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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200+ followers. WOWWWWWW…

Hello Everyone,

Today we have the pleasure of celebrating the fact that we have reached the milestone of 200+ followers on WordPress. Since we started this blog, we have had such a great time connecting with everyone.  we never expected to actually to connect with other people in the blogging community.

we are so incredibly thankful for each and every one of you who follows and comments on my blog posts. Please know that!

we would continue our blogging in these areas FDA Regulation, Medical Devices, Drugs and Biologics, Healthcare Compliance, Biotechnology, Clinical Research, Laboratory Compliance, Quality Management ,HIPAA Compliance ,OSHA Compliance, Risk Management, Trade and Logistics Compliance ,Banking and Financial Services, Auditing/Accounting & Tax, Packaging and Labeling, SOX Compliance, Environmental Compliance, Microsoft Excel Spreadsheet, Geology and Mining, Human Resources Compliance, Food Safety Compliance and etc.

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Drug dissolution testing and establishing plasma drug levels in humans

Dissolution testing is a very important tool that determines and help understand the performance and effectiveness of oral solid dosage forms. It is significant for the field of medicine because if a drug has to be effective, it must be released first from the product form, and it should then be allowed to get dissolved in the gastrointestinal fluids. This is the first step that leads to the next important phase, that of the dosage’s absorption into the bloodstream. This points to the fact that dissolution from the dosage form is a major determinant of the rate and extent to which the drug gets absorbed by the body.

Drug dissolution testing is very important during the development of drugs and drug formulations. It helps to determine if the right concentration of the drug reaches the desired or expected locus of action. This makes the investigation of the factors which affect drug absorption into the human blood flow when a drug product is taken orally important.

The usual method of measurement of drug absorption is in vivo, or, the body of a living being such as a human or animal. Time blood plasma concentration profiles of drugs after oral administration constitute an important in vivo parameter. In-vitro investigations are carried out for identifying the parameters involved in drug absorption. These are investigations that are conducted in a controlled and simulated environment that resembles biological conditions closely.

Thorough learning of drug dissolution

An important seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will offer valuable learning on all the aspects of drug dissolution testing and explain the ways of establishing plasma drug levels in humans.

At this two-day seminar, Dr. Saeed Qureshi, who has worked as a research scientist with Health Canada and is an internationally known expert on the subject whose expertise spans the areas of drug dissolution testing, pharmacokinetics, biopharmaceutics and analytical chemistry as related to animal and human studies for developing and evaluating pharmaceutical products; will be the Director.

In order to gain the benefit of learning from this world-renowned expert, please enroll for this seminar by visiting Drug dissolution testing and establishing plasma drug levels in humans. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

All aspects of drug dissolution and establishing plasma drug levels

This seminar will provide its participants a unique opportunity to learn scientifically valid drug dissolution testing and establishing plasma drug levels. Lab personnel take several approaches to conduct dissolution testing using different apparatuses and methods. This makes section of an appropriate apparatus and method confusing and challenging. Dr. Qureshi will offer relevant pharmacokinetics and physiological background that is aimed at making this choice easier and intuitive. He will use simple and clear language in helping participants understand how to select or develop a dissolution method. He will describe the theoretical aspect of the drug dissolution testing, including method development, in detail. He will explain the pros and cons of different approaches.

Another important area that Dr. Qureshi will address is in vitro-in vivo correlation (IVIVC). He will address the particular issue of the use of the concepts of convolution/deconvolution and IVIVC in providing an estimate/prediction of expected drug levels in humans through drug dissolution testing. This approach has met with limited success. Dr. Qureshi will explain the reasons for this and suggest alternative approaches and will offer an explanation of the underlying scientific principles involved in convolution, deconvolution and IVIVC techniques with simple practical examples. He will describe a unique and simple approach based on convolution technique using spreadsheet software.

