CBPartners' Pharma Take-Away

Following on from the discussion about the US biosimilar landscape in the previous episode, CBPartners’ experts explore the trends and dynamics of the biosimilar market ex-USA – across the EU, Latin America and Asia Pacific regions, with a focus on:

•  Biosimilar availability and uptake in each region
•  Key barriers limiting biosimilar approval and uptake    
• Biosimilar manufacturer strategies to ensure successful launch 

As the costs of biologic drugs increase, biosimilars have emerged as an appealing option for controlling costs and expanding access to treatment. While the uptake of biosimilars in the USA started off slowly, it has since gained a rapid pace. 

In the first of a multi-part biosimilar series, this episode will explore the evolving biosimilar landscape, including the opportunities and barriers for uptake, as well as the future outlook for biosimilars in the USA. Topics covered include: 

• Current biosimilar landscape and key players 
• Top barriers and incentives to biosimilar uptake in the USA 

During the 2020 US Presidential Election, several campaign promises, policies, and healthcare reforms were presented by both the Republican and Democratic parties. Since winning the election, President Biden, his new administration, and the new democrat-controlled congress have prioritized  efforts to combat the COVID-19 pandemic. However, the administration has not been idle in targeting broader changes promised on the campaign trail, including meaningful expansions to the Affordable Care Act layered into their landmark COVID-19 relief package. 

Uncertainty remains, but more policy proposals, executive orders, and bills are expected in the coming years of the Biden administration.  

This episode, which kicks off season two of CBPartners’ Pharma Take-away, discusses the possible evolution of healthcare and healthcare policy in the United States, and explores the changes we may expect over the next few years as a result of the party transition. Topics covered include: 

• Healthcare-related Trump-era executive orders and review proposals 
• Drug pricing 
• Potential reforms and policy goals  

The rapid growth of digital therapeutics (DTx) in healthcare has seen the emergence of both companion digital treatments and standalone DTx in the market. The development and commercialization of standalone DTx in particular offers an interesting perspective on the reimbursement challenges and regulatory barriers that DTx faces as it continues to expand into new disease spaces and the healthcare market.

In part 3 of the digital health series, this latest CBPartners podcast episode, hosted by Akhil Parlapalli, provides an engaging discussion with guests Matthew Rube, Jeremy Guild, and Nelli Morgulchik on standalone digital therapeutics that covers:

• Standalone DTx potential in the neuro-psychiatric disease space vs chronic disease management 
• The ways in which DTx have been brought to market to date: standard clinical trial approach vs. fast-tracked retail approach
• Developments in the US & EU regulatory landscape for approving DTx products

Digital health is set to transform the collection and sharing of data which could be used in the assessment of new medical technologies. The proliferation of digital health tools has helped to drive innovation in digital therapeutics, clinical trials, and healthcare.

In CBPartners’ latest podcast, part 2 of the digital health series, Jared Louis Wolff, MS, Matt Rube and Akhil Parlapalli discuss how manufacturers can leverage technology in the clinical trial landscape, including: 

• Digital health tools and data collection
• The challenges and successes of incorporating digital health approaches in clinical trials
• Interesting clinical trial developments

The number of virtual medical consultations when compared to in-person consultations is growing dramatically year-on-year. As such, the ‘digital medicine’ trend is revolutionizing healthcare delivery as we know it – and the transition, partially from necessity due to the COVID-19 pandemic, is happening sooner than expected.

In CBPartners’ latest podcast, Jared Louis Wolff, MS, Luke Wiggins, and Temi Coker discuss the rise of digital health and telemedicine, and what this means for patients, physicians, and insurers, including:

• How patients and physicians are adapting to telemedicine
• The benefits and risks of adopting telemedicine
• The future of telemedicine 

Despite $2.8 billion allocated by the NIH to Alzheimer's research in 2020 alone, results to date have been rocky. Why is this disease that affects millions of people so tough to crack? This episode of CBPartners’ podcast seeks to answer this question as healthcare consultant Jared Wolff, is joined by Sophie Katz, and Anna Du, as they delve into:

• The primary focus of Alzheimer’s research and treatments
• Likelihood assessment of the FDA approving Biogen’s aducanumab
•  High value AD targets that should be a future focus

We hope you enjoy the content and thanks for listening! 

This final episode of the COVID-19 trilogy focuses on testing. Specifically, the different types of tests available for COVID-19 and the regulatory environment in which these tests exist. How will an accurate test change how healthcare experts respond to the disease? Healthcare consultant Jared Wolff is joined by the COVID-19 Podcast Team, Matthew Rube and Akhil Parlapalli, to discuss themes about:  

• Testing Basics 
• Regulatory Environment and Implications 
• Big Pharma Moves and Updated for Treatment, Vaccines, and Testing 

We would like to extend a thank you to Dr. Melodie Feather, who recommended the topic of testing to us as one we should cover. We appreciate your input, and look forward to receiving ideas from more listeners. 

We hope you enjoy the content and thanks for listening! 

Patent management is the hot topic of this episode. The focus is on AMARIN’s leading product, VASCEPA, a drug made up of natural derivatives such as fish oil and was approved by the FDA in December 2019.

Healthcare consultant Jared Wolff is joined by Bruna Favetta who has experience with the development of patent strategy, and Kate Jones who has a background in law.

AMARIN has recently found themselves in unchartered territory as VASCEPA’s drug patent is being challenged by generic producers, this episode explores:

• Why this case of VASCEPA is significant
• How this may set a future precedent in drug patent law 

Thanks for listening!

In Part 2 of the COVID-19 series, healthcare consultant Jared Wolff is again joined by Matthew Rube and Akhil Parlapalli from CBPartners’ New York office to discuss some of the most promising treatments that are currently being put to the test against COVID-19. These include:

• REMDESIVIR, Gilead
• Hydroxychloroquine + azithromycin (Z-Pak), Pfizer
• ·A more novel approach by Distributed Bio