Christopher Ignace Email & Phone Number

Salt Lake City, Utah, United States

Responsible for strategic input to support nimble, effective, and compliant engineering and product development programs. Support framework for partnerships with drug developers, facilitating data exchange and regulatory submission strategies. Also facilitate identification and handling of regulatory and quality compliance issues through leadership roles in the Coalition of PET Drug Manufacturers. Joining Nusano provides a unique opportunity to develop a comprehensive view of radiopharmaceuticals, from isotope production to drug development. This is especially relevant in the theranostic space where isotope access has already proven critical to patient care - from clinical development to commercial product availability.

Mesa, Arizona, United States

Responsible, as internal expert, for introducing US and foreign pharmaceutical companies to Cardinal’s CDMO capabilities regarding FDA filing, technology transfer and manufacturing, as well as supporting radionuclide generator manufacturers with risk management, quality and regulatory compliance needs. Leverages Trade Associations involvement (PET Coalition and MITA) to support nuclear corporate strategy, risk management and compliance, and advise on manufacturing versus nuclear pharmacy (cold kit) strategies. Provides oversight of studies and authorship of scientific protocols and reports. Highlights:- Developed compliance and technical documentation to support the distribution of patient syringes from the product vial for a new alpha therapeutic product, driving product acceptability from about 25% to over 70% among healthcare providers without internal nuclear pharmacies.- Justified Tech99m usage level by nuclear pharmacists above package insert in order to increase throughput (>2X), improve margins ($X00K), maintain shelf life, while reducing operator exposure by limiting elution line replacement for newer Moly99/Tech99 generators (100mCi).- The above often positioned Cardinal as the only US drug supplier during Moly99 shortages. - Supported Corporate strategy to join the radioisotope production space with Ac225. - Supported and lead multiple initiatives through MITA and the PET Coalition, such as CMS reimbursement (FIND Act), changes to USP chapters (<823>, <825>), comments to FDA new or revised Guidance, and multiple FDA-Industry Workshops.- Created and presented Webinars on various aspects of theranostics drugs to strengthen Cardinal market leadership position.

Mesa, Arizona, United States

Responsible for optimizing the scientific and medical infrastructure to meet the growing and evolving needs of the company as a result of organic growth and product acquisition, as well as increasing development revenues and decreasing clinical program cost.Highlights:- Created and established staffing levels of Clinical, Medical and Scientific Affairs.- Supported multiple sponsor contracts for technology transfer and clinical trial material (CTM) production, generating millions in revenues within a now self-sustaining CDMO organization.- Moved internally a Phase IV proprietary clinical trial program (NDA), in addition to the pharmacovigilance program for the Cardinal nuclear portfolio (savings in excess of $1M).- Lead a stalled trial turnaround (saving near $1M, while alleviating regulatory compliance risk).

Mesa, Arizona, United States

Responsible for optimizing the regulatory, quality and technical strategies of potential partners. Lead the creation of tools to increase the efficiency of the contracting process as a CDMO, and identify business options that support growth in the theranostic space. Internally, optimize further the technical functions and oversee all FDA regulatory filings and communication. Highlights:- Identified creative regulatory and compliance approaches to Technology Transfer and FDA approval of the first US CMO-produced alpha-therapeutic drug for Bayer (Xofigo®) ($X00M).- Secured the FDA approval of 3 PET drug ANDAs without business and operational disruptions.- Fostered a constructive FDA communication (on-site FDA inspections, direct FDA interface such as Type C meetings, and FDA forums/symposia), growing FDA leadership relations.- Reduced the time of new program financial costing 10-fold through spreadsheet automation, from about 20 to 2 hrs, while allowing margin calculations and what-if scenarios.- Integrated Product Development and Validations under Technical Operations.- Developed from personal network the first sponsor partnership at the Innovation Center, now a multi-million dollars CDMO theranostic endeavor under facility expansion (2023-24).

Mesa, Arizona, United States

Responsible for adapting the regulatory and scientific functions and staffing to the new FDA compliance/CFR regulations. Concurrently lead the CMC development and filing of 3 ANDAs within 18 months. Highlights:- Staffed and formalized Regulatory Affairs, while identifying and remedying talent gaps.- Promoted project and risk management tools, lead cross-team planning sessions, which was critical to CMC development and FDA filing of 3 ANDAs in 18M.- One of 2 US companies (out of 60) able to meet the original FDA deadline of 12/11.- Optimized product specifications and processes for all PET products.- Formalized and ensured compliance of O18 water recycling, leading to x$100K/year in savings.

