Gene Therapy Assays: Regulatory Compliance with Unified Immunogenicity
|
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778875, hs_child_table_id=0, hs_updated_at=1716454216458, hs_published_at=1736962071401, description=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., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Deb%20Phippard.webp',altText='Deb Phippard',fileId=165892372605}, linkedin=https://www.linkedin.com/in/deb-phippard-103b54, team=[{id=163072475007, name='Precision for Medicine Leadership'}], hs_name=, hs_path=, lastname=Phippard, PhD, hs_initial_published_at=1716212769184, hs_created_at=1709645745106, hs_is_edited=false, hs_deleted_at=0, name=Deborah, job= Chief Scientific Officer, slug=deborah-phippard, email=, hs_updated_by_user_id=26433386}, second={hs_id=159488778840, hs_child_table_id=0, hs_updated_at=1716132440837, hs_published_at=1736962071401, description=Maham Ansari, MS, RAC is a Senior Director, IVD Regulatory Affairs. Her focus is on companion diagnostic co-development programs, where she leverages her regulatory expertise to secure approvals in the US, Europe and beyond for companion diagnostics with a specific focus on gene therapy. She brings more than 16 years of global regulatory leadership experience in the medical device and in vitro diagnostics industry, spanning major multinationals to small start-ups, including full life cycle management across all stages of product development, execution of global regulatory strategies, and post-market surveillance.sh, avatar=Image{width=710,height=710,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Maham_Ansari.png',altText='Maham_Ansari',fileId=167373022876}, linkedin=https://www.linkedin.com/in/maham-ansari-ms-rac-6a735739, hs_name=, hs_path=, lastname=Ansari, hs_initial_published_at=1716212769184, hs_created_at=1709645745071, hs_is_edited=false, hs_deleted_at=0, name=Maham, job=, slug=maham-ansari, email=, hs_updated_by_user_id=26433386}, third={}})
has not third author: true, (SizeLimitingPyMap: {main={hs_id=167363064857, hs_child_table_id=0, hs_updated_at=1719905898183, hs_published_at=1736962071401, description=Industry-leading oncologist and demonstrated medical leader in precision medicine, novel trial design and innovative regulatory initiatives designed to expedite drug approvals. Draws on nearly a decade leading oncology and rare disease programs at the FDA. Former fellow at the National Cancer Institute and frequent featured speaker at ASCO and AACR. CDER technical authority on oncologic drug and biological products for thoracic and head and neck malignancies, neurologic tumors, pediatric solid tumors and rare tumors., avatar=Image{width=553,height=580,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Harpreet-Singh2.png',altText='Harpreet-Singh2',fileId=171747124346}, linkedin=https://www.linkedin.com/in/harpreetsinghmd/, team=[{id=163072475007, name='Precision for Medicine Leadership'}], lastname=Singh, MD, hs_initial_published_at=1715692570942, hs_created_by_user_id=2737751, hs_created_at=1715692477118, hs_is_edited=false, hs_deleted_at=0, name=Harpreet, job=Chief Medical Officer, slug=harpreet-singh, hs_updated_by_user_id=26433386}, second={}, third={}})
Therapeutic Genome Editing – Reshaping the Landscape of Advanced Therapies
|
has not third author: true, (SizeLimitingPyMap: {main={hs_id=169567234066, hs_child_table_id=0, hs_updated_at=1723217613021, hs_published_at=1736962071401, description=Precision Experts are among the most experienced specialists in clinical research. We focus our hiring strategy on select indications to deliver excellence across each role. , avatar=Image{width=800,height=800,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Precision%20Expert.png',altText='Precision Expert',fileId=164175466823}, lastname=Experts, hs_initial_published_at=1718988967067, hs_created_by_user_id=26433386, hs_created_at=1717603871601, hs_is_edited=false, hs_deleted_at=0, name=Precision, slug=precision-experts, hs_updated_by_user_id=26433386}, second={}, third={}})
FDA ODAC Vote: Key Changes for Perioperative Cancer Trials
|
has not third author: true, (SizeLimitingPyMap: {main={hs_id=167363064857, hs_child_table_id=0, hs_updated_at=1719905898183, hs_published_at=1736962071401, description=Industry-leading oncologist and demonstrated medical leader in precision medicine, novel trial design and innovative regulatory initiatives designed to expedite drug approvals. Draws on nearly a decade leading oncology and rare disease programs at the FDA. Former fellow at the National Cancer Institute and frequent featured speaker at ASCO and AACR. CDER technical authority on oncologic drug and biological products for thoracic and head and neck malignancies, neurologic tumors, pediatric solid tumors and rare tumors., avatar=Image{width=553,height=580,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Harpreet-Singh2.png',altText='Harpreet-Singh2',fileId=171747124346}, linkedin=https://www.linkedin.com/in/harpreetsinghmd/, team=[{id=163072475007, name='Precision for Medicine Leadership'}], lastname=Singh, MD, hs_initial_published_at=1715692570942, hs_created_by_user_id=2737751, hs_created_at=1715692477118, hs_is_edited=false, hs_deleted_at=0, name=Harpreet, job=Chief Medical Officer, slug=harpreet-singh, hs_updated_by_user_id=26433386}, second={}, third={}})
Navigating Site Activation Strategy Under the EU Clinical Trials Regulation
|
