EXECUTIVE TEAM

Mario Saltarelli MD, PhD

Mario Saltarelli, M.D., Ph.D. – Chief Executive Officer / Chief Medical Officer

Dr. Saltarelli has over 25 years of experience in the biopharmaceutical industry, primarily in senior executive awith extensive experience in anxiety, depression and other CNS disorders, and has led companies through all aspects of clinical development, regulatory approvals, strategic planning and major capital raises and mergers & acquisitions. Dr. Saltarelli was formerly with several market-leading companies including Pfizer, Abbott (AbbVie), Annexon, and Syntimmune.

Dr. Saltarelli earned his bachelor of science degree in psychology from the University of Illinois at Urbana-Champaign, a doctor of medicine degree and a doctor of philosophy degree in neuropharmacology from The Johns Hopkins University School of Medicine. He was an intern in internal medicine at the University of Maryland Medical Center and completed neurology residency at The Johns Hopkins Hospital.

Richard G Farrell

Richard G Farrell – Co-Founder, Chief Financial Officer

Richard is a former Investment Banker with over 25 years of experience in finance, M&A, capital raises and corporate restructures in Australia and the United States. Richard has been founder and CFO of several companies and was formerly an Investment Banker with Beerworth & Partners in Sydney Australia, where he advised on takeovers and private placements. Prior to that, Richard was with Ernst & Young Corporate Finance and formerly Deloitte Touché Corporate Finance. Richard has a BComm. (Australian National University), LLB (Australian National University) and a Graduate Diploma in Finance & Investment from the Financial Services Institute of Australasia.

Kathryn King Ph.D. – Chief Operating Officer

Kathryn King, PhD, is a pharmaceutical industry executive with more than twenty-five years of clinical development achievements at large, global pharma companies and small, start-up biotech organizations. Kathryn has held senior leadership roles at Pathos, Aptinyx, Levo, AbbVie, Takeda, Veeva Systems and Abbott. She is an experienced clinical trialist dedicated to designing and driving innovation in clinical research studies, with the goal of addressing unmet medical needs for patients and their families.  Kathryn brings deep domain expertise in Clinical Operations and complementary strengths in CMC, Quality & Compliance, Regulatory Strategy, Data Management, Statistical Analysis, and cross-functional leadership.  In addition to her current role, Kathryn serves as an Adjunct Instructor in the Graham School at the University of Chicago. She earned a BS in biochemistry (with a second major in Philosophy) from the University of Notre Dame, followed by a MA in Health Care Ethics and a PhD in Philosophy from Loyola University in Chicago.

Olivier Dasse Ph.D.

Olivier Dasse Ph.D. – Co-Founder & Senior VP of Chemistry

Dr. Dasse has 18 years of drug discovery and development experience that resulted in multiple preclinical and clinical candidates. Dr. Dasse co-founded Anvyl LLC, a company focused on the development of nicotinic and gabaergic positive allosteric modulators for the treatment of central nervous system disorders. Dr. Dasse served as program leader at Kadmus pharmaceuticals where he spearheaded medicinal chemistry efforts on inhibitors of fatty acid amide hydrolase, the main enzyme involved in endo-cannabinoid pharmacology. The program was sold to Organon for $270M. Prior to Kadmus, Dr. Dasse served as a senior scientist at UCB pharma where he conducted research on anti-inflammatory chemokine antagonists. Dr. Dasse has co-authored over 30 published scientific publications and patents. Dr. Dasse also served as an instructor/researcher in the French Military Forensics Institute. There, he worked on the development of methods for gun powder residue dating by UV spectroscopy as well as blood print enhancement by luminescence. Dr. Dasse earned his Ph.D. in organic chemistry at Florida State University where he worked on the total synthesis of anti-histaminic natural product steroids. He also earned his diplôme d’ingénieur from Ecole Supérieure de Chimie Organique et Minérale, Paris, France.

Yvonne Sandner CPA MBA

Yvonne Sandner CPA, MBA – Financial Controller (Consultant)

Yvonne has over 20 years of experience in corporate finance including SEC reporting, system implementations, and expatriate assignments. She began her career at the Delphi Energy and Engine Management division of General Motors. After completing an expatriate assignment near Milan, Italy, Yvonne transitioned to start-ups spanning the e-Commerce, pharmaceutical, and SaaS industries. In her capacity as Corporate Controller at Durata Therapeutics, Yvonne led the commercial launch activities as they related to finance. She also led the subsequent transition of activity to Actavis (now Allergan) following its acquisition of Durata.

Yvonne holds a BA in Accounting from Michigan State University, an MBA from DePaul University in Management Information Systems, and is a Certified Public Accountant (IL).

Mary Richardson, PhD DABT

Mary Richardson, PhD DABT – Preclinical Safety, Pharmacology And Toxicology

Mary Richardson is currently Executive Vice President and Chief Scientific Officer at iuvo Bioscience, a Rochester –based R+D contract research organization. She also leads the Lumino Advisors Consulting team at iuvo BioScience and serves as a consultant for both pharmaceutical and medical device programs which involves all aspects of serving as a preclinical representative including creating and executing testing programs, issue management and preparation and defense of regulatory submissions.

