Manufacturing Focus Day | Tuesday, December 3

A critical challenge in the personalized cancer vaccine field is the long manufacture times of the vaccine, which can take up to 4 months; this includes tumor sequencing, neoantigen target identification, and design of the mRNA, DNA, peptide, viral, or dendritic cell for the vaccine. The Pre-Conference Manufacturing Focus Day dives into key bottlenecks with innovative sequencing strategies, highlighting the importance of bioinformatics in the manufacturing pipeline, and re-imagining the scale of drug development to create the most effective therapies at an affordable price. Take this chance to participate in a day dedicated to the manufacturing challenges with the leading industry minds to streamline your neoantigen selection, harness AI strategies, and employ better design and synthesis methods.

8:00 am Morning Coffee & Check In

8:50 am Chair’s Opening Remarks

Developing Computational Methods for Design & Neoantigen Discovery to Develop More Targeted Personalized Cancer Vaccines

9:00 am Conquering Design Bottlenecks by Computer-Aided Design to Improve Manufacturing Time

Synopsis

  • Exploring novel algorithms used in design and score mRNA structures for synthesis viability
  • Diving into best design practice of personalized vaccines to achieve a T cell response
  • Enhancing personalized cancer vaccine injectables and mitigating complexities by separating into fragments for more effective vaccines

9:30 am Exploring Tumor Sequencing, Antigen Prediction & Validation for Personalized Cancer Vaccines to Develop a Fast & Effective Workflow

  • Yan Asmann Associate Professor of BioMedical Informatics, Mayo Clinic

Synopsis

  • Delving into the tumor microenvironment, novel mutational source of neoantigens, and non-canonical antigens in patients to determine the un-utilized antigens for more effective individualized therapies
  • Streamlining the sequencing, prediction, and validation of tumor samples for personalized cancer vaccines by a bioinformatics workflow combining public and inhouse developed algorithms
  • Verifying the antigens used in individualized therapies in patients’ post-vaccination blood to determine the accuracy of the workflow

10:00 am Morning Networking Break

Overcoming the Manufacturing Scale-Out Challenge of Personalized Cancer Vaccines to Deliver Therapies to Patients Faster

11:00 am Roundtable Discussion: Redefining the Scale of Personalized Cancer Vaccine Manufacture as Fast & Cost-Effective Treatments

Synopsis

  • How to reimagine the large-scale drug development pipeline to small-scale for highquality personalized cancer vaccines
  • How to evaluate the turnaround time required to create the most effective personalized cancer vaccines
  • How can the cost of personalized cancer vaccines be reduced by efficient sequencing and better bioinformatics?

12:00 pm Networking Lunch Break

Spotlighting Design & Synthesis Strategies to Manufacture High Quality Personalized Cancer Vaccines on a Rapid Timescale to Obtain a Strong Immune Response

1:00 pm Diving into Novel Small-Scale Manufacture of Dendritic Cells & Peptide- Based Personalized Cancer Vaccines for Efficient Production

Synopsis

  • Maintaining quality control of peptide-based cancer vaccines on a small scale to ensure the best possible therapy
  • Efficiently packing dendritic cells with multiple antigens for high patient immune response
  • Uncovering innovations in peptide synthesis for individualized vaccines to shorten manufacturing time

1:30 pm Employing Mass Spectrometry per Patient Combined with Machine Learning to Find the Best Targets

  • Roy de Souza Chief Executive Officer & Co-Founder, BreakBio

Synopsis

  • Using mass spectrometry to find presented antigens per patient for a targeted, personalized vaccine
  • Creating software with AI/machine learning to find cancer vaccine targets based on DNA mutations, RNA expression, and mass spectrometry per patient
  • Searching for the best targets in low tumor mutational burden cancers for the most effective personalized cancer vaccines

2:00 pm Afternoon Networking Break

Assessing the Cost, Speed, & Viability of Personalized Cancer Vaccines to Develop Targeted Therapies for More Patients

3:00 pm Panel Discussion: Personalized vs Off-the-shelf Cancer Vaccines: Evaluating the Advantages & Disadvantages for Better Clinical Efficacy

Synopsis

  • Debating the feasibility of individualized cancer vaccines vs targeting shared neoantigens
  • Highlighting successes in personalized cancer vaccines that prove clinical efficacy and viability
  • Considering the future opportunities for cancer vaccines in personalized & off-the-shelf for positive patient response

4:00 pm Goldspireâ„¢: Developing a Fast Turnaround Individualized Cancer Vaccinelike Immunotherapy to Reduce Manufacturing Time & Treat Patients Faster

Synopsis

  • Creating an individualized treatment by whole tumor to overcome heterogeneity with the most comprehensive antigens
  • Reducing the personalized cancer vaccine timeline by central manufacturing and optimized logistics
  • Ensuring cGMP cancer vaccine process consistency and quality by using a central manufacture site for alignment with the FDA

4:30 pm Chair’s Closing Remarks

4:45 pm End of Pre-Conference Focus Day