Contact

info@syndevrx.com

1 Broadway # 14, Cambridge, MA 02142

SynDevRx is led by biotech veterans with deep experience in drug development, corporate governance, operations, finance and business development.

They take pride in running an innovative, results-oriented business in a cash-efficient manner. Since launching the company in 2007, the co-founders have surrounded themselves with a dedicated team of brilliant people who share their passion for bringing life-changing therapeutics to market.

Bradley Carver

Co-Founder, Chairman of the Board, President and Chief Executive Officer

Brad has over 20 years of experience as a biotech senior executive and has led teams that have developed and advanced two novel cancer drugs deep into clinical trials.

Prior to SynDevRx, Brad was president (1993-2006), CEO (2000-2006), chairman of the board (2003-2006) and director (1993-2006) at GlycoGenesys (Russell 2000 and NASDAQ). Under his leadership, the company raised over $80 million in equity financing and co-development funding, completed a partnership deal with Elan Pharmaceuticals, developed one of the first complex carbohydrate cancer drug candidates to be tested clinically and conducted five clinical trials in cancer patients. He grew GlycoGenesys to over 55 employees at its peak, including a subsidiary that developed novel products for the agricultural, consumer and industrial markets.

Brad earned a B.A. degree from the College of Business at Michigan State University.

James M. Shanahan

Co-Founder, Vice President of Business Development and Director

Jim has nearly two decades of business development experience with biotech and technology companies.

In 1998 Jim co-founded JAM Technologies, a fabless semiconductor company serving the consumer electronics and specialty electronics markets, where he served as vice president of corporate development (1998-2006) and on the board of directors (1998-2003). There, he focused on fundraising, executing licensing transactions and forming strategic co-development partnerships, including with AKM, Intel and Apple. Since 2014, he has served as a consultant to Ariana Pharmaceuticals, which provides healthcare data analytics to the pharmaceutical and biotech markets.

Jim is a founding member of the French-American Biotech Springboard, a professional association working under the auspices of the French-American Chamber of Commerce. He is also an active coach and mentor to numerous startups in the Boston area. Jim has three issued patents, studied engineering and French at the University of Massachusetts Amherst and attended L’Universite Catholique (Angers, France) in 1983.

Operations

SynDevRx operates using a semi-virtual business model, outsourcing certain functions to trusted partners in order to maintain a lean organization.

These individuals round out our team by lending their expertise in areas such as medical monitoring, clinical trial execution, finance, business strategy and regulatory strategy.

Neal Salomon, M.D.

Consulting Chief Medical Officer and Medical Monitor

Dr. Salomon has been a medical consultant to pharmaceutical companies, biotechs and clinical research organizations (CROs), advising startups on all aspects of early-phase clinical development. He has also provided protocol development, medical monitoring and pharmacovigilance for numerous Phase 1, 2 and 3 clinical trials, including companies such as Diacrin, Genvec, Mytogen, TMI, Tokai, Cordis and Grifols, and CROs such as PAREXEL International, RPS, SciLucent and CROfessionals.

A clinical and academic cardiovascular/thoracic oncologic surgeon, Dr. Salomon graduated from New York University and then Albert Einstein College of Medicine (Alpha Omega Alpha honors). He did his surgical training at the University of Colorado and Stanford University Medical Center, which included a year as a postdoctoral research fellow. Next, he spent four years on the surgical faculty at the University of Arizona Health Sciences Center, Tucson, and helped establish the state’s first heart transplant program. After a decade in private practice in Portland, Ore., he was recruited to the faculty of Johns Hopkins Medical Center in Baltimore.

Dr. Salomon has been a board member at Chesapeake Research Review, a highly respected, internationally established institutional review board covering all elements of human subject protection in clinical trials. He has also served on a number of data and safety monitoring boards and was founder, coordinator, lecturer and physician mentor at the Johns Hopkins University pre-professional post-baccalaureate program and mini-medical school. He has authored 60+ scientific papers and presented basic and clinical research in 80+ professional presentations.

Peter Cornelius, Ph.D.

Senior Director, Translational Research

Dr. Cornelius earned his B.A. in biology from Skidmore College and his Ph.D. in biochemistry from East Carolina University School of Medicine, where he studied the regulation of lipid and glucose metabolism by inflammatory cytokines. Following postdoctoral work at Johns Hopkins University School of Medicine, where he studied the development and function of adipose cells, he joined the Department of Cardiovascular & Metabolic Diseases at Pfizer. During his career at Pfizer (1995-2011), he initiated numerous projects and led successful teams that identified clinical candidates targeting diverse pathways impacting dyslipidemia, obesity and type 2 diabetes.

