This document is the curriculum vitae of Julia Balfour, outlining her experience and qualifications as a medical writer and editor based in the UK. She has over 20 years of experience in medical writing for medical publishers, pharmaceutical companies, and as a freelancer. She has authored over 50 publications and provides editorial support and manuscript writing services for research teams. Her areas of expertise include oncology, hematology, nephrology, and health economics.
Robert C. Shepard has extensive experience in cancer research and clinical oncology spanning over 40 years. He received his MD from Duke University and has held academic and clinical positions at several prestigious institutions. Currently, he works as a consultant in oncology drug development and clinical trials. He has led numerous clinical trials for both pharmaceutical and biotech companies and has published extensively in peer-reviewed journals. His expertise includes all phases of clinical trial design and implementation.
This document summarizes an abstract from a scientific conference on predictive, preventive and personalized medicine. The abstract describes a study that investigated the role of the enzyme indoleamine 2,3-dioxygenase (IDO) in a mouse model of gingivitis. The study hypothesized that IDO plays a key role in regulating immune and inflammatory responses in gingivitis. The researchers used a multilevel diagnostic approach including medical imaging, multi-omics analysis and subcellular imaging to develop predictive and prognostic biomarker panels to improve individual outcomes from radioembolization treatment for hepatocellular carcinoma. The integrated market access approach described aims to maximize the value of companion diagnostics used with targeted cancer drugs.
The document discusses value assessment frameworks for cancer therapies developed by the European Society for Medical Oncology (ESMO) and the American Society of Clinical Oncology (ASCO). It describes ESMO's Magnitude of Clinical Benefit Scale (ESMO-MCBS), which provides a relative ranking of clinical benefit for new cancer drugs. Studies applying the ESMO-MCBS found that it supported treatment decisions and aligned with reimbursement decisions. While the ESMO-MCBS provides standardized benefit assessment, it only applies to comparative studies and cannot assess single-arm trials. Overall, the ESMO-MCBS provides an unbiased and standardized approach to quantify the clinical benefit of new cancer treatments.
A slide series to learn and appreciate the importance and the potential of Personalized/Individualized Genomic Medicine. It briefly goes through the idea of biotechnology and the advancements we have made in biology and technology. A series of applications for genomic medicine is then explored, not failing to mention the challenges we have to overcome as well, for the next medical revolution.
A case for personalized medicine is presented.
This document discusses developing a "cardiac moonshot" initiative using precision medicine approaches to more effectively treat heart disease. It outlines how precision medicine considers individual genetic and lifestyle factors. The initiative would leverage technologies like remote monitoring, wearables, and electronic health records to integrate diverse health data. This would allow more personalized treatment and risk prediction. Challenges include standardizing large data collection and educating medical professionals on complex multi-omic data analysis.
Descripción de diversas herramientas para el análisis de datos masivos (Real World Data) de las Comorbilidades en la Historia Clínica Electrónica (HCE). Ponencia invitada en el Summer School de la Universidad de Barcelona (UB), 5 julio 2019. Hospital Clínico de Barcelona.
The maturation of genomic technologies has enabled new
discoveries in disease pathogenesis as well as new approaches to patient care.
In pediatric oncology, patients may now receive individualized genomic analysis to identify molecular aberrations of relevance for diagnosis and/or treatment.
Several recent clinical studies have begun to explore the feasibility and utility of genomics-driven precision medicine.
1) The document discusses precision medicine in cancer treatment, which is a medical model that takes into account individual variability in genes, lifestyle, and environment to tailor treatment for each patient.
2) Precision medicine aims to improve cancer treatment outcomes by using biomarkers and genetic/molecular analysis to identify the specific causes of a patient's cancer and select targeted therapies.
3) This approach could help increase survival rates, reduce side effects, and improve overall treatment efficacy compared to traditional one-size-fits-all cancer care.
Robert C. Shepard has extensive experience in cancer research and clinical oncology spanning over 40 years. He received his MD from Duke University and has held academic and clinical positions at several prestigious institutions. Currently, he works as a consultant in oncology drug development and clinical trials. He has led numerous clinical trials for both pharmaceutical and biotech companies and has published extensively in peer-reviewed journals. His expertise includes all phases of clinical trial design and implementation.
This document summarizes an abstract from a scientific conference on predictive, preventive and personalized medicine. The abstract describes a study that investigated the role of the enzyme indoleamine 2,3-dioxygenase (IDO) in a mouse model of gingivitis. The study hypothesized that IDO plays a key role in regulating immune and inflammatory responses in gingivitis. The researchers used a multilevel diagnostic approach including medical imaging, multi-omics analysis and subcellular imaging to develop predictive and prognostic biomarker panels to improve individual outcomes from radioembolization treatment for hepatocellular carcinoma. The integrated market access approach described aims to maximize the value of companion diagnostics used with targeted cancer drugs.
The document discusses value assessment frameworks for cancer therapies developed by the European Society for Medical Oncology (ESMO) and the American Society of Clinical Oncology (ASCO). It describes ESMO's Magnitude of Clinical Benefit Scale (ESMO-MCBS), which provides a relative ranking of clinical benefit for new cancer drugs. Studies applying the ESMO-MCBS found that it supported treatment decisions and aligned with reimbursement decisions. While the ESMO-MCBS provides standardized benefit assessment, it only applies to comparative studies and cannot assess single-arm trials. Overall, the ESMO-MCBS provides an unbiased and standardized approach to quantify the clinical benefit of new cancer treatments.
A slide series to learn and appreciate the importance and the potential of Personalized/Individualized Genomic Medicine. It briefly goes through the idea of biotechnology and the advancements we have made in biology and technology. A series of applications for genomic medicine is then explored, not failing to mention the challenges we have to overcome as well, for the next medical revolution.
A case for personalized medicine is presented.
This document discusses developing a "cardiac moonshot" initiative using precision medicine approaches to more effectively treat heart disease. It outlines how precision medicine considers individual genetic and lifestyle factors. The initiative would leverage technologies like remote monitoring, wearables, and electronic health records to integrate diverse health data. This would allow more personalized treatment and risk prediction. Challenges include standardizing large data collection and educating medical professionals on complex multi-omic data analysis.
Descripción de diversas herramientas para el análisis de datos masivos (Real World Data) de las Comorbilidades en la Historia Clínica Electrónica (HCE). Ponencia invitada en el Summer School de la Universidad de Barcelona (UB), 5 julio 2019. Hospital Clínico de Barcelona.
The maturation of genomic technologies has enabled new
discoveries in disease pathogenesis as well as new approaches to patient care.
In pediatric oncology, patients may now receive individualized genomic analysis to identify molecular aberrations of relevance for diagnosis and/or treatment.
Several recent clinical studies have begun to explore the feasibility and utility of genomics-driven precision medicine.
1) The document discusses precision medicine in cancer treatment, which is a medical model that takes into account individual variability in genes, lifestyle, and environment to tailor treatment for each patient.
2) Precision medicine aims to improve cancer treatment outcomes by using biomarkers and genetic/molecular analysis to identify the specific causes of a patient's cancer and select targeted therapies.
3) This approach could help increase survival rates, reduce side effects, and improve overall treatment efficacy compared to traditional one-size-fits-all cancer care.
This document summarizes a case series of 10 patients who presented with thrombotic microangiopathy associated with intravenous injection of reformulated Opana ER. The patients were treated at the University of Tennessee Medical Center between July 2012 and February 2013. Laboratory findings and clinical characteristics are described for each patient. Treatment included therapeutic plasma exchange for most patients. The total costs of treatment for this group was over $1 million. Reformulated Opana ER has been associated with distinctive thrombotic microangiopathy when injected intravenously, as seen in this case series.
Date held: February 12, 2015
Presented by: Deb Davison, Genomic Health
Topics discussed:
The latest in genomic testing and its role in cancer treatment
The most recent results from Genomic Health’s second independent clinical validation study of Oncotype DX® in DCIS patients
Q&A session about the implications of this research
Hepatocellular carcinoma (HCC) has always been a difficult medical problem for the increasing mortality rate. According to the World Health Organization (WHO), hepatocellular carcinoma (HCC) is the fourth-leading cause of cancer related deaths worldwide [1] and is considered as a highly refractory cancer. Surgery is the most effective treatment to HCC, but HCC is resistant to conventional chemotherapy. In recent years, immunotherapy has been attracting growing attention as a promising therapeutic method to HCC. Immunotherapies to HCC including chimeric antigen receptor T cells (CAR-T), immune checkpoint inhibitor and oncolytic virus have become research hotspots.
