Webinar Insights: Optimizing Cohort Management in Early-Phase Oncology Trials
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2025 Biotech Economics: CROs, Advanced Therapies & Trends in Funding
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778858, hs_child_table_id=0, hs_updated_at=1741014116242, hs_published_at=1741014119284, description=Rob Maiale is a marketing strategist and creative technologist known for shaping content strategies that drive engagement, influence, and business impact. With more than 15 years of experience spanning clinical research, patient education, pharma, and diagnostics, he specializes in turning expert insights into market-shaping narratives. At Precision, Rob leads innovative storytelling initiatives that connect cutting-edge science with the right audiences—leveraging AI, emerging technologies, and deep industry expertise to keep content ahead of the curve., avatar=Image{width=400,height=400,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Rob%20Maiale.jpg',altText='Rob Maiale',fileId=184765575245}, linkedin=https://www.linkedin.com/in/rob-maiale/, hs_name=, hs_path=, lastname=Maiale, hs_initial_published_at=1741014119343, hs_created_at=1709645745089, hs_is_edited=false, hs_deleted_at=0, name=Rob, job=, slug=rob-maiale, email=, hs_updated_by_user_id=26433386}, second={}, third={}})
FDA's Project Optimus: What Pharma and Biotech Need to Know
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=167363064857, hs_child_table_id=0, hs_updated_at=1719905898183, hs_published_at=1741014119284, 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={}})
Case Study: Concurrent Phase 1 Solid Tumor Drug Development Successes
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=185838258545, hs_child_table_id=0, hs_updated_at=1738849388884, hs_published_at=1741014119284, description=Anna Rodecki is a results driven leader with 24 years of experience in clinical research across the pharmaceutical, device, and biotech industries. She has played a pivotal role in shaping clinical development plans on both Sponsor and CRO, successfully supporting First- In-Human (FIH) – Phase IV trials successfully across various therapeutics areas. Anan thrives on building strong, collaborative teams fostering innovation. Her expertise spans strategic planning, risk management, inspection readiness and cross-functional leadership – always with a focus on improving patient outcomes and advancing the future of medicine., avatar=Image{width=1200,height=1200,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Anna%20Rodecki.png',altText='Anna Rodecki',fileId=185842773784}, lastname=Rodecki, hs_initial_published_at=1738849393727, hs_created_by_user_id=26433386, hs_created_at=1738849349748, hs_is_edited=false, hs_deleted_at=0, name=Anna, job=Director, Project Management, slug=anna-rodecki, hs_updated_by_user_id=26433386}, second={hs_id=159488778891, hs_child_table_id=0, hs_updated_at=1709645745122, hs_published_at=1741014119284, description=Kurt Preugschat has over 11 years of statistical experience from Phase I to Phase IV clinical trials. He is a lead statistician, providing statistical support and oversight for numerous clinical trials associated with new drug applications (NDA), supplemental new drug applications (sNDA), and medical devices. His expertise includes the development of study designs to meet complex clinical questions and the measurement of desired outcomes. In addition, Kurt has extensive experience generating statistical analyses and creating complex SAS programs and macros used by study team., avatar=Image{width=150,height=150,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/kurt-preugschat.webp',altText='',fileId=null}, linkedin=https://www.linkedin.com/in/kurt-preugschat-97298923a, hs_name=, hs_path=, lastname=Preugschat, hs_initial_published_at=1716136551646, hs_created_at=1709645745122, hs_is_edited=false, hs_deleted_at=0, name=Kurt, job=, slug=kurt-preugschat, email=, hs_updated_by_user_id=26433386}, third={}})
Progress in Gastrointestinal Oncology: 5 Key Insights from ASCO GI
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=178509987433, hs_child_table_id=0, hs_updated_at=1728330014032, hs_published_at=1741014119284, description=Ivan Barrera, MD is a fellowship-trained expert in Research GI Oncology with over 15 years of clinical research experience across various healthcare systems and facilities. He is a methodical and strategic key player in interdisciplinary drug development teams, specializing in medical monitoring. Dr. Barrera has extensive experience in solid tumors, particularly Gastrointestinal Oncology, including Neuroendocrine Tumors, and has worked on FIH and Phase I-IV studies. His industry clinical development experience spans small molecules, antibodies, vaccines, cytokines, oncolytic viruses, radiopharmaceuticals, and cellular therapies., avatar=Image{width=685,height=649,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Ivan%20Barrera.jpg',altText='Ivan Barrera',fileId=180445483936}, lastname=Barrera, hs_initial_published_at=1726512636738, hs_created_by_user_id=26433386, hs_created_at=1726500269983, hs_is_edited=false, hs_deleted_at=0, name=Ivan, job=Senior Medical Director, slug=ivan-barrera, hs_updated_by_user_id=26433386}, second={}, third={}})
