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VCLS Appoints Carole Jones, Director, Market Access

By: News | May 16, 2017 | 70 view(s)

The appointment of Carole Jones demonstrates VCLS’s commitment to the expansion of their Market Access capabilities. With over 20 years’ experience in the healthcare industry, Ms Jones will deliver strategic counsel to support clients’ efforts to provide patient access to their new and novel products. PARIS--(BUSINESS WIRE)--Voisin Consulting Life Sciences (VCLS) announces the appointment of Carole Jones as Director of Market Access. Ms Jones will focus on expanding the company’s Market Access capabilities, enhancing the variety of services that VCLS already offers. The company’s vision is to support clients to find creative solutions to funding issues and risk sharing strategies, and to manage uncertainty through robust evidence generation. Ms Jones’ responsibilities will span payer strategy, Health Economics and Outcomes Research (HEOR), Health Technology Assessment (HTA) and value communications support. Ms Jones’ extensive experience working directly with NICE and NIHR on HTAs and policy development, as well as her close relationships with various Clinical Commissioning Groups in the UK, Gemeinsamer Bundesausschuss (G-BA) and Haute Autorité de Santé (HAS) in Europe and the Centers for Medicare and Medicaid in the U.S., makes her ideally suited to this position. ‘We at VCLS, are excited about the appointment of Carole Jones and the opportunities it will bring. It further demonstrates our commitment to becoming leaders in product development and commercialization consultation, by offering a well-rounded service to our clients. The extensive experience Carole brings will strengthen our capabilities and put us at the forefront of integrated pharmaceutical development strategy.’ commented Emmanuelle Voisin, Founder and CEO, VCLS. Ms Jones brings with her a wealth of knowledge and experience from a variety of roles within the healthcare sector. Her career started in the clinical environment and she subsequently gained industry experience working in the commercialization team at QLT (now Novelion Therapeutics), the Canadian biotech company that brought a cutting edge, first-in-class age-related macular degeneration product to market in partnership with Novartis. Ms Jones then transitioned to a global consulting role in IMS Health (now QuintilesIMS) where she was promoted to Practice Leader of the Portfolio Strategy practice and managed the EMEA region for 6 years. Since leaving IMS, Ms Jones has led the Market Access Solutions practice at Envision Pharma Group, a medical affairs company, where she was involved in publication strategy, development of manuscripts and white papers for peer-reviewed journals, systematic literature reviews, global value dossiers and interactive field-based assets. ‘I am delighted to be part of an organization with such an active focus on the integration of payer evidence requirements into the clinical development programs of our clients. The combination of world class regulatory and health economics expertise allows us to be powerful advocates for our clients in navigating the complex, evolving pharmaceutical environment. The goal of delivering innovative therapies and making them accessible to patients is at the forefront of the company’s, and my own, vision.’ said Ms Jones. Market access has become all the more critical as payer constraints grow. The development of an evidence-based strategy with an expanded value proposition that meets the needs of multiple stakeholders, including patients, is essential to the success of new entrants, never more so than in the area of Advanced Therapy Medicinal Products (ATMPs) where many of our clients are active. Ms Jones will be presenting a poster on overcoming the challenges of establishing expanded access programs in European member states at the ISPOR annual meeting to be held in Boston in May, 2017 and writes extensively on the topic of access for first-in-class innovative molecules. About Voisin Consulting Life SciencesVoisin Consulting Life Sciences is a global product development consultancy, which guides Biotechnology, Pharmaceutical and Medtech manufacturers throughout product development and commercialization. From discovery to patients, VCLS assists innovators to design product development strategies that optimize clinical development in order to drive commercial success, through an understanding of both regulators and providers of healthcare. VCLS’s team of health product specialists seamlessly supplement innovative life sciences companies’ resources with strategic advice and cross-functional operational capabilities. The firm offers integrated solutions to development planning, manufacturing, quality and controls, nonclinical and clinical testing, safety monitoring, and interactions with regulators and health technology assessment agencies. With offices in Cambridge, Somerville and San Francisco (MA, CA & NJ, USA), London (UK), Paris and Rennes (France), Lausanne (Switzerland) and Bangalore (India), VCLS serves a broad range of developers and investors. For more information, visit www.voisinconsulting.com Contacts Voisin Consulting Life SciencesZhengxi Danard, +33 1 41 31 83 00vcparis@voisinconsulting.com Original Press Release Found Here.

Statement from ASH President Kenneth C. Anderson, MD, on Administration’s Proposed Cuts to NIH

By: News | March 16, 2017 | 57 view(s)

