Lecture 77: Drug Development and Drug Approval Process: From Discovery to Market

When: Thursday October 9, 2014 – 7:30 PM
Where: Montgomery Community College (Rockville Campus) – Humanity Building (HU), Conference Room 009 (Get Directions, Campus Map )

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Speaker: Dr. Kazem Kazempour
Language: Farsi

Synopsis:

This talk covers the discussion of drug development/approval from discovery to market in USA. All clinical products must go through the FDA approval process before they are allowed to go to the US market. This includes all clinical products that have been approved and are being used in other countries. That is after their animal tastings, and before the human testing they must go through FDA approval and review process.
The FDA approval process on average takes around 10 years and costs on average around 100s of million dollars for each clinical product. Maryland in general and Montgomery County in particular houses hundreds of pharmaceuticals, biotech industries and especially it houses the National Institutes of Health (NIH) and Food and Drug Administration (FDA). These two institutions are the essential parts of the clinical research and review in the US.

About the Speaker:

Dr. Kazempour is the President and CEO of Amarex Clinical Research since 1998; in addition he is teaching at The George Washington University, and serving on GW Regulatory Affair Advisory Board. Amarex Clinical Research is a global clinical research organization, working with international pharmaceutical, biotechnology, medical device companies, and the National Institutes of Health (NIH).
Dr. Kazempour received his MS and PhD degrees in Statistics from Colorado State University and began his career as a mathematical statistician by working at the Genetics Institute in 1975. He has worked in multiple therapeutic areas including anti-infective, AIDS, cardiovascular diseases, vaccines, and wound healing. He has chaired, established, presented to, and participated in, several Data Safety Monitoring Boards for compounds within his area of expertise, and has authored and refereed numerous publications and technical reports both in/for mathematical statistical journals as well as clinical literatures.
Dr. Kazempour has presented, and participated in hundreds of US Food and Drug Administration FDA meetings as well as other regulatory bodies around the world. His expertise has earned him multiple recognition awards from the FDA for his contributions to the drug approval process, particularly for his work on HIV and AIDS clinical trial designs and analyses. He has conducted presentations to the FDA meetings and FDA advisory committees on more than 50 different clinical trials and medical devices ranging from Antiviral, HIV to septic shock, to Diabetics and wound healing.

Fee (including dinner): $5 Students, $15 Public

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Lecture 76: Individual Identity vs. Social Identity

When: Thursday September 11, 2014 – 7:30 PM
Where: Montgomery Community College (Rockville Campus) – Humanity Building (HU), Conference Room 009 (Get Directions, Campus Map )

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Speaker: Ashkbous Talebi
Language: Farsi

Synopsis:

Presentation will begin with defining concepts followed by in depth discussion of each topic as outlined below:

  • Development of (self) at early ages: sex, gender, gender role personal identity. Personality development, identity crisis and personality establishment and personality type.
  • Social Identity; Parental influences, Group influences, influences of social factors.
  • Differences between self and society – confusion, conflict, crisis and ways to deal with the crisis.
  • Mental health and identity conflict and coping.

About the Speaker:

Fee (including dinner): $5 Students, $15 Public

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Lecture 75: Energy, Economy, Environment and Sustainable Development in the Middle East

When: Thursday August 7, 2014 – 7:30 PM
Please note that this lecture will exceptionally be held on the 1st Thursday of August instead of the 2nd Thursday.
Where: Montgomery Community College (Rockville Campus) – Humanity Building (HU), Conference Room 009 (Get Directions, Campus Map )

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Speaker: M. R. Riazi, PhD
Language: English

Synopsis:

In this presentation, Dr. Riazi will review the present state of energy demand and production in the Middle East and the world. Oil and gas reserves in the Middle East and North Africa and their role in providing energy demand by the world are examined. Role of oil and gas in the economy of the region and their impact on the global environment and carbon emission will be discussed.
Future of oil and gas reserves in the region and how long they will last along with existing coal reserves and alternative fuels would be discussed. Several models for the energy demand of the world by 2050 and the role of other sources of energy such as biofuel, nuclear, solar, hydro, wind, and wastes on sustainable energy supply will also be reviewed.
The role of population growth on the energy demand of the future and economy of the region will be discussed. The impacts of quality of crude oil and its products on the environment and changing fuel standards in the developed and developing countries and their effects on the market and industry as well as economy of the region will be reviewed.
The region is rich in oil and gas which can be converted into thousands of valuable products rather than burning as fuel. Would that be economical to use oil and gas in refineries just to produce fuels or there are other options for more economical uses of these resources in the future? What would be the best option for the oil producing countries in the region? These issues and more will be presented in this speech.

About the Speaker:

M. R. Riazi (www.RiaziM.com) is currently a professor of chemical engineering at Kuwait University and CEO of PetrogasCanada, Inc. a consulting firm based in Canada. He was previously a faculty of chemical and petroleum engineering at various universities in US, Canada, Europe and Middle East. He has about 140 publications including 3 books as well as more than 50 conference presentations mainly in the field of petroleum technology. Dr. Riazi has been invited speaker and consultant to more than 50 oils companies and research centers worldwide. He is the founding editor and editor in chief of IJOGCT and associate editor of JPSE. He has received Diploma of Honor from National (American) Petroleum Engineering Society and is a Fellow of AIChE.

Fee (including dinner): $5 Students, $15 Public

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