The Independent Chemic Consulting Consortium offers our pharmaceutical and medical device sponsors easy access to a formalized group of independent, expert consultants throughout the product development cycle. The consulting team is available to provide expert direction associated with pharmaceutical, medical device, and biotech development and to assist sponsor representative(s) to evaluate business plans, product data, preclinical and clinical data, relevant agency filings, and review and analyze potential markets within these business sectors. The consulting team operates in a complimentary manner to one another ensuring the sponsor client concise and seamless product development through product launch.

Biographies

John Taylor, Ph.D.
Area of Expertise: Regulatory Affairs

After working with the FDA for more than 16 years in four different FDA Divisions, Dr. Taylor has spent the last 18 years of his career with major pharmaceutical companies or as a private consultant for both large and small companies including startups. As a consultant, he has continued to work on submission strategies, efficient research design to answer regulatory issues, efficient and clear documentation preparation, and repairing troubled companies with regulatory or GMP deficiencies in a priority driven, cost effective manner.

Dr. Taylor has been an Associate Director CMC Liason, a US Director of CMC Regulatory Affairs, a Director of International CMC Regulatory Affairs, a Director of Scientific Affairs, and a Senior CMC Expert for various companies.

Neil Pothier, Ph.D.
Chemic Laboratories, Inc.
Area of Expertise: Extractables/Leachables

Dr. Pothier joined Chemic Laboratories, Inc. in 2001 and currently serves as the Director, Analytical Services with a focus on Extractable/Leachable studies. Dr. Pothier's primary responsibilities include the overall operation and technical direction of the analytical group including analytical method development, validation and guidance of such. Additionally, Dr. Pothier serves on the BioProcess System Alliance (BPSA) Extractables and Leachables subcommittee.

Dr. Pothier received his Bachelor of Arts Degree in Chemistry from Rhode Island College and his Ph.D. in Analytical Chemistry from the University of Rhode Island.

Dr. Pothier was employed for 8 years performing trace organic and inorganic analysis in support of Department of Defense (DOD) remediation & EPA superfund sites under the Contract Laboratory Program (CLP). He served for three years as Technical Laboratory Director for this multi-national organization. He then joined Chemic Laboratories in 2001 as group leader/principle investigator/study director in the Bio-Analytical Department, responsible for method development and validation of GLP assays suitable for pharmo-kinetic (pK) and toxicological studies. In 2002, the additional responsibilities of managing the CMC department, conducting physical and chemical measurements, method development & validation, force degradation and structural elucidation in support of numerous ANDA, IND, and 510K applications were added. In 2003, he was charged with managing the Extractable & Leachable group focused on conducting controlled extraction studies and leachable method development and validation on OINDP, injectables, implantables, parenterals, and single use bio-process systems.

Gerald Jones, Ph.D.
Chemic Laboratories, Inc.
Area of Expertise: Synthetic Medicinal Chemistry

Dr. Jones joined Chemic Laboratories, Inc. in 2001 and currently serves as the Director, Manufacturing/Organic Synthesis. He has played an integral role in Chemic's development as a multi-service, value added company, and has made significant contributions to Chemic's cGMP synthetic programs (fluorescent diagnostic dye; anticholinergic API; proprietary lactate esters). He is also responsible for the successful reformulation of a commercial veterinary product, and the development of novel transdermal gels. Additionally, Dr. Jones has been a member of the American Chemical Society for over 30 years, and is a member of the Division of Medicinal Chemistry within the ACS. He is also a member of the Northeastern Section of the ACS, and the American Association of Pharmaceutical Scientists.

Dr. Jones received his Bachelor of Science Degree in Chemistry from Waynesburg College. Subsequently, Dr. Jones completed advanced postgraduate research earning his Ph.D. in Synthetic Organic Medicinal Chemistry from Purdue University, where his two part thesis described the synthesis of novel tricyclic heterocycles, and the synthesis of various derivatives of the aminoglycoside antibiotic, kanamycin B.