(WASHINGTON, March 16, 2017) — American Society of Hematology President Kenneth C. Anderson, MD, of the Dana-Farber Cancer Institute, responded to the White House’s proposed fiscal year (FY) 2018 budget, which proposes a nearly $6 billion cut to the National Institutes of Health (NIH): “President Trump’s proposal to slash NIH’s FY2018 budget by nearly 20 percent is not what our country needs to remain healthy and competitive. As NIH is the largest funder of biomedical research, robust federal investment in and by the agency has led to innovative bench-to-beside discoveries that have resulted in paradigm-shifting advances in blood disease treatment and cures — from interventions that prevent stroke in young children with sickle cell disease to methods of engineering our own immune cells to attack tumors and beat cancer. In order to continue to make strides in conquering diseases, funding NIH at appropriate and sustainable levels must be a priority. “As we call on the White House to recognize the value of NIH and biomedical research, we remain concerned that Congress still has not passed a FY2017 budget. ASH has called for $34.1 billion for NIH in FY2017, and encourages lawmakers to finalize an appropriations bill before the current continuing resolution expires in April. Through its support of NIH, it is also critically important that Congress continue its commitment to the National Cancer Moonshot and Precision Medicine initiatives, which set aside vital funding to accelerate research progress. Contact: Stephen Fitzmaurice, American Society of Hematologysfitzmaurice@hematology.org; 202-552-4927 “ASH is eager to work with Congress and the president to ensure that the budgets for 2017 and beyond are balanced between nondefense and defense programs. Investments in both are necessary for sustainable, predictable funding that will fuel economic growth, reduce future health care costs, and ensure that the United States remains competitive, safe, and secure.” ### The American Society of Hematology (ASH) (www.hematology.org) is the world’s largest professional society of hematologists dedicated to furthering the understanding, diagnosis, treatment, and prevention of disorders affecting the blood. For more than 50 years, the Society has led the development of hematology as a discipline by promoting research, patient care, education, training, and advocacy in hematology. ASH publishes Blood (www.bloodjournal.org), the most cited peer-reviewed publication in the field, which is available weekly in print and online. In 2016, ASH launched Blood Advances (www.bloodadvances.org), an online, peer-reviewed open-access journal.

VCLS Appoints Dr. Gopalan Narayanan, Vice-President, Disruptive Biologics

By: News | March 13, 2017 | 75 view(s)

Previously head of the MHRA’s Biologicals unit, Dr. Narayanan provides strategic advice to leading developers of complex biologics, in particular Advanced Therapy Medicinal Products (ATMP)s, which address areas of high unmet medical need. PARIS--(BUSINESS WIRE)--Voisin Consulting Life Sciences (VCLS) announces the appointment of Dr. Gopalan Narayanan as Vice-President, Disruptive Biologics. Dr. Narayanan brings over 18 years of experience as a pharmaceutical physician, and has internationally recognized expertise in the development of innovative biotherapies, primarily through his previous role as a regulator. He was at the UK Medicines and Healthcare products Regulatory Agency (MHRA) for nearly 12 years as an expert medical assessor, and 4 years heading the Biologicals Unit. “The appointment of Dr. Narayanan further enhances VCLS’s ability to support biotechnology companies throughout ATMP research and development, and lead scientific interactions with regulators and payers. Narayanan’s considerable experience strengthens our capabilities to provide clients with a global perspective, at the forefront of scientific innovation,” commented Dr. Emmanuelle M. Voisin, Founder and CEO, VCLS. As a member of the Committee for Advanced Therapies of the European Medicines Agency (EMA/CAT) and representing EMA/CAT in the Scientific Advice Working Party (CHMP/SAWP), Dr. Narayanan has extensive experience in the regulatory aspects of ATMPs and other complex biologics. He was a leading Rapporteur for marketing authorization applications (MAAs), as well as a leading coordinator for Scientific Advice procedures. With a focus on advanced therapies and other biologics, he also has extensive experience in the provision of advice from UK MHRA, as well as an in-depth understanding of the functioning of the UK and European regulatory agencies. “ATMPs present unique scientific and regulatory challenges requiring tailored solutions to fulfill their promise. I am delighted to be part of an organization which is leading this very exciting future direction of medicine,” said Dr. Gopalan Narayanan. The Future of ATMPs ATMPs are medicinal products based on genes (gene therapy), cells (cell therapy) and tissues (tissue-engineered therapy). These advanced therapies herald revolutionary treatments for a number of pathologies, with a particular focus on rare diseases, neurodegenerative disorders such as Alzheimer's, or oncology indications. They have huge potential for patients, with a promise of more personalized treatments and regenerative medicine.1 For twenty years, VCLS has been providing expert guidance to help ATMP developers find a regulatory path for their scientific breakthrough innovations. Over 40,000 clinical studies have been conducted with ATMPs2,3, however only eight ATMPs have been approved in the EU since 2009 when the Committee for Advanced Therapies was established.4 This gives an understanding of the challenging scientific and regulatory complexity of these advanced therapies, the potential of which has yet to be realized. As part of VCLS’s commitment to help more ATMPs reach patients, the firm frequently presents its opinions, methodological approaches to ATMP development, or view on environment changes. The next webinar on ATMP development is on the 16thMarch 2017. VCLS is also participating in a series of international conferences, such as the European Section of the Alliance for Regenerative Medicine (ARM) on 23rd March 2017 in Barcelona. About Voisin Consulting Life Sciences Voisin Consulting Life Sciences is a global product development consultancy, which guides Biotechnology, Pharmaceutical and Medtech manufacturers throughout product development and commercialization. From discovery to patients, VCLS assists innovators to design product development strategies that optimize clinical development in order to drive commercial success, through an understanding of both regulators and payers. VCLS’s team of health product specialists seamlessly supplement innovative life sciences companies’ resources with strategic advice and cross-functional operational capabilities. The firm offers integrated solutions to development planning, manufacturing, quality and controls, nonclinical and clinical testing, safety monitoring, and interactions with regulators and payers. With offices in Cambridge, Somerville and San Francisco (MA, CA & NJ, USA), London (UK), Paris and Rennes (France), Lausanne (Switzerland) and Bangalore (India), VCLS serves a broad range of developers and investors. For more information, visit www.voisinconsulting.com. References 1. https://ec.europa.eu/health/human-use/advanced-therapies_en 2. https://clinicaltrials.gov/ct2/results/map?term=cell+therapy 3. https://clinicaltrials.gov/ct2/results?term=gene+therapy&Search=Search 4. http://www.ema.europa.eu/docs/en_GB/document_library/Minutes/2017/02/WC500220811.pdf Contacts Voisin Consulting Life SciencesZhengxi Danard, +33 1 41 31 83 00vcparis@voisinconsulting.com Original Press Release Found Here.

