There is no doubt that the advanced therapies sector is growing at an exponential rate. According to a recently published 2021 Report by ARM (Alliance for Regenerative Medicine), the sector has raised $14.1B in financing in the first half of 2021 which is already 71% of what was raised in all of 2020. In addition, there are over 2,600 advanced therapy clinical trials being conducted with 264 of those trials being Phase 3 trials and another 1,500 being Phase 2 trials.
With a maturing pipeline, more and more products are approaching the point of development where pricing decisions and evidence will be used to support payer and HTA engagement. Our panel of industry experts will discuss some of these considerations when preparing for the launch of an advanced therapy.
Katherine Reedy is Senior Vice President of Commercial of Castle Creek Biosciences, Inc. As a senior commercial leader with nearly 20 years of experience in specialty pharmaceuticals, biotechnology and rare disease, Ms. Reedy’s expertise spans U.S. and global roles in sales, sales management, training, operations, marketing and strategy.
Before joining Castle Creek, Ms. Reedy served as Vice President of Marketing and Business Analytics, working in rare blood cancers for PharmaEssentia. Previously, she was responsible for building and operationalizing the go-to-market strategy and marketing infrastructure foundational to the most successful U.S. launch at Alexion to-date—Soliris, for patients with AchR+ generalized myasthenia gravis (gMG). As a result, Ms. Reedy was hand-selected to spend nearly a year in Germany, re-focusing and prioritizing the Soliris neurology strategic initiatives for gMG and Neuromyelitis Optica Spectrum Disorder (NMOSD).
Earlier in her career, Ms. Reedy was the Group Marketing Director at Mallinckrodt for rare neurology therapeutics and pain care, and also spent nearly a decade at Cephalon (now Teva). She started her career at Eli Lilly following graduation from Southern Methodist University, where she was recognized as the Most Outstanding Student in the Cox School of Business. Ms. Reedy earned her M.B.A. from Texas Christian University.
Maria Törnsén has served as the Chief Commercial Officer of Passage Bio since July 2021. Prior to joining Passage Bio, Ms. Törnsén, who has nearly 20 years of global commercial experience, was at Sarepta Therapeutics, where she was senior vice president, general manager, US. At Sarepta, she led the launch of the company’s second and third products for Duchenne muscular dystrophy. She also led launch preparations for future gene therapies and double-digit-year-over-year sales growth in 2019 and 2020.
Ms. Törnsén joined Sarepta in 2019 from Sanofi Genzyme, where she served as the global therapeutic head for rare neurological, metabolic, and endocrine diseases with responsibility for both marketed and pipeline products. Before Sanofi Genzyme, which she joined in 2017, she worked at Shire from 2011 to 2017, beginning in marketing in rare diseases before moving to the neuroscience division. While at Shire, she relocated to the United States and led US sales and marketing for the endocrine franchise. Before joining Shire, Ms. Törnsén was at Merck KGaA from 2006 to 2011 in Switzerland where she held a number of marketing leadership roles in neurology. She began her industry career as a sales representative in 2002 with Eli Lilly in Sweden, launching three products.
Ms. Pitluck is Vice President and Head of Global Pricing & Reimbursement (P&R) at Spark Therapeutics, Inc., a fully integrated gene therapy company committed to meeting the needs of patients living with genetic diseases. In her current role, Ms. Pitluck priced the first US Food and Drug Administration-approved gene therapy for a genetic disease, LUXTURNA® (voretigene neparvovec-rzyl). She also led the roll-out of Spark’s unique alternate payment options and outcomes-based arrangements for LUXTURNA. She is now working to develop policies and programs to help ensure timely patient access to future one-time gene therapies in development.
Prior to joining Spark, Ms. Pitluck was the Executive Director for Global P&R at Alexion Pharmaceuticals, leading all P&R efforts, including dossier preparation and negotiations for Alexion globally. Ms. Pitluck was formerly the Director of Genentech’s Coverage & Reimbursement Policy and responsible for all US public payer policy and reimbursement issues for Genentech’s products. She also worked at healthcare consulting companies including Avalere Health and Covance Health Economics and Outcomes Services Inc., focusing on policy and reimbursement analyses for a variety of pharmaceutical, biotechnology, and medical device products related to care settings and disease areas.
Phil Cyr is Senior Vice President of Customer Solutions for Precision Value & Health with responsibility for cell and gene therapy. Phil has over 24 years of health economics, outcomes research, health policy, and payer experience including a strong record of conducting published research, conducting health technology appraisal within a U.S. payer, and interacting with global HTAs. Phil and his team have worked on 4 launched cell and gene therapies.
Phil is a subject matter expert with Precision ADVANCE, a collection of interconnected services and complementary teams uniquely focused on the complexities of clinical, regulatory, manufacturing, and commercial needs to successfully bring cell or gene therapies to market.
Greg Gregory is Senior Vice President & Managing Director of PRECISIONadvisors, and Head of Commercial Launch Excellence. Greg brings over 20 years of expertise including over a decade of biomedical research experience from leading research institutions and more than 10 years of strategic consulting experience with biopharmaceutical clients both big and small. Greg has a passion for specialty therapeutics, orphan drugs, cell & gene therapies, and vaccines. Before joining Precision, Greg was a Vice President at Insight Strategy Advisors, a Senior Engagement Manager/Practice Executive for Inventiv’s Commercial Center of Excellence and as a Senior Consultant in Campbell Alliance’s Pricing and Market Access group.
Extensive experience addressing key global commercialization and market access business questions, including market access and commercialization strategy, pricing and reimbursement strategy, trade, specialty distribution and hub services strategies, and customer value proposition. Focused on working with rare disease and specialty products as well as gaining experience working across a range of therapeutic areas, including cardiovascular, hematology/oncology, immunology, respiratory, CNS, autoimmune disorders, infectious disease/vaccines, rare diseases, and digital therapeutics.