Joshua TarnoffDirector, President and Chief Executive Officer
Mr. Tarnoff joined Complexa in 2011 as Director, President and Chief Executive Officer. Mr. Tarnoff brings nearly 30 years of pharmaceutical experience to his leadership of Complexa. He has built and led businesses within large pharma and biotechnology companies, as well as multiple early stage start-ups. His most recent roles include serving as CEO of JDP Therapeutics, CEO of Houston Pharma (and its subsidiary Potomac Pharma), and CCO at ViroPharma. One of his many roles within large pharma was leading a $1.5 billion U.S. business unit at AstraZeneca. He is a recognized industry leader for his expertise in creating successful management teams, building start-up companies, strategic planning and corporate development. Mr. Tarnoff also has a strong record of a series of capital raises. With a career that advanced within the executive ranks of the commercial and operations side of the industry, he brings a unique set of skills that blend clinical and business development activities that lead to successful exits. Mr. Tarnoff received a bachelor’s degree in Biology from LaSalle University. He is also currently a board member of several early stage healthcare companies.
Federica F. O’Brien, CPAChief Financial Officer
Ms. O’Brien brings 30 years of financial and operational leadership for both public and private companies to Complexa. Ms. O’Brien has held a management role at multiple life science companies including Barrier Therapeutics, Cardiokine, Inc, Cervilenz Inc, and Cerecor Inc. Ms. O’Brien has been key to raising capital and readying companies for the public markets. Most recently at Cerecor, Ms. O’Brien was instrumental in a $32 million Series B financing. While at Cervilenz, in addition to raising capital, Ms. O’Brien led the expansion of the patent portfolio worldwide and was influential in obtaining CE marking and ISO 13485 certification for a women’s healthcare device. Previously, Ms. O’Brien was Chief Financial Officer of privately-held Cardiokine Inc., a biotechnology company developing compounds for the treatment and prevention of cardiovascular disease. She helped raise $87 million of venture funding and played a central role in establishing a collaboration agreement which provided Cardiokine with significant funding for development. During 2004, Ms. O’Brien was integral to the IPO at Barrier Therapeutics, where she served as Controller. Earlier in her career, she was Chief Financial Officer of Infonautics, Inc, a publicly held technology based company, and began her career in public accounting, most recently at Coopers & Lybrand (PWC).
Carla Chieffo, VMD, PHDExecutive Director Clinical Operations
Dr. Carla Chieffo recently joined Complexa in 2014 as the Executive Director Clinical Operations reporting the companies CMO. Dr. Chieffo has extensive industry clinical research experience having worked in the pharmaceutical industry for over 18 years. She has lead projects from preclinical toxicology stage through regulatory approval including marketed products. She has expert knowledge in the area of clinical trial design and operational oversight.

Dr. Chieffo received her VMD degree from the University of Pennsylvania Veterinary School. After several years in clinical practice she completed a residency in medical genetics, pediatrics and reproduction. She received her PhD in molecular biology at the University of Pennsylvania isolating the causative gene for DiGeorge Syndrome. She has extensive experience in both large and mid-sized pharmaceutical companies. She joined Pfizer Animal Health in 1998 and transitioned to Pfizer Human Health in 2002 working in early phase clinical development. She later joined GlaxoSmithKline in their Center of Excellence in Drug Discovery and was responsible for the Phase I-IIb programs within the urology and renal disease portfolios. She led the biomarker team where the focus was on validation of “new” biomarkers for progression and treatment of disease with an emphasis on the utilization of gene/protein expression profiling. She implemented imaging modalities for use in clinical trials for early go/no go decisions.
She held positions at ENDO and Janssen Pharmacuetical Companies and most recently with Auxilium Pharmacueticals. She has been responsible for providing strategic as well as clinical and operational expertise for several clinical development programs, US and globally, working across several therapeutic areas including endocrinology, urogenital, CNS, oncology, hematological, renal disorders, inflammation and rare disease (orphan drugs).

When she is not working, she is active within her community as a Rotarian and as a consultant for University of Pennsylvania School of Veterinary Medicine.

