JOANNE T. RUPPRECHT, ESQ., RAC- US, RAC-Global, CCEP

Curriculum Vitae

720-***-****

adcid4@r.postjobfree.com

https://www.linkedin.com/in/compliancesq/

PROFESSIONAL SUMMARY

Accomplished and resourceful legal advocate with a strong scientific background and technical foundation, who embraces a wide variety of disciplines including business, complex contract, government procurement, real estate, compliance/regulatory affairs, public policy, intellectual property and administrative law matters, and who has successfully worked in academic, small office and large corporate environments, is seeking a collegial environment that can benefit from my education and professional experience, and can utilize my desire to achieve and contribute. CONTRIBUTABLE SKILLS

• Academic, Commercial and Government Contracts/Grants

• Regulatory Affairs

• Corporate Compliance and Ethics

• Business Dispute Resolution

• Legal and Medical Research and Writing

• Complex Contract and Regulatory Reviews and Negotiations

• Intellectual Property Protections

• Public Policy Analysis

• Client Relations

• Speaking Engagements, Training Programs and Educational Seminars PROFESSIONAL EXPERIENCE

Rupprecht Consulting Services, LLC (2016-Present)

Owner and Principal Consultant

• Assists in-house and outside counsel teams with legal advisory services, advice, strategies, training, and leadership on Administrative/Regulatory Law, Business Law, Contract Law, and Corporate Compliance and Ethics matters.

• Possesses advanced legal research and professional writing skills for drafting commercial, academic, and government contracts, legal pleadings, memoranda on law, and letters of opinion.

• Effective at negotiating and brokering legal agreements and drafting, reviewing and negotiating service, commercial, clinical, government/grant, and complex service contracts.

• Effective at optimizing business operations for large companies, small businesses, inventors, and entrepreneurs and conducting the due diligence to solidify value propositions, intellectual property strategies and regulatory pathways forward.

• Proficient at developing and implementing risk management systems, risk mitigation strategies, and remediation programs, as well as overseeing governmental reporting activities.

• Dedicated to overcoming information deficits with constructive dialogue and resolving disputes to avoid costly litigation.

• Enjoys collaborating with other professionals, public speaking, and participating in educational initiatives.

University of Colorado Denver, Anschutz Medical Campus (2016-present) Adjunct Professor/Course Director, Regulatory Environment of Life Science Innovation

• Teaches a graduate level course in the Graduate School for the Biomedical Science and Biotechnology (BSBT) program for life science students which focuses on the fundamentals of the quality, clinical, and regulatory processes for nutritional supplements, cannabis/CBD products, drugs, medical devices, biologics, combination products, human cellular and tissue products (CAR T-Cells, Stem Cells), in vitro diagnostics (IVDs), software as a medical device (SaMD), and healthcare IT and platform applications and services. This course also explores over the counter (OTC) regulations including the use of monographs and GRAS pathways. University of Colorado Denver, Anschutz Medical Campus (2017-present) Adjunct Professor/Course Director, Biomedical Entrepreneurship

• Teaches a graduate level course in the Graduate School for the Biomedical Science and Biotechnology (BSBT) program for life science students that focuses on the fundamentals of biomedical and healthcare product innovation and entrepreneurship, including the basics of formation of business entities, contracts, intellectual property protections, technology transfers, early stage accounting and finance, marketing and business development, biobusiness law, and the regulatory environment for the research & development, manufacturing, and commercialization of healthcare products, services, and technologies.

University of Colorado Denver, Anschutz Medical Campus (2017-2019) Research/Translational Services Program Director for Regulatory Compliance

• Effectively interacted and communicated with investigators, sponsors, and cross-functional research and development teams on product feasibility, protocol development, clinical trial preparation, labeling, and regulatory requirements for investigational products.

• Conducted strategic reviews of early development, pre-clinical (animal) and clinical (human) study results, as well as desired marketing claims to determine the most efficient and effective regulatory pathway to commercialization.

• Assisted cross-functional research and development teams with generating and assembling materials for Institutional Review Board (IRB) approval, electronic common technical document (eCTD) submission to FDA through the electronic submission gateway (ESG), and paper submissions for single-patient/compassionate use INDs.

• Prepared teams for informal and formal communications with FDA including medical device investigational device exemptions (IDEs), pre-submissions, requests for designations of class, biologic INTERACT applications, and drug/biologic product pre-IND meeting requests and briefing packages.

