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Document
Big data in drug safety

Safety and efficacy information on drugs shall be communicated to all stakeholders, including physicians, patients, insurers and investors, in a format that allows objective assessment of real value of the intervention compared to other treatments. B...

 

 

ARETE-ZOE, LLC

 

Presenter: Veronika Valdova

PPT
Case Study: The Discovery of Telaprevir (VX-950, IncivekĀ®) for the treatment of Hepatitis C

This Case study shows the drug discovery process of Telaprevir for Hepatitis. IT discusses the background of Hepatitis, and the basic information on Hepatitis C, Preclinical studies, Clinical studies, critical findings, timeline to approval and the f...

 

Brain Science Institute NeuroTranslational Drug Discovery Program

 

Johns Hopkins University

 

Presenter: Dana Ferraris, Ph.D., M.B.A.

PPT
First-In-Man - risk assessment

The example of TeGenero first-in-man case study was used to explore the usability of systems theoretic accident modeling and processes (STAMP) to create control structure of selected critical points in drug development, approval and commercialization...

 

 

ARETE-ZOE, LLC

 

Presenter: Veronika Valdova

Document
Global Pharma Primer, Syllabus and Road Map

The material included in these modules serves many interests by facilitating understanding of construct, dynamics, and influences affecting regulatory policies and corporate decision-making that ultimately determine access, availability, and effectiv...

 

 

ARETE-ZOE, LLC

 

Presenter: ARETE-ZOE

PPT
IND-Enabling Studies and Preparation of the IND

Preparing for submission of an IND to initiate human clinical trials involves three parallel streams of activities that interweave at various points during the development process: Efficacy, Safety and Quality. The objective of the submission is mu...

 

 

AbbVie

 

Presenter: William Bracken, PhD, DABT

PPT
Interacting with the FDA (How to avoid a clinical hold)

This lecture explains when you need an IND and what it should and should not contain to avoid clinical hold ups with the FDA. Reasons for Phase I, 2 and 3 clinical holds are discussed along with clinical reporting requirements.

 

Division of Neurology Products

 

Food and Drug Administration

 

Presenter: Russell Katz, M.D.

PPT
It’s all about dose…. Toxicology in Drug Discovery and Development

Nonclinical toxicology studies are critical during drug development due to the scientific need and regulatory requirement to collect information to define the toxicity profile and provide an evaluation of the relationship of dose and exposure to toxi...

 

 

Ironwood Pharmaceticals

 

Presenter: Adaline C. Smith, PhD, DABT

PPT
Risk, Issue and Opportunity in Drug Deveopment

Holistic risk, issue and opportunity management in drug development requires close coordination and alignment of approaches, strategies and tools across the whole program among all participating stakeholders to account for technical, business and pro...

 

 

ARETE-ZOE, LLC

 

Presenter: Veronika Valdova