview with: [caption id="attachment_54182" align="alignleft" width="200"] Dr. Pandya[/caption] Dr. Ankur Pandya, PhD Assistant Professor of Health Decision Science Department of Health Policy and Management Harvard T.H. Chan School of Public Health MedicalResearch.com: What is the background for this study? Response: The 2013 ACC-AHA cholesterol treatment guidelines greatly expanded statin medication eligibility for individuals between the ages of 40-75 years without known cardiovascular disease, and there was some concern that African Americans at "intermediate risk" per those guidelines could be (arguably) overtreated with statins. The 2018 ACC-AHA guidelines included coronary artery calcium assessment for individuals at intermediate cardiovascular disease risk; those with a "zero" calcium score and no other risk factors would now change the eligibility (from indicated statin to not indicated).
Author Interviews, Brigham & Women's - Harvard, Gender Differences, Genetic Research, Nature / 13.05.2020

MedicalResearch.com Interview with: [caption id="attachment_54205" align="alignleft" width="149"]Nolan Kamitaki PhD Harvard Medical School Dr. Kamitaki[/caption] Nolan Kamitaki PhD Harvard Medical School MedicalResearch.com: What is the background for this study? Response: Previous work from our lab found that the strongest common genetic association to schizophrenia is driven in part by copy number variation of the C4 genes.  Given that lupus and Sjogren's syndrome, two autoimmune disorders, have association patterns that span the same region of the human genome, we wondered if part of the signal for these diseases may also arise from variation of C4 given that both have hypocomplementemia as a characterizing trait.   The other main finding is that these associations appear to be sex-biased, where the protection from each additional copy of the C4 gene was greater in men than in women.  When we went back to the data used in the previous study from our lab association C4 variation to schizophrenia, we found that the effect was stronger in men there as well.  Although the expression of C4 at the RNA level does not appear to differ between men and women, we saw that men had more C4 protein in both cerebrospinal fluid and blood plasma, suggesting that this may explain the greater genetic association in men.
Author Interviews, Infections, OBGYNE, Sexual Health, STD / 13.05.2020

MedicalResearch.com Interview with: [caption id="attachment_54202" align="alignleft" width="200"]Gregory Kaufman, M.D. Senior Vice President Global Clinical and Medical Affairs Specialty at Lupin Dr. Kaufman[/caption] Gregory Kaufman, M.D. Senior Vice President Global Clinical and Medical Affairs Specialty at Lupin MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by trichomoniasis?  How common is this infection? Response: The Phase 3 trial evaluated the effectiveness and safety of a single oral dose of Solosec® (secnidazole) 2g oral granules for the treatment of trichomoniasis in adult women. Top-line results were positive and showed that Solosec was generally well-tolerated. Trichomoniasis is the most common non-viral sexually transmitted infection (STI) in the U.S., and is caused by a protozoan parasite called Trichomonas vaginalis.[i] Trichomoniasis affects 3 to 5 million people in the U.S.,[ii] and is four- to five-times more prevalent in in women, compared to men.[iii].
Author Interviews / 13.05.2020

MedicalResearch.com Interview with: [caption id="attachment_54088" align="alignleft" width="119"]Celine Latulipe PhD Associate Professor University of Manitoba Dr. Latulipe[/caption] Celine Latulipe PhD Associate Professor University of Manitoba MedicalResearch.com: What is the background for this study? What are the main findings? Response: We wanted to find out how many hospitals offer proxy accounts for caregivers of adult patients. Most patient portal systems allow proxy accounts for parents of pediatric patients, so we know the underlying systems support the creation of proxy accounts. When we were starting this research, the two big healthcare systems where I was located did NOT offer such proxy accounts for caregivers of adult patients, and a staff person at one of those hospitals suggested adult patients share their passwords with their caregiver, if the caregiver needed access to the portal. As a computer scientist, I am well aware of the security and privacy risks associated with password sharing, and I was appalled by this advice. So we did this survey across the US and we found that 45% of the staff contacted in our study gave similar password sharing advice. This is hugely problematic. Caregivers using a patient's password means the caregiver can see everything in the medical record, including things the patient might not want the caregiver to know, such as past diagnoses of stigmatized illnesses, substance abuse or reproductive health decisions. Also, because password re-use is common across systems, a caregiver with a patient's portal password may now have access to the patient's online banking.
Author Interviews, Dermatology / 13.05.2020

