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Gene therapy roundup—what to know now from the lab to the FDA

Gene therapy continues to evolve rapidly - from the science to the regulatory requirements. To give you a greater perspective on recent developments, this panel discussion brings together gene therapy experts across assay development, regulatory submissions, and clinical trial strategy who will share observations from the front lines on a multitude of gene therapy and rare disease projects.

This event will be of interest to anyone involved in gene therapy clinical trial conduct, translational research, regulatory affairs – and anyone seeking to ensure successful gene therapy clinical development in the current climate.

Attendees will hear about:
  • Advances in gene therapy assay development
  • Validating gene therapy companion diagnostics--considerations for ensuring CDx approval
  • Optimizing the likelihood of preclinical and clinical trial development success
  • Winning strategies for rare disease trial design and regulatory submissions in the US and EU
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Deborah Phippard

Deborah Phippard

CSO, Precision for Medicine

Deborah Phippard, 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.

Deborah is a subject matter expert with Precision ADVANCE, a collection of interconnected services and complementary teams uniquely focused on the complexities of clinical, regulatory, manufacturing, and commercial needs to successfully bring cell or gene therapies to market.

Maham Ansari

Maham Ansari

Senior Director, Regulatory Affairs, Precision for Medicine

Maham Ansari, MS, RAC is a Senior Director, IVD Regulatory Affairs at Precision for Medicine. In her current role, she focuses on companion diagnostic co-development programs providing her regulatory expertise towards securing successful regulatory approvals in the US, Europe and beyond for companion diagnostics with a specific focus on gene therapy.

Maham has over 16 years of global regulatory leadership experience in the medical device and in vitro diagnostics industry. From major multinationals to small start-ups, Maham’s expertise includes full life cycle management of highly complex medical devices and IVDs from all stages of product development, execution of global regulatory strategies and leading post-market surveillance activities including complaint handling, vigilance, and PMS reports like CER/PER, PMSR, PSUR, PMCF/PMPF, etc. She is well versed in leading interactions with the FDA, Health Canada, EU Notified Bodies as well as authoring and project managing complex submissions including Pre-Subs, IDEs, 510(k)s, PMAs, and CE Technical Files. She also has a proven track record of registering complex products in emerging markets within Latin America, Middle East, and Asia Pacific.

Maham is a subject matter expert with Precision ADVANCE, a collection of interconnected services and complementary teams uniquely focused on the complexities of clinical, regulatory, manufacturing, and commercial needs to successfully bring cell or gene therapies to market.

Andy Kinley

Andy Kinley

VP, Innovation & Clinical Science, Precision for Medicine

Andy Kinley, Ph.D. is Vice President of Innovation and Clinical Science at Precision for Medicine. He is a clinical researcher with over 25 years of combined experience leading basic and clinical research in oncology and hematology. His early scientific career focused on cancer cell signaling, setting a foundation to complement his clinical research roles in trial design and implementation of effective strategies for oncology clinical trials. Andy specializes in immuno-oncology trials (checkpoint inhibitors, T-cell agonists, bispecifics, cytokines, oncolytic viruses, neoantigen cancer vaccines), including autologous and allogeneic adoptive cell therapies (CAR-T, TCR, TIL, NK cells). Today, Andy identifies and implements innovative tools, datasets, and services that can impact clinical trial execution including quality, patient diversity, site identification, and trial timelines.

Andy is a subject matter expert with Precision ADVANCE, a collection of interconnected services and complementary teams uniquely focused on the complexities of clinical, regulatory, manufacturing, and commercial needs to successfully bring cell or gene therapies to market.

ArsalanArif
moderator

Arsalan Arif

Founder & Publisher, Endpoints News

Arsalan Arif is a news media entrepreneur who set out in 2015 to build his vision of an independent biotech news company at Endpoints News.