Accelerating Development of Gene & Cell Therapy

Place
Online training
Site visit
Dates
Next Dates
In-house Available
18 – 20 November 2020, 14:00 - 18:00 CET
Who should attend?

Heads of R&D, Global program leads, Regulatory executives, C-level executives, Senior business development strategists, Portfolio executives, Pricing and market access executives, Medical affairs executives, Marketing and Commercial executives, Finance executives, Patient advocates, Epidemiologists, Outcomes researchers, Health economists, Digital health specialists, Big data and RWE researchers

Summary

This unique online training course focuses on methods enabling to leverage patient engagement, novel rare disease trial designs, regulatory incentives and realworld evidence to accelerate the development, approval and patient access of innovative Advanced Therapy Medicinal Products (ATMPs), including autologous and allogeneic gene therapies, tissue engineered products and somatic cell therapies.

Learning Objectives

  • Explore the opportunities of digital and big data to accelerate discovery, development, regulatory approval and market access for ATMPs
  • Gain insight into the most recent methodologies for faster, smaller, smarter clinical trials robust enough for marketing application
  • Discuss strategies to limit the number of patients and the placebo exposure of patients in pivotal clinical trials in rare and ultra-rare conditions
  • Discover the newest regulatory approaches for gene and cell therapies
  • Consider the crucial role of patient engagement throughout the lifecycle
  • Analyse the current market access challenges for ATMPs  
  • Explore innovative strategies that integrate real-world evidence (RWE)

Key Topics

  • An Introduction to Advanced Therapy Medicinal Products
  • Accelerated Development Strategy for ATMPs
  • “Fast to Patient” Regulatory Strategy
  • ATMPs Pricing and Market Access
  • Gene Therapy Safety & Risk Evaluation
  • ATMPs Interactive Case Studies

Trainers

David Schwicker

ORPHA Strategy Consulting

CEO

David Schwicker has biopharmaceutical consulting expertisespanning more than 25 years. Founder of ORPHA Strategy Consulting, and formerVice President with PAREXEL International in the United States, David is asought-after expert for accelerating marketing authorisation, time to launch,early patient and market access in the hyper-dynamic environment of rareconditions, orphan and advanced therapy medicinal products.

David's extensive therapeutic area experience includes acutemyelogenous leukemia (AML), multiple myeloma (MM), cutaneous t-cell lymphoma(CTCL), non-small-cell lung cancer (NSCLC), breast cancer, neuroendocrinetumors, pulmonary arterial hypertension (PAH), Niemann Pick disease,acromegaly, graft versus host disease (GvHD), primary sclerosing cholangitis(PSC), Mucopolysaccharidosis (MPS), Myasthenia Gravis (MG), Graves Orbitopathy(GO), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP),Antibody-Mediated Organ Rejection (AMR), Leber’s congenital amaurosis (LCA),retinitis pigmentosa (RP), USHER Syndrome, Narcolepsy, and Friedrich’s ataxia.David is currently working in rare Inherited Retinal Dystrophies (IRD),oncology/hematology, metabolic, CNS and dermatological indications. David hasdeveloped a unique understanding of accelerating marketing authorization andmarket access for orphan drugs. This involves indication prioritization,evidence generation planning, patient engagement and PROs, orphan designation,compassionate use programs, product differentiation and early valuedemonstration with fewer data. A crucial component of early access strategy isthe application of innovative pathways that leverage the use of real-worldevidence (RWE).

David is the author and co-author of numerous peer-reviewed publications and speaker at international meetings (ISPOR, RAPS EU Congress,Orphan Drugs Development and Commercialisation, Expanded Access Summit). He isan accomplished trainer in rare diseases, orphan, gene and cell therapymedicinal products, and leads training courses as well as customized in-house training workshops.

David Schwicker

ORPHA Strategy Consulting

CEO

David Schwicker has biopharmaceutical consulting expertisespanning more than 25 years. Founder of ORPHA Strategy Consulting, and formerVice President with PAREXEL International in the United States, David is asought-after expert for accelerating marketing authorisation, time to launch,early patient and market access in the hyper-dynamic environment of rareconditions, orphan and advanced therapy medicinal products.

David's extensive therapeutic area experience includes acutemyelogenous leukemia (AML), multiple myeloma (MM), cutaneous t-cell lymphoma(CTCL), non-small-cell lung cancer (NSCLC), breast cancer, neuroendocrinetumors, pulmonary arterial hypertension (PAH), Niemann Pick disease,acromegaly, graft versus host disease (GvHD), primary sclerosing cholangitis(PSC), Mucopolysaccharidosis (MPS), Myasthenia Gravis (MG), Graves Orbitopathy(GO), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP),Antibody-Mediated Organ Rejection (AMR), Leber’s congenital amaurosis (LCA),retinitis pigmentosa (RP), USHER Syndrome, Narcolepsy, and Friedrich’s ataxia.David is currently working in rare Inherited Retinal Dystrophies (IRD),oncology/hematology, metabolic, CNS and dermatological indications. David hasdeveloped a unique understanding of accelerating marketing authorization andmarket access for orphan drugs. This involves indication prioritization,evidence generation planning, patient engagement and PROs, orphan designation,compassionate use programs, product differentiation and early valuedemonstration with fewer data. A crucial component of early access strategy isthe application of innovative pathways that leverage the use of real-worldevidence (RWE).

David is the author and co-author of numerous peer-reviewed publications and speaker at international meetings (ISPOR, RAPS EU Congress,Orphan Drugs Development and Commercialisation, Expanded Access Summit). He isan accomplished trainer in rare diseases, orphan, gene and cell therapymedicinal products, and leads training courses as well as customized in-house training workshops.

Tour info

Price per Delegate (EUR)

Online Training

1350.00

Public Training

Register Now

Testimonials

Request Full Agenda

For the detailed agenda with a full breakdown of the individual sessions fill out this form.

Thank you! We will verify your request and contact you from this number: +420 223 014 960
Oops! Something went wrong while submitting the form. Please Contact us and we will process your request.

Contact us

Lydia Makori

l.makori@symmetric.events
+421 222 200 543