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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John Doyle, DrPH

President, Consulting

Fortrea

Talk to John about these topics and more:

Tactics for driving health innovation
Optimizing market access strategies for new therapies
Demonstrating value through HEOR
Drug development life cycle strategies

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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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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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Christiane Bardroff

Chief Operating Officer

Rentschler Biopharma

Talk to Christiane about these topics and more:

Process development and cGMP manufacturing for clinical and commercial biopharmaceuticals
Navigating international regulatory bodies for global pharmaceutical product releases
Nurturing collaborative relationships with client partners to accelerate speed to clinic and market
Automation and digitalization in biopharmaceutical manufacturing
Trends and predictions in the biopharmaceutical industry

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