Our business case is simple. If you are a company with a product in late phase II or early phase III, you are about to make a large investment in preparing your supply chain.
Why take that risk of proceeding without us? Companies often don’t value supply chain strategies until they’re well into their commercial form. The decisions a company makes on choosing suppliers (API etc.) in phase II have an exponential impact on valuation years later. Additionally, pre-launch activities if not managed appropriately will set the commercialization process off in the wrong direction (everything from the wrong minimum order quantities in your contract manufacture supply agreement to understanding how to fill the wholesale channels accurately to support your launch……and navigating those fee-for-service agreements you’ll soon be faced with).
Is your business a foreign company that's not familiar with what is required to enter the US market?
We can accomplish this for you.
Through our preferred partner network we’ll help file your drug or
medical device with the FDA to
set up your adverse events reporting database. Value Chain Performance
will get your NDC/UPC codes, get
your 3PL in place, assure your products entry into the US wholesaler
distribution channels. We can
assist in contracting with CMO’s (or manage your entire S&OP
process),
help achieve desired formulary
status for you as well. We’ve done this before and with great success.
We are your entry point for the
US market. We build your foundation.
Value Chain Performance is a group of seasoned veterans that assist your organization today and take on the role of your commercial group without the risk of hiring permanent employees prior to FDA approval. VCP (ValueChainPerformance) can run your organization up to the point and even past your approval date. We are a highly skilled services organization specializing in; QA/Regulatory/Supply Chain/Pharmacovigilance/Managed Care.
Our team approach is a one stop solution for any life science, cosmetic, med-device company closing in on its approval. We work like a symphony with every action part of an integrated approach to success. If you are looking for a 50 page slide deck, you’ve come to the wrong place. We come into your site and get you commercially ready now. That’s what we do.
Because our individual skills are different, each team member has equal value to completing your/our task. However, we do realize that everyone’s needs are not necessarily the same. As a result of where your organization may be in its journey to commercialization, you might not need all our services. Therefore we can assist with individual segments of your business as well. For example, should you have a completed filing and are ready to launch but may not have a strong enough understanding of your customer, we can assist you in your supply chain needs (wholesaler/pharmacies/distribution etc.) and/or managed care (PPO’s/HMO’s etc.) Should you be a foreign company with a US distributor or partner, but one that isn’t an expert on FDA and filing, we can service you here as well.
An often over-looked area for most organizations is their indirect spend. Areas of indirect spend can include cell phone usage by a sales force, travel, fleet, premiums as well as IT related expenditures. An effective sourcing process that is appropriately and timely executed can save an organization not only money but will also enable the organization to develop partnerships and alliances with vendors often leading to quicker introduction and adoption of the latest trends in the relevant industries. This enables an increased expenditure on the core competencies that are the key drivers to the success of an organization.
How we can help:
Forward thinking in an organization needs to encompass knowledge on industry trends, economic trends and leading financial indicators (often globally). A product in phase III today needs to have a strategy today for the next five years or longer. Where do you put a site and why? Do you make or buy? Will your strategy be sustainable over time knowing your industry and competition change daily. How can you prepare for sudden change?
How we can help:
A key understanding of the distribution landscape is essential for any organization to implement its commercial and marketing objectives. Best in class trade and reverse logistics policies, distribution through the appropriate channels, appropriate stocking at the wholesaling and retail level, and effective marketing programs at the retail level are all necessary components of a larger trade strategy that can both assist in achieving and exceeding financial goals as well as providing aerial support to augment and supplement the efforts of the sales force of an organization.
How we can help:
At the backbone of every successful pharmaceutical or biotech organization is an effective distribution system. This distribution system encompasses everything from warehousing, order entry, order processing and final distribution of products to direct customers. To underscore the importance of an effective distribution system, a lack of efficiency, transparency and appropriate processes in a distribution system can often lead to a number of undesired outcomes, ranging from backorders, shortages and disgruntled customers to a lack of financial visibility and even worse, legal implications.
How we can help:
One of the keys to success is to have a solid business plan that has been thoroughly researched and vetted. Understanding the needs of the patients, providers and payers and how they operate is critical to successfully marketing a product. Our business plan would encompass everything from account profiling and targeting through completing the necessary regulatory filings. We have significant experience with both public (VA/ DoD, Medicaid, etc) and private sector (managed markets, GPO’s, etc). This business plan provides a road map with Strategic Imperatives and timelines to insure we achieve our objectives.
How we can help:
An understanding of the inner workings of the private sector is essential for any organization to implement its commercial marketing plan. This begins with knowing how to price and position your product, how to gain maximum reimbursement and who the key players and organizations are. This coupled with years of experience in working with these organizations eliminates the ‘trial and error” approach which is costly in both time and money. Knowing how best to work with the various players leads to efficient execution of the plan.
How we can help:
The public sector is very diverse, complicated and laden with rules and regulations. To the uninitiated this represents enormous challenges; to the experienced this complexity is a competitive advantage.
Responsibilities here include negotiating with the Veterans Administration on a Federal Supply Schedule. Signing a Rebate Agreement with Health and Human Services which allows you to participate in state medicaid programs.
How we can help:
The one area that is generally overlooked in the early stages of an organization is the crucial role that contract manufacturing will play once the organization reaches the stage of maturity in the organizational evolution cycle. Often, contracts or agreements are signed haphazardly causing great stress later on. The importance of a contract manufacturer should not be understated and these “extensions” of your own business should be managed both tactically and strategically to ensure success. This includes a strategic vision and plan for contract manufacturers that includes agreements to maintain a continuity of supply both for the drug substance and product. Having a plan in place well before commercialization will not only provide the relevant groundwork for a smoother validation process but also the greater likelihood of commercial success.
How we can help: