The Overall Complexity Of Biopharma Operations Is Increasing. How Do You Strategize To Meet Current And Future Needs In The Most Efficient (e.g., Cost) Manner Possible?

A | 1. Establish three to seven process technology platforms and map the accompanying product class. For each of the platforms, pre-establish: a) key technical elements (e.g. sterile process, viral clearance, etc.) of the process technology; b) key product class (e.g. recombinant, human derived); and c) key end-to-end supply chain attributes (e.g. sourcing, planning, manufacturing, quality, storage, distribution, and logistics). Note: This broader E2E supply chain view is important because process technology and products are a subset of the larger ecosystem.

2. Align the product-and-platform maps with an integrated team (from e.g. manufacturing, quality, regulatory, science and technology, engineering, commercialization, R&D) and focus on both risks and opportunities. This workstream ensures common understanding and enhances efficiency in forward, strategic cost analysis, technology, and supply planning as well as with strategic investments (e.g. capital/recapitalization, talent, operational excellence initiatives).
3. Establish a business operating process to review and align annually or as needed. Also, consider incorporating this into the broader company strategic long-range operating plan, executive sales and operations planning, and product life cycle management.

JACKS LEE is SVP global manufacturing and supply at Merck. He has 25+ years of experience in vaccines, biopharmaceuticals, and small molecule pharmaceuticals.