Michael Leblanc Email & Phone Number

Durham, North Carolina, United States

Remote (North Carolina)

QED, a BridgeBio CompanyAnalytical Development• Accountable for the analytical development of drug substance and hard-gelatin oral solid doses to support clinical trials and commercial supply via management of third-party domestic and international laboratories.• Accountable for the analytical development of lower dose tablet and capsule formulations to support clinical trials in achondroplasia.• Accountable for management of stability programs of starting materials, intermediates, reference standards, metabolites, drug substance and several dosage forms in support of maintaining adequate shelf-lives for program support.• Responsible for managing all out-of-trend and out-of-specification results with QED and third-party QA groups. Provide technical oversight to problem solving efforts and root cause analysis studies.• Coauthored NDA module 3 for Truseltiq (infigratinib) hard-gelatin capsules which was accepted by FDA, Canada and Australia in 2021 under project Orbis. Supported submissions in other countries for similar oncology indications.• Analytical SME for company and primary contact for all analytical questions posed by Regulators.• Identified a potential alternative formulation of infigratinib, sought out a third-party experts and managed exploratory studies to determine the feasibility of this idea.• Responsible for preparing the analytical technical transfer to international partner sites for drug substance and drug product manufacturing. • Lead analytical team at QED.• CMC technical lead for a new program which was being evaluated by BridgeBio. Identified potential third-party manufactures of drug substance as well as partners with the technical capability to formulate a challenging molecule for pediatric studies.

Remote (North Carolina)

Retinagenix, a BridgeBio CompanyAnalytical Development• Responsible for reviewing analytical methodology for Zuretinol acetate and related oral solution formulations.• Inspected GMP capability of a potential testing facility for release of drug substance and release/stability of formulations.• Worked with team to identify suitable formulation and delivery device for Phase II studies.• Helped to develop an appropriate potential genotoxic control strategy for the oil-based formulation.

Research Triangle Park, North Carolina

Global External Development and Supply• Expert in technical outsourcing of early and mid-phase projects. Continuous responsibility for managing several external projects in parallel across multiple third-parties to deliver to GMP standards. • Primary QC approver of drug substance and drug product specifications, clinical release packages and analytical sections of regulatory submissions on outsourced projects supported by the department. Key resource in Product Development for making technical decisions based on the quality management system.• Responsible for the GMP testing and documentation provided by third party contractors and the data integrity of the supporting package.• Assessed several third parties across North America for technical and quality competency as part of due diligence on-site visits. Experienced with the approval process of a new third party and the withdrawal of approval due to an unsatisfactory regulatory audit.• Member of the initiative team which drove process improvements focused on accelerating the portfolio. Helped design an overarching technical agreement procedure from both an analytical technical specialist and also as an expert in outsourcing work to third-parties.• Authored a quality master plan (QMP) between Pharma and GSK Vaccines to define a release procedure where a small molecule was being provided as an adjuvant in a formulation. This was required as the quality systems are different between these two parts of the company and required significant negotiation between the teams.• Member of the Analytical leadership team and the department extended leadership team. Direct manager of scientists overseeing external development and testing.• Established best practices and continuous improvement plans within the analytical function to deliver sustainable supply chain excellence.

Research Triangle Park, North Carolina

Emerging Markets R&D• Analytical Project Leader for two fixed-dose combination (FDC) drug products of marketed medicines. Performed/coordinated method development, validation, stability program design, formulation support, batch release, method transfer to an external contractor, specifications, OOS investigations and technical troubleshooting activities to progress these projects. Authored several sections of the MAA for one of these projects in preparation for file.• Responsible for identifying suitable drug substance vendors to supply generic API to our projects at several internal and external sites. Acted as a resource for coordinating quality audits, placing orders, importing clinical materials, outsourcing testing and authoring internal release documentation for QA approval.• Designed a specific release process for commercial API being procured by our group, as at the time the SOPs did not provide sufficient guidance for this activity. The process was agreed with the management team and QA and successfully implemented. Subsequently pushed for changes and helped author sections of the SOP involving the release of API procured from a third party.• Played a key role in definitively identifying data falsification at an outside contractor performing stability work for one of these projects.• Assisted QA with authoring Quality/Technical Agreements with API vendors in support of API procurement. Designed a product requirements specification (PRS) document template to compliment the Quality Agreement which specifies certain details required for delivery of the API.• Responsible for coordinating the genotoxic risk assessment (GRA) activities for projects and guiding analytical leads through the process as well as interfacing with the chemistry and degradation experts to author the risk assessment.

Research Triangle Park, North Carolina

Pharmaceutical Development• Accountable for developing, validating, and authoring analytical methods for achiral/chiral purity determination of synthetic route intermediates and drug substance designated for clinical or non-clinical studies under GxP regulations. Skilled at troubleshooting chromatographic and instrumentation problems and validating solutions• Extensive experience with hands-on generation and review of GMP data and issuing batch release documentation• Acted as the department’s Quality leader by designing and operating a Level 1 audit program, becoming the department change control and risk management champion, participating on SOP authoring and revision teams and becoming a primary contact for training activities for the department• Organized and led a multidisciplinary team tasked with transferring the analytical methods of a late phase project from the R&D team to the GMS group via a “one team” approach• Analytical API project team leader on several projects ranging from candidate selection through Phase 3• Designed, authored, and obtained agreement of specifications for drug substances, intermediates, reagents, and starting materials. Authored IND/IMPD sections and quickly organized responses to regulatory questions• Incorporated Quality by Design (QbD) philosophy into methods, specifications, and regulatory filings by understanding the causes of analytical variability and building the precision of the analysis into the specifications. Specific activities include risk assessments, defining critical quality attributes (CQA), failure mode effect analysis (FMEA), and a measurement system analysis (MSA) approach to analytical method transfer to GMS and R&D facilities• Member of two in-house electronic notebook core development teams• Performed drug product analyses on soft gelatin capsules-including identification by infrared spectroscopy, content, impurities, content uniformity, and dissolution assays