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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Think like the FDA to get compliance right

If an organization in an FDA-regulated industry has to show compliance with its systems; the most effective way for it is to think the way the FDA does. This is the right approach to getting its compliance requirements right.

FDA inspections can result in anything going all the way up to Warning Letters, seizures, injunctions, prosecutions, or recalls or consent decrees if serious violations are discovered at inspections. How does one inculcate the FDA line of thinking on compliance? Organizations need to first get an understanding of what the FDA looks for and keep these in compliance.

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The core of all compliance activity is possession and demonstration of control over the company’s Quality System. When an organization shows this using the subsystem approach; it gives the FDA fewer opportunities to cite minor deviations from the quality system regulation. This is the basis to avoid being cited for more serious systemic deviations from the regulation.

Gaining understanding through training

Proper training on these aspects goes a long way in helping organizations steer clear of issues that give an opportunity for the FDA to take these actions. A two-day seminar from GlobalCompliancePanel, a well-known provider of professional trainings in the regulatory compliance area, will be of immense value in helping professionals get a clear idea of how to get their compliance requirements right.

Just log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900523 to learn about the ways of getting into the FDA’s line of thinking on compliance. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

The Director of this seminar, David Dills, Global Regulatory Affairs & Compliance Consultant, who has an accomplished record with more than 26 years of experience within regulatory affairs, compliance and quality consultative services, will offer a clear understanding of all the critical components of dealing with an FDA inspection, such as:

FDA History, Inspectional Strategy and Techniques

  • SOPs
  • Training
  • Audits
  • Managing the Inspection and State of Readiness
  • Responding to FDA Inspectional Observations (483s)/Warning Letters
  • Mock Inspections
  • Compliance Program 7356.002, Drug Manufacturing Inspections and other Compliance Programs Device Manufacturing Inspections
  • IOM (Investigations Operations Manual)
  • RPM (Regulatory Procedures Manual)
  • Field Management Directives
  • Inspection Technical Guides and official documents used as reference material for investigators and other FDA personnel

Warning Letter and Notice of Violation Responses/Communicating with FDA

  • Strategy and Remediation Implementation
  • Drafting
  • Liaison with FDA to ensure Close-out
  • Effective Responses

State of Readiness/Practice/Mock Inspections

  • Prepare for “real” inspections by being ready and not caught off guard
  • Practice Sessions and Dress Rehearsals on Day Two

 

Ensuring Drug Supply Chain Integrity is a critical task

Drug supply chain integrity is a means to ensuring that the drug that is consumed by the patient has come through proper sources and is free of adulteration, and reaches the right hands.

The drug supply chain a complex, yet trackable chain that starts from the time the substances and raw materials are identified for their potency and capability for being developed into drugs, and goes all the way up to the consumer and even after.

Drug supply chain is crucial because a weak cog in this link can make the drug spurious and reduce its efficacy. Worse, when drug supply chain integrity is awry, it gives opportunity for the drugs to become illicit and reach the wrong hands, ending up being put to the wrong use.

Dangerous consequences for society at large

This makes the integrity of the drug supply chain a matter of utmost importance to everyone concerned -the medical fraternity, users and their families, the logistics sector, the drug industry, the retail drug sector and everyone else. It is everyone’s duty to ensure drug supply chain integrity.

When the wrong drug (meaning a drug that is not prescribed) is given out to the patient, it accounts for loss of drug supply chain integrity. In many cases, as the ones relating to the massive scale of the recent diversion of sales of the drugs Avastin and Altuzan, the financial loss can be colossal. It was estimated in 2012 that the American economy stands to lose at least a billion dollars a year because of slackness in drug supply chain integrity.

The Prescription Drug Marketing Act of 1987

Legislative efforts to bring about drug supply chain integrity can be traced to the presidency of Ronald Reagan, who passed the prescription drug marketing act (PDMA) of 1987, which sought to regulate the drug supply chain. This was at the peak of the drug threat in the US. It was believed that bringing about drug supply chain integrity could ease the problem.

The NABP-Accredited-Verified Wholesale Distributors Program

This Act gave way to the NABP-Accredited-Verified Wholesale Distributors Program (VAWD), which was passed mainly because the PDMA did not fully succeed in its mission of bringing about the desired levels of drug supply chain integrity. Following the reemergence of spurious drugs in the market in the 2000’s, this program was initiated by the NABP. It strengthens the existing PDMA and seeks to bring about drug supply chain integrity by:

  • Reviewing sections of the existing law and making them stronger
  • Verifying licensures
  • Making more rigorous inspections and checks of facilities

Want to know more? Read:

http://bit.ly/Safety-Reporting-in-Clinical-Trials-San-Diego

http://bit.ly/Predicting-and-Improving-Product-Reliability

Drug safety and pharmacovigilance are two faces of a coin

If one were to describe the relationship between drug safety and pharmacovigilance; the most concise way of describing it is by calling them as two sides of the same coin. The aspects of drug safety and pharmacovigilance are intricately and inseparably bound together. The whole purpose of pharmacovigilance is the assurance of drug safety. It is precisely to ensure drug safety, more than anything else, that pharmacovigilance has come into being as a discipline.

Pharmacovigilance (PV in drug industry parlance) is a means to ensuring drug surveillance across the entire process, right from procuring of raw materials to consumption and the effects of consumption. So, pharmacovigilance has to be implemented right across the chain of activities that go into drug manufacturing. It has to ensure compliance with regulation at all stages, namely before the product is manufactured, during the manufacture, and after it enters the market. It is an indispensable aspect of a Quality System, and plays a central role in inspections and audits.

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Drug safety and pharmacovigilance are tied together at the level of regulatory bodies. There are different PV rules for different markets. For instance, while the FDA has its own set of PV guidelines; the EU has its own. A clinician or drug company involved in drug safety and pharmacovigilance has to be aware of the regulations in the markets into which the company’s products are sold and has to abide by them.

In order to ensure drug safety, pharmacovigilance is carried out by agencies and governments across the globe in accordance with strict guidelines. Drug safety and pharmacovigilance pair together in a number of areas. These are some of them:

Clinical trial:The work of ensuring drug safety through pharmacovigilance starts at the stage of the clinical trial itself. Pharmacovigilance ensures that drug safety is built into the drug right at the clinical trial stage. PV sets out a number of processes and methods by which a pharmaceutical company involved in clinical trials has to go in order to ensure drug safety.

Marketing:PV is set out in the marketing stage of a drug, too. Drug safety brought about by pharmacovigilance is to be implemented at the marketing stage of the drug, including processes for its safe storage, handling and transit. Throughout all these stages, drug safety and pharmacovigilance guidelines are to be strictly implemented.

Governmental drug distribution:Drug safety and pharmacovigilance are also built in by governments in their interactions with each other. For instance, when the government of a country or an agency such as the UN is shipping drugs to another country to support a health program; utmost drug safety is ensured through the principles of pharmacovigilance.

Drug safety and pharmacovigilance in disease management:Several governments across the world, along with international agencies conduct disease control management or emergency handling across the globe, especially in developing countries. Pharmacovigilance is the means to ensure that the drugs administered at these programs are safe for human consumption.

Learn more on this topic by visiting:

http://bit.ly/Safety-Reporting-in-Clinical-Trials-San-Diego

http://bit.ly/Validation-and-21-CFR-11-Compliance-of-Computer-Systems

http://bit.ly/During-an-Inspection