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COA Files Lawsuit Against Federal Government to Stop Sequester Cut to Cancer Drug Reimbursement

By: coa | June 01, 2018 | 84 view(s)

Application of 2% Sequester Cut to Medicare Part B Drug Reimbursement is Unconstitutional and Illegal; Costing Seniors and Taxpayers Billions The Community Oncology Alliance (COA) has filed a lawsuit in the U.S. District Court for the District of Columbia to stop the United States Department of Health and Human Services (HHS) and the White House Office of Management and Budget (OMB) from applying the Medicare sequester cut to reimbursement for Part B drugs. In the lawsuit, COA, which represents more than 5,000 independent, community-based oncologists, shows the sequester cut has harmed patients, decimated the nation’s independent community cancer care system, and cost seniors and taxpayers billions in unnecessary health care spending. Sequestration is an automatic cut to Federal government spending triggered because Congress was unable to negotiate a balanced budget in 2011. The blunt budget cutting gimmick has been extended multiple times, with the current sequester scheduled to continue through 2027. Beginning in 2013, the Centers for Medicare & Medicaid Services (CMS) began to apply a 2% budget sequester cut to all Medicare Part B reimbursement, including for drugs. The lawsuit seeks injunctive relief to specifically stop CMS from applying the sequester cut to Part B drug reimbursement. The application of the sequester cut to cancer drug payment set up the nation’s cancer care system for the closure or consolidation of independent community oncology practices, where the majority of Americans with cancer are treated. This has created access problems for patients as cancer care moves into the much more expensive hospital system, driving up costs for seniors with limited mobility and fixed incomes, as well as all taxpayers who fund Medicare. As the 2018 Community Oncology Practice Impact Report notes, since the sequester started in 2013, approximately 135 independent community cancer clinics – many comprised of multiple locations – have been forced to close their doors, and approximately 190 clinics have been acquired by hospitals. Research has found that the consolidation of community cancer practices into hospitals cost Medicare and taxpayers an extra $2 billion in 2014 alone. In addition, Medicare beneficiaries responsible for the 20% coinsurance saw their bills rise by $500 million in that same year. The lawsuit notes that application of the sequester cut to Part B drug reimbursement is both illegal and unconstitutional. This is because Part B drug reimbursement was set by Congress at average sales price (ASP) plus 6% in law in the Medicare Modernization Act of 2003. By applying the sequester cut to Part B drug reimbursement, the Administration has bypassed Congress and the law by lowering Part B drug payments to ASP plus 4.3%. As such, HHS and OMB are violating the separation-of-powers doctrine of the Constitution. Simply put, the Executive Branch cannot amend legislation passed by Congress under the guise of executing the laws. In conjunction with the complaint, COA also sent a letter to HHS Secretary Alex Azar explaining why legal action was a last resort, providing preliminary input on why proposed Medicare Part B changes in the President’s blueprint on drug prices will be harmful to cancer patients, and outlining some of COA’s solutions to increasing cancer drug prices, as well as reiterating community oncology’s desire to work together with the Trump Administration. “We are filing this lawsuit on behalf of the millions of Americans who face cancer and should be able to get high-quality, affordable, cancer care close to home. The sequester has been one of the biggest reasons why they can’t do that, and it is time for this to stop,” said Jeff Vacirca, MD, FACP, president of COA and CEO of NY Cancer Specialists. “I see the impact of the sequester cut to Part B drug reimbursement to patients and practices on a daily basis. Because of it, our country is left with less access to cancer care in communities – particularly in rural and underserved regions – as well as unnecessarily high spending to receive it in hospitals.” “Filing this lawsuit was a last resort after numerous meetings, discussions, and letters to HHS and OMB that went nowhere. We had hoped that the current Administration would have fixed what is a constitutional violation that is clearly harming seniors with cancer,” said Ted Okon, executive director of COA. “Community oncologists support and want to work together with the Administration on solutions to reduce drug prices and health care spending. However, the sequester cut does not do that. It has backfired in spectacular fashion, costing seniors and Medicare billions. It is time for this madness to stop.” Independent community oncology practices and providers are dedicated to lowering the escalating cost of cancer care. They have been pioneering oncology payment reform for years, including private payer programs based on the Oncology Medical Home, the Medicare Oncology Care Model (OCM), and working on the next-generation, improved OCM 2.0 model that includes payment for cancer drugs based on value. A copy of the complaint can be found on the COA website here. A copy of the letter to HHS Secretary Azar explaining the lawsuit can be found here.

