Day One

Wednesday August 30 2023

8:50 am Program Director’s Opening Address

8:55 am Chair’s Opening Remarks

Exploring Emerging Analytical Characterization for Oligonucleotides

9:00 am Panel Discussion: Outlining Current Industry Trends in Oligonucleotide Development

  • RAKESH DIXIT President Chief Executive Officer, Bionavigen
  • Raj Pandey Vice President of Chemistry, Cargene Therapeutics
  • Peter Smith Director - New Modalities Chemistry, Astra Zeneca

Synopsis

• Discussing the movement away from the development of oligonucleotides for rare diseases

• Capitalizing on opportunities and changes we anticipate in the future and newer complex oligos coming into pipelines

• Outlining challenges of COGs, scale, impurity characterization and qualification

9:45 am Delving Into Analytical Characterization & Separation of Impurities

Synopsis

• Exploring analytical challenges associated with setting meaningful specifications

• Leveraging platform processes and prior knowledge for impurity characterizations

• Impurity qualification during analytical method validation

10:15 am Morning Break & Speed Networking

11:15 am Analytical Control Strategies for Therapeutic Oligonucleotides – Virtual Session

  • Mahir Ozdemir Associate Director - Scientific Integrator, Johnson & Johnson Services, Inc

Synopsis

• Ensuring the safety, quality and performance of the drug in the absence of dedicated regulatory guidelines that specifically address the quality aspect and requirements for synthetic oligonucleotide products

• Establishing quality aspect of the drug products throughout all phases of development as well as release and shelf life

• Outlining challenges of the analytical control strategies i.e. identification, impurity profiling, analytical instrumentation selection, data processing, phase appropriate specifications

11:45 am Session Reserved for WuXi STA

12:15 pm Networking Lunch

1:15 pm Focussing on the Major Challenges in the Analysis of Oligonucleotides – Virtual Session

  • Mike Webb CEO. and Founder, Mike Webb Pharma

Synopsis

• Establishing identity with sequences

• Separating and quantifying a complex impurity profile

• Establishing a meaningful assay and exploring phosphorothioate diastereomeric ratios

Outlining Regulatory Guidance & Partnering, Control Strategies

1:45 pm Process Design & Control Strategies for Early-Stage Oligonucleotide Development

  • Satya Kuchimanchi Senior Vice President, Technical Operations and CMC, CAMP4 Therapeutics

Synopsis

• Outlining the control and advantages of impurities

• Setting specifications for early-stage programs

• Exploring manufacturing process development and scale-down models

2:15 pm Afternoon Break

3:00 pm Roundtable Discussion: How Are Biopharma Companies Currently Navigating the Regulatory Landscape?

Synopsis

• Are sponsors successful with using the purge argument to justify the omission of tests to monitor small molecule process-related impurities and residual solvents?

• Considering more complex oligonucleotides and conjugates – what factors have sponsors considered and what feedback have they received from regulators?

• What are the next generation of analytical methods used in the industry to answer the most recent regulatory guidance?

3:30 pm In-Process Analytical Control Strategies

Synopsis

• A good control strategy needs to look at the entire process

• Understanding that assay quality is important, regardless of where in the process the test is conducted

• Considering approaches beyond in-process testing such as employing PAT and/or process modelling

4:00 pm Chair’s Closing Remarks & End of Day One

4:00 pm Drinks Reception

No day selected