Prior to joining SynDevRx in 2015, Dr. Cornelius held senior positions at two startup biotech companies, SystaMedic and Wellomics, where he made significant contributions to each company’s pipeline. Throughout his career, he has published extensively in peer-reviewed journals and presented frequently at both national and international conferences.

David Neafus, MBA, CPA

Consulting Chief Financial Officer

David is a seasoned financial and operating executive specializing in startups, turnarounds, IPOs, mergers and acquisitions, debt financings and equity financings. He has substantial experience working with boards of directors for biotechnology companies, high technology, clean technology and others. At SynDevRx, he and his team focus on company finances, including reporting, budgeting, business strategy and funding.

Since 1992 David has operated his own consulting firm, providing executive services and specializing in interim executive management, IPOs, turnarounds, strategic analysis, and mergers and acquisitions. Previous clients include Padlock Therapeutics (where as CFO, he helped the company complete its $600M acquisition by BMS), Stromedix (where as CFO, he helped the company complete its $500M+ acquisition by Biogen), GlycoFi (where as CFO, he helped the company complete its $400M acquisition by Merck), Alnylam Pharmaceuticals (where as VP of finance, he led the company to a successful IPO), Infinity Pharmaceuticals (where he served as VP of finance and administration) and Millennium Pharmaceuticals (where he served as corporate controller). Earlier in his career, he spent four years as an auditor at KPMG.

David received his B.S. degree in accounting from the University of Minnesota and MBA from Bentley University. He is also a certified public accountant.

Benjamin Mayes, Ph.D.

Director, Process Development

Dr. Mayes has worked in the biopharmaceutical industry since 2004. Prior to joining SynDevRx in 2015, he spent 11 years at Idenix Pharmaceuticals working in the field of direct-acting antivirals for the treatment of HBV, HIV and HCV. As director of chemistry, manufacturing and controls, he was responsible for a wide range of activities, including API process R&D, solid-state chemistry, API production, formulation development and CTM manufacturing to enable the rapid progression of Phase 1 and 2 studies. Additionally, he was responsible for leading a focused discovery program into novel nucleosides and nucleotide prodrug inhibitors targeting HCV NS5B polymerase.

Dr. Mayes is the principal inventor of the prodrug technology for IDX21437 (now MK-3682), the key asset within an anti-HCV portfolio for which Idenix was acquired by Merck for $3.85 billion in 2014. He obtained his M.Chem. and D.Phil. (Ph.D.) degrees in synthetic organic chemistry from the University of Oxford under the supervision of Professor G.W.J. Fleet. He is co-author or co-inventor on many journal articles, presentations and patent applications.

David Turnquist, B.S., MBA

Senior Director, Chemistry, Manufacturing and Controls

In a professional career dating back to 1998, David has gained experience across all aspects of chemistry, manufacturing and controls (CMC). Prior to joining SynDevRx in 2014, he was director of analytical development at Concert Pharmaceuticals, where he enabled the advancement of five unique development programs into the clinic.

Earlier in his career, David spent seven years at Vertex Pharmaceuticals. There, he served as CMC project leader for the development of Kalydeco, a first-in-class treatment for cystic fibrosis, and analytical development lead for Incivek, a first-in-class treatment for Hepatitis C. He began his career at Merck Research Labs and was involved in the NDA submission of Cancidas, a novel treatment for invasive aspergillosis.

David received B.S. degrees in biology and chemistry from the University of North Carolina at Chapel Hill and an MBA from Boston College.

Bernhard ("Charlie") Hoffmann, MBA

Consultant for Business Strategy

Charlie is an independent strategy, business development and finance advisor to emerging life sciences companies, primarily in the pharmaceutical and medical device sectors. He has focused on the life sciences sector for over two decades, starting with the Prudential Vector Healthcare Group and then as a founder of EHS Securities, and has extensive experience in PIPES and other financing structures.

Previously, Charlie held positions in both equity and fixed-income capital markets groups and corporate finance at Cleary Gull Reiland & McDevitt, First Boston Corporation and Goldman Sachs. He received an MBA from the Amos Tuck School of Business Administration and an A.B. in English from Dartmouth College.