Community Oncology Alliance Statement on President’s Blueprint to Lower Drug Prices

By: coa | May 17, 2018 | 89 view(s)

Community Oncology Alliance Statement on President’s Blueprint to Lower Drug Prices Putting Cancer Patients First and Lowering Drug is Critically Important, Community Oncology Supports Blueprint and is Working on Solutions Administration Must Fix and Avoid Past Policy Mistakes That Have Contributed to Ongoing Problems with Cancer Care System Washington, DC – Friday, May 11, 2018 – The Community Oncology Alliance (COA) released the following statement regarding President Donald Trump’s recently announced blueprint to lower drug prices and reduce out-of-pocket costs. COA strongly supports President Trump and the Administration’s work to put patients first and lower the price of prescription drugs. Ensuring patients can afford and access life-saving drugs to fight cancer is a top concern for oncologists, nurses, practice administrators, and other cancer care professionals across the country. As the providers of care for the majority of American’s battling cancer, community oncologists are faced with the grim reality that the escalating costs of prescription drugs in the United States has to be contained. COA believes that every stakeholder in our unbelievably complex health care system must come together and collaborate to reduce medical costs. If we are all willing to selflessly work together for the good of patients, the challenge of high drug prices can be addressed. COA looks forward to providing the Administration with detailed input from community oncology practices and professionals on the blueprint put forth by the President today. “As a practicing oncologist, I see the impact of high drug costs firsthand every day,” said Jeffrey Vacirca, MD, FACP, CEO of NY Cancer Specialists and president of COA. “Patients are financially burdened by high drug prices, sometimes even refusing or stopping treatment because they cannot afford it, and I am powerless to change that. Oncologists welcome efforts that learn from past mistakes, strengthen the critically important community cancer care delivery system, and ensure patients can afford and access the life-saving care they need close to home.” COA commends President Trump, Secretary of Health & Human Services Alex Azar, Administrator of the Center for Medicare & Medicaid Services Seema Verma, and Commissioner of Food and Drug Administration Scott Gottlieb, MD, for putting patients first by already moving forward with policies to reduce drug prices. These include ongoing work to reign in abusive fees and misappropriated discounts by middlemen Pharmacy Benefit Managers (PBMs); fix the runaway 340B drug program that is enriching hospitals and not helping patients; and increasing competition through record-setting approval of new generic drugs. The Administration’s efforts are already resulting in billions of dollars in savings for seniors and taxpayers.  While COA applauds the Administration’s efforts and new blueprint, we urge caution. History has shown that even well-intended policymaking can backfire resulting in the unintended consequences of harming patients, increasing costs, and limiting access to care. This has been particularly true in cancer care, where Americans today are facing the financial impact of previous policymaking. Ongoing public policies behind efforts such as the sequester cut to Medicare drug reimbursement, growing negative presence of PBMs, and the out of control 340B drug pricing program in hospitals were all introduced to reduce health care costs but have, ironically, resulted in increased spending and bureaucracy that is adverse to patients, especially those with cancer.  COA is particularly dismayed that the Administration’s blueprint does not include a stop to the ongoing sequester cut to Medicare drug payment. The previous administration began illegally applying the 2% sequester cut to Medicare reimbursement for cancer drugs and other critical specialty therapies beginning in 2013. Many oncology practices have not survived or are struggling to survive under the sequester cut that often places Medicare drug reimbursements below acquisition costs. This has fueled consolidation of the nation’s cancer care system, closing community treatment sites, and forcing cancer care into the much more expensive hospital setting, thereby increasing costs to seniors, Medicare, and taxpayers. According to the 2018 Community Oncology Alliance Practice Impact Report, in the six years since the Medicare sequester cut went into effect, 135 cancer treatment have clinics closed, and 189 practices (often with multiple clinic locations) have been bought by hospitals. Most of these practices have been acquired by 340B hospitals that realize incredible profits from prescribing more or more expensive cancer drugs purchased at discounts without the need to pass savings on to patients in need. “Today, President Trump has proposed several important initiatives to lower drug prices that align perfectly with COA’s ongoing work to advance meaningful, patient-centered solutions aimed at making cancer care less costly and more effective,” said Ted Okon, executive director of COA. “However, it is really disturbing that the blueprint released today does not address the Medicare sequester cut to drug payments that is fueling higher costs and cancer drug prices. All the sequester cut to Medicare drug payments for cancer drugs has produced is less access to cancer treatment, higher costs for patients and Medicare, and increased drug prices. It has to be stopped now.” Community oncology providers are at the forefront of payment reform and are dedicated to lowering the cost of cancer care. COA stands ready to work with policymakers on reforms that will have a meaningful impact on reducing the cost of drugs and cancer care. Community oncology has been pioneering oncology payment reform for years, including private payer programs based on the Oncology Medical Home, the Medicare Oncology Care Model (OCM), and working on the next-generation, improved OCM 2.0 model that includes payment for cancer drugs based on value.

