Investigator Initiated (Sponsored) Trials - ISSs

Why Should You Attend:

The legal and regulatory hurdles are a major pitfall for ISSs. Recent legislation and newly revised guidance documents for the pharmaceutical industry are being introduced regularly in light of the latest anti-kickback statutes. Pharmaceutical companies must carefully navigate the guidelines to ensure a successful outcome in these investigator-initiated studies without violating regulations.

This session is designed for clinical research professionals either at a pharmaceutical company or at a study site who are considering conducting ISSs and would like more information on the process to be able to abide by international regulations as well as understanding the process of how a company and sponsor collaborate.

The goal of this training is to help the clinical research professionals avoid liability, identify opportunities for improving the processes for conducting ISSs and to describe ways companies and study sites can best interact.

Areas Covered in the Seminar:

• Who is the Sponsor?
• Who is the Investigator?
• Who is the Applicant and how do you submit?
• FDA and European nomenclature and regulations.
  • CFR Sec. 312.3 Definitions and interpretations (FDA).
  • Directive 2001/20/EC.
• Who holds the IND?
• Who has the intellectual property rights?
• Who has publication rights?
• Who has liability for drug adverse events?
• Who provides financial support?
• Who provides drug supplies?
• Who write the informed consent?
• What are the regulatory reporting requirements?
• Who provides the study information on Clinicaltrials.gov (US) or European Clinical Trials Database (EudraCT Version 8.0, operational since 10 March 2011?

Who Will Benefit:

• Pharmaceutical Medical Directors in Clinical Research and Medical Affairs
• Pharmaceutical medical support personnel who work in clinical research or medical affairs who may initiate or oversee IISs by their company
• CRAs, CDAs, MSLs, Managers, etc.
• Investigators at study sites interested in conducting ISSs
• Coordinators at study sites who must manage the process
• Farm bureaus and members
• Legal Affairs

Instructor Profile:

Dr. Laudadio, is a Pharmaceutical Executive with more than 32 years of experience in large, small, and mid cap global pharmaceutical companies and CROs. He is an accomplished MD with a multi-faceted background in clinical research and medical affairs coupled with a history of leadership and clinical expertise which has significantly contributed to approval of multiple drugs in small molecules and biologics. Global experience leading drug development programs including multiple INDs, NDAs and BLAs Regulatory interactions with both FDA and European agencies by helping to develop the clinical and regulatory strategy development and clinical trial execution globally.

Dr. Laudadio organized a committee to oversee all non-company sponsored studies (ISSs) and served as its chair for the first year. The committee’s responsibility was to review all requests for ISSs and provide assurance that those activities were in alignment with current directives, company legal policy and provided greater visibility of companywide research grants. Dr. Laudadio also was a speaker at ISSs meetings including ones in Philadelphia and Berlin, Germany.

Topic Background:

Spending on post-marketing clinical studies grants is higher than ever as more restrictions are being implemented that restrict company-physician direct interactions via traditional commercial routes. While most companies are doing these types of trials, not all of them are doing them in the most efficient or cost-effective manner. While many Phase IV studies are company sponsored and provide value, they are also very expensive to conduct. Investigator-initiated/sponsored trials are alternate means of obtaining additional data on their drug that is both cost effective and opens avenues to direct interaction with experts in the field. However, some companies and investigators often find it difficult to navigate the process to initiate such ISSs even after repeated attempts.

The upside for companies is that ISSs:

• Address gaps in current knowledge of product, disease state(s) and/or specific patient populations
• Explore potential new clinical uses of the product
• Explore mechanism(s) of action
• Generate abstracts and publications regarding the product
• Demonstrate company's commitment to supporting the science
• Avoid regulatory pitfalls that might initiate an investigation of the company
• Choose the best trial design that fits the company's intended outcomes
• Collect the best and most relevant data in your trials
• Ensure a rewarding relationship with clinical investigators
• Expand product visibility through case studies of oncology ISSs

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