Practical Recommendations for Accelerating Cell and Gene Therapies

Webcasts

Wednesday, September 28, 2022, 11 am ET Join this webinar to hear industry thought leaders discuss issues that impede cell and gene therapy development. They will cover new approaches for expanding viral vector manufacturing capacity with appropriate quality, share recommendations for streamlining clinical trial design and process development, explore opportunities for adapting the regulatory framework for cell and gene therapy technologies, and examine innovative pricing and contracting models.

Register Free: https://www.pharmexec.com/pe_w/accelerating_therapies

Event Overview:

Cell and gene therapies have been in development since the 1980s. The first NIH-approved gene therapy procedure was performed on September 14th, 1990. Today, cell and gene therapies are widely accepted as the next wave of therapeutic innovation in the life sciences industry and account for approximately 12% of the clinical and 16% of the preclinical biopharma industry pipeline. There are 75 cell and gene therapies approved globally and 1,000+ active clinical trials, and the market is expected to grow from $8.57 Billion in 2022 to $46 Billion by 2030.
While the industry has many successes to show for the decades of development, there remain four substantial problems that impede the velocity with which cell and gene therapies can be brought to market. First, there is simply not enough viral vector capacity to meet the surging demand of researchers and the biopharma industry. Second, existing regulations are too stringent to meet the requirements of this emerging technology. In addition, the clinical processes for cellular therapies, especially the manufacture and administration of CAR-T therapies, are complex and not standardized. Finally, as we move from discovery to commercialization, there are pricing and contracting challenges around these durable and curative therapies that need to be solved for the long-term viability of the global market.
Despite the intricacies of these issues, there are emerging solutions to address them. If the biopharma industry can develop these solutions on a broad scale, cell and gene technologies can accelerate and fulfill the early promise of regenerative medicine.
In this webinar, life sciences industry experts will provide their perspectives on:

  • Demand for viral vector manufacturing capacity with appropriate quality
  • Complexity in clinical trial design and process development
  • Evolving local and global regulatory requirements governing cell and gene therapy technologies
  • Pricing and contracting models



Key Learning Objectives:

  • Discover new approaches for expanding viral vector manufacturing capacity with appropriate quality
  • Learn about streamlining clinical trial design and process development
  • Explore opportunities for adapting the regulatory framework for cell and gene therapy technologies
  • Understand innovative pricing and contracting models

Who Should Attend:

  • Seniority:
    • Director, VP, CXO
  • Job Titles:
    • Technology Assessment
    • Clinical Development
    • Clinical Operations
    • Clinical Research
    • Clinical Innovation
    • Site Engagement
    • Site Monitoring
    • Trial Management
    • Digital Trials
    • Remote Trials
    • Head of R&D IT
    • IT Head Trial Management
    • IT Head Clinical Operations
    • IT Head Clinical Technologies
    • Clinical Trials Business Partner
    • Clinical Operations
    • Clinical R&D IT
    • Assay Development
    • Cell Therapy Manufacturing
    • Compliance/Regulatory
    • Health Economics Assessment
    • Pricing and Contracting

Bob Hutchens
President and Chief Executive Officer
StemBioSys, Inc.

Bob Hutchens is an experienced life sciences business executive. Bob is the President and CEO of StemBioSys, a stem cell and life science tool company based in San Antonio, TX.
StemBioSys has developed a patented technology that provides for superior results in a range of cell culture applications. The company also offers a range of cell and cell expansion tools for use by biopharma, government, and academic labs globally.

Prior to StemBioSys, Bob was a Life Sciences industry Partner with Booz & Company for 10 years (now a member of the PWC network and known as Strategy&) in New York. Prior to that he was a Partner with A.T. Kearney also in New York.

During his nearly 25 years as a management consultant, Bob’s work was primarily with clients in the Life Sciences industry including major pharmaceutical companies as well as a range of medical device and life science tool companies. While at Booz, in addition to his commercial clients, Bob worked with Centers for Disease Control (CDC) and their Vaccine For Children (VFC) program and the President’s Emergency Program for Aids Relief (PEPFAR).

Bob is a member of the Board of Directors and Treasurer of BioMed SA, a not-for-profit group dedicated to furthering the biomedical industry in San Antonio. Bob is also a member of the Ross Business School Advisory Board at the University of Michigan.

Bob has a Bachelor of Business Administration from the Ross School of Business at The University of Michigan with Distinction and a Master of Business Administration in Finance and Operations from the Wharton School at the University of Pennsylvania.