She is an experienced board-certified Toxicologist (Diplomate of American Board of Toxicology; DABT) with broad-based technical skills in preclinical drug development. Mary earned her Ph.D. in Toxicology from the University of Rochester.  Prior to her current role, she has held executive leadership positions at Procter and Gamble and Bausch and Lomb.

Her technical leadership in Preclinical drug development of small molecules, peptides, and medical devices has resulted in Regulatory approval and success of numerous drugs and medical devices. She has been an invited speaker at several scientific meetings and is an author on numerous publications.

James Kanter

James Kanter – CMC, API and Drug Product Consultant

James Kanter is a CMC/Regulatory Affairs consultant with 30+ years of international experience within the biotech and pharmaceutical industry focusing on small molecule compounds across multiple indications including oncology, anti-viral, anti-biotic, anti-coagulant, gastrointestinal, neurodegenerative and pain therapeutics.   James has been responsible for managing all aspects of the drug substance and drug product activities from pre-clinical compound selection through clinical trials and into commercialization.  This has included supply chain and logistics risk mitigation and global launch strategies.  James has played a significant role in  > 50 IND/IMPD filings and seven successful NDA submissions including a recent approval in an orphan disease accelerated/break through designated program. He has worked with regulatory authorities in multiple worldwide jurisdictions including the FDA, MHRA, AIFA, Swiss Medic, KFDA, PMDA, ANVISA and Health Canada among others.   Before moving to consulting fulltime James recently served as the VP of Development at Bridgebio managing the CMC activities of several subsidiary companies.  Previous to Bridgebio, he held roles of increasing responsibilities in CMC/Pharmaceutical Sciences at Ardelyx, Portola and Gilead Sciences.  James received his BSc and MSc degrees in Organic Chemistry from the University of Toronto.  He is also a coauthor of > 25 papers and patents.

Dawn Toronto PhD

Dawn Toronto, Ph.D. – CMC, Regulatory Affairs and Analytical Consultant

Dr. Dawn Toronto is a CMC/QC and regulatory affairs consultant with 25 years of international experience within the pharmaceutical industry. Throughout her career, she has been responsible for developing the quality control strategy for more than 50 clinical drug candidates and has contributed to the development of several commercially approved drugs. She has worked with regulatory health authorities including FDA and Europe National Competent Authorities (ANSM, BfArM, FAMHP, SUKL, FIMEA, MHRA) and across multiple indications such as oncology, UI, CNS, neurodegenerative disorders, sensorineural disorders, IBSC, ESRD.  In the last 5 years she has collaborated on several accelerated path pediatric development programs which have received ultra-rare and orphan designation from the FDA.  Dr. Toronto’s education includes a pH in Chemistry from UC Davis and two post-doctoral fellowships in French research institutions.

Dennis E. Burns

Dennis E. Burns – Business Advisor

Dennis is a distinguished biotech and pharmaceutical executive, with over 30 years of international experience. Dennis was formerly Global Head of Business Development for Roche Pharmaceuticals. Prior to that he was Vice President, New Product Planning, Business Development and Strategic Planning for Roche’s US operations. During his 22-year tenure with Roche, Dennis held positions which include: sales, sales management, marketing research, product management, international product management, marketing, therapeutic area strategy, portfolio planning, new product planning, licensing and acquisitions. Dennis is currently President of PharmaSavv-e, LLC, a consulting organization serving an international client base in the fields of pharmaceuticals, biotechnology and investment. Dennis graduated from the University of New Mexico (UNM) with a degree in Pharmacy and completed an MBA with concentrations in finance and international business from the University of Hawaii. In 2007 Dennis was honored as the UNM College of Pharmacy’s Distinguished Alumnus of the Year. From 2008 through 2012 Dennis served on the University of New Mexico Foundation Board of Directors.

Curt Scribner, MD – Regulatory

Dr. Scribner has more than 25 years of drug development and regulatory affairs experience, specializing in biotechnology. He was previously Senior Vice President of Medical and Regulatory Affairs at RRD International, LLC, and Vice President of Regulatory and Quality Affairs and Chief Regulatory Officer at Intarcia Therapeutics. Previously, Dr. Scribner was Chief Regulatory Consultant for Quintiles Consulting, where he developed and wrote numerous regulatory applications for the FDA and European regulatory agency, EMA. Prior to Quintiles Consulting, Dr. Scribner spent 10 years at FDA, where he held a variety of positions and was involved in reviewing products regulated by the Center for Biologics. Dr. Scribner holds an MD from the University of Colorado College of Medicine, and completed a rheumatology fellowship at National Institute of Health. He holds an MBA from the University of Maryland College of Business and Management, and a BA in biology from Grinnell College.