Provided support related to product and portfolio development and expertise to financial and investment firms.

Melrose Park, Illinois, United States

Responsible for leading the nanotechnology development group (45 employees), supporting scientific and regulatory needs of pre-clinical, clinical and commercial products for US and ROW.Highlights:- Secured termination of one failing developmental program, saving about $300K/year. - Supported key raw material supplier changes (albumin), and further process optimization in support of Abraxane® and derived programs (increased savings and resiliency).

Phoenix, Arizona, United States

Responsible for diverse areas of the business over 9 years through 3 internal positions combined under this section. Initially overseeing site functions, consisting of Production, Engineering, Quality Assurance, Quality Control, Regulatory Affairs, and external CMO performance. Focused on talent management and systems upgrades in support of technology transfers and production of clinical/commercial API/drug products, for OTC/Rx lines. Lead compliance programs and supported FDA site inspections. Expanded to Clinical Affairs to oversee medical device and drug programs, including turning around a faltering global Phase III clinical trial.Highlights:- Successfully addressed CGMP critical issues with a US CMO, limiting shutdown to 3M.- Reached agreement with FDA and salvaged OTC product line without Warning Letter.- Averted foreign market disruptions through support of Qualified Person (QP) (UK)- Selected CRO/Co-CRO and negotiated with Quintiles Inc the then-largest justified relative program cost reductions ($49M to $27M). Remained within budget throughout.- Quintiles Inc. took unsolicited equity position in a lead program ($500K capital).- Identified source of lack of patient enrolment and turned around enrolment by 10-fold.- From above, developed critical scientific rationale for a lawsuit against CRO resulting in $25M favorable settlement.- Upgraded Quality Systems to 21.CFR.800 to develop and receive FDA clearance of Vizilite®, a medical device (510(K)). Secured CE Marking.

Phoenix, Arizona, United States

Phoenix, Arizona, United States

Phoenix, Arizona, United States

Responsibilities expanded from the science and technology space as Senior Scientist to Product Department team oversight following rapid promotion (<1 yr). Seek acceleration of developmental cycles for generic products and streamlining of scale-up activities. Improve approach to corporate portfolio development. Support compliance programs, interfacing with various areas of Quality Assurance and Commercial Operations.Highlights:• Asked to lead multiple aspects of the compliance program at Schein (Watson/Teva) under consent decree; limited the scope of company product recalls and lead a rapid (<3 months) commercial return of InFeD® ($100MM/year). Interfaced with Lachman Consulting as assigned 3rd party.• Developed multiple approvable ANDAs while shortening historical timelines by 30-70%, including resolving within 2 days a 9M old formulation development hurdle for a lead ANDA program.• Facilitated and promoted a systematic approach to portfolio development with Business Development., resulting in the termination of 20% of financially non-viable programs and the adoption of a formal program selection process for future ANDAs.

Napa, California, United States

For Dey Laboratory (Mylan/Viatris), responsible for CMC development, which includes establishing novel technique for discriminating solid particle types in multi-suspended systems, and solving filling robustness issues as a result of rheological formulation properties.Highlights:- Resubmitted the CMC of the 505(b)(2) first US generic of Budesonide nasal spray, addressing both product and process issues, resulting in no deficiencies. - Defined synergies about analytical and manufacturing activities with CROs.

Seattle, Washington, United States

Responsibilities (for ex-ProCyte) expanded from science and technology to Group Leader role following rapid promotion from Senior Scientist (< 1 yr). Responsible for department creation and staffing, for analytical and process development for multiple new drugs and drug products, clinical trial material production, clinical trial compliance, as well as animal testing and modeling. Manage scientific communication with international sponsors, and author publications. Highlights:- Recruited and developed talent in support of new Product Development.- Lead multiple formulations into animal testing, leading to 6 drafted publications supporting a pharmacodynamic model.- Managed cultural and scientific expectations across US/Japanese sponsors.

Iowa City, Iowa, United States

Responsible for formulation and analytical development programs for multiple sponsors under post-doctoral program. This followed a PhD program about drug design and optimization based on biological feedback (for dry eye treatment), which added skills from prior research from France that included API characterization, cell/tissue isolation, growth and stimulation, protein identification, ADME-PK/PD studies, molecular modeling (QSAR), and drug interaction studies in animal models.

Ph.D., Pharmaceutics

Mba, International Management

MBA course work completed. Note: also B.S. Economics from Universite de Rennes, France (1984)

Pharm.D., Pharmacy

Institution: Universite de Haute-Bretagne, Rennes, France (not on drop-down menu, but equivalent to Nimes)