• Conducted cGMP gap analyses and risk assessments to assist the biomanufacturing facility achieve compliant operations; contributed to the writing and submission of the Facility Master File to FDA for use and reference (Letters of Authorization) by its internal and external customers.

• Collaborated with the Technology Transfer Office to guide teams early on in the development of their claims, and the science required to support those claims before FDA, and Federal Agencies in grant applications.

• Worked closely with University Counsel on Master Service, Quality, Clinical Trial, and Manufacturing Agreements/Scopes of Work [SOW] for various projects.

• Established the electronic regulatory submission program for investigational drugs and biologics, including cancer immunotherapy products (CAR T cell and stem cell therapies).

• Supported the biomanufacturing facility with the maintenance of its Quality Manual, standard operating procedures (SOPs), batch records, master bath records, and stability studies required to support regulatory submissions for investigational products; assisted with the drafting and review of required CMC eCTD Modules for submission to FDA.

• Collaborated with internal and external stakeholders to ensure compliant operations during all phases of product development, clinical research, and manufacturing.

• Trained internal teams on manufacturing, clinical study, quality (design control and CAPA Plans), and regulatory requirements for investigational products and the research required to support regulatory submissions.

Aytu Bioscience, Inc. (2015-2017)

Director of Legal and Regulatory Affairs

• Served as the lead on matters involving merger and acquisition efforts, commercial agreements, and pharmaceutical and medical device products.

• Interacted with outside counsel regulatory authorities and consultants on legal and regulatory matters.

• Advised on regulatory and QMS strategies, justifications, decisions, changes, and impacts.

• Drafted, reviewed and negotiated legal contracts and regulatory submissions to ensure they met appropriate standards and content requirements.

• Reviewed/approved product/process changes to ensure compliance with design control

(medical device) and CMC (pharmaceutical) requirements.

• Conducted root cause analysis and identified compliance, process, or systemic breakdowns.

• Reviewed/approved labeling and marketing/sales materials to ensure substantiation of claims, adequate information, and inclusion of cautions/warnings in conformance with regulatory requirements.

• Oversaw compliance with annual and periodic safety reporting requirements, state and federal licensure, import/export law, and medical device and pharmacovigilance reporting. Rupprecht Law, P. C. (2005-2011; 2012-2015)

Principal Attorney/Owner

• Advised and represented corporate clients on matters involving complex commercial and government contracts/grants, corporate governance, business transactions and operations, regulatory compliance, real estate, and risk mitigation.

• Conducted internal investigations and audits to identify legal vulnerabilities and advised clients on changes for optimization of their operations and compliance programs.

• Provided expert knowledge and guidance to resolve complex issues, including drafting and negotiating pre-litigation settlement agreements.

• Served as the point of contact with administrative agencies during compliance audits/investigations; assisted businesses with written responses to resolve disputes; drafted and implemented processes and procedures to safeguard organizational interests.

• Interpreted and analyzed state and federal laws for integration into training materials, standards of procedure, legal memoranda/opinions, and federal agency communications.

• Advised clients about potential risks, legal precedents, costs, available courses of action and potential repercussions of legal matters.

• Drafted legal contracts, pleadings, memoranda, briefs, opinions, risk mitigation plans, compliance programs, and audit/due diligence reports.

• Conducted settlement negotiations and successfully resolved disputes to avoid litigation.

Watson & Associates, LLC (2011-2012)

Federal Government Contracts Attorney

• Increased profitability of Firm more than 50% in fourteen months.

• Developed strategies and secured millions of dollars in federal government contracts on behalf of individuals and businesses worldwide.

• Defended Government Contractors and cultivated working relationships and facilitated communications between clients and administrative agencies, the General Accountability Office and the Department of Justice to expeditiously resolve conflicts and disputes.

• Trained and counseled clients regarding solicitations process, proposal writing, risk management, intellectual property rights, compliance audits and due diligence packages.

BurgSimpson, P.C. (2004 – 2005)

Associate Attorney

• Secured more than 200 Clients for a large mass tort multi-district litigation (MDL) matter.

• Conducted and led extensive document review projects involving complex personal injuries.

• Reviewed data for deficiencies in standards of care, clinical data and medical records.

• Developed strategies and arguments in preparation for presentation of cases.

