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