March 12, 2013
Maxiom Group led a pharmaceutical client through a Detailed Serialization Design project to help in their efforts to comply with upcoming regulations. In order to define Serialization System Design Requirements, Maxiom Group conducted the following activities:
- Identification of design alternatives and trade-offs in key areas
- Determination of a recommended path
- Identification of qualified technology vendors
- Labeling and Marking
- Scanning and Verification
- Application Software
- Integration Methods
March 4, 2013
As lab operations budgets shrink, lab managers are forced to spend more wisely than ever. Although significant spend goes toward lab supplies and new instrument purchases, a substantial budget is allocated every year for maintaining and servicing laboratory instruments.
February 19, 2013
Large pharmaceutical companies have been globally-focused for several years now as most have been faced with patent cliffs, pipeline deficits, pricing pressure and an overall increase in development costs, resulting in a need to expand into new markets. However, as the competition in markets increase, along with reimbursement challenges, stringent regulatory guidelines and pressure to cut costs, a growing trend shows that more mid-size life science companies are also starting to plan global launches in order to maximize revenues and gain stakes in new territories.
February 12, 2013
Maxiom Group led a pharmaceutical client through an ePedigree Strategy project. The objectives included:
1. Understand the upcoming state regulations and how they would affect the company’s supply chain
2. Assess the client’s distribution partner’s ePedigree capabilities and strategy, as well as the implications of the distribution partner’s strategy on the client
3. Develop recommendations on a short-term action plan to meet near term customer and regulatory requirements
4. Develop recommendations for a strategy to meet longer term requirements
February 5, 2013
A few years ago I was wearing a new shirt and tore the sleeve near the cuff. I decided to turn it into a short sleeve shirt rather than throw it out. I brought it to my cleaners and asked then to make it a short sleeve shirt. When I put it on the sleeves were cut like a polo shirt, coming mid-way down my upper arms and looking ridiculous. I asked the cleaner “don’t short sleeves come down to the elbow?” He said “those are half sleeves, you asked for short sleeves”. So I got what I asked for, but not what I needed.
January 29, 2013
A development team in an emerging biopharmaceutical company noticed a significant change in a key characteristic of a candidate. This change posed a threat to the subsequent drug development steps as well as the financial viability of the candidate. Internally, there had been much discussion and problem solving regarding the issue, but no rigorous or organized process had been used. The company approached us to help identify the cause(s) of this change in a structured way. At the same time, they wanted us to coach their employees on a basic problem solving process that could be utilized in similar situations in the future.
January 23, 2013
Preparing a company for a commercial launch requires a transformation across the entire enterprise that necessitates the guidance and leadership of a member of senior management. Many CFO’s are tasked with initiating and overseeing the development of the commercial launch plans. When designing the commercial transformation of the enterprise, CFO’s will need to take into consideration key launch components such as the overall timelines, milestones and investment triggers, as well as long lead financial and IT requirements. In order to successfully prepare for launch, CFO’s should start launch planning as early as possible. 30 to 36 months prior to an expected launch, a commercial readiness roadmap, along with the subsequent costs and capital investments, should be mapped out. By 18 to 24 months before launch, core IT and business infrastructure capabilities should be determined and mapped to the launch milestones.
January 15, 2013
Maxiom Group led a pharmaceutical client through a Transportation RFQ (Request for Quote) process to find cost savings in each of their four most significant transportation categories, based on total annual spend. Together these four transportation categories made up 80% of the total annual transportation spend:
January 8, 2013
I most recently was the lead Project Manager for the implementation of a Change Management module for the QA group of one of our pharmaceutical clients. This new application was an add-on to the existing suite of Quality Management System (QMS) modules, as part of a pre-approval inspection (PAI) readiness initiative.
January 2, 2013
Research Continuity is a term that addresses the ability to continue research activities if/when an adverse event or series of events affects a research lab or facility. Several incidents in the recent past highlight the need for good risk mitigation/avoidance planning for laboratories.