Isagani (Gani) M. Chico, M.D.

VP and Global Head for Oncology

Fortrea

Talk to Gani about these topics and more:

Oncology clinical trials (early phase to post approval)
Oncology medical affairs
Pharmaceutical, academic and regulatory interactions

Biostatistics

Cell and Gene (CGT)

Clinical Data

Clinical Strategic Planning

Clinical Trial Retention

Clinical Trial Supply

Clinical Trial Technology

Clinical Trials

Communication Strategies

Contract Research Organization (CRO)

Corrective and preventive action (CAPA)

Decentralized Clinical Trials (DCTs)

Digital Health

Diversity

FDA

Healthcare

Licensing Strategies

M.D.

Patient Recruitment

Pharmacology 

Phase I/Early Phase Research 

Real-World Data

Regulatory

Research and Development

Research as Care

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Tracy Parker

Vice President, Biometrics

Advanced Clinical

Talk to Tracy about these topics and more:

Biometrics services implementation 
Customer relationship and strategic portfolio management 
Ensuring successful and quality-driven delivery in mixed-model/hybrid engagements 
Navigating data management in complex trial designs 
Diversity considerations in clinical research

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Rebecca Starkie

Talk to Rebecca about these topics and more:

Voice of the patient
Patient engagement, recruitment, and retention
Working with patient advocacy groups
Diversity and health equality/equity in clinical research
Clinical research & project management

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Tara Anne Kervin, MPH

VP Global Operations & Consulting

International Drug Development Institute (IDDI)

Talk to Tara about these topics and more:

Independent Data Monitoring Committees (IDMCs; also known as Data and Safety Monitoring Boards [DSMBs])
Best practices in clinical data science and biometrics operations
Clinical trial design and interim analysis
Biostatistical consulting and regulatory interaction

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Oren Beske, Ph.D.

Amalgamator of Business and Biology

ATUM

Talk to Dr. Beske about these topics and more:

Cell line development
Leap-In Transposase and Transposons

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Claes Gustafsson, Ph.D.

Chief Commercial Officer

ATUM

Talk to Dr. Gustafsson about these topics and more:

GPS Platform
Protein Engineering
AI Machine Learning
Protein Analytics

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Jay W. Mason, M.D.

Chief Medical Officer

Spaulding Clinical, LLC

Talk to Jay about these topics and more:

Understanding cardiac safety requirements, including protocol design
Sponsor support at FDA meetings
Early phase development
Working with data and safety monitoring boards
Cardiac arrhythmias and electrophysiology

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Cassandra Erato, MSN

Chief Executive Officer

Spaulding Clinical, LLC

Talk to Cassie about these topics and more:

Navigating U.S. regulatory requirements, IND Submission, and Phase 1 startup and conduct
Efficiencies and guidance in running Phase 1 of clinical development
Understanding cardiac safety requirements and the best cost-saving methods
Developing new service programs as needs emerge
Rapid operational scaling/growth, strategic planning, and recapitalization

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