CLEVELAND CLINIC RESEARCHERS REVERSE PROSTATE CANCER DRUG RESISTANCE: Laboratory findings may spur new approach for those resistant to current therapies

By: News | February 13, 2017 | 55 view(s)

Monday, Feb. 13, 2017: A Cleveland Clinic research team has uncovered a biological pathway that renders a common prostate cancer drug useless and, for the first time, restored the drug’s cancer-killing power in human prostate cancer tumor cells grown in mice.   Results from the study were published online today in the medical journal, eLife.   Resistance to prostate cancer drugs is a common clinical problem that many patients and their oncologists face. While standard therapies like androgen deprivation (or “medical castration”) can be effective for advanced prostate cancer, they typically stop working at some point, and the disease continues to progress. When medical castration fails, patients are often then treated with a potent drug called enzalutamide to block the tumor’s male hormones. Unfortunately, enzalutamide does not work indefinitely, and tumors eventually become resistant to it as well.   Within prostate tumor cells, male hormones (androgens) bind to and activate an androgen receptor protein. This hormone-receptor complex then instructs the cell to flourish and proliferate. Enzalutamide – an androgen receptor blocker – blocks this interaction so that tumors androgens are no longer active.   The team, led by Cleveland Clinic’s Nima Sharifi, M.D., uncovered a complex cascade of events – a “metabolic switch”– that occurs when androgen receptors are blocked with enzalutamide. Results showed that enzalutamide treatment causes levels of an enzyme called 11βHSD2 to plummet, which creates a surplus of the stress hormone cortisol in the tumor cells. This extra cortisol activates its own receptor protein complex, which then takes on the role of the disabled androgen receptor, instructing the cancer cells to make more androgens.   Since simply blocking cortisol from its receptor is not compatible with life, Dr. Sharifi’s team searched for alternative means of turning off this metabolic switch. Remarkably, they found that restoring levels of 11βHSD2 reversed enzalutamide resistance.   “This major discovery demonstrates that tweaking the metabolism induced by cancer drugs can have major benefits to patients in prostate and possibly other cancers,” Dr. Sharifi said. “We need more studies to determine how to safely increase 11βHSD2 in patients, but we are a step closer to finding answers and hopefully prolonging the lives of men who are in the unfortunate situation of being resistant to all current therapies.”   Dr. Sharifi is on the medical staff in Cleveland Clinic’s Lerner Research Institute Department of Cancer Biology, Glickman Urological & Kidney Institute, and Taussig Cancer Institute. He also holds the Kendrick Family Endowed Chair for Prostate Cancer Research and was recently named a 2016 Harrington Fellow by University Hospitals’ Harrington Discovery Institute.   The research was supported by the National Cancer Institute (R01CA168899, R01CA172382, and R01CA190289), the Prostate Cancer Foundation, and the American Cancer Society. The funders had no role in the study’s design, data collection and interpretation, or the decision to submit the work for publication.   About Cleveland Clinic Cleveland Clinic is a nonprofit multispecialty academic medical center that integrates clinical and hospital care with research and education. Located in Cleveland, Ohio, it was founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based upon the principles of cooperation, compassion and innovation. Cleveland Clinic has pioneered many medical breakthroughs, including coronary artery bypass surgery and the first face transplant in the United States. U.S.News & World Report consistently names Cleveland Clinic as one of the nation’s best hospitals in its annual “America’s Best Hospitals” survey. Among Cleveland Clinic’s 49,000 employees are more than 3,400 full-time salaried physicians and researchers and 14,000 nurses, representing 120 medical specialties and subspecialties. The Cleveland Clinic health system includes a 165-acre main campus near downtown Cleveland, nine community hospitals, more than 150 northern Ohio outpatient locations – including 18 full-service family health centers and three health and wellness centers – and locations in Weston, Fla.; Las Vegas, Nev.; Toronto, Canada; Abu Dhabi, UAE; and London, England. In 2015, there were 6.6 million outpatient visits, 164,700 hospital admissions and 208,807 surgical cases throughout the Cleveland Clinic health system. Patients came for treatment from every state and 180 countries. Visit us at www.clevelandclinic.org.  Follow us atwww.twitter.com/ClevelandClinic.   About the Lerner Research Institute The Lerner Research Institute is home to Cleveland Clinic’s laboratory, translational and clinical research. Its mission is to promote human health by investigating in the laboratory and the clinic the causes of disease and discovering novel approaches to prevention and treatments; to train the next generation of biomedical researchers; and to foster productive collaborations with those providing clinical care. Lerner researchers publish ~1,500 articles in peer-reviewed biomedical journals each year.  Lerner’s total annual research expenditure was $260 million in 2016 (with $140 million in competitive federal funding, placing Lerner in the top five research institutes in the nation in federal grant funding). Approximately 1,500 people (including approximately 200 principal investigators, 240 research fellows, and about 150 graduate students) in 12 departments work in research programs focusing on heart and vascular, cancer, brain, eye, metabolic, musculoskeletal, inflammatory and fibrotic diseases. The Lerner has more than 700,000 square feet of lab, office and scientific core services space. Lerner faculty oversee the curriculum and teach students enrolled in the Cleveland Clinic Lerner College of Medicine (CCLCM) of Case Western Reserve University – training the next generation of physician-scientists. Institute faculty also participate in multiple doctoral programs, including the Molecular Medicine PhD Program, which integrates traditional graduate training with an emphasis on human diseases. The Lerner is a significant source of commercial property, generating 64 invention disclosures, 15 licenses, 121 patents, and one new spinoff company in 2016. Visit us at www.lerner.ccf.org. Follow us on Twitter at www.twitter.com/CCLRI.   Editor’s Note: Cleveland Clinic News Service is available to provide broadcast-quality interviews and B-roll upon request.                                                      ### Contacts: Hope Buggey, 216.444.8853, buggeyh@ccf.org  

