Every new medicine program faces hurdles
Are you competently surmounting them?
Speid & Associates are experts in Global and Strategic Regulatory Affairs. We develop regulatory strategies that enable us to see the hurdles before they arise.
We are experts in new medicine development, and this is what enables us to take the long view of your development program.
Who are you passing the baton to? Pharma and biotech alike strengthen their teams with external consultants.
our motto is “Get it right first time’.
A split second delay in leaving the start line, will lose you the race. We understand how to start and end the race.
Dr. Speid’s BIO
Dr. Speid has achieved a high level of mastery and expertise in the field of global and strategic regulatory affairs. She has achieved a track record of success, securing approvals for new medicines from all the major regulatory authorities, including after conducting appeals to overturn rejections. Her skills with appeals were honed from submitting appeals to the Medicines Control Agency (now MHRA), as well as in US, UK, Belgium, Germany, Sweden, Netherlands, and Australia. She has a 100% success rate for appeals.
Lorna has experience with many therapeutic areas, including oncology (hematological and solid tumors), diabetes, obesity, anti-infectives (anti-bacterial and anti-viral), pulmonary (asthma, COPD), influenza, women’s health (hormone replacement therapy), bone (Paget’s disease and osteoporosis), lupus, Rheumatoid arthritis, transplantation, autoimmune diseases, Malaria, Sickle Cell Disease, and CNS (psychiatry, Alzheimer’s Disease). She has a special practice in rare diseases, and another in neglected diseases. In all of these areas, she develops regulatory strategies, as well as operational approaches that can be used to secure regulatory approvals around the world. Lorna has worked with all treatment modalities, including small molecules, large molecules, gene therapy, combination products (drug and device), companion diagnostic approaches, cellular products, and Biosimilars. She has experience working with oral, injectable and topical medications.
Lorna has worked for large pharma as well as small biotech 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 GeneMedicine/Valentis, Inc. (Director of Regulatory Affairs), NewBiotics (Vice President Regulatory Affairs and Project Management including QA oversight), and Avera, Inc. (Vice President of Regulatory Affairs). Dr. Speid was an officer at the last two companies. She founded and incorporated Speid & Associates in 2004. Since that time, she has been able to use her expertise to make a difference for many other companies and organizations.
Lorna’s writing, negotiation skills, team leadership, and leadership skills enable her to produce the results needed in the regulatory and drug development arenas. She is hands-on as well as strategic. However, her understanding of the need to delegate and how to develop the Team have been demonstrated throughout the years. She is able to operate at a senior level, providing input at the Board level, as well as at the executive management level.
Lorna is the Founder and President of Putting Rare Diseases Patients First!®, a 501 c 3 Charity set up to enable patients with rare diseases to effectively engage with the new medicine development process. The organization provides expert information on new medicine development to patients and parents. The organization takes steps that are challenging for other rare disease patient organizations to take because of the expert knowledge of the new medicine process, and expertise in regulatory affairs.
- Some recent achievements
- Worked on a COVID-19 program. Developed tactics to accelerate movement of the Phase 1 molecule into a registrational Phase 2 study in patients with Acute Respiratory Distress Syndrome secondary to COVID-19 infection. Wrote the Pre-IND package, presented to the senior management Team, provided input on regulatory strategy, TPP, CMC, clinical trial supplies, clinical protocol development, toxicology program, and many other areas.
- Under the auspices of PRDPF!, Submitted a Citizen’s Petition to the FDA to add Sickle Cell Disease to the FDA’s Tropical Disease Priority Review Voucher List. If effective, this will encourage additional investment in new medicine development for Sickle Cell Disease. Coordinated support including from major pharma, small biotech, patient groups, and Access to Medicines Index.
- Filed INDs and CTAs to US and many other major regulatory jurisdictions. These achievements have translated to many new treatments now marketed, included Foradil Dry Powder, Foradil Solution Formats, Skelid – UK and European Strategy, an anti-obesity treatment (FDA), and many other treatments, and line extensions.
- Secured approvals for all major health authorities for many drugs, as well as new indications, including the following.
- Skelid – European approvals after an appeal process through the United Kingdom Health Authority
- Anti-depressant drug – generic, and other generics through the UK Health Authority
- Foradil – several different formats – global approvals after appeals in many countries
- CellCept – line extension development for Lupus Nephritis
- Obesity drug – played a major role in the development of the appeal after FDA rejection. The drug was approved.
- Numerous other programs that have ultimately progressed through clinical development, and to approval
- Successfully filed appeals – 100% success rate for all appeals submitted
- Secured regulatory approvals for Foradil Dry Powder in all the major markets, after launching appeals [Ciba Geigy – Switzerland], Skelid for equivalent of the Centralized European Procedure.
- Founder and Chair of Drug Development Boot Camp®, an internationally recognized intensive training program in new medicine development for decision makers.
- Published author of a book on clinical trials written for patients and healthy volunteers.
- Set up Phase 1 / 2 oncology clinical trials at Dana Farber Cancer Center, University of Pennsylvania, UCLA, and USC. Indications were head and neck cancer, and advanced colorectal cancer.
- Created strategies for companion diagnostic and therapeutic treatment programs for cancer and transplantation.
- Founded the Drug Development Boot Camp® in 2009 and ran the first intensive training program in 2010 with Cornell University. The next eight years were run with Harvard University OTD. The following three years were run with Brown University. Hundreds of participants have been trained from pharma, biotech, academia and NIH/NCI. Participants have come from many countries