Experience
Independent Consultant (Franco Pasquale Consulting LLC) May 2019 - Present
Supporting Pharmaceutical and Biotech companies with their supply chain and project management needs
Supporting a three clinical phase pharmaceutical companies with their new product launch preparations (2024)
Developed a Supply Chain Launch Roadmap
Developed supply related timelines for launch
Assisting with Commercial Packaging and Distribution sourcing
Supporting commercial supply agreement negotiations (manufacturing, packaging and distribution)
Supported a mid-size mRNA vaccine manufacturer with their procurement needs (2023)
SWOT analysis of Commercial Supply Agreements with Drug Product, Drug Substance and Raw Material suppliers.
Reviewed contract manufacturing agreements
Supported Albireo Pharma with their manufacturing and supply chain needs in preparation for their first commercial launch in the US and EU (2019 - 2022)
Implemented two commercial packagers, two 3PLs and a serialization service provider in the US and the EU including completing all validation activities.
Managed the development of US and EU commercial artwork and packaging design including collaborating with the Albireo Commercial team and graphic design service providers.
Collaborated with Regulatory Affairs and Legal group to assure labeling compliance and implementation of anti-counterfeiting measures.
Reviewed packaging validation protocols and batch records.
Implemented serialization systems in the US and the EU including leading the validation effort with support from serialization and validation consultants.
Developed commercial supply chain SOPs,.
Project management of the state distribution licensing effort.
Logistics Management
Albireo’s launch was ultimately successful and the drug product was available for sale ahead of the first drug orders.
Advised a small BioPharma on clinical supply (2021)
Provided a risk assessment on the company's proposed product strength matrix.
Developed a 3 year clinical manufacturing and packaging budget.
Agios Pharmaceuticals, Cambridge MA Aug 2015 – May 2019
➢ Vice President, Supply Chain (Oct 2018 to May 2019)
Directed the Agios supply chain department responsible for Agios’ clinical and commercial supply chain groups. This included managing a staff of 15 who were responsible for the planning, contract manufacturing and logistics of clinical and commercial small molecule products (from raw materials to final distribution)
Oversight of the supply chain for five products; TIBSOVO, AG-348, AG-270, AG-881 and AG-636 which included oversight of 13 suppliers
Decision maker (Directly Responsible Person) for the selection of commercial packagers, third party logistics partners (3PLs) and supply chain system providers
Chinese Partner Management
Chair of the Joint Manufacturing Committee for a development partner in China; C-Stone
Member of the Joint Steering Committee representing Technical Operations
EU Organizational Build Representative for Technical Operations
Represented Technical Operations in a senior management cross functional team that was assembled to develop a roadmap for building a new Agios European based organization.
This included sponsoring the selection of the EU based packager and distributor.
Reviewed of IND and CMC content in preparation for regulatory submissions
Partnered with CMC in the selection of API and drug product commercial manufacturers
Responsible for a budget of approximately $20 million (external spend)
➢ Senior Director, Supply Chain (Aug 2015 to Oct 2018)
Directed the Agios supply chain group (staff of 13) responsible for Agios’ clinical and commercial supply chain including commercial manufacturing, packaging, distribution and logistics activities
Started with a group of two and developed a fully functional supply chain organization
No stockouts and no clinical timelines missed due to supply chain during my oversight of the Agios supply chain
Successfully launched TIBSOVO in the US (July-2018)
Assured finished product availability in the supply channel within 9 hours of NDA approval
Selected three critical suppliers; Commercial Packager, Commercial Distributor and DSCSA service provider including MSA negotiations
Over 600 successful major material moves between CMOs with no material losses and 98%+ OTIF
Negotiated and implemented commercial supply agreements with API, spray dried dispersion, drug product, packaging and 3PL suppliers and service providers.
Developed and mentored high-performance leaders with career transitions
Transition of Head of Clinical Supply Chain to Head of Commercial Supply Chain. This person ultimately succeeded me when I left Agios.
Transition of QA Manager to Head of Logistics
Agios liaison for a Japanese supplier and Brazilian supplier for sourcing a comparator drug for Agios’ clinical trials.
This included negotiation of the supply agreements
Apple Inc., Cupertino, CA Jul 2014 - Jul 2015
➢ Global Sourcing Manager, Corporate Procurement
Sourcing manager (Procurement) of indirect procurement services for facilities projects and Apple retail store maintenance
Sourcing of General Contractors for the construction of a $200 million research facility in Japan
This project required living in Japan for approximately six months and it involved negotiating and implementing contracts with various Japanese construction suppliers.
Regional champion for Asia-Pacific sourcing team.
This included coordinating a remote team responsible for the sourcing of HVAC, electrical, plumbing, janitorial, fixture refurbishment and other services that support Apple retail stores
Developed RFP templates, processes and KPIs for Corporate Procurement
Led Supplier Business Reviews with key suppliers in support of Apple Retail Preservation
This opportunity allowed me to demonstrate successful adaptability and flexibility in working within a completely different industry, corporate culture and technical arena.
