Upcoming Webinar

MolDX Proteomics Testing & CMS’s Proposal to Downregulate IVD’s

Date: Tuesday, February 27, 2024
Time: 1:00PM ET / 10:00AM PT

Moderator:
David Deuchler
Managing Director, Gilmartin Group

Speakers:
Hannah Mamuszka
Founder & CEO, Alva10

Ipsita Smolinski
Founder & Managing Director, Capitol Street

Isaac Ro
Partner, Catalio Capital Management

MolDX Proteomics Testing & CMS’s Proposal to Downregulate IVD’s

Recent updates from Palmettos MolDX on coverage for Proteomic diagnostic tests and FDA’s proposal to downregulate IVD’s from class III (high risk) to class II (moderate risk) represent important updates for the Diagnostics industry. What are the implications on these two policy updates? How should companies contemplate these updates in strategic planning? What opportunities have changed as a result? Hear from leading reimbursement expert, Alva10’s Hanah Mamuszka, Washington Policy expert Ipsita Smolinski (Capitol Street) and long-time analyst, executive and investor Isaac Ro (Catalio Capital) in a conversation moderated by Gilmartin’s David Deuchler.


Featured Speakers

Hannah Mamuszka
Founder & CEO, Alva10

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Hannah Mamuszka is Founder and Chief Executive Officer at Alva10, which she founded in 2015 to spur change in healthcare to allow more patients better access to diagnostic technology. Hannah’s career has spanned the laboratory and business sides of healthcare in both the pharma and diagnostics industries. Prior to Alva10, Hannah was VP of Exosome Diagnostics (acquired by BioTechne), where she led some of the earliest deals in the liquid biopsy space. Earlier in her career, she was Global Director of Pharmaceuticals Services for Oncotech, and then by acquisition, Exiqon (acquired by QIAGEN), where she built the Pharmaceutical Services and Companion Diagnostics business in the US, Europe, and ROW. Prior to her time in diagnostics, she worked on the IND submission for VelcadeTM at Millennium Pharmaceuticals (acquired by Takeda). She started her laboratory career at the National Institutes of Health, holding laboratory positions in both the National Cancer Institute (NCI) and the National Institute of Allergy and Infectious Disease (NIAID). Hannah is a frequent speaker and writer on how to drive change in healthcare, and is on the editorial board for the Journal of Precision Medicine, where she also writes a regular column on the challenges of implementing change in medicine. Hannah serves on the Board of Directors for Bionano Genomics (BNGO) and a diagnostic company in stealth mode.  

Isaac Ro
Partner, Catalio Capital Management

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Isaac Ro is a Partner at Catalio Capital Management, LP. He currently serves on the Boards of Anagenex, Pillar Biosciences and Pink Dx. He previously served as Executive Chairman of Haystack Oncology and led the sale of the company to Quest Diagnostics for $450 million.

Prior to joining Catalio, he was the Chief Financial Officer of Sema4 (NASDAQ: WGS) where he took the company public in 2021 at a valuation of $2 billion and subsequently led the acquisition of GeneDx. Prior to Sema4, Isaac served as the Chief Financial Officer of Thrive Earlier Detection where he helped launch the company and raise $367 million in venture funding. He subsequently led the sale of Thrive to Exact Sciences in 2020 for $2.1 billion.

From 2010 to 2019, Isaac led the U.S. Medical Technology and Life Science Tools equity research teams at Goldman Sachs where he was top ranked by FT StarMine for stock picking and earnings accuracy. Prior to Goldman Sachs, he held the same role at Leerink Partners where he was named Best Up and Comer by Institutional Investor and was a Healthcare investor at Independence Investments.

Isaac earned his B.A. in History and was Pre-Med at Middlebury College.

Ipsita Smolinski
Founder & Managing Director, Capitol Group

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Ipsita Smolinski is a veteran advisor on healthcare regulatory and legislative issues with over 20 years of experience in healthcare policy and economic analysis. As the Managing Director of Capitol Street, she advises clients on key trends and major actions coming out of Washington, D.C., as well as at the state, court and stakeholder levels. These include healthcare legislation moving on Capitol Hill, actions from CMS, FDA, NIH, FTC, and other agencies, as well as emerging and commercial market trends e.g., ICER, PBM reform, high deductible health plans, cell and gene therapy novel payment mechanisms, evolution of primary care clinics, and Amazon’s foray into health care delivery. Her primary focus is forecasting the impacts of health policy through data-driven economic analysis.

Smolinski holds a faculty appointment at the Johns Hopkins University Carey Business School where she teaches coursework in Healthcare Economics and Healthcare Finance. She serves as a Senior Strategic Advisor to McAllister & Quinn, a healthcare grants firm that supports large U.S. hospital systems.

Prior to launching Capitol Street in 2009, Smolinski was the Senior Equity Research Analyst for Healthcare Policy at J.P.Morgan. Before joining J.P.Morgan, Smolinski advised clients on health policy and trends at Citigroup and Bear Stearns. Earlier in her career, she spent several years as a healthcare management consultant at the Lewin Group, a Washington-based firm specializing in managed care and healthcare payment policy, and worked at both Pfizer and the Centers for Disease Control (CDC).

Smolinski holds an MBA and a Masters in Public Health (MPH) from Columbia University and received her BA from the Johns Hopkins University in Baltimore, MD. While at JHU, Smolinski played Division III field hockey, was a Delta Gamma national scholar, and published biomedical research findings in otolaryngology at the Johns Hopkins School of Medicine.

Moderator


David Deuchler
Managing Director, Gilmartin Group

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David Deuchler, CFA has over twenty years of capital markets experience as a public equity investor and corporate advisor focused in the Healthcare sector.

Prior to joining the Gilmartin Group, David was the Managing Partner of JAD Advisors, a corporate advisory firm focused on Investor Relations, Capital Markets and Business Strategy Advisory. Before starting JAD Advisors, David spent seventeen years on the buyside as portfolio manager and research analyst at Goldman Sachs Asset Management, Moore Capital, Citadel Investment Group and Suvretta Capital.

David has extensive experience advising senior executives on investor relations strategy, capital markets, business strategy and capital allocation. During his time as an investor, David invested in companies across all sub sectors of the Healthcare universe and participated in more than 150 IPO and follow-on offerings. David received his BSBA with a concentration in Finance from the University of Richmond. David is a CFA Charterholder.

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