Your Favorite Alira Health Publications from 2021

Published on:
December 22, 2021

In 2021, we worked hard to keep you updated on this year’s main healthcare trends. Our team of scientists, strategists, economists, clinicians, and biostatisticians shared their insights throughout the year and as 2021 ends, we’re taking a look at our most popular publications.

A Robotic-Assisted Surgery (RAS) Review: Clinical Landscape, Commercial Arena, and Future Outlook 

Our signature report created in collaboration with Hunniwell Ventures and MassMEDIC. Download the report to understand adoption dynamics today—technologies, business models, stakeholders, decision criteria, funding and more—as well as what’s changing to drive this fast-growing market. 

Enhancing Patient Access with Early Access ProgramsDesign and Implementation Recommendations 

Pharmaceutical companies are facing increased demand from physicians for Early Access Programs (EAPs) and these companies are willing to make their innovative medicines available to patients with a high unmet medical need prior to commercialization. 

Pre-launch strategies look to address public health issues to deliver significant benefits to pharmaceutical companies, patients, and physicians. These strategies also aim to respond to regulatory delays, generate more KOL engagement, and enhance future P&R negotiations. 

In this white paper, “Enhancing Patient Access with Early Access Programs: Design and Implementation Recommendations,” we help our readers understand the complexity of launching EAPs, discover EAPs benefits, and learn about the related challenges and ways to overcome them. 

Tips for Successful Sponsor and CRO Collaboration 

The relationship between a sponsor and CRO is a critical aspect of an effective and timely clinical trialIssues such as poor sponsor and CRO communication and a lack of defined responsibilities and pathways can result in delays, miscommunications, and, at worst, a failed trial. This insightful interview with our Clinical Operations Team outlines how to create a smooth, transparent relationship between a sponsor and CRO that benefits all parties and supports a successful clinical trial. 

Trends and Challenges in U.S. and EU Combination Product Landscapes 

The regulatory environment for drug and device combination products is a dynamic one, with everchanging guidelines and daily new discoveries sparking a full industry evolutionThis timely webinar with our Regulatory leadership team features key insights and advice for U.S. and EU companies as they map out their own regulatory pathways amid this rapidly evolving landscape. 

Understanding the Value of Market Access Insights for Licensing Deals 

In September, our experts shared their thoughts on the importance using of market access insights to drive the success of licensing operations with industry professionals from the Pharmaceutical Licensing Group and the International Pharma Licensing Symposium. 

The article, “Understanding the Value of Market Access Insights for Licensing Deals,” discusses the continuum of services and personalized multi-practice model developed by Alira Health and the value it brings to our clients. 

Pricing in MedTech: Disentangling the Roles of Payers, DRGs, and Procurement 

The second episode of our podcast “Transformation Talks,”  features Kenny Carberry, Associate Director of Clinical Development; Richard Charter, VP of MedTech Market Access in Europe & Asia-Pacific; and Dan Legg, former Director of Clinical Sourcing at Guy’s and St Thomas (London) and CEO and Founder of Quantmed UK. These three experts discuss the latest changes in MedTech pricing by disentangling the roles of payers, DRGs, and procurement, all against the backdrop of recent NHS reforms. 

The Pre-IND to Market Approval Roadmap in the U.S.

When designing an early development pathway, understanding the clinical, preclinical, and technical development requirements is crucial. To clarify these requirements, our Regulatory team built an infographic with tips and insights into the process.

A Primer on Potency Assays for the Release of Biologics

Chamow & Associates, an Alira Health company, delivered insights on best practices for working with a contract development and manufacturing organization (CDMO), including advice on finding and choosing the right CDMO for your product development.

Creating a Lifecycle of Patient Engagement

The relationship between healthcare companies and patients is a partnership, and a patient-centric approach at each stage of a treatment or device’s development can help companies build trust and meet patient expectations. Continual follow-up is a key to this partnership and enriching the patient journey, evaluating satisfaction, and improving outcomes.

In this article, Alira Health provides insight on creating a lifecycle of patient engagement that benefit patients and deliversimpactful, measurable insights and results for healthcare companies.

Recombinant Human Polyclonal Antibodies to Treat Disease

This year, we were proud to announce that Steven Chamow, PhD, Senior Vice President, CMC and founder of Chamow & Associates; Bryan Monroe, Senior Consultant; and Chuck Olson, Senior Consultant, published “Generation of recombinant hyperimmune globulins from diverse B-cell repertoires” in the current issue of Nature Biotechnology.

The publication by Sheila Keating, Rena Mizrahi, and colleagues is a result of a large collaborative effort organized and coordinated by GigaGen, Inc., a U.S. biotechnology company specializing in the discovery and development of recombinant biotherapeutic medicines. It describes a microfluidics and molecular genomics strategy for capturing diverse mammalian antibody repertoires to create recombinant

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