PMI IIS program reopens to new applications

In this interview, Cédric Gubelmann discusses the reopening of the Investigator Initated Studies (IIS) program. He is a physician holding a MD PhD in Cardiovascular Epidemiology from the University of Lausanne, Switzerland. During his academic training, he has published more than ten scientific papers in peer-reviewed international journals and was acting as a medical coordinator of a cohort study aiming to better understand the development of cardiovascular disease in the general population. He joined Philip Morris International (PMI) in 2018, as a member of the Scientific & Medical affairs team. In that role, he leads the programs for collaborative studies, aiming to support scientists to advance knowledge on reduced-risk products (RRPs), also called Smoke-Free Products. He also regularly presents PMI science to scientists and health care professionals.

 

What is the PMI Science IIS program?

The IIS program supports external scientists and institutions who have the relevant expertise to conduct smoke-free product research. We do this by providing financial support, product/equipment support, or technical support. The scope of the IIS program is similar to our own research program, and includes aerosol chemistry, toxicology, systems biology, clinical, and post-market surveillance studies of PMI’s commercialized products.

PMI is committed to transparent and independent advancement of science on RRPs. Therefore, considering the success of completed and ongoing IIS studies, we have reopened for new applications on the website. In particular, we will continue supporting studies that aim to quantify the reduction in smoking related diseases in the population upon switching from cigarette smoking to a smoke-free product.

 

PMI closed the IIS program in 2018 and is now reopening it. What changed?

When there was little independent research on our RRPs, the IIS program was created to encourage more investigator-initiated research. Since then, we are thrilled to see an increasing amount of independent research on our products and our methods and results. These are original, peer-reviewed scientific studies or other reports that are fully independent of PMI support.

We have decided to reopen the program because IIS studies are an important way to complement PMI science, and will play an increasing role to explore the risk reduction of smoking-related disease in the population when switching to RRP compared to continuing smoking. A second pilot phase of the program has just been launched, and applications can now be submitted by external scientists and institutions.

 

What are the goals of the PMI Science IIS program?

Two main goals of the IIS program are to spark new avenues of external research on our products, and to encourage more research originating from outside the company.  Moving forward in the assessment of RRPs, it is important to explore the risk reduction of smoking-related disease in the population among those who switch to an RRP compared to continuing smoking. In that context, these IIS studies will play an important role.

In the spirit of transparency and open science, PMI does not review or influence the study results. We do expect that investigators conducting studies under the IIS Program will make raw data and results available in open access peer-reviewed journals. All investigators that participate in the program must disclose PMI’s support in resulting publications and PMI will publish the details of all approved studies on the PMIScience website. All proposals are evaluated by an IIS committee consisting of senior scientific and non-scientific members against specific criteria in a two-stage gate process.

 

What research does PMI’s IIS program support?

As I mentioned, the scope of the IIS program includes aerosol chemistry, toxicology, systems biology, clinical and post-market surveillance studies of PMI’s commercialized RRPs. This corresponds to our scientific assessment built on a collaborative approach and expertise in the fields of physics, chemistry, biology, informatics, and medicine.

Here are several examples of research that were already supported through the IIS program:

• A 5-year cohort observational study to evaluate frequency of exacerbations, respiratory symptoms, physical exercise intolerance and abnormal lung functions among participants who use Tobacco Heating System (THS) compared to cigarette smokers, by the Academy of Preventive Medicine in Kazakhstan. (Link to protocol) (Link to paper) 
• A 12-weeks open label, non-inferiority trial comparing THS product vs e-cigarette in terms of efficacy and adoption rates, acceptability, tolerability, and tobacco harm reduction in healthy smokers, by the University of Catania in Italy. (Link to protocol)
• Research on the effects of exhaled pollutants from THS on indoor air quality, by the Kaunas University of Technology in Lithuania. (Link to paper).

 

How to submit a proposal to the PMI Science IIS program

Those interested in submitting a proposal to the program should first read the guidelines and the terms and conditions of the program. Then they can download the IIS concept proposal submission template for the first step of the application process, and email their submissions to iis.pmi@pmi.com.