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Speid & Associates, Inc.

Bringing new drugs to market is like a relay race. Every person on the team must be ready to fulfill their role. Speid & Associates, Inc. is a regulatory and drug development consultancy, that will work with you to expedite your compounds' access to the clinic, and ultimately to commercialization.


Dr. Speid is the founder and President of the firm. She is supported by drug development experts, on a program by program basis. Dr. Speid is herself a recognized expert in global regulatory affairs and the development of novel molecules. Besides her track record in addressing unmet medical needs, she has a strong interest in bringing novel medicines to market for rare and neglected diseases.

Dr. Lorna Speid's Bio

Lorna Speid, B.Pharm.(Hons). M.R.Pharm.S., Ph.D., RAC is President of Speid & Associates, Inc. a regulatory and drug development consultancy based in San Diego, California. She works with small and large pharmaceutical companies, assisting them at the various stages of the drug development process, including US, European, international and global strategic regulatory affairs. Dr. Speid has an excellent track record of success in regulatory affairs, and is considered an expert in her field. She has registered therapeutics internationally, and has experience with all the major regulatory authorities. She has experience with many therapeutic areas including oncology, diabetes/obesity/metabolic disease, anti-infectives, pulmonary, women's health, anti-inflammatory, lupus, transplantation, dermatology, and bone. She has worked on all types of products, including small and large molecules, gene therapy, combination products, devices and diagnostics.

Dr. Speid began her career as a pharmacist in the UK, after which she completed a Ph.D. at the Centre for Medicines Research International, into the Safety

Assessment of Medicines, Pre and Post Marketing. She has worked for large as well as small pharma companies, including Sanofi Winthrop in the UK (now Sanofi-Aventis), Ciba Geigy and Novartis in Switzerland (at Headquarters). Small companies that she has worked for include Valentis, Inc. (Director of Regulatory Affairs), NewBiotics (Vice President Regulatory Affairs and Project Management), and Avera, Inc. (Vice President of Regulatory Affairs). Dr. Speid was an officer at the last two companies. She has a Bachelor of Pharmacy degree from the University of London, UK (Kings College), and a Ph.D. from the University of Wales, College Cardiff, UK.

Dr. Speid is the author of Clinical Trials: What Patients and Healthy Volunteers Need to Know, which was published by Oxford University Press in August 2010. This books is available from all major book stores in the US and abroad, and has garnered many awards for the service that it provides to research subjects and the families of those that are eligible for participation in clinical trials.

Lornia's LinkedIn Profile


  • Global and strategic regulatory
  • FDA regulatory
  • International regulatory affairs
  • Chemistry Manufacturing Controls expert advice
  • Clinical research and operations
  • Due Diligence services for Venture Capitalists and Analysts
    In addition:
  • Strategic regulatory affairs support for Biosimilars
  • Strategic regulatory affairs support for rare and orphan diseases
  • NCEs, NBEs, Gene Therapy, Combination Products, diagnostics and devices
  • Novel medicines for rare and neglected diseases - New Initiative involves a funding mechanism
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