After three years of postdoctoral research and teaching at the University of Houston, Dr. Jones accepted a joint appointment at Harvard Medical School/Brigham & Women's Hospital. Two years later, he joined Northeastern University where he worked on a variety of small molecules including levamisole derivatives, and aryloxypropanolamines. In 1986, he accepted a joint appointment at Harvard Medical School/Massachusetts General Hospital (Department of Radiology; [11C]- and [99mTc]-labeled fatty acids as potential myocardial imaging agents for PET and SPECT). In 1988, he joined the faculty of Northeastern University, where his funded research focused on the design and synthesis of heterobifunctional ligands for labeling neuronal nicotinic receptors, and the synthesis of organophosphorus antibacterial agents. He left Northeastern in 1995, where he relocated at the Massachusetts College of Pharmacy. In 1996, he joined RSP Amino Acid Analogues, Inc., a start-up company dedicated to the synthesis of enantiopure, orthogonally protected, unique a-amino acid analogues. As the Vice President of Chemistry, he was responsible for directing the research efforts of 4-6 synthetic organic chemists (Ph.D./BS), while expending ~65% of his time on multi-step, asymmetric, and chemoenzymatic syntheses.

Kerry Gombatz, Ph.D.
Gombatz Consulting, LLC

Area of Expertise: API Procurement and Sourcing

Dr. Gombatz founded Gombatz Consulting, LLC in 2008 to provide consulting services to the pharmaceutical and biopharmaceutical industries in all key areas of CMC activities. He specializes in the development of robust supply chains for pharmaceutical agents in all phases of development and providing tactical and strategic solutions for the outsourcing and supply of all materials necessary for pharmaceutical industry.

Dr. Gombatz received his PhD at the University of Pittsburgh and completed his post-doctorate study at Massachusetts Institute of Technology. Additionally, Dr. Gombatz worked in the procurement and technical sourcing area for GlaxoSmithKline and its heritage companies for 9 years providing sourcing support for the chemical development department. He completed his tenure as manager of the US technical sourcing department in chemical development.

Prior to Dr. Gombatz handling the supply chain development and outsourcing for GSK, he worked in synthetic chemistry within chemical development for 18 years. Dr. Gombatz has successfully developed and scaled numerous chemical processes from g scale to multi-ton, to prepare supplies of API for clinical trials.

Mary Beth Schmidt, Ph.D.
Schmidt Technical Consulting

Area of Expertise: Implantable Medical Device Development

Dr. Schmidt is currently an Independent Consultant at Schmidt Technical Consulting where she works with the medical device industry using her 15 years experience (including over 10 years as a senior researcher at Johnson & Johnson). Dr. Schmidt provides technology and product development services to emerging and established medical device companies. Areas of expertise include implant biomaterials selection and testing, antimicrobial materials processing, wear testing and debris analysis, tissue engineering and cartilage repair. Pre-clinical studies for orthopedic products may be designed and monitored using a variety of small or large animal models. Additional areas of expertise include intellectual property analysis, strategic planning, SBIR proposal development, project management, laboratory design and set-up, manuscript and regulatory document preparation.

Dr. Schmidt received her Bachelor of Science Degree in Mechanical Engineering from Lehigh University in 1982. She was later was awarded her MS and PhD in Biomedical Engineering from Rensselaer Polytechnic Institute in 1985 and 1993, respectively.

Prior to joining Johnson & Johnson, she was employed in world-class academic research laboratories at Columbia University and Rensselaer Polytechnic Institute, studying cell-biomaterial interactions and cartilage biomechanics.

John Dietrich, Ph.D. Mile High Biopharmaceutical Consulting Area of Expertise: Pre-clinical and Clinical Operations

Dr. Dietrich was involved with the founding of Ventrus Biosciences in 2007, a gastrointestinal drug development company. In 2009,  he started Mile High Biopharmaceutical Consulting specializong in pre-clinical and clinical operations.

Dr. Dietrich received his Ph.D. in Pharmacology from the University of North Carolina. He was a postdoctoral fellow in Endocrinology at the University of Connecticut, after which he was on the faculty of the University of Illinois School of Medicine. In 1980 he joined Revlon Health Care Group as Director of Endocrinology where he directed programs involved with discovery of drugs for metabolic bone disorders.

Dr. Dietrich has held senior management positions in research and development at a number of small to mid-sized biopharmaceutical companies in the US and in Canada. He has been involved in all aspects of drug development, including preclinical (pharmacology, toxicology), clinical trials and regulatory affairs. Dr. Dietrich has collaborated extensively with major pharmaceutical companies in Europe and Japan. From 1985 to 1990 he was Vice President of Research at Chemex Pharmaceuticals, a dermatology development company in Denver, Colorado. In 1991 he accepted a position as Vice President of R&D at Allelix Biopharmaceuticals, where he supervised drug discovery, development and regulatory affairs for peptides and organic molecules. In 1999 Dr. Dietrich returned to the US and became Vice President of R&D at Cellegy Pharmaceuticals and the following year accepted a similar position at VIVUS (a biopharmaceutical company specializing in drugs for male and female sexual dysfunction).

