About Laura Parks
Laura L. Parks, Ph.D., was appointed President of DSM Pharmaceuticals, at DSM Pharmaceutical Products, the contract manufacturing organization group of DSM N.V. on June 1, 2102. Dr. Parks has held numerous positions in the life sciences industry including pharmaceuticals and food & nutrition for over twenty years.
Laura L. Parks, Ph.D.
President
DSM Pharmaceuticals, Inc.
1.The global nature of the pharmaceutical industry and the complexity of the supply chain have created several challenges. Can you address some challenges and explain potential solutions.
One of the fundamental challenges this industry continues to face is the predictability and volatility of demand. It requires applying as much rigor as possible to forecasting and execution at each critical step in the supply chain as missteps multiply the problem. Using labor as flex capacity is one solution. Moving to a pull planning system can also reduce Work in Progress (WIP) and minimize inefficiency. Another approach is to use CMO’s to add manufacturing flexibility with very limited capital investment. Given the inherent constraints of the pharmaceutical supply chain, however, this demand volatility will limit the amount of cost that can be driven out.
Another key challenge facing the industry continues to be meeting the expectations of multiple global regulatory agencies. This requires discipline in terms of monitoring and anticipating trends in those expectations and taking an open, collaborative approach to working with regulators. Too many organizations view auditors and regulators in an adversarial way, complicating meeting the mutual goal of delivering patients safe and efficacious medicines. Running into compliance issues and having regulatory intervention quickly negates the impact of supply chain improvement initiatives, often many times over. It pays to work in concert with regulatory agencies and hold them as partners in meeting patient needs.
2.Can you shed some light on best practices for supply chain integrity?
One best practice that needs to be further embraced is the use of expert third parties to conduct supplier audits. The expectations and demands placed on knowledge and scrutiny of suppliers and suppliers’ suppliers creates the need for practical audit solutions like third party experts whose opinions/results are accepted by the industry at large.
3. Collaborative efforts seem to significantly help mitigate supply chain risks. Can you explain the benefits you have experienced/ witnessed with an open communicative approach?
Yes, absolutely. The benefits of transparent collaboration are many. We have seen the speed and consistency of improvements in OTIF (on time, in full) as a result of moving a relationship from somewhat adversarial to collaborative with one of our highest volume clients. Key senior leaders, after a negative incident, set clear expectations for teams to improve and act as one in quality and performance delivery. Providing strong direction made the difference in the significant improvements achieved. Mutual investment in welldefined continuous improvement initiatives in terms of capital, people, and systems, has set the stage for continued success in this strategic relationship.
4. The Pharmaceutical Supply Chain has finally started to catch up with other industries. Where do you see Pharmaceutical Supply Chain five years from now?
Five years from now, I expect the use of scientific principles of Quality by Design (QbD) to be used much more extensively to provide more flexibility in manufacturing improvements and changes. This will result in the opportunity for greater efficiencies while still ensuring the safety of medications. I also expect Continuous Processing, using QbD principles, to have gained a hold in the industry. This will be the beginning of streamlining the manufacturing process of oral dosage forms.
Outsourcing of manufacturing, analytical and development activities is projected to continue to grow. This makes sense as the benefits of securing these services without much capital investment and the resulting flexibility are quite significant. Companies who invest in their competence in managing their supplier chain with third parties will benefit most from this trend. This will not happen by accident, but through clear decisions that excellence in third party management is a strategic imperative and/or competitive advantage.
In addition, five years from now, the industry will be adopting models to address the move away from blockbuster products, to more specialty type products, towards personalized medicines like the Leukemia treatment being developed at the University of Pennsylvania. This trend divides large therapeutic areas into subsets requiring many more products to be developed and commercialized to treat the same population formerly treated by one blockbuster. This brings challenges to a supply chain configured for large volume manufacturing runs. Greater agility and effectiveness in short manufacturing runs will be needed.
About DSM
DSM is a global provider of contract manufacturing services offering R&D through Phase I, II and III to commercial scale production in primary manufacturing of registered, excipients, active pharmaceutical ingredients, generics, large and small microbial-based molecules, and mammalian cell production of monoclonal antibodies and proteins. Secondary manufacturing services include formulation development, clinical trial manufacturing and finished dosage solids, semi-solids, scheduled and cytotoxic drugs, and aseptic liquid and lyophilized products.