Whether your company’s goal is the supply of clinical materials or post-approval commercial production, TCC can help you create and optimize your supply chain.  TCC’s Life Science Supply Chain offering is geared towards the needs of early stage and mid-size life science companies.  While their products may have many benefits, for economic and scale reasons these companies typically have not invested in all of the internal resources and expertise necessary to create a supply chain for new products or to optimize an existing supply chain.

Life science supply chains can be quite complex, involving both in-house and outsourced steps, FDA and other regulations, and many vendors.  As an example, Figure 1 depicts the supply chain of a virtual drug company.  For this company, the vendors might range from raw material suppliers of reagents and packaging components to Contract Manufacturing Organizations (CMOs) that make the drug substance and product to a 3rd party logistics supplier who provides warehouse and order-to-cash services.  Further, it is common for the supply chain to involve suppliers from at least two, if not three or four, continents even if the product is just targeted at the US market.

          Figure 1 – Virtual Drug Company Supply Chain

A further complexity, applying to both small molecule and biologic drugs, is that the CMOs supplying Phase III and post-approval product may not have supplied product for Phases I and II.  Changes in CMOs and other suppliers do occur for technology, scale, economic, supplier performance, and other reasons.  (Please read Establishing a Commercially Viable Supply Chain for Early Stage Drug Companies for more information.)

Early stage and mid-size life science companies need experienced advisors who can “figure it out, get it done, and wear many hats”; early stage and mid-size companies need advisors with functional breadth and depth.  TCC can supply such advisors!

TCC’s supply chain offerings include:

Supply Chain Strategy.  Defining a compelling, credible, investable supply chain strategy that spells out who, what, where, when, how, and how much with respect to creating and managing the supply chain.  It is a concise, credible, actionable plan tailored to the client that will (a) guide decision making, (b) reassure internal (e.g., senior management, board of directors) and external (e.g., venture capital investors) stakeholders throughout development, and (c) provide leverage in licensing and exit discussions by its subtle declaration that “we are prepared and proceeding to market; the deal value goes up from here.”  Further, the supply chain strategy answers the question “Where do we need contracts in our supply chain?”  Finally, supply chain strategies typically include the identification and prioritization of supply chain and process development initiatives to improve performance and mitigate risk.

Supplier Selection.  Identifying, screening, and selecting suppliers based on technical, qualitative (e.g., FDA inspection history, cultural fit, field inspection), and economic criteria, whether the annual supply chain spend is tens-of-thousands or tens-of-millions of US dollars (or other currency).  As part of its Supplier Selection offering, TCC will (a) determine the sourcing and contract strategy, (b) prepare the Requests for Proposal and Technology Packages as appropriate, (c) oversee the bidding process among the several suppliers, and (d) draft (the commercial, quality, and technical sections) and negotiate the appropriate supply and quality agreements.

Risk Assessment.  Assessing the supply chain, at least on an annual basis and more frequently if needed, to understand risks, develop risk mitigation strategies, and determine the decision criteria and timeframe to implement these risk mitigation strategies.  Supply chains evolve and their risk profiles change based on internal (e.g., clinical progression, process and product development, expanded therapeutic indications) and external (e.g., natural disasters, feedstock interruptions, quality issues at suppliers) events.  Acquirers and licensees find risk assessment and mitigation initiatives valuable because they reduce uncertainty.

Deal Advisory.  Reviewing, drafting (the commercial, quality, and technical sections), and negotiating supply and quality agreements.  TCC can also prepare and present the supply chain and process technology parts of road show presentations to potential acquirers and licensors.

Supply Chain Management.  Managing the supply chain on the client’s behalf, including providing oversight of CMOs and other service providers, until business conditions justify the client’s investment in internal supply chain resources.  As part of this offering, TCC can manage the client’s Sales & Operations Planning (S&OP) process.

Economic Analysis.  Developing volume, price, COGS, SG&A, R&D, working capital, capital expenditure, and cash flow forecasts; providing sensitivity analyses around the key parameters that impact the supply chain and/or overall business.

Process Technology & Supply Chain Assessment (PTSCA).  A stand-alone assessment of a clinical stage or post-approval product to identify, prioritize, and justify process development priorities based on economic, regulatory, technical, and timing merits; determine weak points in the post-approval commercial supply chain; and recommend key supply chain initiatives.

Process Development & Regulatory.  Through its alliance with Reaction Science Consulting, TCC provides small molecule drug sponsors with bench top process development expertise (including simulated moving bed chromatography), analytical method development, technical oversight of larger scale process development activities at CMOs, and CMC regulatory support.

Supply Chain Optimization.  More extensive than PTSCA, Supply Chain Optimization involves evaluating and detailing improvements to an existing or proposed supply chain to optimize supply chain performance (e.g., reduce COGS, reduce or delay capital investment, reduce working capital, improve quality, increase flexibility, align for future growth, etc.) and mitigate risk.

As with its other offerings, TCC is engaged by the client to provide its supply chain services.  TCC is not an agent or broker.