This document discusses using data from the Veterans Affairs (VA) healthcare system to conduct precision oncology research. It describes extracting data from the VA Corporate Data Warehouse, including clinical records from cancer registries and records of patients who received tumor sequencing and immunotherapy. The author builds a cohort of 330 non-small cell lung cancer patients who received immunotherapy before 2018 and had their cancer verified in the registry to study outcomes like the impact of PD-L1 expression on response to treatment. Challenges include lag times in cancer registry reporting and building a large enough cohort to draw powerful conclusions from retrospective analyses.
This document contains 23 references related to nausea and vomiting caused by cancer treatment. The references describe research on different antiemetic drugs for preventing chemotherapy-induced nausea and vomiting, including ondansetron, dolasetron, granisetron, metoclopramide, dexamethasone, aprepitant, palonosetron, netupitant, and rolapitant. Many of the references are randomized controlled trials that compare the efficacy of different antiemetic combinations in reducing nausea and vomiting from chemotherapy. The references also include guidelines on managing chemotherapy-induced nausea and vomiting from cancer organizations.
ciclo autonomico-short paper - Witfor 2016 paper_42.. ..
This paper presents an ongoing project to develop a biocomputational platform to analyze genomic data from cancer patients and bacteria in Costa Rica. The platform will integrate genomic data processing, prediction of drug sensitivity, and identification of new therapeutic targets. It will use pattern recognition techniques and mathematical models on genomic and drug response data to predict personalized therapy. Preliminary results include databases to store cancer and bacteria genomic data, and tools for exploring relationships between genomic features and drug responses. The platform aims to help identify optimal personalized treatments to overcome drug resistance in cancer and bacterial infections.
This document outlines the rationale, objectives, hypotheses, study design, and planned analyses for investigating the potential association between calcium channel blocker (CCB) use and cancer risk. The study will be conducted using multiple epidemiological databases from the UK, Denmark, Netherlands, Spain, and Germany. The specific objectives are to conduct descriptive studies, a population-based cohort study, and nested case-control analyses to compare cancer outcomes between CCB users and non-users. The primary outcome of interest is risk of all cancers combined, and secondary outcomes include breast, prostate, and colon cancers analyzed separately.
Ultrasound Technology as a Novel Treatment Strategy in Pancreatic Cancer_Crim...CrimsonpublishersCancer
Adenocarcinoma of the pancreas (PDAC) accounts for 2.4% of all cancers diagnosed and is the fourth leading cause of cancer death, with almost equal rates of incidence and mortality [1]. By 2030, pancreatic cancer is projected to be the second leading cause of cancer-related death [2], surpassing breast, prostate and colorectal cancer. The overall survival at 5 years of around 7.2% as the majority of patients present with advanced disease at diagnosis. Patients with localized disease are treated with surgery, with or without neoadjuvant chemotherapy/ radiotherapy, followed by adjuvant chemotherapy. The majority (around 80%) of patients are treated only with chemotherapy as they have an advanced disease. Patients are treated in the first line with gemcitabine-abraxane or Folfirinox and with Naliri plus 5FU in the second line. There have been few clinical advances in PDAC treatment over the last 20 years and chemotherapy is the only treatment option available for the majority of patients. These tumours are also resistant to many targeted therapies such as anti-EGFR therapy like cetuximab [3] due to the presence of a KRAS mutation in the majority of primary tumors. Personalized medicine strategies have not yet been established in pancreatic cancer as in other more common tumour types. Thus, novel anti-tumour strategies are an important clinical need in order to improve survival rates.
Please share this webinar with anyone who may be interested!
Watch all our webinars: https://www.youtube.com/playlist?list=PL4dDQscmFYu_ezxuxnAE61hx4JlqAKXpR
Cancer care is increasingly tailored to individual patients, who can undergo genetic or biomarker testing soon after diagnosis, to determine which treatments have the best chance of shrinking or eliminating tumours.
In this webinar, a pathologist and clinical oncologist discuss:
● how they are using these new tests,
● how they communicate results and treatment options to patients and caregivers, and
● how patients can be better informed on the kinds of tests that are in development or in use across Canada
View the video: https://youtu.be/_Wai_uMQKEQ
Follow our social media accounts:
Twitter - https://twitter.com/survivornetca
Facebook - https://www.facebook.com/CanadianSurvivorNet
Pinterest - https://www.pinterest.com/survivornetwork
YouTube - https://www.youtube.com/user/Survivornetca
This document discusses personalized medicine, which aims to provide the right treatment for each individual patient based on their genetic profile. It defines personalized medicine as tailoring medical treatment to each patient's characteristics, needs and preferences. The development of genomic sequencing allows for more precise treatment by understanding how genetic variations impact drug metabolism and response. Pharmacogenomics studies how DNA and RNA variations affect drug effectiveness. Implementing personalized medicine through genetic testing can help reduce disease burden by improving prevention, treatment and healthcare costs while minimizing risks.
With recent advances in Healthcare, Personalized medicine has become a buzzword. The customization of health care, based on DNA sequencing, patient's environmental information, can lead to more efficient treatments.
By integrating various sources of data, personalized medicine improves all aspects of healthcare from prevention to monitoring.
Cancer testis antigens and NY-BR-1 expression in primary breast cancer: prog...Enrique Moreno Gonzalez
Cancer–testis antigens (CTA) comprise a family of proteins, which are physiologically expressed in adult human tissues solely in testicular germ cells and occasionally placenta. However, CTA expression has been reported in various malignancies. CTAs have been identified by their ability to elicit autologous cellular and or serological immune responses, and are considered potential targets for cancer immunotherapy. The breast differentiation antigen NY-BR-1, expressed specifically in normal and malignant breast tissue, has also immunogenic properties. Here we evaluated the expression patterns of CTAs and NY-BR-1 in breast cancer in correlation to clinico-pathological parameters in order to determine their possible impact as prognostic factors.
This document summarizes recent advances in the treatment of colorectal cancer from the perspective of a medical oncologist. It highlights how genetic testing of both patients and tumors is important for precision medicine approaches. It also discusses the heterogeneity of colorectal cancers and the various treatment options now available including targeted therapies and immunotherapy. The talk emphasizes the importance of clinical trials in advancing the management of colorectal cancer.
The document summarizes the activities of the Experimental Therapeutics program at an annual retreat. It discusses the program's aims of identifying new drug targets and mechanisms of drug resistance. It provides an overview of clinical trials and preclinical research underway, including studies on cell cycle targets, drug sensitivity and resistance, and novel cancer therapeutics. The document also reviews funding, publications, and plans to renew the program's P30 grant.
Gemcitabine and Cisplatin In Metastatic Carcinoma Gallbladder. A Single Insti...iosrjce
IOSR Journal of Dental and Medical Sciences is one of the speciality Journal in Dental Science and Medical Science published by International Organization of Scientific Research (IOSR). The Journal publishes papers of the highest scientific merit and widest possible scope work in all areas related to medical and dental science. The Journal welcome review articles, leading medical and clinical research articles, technical notes, case reports and others.
This document discusses advances in personalized cancer treatment and improving patient quality of life. It outlines goals of anti-cancer therapy including maximizing survival, treating symptoms, and improving quality of life. Studies show quality of life scores can predict survival, and improvements in physical functioning correlate with better outcomes. Targeted and precision therapies are highlighted like treatments for EGFR mutations in lung cancer and BRAF mutations in melanoma. Challenges in developing precision medicines are addressed, but new technologies are making genome sequencing cheaper and more accessible to guide individual treatment.
MolMed NGRhTNF ASCO New Data Show Significantly Extended Survivalsocial_molmed
- A Phase III trial of 400 patients with malignant pleural mesothelioma found that treatment with NGR-hTNF in combination with chemotherapy led to a 40% improvement in overall survival and progression-free survival compared to chemotherapy alone.
- Survival times were particularly improved for patients who received at least three months of NGR-hTNF therapy, with a median survival of 16.5 months compared to 9.8 months for the control group.
