Mark Von Eisenburg supports clients by understanding translational research and science policy in a range of therapeutic areas.
He couples his training in age-related diseases and a focus on Alzheimer’s disease with a background in effective science communication, delivering digestible insights that help clients with market access strategies.
Prior to joining Avalere, Mark worked in biomedical research advocacy at the non-profit alliance Research!America, where he liaised with industry, professional society, patient group, and federal agency stakeholders across a suite of topic areas ranging from vaccine development to patent legislation, garnering deep knowledge of grass roots and grass tops methods to influence federal decision making. He previously interned with the Clinical Development and Medical Affairs team at Novartis, where he focused on pre-market oncology immunotherapy and cell therapy landscapes.
Mark holds a MS in integrative neuroscience from Georgetown University and a BS in neuroscience from Lafayette College.
Authored Content
A white paper explores the RNA-based therapy pipeline and how FDA classifications can influence product development, commercialization, and patient access.
Women are more likely to experience reduced cognitive health later in life. Recent federal efforts seek to address the paucity of research on this phenomenon.
The FDA’s final rule to regulate LDTs as medical devices brings on numerous uncertainties for stakeholders.
CMS’s definition of a “qualifying single-source drug” in the Medicare Drug Price Negotiation Program may impact manufacturers’ investment strategies.
This spring, the FDA will issue a rule to begin regulating LDTs as medical devices. A multi-faceted legislative, legal and market response is anticipated.
In this installment of our 2024 Trends Influencing Rare Disease series, Avalere experts summarize key learnings for pharmaceutical companies to consider.
In this installment of our 2024 Trends Influencing Rare Disease series, Avalere experts dive into access drivers and considerations in the rare disease space.
In this installment of our 2024 Trends Influencing Rare Disease series, Avalere experts provide an introduction into regulatory approaches to rare diseases.
Recent FDA authorization of Florida’s Section 804 Importation Program has prompted increased focus on importation pathways.
Analysis of Dispense as Written codes highlight that many factors influence stakeholder preferences for brand or generic drugs after loss of exclusivity.
Receiving a complete response letter is not a rejection, but it introduces important business questions for product launch planning.
The FDA proposed to begin regulating LDTs as medical devices over the next 5 years. This has important implications for market dynamics and clinical care.
A new Avalere white paper raises important considerations on potential added lifecycle pressures for sponsors of cardiovascular disease products.
Rare disease drug manufacturers can advance clinical development through FDA programs aimed at facilitating pipeline innovation.
Multiple Inflation Reduction Act provisions impact biologics and biosimilars, but the net impact and potential consequences will vary across products.
Clarifications in the PIE Act may shift manufacturer-payer engagement strategy and improve coverage and reimbursement of new drugs and devices.
Policies within the IRA and at the FDA in response to recent litigation could influence commercialization decisions for orphan drugs and may need to be clarified by policymakers.
Amid growing safety issues in America’s food supply, the FDA’s proposal for a new Human Foods Program presents opportunities for stakeholders to act.
Increasing clinical trial diversity presents unique challenges for rare disease treatments due to population size, disease heterogeneity, and low awareness.
New report on the evolving cell and gene landscape features Avalere Health experts Kylie Stengel and Mark Von Eisenburg.
Cell and gene therapy (CGT) technology continues to outpace regulatory and reimbursement mechanisms, requiring sponsors to think proactively about development.
FDA and CMS have historically had complementary roles, yet prior collaboration between the agencies generally has been limited.
The FDA and CMS have historically had complementary roles. Recent activity highlights how their unique functions affect access to medicines.
Tune into the second episode in the Avalere Health Essential Voice podcast series focused on the how CMS and Medicare coverage decisions define patient access. In this segment, our experts continue the conversation around national coverage determinations (NCDs)that have coverage with evidence development (CED) requirements, how FDA and CMS’s evidence questions can be complimentary, and the ways in which manufacturer evidence generation plans can address those goals, using the NCD on monoclonal antibodies for Alzheimer's disease as an example.
Tune into the first episode in the Avalere Health Essential Voice podcast series focused on how CMS and Medicare coverage decisions define patient access. In this segment, our Market Access experts discuss national coverage determinations (NCDs), specifically those with coverage with evidence development (CED), their impacts to patient access, and considerations for life sciences companies.
Tune into the first episode in the Avalere Health Essential Voice podcast series focused on how CMS and Medicare coverage decisions define patient access. In this segment, our Market Access experts discuss national coverage determinations (NCDs), specifically those with coverage with evidence development (CED), their impacts to patient access, and considerations for life sciences companies.
Join Avalere’s panel of market access and policy experts for a discussion on the growing cell and gene therapy (CGT) pipeline, an in-depth look at the unique opportunities and challenges these novel therapies present, and an overview of the many hurdles stakeholders need to navigate for success.
The final CMS NCD for amyloid beta-targeting monoclonal antibodies for Alzheimer’s Disease establishes a dual pathway to Medicare coverage based on FDA approval and likely creates access and operational challenges for stakeholders.
The rollout of COVID-19 vaccines highlights the need for continued innovation in how vaccines are delivered.
The first Congressional hearings for user fee reauthorization begin on February 3, 2022, and current legislative authority for UFAs will expire in September 2022.
Stakeholders in the COVID-19 pandemic response face regulatory and commercial uncertainties as emergency operations transition and market access of products face both emergency use and full licensure.