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Speaker Profiles
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| For the past two decades, Beth Roberts has helped life science companies optimize the value of their innovations. She helps clients navigate the complex coding, coverage, and reimbursement challenges faced by their new technologies. Beth counsels on Medicare and other health care issues and lobbies the U.S. Congress and regulatory agencies on her clients' behalf. Her clients include health care providers; pharmaceutical, biotechnology, and medical device manufacturers; investors; and professional and trade associations. Beth is a creative problem solver who is passionate about improving patient access to care. She works collaboratively to solve bet-the-company issues in innovative ways. She helps turn reimbursement challenges and changes into business opportunities. She also explains complicated laws and regulations in a simple and straightforward way. Beth guides clients from reimbursement strategy through implementation. She applies for new International Classification of Disease (ICD-10), Health Care Common Procedure Coding System (HCPCS), and Current Procedural Terminology (CPT) codes. She helps clients obtain favorable coverage for their products through the Local Coverage Determination (LCD) and National Coverage Determination (NCD) processes and advises on the opportunities and pitfalls of coverage with evidence development (CED) and parallel review. She also helps clients obtain appropriate payment, often through new technology add-on payments (NTAPs), drug and device pass-through payments, and new technology ambulatory payment classifications (APCs). Over and above, Beth advises on seizing opportunities through the Centers for Medicare and Medicaid Innovation (CMMI), including Accountable Care Organizations (ACOs) and the Oncology Care Model (OCM). When existing mechanisms do not work, Beth creates new solutions through policy initiatives or by amending the law. |
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| Since joining the FDA in 2004, Melissa Torres has held numerous positions prior to becoming the Associate Director for Internal Affairs focused on Global Harmonization. This includes: Biomedical Engineer/Reviewer, Branch Chief - Cardiac Rhythm and Electrophysiology Devices Branch Quality System Specialist, Branch Chief - Interventional Cardiology Devices Branch Deputy Director - Division of Cardiovascular Devices PMA/HDE - Director In addition to receiving numerous FDA recognition awards, she also serves as an FDA instructor for the Association for the Advancement of Medical Instrumentation (AAMI). |
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| Raissa H. Downs cofounded Tarplin, Downs & Young, LLC 10 years ago after spending nearly a decade on Capitol Hill and in the Executive branch in senior staff positions. Downs served as Subcommittee Staff Director and Healthcare Policy Advisor to Senator Mike Enzi on the Health, Education, Labor and Pensions Committee before leaving the Senate. She then joined the legislative team at the Department of Health and Human Services in 2002 as Deputy Assistant Secretary for Legislation, finishing her tenure after a promotion to Principal Deputy. While her portfolio captured all of the programs under the HHS jurisdiction, she spent a significant amount of time on implementation of the Medicare Part D program and other major regulatory matters before CMS and FDA. Prior to the creation of the firm, Downs was a Vice President at the lobby firm Barbour, Griffith, and Rogers. |
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| With a background in biology and economics, Kristin Zielinski Duggan provides strategic advice to companies on scientific and U.S. Food and Drug Administration (FDA) regulatory challenges, while always keeping business needs in mind. For over 20 years, she has been counseling cutting-edge companies regarding the development and regulation of medical devices, pharmaceuticals, and combination products. Kristin has a wealth of experience with the entire FDA regulatory process and agency interactions, from devising regulatory strategy for innovative products to pre-submission meetings; to assisting with preclinical and clinical programs and IDEs; to preparing regulatory submissions (510(k)s), de novo petitions and premarket approvals (PMAs); to appeals of agency decisions. Having prepared companies for dozens of advisory panel meetings over the years – including panel meetings to review 510(k) notices and PMAs, general issues panels, and classification panels – Kristin is a top thought leader in this area. She has been involved with all of the meetings of the Medical Devices Dispute Resolution Panel (MDDRP) to date. |
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| Lina Kontos' technical engineering background lets her craft strategic and creative solutions for companies facing regulatory matters before the U.S. Food and Drug Administration (FDA). She works exclusively with medical device companies with a deep focus on the premarket clearance and approval of new medical devices. Lina leverages her professional experience to view medical devices both from the company's perspective in designing and marketing a new product and from the perspective of an FDA reviewer. She has wide-ranging experience in assisting companies in matters pertaining to product development, regulatory strategy and product submissions (pre-submissions, 510(k)s, IDEs, de novo petitions, and premarket approval applications (PMAs). She works with companies through the entire medical device life cycle, providing advice from the product development phase in order to optimize the regulatory pathway, helping to navigate the FDA process in determining the testing and information necessary to get to market, presenting the strategy to FDA, and advising on issues once a product is being distributed, including advertising and promotion and diligence for mergers and acquisitions. |
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| James Huang supports clients on an array of health care regulatory matters. He counsels pharmaceutical and device manufacturers and managed care plans on Medicare coverage and reimbursement policy, Medicare Advantage and Medicare Part D requirements, and Medicaid regulations and policies. He also advises on a range of provider issues, including price transparency, Medicare and Medicaid telehealth requirements, the provider-based rules, Emergency Medical Treatment and Labor Act (EMTALA), cost reporting, and the Medicare Conditions of Participation. He also has significant experience in health care litigation, including providing health care subject matter knowledge in litigations challenging hospital price transparency, Medicare site neutrality payment reductions, Medicare administrative law judge appeal delays, and Medicaid upper payment limit disputes. Further, he is experienced in developing statutory and regulatory advocacy strategies, including drafting legislative and regulatory reforms and advising on the interaction of proposed reforms with existing legal frameworks. James also advises on COVID-19 related issues; section 1135 emergency waiver authorities; and Medicare and Medicaid policies, waivers, and flexibilities implemented in response to the COVID-19 public health emergency. |
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Details |
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| Washington and Maryland: Medtech and Digital Health Series |
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| Date: March - April 2022 | |||
| Time: All times shown are GMT | |||
| Location: Online | |||
| Cost: Free | |||
Contact DIT East Midlands |
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| If you have any queries relating to international trade why not contact us. With staff in offices across the globe and Trade Advisers in every East Midlands county, we can help you find the answers. | |||
| email: events@tradeEM.co.uk | |||
| call: 0345 052 4001 | |||
| visit: great.gov.uk | |||
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| The Midlands Engine partnership works to promote the extensive opportunities and vast capabilities of our region, both across global markets and within every part of the UK. | |||
| Visit: midlandsengine.org | |||
| In association with: | |||
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| Midlands Engine |
Organised by:
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The Midlands Engine is the heartbeat of Britain’s economy Built on a strong advanced manufacturing base and enhanced by a range of sectoral strengths, the Midlands Engine is perfectly positioned to take advantage of economic growth, productivity and skills opportunities. We will improve the economy of the Midlands and the UK, deliver an enhanced quality of life for our citizens and communities and become a globally recognised driver of the economy. We will create a thriving environment for businesses to flourish. |