Community Oncology Alliance Names Dr. Frederick M. Schnell to Newly Created Medical Director Position

By: coa | May 17, 2018 | 79 view(s)

Community Oncology Alliance Names Dr. Frederick M. Schnell to Newly Created Medical Director Position Experienced Community Oncologist Will Provide Valuable Guidance on Patient Care and Practice Operations Washington, D.C. – February 22, 2018 – The Community Oncology Alliance (COA) announced today that Frederick M. Schnell, M.D., F.A.C.P., has been appointed to the newly created staff position of Medical Director. He brings more than three decades of experience as a physician and community oncology practice CEO. Among the first issues Dr. Schnell will help community oncology practices address is the future of oncology payment reform. Previously, Dr. Schnell was a practicing community oncologist for 34 years, most recently as CEO, at Central Georgia Cancer Care in Macon, Ga. He is also currently a Clinical Asssitant Professor, Department of Medicine, Mercer Uiversity School of Medcine, Macon, Ga. and a Clinical Assistant Professor of Hematology and Oncology at the Winship Cancer Institute, Emory University School of Medicine, Atlanta, Ga. Dr. Schnell has been the recipient of the Distinguished Cancer Clinician Award from the Georgia Cancer Coalition. He was a founding physician of COA, served as the third COA president, and as a member of the COA Board of Directors for many years. “This position is coming back to a ‘family’ I know well,” said Dr. Schnell. “This is a crucial time for community oncology. There are obstacles and issues to be sure, but the future is so much more positive and COA has more resources than at any time in its history.” “We are pleased to have Dr. Schnell joining the Community Oncology Alliance team. His years of practice, patient care and an intimate understanding of the issues facing cancer care providers and cancer patients make Dr. Schnell perfectly suited to be our Medical Director,” said Jeff Vacirca, MD, CEO of NY Cancer Specialists in New York and president of COA. “The rapidly changing landscape of cancer care delivery in the United States demands insight like his to craft the future strategies for community oncology.”   Dr. Schnell’s full biography is available on the COA website athttp://www.communityoncology.org/home/about-us/coa-leadership/.

Community Oncology Alliance Statement on White House Budget Proposal Drug Price Recommendations

By: coa | May 17, 2018 | 113 view(s)