Michael Ruberto, Ph.D.
Material Needs Consulting, LLC

Area of Expertise: Medical Devices and Packaging

Dr. Ruberto is the President of Material Needs Consulting, LLC which provides consulting services to manage the development and commercialization of medical devices and packaging, with a special emphasis on material selection, extractables and leachables, and supply chain management. He has been an active member of various pharmaceutical working groups that have developed "best practices" for characterizing and evaluating the safety of container closure systems and packaging for several different drug dosage forms.

Dr. Ruberto received his Bachelor of Science Degree with thesis from Stevens Institute of Technology and a Ph.D. in Analytical Chemistry from Seton Hall University.

Dr. Ruberto was formerly the Head of Regulatory Services for the NAFTA region at Ciba Specialty Chemicals where he was responsible for world wide notifications of new products, food contact notifications, and regulatory compliance of Ciba chemicals. He also designed leachable and extractable studies for the FDA approval of medical devices, packaging, and labels used on drug containers. Dr. Ruberto was previously the Director of Analytical Research, where he led a full service analytical laboratory that specialized in performing testing associated with the development and commercialization of new products including chemical characterization, migration studies, applications support, and technical service. Dr. Ruberto was employed by Ciba for fifteen years where he has performed numerous migration studies to support FDA and European Union indirect food contact notification for various additives, pigments, and polymers. He was part of a team commissioned to establish a Good Laboratory Practice and Good Manufacturing Practices program in Ciba's Analytical Research Department and served as GLP Study Director for many product characterization and Base Set studies needed for global product registration of novel additives.

Robert Kaster, Jr., R.Ph.
Area of Expertise: CMC Regulatory Affairs (Drug Product)

Mr. Kaster is currently an Independent Consultant specializing in CMC drug product development including formulation development, quality assurance and regulatory affairs. He has 25 years of pharmaceutical experience in both small and large organizations with capabilities ranging from the technical bench/laboratory environment through senior management and executive strategic level. Depth of prior experience also includes pre-clinical through clinical, validations/PAIs and commercial manufacturing, extensive worldwide CRO vendor oversight, contributions to corporate agreements such as commercial contracts, master service agreements, joint ventures/licensing agreements, due-diligence reviews, etc. He has also consulted as an expert witness as part of pharmaceutical litigation.

Mr. Kaster is a Registered Pharmacist and received his Bachelor of Science Degree from The Philadelphia College of Pharmacy and Science (now University of the Sciences in Philadelphia).

Prior to consulting, he served as Director of Pharmaceutical Development at Vitae Pharmaceuticals, Inc. Responsibilities included all aspects of CMC drug product development, clinical and commercial manufacturing, validation, and preparation of all associated regulatory submissions including FDA and EU interaction. His responsibilities also included significant CMC QA and cGMP/GLP compliance activities related to QC data oversight, vendor qualification, manufacturing and auditing. Previous positions Mr. Kaster held include Director of Pharmaceutics at Eximias Pharmaceutical Corporation responsible for drug product development through commercialization, Director of Pharmaceutical Development at Afferon and Maret Corporation overseeing development, QA/QC, clinical and scale-up activities for both API and drug product. He held positions of increasing responsibility with Du Pont Merck Pharmaceutical Company in research and development, clinical manufacturing and process scale-up through commercialization and in research and development with Controlled Therapeutics Corporation and Wyeth Laboratories.

Francis McAteer, MS, MBA Microbiology Research Associates Area of Expertise: Microbiology

Mr. McAteer has been with Microbiology Research Associates, Inc. for the past 9 years, serving as Vice President. In this role, Mr. McAteer has been involved with quality systems, customer service, and technical affairs. He has also been involved in biotechnology, pharmaceuticals, and medical devices over the last 20 years. Mr. McAteer's exhibits expertise is in USP/EU compendial microbiology testing, medical device sterilization validation, contamination control, pharmacy sterile compounding, aseptic training, clean room validation, disinfection efficacy and environmental monitoring. Additionally, Mr. McAteer is currently a member of the Parenteral Drug Association (PDA) and the International Society of Pharmaceuticals Engineers (ISPE).

Mr. McAteer received his Bachelor of Science Degree from Boston College, his Master of Science Degree from Northeastern University, and his Master of Business Administration Degree from Salem State College.

Prior to his time at Microbiology Research Associates, Mr. McAteer held the positions of Senior Director of Operations (Organogenesis, Inc.), Director of Operations (Medica Corp.) and Director of Manufacturing (CIS-US, Inc.)

