Bing Guan Email & Phone Number

Boston, Ma, Us

Boston, Ma, Us

Oligonucleotide Analytical Development

Parsippany, New Jersey, Us

Supported CMC and NDA for the fast-paced launch of Izervay (avacincaptad pegol), the only commercially available pegylated oligonucleotide (aptamer) drug.

Cambridge, Ma, Us

• Led a late phase oligonucleotide cross-functional (synthesis, purification, drug product, AD and QC) task team in support of phase 3 DS/DP manufacturing, release, and stability studies.• Analytical leader of 5 oligonucleotide and small molecule programs from pre-clinical to Phase III development.• Extensive experience in phase appropriate control strategies to guide end-to-end drug development activities, including setting DS/DP specifications based on quality attributes and regulatory requirements. • Working knowledge of cGMP, ICH, FDA, and USP guidelines, including ICH guidelines on the control of impurities (process/product related, residual solvents, elemental, genotoxic and nitrosamines).• Rich experience in preparing sections of IMPD/IND/NDA filings and responding the questions.• Proven record in developing outsourcing strategies and effectively managing CDMOs by guiding method development, qualification, validation, transfer, release/stability testing, deviation investigations, and troubleshooting.• Proficient in various analytical techniques such as U(H)PLC-MS (SQ, QQQ, qToF etc.), IEX, SEC and CE, with rich experience in coaching junior scientists. • Recognized strength in high throughput data analyses and management.• Impactful delivery to multiple projects in a fast-paced environment by efficiently managing priorities/timelines• Accelerated Spinraza China registration test by strategic planning and onsite technical support at China’s national lab (NIFDC). Allowed first dosing to 10 patients in China on 10Oct2019, several months ahead of the schedule, making it possible that Spinraza was awarded China’s top-ten innovative medicine (2019).

Education record

Education record