We are lawyers dedicated to employing our deep knowledge and unique experience to support the needs of health care providers and life sciences clients.  We understand the complex legal issues that surround health care delivery and the development and marketing of innovative products and services.  Our lawyers have immersed themselves in the health care and life sciences industry and bring many years of experience to their practice.  We bring energy, commitment, passion, and integrity to all that we do.

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Robyn S. Shapiro

Attorney and Founder

(414) 206-2101 phone
(414) 206-2109 fax
Robyn.Shapiro@HealthSciencesLawGroup.com

My longstanding passion and experience within the health care and life sciences industries drive the manner in which I provide legal services to clients.  My goal in working with health care providers and life sciences companies is to protect the innovative products and services that they provide, to guide and help give expression to their passion to improve human health.

In my practice, I provide legal counsel on matters relating to health care compliance, research compliance, corporate compliance, bioethics, medical staff matters, health information privacy, and corporate and commercial issues faced by pharmaceutical and medical device manufacturers and health care providers.

I have been ranked by Chambers USA as a Leader in Life Sciences: Regulatory/Compliance (Nationwide) for the past 3 years; I was named one of 10 “Outstanding Hospital Lawyers” by Nightingale’s Healthcare News; I was one of 12 honorees selected as “Leader in the Law” by the Wisconsin Law Journal; I have been listed in Best Lawyers in America, a number of Who’s Who listings and Wisconsin Super Lawyers;  and I have been named a “Woman of Influence” by the Milwaukee Business Journal and Milwaukee’s Health Care Law “Lawyer of the Year” by Best Lawyers.  My past position as Ursula von Der Ruhr Professor of Bioethics at the Medical College of Wisconsin and my 26-year leadership as Director of the Center for the Study of Bioethics at the Medical College of Wisconsin complement my wide-ranging experience in health care and life sciences law.

I have been honored to provide counsel to policymakers at the state and federal levels, including service as an appointed member of the NIH Recombinant DNA Advisory Committee, the FDA Drug Safety and Risk Management Advisory Committee, and the HHS Secretary’s Advisory Committee on Xenotransplantation.  I frequently present at national conferences on health care and life sciences issues, and I have authored more than 60 articles and book chapters on these and other topics.

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Roger Cepeda

Attorney

(414) 206-2105 phone
(414) 206-2109 fax
Roger.Cepeda@HealthSciencesLawGroup.com

I have spent the majority of my 20+ year career as in-house counsel to global healthcare companies, where my participation on cross-functional teams focused on the clinical and commercial success of medical devices, pharmaceuticals, and services. My primary areas of expertise include regulatory (FDA and global counterparts), compliance, and a broad range of commercial/transactional work.

At GE Healthcare, I supported dozens of product teams and provided regular legal counsel on FDA matters, including compliant medical device promotional practices at all stages of product development– from feasibility assessments, through early adopter clinical research, to full commercial launch of multiple Class II and III devices in oncology, cardiology, and neurology.

In addition to 510(k) go-to-market strategies, QSIT/directed audit support, and tradeshow promotional reviews, I was the lead commercial attorney that managed an FDA consent decree negotiation, including writing the provisions that accounted for virtually all of a formerly $500M surgical c-arm business unit’s revenue during an initial global shutdown.

In a $2B global computed tomography unit, I was the lead division counsel that helped manage a major radiation-related legal, regulatory, and public relations matter, including class-action litigation, an FDA audit/hearing, a Congressional hearing, and intense media scrutiny, all while continuing to support existing customers and launch new products. I handled thousands of commercial contract negotiations involving hundreds of millions of dollars for capital equipment and services purchased by hospitals in the US, as well as dozens of complex research and clinical trial agreements for investigational radiology devices evaluated at major academic medical centers in the US, Europe, and Asia. In addition to working with internal teams (e.g., sales & marketing, QA/RA, product development, legal, finance, P&L leadership), I have direct experience with clinical customers, suppliers, regulators, alliance partners, and other stakeholders in major countries around the world.

At Baxter Healthcare, I provided upstream and downstream support to a renal dialysis division, including counsel on global privacy issues associated with the first-in-industry cloud-based data connectivity capability on a medical device that was the biggest product launch in over 20 years in the US and Europe. With respect to reimbursement and market access, I worked closely with internal and external lobbying experts focused on improving CMS renal dialysis-related coverage in ways that would benefit patients, industry, and payors. As part of a coordinated industry effort, I was part of a team that met in person with Congressional representatives to discuss specific issues, such as the medical device tax.