Katya Tsaioun, Ph.D. Apredica Area of Expertise: ADME Toxicology

Dr. Tsaioun is founder and President of Apredica. Apredica is the oldest firm in New England specializing in the rapid preclinical in vitro assessment of the ADME Tox (Absorption, Distribution, Metabolism, Elimination and Toxicity) properties of small-molecule and peptide therapeutics. Dr. Tsaioun is active in many local and international professional and business societies such as AAPS, ACS, WEST, HBA, and the MIT Enterprise forum. She was invited to serve as a judge in the Yale Entrepreneurship Society's 2007 and 2008 business plan competitions. Dr. Tsaioun serves on the Scientific Review Boards of Alzheimer's Drug Discovery Foundation and International Rett Syndrome Foundation. Dr. Tsaioun is regularly interviewed by trade publications such as Genetic Engineering News, and Drug Discovery Technology, and is invited to speak at conferences on the topics of ADME, early toxicity assessment, building productive Research and Development teams, and entrepreneurship.

Dr. Tsaioun earned her Master's Degree in solid-state chemistry from the Leningrad Institute of Technology, and her Ph.D. from Tufts University. Dr. Tsaioun's Ph.D. thesis on effects of signal transduction and apoptosis factors in the rat brain was done under direction of Drs. James Sadowski and James Joseph in the Neuroscience Laboratory. She completed her academic training in the Neurochemistry Department at the Harvard University Primate Center, working on in vivo and in vitro drug-dependence models with cannabinoid receptor and dopamine transporter systems.

Prior to founding Apredica, Dr. Tsaioun worked as a Group Leader at NitroMed, and before that, at Surface Logix. For both companies, she built teams to support complete in vitro ADME and in vivo DMPK programs. Prior to Surface Logix, Dr. Tsaioun worked at Mitotix (subsequently merged into GPC Biotech), where she pioneered cell-based assay development in the area of angiogenesis (oncology) and infectious disease. She gained expertise in assay validation, transfer to automation, running compound-library screens, and managing hit-to-lead and lead-optimization programs. While at GPC Biotech, Dr. Tsaioun managed the outsourcing of in vitro ADME assays, and introduced and pioneered the establishment of in-house in vitro ADME capabilities, developing and validating a high-to-medium-throughput ADME assay panel and bringing in house in silico ADME prediction models.

Caesar Snodgrass-Pilla, MS
CSP Pharma
Area of Expertise: Analytical CMC / Solid State Characterization

Caesar Snodgrass-Pilla is currently an independent consultant specializing in the areas of Analytical CMC and Solid State Characterization. He was an active member of the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) and was a founding member and an executive board member for the Extractables/Leachables Safety Information Exchange (ELSIE). Additionally, he is also a member of the American Chemical Society, American Association of Pharmaceutical Scientists and the Chromatography Forum of the Delaware Valley.

Mr. Snodgrass-Pilla received his Bachelor of Science Degree in Chemistry from Drexel University and his Master of Science Degree in Physical Analytical Chemistry from Villanova University. He has also taken numerous technical and managerial short courses.

Mr. Snodgrass-Pilla most recently served as Senior Developmental Fellow in Pharmaceutical Sciences at Schering Plough Research Institute. Mr. Snodgrass-Pilla has 35+ years of diversified experience in Pharmaceutical Analysis and Characterization. During this period his responsibilities included drug characterization, chemical and solid state method development/validation for drug substances, excipients, process development and formulated products, initiating stability programs, testing/release of clinical supplies, and method transfer to commercial sites. He was also responsible for the preparation of numerous technical reports, specifications, and documents for regulatory submissions. Caesar Snodgrass- Pilla has published and/or presented numerous scientific papers. Caesar has also served as a Subject Matter Expert in PAI Inspections and in meetings with regulatory agencies. Before joining Schering Plough, Caesar worked for 3 years as a Manager of Analytical Services at Controlled Therapeutics, a small company specializing in controlled release dosage forms. Prior to Controlled Therapeutics, he worked for 16 years in positions of increasing responsibility in the Analytical Laboratories of Wyeth Laboratories.

Toshiyuki Sakakibara, Ph.D.
GMP Consulting, Inc.

Area of Expertise: Japan cGMP Regulatory Affairs

Dr. Sakakibara joined GMP Consulting, Inc. in 2003 and currently serves as President of the company. Dr. Sakakibara's primary responsibilities include supplying GMP (FDA and EU) consultancy and compliance training, serving as an inspection liaison for clients with U.S. and EU agencies, product registration, notification, petitions and other related liaison with U.S. and EU regulatory agencies, and providing process validation consultancy for clients of pharmaceutical Industries. Dr. Sakakibara has also consulted several API validations including new materials.