University of Virginia Cancer Center Joins CancerLinQ® as Participating Practice

By: News | February 08, 2017 | 61 view(s)

ALEXANDRIA, Va. – CancerLinQ LLC, a wholly owned nonprofit subsidiary of the American Society of Clinical Oncology (ASCO®), has announced that the University of Virginia (UVA) Cancer Center has signed an agreement to participate in the CancerLinQ® platform. “As CancerLinQ® continues to rapidly grow, we are thrilled to have the University of Virginia Cancer Center join our network of oncology practices,” said CancerLinQ LLC CEO Kevin Fitzpatrick. “This large academic large institution will be a great ally in our goal of improving cancer care through aggregating and analyzing patient records.” CancerLinQ® is a powerful platform containing growing amounts of real-world cancer information. This national initiative will allow cancer providers to improve the quality and value of care by analyzing millions of cancer patient medical records, uncovering patterns and trends, and measuring their care against that of their peers and recommended guidelines. UVA Cancer Center, a National Cancer Institute (NCI)-designated cancer center, is one of many academic medical centers to join the CancerLinQ® initiative.  To date, over 75 practices in 40 states, representing more than 1,500 oncologists, have signed agreements to participate in CancerLinQ. To see the full list of practices currently participating, visit http://cancerlinq.org/care-team. CancerLinQ® is supported in part through the Conquer Cancer Foundation, whose generous donors have helped make the system possible. Major supporters include Amgen; Astellas; AstraZeneca; Bayer HealthCare Pharmaceuticals Inc.; Boehringer Ingelheim Pharmaceuticals, Inc.; Cancer Treatment Centers of America®; Chan Soon-Shiong Family Foundation; Genentech BioOncology™; HELSINN; Janssen Oncology; Lilly; Raj Mantena, RPh; Novartis Oncology; Pfizer Oncology; Thomas G. Roberts, Jr., MD, and Susan M. DaSilva; and Susan G. Komen®. CancerLinQ® is a project of CancerLinQ LLC. For more information, please visit CancerLinQ.org. About ASCO:  Founded in 1964, the American Society of Clinical Oncology, Inc. (ASCO®) is committed to making a world of difference in cancer care. As the world’s leading organization of its kind, ASCO represents more than 40,000 oncology professionals who care for people living with cancer. Through research, education, and promotion of the highest-quality patient care, ASCO works to conquer cancer and create a world where cancer is prevented or cured, and every survivor is healthy. ASCO is supported by its affiliate organization, the Conquer Cancer Foundation. Learn more at www.ASCO.org, explore patient education resources at www.Cancer.Net, and follow us on Facebook, Twitter, LinkedIn, and YouTube. Contact Julianne Lee 571-483-1381 Julianne.Lee@asco.org

Clinical Practice Guideline Focuses on Molecular Biomarker Testing for Patients with Colorectal Cancer

By: News | February 08, 2017 | 69 view(s)

