Archives -- Transactions, Outsourcing, & Contracting


Before Merging, Check for FDA-related Problems, National Law Journal, September 4, 2000, pages B13-B14. 

 Author, “How Data Integrity Issues Sunk a $4.3 Billion Drug Company Acquisition – Lessons Not Just for Quality Professionals, But Also Their Top Management. Legal Letter from America. GMP Review,.  October  2018. Volume 17, No. 3, pp. 18-20.  

Presentations & Panel Discussions

Due Diligence: The Regulatory, Quality and Clinical Challenges Posed by Transactions Involving Highly-Regulated Biotech Products and Companies.  Moderator. 19th Annual FDA-OCRA Educational Conference. May 5, 2016.  Irvine. CA.  [moderator; no slides]

Legal Aspects of Outsourcing.  Outsourcing 101.  SDRAN/OCRA Conference. November 19, 2014.  Carlsbad, CA.

Quality Aspects of Due Diligence for Biopharmaceutical Transactions. DIA Annual Conference.  June 21, 2011, Chicago.

Regulatory, Quality & Clinical Due Diligence: The Oft-Overlooked Keys to Successful Transactions.  The Weinberg Group Inc. Webinar, June 23, 2010.

The Forgotten Keys to Bio-Pharma Transactions -- Regulatory, Clinical & Quality Challenges in Contracting and Due Diligence.  Cambridge Healthcare Institute Second Annual Bridging the Business Development-Alliance Management Interface Conference. November 6, 2008, Boston.

Contract Terms for Clinical Trials, North Texas Chapter, ACRP, October 16, 2004, Dallas, Texas.

How to Negotiate Other Important Contract Terms. 14th International Contracting & Negotiating Clinical Trials.  Strategic Research Institute. September 27-28, 2004, La Jolla, CA.  

Legal and Regulatory Concerns in the Sourcing of FDA-Regulated Products, Components & Services. Center for Professional Advancement -- In-House Seminar on "Vendor & Supplier Qualification." Siemens, Concord, California.  January 2004.

    Part 1 – The Impact of FDA Legal & Regulatory Requirements on Device Company Sourcing Activities

    Part 2 – The Contract and Related Legal Strategies

Legal Strategies in Sourcing of FDA-Regulated Goods and Services – Seeking a Win-Win Relationship with Your Contract Manufacturing rganization. IBC Conference on “Scale-Up:  From Bench to Clinic”, August 2002, San Diego.

Legal and Regulatory Strategies in Sourcing of Products, Components and Services for FDA-Regulated Companies. Biotechnology Industry Organization (BIO) Annual Conference, June 2001, San Diego, CA.

Indemnification in Clinical Research. DIA Good Clinical Practice Conference, February 2001, Tucson, AZ.

For my services relating to Transactions, Outsourcing & Contracting, ...