Matthew W Davis, MD, RPh

Seasoned C-suite biotech and pharmaceutical executive with 25+ years experience leading clinical development, regulatory strategy, and medical affairs across startups and large pharma.

Contact: mwd@mwdavis.llc   |   +1 (267) 261-5882

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Patents

17 current Orange Book-listed patents.

Transactions

Experienced in structuring partnerships, financings and exit strategies (including a $3.2B transaction).

About

Drawing on 25+ years of leadership across startups, mid-sized biotech, and large pharmaceutical companies, MWDavis LLC provides strategic consulting in clinical development, regulatory interactions (FDA strategy), program prioritization and partnering to accelerate time-to-market while managing risk and cost.

Proven track record securing FDA agreement and approvals, delivering program-focused cost reductions while preserving R&D integrity, and driving novel lifecycle management.

Quick Facts
Profile Photo
  • Location: Malvern, PA
  • License: NY Medical License 237105 (Active)
  • Education: MD (Drexel), BSc Pharmacy (Temple)
  • Patents: 17 Orange Book-listed

Services

Tailored consulting services for biotech and pharma sponsors, investors and partners.

Regulatory Strategy & FDA Engagement

Design FDA meeting strategy, pathway selection, and agree clinical endpoints and trial designs to de-risk development and accelerate approval.

Clinical Development & Operations

Full-program design from Phase 1 to 4, vendor selection, FSP models, trial design and execution oversight.

Business Development & Partnering

Due diligence, term-sheet negotiations, investor introductions, and lifecycle/opportunity assessment.

Experience (Selected)

Chief Medical Officer - Neuvivo (Palo Alto)

2024 - Present

Advanced stalled NP001 regulatory pathway dramatically accelerating potential time-to-market, focusing on ALS & neuroinflammation programs.

Chief Operating Officer - Tiziana Life Sciences (London)

2022 - 2024

Oversaw clinical, regulatory and CMC. Reprioritized pipeline toward neuroinflammation delivering $12M first-year cost savings and restored NASDAQ compliance.

Chief Medical Officer - Endo Pharmaceuticals (Malvern)

2017 - 2022

Restructured R&D saving $40 million, implemented FSP models, and secured BLA approval for QWO®.

Chief Medical Officer - URL Pharma and Lupin

2005 - 2016

Led approvals (eg. Colcrys®, Impleko®, Solosec®), M&A activity, and multiple successful regulatory negotiations and filings.

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Approvals

Selected NDA, BLA, and PMA approvals.

NDA
BLA
PMA

Patents

Patent Name Timeline
US 7,906,519 Concomitant administration of colchicine Filed: Aug 18, 2010 → Granted: Mar 15, 2011 (6.9 mo)
US 7,915,269 Concomitant administration of colchicine Filed: Aug 18, 2010 → Granted: Mar 29, 2011 (7.1 mo)
US 7,601,758 Colchicine dosing & drug interactions Filed: Feb 17, 2009 → Granted: Oct 13, 2009 (8.0 mo)
US 7,820,681 Methods for prophylaxis of gout flares Filed: Feb 17, 2009 → Granted: Oct 26, 2010 (8.3 mo)
US 8,415,395 Ultrapure colchicine compositions Filed: Apr 19, 2012 → Granted: Apr 9, 2013 (11.7 mo)
US 8,440,721 Concomitant administration - dosing guidance Filed: Apr 19, 2012 → Granted: May 14, 2013 (13.0 mo)
US 7,935,731 Colchicine dosing during macrolide therapy Filed: Feb 17, 2009 → Granted: May 3, 2011 (14.4 mo)
US 7,619,004 Methods for concomitant administration - macrolides Filed: Jul 22, 2008 → Granted: Nov 17, 2009 (16.8 mo)
US 7,981,938 Colchicine compositions and methods Filed: Jan 14, 2010 → Granted: Jul 19, 2011 (17.2 mo)
US 8,093,297 Concomitant administration of colchicine (ketoconazole/ritonavir) Filed: Jan 15, 2010 → Granted: Jan 10, 2012 (24.0 mo)
US 8,093,296 Concomitant administration - clinical methods Filed: Jan 14, 2010 → Granted: Jan 10, 2012 (24.0 mo)
US 8,097,655 Drug interaction alerts / dispensing warnings Filed: Jan 15, 2010 → Granted: Jan 17, 2012 (24.1 mo)
US 7,964,648 Concomitant administration dosing methods Filed: Oct 6, 2008 → Granted: Jun 21, 2011 (26.5 mo)
US 7,964,647 Ultrapure colchicine compositions Filed: Oct 6, 2008 → Granted: Jun 21, 2011 (26.5 mo)
US 8,093,298 Methods related to colchicine and macrolides Filed: Aug 21, 2009 → Granted: Jan 10, 2012 (28.6 mo)
US 8,415,396 Colchicine compositions & methods Filed: Jan 14, 2010 → Granted: Apr 9, 2013 (38.7 mo)
US 8,440,722 Drug-drug interaction alert systems Filed: Jan 15, 2010 → Granted: May 14, 2013 (40.0 mo)

Selected Publications

Key peer-reviewed publications (selected).

Arthritis & Rheumatism (2010) - Cited by 687 articles.

High Versus Low Dosing of Oral Colchicine for Early Acute Gout Flare: Twenty-Four-Hour Outcome of the First Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Comparison Colchicine Study.

Terkeltaub RA, Furst DE, Bennett K, Kook KA, Crockett RS, Davis MW. Arthritis Rheum 2010. PubMed / DOI

Arthritis & Rheumatism (2011) - Cited by 281 articles.

Novel evidence-based colchicine dose-reduction algorithm to predict and prevent colchicine toxicity in the presence of cytochrome P450 3A4/P-glycoprotein inhibitors.

Terkeltaub RA, Furst DE, Digiacinto JL, Kook KA, Davis MW. Arthritis Rheum 2011. PubMed / DOI

Annals of Pharmacotherapy (2002) - Cited by 160 articles.

Pharmacokinetics and Tolerability of Lidocaine Patch 5% with Extended Dosing.

Gammaitoni AR, Davis MW. Ann Pharmacother 2002. PubMed / DOI

Pain Medicine (2002) - Cited by 123 articles.

Lidocaine Patch 5% Reduces Pain Intensity and Interference with Quality of Life in Patients with Postherpetic Neuralgia: An Effectiveness Trial.

Katz NP, Gammaitoni AR, Davis MW, Dworkin RH. Pain Med 2002. PubMed / DOI

Advances in Therapy (2011) - Cited by 51 articles.

Unapproved drugs in the United States and the Food and Drug Administration. Nasr A, Lauterio TJ, Davis MW. Adv Ther 2011. PubMed / DOI

Contact

Interested in regulatory strategy, clinical program rescue, partnering, or board-level advisory? Reach out via email or phone and I'll reply promptly.