Chicago, IL, Northfield, IL, Bethesda, MD, Alexandria, VA—A new, evidenced-based clinical practice guideline on molecular biomarker testing for patients with colorectal cancer identifies opportunities for improving patient outcomes. The American Society for Clinical Pathology (ASCP), the College of American Pathologists (CAP), the Association for Molecular Pathology (AMP), and the American Society of Clinical Oncology (ASCO) collaborated to develop the Molecular Biomarkers for the Evaluation of Colorectal Cancer guideline. The guideline will be published online on Feb. 6, 2017, in AJCP/American Journal of Clinical Pathology, Archives of Pathology & Laboratory Medicine, JMD/Journal of Molecular Diagnostics and JCO/Journal of Clinical Oncology, from each collaborating organization, respectively. This pivotal guideline addresses testing a wide range of molecular biomarkers in patients with early and advanced colorectal cancer. It will help establish standard molecular biomarker testing, guide targeted therapy decisions, and advance personalized care for patients with colorectal cancer, which is the second leading cause of cancer-related death in the U.S. for women and men combined*. “Realizing that molecular diagnostics is a rapidly evolving field of medicine, the collaborating organizations of CAP, ASCP, AMP, and ASCO are committed to updating this guideline routinely in order to capture and make recommendations for new discoveries in the field,” said Stanley R. Hamilton, MD, FCAP, AGAF, the University of Texas MD Anderson Cancer Center, project co-chair on behalf of the CAP. A multi-disciplinary panel of experts, appointed by each of the organizations, included pathologists, oncologists, methodologists, and patient representatives, who worked collaboratively to develop the guideline through an evidence-based process following the Institute of Medicine standards for guideline development. “The evidence-based recommendations for this guideline focused on molecular biomarkers identified as the most useful in patients with colorectal cancer, in order to select patients who can benefit from enhanced treatment with targeted therapies,” said Antonia R. Sepulveda, MD, PhD, FASCP, FCAP, Columbia University, project co-chair on behalf of AMP. “This guideline was created to offer physicians and patients guidance concerning the value of each of the new biomarkers relevant to colorectal cancer,” said Carmen Allegra, MD, University of Florida Health Cancer Center, project co-chair on behalf of ASCO. “Hopefully, the widespread application of these recommendations will result in improved outcomes for all patients with colorectal cancer.” “While many existing recommendations cover the application of individual molecular biomarkers in colorectal cancer, this guideline fills the need for an overarching set of recommendations spanning the breadth of current knowledge,” said Wayne W. Grody, MD, PhD, FASCP, FCAP, UCLA School of Medicine, project co-chair on behalf of ASCP. “This comprehensive guideline will prove useful for pathologists and oncologists to support decision-making on what molecular tests to order for patients with colorectal cancer.”  Twenty-one guideline statements were established (eight recommendations, 10 expert consensus opinions, and three “no recommendation”) based on evidence from a comprehensive literature review, which included over 4,000 articles. The guideline supports mutational testing for genes in the epidermal growth factor receptor (EGFR) pathway to inform targeted therapy decisions. Additional recommendations are intended to streamline molecular testing processes and contribute to improving patient outcomes. An ongoing communication and information dissemination campaign to the professionals and the public will be launched for awareness and to assist in the integration of guideline recommendations into pathology, laboratory, and clinical practice. The guideline will be reviewed every four years, or earlier in the event of publication of substantive and high-quality evidence that could potentially alter the original guideline recommendations.   * Cancer Facts & Figures 2017. American Cancer Society, 2017.   About the American Society for Clinical Pathology Founded in 1922 in Chicago, ASCP unites more than 120,000 anatomic and clinical pathologists, residents and fellows, medical laboratory professionals and students to accelerate the advancement of laboratory medicine to better improve patient care through knowledge, collaboration and global community. ASCP’s mission is to provide excellence in education, certification, and advocacy on behalf of the patients, pathologists, and laboratory professionals across the globe. To learn more, visit www.ascp.org. Follow us on Twitter at and connect with us on Facebook. About the College of American Pathologists As the world’s largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programs, the College of American Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. For more information, READ THE CAP ANNUAL REPORT at cap.org. About the Association for Molecular Pathology The Association for Molecular Pathology (AMP) was founded in 1995 to provide structure and leadership to the emerging field of molecular diagnostics. AMP's 2,300+ members practice in the various disciplines of molecular diagnostics, including bioinformatics, infectious diseases, inherited conditions and oncology. They include individuals from academic and community medical centers, government, and industry; including pathologist and doctoral scientist laboratory directors; basic and translational scientists; technologists; and trainees. Through the efforts of its Board of Directors, Committees, Working Groups, and members, AMP is the primary resource for expertise, education, and collaboration in one of the fastest growing fields in healthcare. AMP members influence policy and regulation on the national and international levels, ultimately serving to advance innovation in the field and protect patient access to high quality, appropriate testing. For more information, visit www.amp.org. Follow AMP on Twitter: @AMPath. About ASCO:  Founded in 1964, the American Society of Clinical Oncology, Inc. (ASCO®) is committed to making a world of difference in cancer care. As the world’s leading organization of its kind, ASCO represents more than 40,000 oncology professionals who care for people living with cancer. Through research, education, and promotion of the highest-quality patient care, ASCO works to conquer cancer and create a world where cancer is prevented or cured, and every survivor is healthy. ASCO is supported by its affiliate organization, the Conquer Cancer Foundation. Learn more at www.ASCO.org, explore patient education resources at www.Cancer.Net, and follow us on Facebook, Twitter, LinkedIn, and YouTube. Contact Amanda Narod 571-483-1795 amanda.narod@asco.org

Study Links Intentional Weight Loss to Decreased Risk of Endometrial Cancer in Postmenopausal Women

By: News | February 08, 2017 | 50 view(s)