- Additional Phase II trials found NGR-hTNF improved survival rates when combined with chemotherapy for sarcoma and ovarian cancer patients.
Precision Medicine in Oncology InformaticsWarren Kibbe
Precision medicine in oncology aims to provide targeted cancer treatments based on a patient's individual tumor characteristics. The presentation discusses precision oncology initiatives including NCI-MATCH clinical trials which assign cancer therapies based on a tumor's molecular abnormalities rather than location. It outlines plans to expand genomically-based cancer trials, understand and overcome treatment resistance through molecular analysis, and establish a national cancer database integrating genomic and clinical data to accelerate cancer research. Cloud computing platforms are being developed to provide researchers access to large cancer genomic and clinical datasets. The goal is to advance precision cancer treatment by incorporating individual patient genetics and biomarkers into therapeutic decision making.
Scott W. Baumgartner is a rheumatologist and clinical researcher with extensive experience leading clinical trials and medical affairs functions at pharmaceutical companies. He has held roles such as Vice President of Medical Affairs and Clinical Research & Development at Ardea Biosciences and Amgen, where he oversaw global clinical development programs and medical evidence generation activities. Currently, he works as an independent consultant providing advice to pharmaceutical companies on various healthcare issues.
Tony Lockett has over 25 years of experience in the pharmaceutical and medical devices industry. He has acted as a consultant advising clients on regulatory and clinical strategies, and has also acted as Chief Medical Officer for an AIM-listed company. Currently, through his company, he is co-developing re-positioned and re-profiled medical products.
This document summarizes a case series of 10 patients who presented with thrombotic microangiopathy associated with intravenous injection of reformulated Opana ER. The patients were treated at the University of Tennessee Medical Center between July 2012 and February 2013. Laboratory findings and clinical characteristics are described for each patient. Treatment included therapeutic plasma exchange for most patients. The total costs of treatment for this group was over $1 million. Reformulated Opana ER has been associated with distinctive thrombotic microangiopathy when injected intravenously, as seen in this case series.
Date held: February 12, 2015
Presented by: Deb Davison, Genomic Health
Topics discussed:
The latest in genomic testing and its role in cancer treatment
The most recent results from Genomic Health’s second independent clinical validation study of Oncotype DX® in DCIS patients
Q&A session about the implications of this research
Hepatocellular carcinoma (HCC) has always been a difficult medical problem for the increasing mortality rate. According to the World Health Organization (WHO), hepatocellular carcinoma (HCC) is the fourth-leading cause of cancer related deaths worldwide [1] and is considered as a highly refractory cancer. Surgery is the most effective treatment to HCC, but HCC is resistant to conventional chemotherapy. In recent years, immunotherapy has been attracting growing attention as a promising therapeutic method to HCC. Immunotherapies to HCC including chimeric antigen receptor T cells (CAR-T), immune checkpoint inhibitor and oncolytic virus have become research hotspots.
This document discusses using data from the Veterans Affairs (VA) healthcare system to conduct precision oncology research. It describes extracting data from the VA Corporate Data Warehouse, including clinical records from cancer registries and records of patients who received tumor sequencing and immunotherapy. The author builds a cohort of 330 non-small cell lung cancer patients who received immunotherapy before 2018 and had their cancer verified in the registry to study outcomes like the impact of PD-L1 expression on response to treatment. Challenges include lag times in cancer registry reporting and building a large enough cohort to draw powerful conclusions from retrospective analyses.
This document contains 23 references related to nausea and vomiting caused by cancer treatment. The references describe research on different antiemetic drugs for preventing chemotherapy-induced nausea and vomiting, including ondansetron, dolasetron, granisetron, metoclopramide, dexamethasone, aprepitant, palonosetron, netupitant, and rolapitant. Many of the references are randomized controlled trials that compare the efficacy of different antiemetic combinations in reducing nausea and vomiting from chemotherapy. The references also include guidelines on managing chemotherapy-induced nausea and vomiting from cancer organizations.
ciclo autonomico-short paper - Witfor 2016 paper_42.. ..
This paper presents an ongoing project to develop a biocomputational platform to analyze genomic data from cancer patients and bacteria in Costa Rica. The platform will integrate genomic data processing, prediction of drug sensitivity, and identification of new therapeutic targets. It will use pattern recognition techniques and mathematical models on genomic and drug response data to predict personalized therapy. Preliminary results include databases to store cancer and bacteria genomic data, and tools for exploring relationships between genomic features and drug responses. The platform aims to help identify optimal personalized treatments to overcome drug resistance in cancer and bacterial infections.
This document outlines the rationale, objectives, hypotheses, study design, and planned analyses for investigating the potential association between calcium channel blocker (CCB) use and cancer risk. The study will be conducted using multiple epidemiological databases from the UK, Denmark, Netherlands, Spain, and Germany. The specific objectives are to conduct descriptive studies, a population-based cohort study, and nested case-control analyses to compare cancer outcomes between CCB users and non-users. The primary outcome of interest is risk of all cancers combined, and secondary outcomes include breast, prostate, and colon cancers analyzed separately.
Ultrasound Technology as a Novel Treatment Strategy in Pancreatic Cancer_Crim...CrimsonpublishersCancer
Adenocarcinoma of the pancreas (PDAC) accounts for 2.4% of all cancers diagnosed and is the fourth leading cause of cancer death, with almost equal rates of incidence and mortality [1]. By 2030, pancreatic cancer is projected to be the second leading cause of cancer-related death [2], surpassing breast, prostate and colorectal cancer. The overall survival at 5 years of around 7.2% as the majority of patients present with advanced disease at diagnosis. Patients with localized disease are treated with surgery, with or without neoadjuvant chemotherapy/ radiotherapy, followed by adjuvant chemotherapy. The majority (around 80%) of patients are treated only with chemotherapy as they have an advanced disease. Patients are treated in the first line with gemcitabine-abraxane or Folfirinox and with Naliri plus 5FU in the second line. There have been few clinical advances in PDAC treatment over the last 20 years and chemotherapy is the only treatment option available for the majority of patients. These tumours are also resistant to many targeted therapies such as anti-EGFR therapy like cetuximab [3] due to the presence of a KRAS mutation in the majority of primary tumors. Personalized medicine strategies have not yet been established in pancreatic cancer as in other more common tumour types. Thus, novel anti-tumour strategies are an important clinical need in order to improve survival rates.
Please share this webinar with anyone who may be interested!
Watch all our webinars: https://www.youtube.com/playlist?list=PL4dDQscmFYu_ezxuxnAE61hx4JlqAKXpR
Cancer care is increasingly tailored to individual patients, who can undergo genetic or biomarker testing soon after diagnosis, to determine which treatments have the best chance of shrinking or eliminating tumours.
In this webinar, a pathologist and clinical oncologist discuss:
● how they are using these new tests,
● how they communicate results and treatment options to patients and caregivers, and
● how patients can be better informed on the kinds of tests that are in development or in use across Canada
View the video: https://youtu.be/_Wai_uMQKEQ
Follow our social media accounts:
Twitter - https://twitter.com/survivornetca
Facebook - https://www.facebook.com/CanadianSurvivorNet
Pinterest - https://www.pinterest.com/survivornetwork
YouTube - https://www.youtube.com/user/Survivornetca
This document discusses personalized medicine, which aims to provide the right treatment for each individual patient based on their genetic profile. It defines personalized medicine as tailoring medical treatment to each patient's characteristics, needs and preferences. The development of genomic sequencing allows for more precise treatment by understanding how genetic variations impact drug metabolism and response. Pharmacogenomics studies how DNA and RNA variations affect drug effectiveness. Implementing personalized medicine through genetic testing can help reduce disease burden by improving prevention, treatment and healthcare costs while minimizing risks.
With recent advances in Healthcare, Personalized medicine has become a buzzword. The customization of health care, based on DNA sequencing, patient's environmental information, can lead to more efficient treatments.
By integrating various sources of data, personalized medicine improves all aspects of healthcare from prevention to monitoring.