He will show in vitro drug dissolution testing and convolution/deconvolution techniques for predicting plasma drug levels using the principles of pharmacokinetics and physiology. Dr. Qureshi will cover the following main areas at this seminar, with its relevant subtopics:

• Physiological and Pharmacokinetic Principles
• Drug Dissolution Testing
• Linking Dissolution Results to Plasma Drug Levels.

Personnel who work in various levels of the areas of Pharmaceutical Development, setting up analytical methods (pharmacopeial, regulatory or in-house developed), R & D (both analytical and formulation), Project Management, Quality Control, Quality Assurance, and Regulatory Affairs will benefit enormously from this learning.

To join us for more information, get in touch

 

Breast cancer warning from man stunned by ‘impossible’ diagnosis

When you think of breast cancer, you think of a form of cancer that affects only women. It doesn’t.

While breast cancer in men is rare it’s still an issue for the 10 men on average who are diagnosed with it every year in Northern Ireland.

Ian Cranston, 70, was diagnosed with breast cancer in May. Two weeks later he had a mastectomy.

The Portadown father-of-two was given the all-clear in June and has decided to speak publicly to make men aware that it’s a cancer that doesn’t just affect women.

He said “men also need to check their breasts for changes”.

Inverted nipple

In May, Ian’s wife Elizabeth noticed something wrong when he got out of the shower.

Image copyright SPL

Image caption About 10 men in Northern Ireland are diagnosed with breast cancer each year

She told him he had an inverted nipple and needed to see his GP.

“I didn’t know what that meant,” said Ian.

“Men can’t get breast cancer, I don’t have to go to the doctor.

“I wasn’t aware I had breasts. This is my chest, men don’t have breasts, it’s impossible,” he added.

Eventually his wife persuaded him to go to his GP, who referred him to Craigavon Area Hospital.

Image caption Ian Cranston alongside breast care specialist nurse Annie Treanor

The diagnosis stunned him.

“Men having breast cancer, I couldn’t believe it,” he said.

“I couldn’t do or say anything. My wife Elizabeth cried.”

Four days later Ian said he “just broke”.

He has decided to help try and raise awareness of the disease, saying that if his speaking out helped one man, it would be worth it.

“I can understand where women are coming from because I’ve had breast cancer myself,” he said.

How We Need to Keep Growing Up: http://snip.ly/ljoxy#http://www.bbc.com/news/uk-northern-ireland-41616265

MS could be reversed with existing allergy drug

In a recent phase II clinical trial, an over-the-counter allergy drug was shown to improve nervous system function in patients with multiple sclerosis.

Multiple sclerosis (MS) is an autoimmune disease affecting more than 2.3 million people around the world. The condition attacks myelin, or the waxy coat around nerves, and compromises the nerves’ ability to transmit messages.

Over time, as the nerves’ function is steadily reduced, a range of symptoms — including problems with vision, muscle weakness, difficulty walking, and issues with balance and coordination — develop.

Current treatment focuses on preventing the immune system from causing further damage, and as it stands, no drugs can repair the damaged myelin.

Discovering a medication capable of rebuilding the damaged myelin would be a huge step forward. And according to the latest study, this may be just around the corner.

New MS drug on the horizon?

In 2014, studies carried out by Prof. Jonah R. Chan at the University of California, San Francisco showed that clemastine fumarate may be a candidate for the treatment of MS.

Because of the potential importance of the findings, the drug quickly progressed to clinical trials. This week, the results from a phase II clinical trial on clemastine fumarate are published in The Lancet.

Multiple sclerosis: Are we close to a cure?

How far have we come in treating the symptoms of MS and how close are we to a cure?

Read now

Clemastine fumarate was first approved by the Food and Drug Administration (FDA) in 1977. It is an antihistamine medication for allergies and has been available over the counter since 1993. Its potential to treat MS is therefore as surprising as it is welcome.