Impact of US Tariffs on Biopharmaceutical Industry
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=164426546550, hs_child_table_id=0, hs_updated_at=1716454235474, hs_published_at=1741014119284, description=Groundbreaking biotech entrepreneur, executive, and investor, dedicated to delivering transformative treatments to the patients who need them. Pioneered the industrialization of advanced therapeutics, including some of the earliest commercially approved cell and gene therapies, radioligand treatments, RNA-based therapies, and cutting-edge biologics. Created the leading global biologics and advanced therapy engineering consulting firm and developed the largest cell and gene therapy manufacturing footprint in the world. Deeply committed to advancing next-generation medicines, serves on multiple boards, philanthropic organizations, and patient-advocacy groups, including IQHQ, Alliance for Regenerative Medicines, and Alliance for mRNA Medicines., avatar=Image{width=720,height=812,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Anshul-Mangal.png',altText='Anshul-Mangal',fileId=167370347684}, linkedin=https://www.linkedin.com/in/amangal/, team=[{id=163072475007, name='Precision for Medicine Leadership'}], lastname=Mangal, hs_initial_published_at=1713174153602, hs_created_by_user_id=62155952, hs_created_at=1713169484118, hs_is_edited=false, hs_deleted_at=0, name=Anshul, job=President, Manufacturing Solutions, slug=anshul-mangal, hs_updated_by_user_id=9297597}, second={}, third={}})
Case Study Phase 3 NSCLC: Site Relationships Streamline Feasibility
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=185838258545, hs_child_table_id=0, hs_updated_at=1738849388884, hs_published_at=1741014119284, description=Anna Rodecki is a results driven leader with 24 years of experience in clinical research across the pharmaceutical, device, and biotech industries. She has played a pivotal role in shaping clinical development plans on both Sponsor and CRO, successfully supporting First- In-Human (FIH) – Phase IV trials successfully across various therapeutics areas. Anan thrives on building strong, collaborative teams fostering innovation. Her expertise spans strategic planning, risk management, inspection readiness and cross-functional leadership – always with a focus on improving patient outcomes and advancing the future of medicine., avatar=Image{width=1200,height=1200,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Anna%20Rodecki.png',altText='Anna Rodecki',fileId=185842773784}, lastname=Rodecki, hs_initial_published_at=1738849393727, hs_created_by_user_id=26433386, hs_created_at=1738849349748, hs_is_edited=false, hs_deleted_at=0, name=Anna, job=Director, Project Management, slug=anna-rodecki, hs_updated_by_user_id=26433386}, second={}, third={}})
has not third author: true, (SizeLimitingPyMap: {main={hs_id=183222587782, hs_child_table_id=0, hs_updated_at=1732630460690, hs_published_at=1741014119284, description=Jelena Alexander brings 18 years of industry experience across the CRO, biotech and R&D arenas, with the last eight years focused on clinical operations oversight and aligning resources with project needs. Prior to transitioning to clinical research, Jelena obtained a Master’s degree in infectious disease and immunology, specializing in the development of cross-reactive and neutralizing monoclonal antibodies to foot-and-moth disease virus. Jelena is a collaborative leader recognized for fostering relationships with stakeholders to embed sustainable workflow processes and for delivering high quality outputs to ensure business needs are accomplished on time and within budget. Jelena’s expertise extends to evaluating and assessing clinical proposals, with a focus on monitoring strategies, and operational feasibility. In this role, Jelena leverages operational and leadership expertise to deliver high-quality, client-focused solutions while enhancing efficiency and sustainability in proposal strategies. Jelena is devoted to driving innovation, mentoring teams, and achieving results through adaptability and commitment to quality., avatar=Image{width=800,height=800,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Jelena%20Alexander.jpg',altText='Jelena Alexander',fileId=183228271491}, lastname=Alexander, hs_initial_published_at=1732630470588, hs_created_by_user_id=26433386, hs_created_at=1732630317363, hs_is_edited=false, hs_deleted_at=0, name=Jelena, job=Senior Manager, Global Clinical Monitoring, slug=jelena-alexander, hs_updated_by_user_id=26433386}, second={}, third={}})
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