Cancer testis antigens and NY-BR-1 expression in primary breast cancer: prog...Enrique Moreno Gonzalez
Cancer–testis antigens (CTA) comprise a family of proteins, which are physiologically expressed in adult human tissues solely in testicular germ cells and occasionally placenta. However, CTA expression has been reported in various malignancies. CTAs have been identified by their ability to elicit autologous cellular and or serological immune responses, and are considered potential targets for cancer immunotherapy. The breast differentiation antigen NY-BR-1, expressed specifically in normal and malignant breast tissue, has also immunogenic properties. Here we evaluated the expression patterns of CTAs and NY-BR-1 in breast cancer in correlation to clinico-pathological parameters in order to determine their possible impact as prognostic factors.
This document summarizes recent advances in the treatment of colorectal cancer from the perspective of a medical oncologist. It highlights how genetic testing of both patients and tumors is important for precision medicine approaches. It also discusses the heterogeneity of colorectal cancers and the various treatment options now available including targeted therapies and immunotherapy. The talk emphasizes the importance of clinical trials in advancing the management of colorectal cancer.
The document summarizes the activities of the Experimental Therapeutics program at an annual retreat. It discusses the program's aims of identifying new drug targets and mechanisms of drug resistance. It provides an overview of clinical trials and preclinical research underway, including studies on cell cycle targets, drug sensitivity and resistance, and novel cancer therapeutics. The document also reviews funding, publications, and plans to renew the program's P30 grant.
Gemcitabine and Cisplatin In Metastatic Carcinoma Gallbladder. A Single Insti...iosrjce
IOSR Journal of Dental and Medical Sciences is one of the speciality Journal in Dental Science and Medical Science published by International Organization of Scientific Research (IOSR). The Journal publishes papers of the highest scientific merit and widest possible scope work in all areas related to medical and dental science. The Journal welcome review articles, leading medical and clinical research articles, technical notes, case reports and others.
This document discusses advances in personalized cancer treatment and improving patient quality of life. It outlines goals of anti-cancer therapy including maximizing survival, treating symptoms, and improving quality of life. Studies show quality of life scores can predict survival, and improvements in physical functioning correlate with better outcomes. Targeted and precision therapies are highlighted like treatments for EGFR mutations in lung cancer and BRAF mutations in melanoma. Challenges in developing precision medicines are addressed, but new technologies are making genome sequencing cheaper and more accessible to guide individual treatment.
MolMed NGRhTNF ASCO New Data Show Significantly Extended Survivalsocial_molmed
- A Phase III trial of 400 patients with malignant pleural mesothelioma found that treatment with NGR-hTNF in combination with chemotherapy led to a 40% improvement in overall survival and progression-free survival compared to chemotherapy alone.
- Survival times were particularly improved for patients who received at least three months of NGR-hTNF therapy, with a median survival of 16.5 months compared to 9.8 months for the control group.
- Additional Phase II trials found NGR-hTNF improved survival rates when combined with chemotherapy for sarcoma and ovarian cancer patients.
Precision Medicine in Oncology InformaticsWarren Kibbe
Precision medicine in oncology aims to provide targeted cancer treatments based on a patient's individual tumor characteristics. The presentation discusses precision oncology initiatives including NCI-MATCH clinical trials which assign cancer therapies based on a tumor's molecular abnormalities rather than location. It outlines plans to expand genomically-based cancer trials, understand and overcome treatment resistance through molecular analysis, and establish a national cancer database integrating genomic and clinical data to accelerate cancer research. Cloud computing platforms are being developed to provide researchers access to large cancer genomic and clinical datasets. The goal is to advance precision cancer treatment by incorporating individual patient genetics and biomarkers into therapeutic decision making.
Scott W. Baumgartner is a rheumatologist and clinical researcher with extensive experience leading clinical trials and medical affairs functions at pharmaceutical companies. He has held roles such as Vice President of Medical Affairs and Clinical Research & Development at Ardea Biosciences and Amgen, where he oversaw global clinical development programs and medical evidence generation activities. Currently, he works as an independent consultant providing advice to pharmaceutical companies on various healthcare issues.
Tony Lockett has over 25 years of experience in the pharmaceutical and medical devices industry. He has acted as a consultant advising clients on regulatory and clinical strategies, and has also acted as Chief Medical Officer for an AIM-listed company. Currently, through his company, he is co-developing re-positioned and re-profiled medical products.
This document provides biographical and professional information about Richard L. McKnight, Pharm.D. It includes his contact information, education history, professional experience since 1999 as a critical care clinical specialist at West Virginia University Hospitals, publications, presentations, and committee/protocol work primarily related to critical care pharmacy.
Dr Paul Cornes has received salary from the UK National Health Service and honoraria from several pharmaceutical companies including Roche, Janssen, Sandoz, Lilly, European Generics Association, Teva, and Hospira. The document discusses the increasing cost of cancer drugs and argues that greater use of generics and biosimilars can help contain costs while maintaining treatment effectiveness. It provides examples showing that in the US, increased generic drug use has saved over $1 trillion in healthcare costs in the past decade through lower prices.
The document discusses the benefits of a multi-disciplinary diabetes centre model of care compared to other models. A diabetes centre provides comprehensive care through a team that includes doctors, nurses, dietitians, podiatrists, and other specialists. This coordinated model results in better screening and management of complications, standardized processes, shorter wait times, and more flexibility compared to a clinic-based model with rotating doctors. The author argues the centre model can better serve the complex needs of people with diabetes.
This document discusses Dr. Paul Cornes and his presentation on affordable cancer treatment in Malaysia. It notes that Dr. Cornes has received salary from the UK National Health Service and honoraria from several pharmaceutical companies. The document then discusses evidence that the radiosensitivity of normal tissues may change during the day, with studies finding less toxicity for head and neck cancer patients receiving morning radiation. It advocates researching existing cheaper drugs and educating patients and doctors about value in cancer care.
The benefits of patient involvement in research and development (RE:ACT Congr...jangeissler
This document discusses the benefits of patient involvement in health research and development. It notes that innovation is transforming lives but more breakthroughs are still needed. Patients can provide unique perspectives to improve trial design and address unmet needs. However, public distrust and lack of knowledge limit patient participation in research. The document advocates for greater patient involvement at all stages of research, from setting priorities to disseminating results. It highlights the EUPATI initiative which aims to educate patients and the public about medicines research through training courses, educational tools, and national platforms. The goal is empowering patients as partners in research.
This document provides the professional summary and background of Lindsay Craik, a senior medical writer with over 20 years of experience in medical writing across various healthcare markets. She has extensive therapeutic area experience and capabilities in areas such as medical writing, continuing medical education, pharmaceutical advertising, and promotional copywriting. Her background includes experience as a freelance medical writer and in senior medical writing roles for pharmaceutical companies.
This document provides biographical and professional information about Adam DiPippo. It summarizes his education, including pharmacy residency training and clinical rotations. It also outlines his professional experience as a pharmacist at MD Anderson Cancer Center and previous positions. Finally, it lists leadership experience, research activities, and presentations given.
A Catalyst For Transforming Health Systems And Person-Centred Care Canadian ...Becky Gilbert
This document presents a Canadian national position statement on patient-reported outcomes (PROs) from a steering committee of PRO experts.
The key points are:
1. PROs capture the patient perspective on health and quality of life and can improve care, but their use is not consistent in Canada. This position statement aims to support greater PRO implementation.
2. The position statement was developed through an expert consensus process and stakeholder feedback. It contains recommendations in 4 areas: patients and families, health policy, clinical implementation, and research.
