Featured Speakers

• 

  Cynthia Pussinen
  

  Former Chief Technical Officer & Board Member

  Spark Therapeutics, Inc.
• 

  Peter Marks, MD, PhD
  

  Director, Center for Biologics Evaluation and Research

  CBER/FDA
• 

  Jim Faulkner, PhD
  

  Venture Partner

  Apple Tree Partners
• 

  Talia Faison
  

  Biologist

  CDER/FDA
• 

  Michelangelo Canzoneri
  

  Global Head of Group Smart Manufacturing

  Merck Group

Overview

The 2023 ISPE Biotechnology Conference in Dublin from 26-27 June 2023, will give an overall view of the development and manufacturing of biotechnology products.

For the current originator pharmaceuticals, like mABs or vaccines, the challenges to increase productivity, process intensification, flexibility, and agility are distinctive when it comes to mass production. The conference will present and discuss modular facility design and collaborative project delivery.

The focus is on different challenges for innovative, biosimilar, and follow-up biotechnology products, like cell and gene therapy, Advanced Therapeutic Medicinal Products (ATMPs), and mRNA-based products - such as vaccines. The conference will feature presentations with a focus on time to market, shortened submission approval times, product transfer, new concepts for control strategy, quality oversight, manufacturing, and logistics.

The 2023 ISPE Biotechnology Conference will focus on the overarching themes that represent learnings from the originator pharmaceutical products that can be applied and transferred to the (new) biosimilar and follow-up biotechnology products. Methodological enablers for process development, supply chain resiliency, and more critically, driven by the energy crisis, sustainability will be the primary focus of our event. Discussions will be presented and considered within the current regulatory framework.

The conference will provide a leading interdisciplinary platform for all stakeholders of the pharmaceutical and biopharmaceutical value chain to present recent innovations and trends, and openly discuss practical challenges and solutions, from a technical, logistical, and regulatory perspective.

The impact of the evolving regulatory environment and the need to ensure continued innovation and continuity of the supply chain, considering the current energy crisis and assuring preparedness for future crises, will be integrated throughout the conference programme and panel discussions. Participants will have the opportunity to engage with industry leaders, regulators, and peers through networking events and the conference programme.

Objectives:

• How to prepare successful Biopharmaceutical Operations
• How to unlock opportunities given by Digitisation
• Learn from Covid-19 challenges and resiliency

Featured Topics 

• Road Mapping Digital Transformation in the Biotech Industry
• Resiliency and Sustainability in Supply Chains
• ATMPs/C&GTs: From Concept to Commercialisation
• Applications of mRNA Technologies
• Product Lifecycle Innovation through Cross-Fertilising Methodological Enablers across Gen 1 and Gen 2 products
• When Speed to Market Counts: Exploring the Promising Future of Agile Manufacturing, Modular Facility Design, and Collaborative Project Delivery

Conference Highlight

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  iSpeak Blog

  Message From The Chair: Why Attend The 2023 ISPE Biotechnology Conference

  22 March 2023

  The Biopharmaceutical industry continues to grow and deliver life-changing medicines to patients as evidenced by the number of drug approvals by the FDA year after year. In 2022 alone CDER approved 37 novel drugs, either as new molecular entities (NMEs) under New Drug Applications (NDAs) or as new therapeutic biological products under Biologics License Applications (BLAs). This has all been...