About Lisa Lewin

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So far Lisa Lewin has created 26 blog entries.

Article: Anshul Mangal of Project Farma Discusses Policy Strategies to Address the Current Cancer Drug Shortage

2023-11-09T15:48:39-05:00Cell & Gene Therapy|

In September, the American Association for Cancer Research reported that hospitals are facing the worst chemotherapy drug shortage crisis the US has ever seen. Anshul Mangal, President of Project Farma, sat down with AJMC to address the primary reasons for the current cancer drug shortages and how Project Farma is helping to address these challenges.

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Webinar: Driving Successful Therapeutic and Diagnostic Development: Effective Practices for Integrating Biomarkers, Biospecimens, and Science from Concept through Clinic to Cloud

2023-07-07T10:42:48-04:00Events|

In the rapidly evolving world of precision medicine, the successful integration of high-quality biospecimens and well-defined biomarkers is a fundamental aspect. Together with robust scientific methodologies and validation procedures, they drive discovery, clinical development, and the advent of Artificial Intelligence (AI)-driven diagnostics.

This webinar delves into the practical application of biospecimens in critical areas like neurodegeneration, immuno-oncology, and oncology. It outlines the development of assays for clinical application, the creation of multiplexed Immunohistochemistry (IHC) assays, and the use of sequenced biospecimens in the development and diagnosis of targeted therapies.

Key topics will also highlight the value of Tissue Microarrays (TMAs), the advantage of accessing diverse disease indications, the necessity for substantial tissue cohorts for clinical trial assay validation, and the role of tissue images (Hematoxylin & Eosin (H&E), IHC) and related sample data (Next-Generation Sequencing (NGS)) in shaping AI-based diagnostics.

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On-Demand: Cell & Gene Day, 2023

2023-07-10T12:09:50-04:00Cell & Gene Therapy, Events|

Even as cell and gene therapies inspire hope for patients who previously had none, the path to commercialization is littered with roadblocks. There is a pressing need for increased efficiency, enhanced safety, and innovative approach to pricing and access. How are leading CGTx innovators approaching these challenges?  Find out at Cell & Gene Day 2023, a free virtual event, streaming on demand HERE.

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Article: The Future of Gene Therapies: Three Trends

2023-06-06T14:38:00-04:00Cell & Gene Therapy|

Since the first gene therapy procedure more than 30 years ago, the field has seen significant advances and development, but also setbacks and issues. What is the future direction for gene therapies? Precision’s Phil Cyr, Richard Macaulay and Andy Kinley identify three future trends and how they might impact safety, manufacturing development, and reimbursement and payment.

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Article: The FDA and AAV-Based Gene Therapy Safety: What You Should Know

2023-07-11T09:35:59-04:00Cell & Gene Therapy|

Over the last couple of years, we have witnessed the tremendous potential of adeno-associated virus (AAV)-based gene therapies. However, there have been a few high-profile safety issues that have occurred, including deaths associated with AAV vector gene therapies that have raised safety concerns among the public and regulators. Don’t miss this great primer on AAV-based gene therapies by Precision’s Deb Phippard and Phil Cyr, including basic background on the vectors, safety concerns, strategies to mitigate safety issues, and recent FDA safety meetings.

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Precision Medicine Group Appoints John Hubbard, PhD, as Board of Directors Chair

2023-03-14T08:33:58-04:00News, Press Releases|

BETHESDA, MD, March 14, 2023 – Precision Medicine Group (PMG), a leading next-generation provider of drug development and commercialization services, today announced the appointment of John Hubbard, PhD, as Chairman of its Board of Directors.

“We are thrilled to welcome John to our Board. He is a highly regarded leader in the pharmaceutical industry with extensive experience in clinical development and operations, strategic planning and business development,” said Mark Clein, Chief Executive Officer of Precision Medicine Group. “His impressive qualifications make him uniquely qualified to appreciate the breadth of services offered across our organization and to provide valuable insight as we continue to expand our global footprint and integrated capabilities.”

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Stern IR Launches an ESG Advisory Practice

2023-03-03T12:00:20-05:00News, Press Releases|

Stern IR, part of Precision Value & Health, enhances market leadership position by integrating IR expertise, deep biotech knowledge, and ESG solutions to bring substantive value to clients. ESG Expert Molly Podolefsky, PhD, to lead complementary new ESG capability

NEW YORKMarch 2, 2023 — Stern IR, Inc., a Precision Value & Health company, today announced the launch of its new environmental, social, and governance (ESG) advisory practice. The addition of the ESG practice will deliver a suite of solutions, including materiality assessments, ESG strategy and roadmap development, reporting, and communications packages that are well integrated with Stern’s core investor relations (IR) competencies. These complementary ESG solutions are designed to meet the evolving IR needs of biotechnology and healthcare companies, which increasingly involve and are influenced by ESG considerations and factors with ESG rapidly becoming a core component of best-in-class IR.

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