December 08
12:00 pm - 1:00 pm EST

LOCAL TIME

State of the union for advanced medicines

We are in the midst of a therapeutic revolution. An H1 report released by Alliance for Regenerative Medicine (ARM) highlights a record-breaking year, with over 1,320 ongoing clinical trials worldwide and 1000+ therapeutic developers. We are on track to expect the highest number of advanced therapy regulatory approvals during 2021, when compared to previous years.

This panel, sponsored by Precision ADVANCE, will feature insights from industry leaders on the current state of the CGTx sector, and the future of advanced medicines 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 the evolution of reimbursement payment models.

Attendees will hear from industry experts about:
  • Current state of the advanced medicines industry
  • Continued investment in the advanced medicines sector
  • New technologies, bottlenecks, and solutions
  • The evolution of reimbursement payment models
  • Anticipating regulatory hurdles and navigating political dynamics specific to cell and gene therapies

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Anshul Mangal

Anshul Mangal

President, Project Farma & Precision ADVANCE

Anshul is the President of Project Farma (PF) and Precision ADVANCE. He founded and grew PF into a leading global biologics and advanced therapy engineering consulting firm. In addition, Anshul has served as general counsel and managed all corporate legal transactions. Under Anshul's leadership, PF pioneered the industrialization of advanced therapies including two notable, commercially approved cell and gene therapies, and created PF's Advanced Therapy Manufacturing Playbook. This playbook helped develop the largest cell and gene therapy manufacturing footprint in the world. To date, PF has led 20+ facility builds with over $1BB in capital spend, selected and managed 60+ CDMO engagements, and partnered with over 40+ advanced therapy organizations.

Project Farma was acquired by Precision Medicine Group in 2020 to be the cornerstone of Precision ADVANCE. ADVANCE is a collection of Precision's interconnected services and complementary teams that uniquely focuses on the complexities of clinical, regulatory, manufacturing, and commercial needs to successfully bring a cell or gene therapy to market. Anshul is also dedicated to advancing next-generation medicines through his philanthropic efforts at the Institute for Life Changing Medicines, various patient-advocacy organizations, and the Alliance for Regenerative Medicine.

Dave Lennon

Dave Lennon

President & CEO, Stealth Startup

Dave Lennon is currently President and CEO of a stealth startup company based in Cambridge, MA. Previously, he served as President of Novartis Gene Therapies (formerly AveXis) from June 2018 until July 2021, where he was responsible for the development, approval, and launch of Zolgensma, a gene therapy for the treatment of Spinal Muscular Atrophy. He also led the fully integrated R&D, Manufacturing and Commercialization for Novartis’ extensive gene therapy pipeline. Over his 15 year career with Novartis, Dave served across the oncology, specialty and primary care businesses working in the US, Switzerland, Japan, and China.

Prior to Novartis, Dave worked for 5 years at McKinsey & Company, departing as an Associate Principal. Dave holds a Ph.D. in cell biology from Weill Medical College at Cornell University and a B.A. in biophysics from Columbia University. He is a board member of the Alliance for Regenerative Medicine.

Janet Lambert

Janet Lambert

CEO, Alliance for Regenerative Medicine

Janet Lynch Lambert joined ARM in 2017 as the organization’s first CEO. With more than 25 years in public and private sector management, Janet is an experienced government relations and business professional with an extensive record of accomplishment. Janet most recently served as the Acting Head of Engagement for the All of Us Research Program at the National Institutes of Health and as head of the Outreach Office in the Office of the NIH Director. Prior to joining NIH, she was Vice President of Government Relations and head of the Washington office of Life Technologies, aiding the company in its growth from $300 million in annual sales to more than $3 billion.

Prior to Life Technologies, Janet held leadership positions in government relations, marketing and business development at large and small life science organizations, including GE and InforMax. Her experience also includes legislative and staff leadership positions in the U.S. Senate and House of Representatives.

Pavan Cheruvu

Pavan Cheruvu

CEO, Sio Gene Therapies

Pavan Cheruvu, MD, has served as Sio’s President and Chief Executive Officer since February 2018. A board-certified physician, Dr. Cheruvu completed his residency in internal medicine at Johns Hopkins Hospital and continued his training as a clinical fellow in cardiovascular medicine at the University of California, San Francisco. Dr. Cheruvu previously worked as a management consultant at McKinsey & Company, where he focused on organizational and R&D strategy while serving a variety of clients, including large- and mid-cap biopharmaceutical firms. Dr. Cheruvu graduated summa cum laude from Duke University, obtained a master’s degree from Oxford University as a Rhodes Scholar, and obtained his medical degree in a joint program between Harvard Medical School and the Massachusetts Institute of Technology. He currently lives with his wife and daughter in New York City.

Ran Zheng

Ran Zheng

CEO, Landmark Bio

Ms. Zheng is a biotechnology industry veteran who brings more than 25 years of experience in biotechnology operations across multiple geographies to Landmark Bio. Ms. Zheng most recently served as Chief Technical Officer at Orchard Therapeutics, a commercial-stage global gene therapy company specializing in HSC based gene therapies. In this role, Ms. Zheng established the technical operations function and manufacturing network, and advanced the company’s product pipeline, including the approval of Libmeldy™ - the first gene therapy product for metachromatic leukodystrophy. Ms. Zheng has also held leadership positions at several major biotechnology companies including Genzyme (now Sanofi) and Amgen. At Amgen, Ms. Zheng played a key role in building differentiating capabilities in manufacturing for clinical supply and commercial product launch to enable speed to clinic and speed to market strategies for Amgen’s innovative products.

Mark Clein
moderator

Mark Clein

Co-Founder & CEO, Precision Medicine Group

Mark P. Clein is the Co-Founder and Chief Executive Officer of Precision Medicine Group (Precision), a next-generation life science services company built to support biopharmaceutical companies from early development through the commercial life cycle. He has over 20 years of experience in the health care industry.

Prior to Precision, Mr. Clein was Co-Founder, President, and CFO of United BioSource Corporation (UBC), which became the leader in real-world research addressing safety, value, and comparative effectiveness for the life science industry. Among other service lines, UBC initiated a division now known as BRACKET, which trains and certifies investigators on the use of scales and other rating instruments used in trials with subjective endpoints (e.g., CNS). UBC was acquired by Medco in late 2010 and is now part of Express Scripts.

He received his MBA from the Columbia Graduate School of Business and his undergraduate degree from the University of North Carolina. Mr. Clein also served on the Arts and Sciences Foundation Board at the University of North Carolina and the Precision Medicine Council at Columbia University.