15.136J | Fall 2013 | Graduate

Principles and Practice of Drug Development

News of the Week

Each project team will be assigned by the TA to present the News of the Week once during the term. The main objective of the News of the Week assignment is to broaden the perspectives of the students in the class, keeping them up-to-date on the latest developments related to pharmaceuticals that are covered in the news media. We aim for students to develop insights into the implications of the various happenings for public policy and business strategy. News within the following topics may be covered:

  • Research Milestones or Developments
  • Industry News
  • Policy News
  • Product Developments
  • Corporate News

The above are suggested topic areas; the team should feel free to share any news outside of the topics, but relevant to the News of the Week assignment. We are not, however, requesting that you choose subjects that relate to your project topic. The presentations should be no more than 20 minutes during which the team presents a summary of each news item, its importance (how it relates to any of the class topics), its implications (broadly, at the micro and macro levels) and any brief analysis, insights, and viewpoints.

This assignment is very open ended. Some students choose to provide a survey of multiple articles while others prefer to focus on only one or two topics. It may be relevant to supplement a particular news item with contextual information relevant previous research, but this is not required. Please keep in mind that the main objective of this exercise is to bring noteworthy news items to the attention of your classmates, to consider the implications of these topics, and to make connections to topics being covered in class.

Sample News Articles

Below are sample news articles presented in the Fall 2013 class.

1 Introduction [No Articles]
2 Brief economic history of the pharmaceutical industry

Pollack, Andrew. “FDA Approves Drug, Abraxane, for Late Stage Pancreatic Cancer,” New York Times, September 6, 2013.

Japan’s Otsuka Pharmaceutical Set to Buy US Drugmaker Astex,” Financial Times, September 5, 2013.

3 Basic Science [No Articles]
4 Business of Biopharmaceuticals The Cost Of Creating A New Drug Now $5 Billion, Pushing Big Pharma To Change,” Forbes, August 11, 2013, Business section.
5 Accelerating Cancer Cures: A Global Frontier

Lilly’s Experimental Cancer Drug Misses Target,” Wall Street Journal, September 26, 2013.

Lilly Announces Second Positive Ramucirumab Phase III Gastric Cancer StudyMeets Primary Endpoint,” PR Newswire (Press Release), September 26, 2013.

6 Clinical Drug Development

UK Firm Seeks to Market World’s First Malaria Vaccine,” BBC News Health, October 8, 2013.

PheWAS–the Tool That Is Revolutionizing Drug Development That You’ve Likely Never Heard Of,” FierceBiotech, October 3, 2013.

Shutdown Halts NIH Drug Trials as Researchers Hit Brakes on Preclinical Research,” FierceBiotech, October 3, 2013.

Amgen Starts Another Phase III Trial for Biosimilar Adalimumab,” GaBI Online, September 27, 2013.

7 Drug Delivery Systems

Abbott, A. “Novartis Reboots Brain Division.” Nature News 502, no. 7470 (2013): 153–54.

Regeneron, Sanofi Drug Slashes Cholesterol in Late-stage Trial,” Reuters, October 16, 2013.

8 Regulation

FDA Approves First New Atherectomy Device In 20 Years,” Forbes, October 22, 2013.

Amarin Slashes Staff by Half After FDA Panel Rejection,” FiercePharma, October 22, 2013.

9 Manufacturing I

Array Biopharma Outlines Path To Market For New Myeloma Drug,” Forbes, October 31, 2013.

Eli Lilly: Cymbalta Patent Expiry Quantified,” Seeking Alpha, October 28, 2013.

10 Reimbursement

Stapled Peptide Reactivates p53.” Nature Reviews Drug Discovery 12, no. 741 (2013).

Jensen, V. “A New Plan for Drug Shortages to Build on FDA’s Success,” FDA Voice, October 13, 2013.

11 Manufacturing II

Novartis Hives Off Blood Diagnostics for $1.7B in First Slim-down Sale,” FiercePharma, November 11, 2013.

F. D. A. Ruling Would All but Eliminate Trans Fats,” New York Times, November 7, 2013, Health.

12 Manufacturing III

Princeton May Offer Meningitis B Vaccine After Seventh Case,” Bloomberg, November 18, 2013.

Cholesterol Drug From Trash Seen Preventing Heart Attack,” Bloomberg, November 21, 2013.

13 Student Presentations [No Articles]