Who We Are
Emalex Biosciences is a biopharmaceutical company dedicated to the development of new and novel treatments for patients with central nervous system disorders who have limited or no treatment options. Emalex is headquartered in Chicago, Illinois.
Our Commitment
At Emalex, we are committed to improving patients’ lives by providing novel treatments to patients with rare diseases which have limited or no treatment options. We partner with patient advocacy organizations to raise awareness of rare diseases, support their outreach efforts and communicate with patients and caregivers.
Leadership
Eric Messner – Chief Business Officer
Eric Messner is Chief Business Officer at Emalex Biosciences. Mr. Messner is also Senior Vice President of Business Development at Paragon Biosciences, where he advises early-stage portfolio companies on their commercial operations and completes due diligence for new investment opportunities. He came to Paragon with a long and successful career in the pharmaceutical industry.
Mr. Messner previously served as CEO of Anagin, LLC, which develops drugs for post-traumatic stress disorder and traumatic brain injury. He also served as General Manager & Executive Vice President of Sales and Marketing for OPKO Health, where he had commercial responsibility for the renal division and urology laboratory division. Earlier in Mr. Messner’s career, he was a founder & Vice President of Marketing and Commercial Operations of Proventiv Therapeutics, which was acquired by Cytochroma. At Cytochroma, he was Vice President of Commercial Operations and later the Chief Operating Officer and helped lead the sale of Cytochroma to OPKO Health. Mr. Messner also previously held senior marketing roles at Bone Care International and Abbott Laboratories.
Mr. Messner earned his MBA from the Kellogg School of Management at Northwestern University and his Bachelor of Science in Business Administration from Miami University.
Atul Mahableshwarkar, M.D. – Senior Vice President of Drug Development
Dr. Atul Mahableshwarkar leads the Clinical Affairs, Pharmacovigilance, Regulatory Affairs and Quality Assurance divisions at Emalex Biosciences.
Dr. Mahableshwarkar is a board-certified adult psychiatrist who was formerly an Associate Professor and Vice Chair of the Department of Psychiatry and Behavioral Sciences at the Chicago Medical School of Rosalind Franklin University. Previously, he also led mental health services at the former North Chicago VA Medical Center, providing care to patients with psychiatric disorders.
Dr. Mahableshwarkar has nearly two decades of drug development experience. Prior to joining Emalex, he served as Vice President of Clinical Development at Revance Therapeutics and BlackThorn Therapeutics; Senior Medical Director at Takeda Development Center Americas; as well as Director of Clinical Development at GlaxoSmithKline and Janssen Pharmaceuticals. Dr. Mahableshwarkar has designed and conducted global clinical trials in Alzheimer’s disease, anxiety disorders, bipolar disorder, major depression, Parkinson’s Disease and schizophrenia and led the development program resulting in the approval of a novel antidepressant. He is a founding member of the International Society for CNS Clinical Trials and Methodology (ISCTM) and the CNS Summit.
Dr. Mahableshwarkar is a graduate of the Armed Forces Medical College in India and completed a residency in adult psychiatry and a fellowship in neuropsychiatry at the Chicago Medical School of Rosalind Franklin University.
Jay White, Ph.D. – Vice President, Chemistry, Manufacturing and Controls (CMC)
Jay White serves as the Vice President of Chemistry, Manufacturing and Controls (CMC) at Emalex Biosciences. He oversees all aspects of drug substance and drug product research and development.
Dr. White has over 20 years of experience in pharmaceutical product development, including CMC and non-clinical activities. Previously, he served as Vice President, Product Development at OPKO Health Inc., Renal Division. Prior to that, Dr. White held various positions at Cytochroma Inc. over a 16-year period, including Vice President, Product Development and Vice President, Operations. During his tenure at Cytochroma and OPKO Health, Dr. White oversaw all aspects of the CMC and non-clinical programs for Rayaldee® extended-release capsules, which were approved by the FDA in 2016 for treatment of Secondary-Hyperparathyroidism in Stage 3 & 4 Chronic Kidney disease patients with Vitamin D deficiency.
Dr. White holds a B.Sc. in Biology from McMaster University and earned his Ph.D. in Pathology from Queen’s University.
David Kim – Senior Director, Clinical Operations
David Kim serves as the Senior Director of Clinical Operations at Emalex Biosciences. He is responsible for managing all operational aspects of the clinical development program.