John E. Dillberger, DVM, PhD Diplomate ACVP and ABT, Fellow IATP Toxicology and Regulatory Affairs
Dr. Dillberger provides strategic toxicological and regulatory oversight for all Complexa programs. He is the president of J. Dillberger, LLC, a nonclinical development consulting company specializing in the application of toxicology, pathology, and pharmacology expertise to the safety evaluation of drugs, biologics, medical devices, imaging agents, diagnostic agents, and combination products. Over his 26 years in the industry, Dr. Dillberger has held positions of increasing responsibility at Marion Merrell Dow, GlaxoWellcome, and Triangle Pharmaceuticals. He served as Head of USA Pathology, Director of Safety Evaluation for USA-Based Development Projects, and Worldwide Specialist in Oncology Drug Projects for GlaxoWellcome and as Director of Toxicology at Triangle Pharmaceuticals. Dr. Dillberger has prepared or helped prepare safety evaluation packages for numerous clinical trial and marketing applications in the USA and Europe, including the successful NDAs for Coviracil®, Kapvay®, and Northera™, and CTDs for Thelin™ and Tyvaso®. Dr. Dillberger received his DVM degree from Iowa State University in 1979, completed a 3-year residency in Comparative Pathology at the University of Miami School of Medicine and the Papanicolaou Cancer Research Institute in 1986, and received a PhD degree in Pathology and Environmental Toxicology from Michigan State University in 1989 for research into the molecular mechanisms of carcinogenesis. He was certified in Veterinary Pathology by the American College of Veterinary Pathologists in 1987 and in Toxicology by the American Board of Toxicology in 1992. In 2001, he became one of a handful of pathologists accepted as a fellow in the International Academy of Toxicologic Pathology, and he served as Treasurer for the organization from 2006 to 2012. He is the author of numerous scientific papers and a book chapter entitled “Nonclinical Development of Drugs and Biologics: Pharmacology and Toxicology,” serves as reviewer for Antimicrobial Agents and Chemotherapy, and has served two terms on the editorial board of Veterinary Pathology.
Bruce Rehlaender, PhDFormulation Development and Manufacturing
Dr. Rehlaender has been leading the Complexa Product Development effort for >2 years as an expert in bioavailability optimization, formulation of poorly soluble drugs, lyophilized product development, and particle size analysis.Dr. Rehlaender has over 20 years experience in pharmaceutical research and development, primarily in the arena of formulation development. He has worked with both small and large molecules and has developed products for oral, parenteral, topical, pulmonary, intranasal, and intrauterine delivery. His areas of expertise include bioavailability optimization, formulation of poorly soluble drugs, lyophilized product development, and particle size analysis. Dr. Rehlaender also has extensive experience in process development, including lyophilization and sterilization cycle development, and in the overall manufacturing of clinical and commercial drug products.
Francisco Schopfer, PhD, MBAPharmacology
Dr. Schopfer is a biochemist and pharmacologist, currently serving as an Associate Professor at the Department of Pharmacology and Chemical Biology, University of Pittsburgh School of Medicine. After obtaining a PhD from the University of Buenos Aires, Argentina in 2001, he continued his post-doctoral studies at the University of Alabama at Birmingham with Dr. Freeman. He became a faculty member at the University of Pittsburgh in 2006 and also received an MBA in Entrepreneurship and Start-ups in 2011 from the University of Pittsburgh School of Business. Dr. Schopfer brings to the scientific founders and Complexa his vast knowledge in lipid mediators, ranging from analytical methods to biochemistry, cell biology and animal models of disease. In addition to his basic research program, he serves as a liaison between academic lab-based advances and their commercialization by Complexa. His laboratory effort focuses on identifying and characterizing both the structure and function of reactive mediators of inflammation. He has over 60 high- impact publications, is an inventor on several patents and has made seminal contributions to the area of electrophilic fatty acid identification, synthesis and their signaling actions. This includes the description of the in vivo formation of nitrated fatty acids and their therapeutic utility in controlling and resolving acute and chronic inflammatory processes. Dr. Schopfer works as a consultant with the Development Team, led by Michelle Higgin, advising on electrophilic lipid synthesis, identification and pharmacology, the platform technology being developed by Complexa.
Diane K. Jorkasky, M.D., F.A.C.P.Chief Medical Officer and Head of Development
Dr. Jorkasky is a highly regarded medical scientist and researcher in the pharmaceutical industry with a broad background across research and all phases of clinical development in every therapeutic area. She has played a seminal role in developing nitro-fatty acid signaling technology for treatment of inflammatory, fibrotic and metabolic diseases. She also sits on the Board of Directors of Tengion Inc., a regenerative medicine company, and Q Therapeutics, a CNS regenerative medicine company, as well as the Strategic Advisory Board of BioMotiv. Her broad experience includes positions as Head of Development and Chief Medical Officer at Endo Pharmaceuticals, with involvement in the development of drugs, devices and generics, and Aileron Therapeutics in Cambridge, Massachusetts. Prior to these appointments she had been at Pfizer in New London, CT where she had held several leadership positions in development, with the most recent being Vice President of Global Clinical Research Operations. She led the complete alignment of the three Pfizer Clinical Research Units, located in the US, Europe and Asia, which led to being awarded certification by American Accreditation for Human Rights Protection Policies for their clinical research process, the first in industry to achieve such a recognition. Dr. Jorkasky has been vice president of Clinical Pharmacology at SmithKline Beecham, chief of the renal division at Presbyterian Medical Center and faculty member at the University of Pennsylvania School of Medicine, where she had received her medical degree and did her nephrology fellowship. Dr. Jorkasky is a member of the Connecticut Academy of Science and Technology. She has been recognized by the Connecticut Women’s Hall of Fame for her scientific leadership and mentoring of young women and the Connecticut Council on Technology for her leadership in driving the creative technological advances in Pfizer’s clinical research units. Dr. Jorkasky is board certified in internal medicine, nephrology and clinical pharmacology. She has been on the faculties of UCSF, Yale, Penn and Uniformed Service of Health Sciences Medical Schools. She has published over 100 peer review articles and teaches internationally on drug development. Recently Dr. Jorkasky was selected to be a Woodrow Wilson visiting fellow. The College of Wooster, where she obtained her undergraduate degree in chemistry, has honored her with the Distinguished Graduate award in 2013.
