tHEORetically Speaking2023-11-08T12:50:43-05:00

tHEORetically Speaking

FDA Issues Draft Guidance Recognizing the Role of Real-World Evidence in Learning More about Populations Underrepresented in Clinical Trials for Drugs and Biological Products

By: Ulka Campbell, Head of Scientific Strategy, Aetion Of the many potential use cases for real-world data (RWD) and real-world evidence (RWE), one of the most important is improving the information available about how medical products work in populations that have been historically underrepresented in clinical trials. Striving [...]

November 1st, 2023|Categories: Blog|Tags: , , |
  • The Future of Diversity in Clinical Trials - Real-World Evidence

The Future of Diversity in Clinical Trials: Real-World Evidence

This episode of tHEORetically Speaking features real-world evidence experts Alexandrina Balanean, Parisa Asgarisabet, and Danielle Gentile from Cardinal Health discussing the problems caused by lack of diverse representation in clinical trials.

Global Planning to Local Execution Market Success

Moving beyond static evidence development to ensure local market access success; responding to recent changes in governmental drug regulations and the role of automation Written by Grammati Sarri and Radek Wasiak The worldwide drug regulation landscape is rapidly changing. The introduction of the EU health technology assessment (HTA) Regulation [...]

October 16th, 2023|Categories: Blog|Tags: , |

Ongoing Medicare Privatization Will Hurt Pharma As Much As the IRA

  The pharmaceutical industry is in a frenzy over the recently released list of the drugs subject to price negotiation under the Inflation Reduction Act of 2023 (IRA) and the Act’s potential impact on profits. But an even bigger force has been slowly transforming Medicare in a way [...]

Get to know LexisNexis Risk Solutions

Supplier Spotlight® highlights the unique skills and services offered by organizations that are part of our CONNECTED COMMUNITY™. Recently, we spoke with LexisNexis Risk Solutions which supports the biopharma industry by offering scientific data solutions and consultancy centered around regulatory expertise. Check out the interview below and visit LexisNexis Risk Solutions. What is [...]

July 5th, 2023|Categories: Blog, Featured, Industry News|Tags: , |

The hēRo3 Revolution: Accelerating and Empowering HEOR Analytics with Cutting-Edge Digital Solutions

In this interview with Chad Rose, General Manager of hēRo3, he explains how biopharma is incorporating critical HEOR insights into decision-making for early pipeline assets. Why is there a need to revolutionize the way HEOR insights are used in the decision-making process? Now more than ever, there [...]

June 21st, 2023|Categories: Blog, Featured, HEOR Feature, Industry News|Tags: , , |

Three Considerations to Expand Physicians’ Bandwidth and Improve Real-World Safety Reporting

The ever-expanding field of pharmacovigilance highlights the importance of identifying and tackling problems with real-world safety reporting. Despite this drive to improve healthcare, overtaxed healthcare providers face a current real-world safety reporting process that is too burdensome. For example, researchers reviewed 29 studies and identified four priorities to [...]

June 19th, 2023|Categories: Blog, Featured, Industry News|Tags: , , , , |

Podcast Q&A: The Benefits of Linking SDOH with Other Real-World Data

This podcast segment features the Q&A from Magnolia Market Access’ April 6, 2023 webinar with HealthEconomics.Com. In this episode of tHEORetically speaking, join Dr. Pamela Landsman-Blumberg from Magnolia Market Access and Dr. Rick Chapman from Innovation and Value Initiatives as they answer questions on the importance of social determinants [...]

How Quality Research Initiatives are Advancing Precision Oncology and Value-Based Care

Precision medicine and value-based care are buzzwords used over the last two decades. At inception, these principles were seen as two opposing forces in the fight against cancer. Now, industry leaders view precision medicine and value-based care as two sides of the same coin. Data demonstrating the impact [...]

Podcast Q&A: Literature Reviews and Global Value Dossiers

This podcast segment features the Q&A from DistillerSR’s March 15, 2023 webinar with HealthEconomics.Com. Join Gillian Sibbring, Sue O’Leary, Ben Rousseau, Patti Peeples, and Rachel Forrest as they answer questions on systematic literature review issues that can negatively affect your Global Value Dossiers (GVDs) and how automation can improve [...]

Podcast Q&A: Improving the Representativeness of Research

This podcast segment features the Q&A from Cardinal Health's March 23, 2023 webinar with HealthEconomics.Com. Join Dr. Bruce Feinberg, Dr. Danielle Gentile, Dr. Parisa Asgarisabet, and Alexandrina Balanean from Cardinal Health as they answer questions on the economic impact and role of real world evidence (RWE) in improving representativeness of [...]

The Emerging Outcomes Demonstration / Cost Management Challenge

The current healthcare environment reshapes the three key factors in market access – value, evidence, and commercial positioning of new treatments. Greater emphasis on patient centricity meets budget cuts. Leading to a sharper focus on demonstrating patient benefit value specific to the treatment situation. At the same time, the [...]

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