Nicolas Mourier Email & Phone Number

Boston, Ma, Us

Cambridge, Massachusetts, United States

Provide technical and operational leadership for the drug development activities and guide the strategic direction of the development-stage pipeline.

(Now Sumitomo Pharma America)

Head of CMC for the preparation, development, and regulatory filling of Enzyvant clinical lead product rodatristat ethyl (tablet – small molecule solid oral dosage) in Phase IIb clinical trial for pulmonary arterial hypertension (PAH) and pre-IND stage development of ALTA-2530 (sterile recombinant protein solution and inhalation device) for bronchiolitis obliterans syndrome (BOS).

(Now Chemomab Therapeutics)

Head of CMC for the upstream and downstream Drug Substance (DS) and Drug Product (DP) manufacturing and regulatory filling of Anchiano lead product inodiftagene vixteplasmid (sterile solution for gene therapy) in Phase II clinical trial for bladder cancer.

(Previously Laboratoris Sanifit S.L.)

Head of Manufacturing for the preparation, development, and regulatory filling of Sanifit lead product SNF472 (small molecule sterile injectable) in Phase III clinical trial for calciphylaxis (CUA).

(Now Rocket Pharmaceuticals)

Head of CMC for the preparation, development, and regulatory filling of Inotek lead product trabodenoson (small molecule ophthalmic sterile suspension) in Phase III clinical trial and fixed dose combination (FDC) with latanaprost in Phase II clinical trial against glaucoma and ocular hypertension.

(Previously Celsus Therapeutics Plc)

Head of CMC for the preparation, development, and regulatory filling of Celsus single asset product MRX-6 (small molecule topical cream) in Phase II clinical trial for atopic dermatitis.

ARIAD PHARMACEUTICALS (August 2013 – October 2013) Consultant within the Quality Assurance department for the technical support of commercial API ponatinib (Iclusig)MILLENNIUM PHARMACEUTICALS (July 2012 – July 2013) Consultant within the Technical Operation department for the transitioning of MLN8237 into commercial development and technical support of commercial APIs bortezomib (VELCADE) and MTP-PE, Na (MEPACT)DECLION PHARMACEUTICALS (November 2011 – June 2012) Consultant for the development of the clinical phase II material PI-2301 with partner MERCK SERONO (manufacturing and analytical development).INSPIRATION BIOPHARMACEUTICALS (November 2010 – March 2012) Helped in the program management and the development of the phase III biological product OBIZUR in collaboration with partner IPSEN PHARMACEUTICALS. OBI-1 was acquired by Baxter on Mach 2013. OBIZUR is approved in USA, CANADA and EU.SHIRE (April 2010 – August 2010): Provided expertise on a manufacturing issue of the commercial product FIRAZYR that did not meet specifications for the last five DP manufacture. Evaluated the entire DS and DP manufacturing processes, assessed analytical released methods and specifications and evaluated raw materials purity. Worked with third parties CROs and CMOs to harmonize DS and DP HPLC analytical method and recommend path forward with DS and DP manufacturing processes. Successfully identified raw material impurity responsible for batch failure. Made recommendations for regulatory options to optimize manufacturing process, harmonize analytical methods and revise specifications.

Head of CMC for the preparation, development, and regulatory filling of lead product PI-2301 (sterile injectable of peptide mixture) in Phase II clinical trial for relapsing remitting multiple sclerosis (RR-MS) and early-stage peptide discovery.

(Previously Wolfe Laboratories, Inc.)

Wolfe Laboratories, Inc. (www.wolfelabs.com) provides support for analytical development, preformulation, formulation development, and stability studies.

(Previously Johnson Matthey Pharma Services)

Phd, Organic/Medicinal Chemistry

Master'S Degree, Organic Chemistry

Bachelor Of Science - Bs