According to principal investigator Dr. Ari Green, “To the best of our knowledge, this is the first time a therapy has been able to reverse deficits caused by MS. It’s not a cure, but it’s a first step toward restoring brain function to the millions who are affected by this chronic, debilitating disease.”

Read More: https://www.medicalnewstoday.com/articles/319732.php

Drugstore stocks tumble as Amazon considers selling prescription drugs online

Shares of drugmakers dropped in midday trading Friday after CNBC reported Amazon is in the final stages of considering an entrance into selling drug prescriptions.

Walgreens, Rite Aid and CVS Health stocks each slipped 4 percent or more as investors worried Amazon may disrupt the traditional distributors’ hold on the drug prescription market.

Amazon will decide before Thanksgiving whether to move into selling prescription drugs online, according to a source and an email from Amazon viewed by CNBC.

Amazon typically spends years researching opportunities before it telegraphs its intentions. The opportunity to sell drugs online is alluring given its market size – analysts have estimated the U.S. prescription

 

Read More: http://snip.ly/j7tf0#https://www.cnbc.com/2017/10/06/drugstore-stocks-tumble-as-amazon-considers-selling-prescription-drugs-online.html

Are any weight loss supplements considered safe?

Every year, millions of Americans go after this same goal, some successful and others not so much. To attain their goals, they may choose from the over-abundance of diets and exercise programs available, and some turn to weight loss supplements as well.

While you shouldn’t rely on supplements to do all the work for you, there are a few that can be used safely to boost your weight loss efforts.

Before you decide on weight loss supplements, though, you should consider the health effects carefully. Always check with your doctor first to be sure about safety, and remember that these pills are supplements. They’re meant to be used alongside healthy eating habits and proper exercise.

DO YOU HAVE LIVER DAMAGE?

Again, never use supplements by themselves to lose weight. Some people turn to weight loss pills so that they can continue an unhealthy lifestyle while staying thin.

Continue Reading Below

 This dangerous mentality could lead to frightening situations like addiction, overdose or death. Also, brands that claim to shed weight without any effort may contain ingredients that will do you more harm than good. If you have any doubt about a supplement, stay away.

Weight Loss Supplements that Work

Just like any other medication, weight loss supplements have both benefits and side effects. When choosing a supplement, you should know all the possible effects and consider them in light of your own health history. Especially if you have other health issues, you should check carefully for ingredients that may trigger or worsen your symptoms.

Let’s look at 3 supplements that you could consider adding to your weight loss program:

1. Green Tea Extract

Green tea has long been known for its health benefits, mainly because the drink is high in antioxidants. In particular, green tea contains large amounts of polyphenol antioxidants called catechins, which may help reduce oxidative stress.

For weight loss, studies have shown that green tea extract can help boost the metabolism. Researchers think that the combination of antioxidants and caffeine work together to accomplish this goal.

 

Read More: http://snip.ly/1alkc#http://www.foxnews.com/health/2017/10/06/are-any-weight-loss-supplements-considered-safe.html

Depression: Is brain inflammation tied to suicidal thoughts?

A new study confirms the link between inflammation of the brain and the prevalence of suicidal thoughts in people diagnosed with major depression. This is the first study of its kind to measure relevant biomarkers in living individuals.

Major depression is a very common mental condition, with 6.7 percent of all adults in the United States having had at least one severe depressive episode in 2014 or 2015.

According to the World Health Organization (WHO), depression is also currently the leading cause of years spent with disability worldwide.

Some people diagnosed with major depression experience suicidal thoughts, which may result in suicide attempts. In the U.S., “suicide is the 10th leading cause of death.” Now, researchers wonder whether or not suicidal ideation in people with major depression may be linked to abnormal inflammation of the brain.

Dr. Peter Talbot and other researchers based at the University of Manchester in the United Kingdom have conducted a study testing the levels of a biomarker associated with brain inflammation in the systems of people diagnosed with clinical depression.

The scientists’ findings were reported in the journal Biological Psychiatry.