3. The overarching recommendations are that resources should be invested to integrate PROs into care, a national PRO body is needed for guidance, and PRO tools must
Paul Coplan, VP, Johnson & Johnson_mHealth IsraelLevi Shapiro
Pesentation, October 19th, 2021: What’s Next in RWE for Medical Devices: The Art of the Possible. Presented by Paul Coplan, ScD, MBA, FISPE, Vice President, Med Device Epidemiology and RWD Sciences, Johnson & Johnson; Adjunct Professor, Department of Biostatistics, Epidemiology and Informatics, University of Pennsylvania, Perelman School of Medicine; Fellow of the International Society of Pharmacoepidemiology
- Why RWE is Important for Medical Devices: Challenges with Clinical Trials of Medical Devices (Blinding, Surgeon skill/technique, Hospital process, Product modifications, Long term Follow up, Enrolment challenges)
- Types of Real-World Data Sources (Complaints like MAUDE, Eudramed and Company Databases, Hospital Databases, Electronic Health Records, Claims, Registries, Patient surveys, Surgeon surveys, PROs, Patient Preferences, wearables, sensors, social media, Surgical videos, device generated data, radiographic images)
- FDA CDRH Report on RWE Examples for Regulatory Decisions
- J&J Med Device Epidemiology & Real-World Data Sciences
- US National Evaluation System for Health Technology (NEST)
- RWE for Safety Assessments: Cobalt in Implants and at Work and Risk of Cancer
- Summary of Cobalt Exposure and All-Site Cancer Risk, by Study Type
- Comparative Effectiveness Studies Using RWE
- Summary
a. Use of RWE is important to benefit patients globally and enhance the safety and innovation of medical devices
b. Regulators are interested in using RWE for regulatory decisions but data quality and evidence needs to be regulatory grade
c. NEST has been a useful forum to advance the use of RWE for regulatory decisions in the US
d. RWE can be used for safety assessments, regulatory decisions, comparative effectiveness research, and R&D of products
The document discusses various perspectives on health literacy and patient education. It addresses:
1) The clinician viewpoint that patient education improves compliance and outcomes, though patients and doctors often differ in their risk/benefit perceptions.
2) Health literacy, defined as people's ability to obtain, understand, and apply health information to make appropriate decisions.
3) Ways to improve health literacy through organizations like SEPAR that promote education activities for patients and encourage their participation in scientific meetings.
Cancer survival mortality_and_incidence_7_countries_1568689974RamiroCazco2
This study analyzed cancer survival, incidence, and mortality trends for seven cancers in seven high-income countries between 1995-2014 using data from 21 population-based cancer registries. The study found that 1-year and 5-year cancer survival increased across almost all cancer types and countries over this period. Survival was generally higher in Australia, Canada, and Norway than other countries for 2010-2014. Larger survival improvements were seen for younger patients and for cancers with poor prognosis like esophagus, stomach, pancreas, and lung. Progress in cancer control was evident for stomach, colon, lung (males), and ovarian cancers, as shown by increased survival and decreased mortality and incidence over time. However, international survival disparities
- Cardiovascular disease is the leading cause of death in Canada, and high blood pressure is the number one modifiable risk factor. However, many Canadians are unaware they have high blood pressure or it is not adequately controlled.
- The document outlines a strategy to improve hypertension management in Canada through initiatives targeted at primary healthcare providers and patients. It involves developing and testing education and management tools.
- An evaluation of the initial pilot phase found improvements in screening, diagnosis and control of high blood pressure among participating providers and patients compared to non-participants. Most providers also reported the strategy was effective and positively impacted their management of hypertensive patients.
Weight loss among patients with Head and Neck Cancer at St Vincent's Hospital...Cancer Institute NSW
Patients with Squamous cell carcinoma (SCC) of the Head and Neck (H&N) are often treated with curative intent using treatment protocols placing them at high risk of nutritional decline. Recently released COSA guidelines recommend that prophylactic enteral feeding should be considered for T4 upper aerodigestive tract tumours undergoing concurrent chemoradiotherapy. Evidence is yet to identify optimal method of nutrition intervention and timing across all tumour stages in this population.
This document discusses the importance of clinical trials for developing new medicines and treatments. It notes that clinical trials contribute to scientific advances in areas like cancer genomics and new drug technologies. However, clinical trial activity has been lower in Greece compared to similar EU countries due to inadequate regulatory and administrative support. The document advocates for partnerships between government and industry to improve the clinical trial environment and facilitate access to innovative medicines. It outlines Roche's investments in clinical trials and new cancer treatments in Greece.
- The document discusses treatments and costs for recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) in the Netherlands.
- 125 patients received palliative, non-trial first-line systemic treatment for R/M SCCHN between 2006-2013, with the most common treatments being platinum + 5FU + cetuximab (32%), methotrexate monotherapy (27%), and capecitabine monotherapy (14%).
- Median progression-free survival was 3.4 months and median overall survival was 6.0 months. 27% of patients experienced severe adverse events. Mean total hospital costs ranged from €10,075 to €
Pharmacology Forever ! has been set as a meeting in recognition of Frits Peters tremendous involvement in pharmacology. This presentation discusses latest drug development methods and is illustrated by exemple of new drugs and target in oncology.
This document provides information about Dr. Paul Cornes and his work in oncology. It discloses that Dr. Cornes receives a salary from the UK National Health Service and has received honoraria from several pharmaceutical companies. The bulk of the document discusses the costs of cancer to individuals and societies and highlights both challenges and areas of progress in cancer treatment, including improved survival rates due to innovations in targeted therapies and monoclonal antibodies.
1. JULIA BALFOUR CV SEP 2015
JULIA ANNE BALFOUR
MEDICAL WRITER/CONSULTANT
Address: 28 Cortachy Crescent, Broughty Ferry, Dundee DD5 3BF, United
Kingdom
Phone +44 1382 731 622 Email: juliabalfour1@btinternet.com
Website: http://www.northstarmedwrite.com/
• UK-based freelance medical writer & editor (Manuscript specialist)
• > 20 years medical writing & technical editing experience (Medical Publishers/ Med
Comms Agencies/ Pharma Industry/ Freelance)
• Proven publishing success: author of > 50 publications, including state of the art
reviews (see appendix for extensive bibliography)
• Extensive experience providing editorial support for leading research teams worldwide
• Specialist ‘Manuscript Doctor’ service offered, as well as abridging & repurposing
• Excellent clinical knowledge (ex-Hospital Pharmacist)
NATIONALITY: Dual Citizenship: British/New Zealand (Native English Speaker)
QUALIFICATION: Bachelor of Science in Pharmacy – Honours, Upper Second Class (Heriot Watt University,
Edinburgh)
MEMBERSHIP: European Medical Writers Association
Therapeutic/Specialist areas
• Oncology (targeted agents and
supportive care)
• Haematology
• Nephrology, Urology
• Endocrinology/metabolism (especially
diabetes), rare diseases
• Infectious diseases
• Experience across all major therapeutic
areas
• Health Economics
Types of projects undertaken
• Primary Manuscripts & Review articles*
• Editing and Publication Support*
• Rewriting (‘Manuscript Doctor’), Abridging,
Repurposing*
• Development of new article types
• Bulletins, Newsletters
• Abstracts, Posters, Slidesets
• Monographs, Dossiers,Textbooks
*see bibliography
1
2. JULIA BALFOUR CV SEP 2015
MEDICAL WRITING CAREER SUMMARY
Title Date Role
Freelance Medical Writer Jul 2007-
continuing
Writing/editing manuscripts with
Research Groups and Pharma
companies; support with publication
process
Principal Medical Writer (Temp contract)
Amgen GmbH, Zug, Switzerland
Feb 2006-Jun 07 Liaising with KOLs to develop and edit
manuscripts and conference abstracts
for 6 Amgen product teams
Freelance Medical Writer Nov 2003-Dec
2005
Various writing projects as required
Editorial Projects Manager (Temp contract)
Adelphi Communications Ltd, Macclesfield, UK
May 2003-Nov
2003
Medical Writer (Temp contract)
Gardiner-Caldwell Communications, Macclesfield, UK
Aug 2002-Apr
2003
Manuscript writing; planning/slide
development for standalone meeting
Freelance Medical Writer Jan 2000-April
2002
Drug reviews; Newsletter reports
Various positions, Adis International, Auckland, New Zealand:
• Senior Medical Writer, Scientific Writing Group
• Managing Editor (Drug Evaluations), Disease
Management & Health Outcomes journal
• Associate Editor/Medical Writer, Scientific Writing
Group
• Associate Managing Editor, Literature Monitoring
Service (LMS)
• Associate Editor, LMS
1988-99
Apr 1993-Dec 1999
Dec 1996-Jun 1998
June 1989-Apr
1993
April 1989-June
1989
May 1988-April
1989
Developing/editing state-of-the art
review manuscripts for Adis/Springer
Journals (Drugs, Pharmacoeconomics,
Drugs in Aging etc);
Technical editing of contributed
manuscripts/conference material;
Managing program of review articles;
Writing reports for Newsletters (e.g.