has not third author: true, (SizeLimitingPyMap: {main={hs_id=169565849890, hs_child_table_id=0, hs_updated_at=1723217327146, hs_published_at=1736962071401, avatar=Image{width=800,height=800,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Barbara%20Kathage.jpg',altText='Barbara Kathage',fileId=168426405902}, lastname=Kathage, hs_initial_published_at=1718988967067, hs_created_by_user_id=26433386, hs_created_at=1717603865843, hs_is_edited=false, hs_deleted_at=0, name=Barbara, job=Vice President, Site Start Up, slug=barbara-kathage, hs_updated_by_user_id=26433386}, second={hs_id=159488778852, hs_child_table_id=0, hs_updated_at=1716212815818, hs_published_at=1736962071401, description=Chris Ingram, BSc (Hons) is Head of Regulatory Consultancy (Europe) for Precision for Medicine. Chris received his BSc(Hons) in immunology and pharmacology from the University of Strathclyde and has since spent over 21 years working in regulatory affairs with a focus on clinical development. Chris’ regulatory expertise covers clinical development across all phases, regulatory strategy, marketing authorisations, scientific advice, orphan drug designation and paediatric investigation plans across a wide variety of therapeutic areas, including but not limited to, oncology, CNS, metabolic, endocrinology, analgesia and cardiovascular., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Chris%20Ingram.webp',altText='Chris Ingram',fileId=165893120791}, linkedin=https://www.linkedin.com/in/chris-ingram-0255b216, hs_name=, hs_path=, lastname=Ingram, hs_initial_published_at=1716212950453, hs_created_at=1709645745083, hs_is_edited=false, hs_deleted_at=0, name=Chris, job=Executive Director, Regulatory Affairs, Europe, slug=chris-ingram, email=, hs_updated_by_user_id=26433386}, third={}})
Considerations for Your Pre-IND Meeting With the FDA
|
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778884, hs_child_table_id=0, hs_updated_at=1709645745115, hs_published_at=1736962071401, description=Vann Parker is the Head of Regulatory Consultancy (North America) for Precision for Medicine. He received his PhD in Molecular Biology from The California Institute of Technology and spent the past 30 years supporting biopharmaceutical and drug development. He currently focuses on strategies for clinical development and interactions with FDA and other regulatory agencies. In addition to support of pre-IND activities, Vann has supported sponsors throughout the drug development process including applications for Fast Track, Breakthrough Therapy and Orphan Designations, formal meetings with FDA and full NDA/BLA submissions., avatar=Image{width=150,height=150,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/vann-parker.webp',altText='',fileId=null}, linkedin=https://www.linkedin.com/in/vann-parker-69565a6/, hs_name=, hs_path=, lastname=Parker, hs_initial_published_at=1716136551646, hs_created_at=1709645745115, hs_is_edited=false, hs_deleted_at=0, name=Vann, job=, slug=vann-parker, email=, hs_updated_by_user_id=26433386}, second={}, third={}})
FDA Draft Guidance Encourages Broader Inclusion Criteria in Oncology Trials
|
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778884, hs_child_table_id=0, hs_updated_at=1709645745115, hs_published_at=1736962071401, description=Vann Parker is the Head of Regulatory Consultancy (North America) for Precision for Medicine. He received his PhD in Molecular Biology from The California Institute of Technology and spent the past 30 years supporting biopharmaceutical and drug development. He currently focuses on strategies for clinical development and interactions with FDA and other regulatory agencies. In addition to support of pre-IND activities, Vann has supported sponsors throughout the drug development process including applications for Fast Track, Breakthrough Therapy and Orphan Designations, formal meetings with FDA and full NDA/BLA submissions., avatar=Image{width=150,height=150,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/vann-parker.webp',altText='',fileId=null}, linkedin=https://www.linkedin.com/in/vann-parker-69565a6/, hs_name=, hs_path=, lastname=Parker, hs_initial_published_at=1716136551646, hs_created_at=1709645745115, hs_is_edited=false, hs_deleted_at=0, name=Vann, job=, slug=vann-parker, email=, hs_updated_by_user_id=26433386}, second={}, third={}})
Inside a CRO: The Critical Role of Regulatory and Startup Specialists in Clinical Research
|
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778850, hs_child_table_id=0, hs_updated_at=1709645745081, hs_published_at=1736962071401, description=Mar Galan is Sr. Start-up Line Manager for several EMEA countries at Precision. She has a Pharmacy Degree and a MSc in pharmaceutical industry and has spent over 16 years working in the CRO industry, mainly in the start-up area, in different roles. Mar’s experience covers for a wide variety of studies, from phase I to IV. Her well-rounded background spans multiple disease states across the various stages of drug development., avatar=Image{width=150,height=150,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/mar-galan.webp',altText='',fileId=null}, linkedin=https://www.linkedin.com/in/mar-galan-dalmau-9b068a1a, hs_name=, hs_path=, lastname=Galan, hs_initial_published_at=1716212769184, hs_created_at=1709645745081, hs_is_edited=false, hs_deleted_at=0, name=Mar, job=, slug=mar-galan, email=, hs_updated_by_user_id=26433386}, second={}, third={}})
Unpacking FDA’s Draft Guidance on Psychedelic Research for Clinical Success
|
has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778843, hs_child_table_id=0, hs_updated_at=1714461297945, hs_published_at=1736962071401, description=Robert Bauer is an Executive Director of Operational Strategy at Precision with over 20 years of clinical trial operations experience from both the sponsor and CRO perspectives. He has led teams in the conduct of trials from Phase I through IV and has experience across a wide variety of trial designs. Bob has experience across many therapeutic areas some of which include rare diseases, oncology, depression, schizophrenia, and substance use disorders., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Robert%20Bauer%20Square.webp',altText='Robert Bauer Square',fileId=165892429961}, linkedin=https://www.linkedin.com/in/robert-bauer-a78b704b, hs_name=, hs_path=, lastname=Bauer, hs_initial_published_at=1716212769184, hs_created_at=1709645745074, hs_is_edited=false, hs_deleted_at=0, name=Robert, job=, slug=robert-bauer, email=, hs_updated_by_user_id=26433386}, second={}, third={}})