MedicalResearch.com Interview with: [caption id="attachment_54196" align="alignleft" width="145"]Brian S. Kim, MD, MTR, FAAD Associate Professor of Medicine (Dermatology) Co-Director, Center for the Study of Itch and Sensory Disorders Division of Dermatology, Department of Medicine Washington University School of Medicine St. Louis, MO Dr. Kim[/caption] Brian S. Kim, MD, MTR, FAAD Associate Professor of Medicine (Dermatology) Co-Director, Center for the Study of Itch and Sensory Disorders Division of Dermatology, Department of Medicine Washington University School of Medicine St. Louis, MO  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Itch is the central and most debilitating symptom of atopic dermatitis. However, surprisingly, measuring itch or quality of life in clinical trials is not often a primary endpoint. Therefore, this study focuses in very detailed fashion on how ruxolitinib cream improves pruritus in a clinically meaningful way and its ultimate impact on quality of life. What patients want to know at the end of the day is how much will this drug change my life?  Not, whether it statistically beat out a placebo group. Indeed, what this study shows is that ruxolitinib cream has a major impact on itch in a meaningful way that is also tied to improvements in quality of life.
AACR, Author Interviews, Boehringer Ingelheim, Cancer Research / 13.05.2020

MedicalResearch.com Interview with: [caption id="attachment_54185" align="alignleft" width="200"]Dr. Udai Banerji, MD The Institute of Cancer Research and The Royal Marsden Dr. Banerji[/caption] Dr. Udai Banerji, MD The Institute of Cancer Research and The Royal Marsden MedicalResearch.com: What is the background for this study? Response: Not only have I been working in the RAS mutations oncology world for a while, but I also have prior preclinical experience working with VS-6766 (RAF/MEK inhibitor) and defactinib (FAK inhibitor), the two drugs in the Phase 1 study that was presented at the American Association for Cancer Research (AACR) annual medical meeting on April 27th. It is important to know that there is a great significant medical need for novel treatments for KRAS mutant tumors, which are difficult to treat, aggressive, and quite common across advanced solid tumors, including low-grade serous ovarian cancer (LGSOC), non-small cell lung cancer (NSCLC) and colorectal cancer (CRC), resulting in the need for novel treatments in an area of significant medical need. I felt that early signals in preclinical research warranted a clinical trial; so that, combined with my RAS experience, made pursuing the Phase 1 study a clear fit. A clinical trial setting allowed us to explore RAF and RAS inhibitor combinations in multiple tumor trials, which was our aim. The data presented at AACR convey safety and dose response results from the dose-escalation portion and expansion cohorts from an open-label, investigator-initiated Phase 1 study evaluating the combination of VS-6766 (RAF/MEK inhibitor) and defactinib (FAK inhibitor) therapy in patients with LGSOC and KRAS mutant NSCLC. The introductory data described in the study suggest that a novel intermittent dosing schedule of RAF/MEK and FAK inhibitor combination therapy has promising clinical activity in patients with KRAS mutant LGSOC and KRASG12V mutant NSCLC, including patients formerly treated with a MEK inhibitor. Expansion cohorts remain ongoing. 
Author Interviews, COVID -19 Coronavirus / 12.05.2020

MedicalResearch.com Interview with: Peter Jüni, MD, FESC Director, Applied Health Research Centre Li Ka Shing Knowledge Institute of St Michael's Hospital Department of Medicine University of Toronto, Ontario  MedicalResearch.com: What is the background for this study? Response: It is unclear whether seasonal changes, school closures or other public health interventions will result in a slowdown of the current coronavirus disease 2019 (COVID-19) pandemic. We studied 144 geopolitical areas around the world with more than 375,000 COVID-19 cases by March 27 to determine whether epidemic growth is globally associated with climate or public health interventions intended to reduce transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Author Interviews / 11.05.2020

MedicalResearch.com Interview with: [caption id="attachment_54164" align="alignleft" width="160"]David Spetzler, M.S., Ph.D., M.B.A. President and Chief Scientific Officer Caris Life Sciences Dr. Spetzler[/caption] David Spetzler, M.S., Ph.D., M.B.A. President and Chief Scientific Officer Caris Life Sciences MedicalResearch.com: What is the background for this announcement (WES)? Response: The announcement is about the launch of Caris’ latest molecular profiling test, called MI ExomeTM.  MI Exome a next-generation sequencing-based assay analyzing the whole exome of 22,000 DNA genes.  It is unique in that it will be run on every patient and will deliver unprecedented detail into the genomic characteristics of cancers, which will greatly improve our ability to understand cancer and provide insights needed to help physicians and patients make more informed treatment decisions that improve outcomes.
Author Interviews, Neurological Disorders, Neurology, Pain Research / 11.05.2020

