Biotech Executive's Address Issues

Marie A. Dray, MBA, President, DIA Board of Directors; and President, International Regulatory Affairs Group LLC offered the opening remarks to a limited gathering of invitees to the DIA’s second Executive Roundtable focused on biotech issues.

Specifically, this year, “Navigating the Waters of Development and Regulatory Approval: Next Generation Biomedical Technologies & Innovative Medicines,” featured a panel of distinguished experts including Janet Woodcock, MD, Director, Center for Drug Evaluation and Research, FDA; Paul Eisenberg, MD, MPH, Sr. Vice President, Regulatory Affairs and Safety, Amgen; Joseph F. Johnston, Vice President, Regulatory Affairs and Quality, Isis Pharmaceuticals, Inc.; and John Mendlein, PhD, Executive Chairman, Fate Therapeutics.

Dray shared with Applied Clinical Trials about this year’s roundtable and the importance of dialogue between regulatory and the biotech industry.

“We are delighted to have Janet Woodcock at this year’s roundtable,” said Dray. “She started in biologics and she is very savvy about the current issues in biotech that will be addressed by the roundtable members.” Dray believes that the intimate gathering of 40 fosters a collaborative and small-venue environment that helps in information exchange.

Specifically, in regard to regulatory issues, the biotech has a different perspective than pharma. Says Dray, “Some of the companies have an unfamiliarity with the regulators, but the regulators also may have an unfamiliarity with the science. So there is a learning curve on both sides.”

“We provide the opportunities for this learning,” said Dray. For the past few years, DIA has held biotech-focused meetings in London to provide a cutting edge opportunity for both EU and US regulatory discussion. “Then there is smart regulation when it finally happens,” said Dray.

To that end, at last year’s DIA Annual Meeting in Boston, the pilot run of this biotech executive roundtable was held. Boston, like San Diego, is a hub for biotech companies, which this year is a natural from which to continue the biotech discussion.

Specifically, with this year’s focus on safety in medicines, Dray elaborated on the biotech’s role. “They may not have marketed products yet that the safety discussion addresses. However, the safety issues are important to them as they will impact their drug development activities.”

In fact, Dray says that not all biotech members at DIA are at the same place “depending on what stage of the development they are in.” And again, this is where Dray believes DIA’s ability to bring together people to either network or share commonalities helps the individual professional.

In regard to biotech, Dray says the clinical trials professional will have a lot to learn from DIA including personalized medicine, biomarkers, follow-on biologics, and stem cell research-just to name a few.