Dr. Gunther Busam

Build and Lead from scratch the European Supply Chain Operations incl. the apheresis network to support clinical studies and prepare for commercial launches for CAR-T assets liso-cel (CD19, Breyanzi) and ide-cel (BCMA, Abecma). Managed a.i. external manufacturing to prepare a CMO for launch readiness. From 2021 managing additionally CT Supply Chain Japan and Global CT Logistics. Key Accomplishments: Delivered launches on-time in Europe/Switzerland of Abecma, Breyanzi and for Abecma in Japan in 2021/22

Lead the Cell&Genetherapy/Biol Development procurement team to support development and commercialization of CTL019 (Kymriah) and further CAR-T programs; support the cell&gene line function on capacities, technologies and expansion of footprint EU/JPN; support biologics development (early and late phase); manage other cell&genetherapy programs and novel biologics entities and biosimilars Key Accomplishments First-in-class launch of Kymriah in US (2017) and in Europe (2018) for pedALL/DLBCL

Championed the newly created Cell&Genetherapy procurement team to develop the supply base and prepare for commercialization for CTL019 (Kymriah); manage Novartis cell&genetherapy programs as sourcing accountable. Build the contract manufacturing and supplier network for CAR-T. Develop integrated sourcing plans and make vs. buy analysis. Worked on end-to-end value chain on autologous CAR-T as make-to-order. Key Accomplishments: Achieved commercial launch readiness for CTL019, US/EU/JPN.

Spear headed the sourcing activities for development innovation projects in a newly designed role with the goal to build new capabilities to capture innovation from suppliers&partners. Sourcing partner of the Trial-of the-future team, and the new Cell&Genetherapy Unit to accelerate Novartis` Cell&Gene programs. Key Accomplishments: Piloted crowd sourcing and tested open innovation approaches Identified, Evaluated and Engaged Suppliers on Novel Clinical Settings Developed&Implemented technology roadmap

Established a cohesive Technical R&D Sourcing team from fragmented parts in the organization. Developed efficient buying processes and sourcing strategies for drug substance synthesis, formulation development, clinical manufacturing, testing, comparators, drug supply packaging and logistics as basis for multi-year savings and supplier strategy. Key accomplishments: Achieved significant multi-year annual cost savings of 9%+ annually; delivering 20% of overall development productivity.

Led the global team managing company’s international external packaging, labeling and distribution activities and supported the majority of Novartis`phase III programs. Managed ~ 80+ annual major development studies externally; submission relevant, complex phase II to III/IV studies across Novartis therapeutic disease portfolio; including QAB149 (Onbreeze) and its combinations, Galvus, SPP100, FTY720 (Gilenya), Diovan combinations with Enalapril and SPP100; managed US$50,000,000 external spending.

Managed a supply team and held responsibility for clinical trial preparation and timely delivery for assigned portfolio of 14 development programs with ~120 studies (tox, phase I to phase IV and IITs) including Exelon patch, Myfortic, Tasigna, Afinitor, Femara, Zometa, Lucentis. Acted as member of international clinical team and liaison role with clinical trial teams and technical R&D teams. Developed a Clinical Supply Simulation Tool to reduce waste and mitigate risk in the supply chain.

Managed assigned outsourced studies; ensured timely clinical supply availability. Collaborated on GMP audits and supervised supplier quality and performance; performed in-sourcing, outsourcing and vendor selections; managed several complex phase III clinical supply studies (i.e. for Exelon, Gilenya, Lucentis) including evaluating suppliers and closing frame agreements with selected DSM suppliers.


Led a team and managed all internal and external clinical supply activities with clinical trial supply team, included ~5 programs with approx. 20 phase I to III studies. Worked with clinical teams and CROs to set-up externally drug supplies packaging and distribution. Conducted audits, negotiated quality and commercial agreements with external partners. Held production head responsibility for clinical trial supplies manufacturing and release based on German law.

Held 12-month rotating role in majority of company’s departments including site visits of several facilities in Germany and Ireland to prepare implementation of new production strategy. Supported production head in coordinating site transfers of equipment, processes and technologies for re-organization project of global manufacturing footprint.

Biochemische und Molekularbiologiesche Untersuchung zu Induzierter Systematischer Resistenz der Weinrebe