Parexel Industry Insights

1. Expand The Use And Value Of Your Product Over Time 12/2/2024

   This discussion explores a forward-thinking approach that encourages biotech companies to look beyond initial approval, exploring new indications, markets, and patient populations.

2. Implement Market Launch Strategy, Pre-Approval 12/2/2024

   By focusing on proactive planning and risk mitigation, this episode offers biotech leaders actionable insights to optimize their pre-launch strategies, setting the stage for a strong market debut and sustained commercial success.

3. Plan How To Get To Market Quickly, Post Proof-Of-Concept 12/2/2024

   This episode of the De-risking Drug Development series focuses on accelerating drug development and enhancing product differentiation through innovative trial design.

4. Focus On Safety And Efficacy And Prove Quickly That Your Product Works 12/2/2024

   Examine essential decisions for the early phases of the development process where safety, tolerability, and efficacy play critical roles in determining a drug’s success.

5. Challenges And Best Practices For Developing ADCs 11/19/2024

   Through this workshop, participants will gain insights into the development and evaluation of ADCs, from preclinical research to manufacturing intricacies (CMC) and clinical advancements.

6. The Potential Of Neoadjuvant Therapy In The Treatment Of Solid Tumors 11/19/2024

   Neoadjuvant therapy, integrating chemotherapy and immunotherapy, shows promise in treating NSCLC and other cancers, improving outcomes, enabling earlier resection.

7. Improving Protocol Design With An Early Think-Tank Initiative 11/19/2024

   Explore how a client's first-in-human trial for a cancer drug was improved by using a think-tank approach and gap analysis, accelerating protocol design and streamlining development. 

8. Accelerate Cell And Gene Therapy Trials With Targeted Site Selection 11/19/2024

   Despite the inherent complexity and resource demands of CAGT trials, there is a large push by community-based, non-academic hospitals and clinics to strategically complete multiple studies.

9. Parexel Introduces FDA Expedited Designation Trends For Advanced Therapies 11/19/2024

   The trend for advanced therapies seeking regulatory designations is shifting to favor RMAT and FT, which offer a more accessible alternative compared to the stringent BTD.

10. Supporting A One-Time Gene Therapy With A Population PD Model 11/19/2024

    How was predictive population PD modeling used to help a gene therapy for beta-thalassemia achieve FDA approval?