Community Oncology Alliance Statement on White House Budget Proposal Drug Price Recommendations Administration’s Budget has Numerous Smart, Overdue Policy Solutions; but Certain Medicare Part B Proposals Ignore History and will Backfire  Washington, DC – February 13, 2018 – Today, the Community Oncology Alliance (COA) released the following statement regarding the White House’s proposed budget recommendations and a recent report from President Trump’s Council of Economic Advisors on strategies to reform biopharmaceutical pricing. Ensuring patients can afford and access life-saving therapies to fight cancer is a top concern for oncologists, nurses, practice administrators, and other cancer care professionals. Every day we are faced with the grim reality that the prices for critical cancer drugs in the United States are too high and unsustainable. COA believes that all stakeholders in our health care system must come together to reduce the cost of cancer care.   COA commends President Trump and his Administration for moving forward with several bold reforms to tackle drug prices. Notably, this includes the recent Centers for Medicare & Medicaid (CMS) change to hospital payments in the 340B Drug Discount Program. The White House budget proposal recommendations for continuing 340B reforms are absolutely correct and will help ensure that cancer patients in need benefit, not large hospitals. Along with efforts underway in Congress through legislation, such as the 340B PAUSE and 340B HELP acts, COA is hopeful that we will finally be able to achieve transparency and accountability in the runaway 340B program in hospitals. The White House budget proposal for sharing manufacturer rebates and discounts with seniors in Medicare Part D is also a great idea. Pharmacy benefit managers (PBMs) have been enriching themselves with these rebates for too long, and their growing scale has resulted in higher drug costs for everyone. COA believes that the proposed Part D change to share rebates and discounts proposed will lower costs for patients, taxpayers, and the government. Additionally, COA believes that President Trump’s proposal to expand Medicare’s policy on site-neutral payments is an extremely wise move. While saving Medicare $33.9 billion over the next decade, paying hospitals and independent physician practices the same rate would also lower patient costs for cancer care and reduce incentives for hospitals to take over independent practices.  However, COA cautions the White House that several elements of the budget could, if enacted, have extremely negative unintended consequences for patients and the cancer care system. In particular, the proposals to cut payments for Medicare Part B drugs, as well as shifting the Part B program into the Part D program are misguided. History shows that these changes will backfire, raising drug prices, driving consolidation of our nation’s cancer care system into the much more expensive hospital setting, expanding the negative influence of PBMs, and reducing patient access. Proposal to Cut Medicare Part B Reimbursement COA completely disagrees with the White House proposal to cut provider reimbursement for new drugs in Medicare Part B. For community oncology practices this would put reimbursement for many drugs below acquisition cost, jeopardizing the ability of oncologists to deliver the therapies and causing the practices to close their doors. It should be noted that CMS under previous administrations has already substantially cut Medicare Part B drug reimbursement by requiring the inclusion of wholesaler prompt pay discounts starting in 2005 and the application of the Medicare sequester to Part B drugs starting in 2013. These past cuts did not reduce drug prices, but rather fueled them and drove a huge shift of cancer care to the more expensive hospital setting, increasing costs to patients with cancer and taxpayers. In 2004, 84 percent of chemotherapy was delivered in independent community oncology practices, but by 2016 that had fallen to 51 percent, with the remainder delivered in the far more expensive hospital outpatient setting. This significantly increased costs to Medicare—in 2014, it cost Medicare $2 billion more for just chemotherapy than had the site-of-service not shifted to the hospital setting. Now, the White House has proposed cutting Part B reimbursement even more with the expressed purpose of lowering costs and drug prices, despite clear evidence that it will increase Medicare costs and further raise drug prices. Finally, it is insulting to suggest that oncologists paid under Medicare Part B practice medicine based on financial profit incentives, not the best interests of their patients. This is not only highly offensive and derogatory, but also simply not grounded in fact. Numerous independentstudies have shown that the ‘incentive’ of reimbursement rates does not change oncologists’ prescribing patterns. Rather, it is the introduction of new, groundbreaking drugs and clinical evidence that dictates which treatment is in the best interest of the patient. Proposal to Move Medicare Part B to Part D COA is also extremely concerned by the White House proposal to move some prescription drugs currently paid for under Medicare Part B to Medicare Part D. This is an extremely risky proposal for patients battling cancer who already have extremely negative and dangerous experiences dealing with the influence of the large PBMs that dominate the Part D program. Today, PBMs control an estimated 80-85 percent of drug benefits for over 260 million Americans who are forced to deal with these expensive, bureaucratic corporate middlemen. Patients battling cancer have experienced a very clear, negative shift in their ability to access needed medications in the Medicare Part D program because of PBMs. COA encourages the administration to read our series of white papers documenting the horror stories that patients face in dealing with PBMs, including a complete indifference to sick patients, dangerous mistakes, and deadly bureaucracies. Additionally, policymakers should note that the growth of middlemen PBM corporations in Medicare Part D has only served to increase drug prices. Conclusion COA applauds the administration for continuing to work on reducing drug prices. As providers on the frontlines of our nation’s fight against cancer, we see firsthand the impact that high drug prices have on patient care, access to treatment, and the entire health system. We also commend the administration for taking real steps towards reform of the broken 340B program and look forward to more action from Congress in the future. However, the search for solutions to high drug prices should be done thoughtfully and with consideration of the lessons learned from history. Oncologists have seen several of these proposals before and they have had extremely negative unintended consequences for patients with cancer. COA urges the administration to use extreme caution and reconsider some of the proposals put forth as they will backfire, raising costs and reducing access. Community oncology providers and COA stand ready to work with policymakers on reforms that will have a meaningful impact on reducing the cost of drugs and cancer care. We are fully committed to reducing the cost of cancer care and have been working on oncology payment reform for a number of years. Currently, COA is helping practices participating in the Oncology Care Model (OCM) succeed while planning for a future iteration of the effort we are calling the ‘OCM 2.0’ which incorporates concepts such as value-based insurance design and value-based payments for cancer therapies. These hold great promise and should be explored seriously.

VCLS Appoints Carole Jones, Director, Market Access

By: News | May 16, 2017 | 187 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 | 173 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 | 206 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 | 190 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 | 181 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 | 191 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