Matthew Davis Email and Phone Number
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C-Suite executive with over 25 years of diverse Biotechnology and Pharma experience. Directly responsible for the $3.2B ($800M up front and $2.4B in contingency earnouts) sale of URL Pharma to Takeda in 2012. Drove the first modern neuropathic pain approval, Lidoderm® (peak sales of $1.4B), in 1999. Leader of multinational teams of 1,200 employees on three continents. Controlled $275 annual budgets. Inventor of 17 Orange Book listed patents. Lobbied a sitting US President, 2 US Speakers of the House and multiple Senators and House Representatives.
Aquestive Therapeutics
View- Website:
- aquestive.com
- Employees:
- 147
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Chief Development Officer (Cdo)Aquestive TherapeuticsMalvern, Pa, Us -
Chief Medical OfficerNeuvivo Aug 2024 - Present -
Chief Operating Officer & Chief Medical OfficerTiziana Life Sciences Jun 2022 - Jul 2024London, Mayfair , GbI 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 -
Chief Medical / Scientific Officer, Global Head Branded R&DEndo International Plc 2017 - 2022Malvern, Pa, UsRecruited 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 includes Clinical Development, Regulatory Affairs, and Chemistry Manufacturing and Control (CMC). Was given the additional responsibility of COO and accountability for Investor Relations, Media Relations, Business Development / Partnering and recapitalization.Selected Accomplishments: • 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.• Gained NASDAQ compliance preventing delisting or reverse stock split.• Gained agreement with the FDA to use healthy normal safety and pharmacokinetic data as Phase 1 allowing the company to leapfrog immediately to Phase 2a in both Multiple Sclerosis and Alzheimer’s Disease.• Grew the Expanded Access intranasal foralumab multiple sclerosis program from 2 patients to 10 in a year.• Gained FDA approval to expand the Expanded Access intranasal foralumab multiple sclerosis program from 10 patients to a total of 30 patients. -
Chief Medical OfficerLupin Pharmaceuticals 2014 - 2016Somerset, Nj, UsRecruited 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, Clinical Operations, Medical Affairs, Regulatory Affairs, Statistics, Pharmacovigilance, Medical Science Liaison, Drug Information Call Center, and FDA interactions. Directly oversaw a team of 200 employees based on three continents. Directly oversaw $75M yearly budget.Selected Accomplishments: • 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 royalties. • 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. -
Chief Medical OfficerUrl Pharma, Inc. 2005 - 2014Philadelphia, Pa, UsRecruited 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, Phase 2, Phase 3, Phase 4, Clinical Development, Clinical Operations, Medical Affairs, Regulatory Affairs, Project Management, Health Economics and Outcomes Research, Statistics, Data Management, Pharmacovigilance, Medical Science Liaison, Drug Information Call Center, Media Relations, lobbying and FDA interactions. Directly oversaw a team of 30 employees. Directly oversaw $25M yearly budget.Selected Accomplishments: • 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. -
Vice President, Clinical Development And Medical AffairsDr. Reddy'S Laboratories 2003 - 2004Hyderabad, Ts, InRecruited 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 Phase 1, Phase 2, Phase 3, Phase 4, Clinical Development, Clinical Operations, Medical Affairs, Regulatory Affairs, Statistics, materialvigilance, Drug Information Call Center, and FDA interactions. Directly oversaw a team of 5 employees. Directly oversaw $20M yearly budget.Selected Accomplishments: • 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 executive course at Wharton and at Sorbonne Université (honor declined as commitment to Dr. Reddy’s Laboratories already occurred).• 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 -
Director, Clinical Development And Medical AffairsSanofi (Formerly Dermik Laboratories) 2000 - 2003Paris, France, FrRecruited 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 Phase 1, Phase 2, Phase 3, Phase 4, Clinical Development, Clinical Operations, Medical Affairs, Regulatory Affairs, Statistics, materialvigilance, Drug Information Call Center, and FDA interactions. Directly oversaw a team of 5 employees. Directly oversaw $20M yearly budget.Selected Accomplishments: • 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 executive course at Wharton and at Sorbonne Université (honor declined as commitment to Dr. Reddy’s Laboratories already occurred).• 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). -
Manager (Head), Medical AffairEndo Pharmaceuticals 1998 - 2000Malvern, Pa, UsHired 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 separating from Dupont-Merck into its own independent company. Direct scope of responsibility included Phase 1, Phase 2, Phase 3, Phase 4, Clinical Development, Clinical Operations, Medical Affairs, Statistics, pharmacovigilance, Medical Science Liaison, Drug Information Call Center, and FDA interactions. Directly oversaw a team of 15 employees. Directly oversaw $10M yearly budget.Selected Accomplishments: • 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 Pharmaceuticals with peak sales of $1.4B.• 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. -
Urology ResidentMedstar Washington Hospital Center 1996 - 1998Washington, Dc, Us -
Surgical ResidentBrown University (Rhode Island Hospital) 1994 - 1996Providence, Ri, Us
Matthew Davis Skills
Matthew Davis Education Details
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Brown UniversitySurgical Residency -
Drexel University College Of MedicineDoctor Of Medicine (Md) -
Temple UniversityBachelor Of Pharmacy (B.Pharm.) -
University Of PennsylvaniaPre-Pharmacy Studies
Frequently Asked Questions about Matthew Davis
What company does Matthew Davis work for?
Matthew Davis works for Aquestive Therapeutics
What is Matthew Davis's role at the current company?
Matthew Davis's current role is Chief Development Officer (CDO).
What is Matthew Davis's email address?
Matthew Davis's email address is md****@****nfo.com
What is Matthew Davis's direct phone number?
Matthew Davis's direct phone number is +144380*****
What schools did Matthew Davis attend?
Matthew Davis attended Brown University, Drexel University College Of Medicine, Temple University, University Of Pennsylvania.
What are some of Matthew Davis's interests?
Matthew Davis has interest in Electronics.
What skills is Matthew Davis known for?
Matthew Davis has skills like Clinical Development, Pharmaceutical Industry, Clinical Trials, Oncology, Pharmacovigilance, Fda, Rheumatology, Medical Affairs, Clinical Research, Medicine, Urology, Dermatology.
Who are Matthew Davis's colleagues?
Matthew Davis's colleagues are Patricia D., Kimberly Lorenz, Anthony Davis, James Wethington, Michael Lattanzi, Michael Hughes, Cpa, Rocio Ibarra.
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