Inpharma, GP Weekly) and summaries
for LMS;
Custom projects as required
PHARMACY CAREER SUMMARY
• Basic Grade Pharmacist at City Hospital, Edinburgh, Royal Infirmary of Edinburgh and Ninewells Hospital and Medical
School, Dundee, various posts held between 1975 and 1988.
• Locum/temporary work includes Pharmacist/Manager for chain of chemist shops and Staff Pharmacist, Royal Hospital
for Sick Children, Edinburgh.
• Temporary Pharmacist (Section leader), Clinical Trial Supplies, Rorer Health Care (UK) Ltd.
• Pre-Registration Pharmacist, Falkirk Royal Infirmary/City Hospital, Edinburgh.
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3. JULIA BALFOUR CV SEP 2015
APPENDIX (BIBLIOGRAPHY AND FEEDBACK)
Julia Balfour provided editorial support for the following manuscripts:
Oncology and Supportive Care
EBMT Mucositis Advisory Group
• Blijlevens N, Schwenkglenks M, Bacon P et al. Prospective oral mucositis audit: oral
mucositis in patients receiving high-dose melphalan or BEAM conditioning
chemotherapy--European Blood and Marrow Transplantation Mucositis Advisory Group. J
Clin Oncol 2008;26(9): 1519-25.
• Blijlevens N, Sonis S. Palifermin (recombinant keratinocyte growth factor-1): a pleiotropic
growth factor with multiple biological activities in preventing chemotherapy- and
radiotherapy-induced mucositis. Ann Oncol 2007;18(5): 817-26.
• McCann S, Schwenkglenks M, Bacon P, et al. The Prospective Oral Mucositis Audit:
relationship of severe oral mucositis with clinical and medical resource use outcomes in
patients receiving high-dose melphalan or BEAM-conditioning chemotherapy and
autologous SCT. Bone Marrow Transplant 2009;43(2):141-7.
SAKK Group
• Helbling, D., G. Bodoky, et al. Neoadjuvant chemoradiotherapy with or without
panitumumab in patients with wild-type KRAS, locally advanced rectal cancer (LARC): a
randomized, multicenter, phase II trial SAKK 41/07. Annals of Oncology 2013; 24(3): 718-
725.
• Koeberle, D., D. C. Betticher, et al. Bevacizumab continuation versus no continuation
after first-line chemotherapy plus bevacizumab in patients with metastatic colorectal
cancer: a randomized phase III non-inferiority trial (SAKK 41/06). Annals of Oncology:
official journal of the European Society for Medical Oncology / ESMO 2015; 26(4): 709-714.
German Breast Group
• von Minckwitz G, Kummel S, du Bois A et al. Pegfilgrastim +/- ciprofloxacin for primary
prophylaxis with TAC (docetaxel/doxorubicin/cyclophosphamide) chemotherapy for
breast cancer. Results from the GEPARTRIO study. Ann Oncol 2008;19(2): 292-8.
• Loibl, S., A. Schmidt, et al. (2015). Breast Cancer Diagnosed During Pregnancy: Adapting
Recent Advances in Breast Cancer Care for Pregnant Patients. JAMA oncology. DOI
10.1001/jamaoncol.2015.2413
Other authors
• Pettengell R. Advanced-stage follicular lymphoma in the rituximab era: when should
patients receive anthracycline-based chemotherapy? Drugs 2009;69(13):1727-37.
• Pettengell R, Aapro M, Brusamolino E, et al. Implications of the European Organisation for
Research And Treatment Of Cancer (EORTC) guidelines on the use of granulocyte colony-
stimulating factor (G-CSF) for lymphoma care. Clin Drug Investig 2009;29(8):491-513.
• Aapro M, Crawford J, Kamioner D: Prophylaxis of chemotherapy-induced febrile
neutropenia with granulocyte colony-stimulating factors: where are we now? Support
Care Cancer 2010;18:529-41
• Pradelli, L., K. Mayer, et al. n-3 fatty acid-enriched parenteral nutrition regimens in elective
surgical and ICU patients: a meta-analysis. Critical Care 2012; 16(5): R184.
• Hitz, F., K. Ribi, et al. Predictors of satisfaction with treatment decision, decision-making
preferences, and main treatment goals in patients with advanced cancer. Support Care
Cancer 2013; 21(11): 3085-3093.
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4. JULIA BALFOUR CV SEP 2015
• Kunstfeld, R. Smoothened inhibitors in the treatment of advanced basal cell carcinomas.
Curr Opin Oncol 2014; 26(2): 184-195. (editorial)
Haematology
• Newland, A. Romiplostim – A Thrombopoiesis-stimulating Peptibody for the Management
of Chronic Immune Thrombocytopenic Purpura in Adults. Eur Haematol 2008;2(1):48-51.
Available at. http://www.touchoncology.com/articles/romiplostim-thrombopoiesis-
stimulating-peptibody-management-chronic-immune-thrombocytopen-0
• Molineux G, Newland A: Development of romiplostim for the treatment of patients with
chronic immune thrombocytopenia: from bench to bedside. Br J Haematol.
• Stasi R, Newland A, Thornton P, Pabinger I. Should medical treatment options be
exhausted before splenectomy is performed in adult ITP patients? A debate. Ann Hematol.
2010;89(12):1185-95.
• Rodeghiero, F. and M. Ruggeri, Short- and long-term risks of splenectomy for benign
haematological disorders: should we revisit the indications? British Journal of
Haematology, 2012;158(1): 16-29.
• Rodeghiero, F., R. Stasi, et al. (2013). Long-term safety and tolerability of romiplostim in
patients with primary immune thrombocytopenia: a pooled analysis of 13 clinical trials.
European Journal of Haematology.
Nephrology
• de Francisco ALM. Medical therapy of secondary hyperparathyroidism in chronic kidney
disease: old and new drugs. Expert Opinion on Pharmacotherapy 2006;7(16): 2215-2224.
• Drueke T, Martin D, Rodriguez M. Can calcimimetics inhibit parathyroid hyperplasia?
Evidence from preclinical studies. Nephrol Dial Transplant 2007;22(7): 1828-39.
• Vervloet M, Bencova V Malberti F, Ashman N, Os I, Saha H, Ureña P, Zitt E, Leavey S, Rix
M, Ryba M, Fouque D, Dehmel B, Wheeler T,Jacobson SH. “Real-World” Use of Cinacalcet
for Managing SHPT in Different European Countries: Analysis of Data from the ECHO
Observational Study. Clin Nephrol, 2010. 74(3): p. 198-208.
• Vervloet, M. G., P. W. du Buf-Vereijken, et al. (2013). Cinacalcet for secondary
hyperparathyroidism: from improved mineral levels to improved mortality? Netherlands
Journal of Medicine 71(7): 348-354.
• Frazao, J. M., J. Braun, et al. (2012). Is serum phosphorus control related to parathyroid
hormone control in dialysis patients with secondary hyperparathyroidism? BMC
Nephrology 13: 76.
• Eller, K. and A. R. Rosenkranz (2012). Editorial: Mast cells: subordinates or masterminds
in autoimmunity? Journal of the American Society of Nephrology : JASN 23(12): 1913-
1914.
• Mann J, Kessler M, Villa G et al. Darbepoetin alfa once every 2 weeks for treatment of
anemia in dialysis patients: a combined analysis of eight multicenter trials. Clin Nephrol
2007;67(3): 140-8.
• Mikhail, A. and M. Farouk (2013). Epoetin biosimilars in Europe: five years on. Advances
in Therapy 30(1): 28-40.
• Zitt, E., D. Fouque, et al. Serum phosphorus reduction in dialysis patients treated with
cinacalcet for secondary hyperparathyroidism results mainly from parathyroid hormone
reduction. Clinical Kidney Journal 2013; 6(3): 287-294.
• Hemetsberger, M., R. Oberbauer, et al. EARLIER: an observational study to evaluate the
use of cinacalcet in incident hemodialysis patients with secondary hyperparathyroidism
in daily clinical practice. Wiener medizinische Wochenschrift 2015; Aug 25. [Epub ahead
of print].
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5. JULIA BALFOUR CV SEP 2015
Health Economics
• Khellaf, M., et al., Costs of managing severe immune thrombocytopenia in adults: a
retrospective analysis. Ann Hematol, 2011. 90(4): p. 441-6.
