Think the recent success of biological therapeutics

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Reference no: EM133201122 , Length: 3 Pages

Provide your comments concerning the added value of REMS vs. the former RiskMAPs. Using the attached reference, provide your comments concerning the added value of REMS vs. the former RiskMAPs.

Part 1

In their concluding remarks, Kinch et al suggest that the scaling back of internal R&D by large pharmaceutical companies, the rise of NME acquiring organizations with limited R&D capabilities and the tightening of venture capital funding for early stage biotechnology companies are resulting in a progressive and possibly irreversible shrinking of the R&D infrastructure for drug discovery. 1) Explain why you agree or disagree with this statement. 2) Where do you think the next generation of drugs will originate from?

Part 2

How do you think the recent success of biological therapeutics, like monoclonal antibodies, will affect the future development of small molecule therapeutics? Are there situations or indications for which a small molecule would be preferable?

Part 3

Using the attached file as a reference, provide your comments concerning the practicality and viability of the different models presented. Please use the file Alternative models of IRB Part 4.

Attachment:- Guidance for Industry .rar

Attachment:- Alternative Models of IRB Review.rar

Reference no: EM133201122

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