Brian J. Burns Email & Phone Number

Austin, Tx

Established and continue to grow and support the team of attorneys and other related professionals who are responsible for providing all legal, compliance, investigations, privacy, people services, public policy, and public relations support for best-in-class, patient-focused ABA provider.

Greater Denver Area

Built, developed and supported a team of 15 attorneys and legal professionals responsible for providing legal support to DaVita’s subsidiaries: Nephrology Care Alliance, DaVita Labs, Nephrology Practice Solutions, Lifeline Vascular Care (divested 2020), DaVita Clinical Research, DaVita Hospital Services and Patient Pathways, reporting directly to Group Vice President, Deputy General Counsel As a senior member of DaVita’s legal department, assisted with administrative duties, implemented strategic goals and initiatives and identified and implement best practices across lanesAs a senior member of DaVita’s healthcare regulatory lane within the legal department, advised the management teams of DaVita and its subsidiaries on issues related to value-based care arrangements, physician relationships, practice acquisitions, operations, investigations, litigation, privacy, research and development, real estate, human resources, mergers and acquisitions, commercial contracting, billing and revenue operations, etc. with a concentration on healthcare regulatory and compliance issues including issues related to the Anti-Kickback Statute, False Claims Act, the Stark Law, government inquiries, CAP/CLIA, Qui Tam complaints and compliance with DaVita’s Corporate Integrity AgreementPartnered with DaVita’s compliance department to develop, implement, and provide ongoing support to, subsidiary compliance programs including the development of a referral source arrangement review process designed to ensure compliance with applicable healthcare laws and regulations including the Anti-Kickback StatuteServed as counsel for DaVita’s Innovation group including collaborations and alliances with industry partners and academic institutions for pharmaceutical and medical device development, predictive algorithm development, assay development, biomarker identification, etc.Drafted/reviewed marketing materials, press releases, SEC disclosures, website content and other public disclosures

Denver, Colorado

Served as general counsel for DaVita Clinical Research, DaVita Labs and Lifeline Vascular Care (formerly Lifeline Vascular Access); managed a team of attorneys and legal professionals

Denver, Colorado

Served as general counsel for DaVita Clinical Research and DaVita Labs; managed a team of attorneys and legal professionals

Denver, Colorado

Served as general counsel for DaVita Clinical Research and DaVita Labs; managed a team of attorneys and legal professionals

Northbrook, Il

Served as in-house counsel to Astellas affiliates including Astellas Pharma Global Development, Inc. and Astellas Scientific and Medical Affairs, Inc. reporting directly to the Associate General Counsel, R&DServed as lead counsel for the Astellas Pharma Global Development, Inc. oncology group Offered counsel to internal clients on various issues related to contracts, international clinical operations, alliances and partnerships, licensing, business development, regulatory matters and complianceDrafted and negotiated contracts including Collaboration Agreements, CRO Master Service Agreements, Work Orders, Change Orders, Letters of Intent, Confidentiality Agreements, Clinical Trial Agreements (including international Clinical Trial Agreements and Investigator Initiated Trials), Laboratory Service Agreements, Consulting Agreements, Speaker Agreements, Advisory Board Agreements, etc.Lead effort to revise Clinical Trial Agreement templates, processes and procedures globally allowing for faster study start up including training of internal clients and the Functional Service Provider CRO responsible for management of the Clinical Trial Agreement negotiation processNegotiated multiple Master Service Agreements and Work Orders for Functional Service Provider CRO relationships as Astellas looked to outsource pre-clinical and clinical research activities on a large scale with small number of CROsServed as lead counsel for Astellas' first Expanded Access Program and Named Patient Program for XTANDI (enzalutamide) working closely with in-house regulatory attorneys and outside counselDrafted and reviewed press releases, website materials and clinical trial recruitment materialsLiaised closely with in-house regulatory and commercial attorneys as investigational compounds were submitted for regulatory approval and preparations were being made for product launchManaged paralegals responsible for negotiating agreements globally

Bridgewater, Nj

Served as in-house counsel for sanofi-aventis US Inc.'s Research and Development Division reporting directly to Vice President & General Counsel, U.S. Research and Development Division Served as counsel to internal clients on various issues related to contracts, clinical trials, alliances and partnerships (including academic and sponsor partnerships), licensing, business development, regulatory and compliance, etc.Drafted and negotiated contracts including Collaboration Agreements, Partnership Agreements, License Agreements, Material Transfer Agreements, CRO Master Service Agreements, Work Orders, Change Orders, Manufacturing Agreements, Letters of Intent, Confidentiality Agreements, Clinical Trial Agreements, Laboratory Service Agreements, Consulting Agreements, Speaker Agreements, Advisory Board Agreements, etc.Served as lead counsel on all Information Technology related License and Service Agreements

Malvern, Pa

Served as part of the small core team of employees that completed a successful Phase II clinical trial and due diligence process which resulted in Gemin X being acquired by Cephalon, Inc.Served as in-house counsel for business development, clinical operations and drug development issuesManaged all contracts, reporting directly to the Chief Financial OfficerDrafted and implemented contract management SOP’s, including training all staff prior to implementationDrafted and negotiated all contracts for all functional areas including CRO Master Service Agreements, Work Orders, Change Orders, Manufacturing Agreements, Letters of Intent, Confidentiality Agreements, Engagement Letters, Clinical Trial Agreements, Laboratory Service Agreements, Material Transfer Agreements, Licensing Agreements, Share Purchase Agreements, etc.Identified legal and business risks in all contracts and worked with the management team as necessary to address those risksManaged dispute resolution process and negotiated settlements by liaising with management team, vendors and outside counsel when necessaryNegotiated Phase II oncology clinical trial budgetsSupervised and managed CRO negotiation of Clinical Trial Agreements and clinical trial budgets for international clinical oncology sitesManaged grants administration process for all clinical sitesAssisted management team throughout the due diligence process including organization of all relevant documents, negotiation of relevant agreements, etc.

King Of Prussia, Pa

Held multiple positions of increasing responsibility in the Agreements department ultimately being promoted to Manager, AgreementsSupervised team of Contract Negotiators (attorneys) and Study Initiation Services staff membersDrafted and negotiated clinical site related agreements globally for Phase I-IV clinical trials including Clinical Trial Agreements, Confidentiality Agreements, Indemnification Letters, Facility Letters, Agency Letters, Amendments, etc.Recommended language and budget negotiation parameters to Sponsors based on past experienceTrained staff on template usage and negotiation parametersNegotiated clinical trial budgets for Phase I-IV clinical trialsLiaised with Sponsors, Project Directors, Grants Management, and other global team members during Clinical Trial Agreement and clinical trial budget negotiation processReviewed Informed Consents, 1572s and other essential documentsRecognized revenue and worked with Finance Department and Business Development Department to issue change orders to Sponsors when appropriate

Jd

Bs, Economics

Education record