The Industry Shaping Agenda

10:00am–10:05am (EST)

Chairperson’s opening address

Izzy Gladstone VP Marketing, Pharma Reuters Events

10:05am–10:20am (EST)

Building a strong foundation for a novel gene therapy launch

  • Explore the challenges of developing and commercializing a gene therapy product and the logistical hurdles to overcome.
  • Understand the critical nature of cross-functional collaboration and the important role that each department plays in overall success.
  • Assess the payer landscape and how to ensure favorable access to novel gene therapy treatments.

David Meek CEO FerGene

10:20am–10:35am (EST)

Visualizing the future of cell & gene therapy commercialization— expansion, collaboration, transformation

  • Imagine what the industry will look in the near future and beyond as more curative treatments go to market and the number of patients served grows dramatically.
  • Explore inevitable industry changes as commercialization matures, from the shift to outcomes-based reimbursement models to diversified therapy choices to implications for key players in the value chain.
  • Understand how a trusted data exchange platform can enhance collaboration and help CGT achieve greater scale and efficiency.

Adlai Goldberg Global Digital, Social and Commercial Innovation Life Sciences Leader EY

10:35am–10:50am (EST)

How do we deliver value beyond the therapy?

  • Discuss how industry could play a greater role with CGT to deliver more value to the system and our customers
  • Discuss how we could build a new GtM model to streamline launches and deliver on providing more value

Brent Warner Vice President, Gene Therapy Novartis Canada

10:50am–11:00am (EST)

Live Q&A

David Meek CEO FerGene

Adlai Goldberg Global Digital, Social and Commercial Innovation Life Sciences Leader EY

Brent Warner Vice President, Gene Therapy Novartis Canada

11:00am–11:15am (EST)

Coffee break and check out the Virtual Exhibition

11:15am–12:00pm (EST)

Live Panel: Disease and science awareness: Accelerate commercial success with payer, physician and patient buy-in

  • How first-gen CGT treatments are breaking through patient, physician and payer scepticism with smart partnering and strategic disease education
  • Discover best-in-class examples of targeting, storytelling, media coverage strategies, and more in disease awareness campaigns
  • Hear how to approach patient advocacy and HCP network partnerships to reach and educate key groups

Kelly Page Head of Global Cell Therapy Commercialization Takeda

Oscar Segurado, MD, PhD Chief Medical Officer ASC Therapeutics

Chia Chen-Rogers Senior Director, Oncology Cell Therapy New Products GSK

Introduction and moderation: Dean Griffiths Principal IQVIA Consulting Services

12:00pm–12:15pm (EST)

Genomic Medicine and Bioethics: Addressing informed consent to get medicines to patients

  • Understand the challenges around informed consent specific to one-time and potentially permanent treatments, and how to consent someone for life with uncertainty around lifelong effects
  • Reimagine what bioethics looks like for cell and gene treatments, and the important role it will play in defining and enhancing the long-term patient experience
  • How to define a bioethical framework now to maximize the potential of genomic medicine in the clinic and for future commercialization

Sandy Macrae CEO Sangamo Therapeutics

12:15pm–12:30pm (EST)

Presentation by Accenture

Sanjay Srivastava, PhD Managing Director - Life Sciences, Cell and Gene Lead Accenture

12:30pm–12:45pm (EST)

Partner with treatment centers to develop infrastructure through rapid certification and process design

  • Develop effective guidelines for working with labs, sites and treatment centers in a streamlined, speedy and compliant manner to enable wider access and boost commercial potential
  • Explore simplification, innovation and specialization models for determining the optimum treatment

Alexandra Gomez Associate Director Patient Services Operations bluebird bio

12:45pm–1:00pm (EST)

Live Q&A

Sandy Macrae CEO Sangamo Therapeutics

Alexandra Gomez Associate Director Patient Services Operations bluebird bio

Accenture

1:00pm–1:15pm (EST)

An outside the US case study: Make the patient voice heard in HTA decision making

  • How the Patient Voice Initiative is working with the Department of HTA to include patient perspectives on the value of innovative medicines in assessment
  • Find novel patient insight using new digital tools to engage hard-to-reach patient communities
  • How to create capacity then train your team to empower patients to participate in access model creation

Jessica Bean Chair Patient Voice Initiative

1:15pm–2:00pm (EST)

Panel: Addressing cell and gene treatment affordability in the post-COVID world

  • Assess the economic stress on payers caused by the pandemic and the knock-on effect this could have on access to therapies
  • Co-create a new paradigm for financing treatments, involving government, non-profit, payers, pharma and/or other
  • New routes to reimbursement? Explore novel pricing solutions, contracts and alternative models including subscriptions, pay for performance and instalments
  • Prepare now and overcome the COVID-19 affordability setbacks which could impact your commercial success

Lung-I Cheng Director Value and Access Oncology Takeda

Mark Trusheim Strategic Director (and Biotech Exec including Precision Financing for Gene Therapies) MIT NEWDIGS

Nick Li Senior Director, Health Economics and Outcomes Research (HEOR) UniQure

Don Creighton Managing Director Huron Consulting Group

2:00pm–2:15pm (EST)

Fireside chat: Scaling up gene therapy for rare genetic diseases

Gene therapy has the potential transform the lives of patients living with rare genetic diseases, many of whom have urgent unmet medical needs. But bringing gene therapies to scale for these communities presents unique challenges and requires innovative solutions.