Dr. Sakakibara received his Ph.D. in Applied Chemistry from Osaka University. Additionally, he received The Chemical Technology Award from Japan Oil Chemical Society in 1993.

Prior to his work at GMP Consulting, Dr. Sakakibara worked at Nippon Fine Chemical Co., Ltd where he held the positions of Manager, Research & Development Department, Director, Development Department and Sales Department, and Director, Project Manager for New Pharmaceuticals over a 20 year time frame.

Dr. Sakakibara also worked at Teijin Limited for approximately 9 years dedicating his time to the research & development of synthetic fibers, synthetic resins, petrochemicals, and pharmaceuticals.

René Bommer, Ph.D.
pharmAccel Consulting

Dr. Bommer founded pharmAccel Consulting in 2007. pharmAccel Consulting delivers to the client a service to support an accelerated entry into the market considering technical, regulatory, marketing and pharmaeconomical aspects of the drug delivery device business. The activities are concentrated on drug products and medical devices intended to be dispensed in liquid or solid forms. The administration routes of interest are the pulmonary, nasal, oral/sublingual, ophthalmic, optic and topical routes. The service consists of individual modules covering the delivery system itself and the corresponding commercial and technical issues.

Dr. Bommer received his Ph.D. in Chemistry from the University of Constance in Germany in 1990.

After research positions at the Scripps Clinic in La Jolla, at Altana Pharma (now Nycomed) and a lectureship at the University of Buenos Aires he joined the device developing and manufacturing company E. Pfeiffer in Germany, Dr Bommer became Director Business Development. The company Pfeiffer and its sister company, Valois, belong to the leading pharmaceutical device supplier, Aptar Group.

Julie D. Suman, R.Ph.
Next Breath, LLC

Area of Expertise: Inhalation and Nasal Delivery Device Development

Dr. Suman is co-founder and President of Next Breath, LLC, a contract research organization dedicated to the development and analytical testing of nasal and inhalation delivery systems. Dr. Suman directs the research division that supports product development and regulatory submissions for North American and International Clients in the pharmaceutical, biotechnology and medical device markets. Additionally, Dr. Suman is a co-editor for Respiratory Drug Delivery Proceedings, an international symposium, and an adjunct assistant professor at the University of Maryland, School of Pharmacy in Baltimore, Maryland. She is also an Affiliate Assistant Professor in the Department of Pharmaceutics, School of Pharmacy, Virginia Commonwealth University.

Dr. Suman holds a B.S. in Pharmacy from Duquesne University and a Ph.D. in Pharmaceutical Sciences from the University of Maryland, Baltimore.

Dr. Suman is the Past-Chair of the AAPS Inhalation Technology Focus Group. She is also a licensed Maryland pharmacist and a member of the Maryland Pharmacy Volunteer Corp. Dr. Suman has published her research in peer-reviewed journals and has been presented during podium sessions at international meetings and the FDA Visiting Professor Lecture Series. Dr. Suman's doctoral research, which focused on the relationship between in vitro tests for nasal sprays and in vivo deposition, has been recognized for excellence by a research award presented at the International Society for Aerosols in Medicine, 2001. In 2008, Dr. Suman received an award from the Greater Baltimore Committee for Entrepreneurial Spirit. She was also recognized as an entrepreneur in 2004 at Enterprising Women: 250 Years of American Business hosted by the organization, Women in Biotechnology.

Joseph St. Laurent
President, Chemic Laboratories, Inc.
Area of Expertise: Business Development

Mr. St. Laurent co-founded Chemic Laboratories, Inc. in 1998 and currently serves as President and Chief Scientific Officer. Mr. St. Laurent's primary responsibility includes the management of technical affairs and business development, ensuring that the company offers unparalleled contract analytical, formulation development, API synthesis and small scale manufacturing to the pharmaceutical, specialty chemical, biotech, and medical device industries. Furthermore, Mr. St. Laurent has also offered his drug development and consulting expertise to a virtual pharmaceutical company serving as CSO since 2008, aiding in product process development.

Joseph St. Laurent's received his Bachelor of Science degree in Biology/Biochemistry from Bridgewater State College. Mr. St. Laurent also completed advanced postgraduate analytical, organic and physical chemistry studies (Bridgewater State College); advanced studies in Mass Spectral Data Interpretation (Analytical Education Center) and Management Development Studies (Suffolk University, Boston, MA).