• Iannazzo, S., et al., Cost-effectiveness analysis of LHRH agonists in the treatment of
metastatic prostate cancer in Italy. Value in health: the journal of the International Society
for Pharmacoeconomics and Outcomes Research, 2011. 14(1): p. 80-9.
• Eandi, M., L. Pradelli, et al. (2010). Economic evaluation of cinacalcet in the treatment of
secondary hyperparathyroidism in Italy. PharmacoEconomics 28(11): 1041-1054.
• Lee, D., P. Thornton, et al. (2013). Cost effectiveness of romiplostim for the treatment of
chronic immune thrombocytopenia in Ireland. Applied Health Economics and Health
Policy 11(5): 457-469.
• Pradelli, L., et al., Effectiveness and cost-effectiveness of supplemental glutamine
dipeptide in total parenteral nutrition therapy for critically ill patients: a discrete event
simulation model based on Italian data. International Journal of Technology Assessment
in Health Care, 2012. 28(1): p. 22-8.
• Pradelli, L., K. Mayer, et al. (2012). n-3 fatty acid-enriched parenteral nutrition regimens in
elective surgical and ICU patients: a meta-analysis. Critical care 16(5): R184.
• Pradelli, L., M. Eandi, et al. (2013). Cost-effectiveness of omega-3 fatty acid supplements
in parenteral nutrition therapy in hospitals: A discrete event simulation model. Clinical
nutrition.
Laboratory Science (Proteomics)
• Paulitschke, V., C. Gerner, et al. (2014). Proteome profiling of keratinocytes transforming
to malignancy. Electrophoresis. 36(4): 564-576.
• Paulitschke, V., W. Berger, et al. (2015). Vemurafenib Resistance Signature by Proteome
Analysis Offers New Strategies and Rational Therapeutic Concepts. Molecular Cancer
Therapeutics. 14(3); 1-12.
Chronic Prostatitis
• Rees J, Abrahams M, Doble A, Cooper A, Prostatitis Expert Reference Group (PERG).
Diagnosis and treatment of chronic bacterial prostatitis and chronic prostatitis/chronic
pelvic pain syndrome: a consensus guideline. BJU Int. 2015 Feb 24. doi:
10.1111/bju.13101. [Epub ahead of print]
Manuscripts authored/co-authored by Julia Balfour
• Peeters M, Balfour J, Arnold D: Review article: panitumumab - a fully human anti-EGFR
monoclonal antibody for treatment of metastatic colorectal cancer. Aliment Pharmacol
Ther 2008.
• Siena S, Sartore-Bianchi A, Di Nicolantonio F, Balfour J, Bardelli A. Biomarkers
predicting clinical outcome of epidermal growth factor receptor-targeted therapy in
metastatic colorectal cancer. J Natl Cancer Inst 2009;101(19):1308-24.
• Balfour JA, Benfield P. Cefpodoxime proxetil. An appraisal of its use in antibacterial
cost-containment programmes, as stepdown and abbreviated therapy in respiratory
tract infections. Pharmacoeconomics 1996;10(2): 164-78.
• Balfour JA, Bryson HM, Brogden RN. Imipenem/cilastatin: an update of its antibacterial
activity, pharmacokinetics and therapeutic efficacy in the treatment of serious
infections. Drugs 1996;51(1): 99-136.
• Balfour JA, Buckley MM. Etodolac. A reappraisal of its pharmacology and therapeutic
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6. JULIA BALFOUR CV SEP 2015
use in rheumatic diseases and pain states. Drugs 1991;42(2): 274-99.
• Balfour JA, Clissold SP. Bendazac lysine. A review of its pharmacological properties
and therapeutic potential in the management of cataracts. Drugs 1990;39(4): 575-96.
• Balfour JA, Faulds D. Terbinafine. A review of its pharmacodynamic and
pharmacokinetic properties, and therapeutic potential in superficial mycoses. Drugs
1992;43(2): 259-84.
• Balfour JA, Faulds D. Oral ciprofloxacin: a pharmacoeconomic evaluation of its use in
the treatment of serious infections. Pharmacoeconomics 1993;3(5): 398-421.
• Balfour JA, Faulds D. Repaglinide. Drugs Aging 1998;13(2): 173-80.
• Balfour JA, Figgitt DP. Telithromycin. Drugs 2001;61(6): 815-29; discussion 830-1.
• Balfour JA, Goa KL. Benazepril. A review of its pharmacodynamic and pharmacokinetic
properties, and therapeutic efficacy in hypertension and congestive heart failure. Drugs
1991;42(3): 511-39.
• Balfour JA, Goa KL. Dolasetron. A review of its pharmacology and therapeutic potential
in the management of nausea and vomiting induced by chemotherapy, radiotherapy or
surgery. Drugs 1997;54(2): 273-98.
• Balfour JA, Goa KL. Raloxifene. Drugs Aging 1998;12(4): 335-41; discussion 342.
• Balfour JA, Goa KL. Bendamustine. Drugs 2001;61(5): 631-8; discussion 639-40.
• Balfour JA, Goa KL, Perry CM. Alosetron. Drugs 2000;59(3): 511-8; discussion 519-20.
• Balfour JA, Heel RC. Transdermal estradiol. A review of its pharmacodynamic and
pharmacokinetic properties, and therapeutic efficacy in the treatment of menopausal
complaints. Drugs 1990;40(4): 561-82.
• Balfour JA, Lamb HM. Moxifloxacin: a review of its clinical potential in the management
of community-acquired respiratory tract infections. Drugs 2000;59(1): 115-39.
• Balfour JA, McClellan K. Topical eflornithine. Am J Clin Dermatol 2001;2(3): 197-201;
discussion 202.
• Balfour JA, McTavish D. Transdermal estradiol. A review of its pharmacological profile,
and therapeutic potential in the prevention of postmenopausal osteoporosis. Drugs
Aging 1992;2(6): 487-507.
• Balfour JA, McTavish D. Acarbose. An update of its pharmacology and therapeutic use
in diabetes mellitus. Drugs 1993;46(6): 1025-54.
• Balfour JA, McTavish D, Heel RC. Fenofibrate. A review of its pharmacodynamic and
pharmacokinetic properties and therapeutic use in dyslipidaemia. Drugs 1990;40(2): 260-
90.
• Balfour JA, Plosker GL. Rosiglitazone. Drugs 1999;57(6): 921-30; discussion 931-2.
• Balfour JA, Todd PA, Peters DH. Fleroxacin. A review of its pharmacology and
therapeutic efficacy in various infections. Drugs 1995;49(5): 794-850.
• Balfour JA, Wilde MI. Dorzolamide. A review of its pharmacology and therapeutic
potential in the management of glaucoma and ocular hypertension. Drugs Aging
1997;10(5): 384-403.
• Balfour JA, Wiseman LR. Moxifloxacin. Drugs 1999;57(3): 363-73; discussion 374.
• Coukell AJ, Balfour JA. Levonorgestrel subdermal implants. A review of contraceptive
efficacy and acceptability. Drugs 1998;55(6): 861-87.
• Davis R, Balfour JA. Terbinafine. A pharmacoeconomic evaluation of its use in
superficial fungal infections. Pharmacoeconomics 1995;8(3): 253-69.
• Davis R, Markham A, Balfour JA. Ciprofloxacin. An updated review of its pharmacology,
therapeutic efficacy and tolerability. Drugs 1996;51(6): 1019-74.
• Dooley M, Balfour JA. Ibandronate. Drugs 1999;57(1): 101-8; discussion 109-10.
• Faulds D, Balfour JA, Chrisp P, Langtry HD. Mitoxantrone. A review of its
pharmacodynamic and pharmacokinetic properties, and therapeutic potential in the
chemotherapy of cancer. Drugs 1991;41(3): 400-49.
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7. JULIA BALFOUR CV SEP 2015
• Foster RH, Balfour JA. Estradiol and dydrogesterone. A review of their combined use as
hormone replacement therapy in postmenopausal women. Drugs Aging 1997;11(4): 309-
32.
• Friedel HA, Balfour JA. Tinzaparin. A review of its pharmacology and clinical potential in
the prevention and treatment of thromboembolic disorders. Drugs 1994;48(4): 638-60.