George S. Goldberger
Founder and Chief Executive Officer
Cell One Partners Inc.


George S. Goldberger is founder and chief executive officer of Cell One Partners Inc., a strategy advisory firm, helping cell and gene therapy companies advance quickly and efficiently towards the commercialization of their therapies, leveraging the expertise and hands-on experience of a global team of cell and gene therapy veterans. Previously George cofounded Progenitor Cell Therapy (later known as PCT) in 1998, one of the earliest cell and gene therapy contract development and manufacturing organizations (CDMO). As chief financial and business officer and later chief development officer, he was instrumental in expanding PCT into a global leader, with facilities today in the U.S., and in Europe and Japan. PCT was sold to Hitachi, Ltd. for $100+ million. During his tenure at PCT, George also oversaw the construction and development of a cell and gene therapy facility in Beijing. Earlier he was president and chief executive officer of Goldberger & Associates, Inc., a global management consulting firm with offices in New York, Bucharest and Kiev. His firm advised U.S., European and Asian companies on developing private and public sector businesses in Hungary, Romania, the Czech Republic, Slovakia, Slovenia, Ukraine, Moldova, Armenia and Georgia. Previously George was assistant to the chairman of W. R. Grace & Co., with responsibilities in the U.S. and Asia. He also served on the Grace Commission as project director, working with the CEOs of 160+ leading companies in a survey of federal government operations, identifying cost savings of $424 billion through application of private sector management practices, and assembled and presented the Commission’s final report to President Reagan and to the U.S. cabinet. He started his business career as management consultant for Booz, Allen & Hamilton, now a unit of PricewaterhouseCoopers LLP. George holds an MBA in finance and international business from the Wharton School of Business of the University of Pennsylvania and a B.S. in systems engineering from the New York University Tandon School of Engineering.


Avi Kulkarni, Ph. D
Senior Vice President of Health Sciences
Cognizant

Avi Kulkarni leads Cognizant’s global life sciences business. He is responsible for commercial development, planning, and P&L execution for Cognizant’s biopharma and medical device clients across research and development, commercial, and digital functions.

Avi has been at the forefront of the drugs and diagnostics industry for over three decades, building new drug formulations, launching new diagnostic tests, publishing extensively in personalized medicine and building capabilities in cellular therapies. Prior to joining Cognizant in June 2021, he served as Managing Director and head of Accenture’s global clinical business, where he drove double digit annual growth.

Before Accenture, Avi was SVP and leader of IQVIA, a clinical research organization. Previously, he was Global Head of Life Sciences R&D at Booz & Co., a management consulting company. He also held CXO roles at three biotechnology start-ups spun out from Stanford University and funded by Sand Hill Road venture capital.

Avi is a pharmacist who holds a Ph.D. degree in pharmaceutics from Temple University, Pennsylvania, and an MBA from Stanford University. He has been a San Francisco Bay area resident for three decades, where he currently lives with his wife and daughter.



Dr. Mohit Sehgal
Cell and Gene Therapy SME, Life Sciences ISG
Cognizant


Dr. Mohit Sehgal is a Cell and Gene Therapy (CGT) Subject Matter Expert at Cognizant. He is part of the Johnson & Johnson CAR-T Clinical and Commercial team focused on digitizing Johnson & Johnson/Legend Biotech’s CAR-T value chain for their FDA and EMA approved BCMA-directed CAR-T Cell Therapy (CARVYKTI) for the treatment of Multiple Myeloma. He is also playing a pivotal role in establishing Cognizant’s Cell and Gene Therapy COE for helping life sciences companies build digital capabilities required to commercialize and scale CGTs. He has in-depth understanding of best practices for preclinical development, clinical development and commercialization of cell and gene therapies.

Before joining Cognizant, Dr. Sehgal worked as Cell and Gene Therapy Team Lead at Intas Pharmaceuticals. He led a high performing, innovative and cross-functional team of scientists focused on developing and commercializing cell and gene therapies for the treatment of hematological malignancies, solid tumors and genetic diseases.

Dr. Sehgal obtained his Bachelor of Engineering (B.E) in Biotechnology from University of Rajasthan and PhD in Biological Sciences from Drexel University. After PhD, he worked as a postdoctoral scientist in Drexel University College of Medicine and Wistar Institute. He has 10+ years of hands-on research experience and is passionate about helping cell and gene therapy companies build R&D, operations and digital capabilities needed to drive innovation, improve productivity and performance, and develop successful portfolio and asset strategies.

Register Free: https://www.pharmexec.com/pe_w/accelerating_therapies