ASCO PerspectiveJennifer Ligibel, MD, ASCO Expert in Cancer Prevention“There have been more than a thousand studies linking obesity to an increased risk of endometrial and other cancers, but almost none that look at the relationship between weight loss and cancer risk. This study tells us that weight loss, even later in life, is linked to a lower risk of endometrial cancer. The findings also support the development of weight loss programs as part of a cancer prevention strategy in overweight and obese adults.” A new study suggests that weight loss could decrease the risk of endometrial cancer in postmenopausal women by as much as 29 to 56%. Researchers observed that the benefit was greatest for obese women who actively worked to lose weight. These findings, which draw from the Women’s Health Initiative (WHI) study data, were published online today in the Journal of Clinical Oncology. Endometrial cancer is the most common gynecologic cancer and the fourth most common cancer among women in the United States; more than 75% of cases occur in women age 55 and older.1 “Many older adults think it’s too late to benefit from weight loss, or think that because they are overweight or obese, the damage has already been done. But our findings show that’s not true,” said study author Juhua Luo, PhD, an associate professor of epidemiology and biostatistics at the Indiana University School of Public Health in Bloomington, Indiana. “It’s never too late, and even moderate weight loss can make a big difference when it comes to cancer risk.” About the StudyThis study evaluated more than 35,000 women from the Women’s Health Initiative (WHI) Observational Study, which enrolled postmenopausal women ages 50-79. Researchers measured participants’ weight at the beginning of the study, and then again three years later to calculate change in body weight. Women who lost weight were also asked at this time whether their weight loss was voluntary or involuntary. Researchers then followed participants for more than 10 years on average to identify those who were diagnosed with endometrial cancer. Key FindingsWomen who intentionally lost weight saw a significant decrease in their risk of endometrial cancer compared to women whose weight remained stable. Specifically: Among women who lost 5% or more of their body weight after age 50, endometrial cancer risk was 29% lower, regardless of their age or how much weight they lost. The greatest reduction of endometrial cancer risk was found among women who were obese and voluntarily lost weight. Women who were obese and intentionally lost 5% or more of their body weight saw a 56% reduction in their risk. Furthermore, women who were overweight or obese and achieved a normal BMI after intentional weight loss had the same risk as women who maintained a stable, normal BMI. On the other hand, women who gained more than 10 pounds had a 26% higher risk of endometrial cancer. “It’s never too late to improve your health, and this study demonstrates losing weight’s potential in reducing the risk for cancer,” said Karen H. Lu, MD, chair of ASCO’s Cancer Prevention Committee. “We hope these findings will encourage individuals who may be overweight to change their behaviors to reduce the amount of food eaten and increase their physical activity.” The authors also analyzed their findings to determine the influence of hormone use, as endometrial cancer is known to be highly hormone-related. However, the researchers found no significant difference in risk between women who used hormones and those who did not. Many prior studies have shown that obesity increases the risk of endometrial cancer, but evidence on whether weight loss can reduce that risk is limited. According to the authors, this is one of the first studies to evaluate the effects of weight loss on cancer risk, and the first that measures actual change in weight rather than relying on patients’ self-reported weight. This study is also one of the first to distinguish whether participants’ weight loss was intentional. Unintentional weight loss is usually associated with other comorbidities or illnesses, and these patients typically have poorer outcomes, which may affect the research findings. Next Steps                                                                               More studies are needed to determine whether these findings are generalizable beyond endometrial cancer. As such, the researchers are currently planning studies that will evaluate the effects of intentional weight loss on both cancer risk and mortality in other cancer types. The authors would also like to explore the role of weight loss in other populations, as this research was limited to older, postmenopausal women. “We’re interested to see whether weight loss plays a role in the prevention of other cancers that are linked to obesity,” said Dr. Luo. “We already know that avoiding obesity is associated with many health benefits, but we do not know enough about the benefits of weight loss for adults who are already obese.” The Women’s Health Initiative program is funded by the National Heart, Lung, and Blood Institute; the National Institutes of Health; and the U.S. Department of Health and Human Services. More information about the link between obesity and cancer can be found in a recent Journal of Clinical Oncology special series, “Obesity and Cancer: An Exploration of Biological Processes, Clinical Implications and Future Directions.” Resources for your readers from Cancer.Net: Guide to Uterine Cancer Obesity, Weight, and Cancer Risk Physical Activity Tips for Survivors Journal of Clinical Oncology, the flagship journal of the American Society of Clinical Oncology, is a leader in reach, readership, impact, and influence. With a focus on significant clinical oncology research, Journal of Clinical Oncology publishes over 1,000 articles in 36 issues a year.  ATTRIBUTION TO THE JOURNAL OF CLINICAL ONCOLOGY IS REQUESTED IN ALL NEWS COVERAGE. # # # 1 https://seer.cancer.gov/statfacts/html/corp.html About ASCO:  Founded in 1964, the American Society of Clinical Oncology, Inc. (ASCO®) is committed to making a world of difference in cancer care. As the world’s leading organization of its kind, ASCO represents more than 40,000 oncology professionals who care for people living with cancer. Through research, education, and promotion of the highest-quality patient care, ASCO works to conquer cancer and create a world where cancer is prevented or cured, and every survivor is healthy. ASCO is supported by its affiliate organization, the Conquer Cancer Foundation. Learn more at www.ASCO.org, explore patient education resources at www.Cancer.Net, and follow us on Facebook, Twitter, LinkedIn, and YouTube. Contact Alise Fisher 571-483-1354 alise.fisher@asco.org

Immunotherapy 2.0 Named Advance of the Year in ASCO’s 12th Annual Cancer Progress Report: Ahead of World Cancer Day, Report Calls for Increased Federal Funding for Cancer Research

By: News | February 08, 2017 | 57 view(s)

