Princeton, NJ - Advaxis, Inc., a clinical-stage biotechnology company developing cancer immunotherapies, today announced that it has appointed Fred J. Frullo as Vice President, Regulatory Affairs. With more than 20 years of experience in the biopharmaceutical industry, Mr. Frullo is well versed in the development of global regulatory strategies for the supervision, review and assembly of pharmaceutical product submission and coordination with global health authorities to obtain approvals.
As Vice President, Regulatory Affairs, Mr. Frullo will oversee regulatory submissions for the company's Lm-LLO cancer immunotherapy clinical programs, including ADXS-HPV, ADXS-PSA and ADXS-HER2, as well as combination studies involving complementary immunotherapy technologies. Mr. Frullo will lead the development and submission of all regulatory documents on behalf of Advaxis to the appropriate health agencies and coordinating joint submissions with Advaxis's strategic partners as warranted. In this role, Mr. Frullo will succeed Ms. Chris L. French, MBA, who will now lead the company's compliance program.
"Over the past 12 months, Advaxis has significantly expanded and accelerated its clinical development activities requiring an individual of Fred's expertise and experience to manage our regulatory processes," said David J. Mauro, Advaxis's Executive Vice President, Chief Medical Officer. "As Vice President, Regulatory Affairs, Fred will be responsible for leading Advaxis's global regulatory strategy and will be a primary liaison between the company and the global health authorities where we are conducting our clinical studies and working to bring our immunotherapy products to market."
Mr. Frullo was previously the Director, Global Regulatory Strategy at Bristol-Myers Squibb, where he was responsible for maintaining regulatory compliance for the oncology portfolio of marketed products and providing global regulatory strategy support for both Life Cycle Management Teams and Early Development Teams. Mr. Frullo's notable career in regulatory affairs is comprised of executive positions at several prominent pharmaceutical companies, including Pharmacia Corporation, McNeil Consumer Healthcare, and Johnson & Johnson. Mr. Frullo holds a Bachelor of Science, Biology from Ohio University.
In connection with his appointment, Mr. Frullo received a one-time inducement award of 75,000 restricted shares, of which 25% are fully vested as of the grant date. The remaining shares vest annually over a three-year period. The company approved the award as an inducement material to Mr. Frullo entering into employment with the company in accordance with NASDAQ Listing Rule 5635(c)(4).
"Over the past 12 months, Advaxis has significantly expanded and accelerated its clinical development activities requiring an individual of Fred's expertise and experience to manage our regulatory processes," said David J. Mauro, Advaxis's Executive Vice President, Chief Medical Officer. "As Vice President, Regulatory Affairs, Fred will be responsible for leading Advaxis's global regulatory strategy and will be a primary liaison between the company and the global health authorities where we are conducting our clinical studies and working to bring our immunotherapy products to market."
Mr. Frullo was previously the Director, Global Regulatory Strategy at Bristol-Myers Squibb, where he was responsible for maintaining regulatory compliance for the oncology portfolio of marketed products and providing global regulatory strategy support for both Life Cycle Management Teams and Early Development Teams. Mr. Frullo's notable career in regulatory affairs is comprised of executive positions at several prominent pharmaceutical companies, including Pharmacia Corporation, McNeil Consumer Healthcare, and Johnson & Johnson. Mr. Frullo holds a Bachelor of Science, Biology from Ohio University.
In connection with his appointment, Mr. Frullo received a one-time inducement award of 75,000 restricted shares, of which 25% are fully vested as of the grant date. The remaining shares vest annually over a three-year period. The company approved the award as an inducement material to Mr. Frullo entering into employment with the company in accordance with NASDAQ Listing Rule 5635(c)(4).