Mr. Kim has over 27 years of experience in the pharmaceutical industry, beginning his career at Abbott Laboratories as a scientist. Previously, he served as Associate Director at Takeda, where he led the Clinical team in submission of New Drug Applications (NDAs). He also served as a Director of Clinical Operations at Baxter, where he led the formation of the Clinical Operations team in their Deerfield, IL and Beltsville, MD offices. He served the last seven years as Director of Project Management and Director of Clinical Trial Management at ICON Clinical Research in rare diseases, anti-infectives and oncology therapeutic areas.
Mr. Kim holds a Bachelor of Science degree from the University of Illinois at Urbana-Champaign.
Research & Development Advisory Board
Timothy Cunniff, PharmD – Executive Vice President, Research & Development
Tim Cunniff leads the Emalex Clinical Advisory Board and serves as Executive Vice President of Research & Development at Paragon Biosciences. He oversees all scientific and regulatory matters associated with new product development, approval, and maintenance, across portfolio companies as needed. He is also a Clinical Instructor of Pharmacy at the University of Michigan College of Pharmacy.
Dr. Cunniff has nearly 30 years of experience in clinical development, pharmacovigilance, quality assurance and regulatory affairs. Previously, he served as Executive Vice President of Research & Development at Marathon Pharmaceuticals. He also served as Vice President of Global Regulatory Affairs at Lundbeck/Ovation Pharmaceuticals, as well as Interim President at Lundbeck. Prior, Dr. Cunniff was Senior Director of Regulatory Affairs at Abbott Laboratories, Agouron/Pfizer, and Warner-Lambert/Parke-Davis. He is also a Member of the Dean’s Advisory Board at the University of Michigan College of Pharmacy and a past advisor at Aquarius Biotechnologies.
Dr. Cunniff holds a Doctor of Pharmacy degree from University of Michigan College of Pharmacy.
Jenny Swalec – Vice President, Regulatory Affairs
Jenny Swalec serves as Vice President of Regulatory Affairs at Paragon Biosciences, where she is responsible for regulatory submissions and interactions with global health authorities, across portfolio companies as needed.
Ms. Swalec has over 25 years of regulatory affairs experience. Previously, she was Vice President of Regulatory Affairs at Castle Creek Pharmaceuticals, a Paragon portfolio company. Ms. Swalec served in the same role at Marathon Pharmaceuticals and as Senior Director of Global Regulatory Affairs at Lundbeck. She began her career as Manager of Regulatory Affairs at Parke Davis.
Ms. Swalec earned her bachelor’s degree from Eastern Michigan University in both biology and chemistry.
Stephen Wanaski, PhD – Vice President, Research & Exploratory Development
Dr. Stephen Wanaski serves as Vice President of Research & Exploratory Development at Paragon Biosciences, overseeing the pharmacology/toxicology and clinical pharmacology development activities for drug candidates across portfolio companies as needed.
Dr. Wanaski brings a wealth of experience to Paragon including orphan drug development of small and large molecules from discovery through late stage clinical studies and approval.
Previously, Dr. Wanaski served as Vice President of Research & Exploratory Development at Castle Creek Pharmaceuticals, a Paragon portfolio company. He held the same role at Marathon Pharmaceuticals playing an integral role in the development and FDA approval of Emflaza® for the treatment of Duchenne muscular dystrophy. Prior to Marathon, Dr. Wanaski was VP, Research & Development at NeuroTherapeutics Pharma and led scientific and drug discovery efforts of the "virtual" Series A funded company into clinical development and helped to secure over $43MM in Series B venture investment. He led preclinical and clinical pharmacology development at Ovation Pharmaceuticals (acquired by Lundbeck) and was responsible for late-stage NDA-enabling activities for four, first-cycle NDA approvals in various CNS indications (Sabril® for treatment of refractory complex partial seizures and infantile spasms, Onfi® for the treatment of Lennox-Gastaut syndrome, and Carnexiv® as intravenous replacement therapy for oral carbamazepine). He also worked at an oncology-based biotech company, NeoPharm, across various departments with responsibilities ranging from drug formulations and bioanalytical to translational medicine and biomarker development.
Dr. Wanaski received a B.A. from the University of Notre Dame and earned his Ph.D. in biochemistry from the University of Illinois in Urbana-Champaign.