WASHINGTON — A growing number of patients with cancer are benefitting from research advances in immunotherapy, leading the American Society of Clinical Oncology (ASCO) to name immunotherapy as the Society’s advance of the year for a second year in a row. Released today, this year’s report, Clinical Cancer Advances 2017: ASCO's Annual Report on Progress Against Cancer highlights the expanding role of immunotherapy. Evolving research findings are providing new insights on how to get the optimal results from these relatively new treatments. The annual ASCO report, released today on Capitol Hill, emphasizes federal funding for research as a major driver for progress against cancer. Just days ahead of World Cancer Day, leading oncologists are calling on lawmakers to provide sustained annual increases in federal funding for cancer research. Although Congress recently approved funding increases for the National Institutes of Health (NIH) and National Cancer Institute (NCI) for 2017, annual increases that keep pace with inflation are critical to build on the promising research results highlighted in the report. “In less than a decade, immunotherapy has gone from being considered a promising theoretical treatment to one that has become a standard of care that is helping extend or improve the lives of thousands of patients,” said ASCO President Daniel F. Hayes, MD, FACP, FASCO. “Today, increasing knowledge about both cancer and immunology is leading to more and smarter use of treatments that activate a patient’s own immune system. Federal funding has made these life-saving advances possible and remains essential to increasing the pace of discovery and progress.” Immunotherapy 2.0: Expanding Use and Refining Patient Selection  While scientists have been exploring various immunotherapy approaches for more than a century, the biggest success so far has been with treatments known as immune checkpoint inhibitors. Since 2011, the Food and Drug Administration (FDA) has approved 15 uses for such drugs in cancer care -- five in the past year alone. These new approvals have expanded treatment options for patients with lung, kidney, bladder, and head and neck cancers, as well as Hodgkin lymphoma. The approval of atezolizumab, in fact, marked the first new bladder cancer treatment in over three decades. Immunotherapy 2.0 also refers to the next wave of immunotherapy discovery, focused on identifying patients in whom these treatments work best, discovering mechanisms of resistance that can be overcome, and developing better means of reducing toxicities. Over the past year, research showed that checkpoint inhibitors are more effective against certain tumors that have a large number of genetic changes and those that have high levels of the PD-L1 protein.  Advances Shaping the Future of Patient Care  A range of other important advances and trends are featured in Clinical Cancer Advances: Precision medicine -- Last year brought approvals of new treatments targeting molecules important in the growth of certain types of kidney, lung, breast and blood cancer. Liquid biopsies -- The first test for  circulating plasma tumor DNA was approved by FDA in 2016 for certain patients with lung cancer. This new technology allows physicians to assess key cancer-driving tumor mutations through a simple blood draw, as opposed to invasive tissue biopsies, which in turn facilitates selection of optimal treatment and monitoring changes in the status of the tumor over time. New tools help bridge gaps between patients and physicians -- The report highlights a web-based tool for self-monitoring symptoms that immediately alerts the cancer care team when patients report that a symptom is worsening. In addition, education and patient navigation programs for underserved populations demonstrate ways to increase treatment adherence. “To conquer cancer, we must conduct research across the cancer care continuum, from screening to new treatments and strategies that help ease treatment side effects,” said Harold J. Burstein, MD, PhD, FASCO, co-executive editor of Clinical Cancer Advances. “With World Cancer Day around the corner, I’m excited by the advances we’ve made in just this past year as they will help many patients around the world live longer, healthier lives.” Progress Ignited by National Investment in Research This year, almost one in three top advances featured in ASCO’s Clinical Cancer Advances report was made possible by federal grants. Despite recent budget increases, the NIH still has less purchasing power than it did a decade ago. ASCO calls on the new Congress and Administration to build on its recent investments in cancer research, and provide at least $34.1 billion for the NIH in Fiscal Year 2017. “Much work still lies ahead. After a decade of flat funding, we are encouraged by the recent increase in NIH support. Sustained federal investment is needed to continue our momentum and build on the progress we’ve achieved. We need to catch up and keep up,” Dr. Hayes said. Clinical Cancer Advances, ASCO’s award-winning report, is now in its 12th year of publication. The report is available online at asco.org/CCA and is published in the Journal of Clinical Oncology.  About ASCO:  Founded in 1964, the American Society of Clinical Oncology, Inc. (ASCO®) is committed to making a world of difference in cancer care. As the world’s leading organization of its kind, ASCO represents more than 40,000 oncology professionals who care for people living with cancer. Through research, education, and promotion of the highest-quality patient care, ASCO works to conquer cancer and create a world where cancer is prevented or cured, and every survivor is healthy. ASCO is supported by its affiliate organization, the Conquer Cancer Foundation. Learn more at www.ASCO.org, explore patient education resources at www.Cancer.Net, and follow us on Facebook, Twitter, LinkedIn, and YouTube. Contact Amanda Narod 571-483-1795 Amanda.Narod@asco.org

Medical Societies, Advocacy Groups Develop Genetics Toolkit: Working together to improve patient care

By: News | February 08, 2017 | 55 view(s)