Susan Stewart, J.D.

Consultant for Regulatory Strategy

Susan has 25+ years of regulatory affairs and quality assurance experience in the development and commercialization of a broad range of drugs, biologics and devices intended to treat conditions considered to have unmet medical needs. She is currently president of Stewart Regulatory Consulting.

Prior to establishing her consulting business, Susan was senior vice president of regulatory, quality and compliance at Tokai Pharmaceuticals. Earlier career roles included vice president of regulatory affairs at TransMolecular and Genzyme, as well as a director for MG Biotherapeutics, a joint venture of Medtronic and Genzyme. While at Genzyme, she was the regulatory lead on novel drug development collaborations with Medtronic, Diacrin, Cambridge Antibody Technologies and Dyax. Her commercial product experience includes global registration and life-cycle management of Renagel®, Synvisc®, Carticel® and Thyrogen®. Prior to joining Genzyme, she served as quality assurance supervisor for Abbott Laboratories.

Susan holds a J.D from Concord Law School and a B.A. from the University of Massachusetts. She is a fellow of the Regulatory Affairs Professionals Society and is both U.S. and European Union Regulatory Affairs Certified.

David M. Browning, M.T., MBA

Consulting Clinical Operations Manager

David has over two decades of clinical drug development experience. Prior to joining SynDevRx in 2016, he helped start and build the international oncology-focused clinical research organization, Medelis. As COO and vice president of clinical operations, he made key contributions to the company’s growth by closing over $50 million in research service agreements; managing worldwide clinical operations; establishing a global network of medical, regulatory, safety and quality assurance experts; and ensuring clinical trial compliance with ICH/GCP principles.

While at the NCI-designated Comprehensive Cancer Center, Vanderbilt-Ingram Cancer Center, David oversaw the daily operations of the Clinical Trials Office, which was responsible for 175+ oncology clinical trials and 13 investigational new drugs. He has directly managed over 30 Phase 1 through 3 clinical trials worldwide from research through drug approval. Most of these trials were oncology studies, but he also has experience in the infectious disease, cardiovascular, ophthalmology, central nervous system and dental therapeutic areas.

David holds an MBA in marketing and new venture analysis and a bachelor’s degree in biology/biological science from the University of Tennessee, Knoxville, as well as a master’s degree in theology/theological studies from Lipscomb University.

Pierre J. Dufour, M.S.

Senior Director, Data Analytics

Pierre is responsible for designing and building SynDevRx’s data warehouse and data mining solutions. He brings 30 years of accomplishment and invention in the areas of data management, data warehouse design and implementation, and advanced data analytics.

After earning a B.S. in computer science from MIT, Pierre was one of the early employees at Oracle and worked with the database development team as a development manager. Over a 17-year period, he invented or co-invented numerous technologies that proved of enormous benefit to Oracle’s clients, including the PL/SQL language and parts of the JDBC specification. He also invented and built foundational technologies for Oracle’s eBusiness suite that enabled the development of robust eCommerce applications and avoided the necessity of rewriting millions of lines of code. In addition, he led multiple teams that have designed and built the industry standards for database-tier programming and in supporting highly scalable web servers (e.g. Amazon.com), which must handle tens of thousands of concurrent transactions.

Over his career, Pierre has designed and built data analytics solutions on a wide variety of topics, including bioinformatics and genomics, and corporate client analysis (using cluster analysis and neural networks, etc.). His research has included genetic algorithms and web scraping of social media. In 2016, he completed a master’s in business data analytics from Bentley University.

Robert Lutz, Ph.D.

Consulting on Translational Research, Pharmacokinetics and Clinical Strategy

Dr. Lutz provides strategic, tactical and operational input for SynDevRx’s R&D efforts. Prior to joining our company in 2015, he held various R&D roles over a 23-year span at ImmunoGen, most recently as vice president of translational research and development, in which he was responsible for all early-stage antibody drug conjugate (ADC) development programs. In addition to project team leadership, he directed the clinical pharmacology, biomarkers, pharmacology and toxicology departments. He also was a member of the portfolio research committee responsible for internal pipeline decisions, served on numerous alliance committees supporting the R&D programs of ImmunoGen’s licensed partners and was involved in multiple business development activities.

