Archives: Agenda

• Reviewing last year’s FDA feedback on audits: what were the main reasons for failure?
• Tips and tricks to ensure you are ready for inspection
• Simplifying processes in order to prepare for an FDA inspection

• • How vital is knowledge of therapeutic area in CRO selection?
  • As a small biotech, is it beneficial to work with a smaller CRO or a large global CRO?
  • Ensuring your CRO and vendor partners prioritize your study

• An overview of emerging therapy areas including women’s health, cell and gene therapy and rare diseases
• Designing a successful patient recruitment strategy: common challenges and how to overcome these
• Vendor sourcing: key considerations in vendor selection
• How important is therapeutic area knowledge when choosing CROs and partners?

MODERATOR:
Judyth Zahora, Senior Director, Clinical QA and Process Improvement, Zentalis Pharmaceuticals
PANELLISTS:
Gurdyal Kalsi, Chief Medical Officer, Asklepion Pharmaceuticals
Mohan Bangalore, PhD, Director, Global R&D Procurement and Supplier Management, Organon
Harsha K. Rajasimha, MS, Ph.D, Founder and Executive Chairman, Indo US Organization for Rare Diseases
Priya Marreddy, Vice President, Clinical Operations, OnCusp Therapeutics

• Key themes and technology advancements in biopharma
• Spotlight on clinical trial technologies for drug development
• Leveraging data to predict the outlook for 2025 clinical trial outsourcing
• Trends, key players, opportunities and threat in biopharma
• What the latest investment trends show for small to medium biotechs

During the roundtable discussion session, the conference hall will be divided into four ‘zones’. Delegates can choose which zone they would like to join. Each zone will focus on a different challenge within clinical operations.

ROUNDTABLE 1: Developing a successful Diversity Action Plan for your clinical trial
ROUNDTABLE 2: Creating an AI strategy to support clinical research
ROUNDTABLE 3: Key considerations when selecting a CRO
ROUNDTABLE 4: Working with advocacy groups to keep the patient voice at the heart of your trial

• Technology and innovation for addressing health literacy and how information is presented to patients
• Integrating health literacy principles into all phases of clinical research
• How low health literacy can