Breakthrough Therapy Designation: Oncology Lessons

Clinical Trials, Drug Discovery and Development, Life Sciences, Pharmaceutical, Pharmaceutical Regulation,
  • Wednesday, July 16, 2014

Much conversation and excitement have been generated since the introduction of a Breakthrough Therapy Designation (BTD) and oncology therapies have become an area of focus for this designation. With many questions surrounding the topic, this webinar will first provide an introduction to the criteria and process for obtaining FDA’s BTD, including a working understanding of the use of the BTD in cancer therapies. Next, the role of timely and robust health economic and outcomes research (HEOR) data will be examined, reflecting how evidence can be generated to support a product with BTD.

A case-study approach will be used to demonstrate how quickly evolving data can affect timelines and impact HEOR initiatives. Key take aways include:

  • Knowledge of the key components of FDA’s BTD
  • Familiarity with the qualifying criteria for expedited programs
  • Ability to discriminate between different pathways to FDA expedited drug development
  • Awareness of products (oncology and non-oncology) that have been granted BTD status
  • Recognition of HEOR opportunities and challenges specific to preparing and supporting a value story for a BTD product
  • Expertise to apply these learnings to the development and commercialization of future BTD products


Jay Jackson, PharmD, MPH ,Vice-President, GHEOR Xcenda

Dr. Jackson is Vice President of Xcenda’s Global Health Economics & Outcomes Research (GHEOR) consulting practice. He leads a team of professionals specializing in the use of best-in-class scientific methodologies to develop and translate evidence into favorable coverage decisions. During his tenure at Xcenda, Dr. Jackson has partnered with manufacturers to develop early stage HEOR strategies, uncover new evidence supporting a product’s value story as well as communicate evidence through innovative tools, medical communications, and contract HEOR staff. His contributions have also been instrumental to the development of numerous Outcomes Analyzers, an innovative value-demonstration tool first launched by Xcenda more than ten years ago.

In 2010, Dr. Jackson served as a primary faculty member and author of “REMS in Rheumatology: Implications for Physicians, Nurses, and Pharmacists”, the number one most read CE article of that year, according to He received his Doctor of Pharmacy degree from the Mercer University Southern School of Pharmacy in 1999. His postdoctoral training includes the completion of an Outcomes Research Fellowship at Mercer University Southern School of Pharmacy and Applied Health Outcomes. Dr. Jackson also holds a Masters of Public Health in Epidemiology from the University of South Florida College of Public Health and is currently serving there as an adjunct professor.

Message Presenter

Kasia Puto, PharmD, MBA, BCOP, BCPS, Associate Director, Xcenda

As Associate Director with the Medical Communications team in Health Economics and Outcomes Research (HEOR) at Xcenda, Dr. Puto’s primary responsibilities include content development and review of US/global value dossiers, formulary kits, advisory board/training slide decks, and scientific publications. She also provides strategic oncology insights and assists in development of value brochures/propositions, compendia analyses, and budget impact models. Dr. Puto’s experience ranges across various cancer areas including hematology, oncology, stem cell transplant, supportive care, and non-malignant hematology. Before joining Xcenda, Dr. Puto was the Clinical Oncology Pharmacy Specialist and Pharmacy Clinical Finance Coordinator at Jackson Memorial Hospital in affiliation with University of Miami.

Dr. Puto received her Doctor of Pharmacy degree from University of Illinois at Chicago College of Pharmacy. She completed general pharmacy residency at Jackson Memorial Hospital/Florida Agricultural and Mechanical University and oncology pharmacy residency at University of Texas MD Anderson Cancer Center. Her Master of Business Administration with a Specialization in Health Administration and Policy was completed at University of Miami. She is also dually certified as a Board Certified Oncology Pharmacist (BCOP) and Board Certified Pharmacotherapy Specialist (BCPS).

Message Presenter

Who Should Attend?

Persons working in, or for, the HEOR and managed markets groups within the pharmaceutical industry. Also appropriate for those new to the industry who are members of, or work with, other groups such as a medical team.

Xtalks Partner


Xcenda is a strategic consulting firm with 20 years of experience applying real-world expertise in health economics and outcomes research, reimbursement, health policy, market research, and market access strategy. We support global Pharmaceutical companies as well as emerging pre-commercialization phase firms with challenges such as developing an evidence package to optimize access in key global markets, predicting product performance, and identifying reimbursement strategies and programs to maximize patient access. From development through market maturity, Xcenda helps manufacturers identify, demonstrate, and deliver their brand’s value proposition to key healthcare stakeholders.

Xcenda is backed by an even wider breadth of healthcare knowledge and partnerships through AmerisourceBergen Corporation (NYSE: ABC), one of the world’s largest Pharmaceutical services companies. Xcenda’s strategic consulting services support the design of patient support services and specialty distribution programs to improve product access and adherence at every stage of its life cycle.

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