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Expert Interview

Slingshot members are talking to an expert! The topic is:

Evaluating Scarcity & Value of Sterile Manufacturing Facilities

Ticker(s): TEVA, PFE

Who's the expert?

Name: Frank Settineri

Bio:

  • 35 years of medical device, pharmaceutical, manufacturing and business expertise ranging from aseptic medical device manufacturing and processing to sterile and non-sterile manufacturing.
  • Expertise includes: designing and conducting micro validation for clean rooms/transfer rooms for sterile manufacturers (ophthalmics, inhalation products), Solving potential sterility failure issues for contract manufacturers as well as written responses to 483s and Warning Letters
  • First hand experience with Teva/Hospira

Interview Questions
Q1.

Discuss global supply/demand for sterile manufacturing.  Is any capacity being shuttered?

Added By: hc alpha
Q2.

What are approximate costs and timeline to build a mid-sized sterile plant? Please cite examples.

Added By: hc alpha
Q3.

Are mid-and-large pharmas outsourcing more or less sterile manufacturing?

Added By: hc alpha
Q4.

Is sterile manufacturing capacity viewed as a differentiated/valuable by mid-and-large pharmas?

Added By: hc alpha
Q5.

Post Hospira/Teva issues, how has FDA regulatory oversight changed?

Added By: hc alpha
Q6.

What key concerns/risks should any investor in a sterile manufacturing business understand?

Added By: hc alpha
Q7.

Why are US-based specialty pharmas outsourcing mostly to ex-US CMOs for these products?  And (related), how current is FDA on inspecting these facilities (i.e. Lonza, Corden, etc.)?

Added By: caleb_eugenius
Q8.

How does this tie-in with sterile compounding / outsourcing facilities?  (503B)

Added By: caleb_eugenius

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