Consulting Consortium


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

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.

Scioanalytical Dan Norwood, Ph.D.

SCĪO Analytical, LLC

Area of Expertise: Extractables/Leachables

 

Dr. Norwood is an internationally recognized expert in the field of leachables and extractables assessment in pharmaceutical development and manufacturing. He served as chair of the widely-quoted Product Quality Research Institute (PQRI) Working Group on leachables and extractables in inhalation drug products. He is also a member of the PQRI Working Group on leachables and extractables in parenteral and ophthalmic drug products (PODP), and has served on various technical teams of the International Pharmaceutical Aerosol Consortium on Regulations and Science (IPAC-RS).

 

Since 2010, he has served as a member of the USP Expert Committee on Packaging, Storage and Distribution where he chairs the subcommittee on extractables and leachables. Dr. Norwood has received several industry awards, including the CEO’s Award from Glaxo (1994), the President’s Award from Boehringer Ingelheim (2007), the Excellence in Research Award from PQRI (2009), and the Award for an Innovative Response to Public Health Challenges from USP (2013). Dr. Norwood completed his bachelor’s degree in Biochemistry at Virginia Tech and his doctorate degree in Environmental Chemistry at the University of North Carolina at Chapel Hill, School of Public Health.

Scioanalytical Thomas Feinberg, Ph.D.

SCĪO Analytical, LLC

Area of Expertise: Extractables/Leachables

 

Dr. Thomas Feinberg founded SCIO Analytical in 2014 as a science-based consulting resource focused on helping clients find solutions for difficult analytical chemistry problems such as extractables and leachables. Prior to SCIO Analytical, Dr. Feinberg worked for four years at the University of North Carolina at Chapel Hill in Chemistry and Environmental Sciences followed by a two-decade career at the Morrisville, North Carolina site of Catalent Pharma Solutions (formerly Cardinal Health and Magellan Laboratories). As the first LC-MS chemist at Magellan, he grew the Structural Chemistry function to become the industry leader in CMC support laboratory services for small molecule investigations with a specialty in designing and conducting extractables and leachables studies for MDI, DPI, ophthalmic, sterile, and topical drug products.

 

Dr. Feinberg is internationally recognized, serving as an active member of the Product Quality Research Institute (PQRI) since 2001 and the International Pharmaceutical Aerosol Consortium on Regulations and Science (IPAC-RS) since 2012. Dr. Feinberg completed his bachelor’s degree in Chemistry at Cornell University and his doctorate degree in Physical Chemistry at the University of North Carolina at Chapel Hill.

Gombatz Consulting, LLC 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.

Schmidt Technical Consulting 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.

Mile High Biopharmaceutical Consulting 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).

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.

Microbiology Research Associates 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.)

Apredica Katya Tsaioun, Ph.D.

Pharma Launcher

Area of Expertise: ADME Toxicology

 

Dr. Tsaioun is a widely recognized expert in preclinical drug-discovery research. Her book, ADMET for Medicinal Chemists, was published in 2011 by Wiley & Sons. Dr. Tsaioun serves on the scientific review boards of the National Institute of Aging, the Alzheimer's Drug Discovery Foundation, and the International Rett Syndrome Foundation. Dr. Tsaioun is regularly interviewed by trade publications such as Genetic Engineering News and Drug Discovery News, and is invited to speak at conferences on the topics of early toxicity assessment, building productive R&D teams, and entrepreneurship.

 

Dr. Tsaioun earned her B.S./M.S. degree in solid-state chemistry from the Leningrad Institute of Technology, and her Ph.D. from Tufts University. Her 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.

 

Before founding Pharma Launcher, Dr. Tsaioun was Chief Scientific Officer at Cyprotex, the world's largest contract research organization specializing in ADME Tox. Cyprotex is a publicly traded, UK-based company with laboratories in the US and UK.. Dr. Tsaioun joined Cyprotex subsequent to Cyprotex's 2010 acquisition of Apredica, where she was a co-founder and President. At Cyprotex, Dr. Tsaioun managed scientific strategy and strategic alliances, particularly focusing on the ADME Tox technologies developed at Apredica, and those which Apredica acquired from Cellumen. Apredica opened for business in 2006. In four years Dr. Tsaioun grew Apredica from 1.5 to 12 FTEs. Apredica initially focused on preclinical ADME contract research, then expanded to become an early leader in the in vitro toxicology market.

 

Prior to founding Apredica, Dr. Tsaioun managed the ADME programs for NitroMed, and before that, Surface Logix.

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.

pharmAccel Consulting 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.

Next Breath, LLC 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.

Ken Wong, MS

Area of Expertise: Extractables/Leachables, Compliance Remediation Strategy, Supplier Initiated Change Management/Strategy, Single-Use System Qualification Design, Risk Assessment Model Design.

 

Mr. Wong has been providing Extractables/Leachables support full-time since joining Schering-Plough in 2001 and now at Merck & Co . He currently has global responsibilities for development programs and in-line support of all dosage forms in Merck’s human health division. On numerous occasions, he has provided E/L support to the animal health division. He is currently representing Merck on BPOG's standard extractable protocol team, ASME-BPE extractable sub-team, and PDA single-use technical report working group.

 

Mr. Wong received his Bachelor of Science Degree in Chemistry from University of Lethbridge (Canada) and Master of Science Degree in Analytical Chemistry from University of Saskatchewan (Canada). He has also received diplomas in QA/RA from Temple University and Packaging Technology/Material Science from IOPP (www.iopp.org). He has later gained Six-Sigma Black Belt certification at Merck.

 

Mr. Wong has led global manufacturing sites, E/L compliance, remediation strategy development, and delivered an effective low cost approach in several projects. He has led cross-functional teams to design and implement a global qualification/validation and risk assessment model standard documents on single-use/multi-use components in both companies. With his strong interpersonal and leadership skills, he was able to balance the business needs, compliance, and budget with the use of supplier data in all of his E/L projects with first round approvals throughout his tenure. His experience in all dosage forms and medical devices, and RFT mindset enabled him to develop E/L data in cost effective manners for all CMC submissions.

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).

 

Prior to establishing Chemic Laboratories, Inc., Mr. St. Laurent served for ten years in various technical and management roles at several New England Contract Research Organizations. Additionally before entering the contract facility environment, Mr. St. Laurent served as a research associate studying with Dr. Marvin Natowitz, at the famed Eunice Kennedy Shriver Center. Mr. St. Laurent's research surrounded the area of childhood genetic disorders (specifically those caused by abhorrent levels of lysosomal enzymes) and implications of outside influences on the causation of such disorders.