PD2M Future of Pharmaceutical Manufacturing Workshop

November 21-22, 2019
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Have you ever wondered how the future of pharmaceutical manufacturing is shaped? Want to be part of it? The PD2M Future of Pharmaceutical Manufacturing Workshop will explore the business, regulatory, and technical aspects associated with adopting novel manufacturing platforms to produce medicines. Learn more on how innovations and regulations are working together toward the modernization of the pharmaceutical industry.

Registration still open!

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Program

This latest workshop in the AIChE PD2M series is the first event to address the question of what pharmaceutical manufacturing will look like in 2030 and how we should prepare now to be ready for the changes that are coming.

We have assembled a group of excellent speakers working at the cutting edge of manufacturing innovation.  These include senior regulatory, industry and academic leaders.  There will also be ample opportunities for networking and discussion.

Presentations will address:

  • Why the industry needs to embrace new ways to develop and manufacture medicines
  • How manufacturing needs to adapt to new modalities for medical treatment
  • The impact of the wave of disruptive technologies referred to as Industry 4.0, including Industrial Internet of Things (IIoT), machine learning (ML), automation, robotics, advanced analytics, etc.
  • The role of continuous manufacturing in modernizing pharmaceutical industry
  • Making future manufacturing systems flexible and modular
  • How the industry can learn from innovations in other industries
  • The benefits of advanced process control
  • The value of collaboration and standardization around these topics in order to avoid diluted effort as pharmaceutical companies, CMOs, CROs and their vendors move forward. 

Who should attend?

This workshop will be of interest to:

  • Leaders, scientists and engineers working in pharmaceutical development and manufacturing functions, including technical operations and manufacturing science and technology
  • Innovators, generics, CMOs and CROs
  • Members of Regulatory and Quality functions and those involved in preparing regulatory submissions
  • Pharmaceutical development and manufacturing innovators, including technology and software vendors
  • Consultants, systems integrators, and those providing assistance with delivery of technology projects and implementation

Keynote Speakers:

Invited Speakers:

Session Topics:

  • Plenary Session – The Future of Pharmaceutical Manufacturing
  • Regulatory considerations for QbD of the future
  • Emerging Technologies
  • Overcoming the fear of advanced process control
  • Industry 4.0 
  • Innovation – Foster and Fund

Conference Chairs:

Organizing Committee: 

 

 

Featured Speakers

Paul C. Collins

Paul Collins is currently a Senior Director in Small Molecule Design and Development at Eli Lilly and Company in Indianapolis. In his current role, Paul has responsibility for product and process development activities for Lilly’s pre-FHD synthetic molecule development portfolio. Prior to this role, he oversaw ongoing efforts for technology platform development, including continuous manufacturing, of both API and drug product. Paul has also been a Director in Bioprocess Development, Chemical Technology Development, and...Read more

Klavs F. Jensen

Klavs F. Jensen is Warren K. Lewis Professor and Head of the Chemical Department at the Massachusetts Institute of Technology. He received his chemical engineering education from the Technical University of Denmark (M.Sc.) and University of Wisconsin-Madison (PhD).Read more

Michael Kopcha

Michael Kopcha, Ph.D., R.Ph. is the Director of the FDA’s Office of Pharmaceutical Quality (OPQ). This office has over 1,300 staff responsible for assuring the availability of quality medicines for the American public through assessment, inspection, surveillance, research, and policy. OPQ contributes to the assessment of nearly every type of human drug marketing application including New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and Biologics License Applications (BLAs), including 351(k) applications (i.e., biosimilars). OPQ also performs the quality assessment...Read more