Lawyers / Professionals

 
Kristian A. Werling       
Partner
77 West Wacker Drive
Suite 4100
Chicago, Illinois 60601-1818
T: 312.750.8695
F: 312.558.4382
kwerling@mcguirewoods.com
 

Mr. Werling is chair of the Life Sciences Industry Group. He concentrates in corporate healthcare transactional work and regulatory matters for all participants in the healthcare and life sciences industry. His experience includes representation of healthcare providers including hospitals, health systems, ambulatory surgery centers, specialty pharmacies, dialysis facilities, home health agencies, durable medical equipment suppliers, home infusion providers and large medical practices.

From 2005-2006, Mr. Werling served as in-house counsel to Hospira, Inc., a generic specialty pharmaceutical and medical device manufacturer in Lake Forest, Ill. He regularly counsels life sciences clients in transactional and regulatory issues with a particular focus in negotiating licensing and partnership agreements, clinical research agreements (including clinical trial and CRO agreements), contract manufacturing agreements and distribution agreements. Mr. Werling has also assisted various medical device and pharmaceutical manufacturers with the implementation of compliance plans and related policies, the formation of medical affairs departments, and appropriate grant making procedures. In addition, he regularly advises clients on compliance with the various federal and state disclosure laws applicable to life science companies.

A significant portion of Mr. Werling's practice involves the representation of private equity and venture capital investors in healthcare and life sciences companies. In this capacity he works with cross-disciplinary teams to conduct legal due diligence and execute acquisitions, add-on acquisitions and divestitures as well as provide ongoing legal services to portfolio companies.

Mr. Werling serves as co-author of TheHealthcareInvestor, a blog covering business and legal issues that impact investments in healthcare and life sciences business and is co-chair of McGuireWoods' annual Healthcare and Life Sciences Private Equity and Financing Conference.


Practices & Industries
Firm Management
  • Chair, Life Sciences Industry Group

Honors
  • Journal of Law and Technology Policy

Previous Experience
  • Counsel, Commercial & Compliance, Hospira, Inc., 2005-2006

Publications
Articles
Speaking Engagements
  • AdvaMed 2011: Moderator: Structuring Successful Medtech Strategic Partnership Agreements, Washington, D.C., September 2011
  • Moderator, Interactive Luncheon with U.S. Chief Technology Officer, Chicago DC 2 VC: Investing in Healthcare IT, Chicago, Illinois, July 22, 2011
  • "Fraud & Abuse Concerns: Consultant Involvement & Contracts," Pharmaceutical & Medical Device Sales & Marketing Compliance Conference, Chicago, Illinois, July 19, 2011
  • Moderator, "Best Practices for Business Partnering Meetings," iBIO IndEx, Chicago, Illinois, February 15, 2011
  • "FDA Unveils 25 Initial 510(k) Changes, Refers Controversial Recommendations to Institute of Medicine," McGuireWoods Webinar, February 10, 2011
  • "Compliance Anxieties and Cautionary Practices in Pharmaceutical and Investigator Relationships for IITs," Furthering Medical Strategy through Investigator Initiated Trials Conference, Boston, Massachusetts, February 8, 2011
  • "Shedding Some Fair Market Value Light On the Sunshine Act," American Health Lawyers Association Webinar, February 3, 2011
  • "Healthcare Reform: The Impact on Medical Device Manufacturers," BNA Webinar, May 25, 2010
  • Panelist, McGuireWoods Medical Device Symposium, November, 2009
  • Advamed 2009: Executive Workshop Leader: Strategies for Developing & Maintaining Compliant Industry-Referral Source Relationships, Washington, D.C., October 2009
  • AdvaMed Webinar: "After the Implementation - Next Steps for Building an Effective Compliance Program," September 2009
  • "Life Sciences Sales and Marketing Compliance Update," McGuireWoods Webinar, March 2009
  • "Legal and Regulatory Risks in Grant Funding Practices for Investigator Initiated Studies," ExL 9th Successful Compliance Investigator-Initiated Trials Conference, February 2009
  • "Strategies for Life Sciences Firms in a Bear Market," McGuireWoods Webinar, December 2008
  • "Government Investigations Workshop," AdvaMed 2008, Washington, D.C., September 2008
  • "Bringing Your Medical Device to the United States," Informa Life Science Medical Device Law and Compliance Conference, Brussels, Belgium, September 2008
  • "Current Issues in Off-Label Promotion," Practising Law Institute Briefing, July 2008
  • "Off-Label Promotion: Recent Regulatory Developments and Enforcement Actions Affecting Pharmaceutical and Medical Device Companies," McGuireWoods Webinar, April 2008
  • "Be Ready for Medicare's New ASC Payment System," Keynote Speaker, Improve Billing, Coding & Profitability for Freestanding ASCs Conference, Las Vegas, Nevada, October 15-16, 2007
  • "Compliance Compass: How to Navigate the Risks when Growing Your Business," Improve Billing, Coding & Profitability for Freestanding ASCs Conference, Las Vegas, Nevada, October 15-16, 2007
  • "Grant Funding Practices for Investigator Initiated Studies," Workshop Leader, Bio/Pharmaceutical Medical Device Grants Conference, May 17-18, 2007
  • "Current Issues in Off-Label Promotion," McGuireWoods Sales Force Compliance Conference, May 15, 2007
  • "Update of Fraud and Abuse Provisions in the Deficit Reduction Act of 2005," Pricing Transparency & Other Compliance Issues Affecting the Pharmaceutical Industry, Webinar, March 20, 2007
  • "The Role of MSL: Fostering Sponsor/Investigator Partnerships to Pave the Way for Compliant IITs," Panelist, 5th Successful Compliant Investigator Initiated Trial Programs, February 8-9, 2007
  • "Finding and Evaluating Private Equity Opportunities in the Health Care Space," McLean, Virginia, February 2005
  • "Structuring Compliance Plans for Group Practice Owned ASCs," Medical Group Management Association, San Francisco, California, October 2004
  • "Outpatient Services Market: Identifying Issues and Attractive Niche Investments," Chicago, Illinois, September 2004
  • Springfield and Certificate of Need Update, 2003 Illinois Midwest Hospital Strategies Conference, November 2003

Professional Affiliations
  • American Health Lawyers Association
    • Vice Chair, Life Sciences Practice Group, 2010-2011
  • Advisory Board Member, BNA Medical Devices Law and Industry Report
 

EDUCATION

Northwestern University Kellogg School of Management, Masters of Business Administration, 2010

University of Illinois College of Law, Champaign, Illinois, J.D., magna cum laude, 2002

North Park University, Chicago, Illinois, B.A., cum laude, 1999

 
 

ADMITTED

Illinois 2002