• Gillies PS, Faulds D, Balfour JA, Perry CM. Ganirelix. Drugs 2000;59(1): 107-11;
discussion 112-3.
• Goa KL, Balfour JA. Risedronate. Drugs Aging 1998;13(1): 83-91; discussion 92.
• Goa KL, Balfour JA, Zuanetti G. Lisinopril. A review of its pharmacology and clinical
efficacy in the early management of acute myocardial infarction. Drugs 1996;52(4): 564-
88.
• Hills CJ, Winter SA, Balfour JA. Tolterodine. Drugs 1998;55(6): 813-20; discussion 821-2.
• Langtry HD, Balfour JA. Azithromycin. A review of its use in paediatric infectious
diseases. Drugs 1998;56(2): 273-97.
• Langtry HD, Balfour JA. Glimepiride. A review of its use in the management of type 2
diabetes mellitus. Drugs 1998;55(4): 563-84.
• Lea AP, Bryson HM, Balfour JA. Intracavernous alprostadil. A review of its
pharmacodynamic and pharmacokinetic properties and therapeutic potential in erectile
dysfunction. Drugs Aging 1996;8(1): 56-74.
• Lee CR, Balfour JA. Piroxicam-beta-cyclodextrin. A review of its pharmacodynamic and
pharmacokinetic properties, and therapeutic potential in rheumatic diseases and pain
states. Drugs 1994;48(6): 907-29.
• McClellan KJ, Balfour JA. Eprosartan. Drugs 1998;55(5): 713-8; discussion 719-20.
• Noble S, Balfour JA. Meloxicam. Drugs 1996;51(3): 424-30; discussion 431-32.
• Onrust SV, Lamb HM, Balfour JA. Ofloxacin. A reappraisal of its use in the management
of genitourinary tract infections. Drugs 1998;56(5): 895-928.
• Onrust SV, Lamb HM, Balfour JA. Rituximab. Drugs 1999;58(1): 79-88; discussion 89-90.
• Patel SS, Balfour JA, Bryson HM. Fosfomycin tromethamine. A review of its antibacterial
activity, pharmacokinetic properties and therapeutic efficacy as a single-dose oral
treatment for acute uncomplicated lower urinary tract infections. Drugs 1997;53(4): 637-
56.
• Perry CM, Balfour JA. Didanosine. An update on its antiviral activity, pharmacokinetic
properties and therapeutic efficacy in the management of HIV disease. Drugs 1996;52(6):
928-62.
• Perry CM, Balfour JA. Fomivirsen. Drugs 1999;57(3): 375-80; discussion 381.
• Peters DC, Balfour JA. Tacalcitol. Drugs 1997;54(2): 265-71; discussion 272.
• Wagstaff AJ, Balfour JA. Combination hepatitis a-hepatitis B vaccine. BioDrugs
1997;8(3): 235-9.
• Wagstaff AJ, Balfour JA. Grepafloxacin. Drugs 1997;53(5): 817-24; discussion 825-7.
• Wilde MI, Balfour JA. Gestodene. A review of its pharmacology, efficacy and tolerability
in combined contraceptive preparations. Drugs 1995;50(2): 364-95.
• Wiseman LR, Balfour JA. Ceftibuten. A review of its antibacterial activity,
pharmacokinetic properties and clinical efficacy. Drugs 1994;47(5): 784-808.
• Wiseman LR, Balfour JA. Ciprofloxacin. A review of its pharmacological profile and
therapeutic use in the elderly. Drugs Aging 1994;4(2): 145-73.
• Adkins JC, Balfour JA. Brimonidine. A review of its pharmacological properties and
clinical potential in the management of open-angle glaucoma and ocular hypertension.
Drugs Aging 1998;12(3): 225-41.
• Balfour JA, Fitton A, Barradell LB. Lornoxicam. A review of its pharmacology and
therapeutic potential in the management of painful and inflammatory conditions. Drugs
1996;51(4): 639-57.
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8. JULIA BALFOUR CV SEP 2015
FEEDBACK SAMPLES
[Company X] performance review summary 2006
Julia is widely recognized at [Company X] and by authors and reviewers to be an extremely skilled writer
of manuscripts and review articles. Julia’s writing is of the highest quality and has received comments
from reviewers such as “this is the best written review in this field”. She has an excellent scientific
knowledge and quickly masters a new product/therapeutic area. She very rapidly assimilates new
information and knows how to use it relevantly in her writing. Julia works independently without a lot of
guidance, yet has a good sense of when guidance is needed and appropriately seeks it from team and
authors. She scrutinizes data carefully and does not take things at face value, but rather questions
inconsistencies and thoroughly checks that the data make sense – she adds great value in this capacity
and has detected many errors and flawed analyses that went unnoticed by others. Ensuring quality is
her greatest strength. Julia is very productive; delivering results is also an outstanding strength. She
has also independently driven several projects for the department to help us work faster and smarter.
2. Various emails regarding mucositis review drafted by JB
From Company X
From manager to head office:
We received some really positive comments on the mucositis review that I wanted to share with you.
Julia wrote this and worked directly with the authors through the course of about 4 drafts over 8 months.
As with every piece Julia writes, her superb writing skills receive high praise - her writing makes the
difference between just another review and a high impact publication. I am very proud to have her at
[Company X]!
W
From manager to Julia: On behalf of the [Product Y] team, I’d like to thank you for your truly outstanding
work on this review article. It is rare to achieve the kind of remarks from reviewers that we received on
this paper: Your efforts really made the difference here! It’s great to see it finally in print. W
From Head Office to Julia:
I would like to second W’s comments. I re-read the article this weekend and was very impressed… I am
hoping to find ways in which we can really utilize this manuscript in the future, starting with inclusion as a
pre-read for ad boards.
Thanks for a job well done! B
Peer review comments
Reviewer 1: This is an important and well written review. The data and their interpretation are directly
relevant to clinically significant issues associated with causation and management of mucosal injury in
cancer patients.
Reviewer 2: An excellent review. well-thought out, well-referenced, thorough and timely.
Reviewer 3: This is one of the best written mucositis manuscripts this reviewer has had the opportunity to
review. The presentation of the pathobiology of mucositis is clear, concise, and "state of the arts".
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9. JULIA BALFOUR CV SEP 2015
3. Linked in endorsement.
"I have worked with Julia, while she was a colleague at [Company Y], but also as a client, when she was
freelancing as a medical writer.
I found Julia to a very reliable colleague, who did wonders writing manuscripts and reviews. Even when
she had been inexperienced with a therapeutic area, she was quickly up to speed with the literature. Her
results proved that she had not only understood, but more importantly brilliantly put the most complex
scientific matter into a comprehensive, easy to read, easy to understand story. I have always enjoyed
reading her work.
I highly recommend Julia as a medical writer, especially for complex pieces like reviews, where excellent
linguistic skills and understanding of complex matters are key."
4. Email from Journal editor to author regarding editorial edited by Julia
Dear Professor X
Thank you for doing this [editorial]--it reads beautifully.
It is a pleasure to receive and publish manuscripts of this quality in JASN. I deeply appreciate your
support of the journal, and we look forward to the opportunity to consider further manuscripts from your
group.
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10. JULIA BALFOUR CV SEP 2015
3. Linked in endorsement.
"I have worked with Julia, while she was a colleague at [Company Y], but also as a client, when she was
freelancing as a medical writer.
I found Julia to a very reliable colleague, who did wonders writing manuscripts and reviews. Even when
she had been inexperienced with a therapeutic area, she was quickly up to speed with the literature. Her
results proved that she had not only understood, but more importantly brilliantly put the most complex
scientific matter into a comprehensive, easy to read, easy to understand story. I have always enjoyed
reading her work.
I highly recommend Julia as a medical writer, especially for complex pieces like reviews, where excellent
linguistic skills and understanding of complex matters are key."
4. Email from Journal editor to author regarding editorial edited by Julia
Dear Professor X
Thank you for doing this [editorial]--it reads beautifully.
It is a pleasure to receive and publish manuscripts of this quality in JASN. I deeply appreciate your
support of the journal, and we look forward to the opportunity to consider further manuscripts from your
group.
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