Agenda – 5th Technology Transfer for Biologics

  • Day One
  • Day Two

Day One

 Monday, September 17

8:45AM – 9:00AM

Chairperson’s Opening Remarks
Jayant Aphale, Executive Vice President of Technical Operations, GRITSTONE ONCOLOGY

 Effective Outsourcing and Partnership Management

9:00AM – 10:15AM

Interactive Session:
Transfer Strategy Enabled by Agile Risk Management – A Tactical Fast Lane for Technology Transfer

Victor Melendez Colon, Ph.D., Process Development Principal Scientist, AMGEN

10:15AM – 10:45AM

Networking Break

10:45AM – 11:30AM

Communicate With Your CDMO Through the Creation of a Strategic Partnership of Understanding
Suketu Desai, Ph.D., Chief Technical Officer, Chemistry, Manufacturing and Controls, Quality and CMC Regulatory, SEMNUR PHARMACEUTICALS, INC.

11:30AM – 12:00PM

Bring a Commercial Process Back Home: Tech Transferring From a CMO for Internal Manufacture
Renée Procopio-Melino, Scientist, Bioprocess Research and Development BioTherapeutics Pharmaceutical Sciences, PFIZER

12:00PM – 12:45PM

Implement a CMO Approach to Gene Therapy Tech Transfer
Gene Mehr, Senior Engineer III, Gene Therapy Development, BIOGEN

12:45PM – 1:45PM

Luncheon

1:45PM – 2:30PM

Case Study: Streamline Approaches to Manage Multiple Product Modalities and Phases
Pankaj Paranjpe, Director, Biologics Development and Manufacturing, CELGENE
Jonathan Romero, Director, Technical Operations, CELGENE

2:30PM – 3:15PM

Manage Process Transfer With a CMO: Early Phase Transfer Through Process Validation
James Leverone, Senior Engineer, IMMUNOGEN

3:15PM – 3:45PM

Networking Break

3:45PM – 4:30PM

Conduct Gap and Risk Analysis to Ensure cGMP
VETTER PHARMA

4:30PM – 5:15PM

Understand Technical Application and Manage Risks to Facilitate Mutual Confidence
Padma Malyala, Drug Product Strategy/Biologics Expert, NOVARTIS


Day Two

 Tuesday, September 18

8:00AM – 9:00AM

Continental Breakfast

9:00AM – 9:15AM

Chairperson’s Recap of Day One
Jayant Aphale, Executive Vice President of Technical Operations, GRITSTONE ONCOLOGY

 Biologic Development and Potential Challenges

9:15AM – 10:00AM

Ensure Quality Control Through the Development of a Road Map to Target Successful Technology Transfer
Jayant Aphale, Executive Vice President of Technical Operations, GRITSTONE ONCOLOGY

10:00AM – 10:45AM

Expect the Unexpected and Troubleshoot for Success
Mitch Goetz, Senior Engineer II, BIOGEN

10:45AM – 11:15AM

Networking Break

11:15AM – 12:00PM

Accelerate Tech Transfer While Minimizing Risk
Alex Tschumakow, Program Lead, Launch Center of Excellence, SHIRE

12:00PM – 12:45PM

Navigate Technology Transfer for Continuous Manufacturing Processes
Russell Beste, Senior Director Global Process Development, MYLAN

12:45PM – 1:45PM

Luncheon

1:45PM – 2:30PM

Evaluate Challenges in Analytical Tech Transfer
Dr. Magdalena Leszczyniecka, CEO and President, STC BIOLOGICS
Dr. Zahra Shahrokh, Chief Development Officer, STC BIOLOGICS

2:30PM – 3:15PM

Outline Technology Transfer of CMC Activities in a Small Biotech
Matt Wallace, Director CMC Operations, JOUNCE THERAPEUTICS

3:15PM –

Conference Closing Remarks
Jayant Aphale, Executive Vice President of Technical Operations, GRITSTONE ONCOLOGY