CONSULTING PARTNERS


SAFETY / TOXICOLOGY / REGULATORY

Jim Joly, Ph.D., CEO at Pharma-GPS  
Jim has over 25 years of industry experience managing toxicology and PK development programs. This includes 17 years at Procter & Gamble where he was chief safety assessor, and led technical due diligence on in-licensing deals. Jim advises and provides technical guidance on all preclinical safety and toxicology work at Blue.
 
Janice Lansita, Ph.D., DABT, Practice Leader at ToxStrategies, Inc.  
Janice draws from over 10 years of industry expertise in regulatory toxicology to advise Blue on pharmacology and tox regulatory strategy and planning. From 2009 to 2014, Janice was Pharmacology and Toxicology Reviewer at the U.S. Food and Drug Administration (FDA).
 


CHEMISTRY / CMC

Robert Perni, Ph.D., Principal, JMD Pharma Creativity  
Bob brings to Blue more than 30 years of experience across Big Pharma and Biotech in all aspects of medicinal chemistry/drug discovery research and research management. Specifically, he advises Blue on chemistry outsourcing, small molecule drug design strategy, and evaluation of new chemical entities.
 
Peter Meltzer, Ph.D., Former CEO at Organix, Inc.  
Peter was founder and served for over 30 years as CEO of Organix, Inc., a leading provider of organic chemistry services to biotech and pharmaceutical industries. He lends his decades of expertise in synthetic organic and medicinal chemistry to help guide design and synthesis of new chemical entities at Blue.
 
Anu Mahadevan, Ph.D., CEO at Organix, Inc.  
As CEO and a 20-year veteran of Organix, Inc., Anu supervises organic synthesis efforts for Blue and provides strategic input for our development of new compounds and backup molecules. Additionally, she helps develop scalable synthesis strategies suitable for transition to kilogram-scale GMP manufacturing.
 

CLINICAL DEVELOPMENT

Lynn Webster, M.D., Vice President of Scientific Affairs at PRA Health Sciences  
Dr. Webster is a global leader in the pain drug development space. He is a past president of the American Academy of Pain Medicine with board certifications in pain medicine, anesthesiology and addiction medicine. As part of his career focus on developing safer, more effective therapies for chronic pain, Dr. Webster has led countless clinical trials of experimental analgesics and has developed novel approaches to detect analgesic-evoked disruptions of breathing in the Phase I/II trial setting. Dr. Webster advises Blue on clinical trial design, Phase I analgesic efficacy readouts, human abuse liability assessment and clinical regulatory strategy.
 

BUSINESS DEVELOPMENT / PARTNERING

Jim Dolan, M.B.A., Former SVP, Licensing and BD at Purdue Pharma  
Jim Dolan was formerly Senior Vice President and Head of Business Development at leading analgesics company, Purdue Pharma, where he was responsible for acquisitions, asset purchases, product licenses and discovery alliances. He has a combined 35 years of pharma BD experience, split between Purdue and Pfizer. Jim evaluates all partnership, licensing and acquisition opportunities for Blue and advises on deal strategy and structure.