Kathleen M. Shay, EsquireGeneral Counsel
Kathleen M. Shay, a partner at the law firm of Duane Morris LLP, is a corporate and securities lawyer who focuses her practice on the life science industry, representing public and private biopharmaceutical, medical device and diagnostic companies, healthcare information technology and services companies, venture capital funds and other investors in the life science and healthcare industries, academic and research institutions, and life science industry collaborators and service providers. Ms. Shay represents both established and emerging businesses in a wide range of legal transactions and issues, including debt and equity financings, structuring transactions, licenses and strategic relationships, mergers and acquisitions, governance matters, and employment and compensation issues. Ms. Shay received her B.A. from Villanova University and her J.D. from Villanova University School of Law, where she served as Editor-in-Chief of The Villanova Law Review. Ms. Shay also serves on the Board of Directors of Pennsylvania Bio, the Philadelphia Alliance for Capital and Technologies (PACT) and the Board of Consultors of Villanova Law School and is a Trustee Emeritus of the Academy of Notre Dame de Namur. She is an Advisory Board member and former director of the Alliance of Women Entrepreneurs (AWE) and has served as AWE’s counsel since its inception. She previously served as a director of the Philadelphia Chapter of the Association for Corporate Growth and the Chair of the Executive Committee of the Business Law Section of the Philadelphia Bar Association and is a past-Chair of the Securities Regulation Committee. She is also an active member of the Pennsylvania Biotechnology Association. Duane Morris LLP, among the one hundred largest law firms in the nation, is a full service firm of approximately 750 lawyers. The firm represents clients across the United States and around the world through its offices in the United States, London and Asia, and relationships with two international networks of independent law firms.
Michelle Higgin, PhDDirector of Drug Development Operations
Dr. Higgin has a PhD from the University of Wisconsin in Biochemistry and heads the drug development firm PharmaDirections. She has been working with Dr. Jorkasky to lead the Complexa Drug Development team for >2 years through IND-enabling studies on IV CXA-10 formulations and now the ongoing CMC and preclinical activities to support additional oral and IV drug development programs. Michelle began her pharmaceutical career 20 years ago when she worked in labs at Johnson and Johnson in Raritan, NJ. For the last 10 years, Dr. Higgin has held a wide range of positions and focused her expertise on strategic program management for virtual biotech companies. She enjoys applying her breadth of experience into organizing multi-functional and milestone-focused teams. Dr. Higgin has led many full IND-enabling programs, as well as nonclinical and CMC programs during clinical development.
Thomas B. Grizzle, MS, DABT, DSP Preclinical Operations
Thomas B. Grizzle, MS, DABT, DSP, has been serving as a toxicology/pharmacokinetic drug development expert for the last twelve years in a variety of positions. Prior to that, Mr. Grizzle was employed as a senior toxicologist in two small pharmaceutical companies where he gained drug development experience developing ion channel modulators and antiviral drugs. He also possesses >12 years of experience in the CRO industry, initially as technician, then as a toxicology and pharmacokinetic laboratory supervisor and study director, plus two years of experience in a neurotoxicology laboratory. Mr. Grizzle has extensive knowledge of toxicology, pharmacokinetics, safety pharmacology and of the CRO industry itself, and possesses expertise in designing, placing, managing, interpreting, and reporting outsourced GLP-compliant toxicology, safety pharmacology, ADME, carcinogenicity and bioanalytical studies.
Jay Breaux, PhD, RACChemistry and Analytical Development
Dr. Breaux is a drug development expert with a strong background in medicinal chemistry and regulatory affairs. He joined PharmaDirections in 2008 and is now a senior drug development expert with more than 20 years’ experience working with both innovators and contract research organizations. His primary focus is in the areas of Chemistry, Manufacturing and Controls (CMC) project coordination and CMC regulatory affairs. Before joining PharmaDirections, Dr. Breaux worked as a Director of Medicinal Chemistry at King Pharmaceuticals and as a Senior Director of Analytical Chemistry at AAI Pharma. In addition, he previously worked at Cato Research and Aventis as a CMC expert. Dr. Breaux has led project teams and functioned as a CMC expert on a variety of discovery and development projects. Dr. Breaux has authored and reviewed CMC and other sections of INDs, NDAs, BLAs and other regulatory submissions. He has participated in FDA meetings and authored responses to FDA questions. Dr. Breaux currently holds the Regulatory Affairs Certification and was recertified in 2008.