CHICAGO, IL (Oct. 5, 2016) – In order to help families benefit from precision medicine, several professional medical organizations and patient advocacy groups have collaborated to develop a resource for healthcare providers and patients concerned with gynecologic cancers. The Society of Gynecologic Oncology (SGO) convened experts from the American College of Obstetricians and Gynecologists (ACOG), National Society of Genetic Counselors, Bright Pink and Facing Our Risk of Cancer Empowered (FORCE), to develop the SGO Genetics Toolkit. This unique partnership has resulted in a web-based resource addressing real and common issues surrounding hereditary risk assessment and genetic testing in women with or worried about gynecologic cancers. “Identifying families who may have an inherited risk factor to develop cancer leads to potentially life-saving early detection, risk reduction, and prevention strategies,” said gynecologic oncologist Bethan Powell, MD, who led the collaborative effort. “Once a hereditary risk factor is identified, families may use this powerful knowledge to seek tailored action plans to help protect their health and improve outcomes.” The toolkit includes a series of vignettes designed to help providers and patients understand the implications of a genetic test result for themselves and other members of their family. The toolkit dispels some common misconceptions around the genetics of gynecologic cancers and sheds light on often overlooked nuances of cancer genetic testing while also introducing resources to help families adjust and adapt to results of genetic tests. “It is unique to have this many organizations come together with one goal in mind: to empower patients and providers to work together to improve health,” said SGO President Jeffrey M. Fowler, MD. “The efforts of these organizations demonstrate the value that can be achieved when patients and providers work together to create a meaningful resource.” Collaborating Organizations American College of Obstetricians and GynecologistsThe American College of Obstetricians and Gynecologists (The College), a 501(c)(3) organization, is the nation’s leading group of physicians providing health care for women. As a private, voluntary, nonprofit membership organization of more than 57,000 members, The College strongly advocates for quality health care for women, maintains the highest standards of clinical practice and continuing education of its members, promotes patient education, and increases awareness among its members and the public of the changing issues facing women’s health care. The American Congress of Obstetricians and Gynecologists (ACOG), a 501(c)(6) organization, is its companion organization. www.acog.org Bright Pink®Bright Pink is a national non-profit focused on the prevention and early detection of breast and ovarian cancer in young women. The organization’s mission is to save women’s lives from breast and ovarian cancer by empowering them to live proactively at a young age. Bright Pink’s innovative programs educate and equip young women to assess their risk for breast and ovarian cancer, reduce their risk, and detect these diseases at early, non life-threatening stages. Founded in 2007, Bright Pink strives to reach the 52 million women in the US between the ages of 18-45 with this life-saving education. Put Awareness In Action™ at BrightPink.org. FORCE: Facing Our Risk of Cancer EmpoweredNo one should have to face hereditary breast and ovarian cancer alone. FORCE is the voice of the community affected by hereditary breast, ovarian, and related cancers; providing support, education and awareness to help those facing hereditary breast, ovarian and related cancers know their healthcare options and make informed decisions. The organization is the de facto advocacy leader in guiding critical research and policy issues that impact the HBOC community. For more information about FORCE and hereditary breast and ovarian cancer, please visit www.facingourrisk.org. National Society of Genetic CounselorsThe National Society of Genetic Counselors is the leading voice, authority and advocate for the genetic counseling profession, representing more than 3,500 health care professionals. The organization is committed to ensuring that the public has access to genetic services. www.nsgc.org. Society of Gynecologic OncologyThe Society of Gynecologic Oncology (SGO) is the premier medical specialty society for health care professionals trained in the comprehensive management of gynecologic cancers. As a 501(c)(6) organization, the SGO contributes to the advancement of women’s cancer care by encouraging research, providing education, raising standards of practice, advocating for patients and members and collaborating with other domestic and international organizations. www.sgo.org. Contact:Ellen J. Sullivan, MS, MSJDirector of Corporate Communications and AdvocacySociety of Gynecologic OncologyFoundation for Women’s Cancer

Dr. Jeffrey Fowler Begins SGO Presidency

By: News | February 08, 2017 | 64 view(s)

SAN DIEGO, CA (March 22, 2016) – Jeffrey Fowler, MD, John G. Boutselis Chair in Gynecologic Oncology and Professor and vice-chair of Obstetrics and Gynecology at The Ohio State University Wexner Medical Center in Columbus, started his one-year term as the 48th President of the Society of Gynecologic Oncology (SGO) today at the conclusion of the Society’s 47th Annual Meeting on Women’s Cancer in San Diego. Dr. Fowler has made GYN ONC wellness a priority for his term as SGO president. SGO’s Gynecologic Oncology Wellness Task Force was formed in response to a membership survey on stress/burnout conducted by Dr. Fowler was presented at the 2014 Annual Meeting, and the task force is developing a number of resources to be made available to the Society’s members. “Caring for women with gynecologic cancers and complex gynecologic problems requires a significant and continuous commitment from providers, and unfortunately this can lead to burnout,” said Dr. Fowler. “Through workshops at the Annual Meeting and other resources available throughout the year, the Wellness Task Force seeks to shed light on the high rate of burnout in gynecologic oncology as a subspecialty, promote discussion, as well as provide resources and potential solutions.” Dr. Fowler has authored or co-authored more than 180 journal articles, and numerous book chapters and abstracts. He has been a member of the editorial boards for Gynecologic Oncology and the Journal of Robotic Surgery. His primary research interests have been in advancing the state of the art of surgery in gynecologic oncology, including minimally invasive surgery (laparoscopy and robotics), radical pelvic surgery and pelvic reconstructive surgery. An active SGO volunteer since 1998, he has served on the Education and Clinical Practice Committee and the Managed Care Task Force and Practice Summit Workgroup. He was Annual Meeting Program Committee chair from 2004-2006. A member of the SGO Executive Council since 2007, Dr. Fowler also served on the Board of Governors of the American College of Surgeons, and the Division of Gynecologic Oncology of the American Board of Obstetrics and Gynecology. Dr. Fowler assumes the presidency as the Society enters a new chapter with a new foundation and new Chief Executive Officer, Pierre M. Désy, MPH, CAE. On Dec. 31, 2015, the SGO’s Foundation for Gynecology Oncology merged with the Foundation for Women’s Cancer. A new foundation of the SGO, the FWC will focus its fundraising efforts on building the endowment of SGO, supporting research awards and grants, supporting education, and raising public awareness of gynecologic oncology. “I am eager to begin my tenure as SGO President and work with our dedicated committee volunteers to assist our members in any way we can to promote the highest quality of comprehensive clinical care through education and research in the prevention and treatment of gynecologic cancers,” said Dr. Fowler.                                                    # # # About SGOThe Society of Gynecologic Oncology (SGO) is a 501(c)(6) national medical specialty organization of physicians and allied health care professionals who are trained in the comprehensive management of women with malignancies of the reproductive tract. The Society’s membership, totaling more than 2,000, is primarily comprised of gynecologic oncologists, as well as other related medical specialists including medical oncologists, radiation oncologists, nurses, and pathologists. SGO members provide multidisciplinary cancer treatment including chemotherapy, radiation therapy, surgery and supportive care. www.sgo.org Contact:Ellen J. Sullivan, MS, MSJDirector of Corporate Communications and AdvocacySociety of Gynecologic OncologyFoundation for Women’s Cancer