 

Read More: https://www.medicalnewstoday.com/articles/319526.php?utm_campaign=sniply&utm_medium=sniply&utm_source=sniply

Seminar Calendar of Upcoming Courses – June to July – 2017

GlobalCompliancePanel’s seminars are a wonderful opportunity for professionals in the regulatory compliance areas to understand the latest happenings and updates in the regulatory compliance areas and to implement them, something they need to climb in their professions. GlobalCompliancePanel brings together a few of the best recognized names in the field of regulatory compliance on its panel of experts. The result: Learning that is effective, valuable and helpful.

GlobalCompliancePanel’s experts help you unravel all the knowledge you need in all the areas of regulatory compliance. At these seminars which are held all over the globe, you get to interact with them in person, so that any doubt or clarification you have is sorted out by none other than the honcho. They help professionals like you implement the regulations and stay updated, so that regulatory compliance causes no stress for you.

GlobalCompliancePanel’s experts offer their insightful analysis into the issues that are of consequence to regulatory professionals in their daily work. Their thoughts help you implement the best practices of the industry into your work. They also offer updates on the latest regulatory requirements arising out of a host of the laws and issues related to regulatory compliance, including, but not limited to medical devices, food and beverages, pharmaceuticals, life sciences, biotechnology and pharmaceutical water systems.

Take a look at our upcoming webinars from GlobalCompliancePanel, which will put you on the road to learning about any area that is of importance to your profession. You can plan your learning from GlobalCompliancePanel by looking at our seminars in the next few weeks at locations of convenience to you. You can choose from a whole range of topics. See which among these trainings suit you: Design of Experiments (DOE) for Process Development and Validation, Writing and implementing effective SOP’s, new FSMA rules, risk management and device regulations, data integrity, combination products, and what have you!

Contact us today!
NetZealous LLC DBA GlobalCompliancePanel
john.robinson@globalcompliancepanel.com
Toll free: +1-800-447-9407
FAX : 302 288 6884
Website: http://bit.ly/Courses-June-to-July-2017

The FDA’s requirements for Drug Applications and Submissions

The FDA has set out requirements by which it accepts drug applications and submissions. It accepts drug applications and submissions through two formats, the New Drug Application (NDA) and Abbreviated New Drug Application (ANDA). The NDA and the ANDA are the mediums through which the FDA eventually approves drug applications and submissions.

The NDA process

The NDA is one the two mechanisms through which the FDA accepts drug applications and submissions. This application is available with the FDA. Any sponsor of a clinical study, be it an organization or an individual, can apply for the NDA and can submit the same, when it is convinced that it has sufficient evidence that its study meets the FDA’ requirements for marketing approval.

The way to go about filing for an NDA as part of drug applications and submissions is this:

The ANDA process

The ANDA is the other method of drug applications and submissions to the FDA. Being the counterpart of the NDA; the ANDA is the application a company makes for getting a generic drug approved by the FDA for marketing. The ANDA also has to contain the same data as contained in the NDA drug applications and submissions, but is not required to be accompanied by the data of the clinical research. It is for this reason that they are called by their name.

In place of the clinical research data, the ANDA format of drug applications and submissions has to contain evidence that the product has the ability to perform the same functions of the original drug. This is called the drug’s bioequivalent value. Like in the case of the NDA, the ANDA too is allocated a reference number as part of its drug applications and submissions.

Common factors taken into consideration

In either of these methods, the primary considerations for the FDA include the following:

• The safety and effectiveness of the drug
• Its ability to meet its intended use
• Its ability of its benefits to outweigh its risks
• The appropriateness of the drug’s planned labeling and its contents
• The ability of the methods used in the manufacturing of the drug to meet Good Manufacturing Practice (GMP)
• The capacity of the drug to have to controls in place for maintaining its quality, purity, strength and identity

Read more : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900762SEMINAR?wordpress_seo