THOUGHT LEADERSHIP

• Achieving Excellence In IO Clinical Trials

  Immuno-oncology therapies have revolutionized the treatment of cancer patients worldwide. Learn how to plan for success and reduce risk when developing novel treatments for patients with cancer.

• DLBCL Asia-Pacific Insights And Experiences

  Get an overview of trends and insights into the current development of DLBCL clinical trials in the APAC and excerpts from an expert panel discussion from eight APAC countries.

• Unlocking Europe's Commercial Potential For Biopharma Startups

  Dive into this compelling case for launching emerging biopharma in Europe and how to succeed.

• Mitigating CAR Risks In Autologous CAR-T Therapy Trials In Oncology

  Developed from a clinical trial perspective, consider these practices when managing toxicities associated with autologous CAR-T therapies among patients with B-cell hematologic malignancies.

• The Shifting Paradigm Of Dose Selection In Oncology

  Oncology drug development is undergoing a significant transformation. Explore strategies for integrating dose finding and optimization into early clinical development and how it could benefit oncology patients.

• Navigating An Evolving Global Regulatory Landscape

  Our regulatory experts are closely following the evolution of regulatory guidance on COVID-19 and the approach taken by global regulatory agencies.

• Nuances Of Hematologic Oncology Clinical Trials

  This paper examines the requirements for effectively and successfully conducting hematologic oncology clinical trials.

• Going Virtual: Yes, Oncology Trials Can Do It Too

  How do patients receive necessary continued care when there is limited or no access to providers or trial sites? With the risk of exposure to COVID-19, will immunocompromised patients be safe to participate in trials in the traditional sense now and in the future?

• Natural History Studies For Rare Diseases: Development Strategies For External Comparator Arms Leveraging Real World Insights

  This paper explores essential principles for defining the right strategy for natural history studies and how to design such studies in a way that the data can be used as an external comparator to augment future regulatory filings and payer submissions.

• Partnering Solutions For Emerging Biopharma

  This paper is the first part of a series of articles aimed at helping the EBP team better assess the value of a “partnered” outsourcing approach across the continuum of development and commercialization, and potential approaches to mapping out the right fit for their organizational needs.

• Future Forward View For Biotech Companies

  The pandemic has forced the biotech industry to quickly adapt and, as a result, is fueling the modernization of clinical trials. This article will review the biotech perspective of modern clinical trials and explore what the next normal may look like.

• Helping Non-U.S. Based Biotechs Navigate Entry Into The U.S. Clinical Development Market

  Increasingly, non-U.S. based companies are looking to bring their innovative investigational products to the U.S. for clinical development. Clearing the U.S. FDA not only ensures access to the largest market but also may provide a smoother path to marketing approval in other countries and markets.

• Capturing The Attention Of Investors: Create A Compelling Value Story

  While demonstrating the value of a product is important for any organization, it’s critical to convey to investors that the drug candidate has the potential to meet the unmet needs of patients today and tomorrow. Explore three key components to creating a compelling value story.

• Moving Forward In Immuno-Dermatology: Clinical Trial Considerations

  The global commercial dermatology market is estimated to reach $33.7 billion by 2022. With this momentum and the continued need for safe and effective dermatology treatments, it’s important to understand the strategic needs of clinical trials using novel immuno-dermatology agents.

• Embracing Innovative Designs In Early Phase Oncology Studies

  Discover how advancements in science and technology, combined with unmet patient needs, are driving accelerated timelines and creative pathways for oncology drug development.

• Considerations In Dermatology Gene Therapy Development

  Gene therapies now offer a new trajectory to address the cause of the disease, rather than simply alleviating symptoms. See how gene therapy is changing the trajectory of dermatology therapeutics by direct targeting of mutations.

• Optimizing Immuno-Oncology Clinical Trials For Biotech Companies

  For biotech companies developing an immuno-oncology (IO) therapy, the complexity of oncology clinical trials takes on new dimensions. Review the current IO landscape and considerations for biotech companies preparing for IO studies.

   
• Optimize Your Dermatology Study With A Data-Informed Protocol Assessment

  Nearly 60 percent of clinical trials have protocol amendments, leading to significant timeline delays and additional cost. Discover how four data-driven protocol design analyses can increase the chances of study success in dermatology clinical trials.

• Looking Ahead: The Future Of Cell Therapy In Oncology

  The future is promising for the field of cell therapy. However, there are still challenges to overcome, including the length of time required to manufacture cell therapies, high costs, and logistical challenges.

• Applying Virtual Approaches To Dermatology Trials

  Explore how to integrate virtual approaches into the design and delivery of dermatology trials – to mitigate study risks and enhance patient engagement.

• Reducing Patient Burden: Considerations For Virtual Dermatology Trials

  While it is not practical to think every dermatology trial can be 100% virtual, it is possible to customize and incorporate virtual aspects into these programs with a hybrid approach.

• The Emerging Pharmaco's Dilemma: Make A Deal…Or Not?

  IQVIA Biotech analyzed the approaches of companies that launched products for the first time to understand their funding/commercialization strategies. This white paper presents the results of this analysis and discusses the implications for the three types of players involved.

• Virtual Approaches In Oncology Clinical Trials During COVID-19 And Onward

  Patients living with cancer are among the most vulnerable during the pandemic, but sponsors and researchers understand oncology drug development must continue. This paper discusses how COVID-19 is driving change in the oncology trial landscape and how these insights may shape the future of post-pandemic clinical development.