Onyx Pharmaceuticals, South San Francisco, CA May 2011 - Jan 2014
➢ Senior Director, Global Supply Chain and Logistics (Jan 2013 - Jan 2014)
Directed the Onyx Clinical and Commercial Supply Chain groups. This included managing a staff of 20 who were responsible for the planning, contract manufacturing and logistics of clinical and commercial small molecule products (from raw materials to final distribution)
Launched Kyprolis is five ex-US countries
Developed long term capacity and secondary sourcing strategies for commercial manufacturing
Project sponsor of a successful technology transfer of API and Drug Product manufacturing to secondary sources.
The project leads reported directly to me and the projects involved successful partnership with CMC
Implemented a novel outsourcing model including imbedded Supplier FTEs to supplement Onyx staff resources
Responsible for $60 million in budget (external spend)
➢ Director, Global Supply Chain (May 2011–Dec 2012)
Built a supply chain organization responsible for the planning, contract manufacturing and logistics of clinical and commercial small molecule products (from raw materials to final distribution)
Identified, selected and managed small molecule API and drug product contract manufacturers from raw materials to finished goods
Negotiated contracts and amendments with external parties including the negotiation of five key commercial supply agreements
Prepared Onyx’s global supply chain for the commercial launch of late-stage products including the successful launch of Kyprolis (lyophilized injectable) in the US
Assured finished product availability in the supply channel within 72 hours of NDA approval
Developed and implemented the Sales and Operating Planning (S&OP) process at Onyx
Primary liaison with contractors (CMOs, Third Party Warehouses and Logistic providers)
Developed labeling, packaging and distribution strategies for Clinical Supply
Developed and executed Clinical Comparator sourcing strategies
Supported a CMC chemist in a development opportunity to transfer to a supply chain management role
Genentech, South San Francisco, CA 2006 - 2011
➢ Associate Director, Clinical Contract Manufacturing (2010–2011)
Managed a team of outsourcing professionals responsible for outsourcing clinical manufacturing of antibody drug conjugation and drug product manufacturing
Selected, implemented and managed CMOs who augmented Genentech-Roche’s internal capabilities for clinical manufacturing
Negotiated contracts, changes and amendments with external parties
Managed a budget of $13 million
Developed Genentech-Roche’s clinical antibody drug conjugate contract manufacturing strategy including network, capacity, risk mitigation plans and organizational set-up
Tracked, monitored, and reported performance metrics related to operations, quality, cost, and customer service
Investigated, analyzed, reported, and tracked CMO and industry trends and applied lessons learned to drug product contract manufacturing strategy and tactics
➢ Senior Manager, Manufacturing Collaborations (2006–2010)
Managed a team of professionals responsible for outsourcing clinical manufacturing of small molecule drug product dosage forms (solids and injectables)
Managed 14 Clinical drug product CMOs involving 20 different sites
Added 10 CMOs and 15 different sites to the external clinical supply chain
Lead negotiator for supply agreements with CMOs
Project Manager for the merger integration team responsible for transferring contract operations from Roche-Nutley to Genentech-South San Francisco. This involved an effort comprising 80 people and nine months to execute
Established an Ex-US labeling, packaging and distribution Clinical CMO network
Developed risk assessments on CMOs
CMC team member on GDC-449 and GDC-941 projects
CMC Team Leader of small molecule drug development team for XL518
Led team to successful product development and filing of first IND for XL518
I was the first person outside of CMC to hold a CMC leader role at Genentech
Berlex Laboratories, Wayne, NJ 1997-2006
➢ Associate Director, Inventory Services and Commercial Outsourcing (2004–2006)
Responsible for directing the Inventory Services and Commercial Outsourcing group which included the management of Production Planning, Contract Manufacturing and Inventory Control.
Directed the Operations groups in preparation for product launches. Since I started my career at Berlex, I was involved with ten launches and had personally led the operations effort on two successful launches
Supply forecast management which included representing the Operations Department on corporate Sales Forecast outlook meetings
Led pricing and supply agreement negotiations with vendors and contractors (API, Raw Materials, Semi-Finished Goods, Finished Goods, Labels, Inserts and Packaging Components)
Managed collaborations with outsourcing partners (16 Suppliers). I was the Berlex Manager accountable for commercial supplier critical business issues (contracts, forecasts, binding commitments, disputes)
➢ Manager, Inventory Services (2002 – 2004)
Responsible for Production planning and Inventory management of all Berlex commercial products
Managed the overall planning process of generating and maintaining optimal inventory levels of products marketed by Berlex Laboratories.
Led/oversaw projects regarding significant changes in production sites as well as for other supply chain related projects such as large-scale technology transfers.
Led/oversaw in-house readiness and supplier activities as necessary for product launches
Led the Operations activities launch team of Yasmin
➢ Project Leader (2000 – 2002)
Oversaw outsourcing of manufacturing activities at contract manufacturing facilities.
Project Manager of product launch activities (Operations Team) including the successful launch of Betapace AF
➢ Senior Pharmaceutical Scientist in CMC (1997 – 2000)
Team leader of project teams related to drug product manufacturing and development activities.
Provided technical support to the drug product manufacturing outsourcing partners.
Organon Inc., West Orange, NJ 1988 - 1997
➢ Senior Pharmaceutical Scientist in CMC (1993 – 1997)
➢ Manufacturing Technology Specialist (1992 – 1993)
➢ Quality Control Chemist (1988–1992)