Managing the Aches and Pains of Long Cycle Times: Automating Controls for Pharmaceutical Manufacturers

One of the biggest challenges (or business pain points) for pharmaceutical manufacturers (or life sciences companies) is the long cycles that are required for research and development (R&D) and product approval. This is particularly a challenge for manufacturers of generic drugs, for which cycle times can average 20 months or more (and the full time-to-market period upwards of 12 years).

Why are long cycles a problem?

Simply put, it comes down to the familiar equation that “time = money.” More time needed means more capital spent, and manufacturers watch their bottom lines slip farther and farther away. To begin to formulate a plan to address the issue of long cycle times, it’s important to understand the factors that contribute to this challenge.

Long R&D cycles happen for a number of reasons. One is that there has been increasing need to comply with regulations, including the Food and Drug Administration’s (FDA’s) Title 21 Code of Federal Regulations (CFR) Part 11, for pharmaceutical manufacturers that are employing methods for electronic record-keeping and electronic and digital signatures.

This increasing need often means that additional administrative time must be spent on ensuring that the technical and procedural protocols are set up correctly and doing what they are supposed to do.

Another reason for long cycle times has to do with the need to ensure that all stages of product development are adequately documented for audits. Whether a manufacturer is using paper or electronic methods of data storage, there must be a reliable, consistent, secure, and accessible method of storing all documents related to the research, development, manufacture, and release of all drugs.

Every change to a document must be retained, and the integrity of the versions kept intact. For manufacturers straddling the line between paper-based and electronic methods, all paper-based documents need to be transferred and saved in digital form, a process that can require considerable time for scanning or manually entering data.

What are the business risks involved in longer R&D cycles and product approval?

Fewer products can be developed or manufactured concurrently, which means fewer products get to market. And fewer products to market can mean a decrease in the company’s in-coming cash flow (i.e. decreased profits). Additional worry may come from the fact that with this increase in time-to-market, other competing manufacturers may develop a similar drug and release it sooner, thereby further diminishing profits due to lost market share and a shortened product life cycle. A delayed or lengthened cycle time can seriously affect the return on investment (ROI) for a given new drug or product.

ETO Manufacturers Issue a Challenge to ERP Vendors

Perhaps you may have not heard the term engineer-to-order (ETO) before, but perhaps your business is one of thousands that designs and builds custom equipment that is very precise, adheres to very specific tolerances, is highly technical, and produces low volume and, generally speaking, expensive products. Some examples of such products include ships, aircraft, production machinery, etc.

The typical ETO organization reflects a unique style of manufacturing—they design products to customer specifications, using a unique set of item numbers, bill of materials (BOM), and routings. Business is usually awarded to an ETO manufacturer based on estimates and quotations. Products can be complex, with long lead times and requiring a number of complex subassemblies to build.

Recently a paradigm shift has occurred in the realm of manufacturing, and ETO organizations are leading a call to change as a means of business survival.

ETO Manufacturing Challenges
Unlike standard manufacturing products, in ETO manufacturing environments, the customer is heavily involved throughout the design and manufacturing process. Constraints in the ETO manufacturing process include frequent engineering changes and long lead times from purchasing vendors that can span months—even years. Raw materials themselves are not purchased for inventory purposes, but for a specific phase of the overall manufacturing cycle. Because ETO manufacturers treat each job as a project, all costs and materials are reported to the actual work order and are further compared to the original estimate and quotation. In many cases, once the production phase is complete, the product is shipped to and assembled at the client’s site. Also in many cases, aftermarket sales services continue throughout the life of the product.

Requirements Differ between ETO Manufacturers and Discrete Manufacturers
The ETO manufacturer is faced with maintaining a business model that requires skilled, experienced, and knowledgeable tradespeople who are able to design innovative solutions to complex problems. According to a report by the National Association of Manufacturing in November of 2005, a generation of tradespeople is slated for imminent retirement, and the fewer numbers of young people enrolling in trade schools represents a challenge heading into the post-boomer economy of the early 21st century.

Provia Tackles RFID in a Twofold Manner Part Four: Global Availability

These days when radio frequency identification (RFID) is constantly on everyone's lips, and when every relevant enterprise application vendor is hedging its bets towards becoming RFID-ready or is even convincing the market that its RFID-compliant solution is exactly what the doctor (such as Wal-Mart, Target, Albertsons, and the US Department of Defense [DoD]) ordered, the typically quiet Provia Software (www.provia.com), a privately-held provider of supply chain execution (SCE) software solutions, naturally feels the time has come for it to be more vocal about its RFID endeavors, albeit after it has already put so much effort in terms of the proof of concept in the field.

Most recently, at the end of May, Provia announced at the Distribution/Computer Expo 2004 in Chicago, Illinois (US) that its ViaView event/alert management and decision support product plays a key role in offering visibility to supply chain data for companies supplying RFID-tagged products to Wal-Mart and other retailers.

Moreover, at the end of March, Provia announced that it has aligned itself with its parent company of over fifteen years, Viastore Systems, a leading provider of automated storage and retrieval systems (AS/RS), and material handling control systems, with over 3,000 cranes installed worldwide.

However, RFID has not been the only focus in Provia's recent partnership and product enhancements endeavors. Provia might also stand apart from its peers in the enterprise applications industry by claiming that behind every one of its installations is a satisfied client. The company touts that its number one asset is that it keeps its commitments and delivers on time and within budget, and thus, 98 percent of its clients renew their 24/7 support contracts with the vendor every year. Aiding Provia on the implementation front are several integration partners, including general consulting houses like former PricewaterhouseCoopers (now IBM Global Services), Deloitte Consulting, and smaller system integration services firms like former Digiterra (now ciber), St. Onge, and Q4 Logistics.

Equipped with a direct sales force in North America supported by regional teams, Provia also reports strong presence and sales in South America. It has particularly been successful selling in South America's third party logistics (3PL) market, through its partnership with system integrator Tecsys Latin America (TLA), with offices in Chile, Colombia, and Venezuela. At the beginning of 2004, Provia further announced that its SCE solutions ViaWare and FourSite are now available as logistics software solutions to leading Caribbean companies through an expanded relationship with Provia's Latin American distributor, TLA. The initiative into the Caribbean region involved the collaboration and support of Provia, TLA, and also Roger Marshall, a supply chain service provider with over nineteen years of supply chain experience in the Caribbean region.