Regulatory Affairs, Quality Assurance, FDA-readiness audits, clinical trials, market approval, and strategic development of drugs, biologics and medical devices for approval in the US, Europe, Asia, South America and Australia., FDA meetings, IND, NDA, 510k, BLA, PMA, ANDA, BTD, ODD, dietary supplements, medical foods, and practically all related issues for strategies and clinical trials.

Teach courses in Global Regulatory Affairs and Clinical Research to medical students

Networking, professional development and mentorship in pharmaceutical, biotechnology, medical devices and research for inidividuals and businesses interested in India as a site for business development and outsourcing

Teach a Masters course titled "Drug Development: From Bench to Market", under the Professional Sciences Masters program.

DLTA is a tool for SOP automation and resource maximization for biopharmaceutical development projects. More info visit: www.druglifecyle.com

This course provides an introduction to project management of clinical trials in the pharmaceutical industry. If you want to learn basic project management skills and how they can be applied to the drug development process, especially in the management of clinical trials, this course is for you. If you are looking for careers in the clinical development industry but are not familiar, or experienced, with specific technical tasks involved in clinical trial management, this course is for you. This course will walk you through the various aspects of clinical trial projects with special focus on the need to anticipate, understand, and implement detailed project management activities in a proactive manner. This course will help students understand a highly detailed and fully developed clinical trial management project. Discussions will be led by industry experts via case studies and mock clinical trial projects to train students in the practical aspects of clinical projects to help assure a successful clinical project management career.More details at: http://cms.montgomerycollege.edu/wdce/bits/clinicaltrialpm.html

Amarex BioVentures LLC (ABV) is an investment group in medical technologies. We specialize in creating strategic opportunities in innovative therapeutics, medical devices and diagnostic technologies. We focus on investment opportunities in both private and public companies, academic inventions and non-profits.

Develop regulatory strategies for pharma, biotech and medical device products; interaction with regulatory agencies (FDA, EMEA and DCG-India); quality assurance; training; and business development.

Select topics of discussion within the RAPS community of about 13000 members in about 100 countries. Edited the monthly journal published by the group. Edit and review professional development and training books and other media.

Gene therapy (Lentiviral gene transfer vectors) and viral entry projects. Managing 2 post-docs, three interns and two technicians. Gor two patent applications and 3 peer-reviewed publications

Gene therapy and Viral entry (influenza, HIV)

Part time intern (20 hr/week), helping with technology evaluation, intellectual property protection strategy, marketing of biomedical technology, and licensing negotiations.