• Identified expert consultants, prepared discovery materials and served as a member of the National Scientific Discovery Committee. EDUCATION

University of Denver Sturm College of Law (1999-2003) Juris Doctor

• Admitted to the Colorado Bar and the U.S. District Court, District of Colorado, 2003

• Accredited by the Veteran Administration (VA) as a Veterans’ Benefits Attorney, 2009

• Admitted to the U.S. Court of Federal Claims and the U.S. Court of Appeals for the Armed Forces, 2012

Rocky Mountain Real Estate College (2009)

• Broker Associate License, 2009

• Managing Broker License, 2013

University of Illinois, Champaign-Urbana

Bachelor of Science from the College of Agriculture, Consumer & Environmental Sciences

• James J. Scholar, Phi Eta Sigma National Honor Society Member, Pi Lambda Chi National Honor Society Member

PROFESSIONAL CREDENTIALS

• Colorado Law License #34883

• Colorado Real Estate License #100023212

• Certified as a Corporate Compliance and Ethics Professional (CCEP) by the Society of Corporate Compliance and Ethics (SCCE)

• U.S. Regulatory Affairs Certification (RAC-U.S.) received from the Regulatory Affairs Professional Society (RAPS)

• Global Regulatory Affairs Certified (RAC-Global) received from the Regulatory Affairs Professional Society (RAPS)

• Life Sciences Compliance Certificate received from the Seton Hall University School of Law

• Clinical Research Coordinator (CRC) Certificate received from the Association for Clinical Research Professionals (ACRP)

PUBLICATIONS

• Author of eight (8) 510(k)s for Class II medical devices cleared by FDA (K951541, K952819, K953943, K954045, K954575, K954576, K945634, K951636); substantial contributor to several more 510(k) submissions as well as premarket applications (PMAs) for Class III medical devices.

• Author of two (2) Investigational New Drug Applications (INDs) for stem cell and CAR T cell therapies.

• Author of “Advertising and Promotion” chapter for the RAPS Fundamentals of International Regulatory Affairs manual, 3rd Edition; 2016.

• Author of “Accelerated Filings” and “Good Documentation Practices” chapters for the RAPS Regulatory Writing: An Overview manual, 1st Edition; 2017.

• Author of “Healthcare Fraud and Abuse” chapter for the RAPS Fundamentals of U.S. Regulatory Affairs manual; 2017.

• “Preparing for a Rise in Government Investigations,” The Federal Lawyer Magazine (2012)

• Co-author of a Medical Abstract (Abbott Laboratories, Inc.) “A New IMx Automated Microparticle Enzyme Immunoassay for the Quantitative Measurement of CA 15-3 Assay Values in Human Serum and Plasma”.

PATENTS

• Co-Inventor on a U.S. Patent held by Abbott Laboratories, Inc. titled “Production of Polyclonal Antibodies to Cholesterol and Their Potential Uses”. SPEAKING ENGAGEMENTS

• Panel Member for the Regulatory Panel Discussion: ‘From the Trenches’ at the 2016 and the 2019 Annual Regulatory Affairs Symposium for the Colorado Bioscience Association.

• Guest Speaker on "Leadership and Building Winning Teams" for the Colorado Bioscience Association (CBSA) BioBoot Camp.

• Guest Lecturer on ICH-cGCPs for the course “Conducting Clinical Trials for Investigators” tailored to junior scientific investigators (PhDs, MDs, PharmDs, DVMs) at the University of Colorado Denver, Anschutz Medical Campus.

• Guest Lecturer at the Workshop on Life Science Development & Commercialization on Regulatory Affairs at the University of Colorado Denver Graduate Business School. VOLUNTEER EXPERIENCE

University of Colorado Denver, Anschutz Medical Campus (2018-Present) Bioscience Advisory Board Member for Broadening Experiences in Scientific and Scholarly Training

(BESST)

Colorado General Assembly (2012-2016)

Attorney-Mentor; Senate and House Legislative Fellow

• Supervised law students serving as Legislative Fellows in the externship program at the University of Denver Sturm College of Law and the University of Colorado College of Law.

• Served as s a Legislative Fellow and assimilated the history and legal/fiscal impact of proposed legislative bills into fact sheets for consideration by Colorado Legislators, and conducted informational presentations to legislators and the public policy team.

• Developed proficiency at building consensus and motivating parties to pursue necessary changes based on public health, safety and welfare interests of the people of Colorado. PROFESSIONAL ORGANIZATIONS

• Society of Corporate Compliance and Ethics (SCCE)

• Regulatory Affairs Professional Society (RAPS)

• Association of Clinical Research Professionals (ACRP)

• Colorado Bioscience Association (CBSA)

• Colorado Bar Association Member (CBA)

• Association of College and University Educators (ACUE)

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