David Gibbons Email & Phone Number

Washington, Dc, Us

Vers-Chez-Les-Blanc, Vaud, Ch

Vers-Chez-Les-Blanc, Vaud, Ch

Serve as the lead Legal business partner for commercial brands at Nestlé Health Science | US Pharma (Aimmune Therapeutics, Inc.) and provide counseling on marketing, advertising and promotion, patient support services, pricing and contracting, medical activities and communications, and corporate communications related to the company's marketed prescription drugs and biologics.

Pittsburgh, Pennsylvania, Us

Provided legal-regulatory counseling to U.S. marketing and brand teams regarding promotional strategy, tactics, and materials; served as legal reviewer on multiple, internal, cross-functional advertising and promotion review committees. Provided legal guidance on North America Medical Affairs engagements with healthcare providers and organizations, Medical Science Liaison activities and presentations, and scientific/medical communications.

Washington, D.C., Us

Prescription Drugs and Biologics • Advised on matters involving general FDA product development, pre-clinical and clinical development plans, including all phases of clinical trials, and FDA submission strategies. • Advised on strategies for interacting with FDA before and during the IND/NDA/BLA process, Advisory Committee meetings, and other ad hoc meetings with FDA. Advertising and Promotion • Advised pharmaceutical, biotechnology, and medical device clients on requirements pertaining to labeling and advertising claims in print and electronic media. Health Care • Counseled clients on compliance with federal and state health care fraud and abuse laws. • Advised clients on compliance with federal and state transparency reporting requirements connected with financial arrangements among manufacturers and health care providers. • Worked with companies on compliance with federal and state data privacy and security laws in the conduct of their clinical research, marketing, patient assistance, and other programs. Corporate Transactions • Served as FDA regulatory counsel on corporate transactional matters and conducts regulatory due diligence involving pharmaceutical and biotechnology companies or products.

New York, Ny, Us

I represented and counseled pharmaceutical, biotechnology, and medical device companies as well as other health care companies and private equity firms in the following areas:- Regulatory and reimbursement pathways for innovative products- Clinical trial design, conduct, and implementation- Pre-market and post-market FDA oversight of products- Product marketing issues – both FDA/FTC regulation of promotional activities as well as fraud & abuse implications- Fostering scientific collaborations and partnerships – including corporate services related to business arrangements as well as resolving IP and FDA regulatory issues

Represented clients in complex civil litigation pursuant to N.J. Ct. R. 1:21‐3(b); D.N.J. General Rule 101.1(h)• Played leading role in settlement discussions with opposing counsel • Handled routine communication with client, opposing counsel, and the federal district court• Provided input to legal tactics & strategy• Drafted pleadings, joint discovery plan, & internal memoranda

New York, Ny, Us

• Conducted due diligence for private equity firm in multi-billion dollar acquisition of medical device company, including document review and memo drafting• Analyzed regulatory and agency requirements for transfer of licenses, certifications, permits, and accreditations for health system sale of hospital• Provided regulatory guidance for companies expanding their health care businesses into new states• Participated on legal team advising nonprofit entity regarding federal and state data privacy laws• Co-authored client alert on multi-state qualified health plans that was picked up for national publication by the American Health Lawyers Association

Brentford, Middlesex, Gb

Brentford, Middlesex, Gb

Brentford, Middlesex, Gb

Brentford, Middlesex, Gb

Jd, Health Law

Mph, Public Health

Ba