Drug Development Process – From Discovery to Marketing

Drug Development Process - From Discovery to Marketing

Overview:

This webinar will provide a clinical and regulatory perspectives on requirements to take a new drug from research to market.

We will begin by reviewing the contents of an Investigational New Drug (IND) application, and then follow the process of an IND submission. Next, the contents and approval process of an NDA submission will be discussed. This seminar will also provide a foundation for those who require an understanding of the FDA new drug approval process, and familiarize the attendees with the regulatory landscape in which INDs and NDAs are developed and approved.

Areas Covered in the Session:

  • High level overview of the FDA approval process for a new drug
  • What is an IND? Identify the key contents of an IND
  • What is an NDA? Identify the contents of an NDA
  • The FDA IND and NDA review process
  • Discovery stage
  • Preclinical Testing
  • IND Application
  • Clinical Trials
  • Phases I to IV
  • NDA
  • High-level description of medical device process

Who Will Benefit:

  • CRAs
  • CRCs
  • Nurses
  • Clinical Trials Associates
  • Regulatory Affairs

Speaker Profile

Fatuga is a social-entrepreneur who is actively engaged in three primary roles/companies: (a) founder/president of Caligeo Clinical OneVision; (b) founder/CEO of Caligeo Clinical CRO; and (c) founder/Executive Director of Atlanta Premier SMO. His professional passion lies in promoting clinical trial opportunities in emerging markets (especially in Africa, the Caribbean, East Asia, and Latin America) and among under-represented population (in the USA). He recently completed his MBA degree from Emory University/Goizueta Business School with a focus on Entrepreneurial ship/Organizational Behavior & Management. He received his M.Sc. in Drug Regulatory Affairs and Health Policies from Massachusetts College of Pharmacy and Health Sciences and BS degree in Neuroscience from Brown University. He has more than 15 years of experience in the clinical research industry. Fatuga began his clinical research career as a study coordinator at Brown University. Since then, he has had leadership opportunities as Clinical Team Manager, Project Lead, QA/QC Manager, Lead CRA, CRA Consultant, Medical Research Associate, and CRA Specialist in a variety of companies such as central imaging facility, Contract Research Organizations (CROs), biotechnology and pharmaceutical companies. Fatuga is currently certified as a Project Management Professional (PMP) and a Clinical Research Associate (CCRA). He is an active member of the International GCP Training Advisory Board for the Association of Good Clinical Practices in Nigeria (AGCPN) and also a member of Nigerian Association of Pharmacist and Pharmaceutical Scientists in the Americas (NAPPSA). Fatuga is also a member of the International Committee/Leadership Team of the National Biotechnology and Pharmaceutical Association (NBPA) which is a US based organization functioning in collaborative efforts to discuss challenges and opportunities of conducting clinical trials with diverse communities as well as addressing the disparity issues in the clinical trial industry.

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API GMP vs. Drug Product (DP) GMP

API GMP vs. Drug Product (DP) GMP

At the heart of GMP is the fundamental concept that a GMP is a GMP, no matter whether it is for a drug or for an API. A GMP is meant to inculcate best manufacturing practices, irrespective of whether a company is producing animal products, human use products, cosmetics, excipients, foods or whatever.

GMP is subjective

At the end of the day, you need to have a level of comfort and confidence that you are doing the right thing for your API or DP. There is a strong reason for which GMP’s are needed: There are several purification steps in the API. This said, there is challenge, because how and what is performed on each of these GMP’s can vary. For instance, what is expected in Q11 is not expected in API GMP under Q 7. It is in fact, due to the purification steps that you have greater flexibility over what you can do and what you cannot.

The major differences…

One major difference between GMP for API and GMP for DP is that no matter what you do; it is difficult to obtain a perfect drug. The “junk” is always there, meaning that the essence present in API is diluted or altered in the drug. The same impurity is much less likely to be present in API, because the API is rawer and purer and has a lot less additives.

Another important aspect to be kept in mind is that no purification is usually present in drug product manufacturing. The flexibility that you see in API GMP is acceptable even to FDA and other regulatory bodies.

Validation is usually expected for critical steps, processes or conditions in API unlike in the case of DP, where validation is expected for the entire process.

Cleaning validations may not always be required for API’s, unlike for DP. The basic thing a firm needs to be prepared to do is to document and be able to defend its practices under API GMP, since this allows some flexibility to do something different, something that DP does not afford. 

 

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