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Rabu, 29 November 2017

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Applying Operational Excellence in the Product Development Environment
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The Pharmaceutical Product Development, LLC (PPD) is a global contract research organization (CRO) providing discovery, development and post-approval services as well as compound partnering programs. The company's clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations.


Video Pharmaceutical Product Development



History

PPD was founded by Fred Eshelman, Pharm.D., as a one-person consulting firm in 1985. The following year he expanded the company's scope to include development services and relocated operations from Maryland to North Carolina.

  • July 1985: Fred Eshelman, Pharm.D., founds PPD as a one-person consulting firm based in his home in Maryland.
  • 1986: Eshelman expands the company and relocates operations to Wilmington, North Carolina.
  • Jan. 1989: The company incorporates in North Carolina.
  • Jan. 1996: PPD issues its initial public stock offering and begins trading on the Nasdaq National Market System under the symbol PPDI.
  • Oct. 2005: PPD's board of directors adopts an annual cash dividend policy.
  • July 2009: The company promotes Eshelman to executive chairman and names David Grange chief executive officer.
  • Jan. 2010: The company commemorates the 25th anniversary of its founding.
  • June 2010: PPD spins off its compound partnering division as a new and independent publicly traded company, Furiex Pharmaceuticals.
  • May 2011: David Grange retires as chief executive officer of PPD.
  • Sept. 2011: PPD's board of directors names Raymond Hill as PPD's new chief executive officer.
  • Dec. 2011: The company is acquired by affiliates of The Carlyle Group and affiliates of Hellman & Friedman in an all-cash transaction valued at approximately $3.9 billion.
  • May 2012: PPD's board of directors names David Simmons as chairman and CEO.

Maps Pharmaceutical Product Development



Location

PPD maintains its worldwide headquarters in Wilmington, N.C. The company has more than 18,500 employees and offices in 47 countries.


Challenges in Implementing Quality By Design - An Industry ...
src: www.bioprocessintl.com


Operations

PPD provides drug discovery, development, lifecycle management and laboratory services. PPD has a 300-bed healthy volunteer (Phase I) clinic in Austin, Texas.


Small & Large Molecule Pharmaceutical Product Development
src: www.patheon.com


Clinical Development Services

PPD provides product development and post-approval services for biopharmaceuticals and devices, as well as full service Phase II-IIIb clinical studies for multinational regulatory submissions. PPD also offers clinical data management and information solutions, including consulting and proprietary software tools to speed collection, analysis and reporting of clinical trial data.


QbD: Building Robust Processes
src: www.copybook.com


Laboratory Services

PPD provides bioanalytical, cGMP product analysis, central laboratory, and vaccines and biologics lab services.


Bio/Pharma Product Testing Services - Eurofins Scientific
src: d1jj3zdoktl3jd.cloudfront.net


Discovery Sciences/Compound Partnering

The discovery sciences segment offers biomarker discovery services, nonclinical development and preclinical services. Through its compound partnering program, it also seeks to in-license early-stage compounds, take them through proof of concept, and out-license them to its partners for late clinical testing and commercialization. PPD shares in the risks and rewards of bringing a drug to market, gaining revenues generated by licensing fees, milestone payments and commercial royalties.

The company's post-approval services include epidemiology, risk management and outcomes research; late-stage trials; medical information; product safety; registries and observational studies.


QbD in Generic Drug Development: PAT Application | AIChE
src: www.aiche.org


References


Slide 1 of 45 April 2007 Training Workshop on Pharmaceutical ...
src: images.slideplayer.com


External links

  • PPD Corporate Website

Source of the article : Wikipedia

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