Dr. Sven Kronenberg, DABT, ERT

• Support of Toxicology Project Leaders (TPLs) in day-to-day project activities for all Oncology projects; • Provide advice and guidance for TPLs in project-related topics and facilitate decision making at appropriate levels including recommendations for topic escalation as appropriate. • Review dose settings of toxicology studies and provide active input to dose selection of all studies.

• Lead projects from a toxicology perspective to deliver high quality and timely scientific, strategic and operational support with the beginning of dose-range finding studies through all phases of development and for marketed products (Indications: CNS, cancer, infectious diseases, immunology, opthalmology); • Responsible for design, conduct, monitoring and reporting of preclinical safety activities on early and late stage projects in global project teams; • Responsibility for small molecules and biologics; • Overall accountable for the quality and adequacy of the nonclinical safety component of regulatory submissions and other documents with regulatory submission potential, including but not limited to: preIND meetings requests and material, IBs, INDs, CTAs, BLAs, MAAs, EMA SA requests and meeting packages and other forms of preclinical safety/regulatory communication (consultants, external partners etc.); • Provide support to other preclinical safety related tasks such as development of immunogenicity, PK and PD-assays, general pharmacology, experimental toxicology etc.; • Drive the strategy for setting and calculating the FIH dose (based on e.g. NOAEL, NOEL, MABEL); • Provide general and safety input to the target identification and selection team; • Toxicology representative in due diligence activities to assess the safety profile of possible new drug candidates; • Input on marketed products: PSURs, dealing with requests from regulatory authorities; • State-of-the-Art knowledge of current guidelines for nonclinical development of small molecules and biologics; • Tracking of Toxicology budget within a project.

Toxicology Site Head at Roche Penzberg (Longterm Assignment), responsible on-site for all Toxicology-related acitvities, including: • Participation in review of development projects in local review boards on oncology; • Participation in bioengeneering meetings on technical aspects of biologics for all disease areas (oncology, inflammation, infectious diseases, CNS); • Member of local Site Leader Team (Center Management Team); • Represent Roche’s European Biologics sites globally within the NCS Leadership Team as member of the LT team and participation in the NCS drug safety reviews; • Introduce/train new NCS colleagues on-site on NCS testing and development of biologics, lead interaction with colleagues at the other sites.

• Represent the aligned safety position at Research reviews, Portfolio committee meetings and in Clinical development reviews to support portfolio decisions and ensure that NCS project needs are properly addressed; • Keep track of evolving overall Oncology portfolio; • Serve as contact person for NCS-related questions not related to a specific project; • Align with other disciplines to represent function in review meetings; • Keep close interaction/Single point of contact to the Oncology disease area management.

• Nonclinical expert and study responsible for all types of external in vitro and in vivo toxicology studies of small molecules (e.g., general toxicology, reproductive toxicology, genotoxicology, safety pharmacology, carcinogenicity, immunotoxicology); • Complete toxicology program conducted for two approved drugs; • Leadership and responsibility for non-clinical safety of development projects as team representative; • Study responsible (i.e. planning, conduct and assessment of toxicity studies from single dose to 2-year carcinogenicity studies); • Contact person for all kind of safety issues arising during drug development; • Managing skills in the core and sub team to assure appropriate timing and conduct of safety studies with other colleagues (pharmacologists, bioanalytic and toxicokinetic experts); • Writing documents for authorities (toxicological parts and chapters of e.g., Investigator's Brochures, CTX, and INDs).