Andrew Dibble Email & Phone Number

Initially, my work was essentially 100% research and development of antisense oligonucleotide (ASO) parenteral formulations. Over the past ~ six years, it has evolved to be ~ 50% project management related to: (i) one large research initiative impacting the Ionis platform technology, and (ii) late-stage product development of partnered programs, including writing and reviewing CMC sections of two CTD submissions.Responsibilities include:• Act as the Ionis Pharmaceutical Development primary point of contact for several corporate partners, especially with regard to tech transfer activities, drug product (DP) manufacturing, and cooperation on the preparation of CMC sections of regulatory documents• Write DP sections of regulatory documents (e.g., INDs, IMPDs, CTDs) and review other CMC sections of the same documents• Physicochemical characterization – e.g., viscosity, self-association, injectability, impurity profile – of aqueous solutions of ASOs• Lead interdisciplinary teams on the above initiatives• Coordinate/oversee the manufacture of clinical and process validation DP batches at contract manufacturing facilities -Resolution of nonconformance, out-of-specification, and out-of-trend investigations• Evaluate the viability of alternative dose administration devices that may provide benefits such as facilitation of at-home administration• Periodic written and oral updates to project teams and management• Supervise and train coworkers, with a special emphasis on maintaining productivity, effectiveness, and morale in an intense, data driven, interrogative environment

Oversaw formulation, preformulation, solid state characterization, and analytical method development projects in a GLP/cGMP contract development laboratory. Responsibilities included:• Acted as Study Director on development projects• Wrote quotes, protocols, and study reports for a variety of clients and types of work• Forecasted the resources required for specific tasks, and created project plans/timelines• Communicated frequently with clients• Supervised coworkers, especially with regard to facilitating their ability to multi-task and set priorities in a fast-paced work environment

Research and development of several long-circulating (i.e., Stealth(R)) lipid-based parenteral formulations. Responsibilities included:• Conducted studies to optimize the Stealth liposomal cisplatin formulation and process, especially with regard to extending shelf-life (from 6-9 months to > 18 months), providing freezing protection, and increasing the drug-to-lipid ratio• Assisted with studies to establish a correlation between in vitro and in vivo doxorubicin release from DOXIL(R) (i.e., Stealth liposomal doxorubicin) and helped to write a regulatory submission to the FDA as part of our Phase IV commitments on this topic• Analyzed the viability of a project to develop a Stealth liposomal formulation of a natural compound not worked with previously at Sequus, with regard to scientific feasibility, cost of goods, patent issues, and market potential in the applicable therapeutic area• Supervised and trained coworkers in the use of experimental techniques, and helped them design experiments and interpret their findings

Charlottesville, Va

My postdoctoral research (in the laboratory of Prof. Rodney Biltonen) corroborated the importance of bilayer physical properties (e.g., bilayer curvature, domain formation) in the activation of enzymes (e.g., phospholipase A2, protein kinase C) that bind to the lipid/water interface. Experimental techniques utilized included FTIR, 13C NMR, and 31P NMR spectroscopies, DSC, kinase and lipase reaction assays, and binding of peptides and proteins to vesicles.