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State of the union for advanced therapies

This panel, sponsored by Precision ADVANCE, will feature insights from industry leaders on the current state of the industry, and the future of advanced therapies including innovations in research and development, going from treating rare diseases to prevalent conditions, continued investment, and next-generation technologies. The panelists will also discuss manufacturing and talent bottlenecks, and innovative reimbursement payment models.

Key Takeaways:
  • Current state of the advanced therapy industry
  • Investment landscape for cell and gene therapies in 2024 and beyond
  • New technologies, bottlenecks, and solutions
  • Innovative reimbursement models
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Dan Kirby

Dan Kirby

Chief Commercial Officer, Orca Bio

Dan Kirby leads Orca Bio’s commercial strategy for its cell therapy platform products. His areas of focus include market engagement, reimbursement landscape evaluation, value story creation, key opinion leader outreach, and communications. Previously, Dan was Chief Commercial Officer at Omeros Corporation where he oversaw the market access, medical affairs, advocacy, marketing, sales and operation functions. This includes overseeing all launch preparations for the company’s lectin pathway inhibitor, narsoplimab for HSCT-TMA and all P&L responsibilities for their marketed product, OMIDRIA. Prior to joining Omeros, Dan was Vice President of US Commercial Cell and Gene Therapy at Celgene, overseeing all market access, reimbursement and marketing efforts for their CAR T products. Dan joined Celgene as part of the Juno Therapeutics acquisition where he was Vice President of Marketing and Market Access, responsible for building these functions at Juno. Prior to Juno, Dan was Head of Marketing for Medivation, and spent more than 14 years at Amgen in various commercial roles.

Deborah Phippard

Deborah Phippard

Chief Scientific Officer, Precision for Medicine

Deborah Phippard, PhD, Chief Scientific Officer of Precision for Medicine, is a pharma industry veteran and expert at biomarker-driven clinical trial design and execution. Leader of biomarker and drug development programs for pharmaceutical and diagnostics companies, as well as the National Institutes of Health. Spearheaded the discovery of pharmacodynamic biomarkers and novel targets for inflammatory disease therapy. Currently, working on developing, validating, and implementing companion diagnostic assays for neutralizing and total antibodies for multiple gene therapies.

Helen Sabzevari

Helen Sabzevari

President & CEO, Precigen

Dr. Helen Sabzevari is President and CEO of Precigen, a gene and cell therapy company, and member of the Precigen Board of Directors and Kinnate Board of Directors. Dr. Sabzevari brings extensive expertise in research and development of immunotherapy-based therapeutics as well as experience translating novel treatments from pre-clinical stage into the clinic. From 2015 to 2017, Dr. Sabzevari co-founded and served as Chief Scientific Officer of Compass Therapeutics, a fully-integrated drug discovery and development company focused on manipulating the immune system to treat human disease. From 2008 to 2014, Dr. Sabzevari served as Senior Vice President of Immuno-Oncology as well as Global Head of Immunotherapy, Oncology, Global Research and Early Development at Merck KGaA/EMD Serono, Darmstadt, Germany. During her tenure, she led the immuno-oncology discovery and early development translational innovation platform and brought forward numerous pre-clinical and clinical assets including avelumab, an approved anti-programmed death ligand-1 (PD-L1) checkpoint inhibitor. From 1998 to 2008, Dr. Sabzevari led the Molecular Immunology Group at the Laboratory of Tumor Immunology and Biology at the US National Cancer Institute (LTIB-NCI), where she was focused on design, development and delivery of novel vaccines and immunotherapies for a range of human cancers.

Dr. Sabzevari’s contributions in the field of tumor immunology earned her the National Institutes of Health (NIH) merit award for major contribution to the field of cancer immunotherapy, and she has also received the Mass High Tech’s Women to Watch Award, the PharmaVOICE 100 Award (2013 and 2022) and the Society for Immunotherapy of Cancer (SITC) Team Science Award for her work on the NCI Cancer Immunotherapy Program Team. Most recently, Dr. Sabzevari was recognized on the Forbes 50 over 50: The Visionary List, Maryland’s Top 100 Women by The Daily Record and PM360’s Elite 100 in the Strategists category. Dr. Sabzevari received her doctorate degree in cell and molecular immunology and completed her postdoctoral work at the department of immunology at the Scripps Research Institute working on various immunotherapeutic modalities in the treatment of cancer and autoimmune diseases.

Devyn M. Smith

Devyn M. Smith

Chief Executive Officer, Arbor Bio

Dr. Devyn Smith brings significant cell and gene therapy development and platform expertise from his 20+ year career. Devyn joined Arbor Biotechnologies as Chief Executive Officer on April 27, 2021 after concluding his role as Chief Operating Officer of Sigilon Therapeutics. Prior to Sigilon, Dr. Smith worked in a variety of roles at Pfizer Inc., including COO of the UK-based Neusentis Unit focused on discovering and developing cell therapies. He received his Ph.D. in Genetics from Harvard Medical School. He is an inventor on multiple patents and has published in leading scientific journals throughout his career. Dr. Smith is a board member and officer for ARM (Alliance for Regenerative Medicine), the cell and gene therapy industry group.

Chad Salisbury

Chad Salisbury

Senior Vice President, Project Farma

Chad Salisbury joined Project Farma in October 2022 as Senior Vice President. Chad has over 20 years of experience encompassing gene therapy, vaccines, sterile injectables and small molecules, including the delivery of ~$2B USD of greenfield cGMP manufacturing facilities. Chad has held increasingly responsible management positions in manufacturing, quality, engineering and supply chain.

Chad was most recently VP, Manufacturing at Affinia Therapeutics, a company singularly focused on using innovations in gene therapy to lead the fight against devastating rare and prevalent diseases. Prior to Affinia, Chad held progressive roles at CSL Seqirus, Novartis and Eli Lilly in both the US and Europe.

Chad holds an MBA from Purdue University, an MEM from Duke University and a B.A. from Alfred University.

Anshul Mangal
moderator

Anshul Mangal

President, Precision ADVANCE & Project Farma

Anshul Mangal is President of Project Farma and Precision ADVANCE. Anshul founded and grew PF into a leading global biologics and advanced therapy engineering consulting firm. Under Anshul’s leadership, PF has partnered with over 100+ therapeutic innovators, developed state-of-art manufacturing facilities for complex biologics and pioneered the industrialization of advanced therapies including many commercially approved cell and gene therapies. PF was acquired by Precision Medicine Group in 2020 to be the cornerstone of Precision ADVANCE. ADVANCE is a collection of Precision's services uniquely focused on the complexities of research and clinical development, regulatory, manufacturing, and commercial needs to successfully bring an advanced therapy to market. In addition, Anshul is an investor, board member and advisor at several biotech organizations. Prior to PF, Anshul was a patent litigator at Jones Day and a consultant at Morgan Stanley & Discover Financial Services.