Daniel D'Attilio Email & Phone Number

Deerfield, Il, Us

Madison, Wisconsin, Us

Translating evidence to meaningful value for providers and payers for the screening business, building tools such as budget impact models used in the field, collaborating with providers on developing real-world evidence using EHR.

California, 94086, Us

Establish market access and HEOR function for the Digital Technologies Business Unit with focus building evidence of clinical and economic value of digital technologies and meaningful value transfer to customers, payers, and policymakers. Evidence includes developing novel machine-learning algorithms using surgical data to predict outcomes, comparing learning in robotic surgery vs. conventional laparoscopy, building patient registries that include patient reported outcomes (PROs), and identifying surgical task-based performance indicators by collecting and analyzing kinematic data. In partnership with surgeons and hospital administrators, research is published in terms of conference abstracts and peer-reviewed journal articles. Downstream activities include establishing claims for digital technologies to be used in tenders and in the field, making insights from digital technologies actionable for our customers, and developing a patient engagement platform. Also responsible for mediating patient access with HTAs and healthcare policymakers.

California, 94086, Us

Responsible for establishing and growing the market access function in the Asia Pacific region, Japan, China, Taiwan, India, Korea, Australia, and Southeast Asia); managing a team of 7 direct and indirect reports based in region; implementing initiatives related to P5 stakeholders (payers, providers, physicians, patients, and policymakers); developing market access tools such as core value dossier, cost-utility analyses, budget impact models, and meta-analyses; executing regional evidence generation strategy including clinical trials, patient registries, and observational studies; establishing and capturing real-world data (RWD) in partnership with surgeons and professional societies; and supporting HEOR and publication to drive coverage decisions and market adoption (notable successes include public and private coverage for robotic-assisted surgery (RAS) and instrumentation in China, Japan, India, and Taiwan; private coverage in Taiwan and India); managing account-level market access (Custom Hospital Analytics) in Japan.

Managing HEOR planning and activities for first-in-class vaccine for use in transplant patients (currently in Phase III) including HTA scientific advice, systematic literature review (SLR), network meta-analysis (NMA), core value dossier (CVD), cost-utility and cost-effectiveness analyses (CUA/CEA), budget impact models, and PRO analytics; leading patient reported outcome (PRO) analysis of Phase II trial data; facilitating development of a patient-level simulation cost-effectiveness model for separate Phase III program; coordinating analysis of patient registry data using joint model methodology to establish risk equations in chronic kidney disease patients, working with real-world informatics to analyze claims data to model prevalence of a pain disorder; developing HTA landscaping pieces and executing targeted literature searches for early development programs in several neurological disorders.

Irvine, Ca, Us

Creating and deploying health economic models to reimbursement field staff in the US; preparing cost-effectiveness analysis (CEA) and other economic models focused on TAVR; preparing core value dossier and Value Assessment Committee pack, working with KOL’s in US, Europe, and Japan to expand evidence development (journal articles, posters) through analysis of claims data, patient registries, and clinical trial outcomes; preparing for and responding to HTA evaluations in Canada and Japan.

Alameda, Ca, Us

Formulating regulatory and reimbursement strategy for Japan; supporting Japan regulatory, QMS, and reimbursement submissions; composing US (510k), Canada, and CE Mark submissions; creating value propositions/stories to support tenders in Europe; producing budget impact models for the US and Europe, preparing cost-effectiveness analysis models to be used in publication on retrospective outcomes data; working with marketing in Europe to formulate reimbursement strategy.

Abbott Park, Illinois, Us

FResponsible for formulating global reimbursement strategy for oncology biomarkers and infectious disease viral load tests (with focus on companion diagnostic for immunotherapy for NSCLC and melanoma); developing core value dossier; composing and submitting reimbursement dossier (e.g. US, Japan, Germany, UK, France, Australia); analyzing patient registry data to assess survivability; conducting micro-costing analyses for new assays; preparing cost-effectiveness models, managing reimbursement timelines with pharmaceutical partners; crafting economic models in BaseCase for use with providers and payers; driving reimbursement submissions for the Japan Abbott Diagnostics Division.

