Matthew Davis Email & Phone Number

Malvern, PA, US

London, Mayfair, GB

I am thrilled to join the Tiziana team, and for the opportunity to help advance Foralumab, TZLS-501 and Milciclib. I am energized to work with the passionate and dedicated R&D team and to meet the prestigious Scientific Advisors who are helping to guide the company

Malvern, PA, US

• Recruited by and reporting into the Chair (founder) originally as CMO to be accountable for strategy and development of only fully nasally administered human monoclonal antibody (mAb) foralumab. Scope of responsibility.
• Promoted after 6 months from CMO to COO & CMO (there is no full-time CEO).
• Reprioritized corporate focus to neuroinflammation directly leading to cost savings of $12M in first year.
• In the first 18 months, met with 120 investors and bankers leading to a term sheet for a Standby Equity Purchase Agreement (SEPA) and a term sheet for a capital raise.
• In the first 18 months, met with over 50 biotech and pharmaceutical companies and negotiated a term sheet for a strategic investment.
• In the first 18 months, created personal relationships and directly presented to most Business Development heads of major multi-national pharmaceutical companies in the Multiple Sclerosis and Alzheimer’s Disease space.

Somerset, NJ, US

• Recruited to rationalize R&D pipeline and increase US revenue via 505(b)(2) approvals or accretive purchases. Direct scope of responsibility included US Phase 1, Phase 2, Phase 3, Phase 4, Clinical Development.
• Conducted due diligence, then recommended to the BOD the purchase of Symbiomix Therapeutics and its Phase 3 asset, Solosec® (NDA 209363), which was then FDA approved in 2017 and accretive in 2018.
• Conceived the 505(b)(2) Impleko® (NDA 213691), gained BOD approval for funding, strategy, led program, and led FDA meetings resulting in approval and eventual sale to Mylan in 2018 for undisclosed royalties.
• In the first 6-months, completed review of bio-similar R&D pipeline and gained BOD consensus to focus on non-US (EU) market which were also part of the Mylan Impleko® deal for $15M upfront payment with undisclosed.
• In the first 6-months, completed review of NCE R&D pipeline and gained BOD consensus to deprioritize program and focus on non-US/EU/JP markets.

Philadelphia, PA, US

• Recruited to select an “unapproved ” drug candidate, gain its approval, and discover valid and ethical intellectual property which could be applied to the “orange book”. Direct scope of responsibility included Phase 1.
• Led process, which in 2012 resulted in the sale of Colcrys® and URL to Takeda for $3.2B ($800M up front and $2.4B in contingency earnouts).
• In 2009, gained FDA approval of Colcrys® (NDAs 022351, 022352, 022353) with orphan status and orange book listed intellectual property.
• Inventor of all 17 Orange Book Listed Colcrys® patents.
• Personally met and lobbied corporate concerns about “Unapproved” drugs directly to President Bush, Speaker Baner, Senators Specter and Snow, and Chief of Staff Rowe.

Hyderabad, TS, IN

• Recruited into the company as head of Clinical Development and Medical Affairs. Directed to reverse poor managed care coverage of Penlac® which was dramatically underperforming. Direct scope of responsibility included.
• Conceived and implemented successful managed care strategy for Penlac® (NDA 021022) that led to added $100M in revenue in FY 2002 – this effort was recognized by Aventis by an award of a fully paid 8-week intensive.
• Led efforts to acquire Sculptra® and developed program which led to the FDA allowance of Sculptra®(PMA P030050/S2)
• As Aventis did not own any devices at in 2001, found and outsourced a materialvigilance group to handle all Scultra® adverse events.
• Successfully gained approval of BenzaClin® (NDA 050756), Carac® (NDA 020985) and Dermatop® (NDA 020279

Paris, France, FR

• Recruited into the company as head of Clinical Development and Medical Affairs. Directed to reverse poor managed care coverage of Penlac® which was dramatically underperforming. Direct scope of responsibility included.
• Conceived and implemented successful managed care strategy for Penlac® (NDA 021022) that led to added $100M in revenue in FY 2002 – this effort was recognized by Aventis by an award of a fully paid 8-week intensive.
• Led efforts to acquire Sculptra® and developed program which led to the FDA allowance of Sculptra®(PMA P030050/S2)
• As Aventis did not own any devices at in 2001, found and outsourced a materialvigilance group to handle all Scultra® adverse events.
• Successfully gained approval of BenzaClin® (NDA 050756), Carac® (NDA 020985) and Dermatop® (NDA 020279).

Malvern, PA, US

• Hired as the 23rd employee of Endo while it was still a Dupont-Merck subsidiary. Tasked learning Medical Affairs, Pharmacovigilance and clinical development at Dupont-Merck within the 6-month period prior to Endo.
• Championed the rapid 3-month due diligence and acquisition of Lidoderm® (NDA 20-612) from Hind Healthcare after hearing about the phase 3 study from a KOL. Lidoderm® was the most successful drug in the history of Endo.
• Solely on own initiative, achieved Lidoderm approval by US Olympic committee for Olympic use.
• Successfully created and ran Medical Affairs and Pharmacovigilance, meeting the 6-month deadline given by CEO/BOD.

Washington, DC, US

Providence, RI, US

Surgical Residency

Doctor Of Medicine (Md)

Bachelor Of Pharmacy (B.Pharm.)

Pre-Pharmacy Studies