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Workshops

Workshop Day | Tuesday December 3, 2019

Workshop A

9:00am-12:00pm

How to Design and Develop an Internal Manufacturing Capability

  • Develop process with plan to transition to large-scale
    commercial production to meet regulatory requirements

 

  • Structure all manufacturing operations to reduce
    potential failure points and ensure reproducibility
  • Design facility with flexibility for process change or future
    business requirements

 

  • Ensure facility design controls for viral containment,
    material flow, people flow, product flow, sample flow and
    waste flow

Workshop Leader

Lance Weed

Lance Weed
Vice President
Operations
uniQure

Lance Weed has more than 30 years of extensive experience in the design, construction, process development, manufacturing and establishment of operations for biopharmaceutical facilities including drug substance and drug product lines where no prior manufacturing capability was established. This includes uniQure’s multiproduct gene therapy facility utilizing 100% disposable process systems for drug substance and drug product. Lance also built BioVex’s oncolytic virus productionfacility which is currently the commercial production facility for Imlygic under Amgen’s ownership. Lance has a degree in Chemical Engineering from University of New Hampshire.

Workshop B

1:00pm-4:00pm

Harness the Natural Ability of the Immune System in Paediatric Oncology

  • Biology of childhood tumours and how this differentiates
    from adult cancers
  • Learnings from paediatric immunotherapy that can be
    applied to adult indications
  • Understanding the tumour response to virus injection and
    modulating this response by altering the tumour microenvironment

Workshop Leader

John Goldberg

John Goldberg
Senior Vice President Clinical
Development and Practicing
Paediatric Oncologist
Oncorus

John Goldberg is the Senior Vice President of Clinical Development at Oncorus, Inc. a Cambridge, MA based oncolytic virus therapy company advancing both intratumoral and systemic approaches. A practicing pediatric oncologist, Dr. Goldberg previously led the pediatric oncology phase 1 clinical trials program at the University of Miami prior to joining industry. In Miami, he led studies in children and adults using a variety of modalities including cellular and targeted therapy, and treated patients with leukemia, brain tumors and sarcoma. He made the leap to biotech to help bring a seasoned clinical perspective to drug development, and has developed immunotherapy and RNA targeted treatments subsequently. Responsible for all of clinical development at Oncorus, Dr. Goldberg is passionate about bringing new therapies to patients with unmet medical needs, including children with difficult to treat cancers.