Prior to his role leading development programs, Dr. Lutz was the senior director of ADC research. In this role, he was responsible for ImmunoGen’s ADC R&D efforts, bringing eight internal candidate compounds into development. He also served as ImmunoGen’s research lead on Genentech’s now approved trastuzumab emtansine (T-DM1) program. Before the ADC research position, he was part of ImmunoGen’s Apoptosis Technology subsidiary, where he led the research collaboration leading to the discovery of the BH3 domain of the BCl-2 family of death regulatory proteins.

Before his time at ImmunoGen, Dr. Lutz was a research and postdoctoral fellow at the Eleanor Roosevelt Institute in Colorado. He earned his doctoral degree in biochemistry at Brandeis University.

Tad Archambault, Ph.D.

Consulting Biostatistician

Dr. Archambault is a biostatistician and clinical trialist with over 40 years of experience in and consulting to the pharmaceutical industry. He led statistics and clinical data management groups at several pharmaceutical companies prior to co-founding Virtu Stat, Ltd., in 1996. Virtu Stat is principled on the idea of the virtual company where a small group manages all statistical and data management services while working with a select group of highly skilled contractors who collaborate to finalize project goals.

Dr. Archambault has significant experience with many drugs in many drug classes, including cardiovascular, oncology, infectious diseases, vaccines and pain management. He has designed and analyzed clinical trials and presented results of these classes to the U.S. FDA, Health Canada and the EMA, including the approved products Celebrex®, Arthrotec®, CIVANEX®, Dilaudid®, Vicodin®, Vicoprofen®, DayPro®, Platinol®, Vepesid®, Vumon®, Multiferon®, Dacogen®, Isoptin® SR, Ryhthmol®, Hepagene®, Vicoprofen®, Ceforanide, ArilVax®, ACAM2000®, BiDil®, Amikin® and Maxaquin®, as well as many drugs in development.

Dr. Archambault earned his A.B. from Boston College and his M.A. and Ph.D. from University of Maryland.

Kimberly N. Sullivan, B.S.

Consulting on Regulatory Affairs and Quality Assurance

Kimberly has over 25 years of experience in regulatory affairs and quality assurance. Prior to joining SynDevRx in 2013, she founded Development Insights, a scientific consultancy that provides development team solutions to emerging pharmaceutical companies. She has experience in the preparation of domestic and international regulatory filings in the European Union, Latin America, Japan, Mexico, Australia and China; quality system development and implementation; and all aspects of GLP/cGMP/GCP compliance.

While at GlaxoSmithKline (formerly Praecis Pharmaceuticals), Kimberly worked on several clinical development programs, one of which was a fumagillin-class methionine aminopeptidase type II (MetAP2) inhibitor. She also supported the development and implementation of the RMP and Phase 4 commitments for the U.S. commercial product Plenaxis®, which ultimately achieved MAA approval in Germany. In addition, she was responsible for the transfer and management of quality and regulatory activities for Plenaxis to Speciality European Pharma, including technical development of MRP applications, the Canadian NDS, and API and drug product process/method transfer activities.

At Inotek Pharmaceuticals, Kimberly directed the regulatory and quality assurance activities supporting several development candidates in oncology and acute care medicine focused on ischemic-reperfusion injury. She was also responsible for corporate licensing, regulated vendor management, U.S. and international regulatory filings, implementation of corporate quality systems and development of laboratory facilities to provide analysis of pharmacokinetic clinical samples.

Earlier in her career, Kimberly spent eight years with Toxikon Corporation, where she was responsible for the design of preclinical, manufacturing and clinical testing programs in support of development programs conducted primarily in the United States, EU and Japan. Kimberly holds a B.S. in biology from the State University of New York.

Freddie Anderson-Villaluz, M.S.

Consulting on Clinical Project Management

Freddie has a decade of biotechnology and pharmaceutical experience in the fields of oncology drug development and neurodegenerative disease research. He has worked to develop and validate immunoassays and bioassays under GLP and EMA guidelines for implementation in clinical settings.

In his consulting role at SynDevRx, Freddie leverages his knowledge of FDA regulations with respect to quality assurance and clinical operations functions. He is also a technical consultant in the Mount Auburn Hospital pathology department and was a research associate at ImmunoGen from 2010 to 2014. Earlier in his career, he held research positions at the University of Nevada, Charles River Labs and Vitruvean.

Freddie holds an M.S. in biology from the University of Nevada, Reno.

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