Phase-appropriate development as a key for the success of the clinical development
The right approach to all the CMC (Chemical, Manufacturing and Controls) aspects is key for the development and approval of new drugs. Taking the wrong decisions in areas such as formulation development, process development or analytics development may result in rejected batches, CMC deficiencies issued by Regulatory Agencies, stability issues, etc. that will significantly delay the clinical trials. These delays may have an impact in our societies, as the treatments cannot reach the patients on-time, but also a significant budget increase that may even cancel the project.
At this webinar, we will go deeply into some key development matters that will allow you to have a clear picture of your CMC needs in your path to the clinic.
Firstly, we will recommend you the appropriate effort level required at all clinical phases in terms of regulatory compliance. Analytics requirements, validation needs, justification of specifications, etc. will be clarified according to our long experience.
Secondly, different alternatives will be proposed for the formulation and process development with a clear focus on oral solid drugs and more specifically, low solubility molecules.
Thirdly, a process map for reaching the clinic in the shortest time will be shown to the audience.
CMC aspects are of paramount importance for pharmaceutical companies that are developing new drugs, no matter the company size or intended clinical application. At this webinar, we will provide you relevant tips for dealing correctly with the regulatory requirements, the formulation or process development strategy and a whole process view that will allow you to avoid some bumps in your road to the clinical study.
Head of site
Alfredo Gómez has more than 20 years of experience in the biopharmaceutical industry.
His experience has been gained in different operational areas, such as Quality Assurance, Quality Control, Regulatory Affairs, Production, Continuous improvement, site management.
In the last years, he has been leading CDMOs focused on providing development and manufacturing services, mostly at clinical stages. These roles have given him a clear view of the development process to reach the clinic, mapping accurately all the itinerary to the clinic.
In addition, having worked in diverse pharmaceutical companies of different sizes, he is able to understand all the requirements that any biopharmaceutical business may have at these key clinical development stages.
Alfredo holds a degree in Pharmacy, MPhil Research and Development of Medicines as well as management training in IE Business School.
Fabiola has more than 12 years of experience in the biopharmaceuticals industry, primarily focused on product development, process transfer, scale-up and clinical manufacturing.
Fabiola has managed multiple development projects at clinical development stages. As Operations Director, she has led the product development, technology transfer, scale-up and clinical manufacturing methodologies, always within an international environment complying with different regulations. She is actively involved in the formulation development and scale up processes, that are previous to the clinical manufacture.
Fabiola has a degree in Biology from the Central University of Venezuela (Venezuela) and an MSc of Strategic management and planning from ESERP Business School (Spain).