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Robb C. Giddings

Robb has experience as both in-house and outside counsel, and works as a transactional, regulatory and compliance attorney, with three primary areas of focus: (1) regulatory advice and outsourced compliance support for regulated industries; (2) day-to-day operational and procurement support (e.g., FSP "outsourced legal department" model); and (3) corporate transactions.

Before joining Hutchison, Robb worked in-house with AbbVie Inc. where he was responsible for legal issues related to AbbVie’s clinical R&D programs, including Viekira™ (AbbVie’s blockbuster hepatitis-C drug) and Humira® (the number one selling drug in the world); worked in-house with PRA Inc., a global clinical research organization, where he supported international compliance and regulatory issues, corporate partnership initiatives and day-to-day operations and contracting; and worked as an associate in a boutique law firm in RTP, Life Sciences Law, where he assisted technology and biotechnology companies with transactional, operational, regulatory and compliance matters.

Robb describes himself as an “in-house” outside counsel because he focuses on developing infrastructure (processes, templates and trainings) that leverage existing resources and legal-spend to improve efficiency and compliance. For example, at AbbVie, Robb worked with a cross-functional team that successfully reduced contract negotiation timelines by several weeks—the improvements resulted in such substantial savings, that the team received a President’s Award (AbbVie’s highest award). More recently, he helped a biotechnology company engage major oncology centers for a phase I, pediatric oncology trial ~75% faster than published industry averages. 

Recognition, Affiliations & Memberships

  • Member, Food and Drug Law Institute’s (FDLI) Austern Writing Awards Committee (2012-2013)
  • Chairman, FDLI’s Austern Writing Awards Committee (2013-2015)
  • Lecturer, University of Delaware Certification in Clinical Trials Management, 2015
  • Member, FDLI’s Journal Editorial Advisory Board (2015-2016)
  • Vice President, Gainesville Area Innovation Network (GAIN), 2016
  • Vice Chairman, FDLI’s Journal Editorial Advisory Board (2016-2017)
  • President and Chairman, GAIN, 2017
  • Chairman, FDLI’s Journal Editorial Advisory Board (2017-2018)
  • Expert in Residence, Sid Martin Biotechnology Incubator
  • Expert in Residence, Tampa Bay Technology Incubator (TBTI)

 Education 

  • J.D., cum laude, Duke University School of Law, 2009
  • B.S., Chemistry, University of North Carolina at Chapel Hill, 2005

Admissions

  • Massachusetts
  • North Carolina
  • Florida

Select Publications & Presentations

  • Pharmaceutical Licensing Agreements, NC State University Poole College of Management
  • Legal Issues Related to Clinical Research & Development, University of Delaware Clinical Trials Management Program
  • Clinical Contracting Efficiency and Clinical Trials: A Simple but Overlooked Means to Save Millions, Applied Clinical Trials (ACT)
  • Deriving Maximum Value from an Overhead Function: The Role of the Legal Department in Clinical Development, North Carolina Regulatory Affairs Forum (NCRAF)
  • Maximizing Efficiency When Working with CROs, ACT
  • CRO-Sponsor Agreements: Compliance Traps for the Unwary, Model Agreements & Guidelines International (MAGI)
  • Clinical Trial Agreements Outside the U.S.: International Considerations When Contracting Abroad, MAGI
  • Fundraising 101, Tampa Bay Technology Incubator (TBTI)
  • Coordinated and managed contractual, regulatory and compliance matters for multiple national and international device trials and Phase I-IV drug trials.
  • Supported several drug and device companies with the design, submission and implementation of compassionate use, expanded access and special access programs for their investigational drugs and devices.
  • Reviewed label, packaging, website and marketing materials for new dietary supplement. 
  • Development and Supply Agreement between Fortune 500 medical device company and medical textile manufacturer.
  • Outsourced compliance function (policy development and review, trainings, audits and advice) for clinical-stage pharmaceutical company.
  • Complete outsourced legal department for contract manufacturer, CRO, orthopedic device manufacturer, clinical-stage oncology company, pre-clinical stage biologics company and many more.
  • Supported $100+M sale of pharmaceutical asset.
  • Counseled Health-IT Company on HIPAA, HITECH and FDA requirements for its product and service offerings.
  • Negotiated License and Investment Agreements between U.S. medical device company and strategic partner in China.
  • Developed intellectual property, development and regulatory strategies for novel application of a stem-cell therapy.
  • Select 2017 IP Agreements: Option Agreements and License Agreements with various University Technology Licensing Offices for stem cell therapies, animal drug, orthopedic implant and fertility drug.
  • Select 2017 financings: $200K seed financing for medical device company; $500K angel financing for biologic manufacturer; $600K bridge financing for consumer product manufacturer; and $1.8M preferred financing for medical device company.

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