Drew Badger

Responsible for oversight of regulatory, medical writing, and toxicology functions at Apogee. Served initially as a hands-on regulatory and toxicology subject matter expert; subsequently built a medical Writing, Regulatory Affairs and Toxicology team (affectionately known as the WRAT Pack) to support Apogee's monotherapy and co-development programs.

With 25 years experience of hands-on and leadership roles in toxicology and regulatory strategy, I seek to support companies needing strategic and hands on work in the early stages of development when toxicology and regulatory strategy are highly interdependent.

• Served as Toxicology / Regulatory consultant for 4 months prior to becoming a full time employee (FTE) • Served as FTE for ~20 months • Responsible for oversight of regulatory and nonclinical strategies and activities related to Capsida's development pipeline, co-development programs, and commercialization activities • Defined regulatory and toxicology strategies and provided subject matter expertise to other development functions and executive management

Responsible for oversight of regulatory and nonclinical strategies and activities related to Dermira’s development pipeline, co-development programs, and commercialization activities. • Lebrikizumab - Led FDA End-of-Phase 2 meeting and Fast track designation submission, PSP and PIP pediatric submissions/negotiations, as well as regulatory aspects of the European partnership with Almirall and acquisition by Eli Lilly • Defined regulatory and toxicology strategies and provided subject matter expertise to other development functions and executive management • Managed the regulatory department, mentored and developed staff, and led regulatory filings and interactions with regulatory agencies • Supervised regulatory promotion, regulatory operations, and regulatory strategy personnel • Developed and oversaw execution of pre-clinical and clinical stage toxicology plans through supervision of consultants or Dermira staff that managed toxicology safety pharmacology, and DMPK vendors

Global Regulatory Strategy Leader from pre-clinical stage through BLA filing and approval of Aimovig for migraine prevention. Also served as global regulatory strategy leader for biologic and small molecule programs spanning multiple therapeutic areas (neurology, oncology, inflammation, rheumatology) and various stages of development. Worked closely with clinical and other project leads to develop and execute drug development strategies including global regulatory submissions, ethnic bridging strategies, pediatric strategies, and device and companion diagnostic strategies, among others. Former supervisor of the US regulatory team in CV, Neurology and Bone Therapeutic Areas.

1) Developed toxicology strategy, development and execution of toxicology studies, and manageed vendors. 2) Served as the single acountable regulatory expert for the company and point of contact with FDA. 3) Directed and oversaw the preparation, review, and submission of regulatory applications including several initial INDs, orphan applications, and annual reports, among others. 4) Participated as toxicology/regulatory expert for due diligence activities.

• Managed 30 individuals spanning Discovery Tox, In Vivo Sciences, Scientific Writing, Project management, and GLP compliance. • Oversaw discovery tox project representatives on early development teams and in vitro genetox/cytox screening lab • Oversaw the design, execution and reporting of (non-)GLP in vivo studies. • Supported prep. of protocols, reports, and submissions (e.g., IND, IMPD, IB, NDA). • Managed GLP/quality systems and acted as Drug Safety Evaluation (DSE) liaison with Quality Assurance; oversaw Master Schedule, DSE project management, DSE budget and manpower forecasting, SOPs, training records, contracts, and computer system validation projects. • Co-hosted 2 FDA audits with the Director of Quality Assurance

Study Director and Project Representative • Provided toxicology project representation for discovery and development programs. Maintained knowledge of modern tools for drug discovery and implemented as appropriate. • Developed and managed toxicology programs/submissions (IND/IMPD/CIB/clinical protocols) • Routinely presented data and study plans to project teams and toxicology department • Acted as Study Director and Study Monitor for GLP and non-GLP studies. • Overhauled discovery screening approach for genotoxicity and systemic toxicity to accommodate limited drug, timing considerations, and overall cost – modernized traditional approaches

Toxicology project representative • Acted as Study Monitor: in vivo / in vitro / clinical studies for hazard profiling of new technologies • Interfaced with regulatory agencies, trade associations, and clinicians as project toxicologist

Dissertation title: Alterations in Chemically-Induced Liver Injury by Immunomodulators.