In today’s drug development world it still amazes me to find companies that don’t have an overall drug develop life cycle plan in place, especially when there is a baseline tool endorsed by FDA that could be used. In March 2007, the FDA released a draft guidance entitled, “Guidance for Industry and Review Staff Target Product Profile – A Strategic Development Process Tool”. The Target Product Profile (TPP) template format described in the guidance is a summary of a drug development program presented in terms of labeling concepts. The guidance describes the purpose of a TPP, its advantages, and its optimal use. It also provides guidance on how to complete a TPP and relates case studies that demonstrate its usefulness.
Archive for May, 2010
Through our work with a client, we’ve discovered a very powerful ERP package designed for extreme project accounting requirements. It’s from Pleasant Valley Business Systems (PVBS) and it has been built on top of Microsoft Dynamics NAV. Many of our clients require extreme project accounting capabilities in order to track clinical and other project spending, to enable re-imbursement from investment partners. This capability supports a key source of very significant funding.
Can Operational Excellence and Compliance coexist? History shows they must and experience proves they can.Monday, May 10th, 2010
I recently read an excellent article (http://immelresources.com/HistoryofGMPs.pdf) recounting events that led up to the formation of the FDA and subsequent key laws. As an Operational Excellence (OE) person, it’s tempting to view compliance as a pain, but this reminded me of the real importance of regulatory oversight.
One of the things that can drive Operational Excellence (OE) folks crazy is the extent of inefficiency and seemingly non-value added work that occurs around maintaining compliance in a life sciences company. Tracking deviations, conducting bio-burden tests, documenting process changes and rigorously controlling documents doesn’t fundamentally change the product coming out of the bioreactors and going into patients. Instead, it is all part of the safety net and oversight that makes it harder for faulty drugs or devices to get out the door. For an OE practitioner dedicated to streamlining operations, eliminating waste, and maximizing customer value, it can be frustrating to slog through layers of red tape and quality systems to drive valuable improvements in the business. Wouldn’t our jobs be so much easier without compliance requirements? Wouldn’t drugs be cheaper? (more…)
Life Sciences companies undoubtedly put more effort into supply chain risk management than any other sector. We’re different. After all, patients’ lives are at stake. It’s more important to us. Isn’t it?
Over the last 6 months the MIT Center for Transportation and Logistics (CTL) conducted a worldwide survey of supply chain risk attitudes, opinions, and management practices. With 12 teams of researchers around the globe we collected 1500 valid survey responses from over 50 countries and 20 industries. Enough Life Sciences responses were obtained (103) to enable meaningful comparison between this industry and others especially industries who act as suppliers to Life Science companies.