Breakthrough Designations – How Can Quality Enable Speed to Innovation?

Breakthrough Designations – How Can Quality Enable Speed to Innovation?

  • Offering an overview of how breakthrough therapy designations have historically worked and how that process is changing
  • Are we as an industry ready for major changes in how drug development is expedited?
  • Discussing how our organizations’ Quality Culture must be an integral part at all stages of this transition
  • Working with all stakeholders to ensure we do not sacrifice safety and quality as we increase the pace of innovation
  • What should we be doing right now to prepare for the future of these developments?

Christie Bielinski, Vice President of Product Quality Management at Janssen Pharmaceuticals, leads a world-wide organization of quality professionals accountable for the development, manufacture and launch of pharmaceutical products across the Janssen therapeutic areas. The scope of her responsibilities include assuring that the quality requirements are built into the product in early and late-stage development, that proactive identification of ‘critical to quality attributes’ are identified, and that the associated risk is quantified so that defects can be prevented during the entire lifecycle of the product. In her 11-year career with Johnson & Johnson, Christie has held positions in both the Medical Device and Pharmaceutical segments and has had responsibility for marketed products that span a diverse portfolio of Pharmaceuticals, Biologics, Devices and Combination Products. Her responsibilities during this tenure have included new product development and lifecycle management, supplier quality, validations/site qualifications, laboratories, quality operations and network optimization.

A New Way to Rapidly Develop Biomanufacturing Capacity and Add Greater Value to the Decision to Build

A New Way to Rapidly Develop Biomanufacturing Capacity and Add Greater Value to the Decision to Build

  • Investing capital in capacity expansion when a drug is early in development is challenging. There are new manufacturing models that reduce risk and add value to your decisions through a concept called optionality
  • Balancing options and critically evaluated risk against probability of success in to-build decisions
  • Introducing a new biomanufacturing solution that leverages manufacturing ecosystems to reduce the need to build infrastructure
  • Effectively transfer non-value added work from the manufacturing site to service providers with this new manufacturing model

Daniel Palmacci has nearly 20 years of leadership experience in Biologics in the area of manufacturing, technical development, supply chain, and Operations Management. He is a member of Novartis Biologics Leadership Team and is Technical Operations Head of Austria’s Country Executive Committee. In his previous role he was the Head of Biologics External Supplier Organization that manages all Contract Manufacturers (CMO) for the cross divisional network of Novartis, Sandoz and Alcon. Daniel was also responsible for Technical Development Project Management organization. As a Member of Sandoz Biologics Executive Committee he managed all TechOps activities (end to end) by coordinating internal and external manufacturing and supply chain to ensure supply of commercial Biosimilars. Prior to joining Novartis Daniel worked for BayerHealthCare for several years in positions with progressively senior roles in leading cross-functional teams responsible for Production, Manufacturing Science, Technical development, Operational Excellence, Supply Chain, Quality Assurance and Engineering.

Redefining Competition: Thinking About Our Industry in a Revolutionary Way

Redefining Competition: Thinking About Our Industry in a Revolutionary Way

  • What are we doing today to get ready for the realities of our industry a decade from now?
  • Debating what we will need in terms of leadership, people, technology, territory, and resources to grow into new markets with new products in an ever-changing regulatory landscape
  • Is the answer steady growth, or improving agility and versatility, or some third option?
  • Making the case that our industry needs to work together better as individual actors on a shared stage

Kimball Hall serves as the Senior Vice President and Head of Drug Substance Biologics Manufacturing and is a member of the Genentech Executive Committee (GEC). Prior to joining Genentech in 2016, she previously worked at Amgen in a variety of leadership positions, most recently as the Vice President for Manufacturing of the Future, where she established advanced manufacturing facilities in Singapore that utilize disposable upstream technology. Kimball’s organization is responsible for managing the biologics drug substance supply – the active ingredient that gets filled at the drug product sites before delivery of the medicines to our patients. The biologics network is comprised of six sites in North America, Europe and Asia. At Genentech, she sponsors the Operational Development Rotational Program and is an advisor to the Genentech Women’s Professional Group.


Leveraging Global Change to Create Strategic Opportunity —and Design a New Future— for Manufacturing and Supply Chain Leaders

  • Discussing the global forces shaping the healthcare environment. How is the industry’s current business model being questioned and the definition of innovation shifting?
  • Understanding how the evolution of patients, consolidation of customers, and pressures on cost will accelerate while new players continue to enter the industry and redefine our paradigms
  • Shedding light on the impact of these changes on manufacturing, quality, and supply chain
  • Making the case that the strategic opportunity for our leaders has never been greater
  • Sharing examples of how Teva is taking a leading role in shaping our new future

R. Ananth (Raghunathan Ananthanarayanan) has more than 30 years of experience in the global pharmaceutical industry as a senior leader specializing in business development, R&D, manufacturing, regulatory affairs, sales and marketing, strategic sourcing, and mergers and acquisitions. Since December 2014, Ananth has been President and Chief Executive Officer of Teva Active Pharmaceutical Ingredients (TAPI), and was additionally appointed head of the company’s Biologics Operations in July 2016.

Prior to joining Teva, Ananth was a member of the management council at Dr. Reddy’s Laboratories Ltd., where he was President of Pharmaceutical Services and Active Ingredients. Ananth previously was a management committee member at Piramal Healthcare as the President of Pharma Solutions for APIs and Finished Dosage.

Earlier in his career, Ananth held several senior-level positions across multiple geographies at Galpharm International Ltd., Zydus Cadila Healthcare Ltd., Wockhardt Ltd., and Rhone-Poulenc Rorer.

Ananth earned a doctorate in Pharmaceutical Technology from the University of Mumbai in India.