MedicalResearch.com Interview with: [caption id="attachment_54158" align="alignleft" width="160"]Holly Yancy, DO Headache medicine specialist Phoenix, AZ Dr. Yancy[/caption] Holly Yancy, DO Headache medicine specialist Banner – University Medicine Neuroscience Institute Phoenix, AZ Dr. Yancy comments on the recent Neurology journal article on the potential impact of yoga on migraine.  MedicalResearch.com: What is the background for this study? How might yoga reduce migraine intensity or frequency?  Response: The authors of this trial have studied the benefits of yoga when added to medical management of episodic migraine. They expand on prior, smaller reports of the potential benefit of yoga and mindfulness to migraine patients with a well-designed study that shows yoga, as an adjunct to preventive medication, can lower the intensity, frequency and impact of migraines. Participants even used less abortive medication. The authors propose multiple potential mechanisms of action, including an increase in parasympathetic / decrease in sympathetic nervous system activity, decreased muscle tension, and stress management.
Author Interviews, COVID -19 Coronavirus, Emergency Care, Infections, NEJM, Stroke / 09.05.2020

MedicalResearch.com Interview with: [caption id="attachment_54149" align="alignleft" width="133"]Akash Kansagra, MD, MS Assistant Professor of Radiology Neurological Surgery, and Neurology Director, Endovascular Surgical Neuroradiology Co-Director, Stroke and Cerebrovascular Center Washington University and Barnes-Jewish Hospital Dr. Kansagra[/caption] Akash Kansagra, MD, MS Assistant Professor of Radiology Neurological Surgery, and Neurology Director, Endovascular Surgical Neuroradiology Co-Director, Stroke and Cerebrovascular Center Washington University and Barnes-Jewish Hospital MedicalResearch.com: What is the background for this study? Response: Over the past five years, medicine has made enormous strides in stroke treatment. The effectiveness of these therapies has been absolutely astounding, and our ability to get patients to hospitals that can provide this life-saving care has also improved dramatically.
AACR, Author Interviews, Biomarkers, Cancer Research, MD Anderson, Pharmaceutical Companies / 09.05.2020

MedicalResearch.com Interview with: [caption id="attachment_54143" align="alignleft" width="140"]David S Hong, M.D Department of Investigational Cancer Therapeutics, Division of Cancer Medicine MD Anderson, University of Texas Dr. Hong[/caption] David S Hong, M.D MD Anderson Department of Investigational Cancer Therapeutics Division of Cancer Medicine University of Texas MedicalResearch.com: What is the background for this study? Response: Larotrectinib is a first-in-class, CNS active, oral TRK inhibitor exclusively designed to treat tumors with an NTRK gene fusion and does not have secondary targets. In previous presentations and published in The Lancet Oncology, larotrectinib demonstrated robust tumor-agnostic efficacy in an integrated dataset of 159 adult and pediatric patients with TRK fusion cancer across three clinical trials (Feb 2019 data cut-off date). In these studies, the objective response rate (ORR), according to investigator assessment, was 79% (95% confidence interval [CI], 72 – 85%), with a complete response rate of 16%. In this analysis presented at AACR 2020, we sought to evaluate the outcomes in patients from the integrated data set based on different baseline characteristics, including prior lines of therapy and Eastern Cooperative Oncology Group (ECOG) performance status. ECOG measures how the disease impacts a patient. ECOG describes a patient’s level of functioning with a numbering scale (0-5) so physicians can uniformly describe a patient’s ability to care for themselves, daily activity and physical activity (selfcare, walking, working, etc).
AACR, Author Interviews, Bayer, Cancer Research / 08.05.2020

MedicalResearch.com Interview with: [caption id="attachment_54143" align="alignleft" width="140"]David S Hong, M.D Department of Investigational Cancer Therapeutics, Division of Cancer Medicine MD Anderson, University of Texas Dr. Hong[/caption] David S Hong, M.D Department of Investigational Cancer Therapeutics Division of Cancer Medicine MD Anderson, University of Texas MedicalResearch.com: What is the background for this study? Response: Larotrectinib is a first-in-class, CNS active, oral TRK inhibitor exclusively designed to treat tumors with an NTRK gene fusion and does not have secondary targets. In previous presentations and published in The Lancet Oncology, larotrectinib demonstrated tumor-agnostic efficacy in an integrated dataset of 159 adult and pediatric patients with TRK fusion cancer across three clinical trials (Feb 2019 data cut-off date). In these studies, the objective response rate (ORR), according to investigator assessment, was 79% (95% confidence interval [CI], 72 – 85%), with a complete response rate of 16%. A variety of NTRK genes have been identified in various tumor types including fusions and non-fusions (e.g., amplifications, rearrangements, deletions, slice variants). In the analysis presented at AACR 2020, we sought to evaluate this pooled data to determine the efficacy of larotrectinib in patients with non-fusion alterations in NTRK genes.