In addition to day-to-day product sale agreements with hospital and mid-sized clinic customers, I negotiated all legal aspects of a multi-billion-dollar supply agreement with the company’s largest customer. I also provided strategic legal guidance with respect to the company’s most profitable dialysis drug in the US that was also subject to the FDA’s REMS (Risk Evaluation and Mitigation Strategy) rules and potentially life-threatening drug/device interactions with the products of seven other companies.

My experience also includes the following: supplier/sourcing/procurement agreements; acquisitions & divestitures, including transition services and due diligence to manage post-closing challenges; new legal entity formation; venture capital funding rounds; compliance-related risk assessment of healthcare investment opportunities, joint venture and alliance agreements; global product distribution agreements; intellectual property protection and negotiation; and direct-to-patient issues (e.g., marketing, data privacy, and therapy support groups).

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Jeremy Shapiro-Barr

Attorney

(414) 206-2103 phone
(414) 206-2109 fax
Jeremy.ShapiroBarr@HealthSciencesLawGroup.com

I rely on my vast experience within the health care and life sciences industries to guide clients through the complex legal challenges that often confront pharmaceutical and medical device manufacturers, hospitals and health systems, and other health care providers.  My practice focuses on providing transactional and regulatory advice in the areas of clinical research and privacy and data security.  Within these focal areas, I assist clients in developing information privacy and security policies, implementing training programs relating to privacy and security practices, drafting and negotiating research related contracts, and advising clients on significant amendments to regulations that affect their business operations.

My practice also includes a variety of other matters, including representation of hospitals and health systems in guardianship matters and advising long-term care providers in compliance with administrative regulations relating to resident care.

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Julie2Julie Rusczek

Attorney

(414) 206-2102 phone
(414) 206-2109 fax
Julie.Rusczek@HealthSciencesLawGroup.com

My experience within the health care and life sciences industries positions me as a reliable go-to for the legal support and guidance needed by institutions, medical device and pharmaceutical companies, and other organizations in their pursuit of developing innovative new products and treatments.  As a biology major in college with a life-long interest in science, I find that practicing law in the health care and life sciences space allows me to follow my passions on a daily basis.

My practice focuses on research compliance issues involving protection of human subjects under FDA and HHS regulations, research policy development and review, research agreement drafting and negotiation, and compliance with privacy laws and transparency reporting requirements.

My work touches the greater health care community as well, as I provide health systems, hospitals and long-term care providers with the legal guidance needed to address day-to-day health law issues, including informed consent, patient confidentiality, fraud and abuse, and medical staff matters.

I regularly speak at national conferences focusing on research issues, including PRIM&R’s Advancing Ethical Research Conference and MAGI’s Clinical Research Conference. I also co-author a chapter covering fraud and abuse in clinical research in Bloomberg BNA’s treatise entitled Health Law Fraud and Abuse: Practical Perspectives.

Outside of the office, I enjoy hiking, camping, baking, and spending time with my husband and young son and daughter.  My family frequently visits the coast of Maine and spends as much time on and near the water as possible, beachcombing, kayaking, sailing, and fishing.  You’ll often find The New Yorker or a Nathaniel Philbrick book on my nightstand and Celtic music playing in the family minivan (when the kids allow a departure from KidzBop and the Frozen soundtrack).

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158Michael Shapiro-Barr

Business Development Director

(414) 206-2104 phone
(414) 206-2109 fax
Michael.ShapiroBarr@HealthSciencesLawGroup.com

Having worked in the legal client services field for the past 8 years, I’ve gained invaluable experience and insight on the processes and needs of clients.  My interest in the life sciences industry serves as a driving force in my desire to work with clients to find creative ways to help excel business processes to support the innovative and groundbreaking products and services they provide.  I work closely with our talented attorneys to ensure that they are able to provide top-notch legal services and innovative new ways of tackling the complex legal issues facing life sciences clients.

Outside of the office, I enjoy gardening, skiing and cooking with my wife and two dogs.  I am an avid bike rider and bike to work throughout the year (yes, even in the harsh Wisconsin winters).