Warsaw, Indiana, Us

Establishing regional and local reimbursement strategies for Asia Pacific (including Japan, Australia, Korea, and Taiwan); supporting development of clinical evidence and economic models for health care economics activities in Asia Pacific and the US; co-writing with Zimmer Japan C1 reimbursement dossier for submission to MHLW; managing SharePoint database to analyze foreign average prices (FAP), transfer prices, list prices, average sales price (ASP), and unit sales in key markets; providing market access input into new product development projects.

Warsaw, Indiana, Us

developed submission strategies with Zimmer Japan, documented Japan unique regulatory requirements for New Product Development (NPD) process, established SharePoint site to track and measure progress and performance of global regulatory submissions (Asia Pacific, Latin America, EMEA, and US), provided documentation to Japan essential to regulatory dossier, coordinated monthly meetings with Warsaw and Zimmer Japan regulatory, communicated answers from research to PMDA deficiency questions, and helped develop and submit reimbursement submissions resulting in new functional categories several million USD incremental.

Minneapolis, Mn, Us

Leading, planning, and follow-up internal audits of the Neuromodulation business unit quality management system (QMS), serving as audit coordinator for all Japan related audits, conducting supplier assessments and audits, leading cross-business cross-functional group on Japan-related quality activities, working on Medtronic Inc.-Medtronic Japan quality agreement, maintaining all standards and quality records related to Japan, developing and maintaining web tool for audit scheduling and responses, passed BSI intensive course that is prerequisite for ISO 13485 certified auditor, coordinating subject matter expert activities during FDA inspections.

Minneapolis, Mn, Us

Coordinating new product planning; liaising with marketing, sales, healthcare economics, and regulatory staff to provide customer needs input to US product development teams; working with US development to relay key product information to Japan; forecasting sales revenue for new products; developing reimbursement applications for new products, scheduling projects for new product introduction; tracking US development project progress; conducting therapy opportunity assessments; coordinating manufacturing and labeling changes with US; refining the Japan regulatory submission process; managing biocompatibility testing for submissions.

managed regulatory timeline for all neuromodulation products, coordinated new production introduction project, worked with marketing staff to identify products under development that best fit Japan markets, prepared Japan unique regulatory requirements for integration into core standards assessment matrix for development, led key project for class II product from development to commercialization in Japan, developed training programs for regulatory affairs specialists, worked on database for Japan-approved raw materials, analyzed sales data to identify candidates for centers of excellence, trained regulatory affairs/vigilance staff in use of design history file database and Business Objects, helped to plan Physicians Advisory Board meeting, served as team member for supplier assessments and supplier audits, coordinated quality agreement with OEM partner.

Prepared regulatory submissions to PMDA (Japanese regulatory body), managed FY08 Neurological/MGU regulatory plan and execution, coordinated communication for vigilance and adverse event reporting to Japan, submission of MSA (Manufacturing Site Accreditation) and QMS submissions to the PMDA, updated old regulatory submissions, conducted presentations on Japanese regulatory requirements to Neurological/MGU business unit core development teams, represented Neuromodulation regulatory on China RoHS (Hazardous Substances) team, liaising with supply chain and Japan TOC, and translated of Japan PAL and ordinances relevant to regulatory submissions, promoted to senior level regulatory affairs specialist in late 2006.

Responsibilities at Osachi, a precision blood pressure monitor manufacturer, included: meeting with customers in Japan, Korea, Singapore, Hong Kong, and the U.S. to negotiate contracts and to expand sales; serving as interpreter to Japanese physicians and researchers at international seminars and meetings; translating medical research papers and submissions to journals; managing foreign/international communications, contracts, and patents; submitting device approval applications to the FDA and HLMW; assisting physicians in composing clinical protocols; coordinating clinical trial efforts among research bodies; licensing of patented company technology to OEM manufacturers; analyzing clinical data; and training/instructing clients and third party sales personnel in product usage and scientific background.

Ba, Anthropology/Sociology

Ma, History Of Asia

Japanese