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Cell and Gene Therapy Landscape: Challenges and Opportunities for Biotech and Investors

October 19, 2021 Executive Summary The American Society of Cell & Gene Therapy (ASCGT) wrapped up their 2021 conference earlier this year, which covered a range of topics, from new scientific advances to the evolving pricing and market access dynamics surrounding cell and gene therapies (CGT). Trinity had the opportunity to attend the conference, which brought together stakeholders from across the CGT landscape to discuss some of the challenges and opportunities within the space today. In this post we will…

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Assessing the Value of Non-Curative Cell and Gene Therapies

October 06, 2021 Executive Summary Given the majority of cell and gene therapies to date have offered the potential of a cure, pricing and access considerations are likely to differ for non-curative agents that are entering this spaceAlthough non-curative cell and gene therapies have demonstrated clinical efficacy (e.g., for multiple myeloma and wet age-related macular degeneration), manufacturers will need to communicate additional value offerings of these therapies to payers in order to avoid pushback and enhance access potential, such as:Robust…

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AI-Based Software Paige Prostate is Granted FDA Approval Through the De Novo Regulatory Pathway

September 27, 2021 Paige Prostate is the first artificial intelligence (AI)-based software designed to identify areas of concern (i.e., high likelihood of containing cancer) on a prostate biopsy image so they can be flagged for further review by a pathologist. The program is intended to be used as an adjunct tool to the review of digital scanner slide images from prostate biopsies. The program was reviewed through the De Novo pathway, a regulatory pathway for low-to-moderate risk novel devices. The FDA…

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Part II: Non-Traditional Players Attempting Entry into the Healthcare Sector

September 22, 2021 Executive Summary In June 2021, Walmart announced it is partnering with Novo Nordisk to produce its own private label insulin, ReliOn, at a discount to Novo Nordisk’s currently available fast-acting insulinThrough this partnership, Americans with a high-deductible health plan (HDHP) or without insurance can save up to 75% and purchase the insulin at their local WalmartNovo Nordisk’s key competitors, Eli Lilly and Sanofi are likely to respond with a similar partnership or price-cut for their insulin to…

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Part I: Non-Traditional Players Attempting Entry Into the Healthcare Sector

September 08, 2021 Executive Summary The healthcare sector is becoming increasingly attractive, and despite the risk of an expensive failed venture, non-traditional players have and will likely continue to take their chances to enter the fieldWhile the market has been profitable for some players such as Fujifilm and Nestlé, others have had a challenging time competing in this uniquely complex market (e.g., Kodak and Heaven) Trinity’s take: Non-traditional players that have been successful in tapping into the healthcare sector seem to…

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Exploring the Impact of COVID-Driven Trends on the US Healthcare Landscape

September 01, 2021 Executive Summary The COVID-19 pandemic has called into question many elements of the US healthcare system across key stakeholders, resulting in changes across patients, providers, payers, researchers, and manufacturersThe pandemic has required many healthcare providers and patients to provide telemedicine options, which for many specialties has proved to be an effective way to dispense and receive careFor payers at the national level, CMS has implemented reimbursable telehealth codes for all medical services that may be provided remotely,…

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Verily to Acquire SignalPath, Expanding the Company’s Clinical Research Capabilities

August 30, 2021 Verily recently announced its first major acquisition, a software platform known as SignalPath. SignalPath’s flagship software, TrialPath, digitizes and modulates individual protocols in a clinical trial, from budgeting to tracking point-of-care communication. The acquisition would fold SignalPath into Baseline, Verily’s clinical research platform designed to improve clinical trial execution, help research manage their clinical trials, and explore flexible study options for decentralized and hybrids trials as well as novel ways to capture real-world data (i.e., generated by novel sensors…

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What Market Access Opportunities Exist for Rare Disease Products in China? An Analysis of Rare Disease Product Inclusion in the 2020 NRDL

August 19, 2021 Executive Summary While 7 additional rare disease drugs were included on the 2020 NRDL in China, this development comes amid a backdrop of rare disease policy development signaling a move towards multi-channel funding mechanism to support more widespread patient access and maintain sustainability of the NRDLAs such, manufacturers cannot solely rely on NRDL inclusion for their rare disease product market access strategy in China and should consider alternative funding opportunities outside of the NRDL (e.g., provincial critical…

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What Market Access Opportunities Exist for Oncology Products in China? An Analysis of Oncology Product Inclusion in the 2020 NRDL

August 16, 2021 Executive Summary Recent updates in the National Drug Reimbursement List (NRDL) have increasingly focused on the expansion of oncology products and highlighted the improving market access environment for innovative oncology therapies in ChinaThis effort first came under the spotlight in 2018 as the National Health Security Administration (NHSA) announced the inclusion of 17 novel oncology agents on the NRDL with discounts averaging ~60%. Subsequent NRDL updates saw comparable levels of price discounts and selection of products targeting…

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