  • Understand the potential of gene therapy for rare genetic diseases
  • Learn about unique challenges in manufacturing, commercialization and treatment access
  • Explore ways innovative strategies to bring therapies to patients with rare genetic diseases at quality and scale

David Lennon President Novartis Gene Therapies

Izzy Gladstone VP Marketing, Pharma Reuters Events

2:15pm–2:30pm (EST)

Creativity and strategy in manufacturing

  • Find ways to squeeze today’s capacity bottlenecks in a systematic fashion that builds your ability to meet patient needs
  • Look beyond efficacy: How to build multi-stakeholder alignment to optimize and industrialize manufacturing processes
  • To go centralized and decentralized? How to define the most appropriate manufacturing model for you to optimize capacity and reach patients faster
  • Overcome supply chain and distribution challenges, including ways to mitigate cost of goods, low shelf life, ensure safety, and patient service delivery

Alberto Santagostino SVP, Head of Cell & Gene Technologies Lonza Pharma & Biotech

2:30pm–2:45pm (EST)

Live Q&A

David Lennon President Novartis Gene Therapies

Alberto Santagostino SVP, Head of Cell & Gene Technologies Lonza Pharma & Biotech

2:45pm–3:00pm (EST)

Coffee and catch-up on the On Demand presentations

3:00pm–3:45pm (EST)

Panel: It’s time to scale up

  • Hear proven strategies to drive your manufacturing costs down by scaling up
  • Deep dive into the likes of iPSC-based CGTs and allogeneic CAR-Ts, and the scalability challenges they can help solve vs new challenges they might bring
  • Devise a blueprint for developing and scaling academic or home-grown manufacturing models for large scale roll out
  • Explore how automation is helping to scale CGT manufacture faster and with reduced risk

Steven Goodman Head of Drug Product Manufacturing bluebird bio

Gary M. Pigeau Director, Centre for Advanced Therapeutic Cell Technologies Cytiva

Moderated by: James Strachan Editor The Cell & Gene Curator

3:45pm–4:00pm (EST)

An outside of the US perspective: Unlocking new systems for Cell & Gene Therapies

  • Discover how health eco-systems can adapt and ensure patient access to a new class of therapies
  • Understand what determines “value” and the more sustainable, risk-sharing pricing innovations available
  • Create a shared mission to widen C> access by forging new collaborative channels with national and state level government

Catherine Vaughan Director of Patient Access and Strategic Partnerships Novartis

4:00pm–4:45pm (EST)

Panel: Beyond rare disease: Preparing the Healthcare system for larger cell & gene therapy patient populations

  • Discover what’s being done to expand the reach of cell and gene therapies beyond rare diseases and small patient populations, and opportunities available for the industry
  • Hear the potential impact commercializing these treatments could have on the US Healthcare system, payer reimbursement strategy and physician workload, specific to treatment administration, outpatient procedures, and aftercare.
  • Explore the possible multi-stakeholder pathways for preparing for development, approval, and commercialization of CGT in larger patient groups

Vanessa Almendro Head of Strategy and Operations, Center for Genetics Guided Dementia Discovery Eisai

David Setboun, Pharm.D., MBA Executive Vice President & Chief Operating Officer Brainstorm Cell Therapeutics

Mariam Alboustani, RPh Clinical Pharmacy Manager, Medicare Pharmacy Services Blue Cross Blue Shield of Michigan

Parag Meswani Chief Commercial Officer Axovant

4:45pm–4:50pm (EST)

Closing remarks

Izzy Gladstone VP Marketing, Pharma Reuters Events

5:50pm– until November 13th (EST)

Please enjoy the networking, virtual exhibition and on demand content until November 13th!

Workshops

Workshops are for pharma and biotech companies only
WORKSHOP: November 10th - 9am ET - 60 mins

Approval, Access, and Reimbursement: Can gene and cell therapies reshape the landscape?

As more gene and cell-based treatments seek approval, and as the approval process itself evolves, what trial design, metrics, endpoints and arguments on long-term uncertainty will companies need in order to satisfy not just regulators but payers and providers? What ongoing measures are required to grow sales post-launch?

Workshop objectives:

  • Understand the key drivers and barriers in demonstrating value to payers and providers
  • Share experiences in how to better leverage value to ensure successful coverage and reimbursement

We will discuss:

  • Key challenges that are faced by HTA/Payers? And what drives their decision making?
  • Impact of landscape at launch, magnitude of response, and data quantity
  • How to optimise trial design and select impactful endpoints
  • Heterogeneity in gene and cell therapy solutions and the resultant impact on pricing models

Find out more and how to register here. Pharma and biotech companies only.

WORKSHOP: November 10th - 11am ET - 60 mins

Free Virtual Workshop: When clinical science outpaces digital technology, how do you keep up?

FOR PHARMA AND BIOTECH COMPANIES ONLY

In this hour long workshop, your moderators from EY and participants will interact together with the following outcomes in mind:

  • How to understand what the essential digital infrastructure is for achieving the aspirations of scaling cell & gene therapies, globally
  • An example of– a trusted data exchange  (a  EY Pointellis™ platform)  built to connect all the stakeholders in the CGT ecosystem
  • How to identify the basic tenets needed to transform the CGT industry to create a more collaborative, connected value chain.

The workshop will also include two breakout sessions to demonstrate and solicit feedback on applications designed to help:

  • The case worker’s experience – addressing the challenges of managing the growing caseload of patient treatment journeys
  • The manufacturing slot scheduler’s experience – overcoming the difficulties of optimizing the limited number of available manufacturing slots

Register now (pharma and biotech companies only)


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