checkAd

     117  0 Kommentare Personalis Appoints Former Roche Diagnostics and GRAIL Executive Deepshikha Bhandari as SVP, Regulatory, Quality and Clinical Compliance

    Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomic testing for precision oncology, today announced the appointment of Deepshikha Bhandari as SVP, Regulatory, Quality and Clinical Compliance. With over two decades of industry marketing and regulatory affairs experience, Ms. Bhandari will help the company navigate the regulatory requirements for the NeXT Personal MRD test. She was most recently VP, Regulatory Affairs at GRAIL, and previously held senior positions at Roche Diagnostics and Abbott Vascular.

    “We are advancing our ultra-sensitive NeXT Personal MRD test as a Clinical Trial Assay (CTA) for our pharmaceutical partners and Deepshikha will further drive the regulatory FDA path for the platform,” said Chris Hall, CEO and President of Personalis. “We are excited to leverage her experience in our space and welcome her on our executive team. We believe NeXT Personal’s leading MRD sensitivity optimizes clinical trial enrollment by accurately segregating ctDNA-negative and ctDNA-positive patients, thereby enrolling only patients who are at significant recurrence risk.”

    Personalis also announced its receipt of International Organization for Standardization (ISO) 13485:2016 certification, a quality system specification that demonstrates the company’s ability to provide medical devices and related services with rigorous quality. This certification is a key part of the strategy to broaden NeXT Personal use in biopharma clinical trials.

    Inducement Awards

    Between October 15-16, 2023, Personalis' Board of Directors and its Compensation Committee granted non-qualified stock options to purchase an aggregate of 107,000 shares of its common stock to five new employees, including Ms. Bhandari, under Personalis’ 2020 Inducement Plan. The 2020 Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously an employee, or non-employee director, of Personalis, as an inducement material to entering into employment with Personalis, pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules. Personalis is making this announcement as required by Nasdaq rules. The inducement stock options granted on October 15, 2023 have an exercise price of $1.06 per share, which is equal to the closing price of Personalis’ common stock on October 13, 2023 and the inducement stock option granted on October 16, 2023 has an exercise price of $1.15 per share, which is equal to the closing price of Personalis’ common stock on October 16, 2023. Each inducement option will vest over four years, with 25% of the shares vesting on the first anniversary of the grant date and 1/36th of the remaining shares vesting monthly thereafter, subject to continued service through each applicable vesting date. The foregoing inducement awards are subject to the terms and conditions of Personalis’ 2020 Inducement Plan, and the terms and conditions of the applicable award agreement covering each grant.

    Seite 1 von 3



    Business Wire (engl.)
    0 Follower
    Autor folgen

    Personalis Appoints Former Roche Diagnostics and GRAIL Executive Deepshikha Bhandari as SVP, Regulatory, Quality and Clinical Compliance Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomic testing for precision oncology, today announced the appointment of Deepshikha Bhandari as SVP, Regulatory, Quality and Clinical Compliance. With over two decades of industry marketing and …