Mr. Como oversees our technology transfer and technical business management teams at our sterile and solid dose facility in Monza, Italy. He joined Patheon in 2005 as a Technology Transfer Specialist. After two years he moved to the business management department, becoming Business Manager in 2008, then was appointed Site Technical Business Manager in 2010. +

Mr. Como oversees our technology transfer and technical business management teams at our sterile and solid dose facility in Monza, Italy. He joined Patheon in 2005 as a Technology Transfer Specialist. After two years he moved to the business management department, becoming Business Manager in 2008, then was appointed Site Technical Business Manager in 2010.

Mr. Como began his career with PharmaFilms, a company spun off from Milan University. He was project leader in the development of a fast-dissolving thin film using hot melt extrusion. He holds a degree in chemistry and pharmaceutical technologies.

Dr. Kane has more than 25 years of experience in the science and business of taking molecules through the entire drug development process. His extensive knowledge spans early stage development to scale-up and commercial manufacturing, and includes technical transfers between global sites and drug life cycle management. +

Dr. Kane has more than 25 years of experience in the science and business of taking molecules through the entire drug development process. His extensive knowledge spans early stage development to scale-up and commercial manufacturing, and includes technical transfers between global sites and drug life cycle management. 

In his current role as Executive Director, Dr. Kane leads, and provides leadership to, all global PDS sites in the complete development of novel lead compounds and line extensions. He works directly with customers to progress their molecules to the next stage of development by helping them to define scientific strategies that take full advantage of Patheon’s capabilities and expertise.

Dr. Kane received his Bachelors, Masters and Ph.D. degrees from the University of Bombay, India, and served as a post-doctoral fellow at the School of Pharmacy, University of Cincinnati, Ohio. He has also earned an executive MBA from Richard Ivey School of Business, University of Western Ontario, Canada. Dr. Kane is a member of various international pharmaceutical professional organizations, and is often asked to speak about scientific topics at major industry events.

Mr. Zinser offers Patheon customers the advantage of more than 39 years’ experience in pharmaceutical manufacturing planning, processes and technologies. With a blend of both technical and business expertise, he brings a unique big-picture point of view to all his projects. +

Mr. Zinser offers Patheon customers the advantage of more than 39 years’ experience in pharmaceutical manufacturing planning, processes and technologies. With a blend of both technical and business expertise, he brings a unique big-picture point of view to all his projects.

Mr. Zinser’s broad technical expertise includes raw material and finished dosage form testing, tablet and capsule equipment and processing, controlled release methodologies and processes, controlled substances handling and regulations, as well as Good Manufacturing Practices and their application.

His management expertise includes planning, purchasing, warehousing, distribution, industrial engineering, accounting and finance, as well as pharmaceutical product transfer, validation and registration.

Previous to his current position, Mr. Zinser has served as Executive Director, Technical Services and Business Management as well as General Manager of Patheon’s Cincinnati site. Before joining Patheon, he held management and director positions with Aventis Pharmaceuticals, Hoechst Marion Roussel, and Marion Merrell Dow. Mr. Zinser earned his B.S./M.S. Chemistry and MBA degrees from Xavier University.

Dr. Jaynes is a veteran in the development and commercialization of several prescription and OTC products. At Patheon, he and his PDS group focus on the development of products using softgel and two-piece hard-shell liquid-filled capsules, as well as bottled product delivery technologies. +

Dr. Jaynes is a veteran in the development and commercialization of several prescription and OTC products. At Patheon, he and his PDS group focus on the development of products using softgel and two-piece hard-shell liquid-filled capsules, as well as bottled product delivery technologies.

Before joining Patheon, Dr. Jaynes was Technology Transfer Liaison at Banner. In this position, he was responsible for internal and external tech transfers. He also established his expertise in business development, market research, quality investigations and formulation development. Dr. Jaynes has also held science and management positions with Campbell Foods, Kraft Foods and General Foods Corporation, and also worked in personal care product development at SC Johnson.

Dr. Jaynes’ postdoctoral and research work at the University of Pennsylvania and Case Western Reserve University included: photo-affinity labeling of ribosomes to locate the site of amino acid transfer to a growing peptide chain, synthesizing of amino acid-carbohydrate hydrogels for drug delivery, and describing the structure and function of the core protein of cartilage proteoglycan subunits. He earned his Ph.D. in Synthetic Organic/Bio-Organic Chemistry from the University of Wisconsin - Madison and a B.S. in Chemistry from West Virginia University. He is a Lieutenant Colonel in the Retired Reserves of the US Army Chemical Corps.

Since joining Patheon in 2003, Mr. Corona has been vital in the development of new liquid and lyophilized parenteral formulations for preclinical and clinical trials, as well as their commercialization. He conducts lyophilization cycle development and presides over our scale-up to fill-finish sterile suite. +

Since joining Patheon in 2003, Mr. Corona has been vital in the development of new liquid and lyophilized parenteral formulations for preclinical and clinical trials, as well as their commercialization. He conducts lyophilization cycle development and presides over our scale-up to fill-finish sterile suite.

Previous to Patheon, Mr. Corona worked at the Pharmacy Research and Development Division of Intervet where he was involved in the formulation of sterile liquid and semi-solid products. He holds a B.S. in Medicinal Chemistry and a B.S. in Pharmacy from Rome University La Sapienza.

Dr. Carr offers Patheon customers 36 years of applying analytical science to the creation of pharmaceutical products. His expertise includes the development and validation of analytical methods, use of spectroscopic techniques to identify impurities, specification development for APIs and drug products design, API characterization, drug degradation chemistry, and management of stability programs. +

Dr. Carr offers Patheon customers 36 years of applying analytical science to the creation of pharmaceutical products. His expertise includes the development and validation of analytical methods, use of spectroscopic techniques to identify impurities, specification development for APIs and drug products design, API characterization, drug degradation chemistry, and management of stability programs.

A respected leader in the field, Dr. Carr is an active member of the United States Pharmacopeia, serving on the Expert Committee for General Chapters, Chemical Methods. Previously he had been a member of both the British and European Pharmacopoeias. Dr. Carr is the author of several journal articles and has spoken and conducted workshops on pharmaceutical analysis in Europe and North America. He also wrote a nine-module distance-learning course on pharmaceutical stability testing.

Before joining Patheon, Dr. Carr was the Head of Analytical Development at Chiroscience and Wyeth Research. He was also the head of the British Pharmacopoeia Laboratory. He earned both his Ph.D. in Synthetic Organic Chemistry and B.S. in Chemistry at London University, U.K.

With a solid foundation of marketing and sales, and expertise in the licensing of generics and drug delivery systems, Mr. Cassisi applies his deep knowledge of the pharmaceuticals industry to Patheon’s global strategic business development. +

With a solid foundation of marketing and sales, and expertise in the licensing of generics and drug delivery systems, Mr. Cassisi applies his deep knowledge of the pharmaceuticals industry to Patheon’s global strategic business development.

Mr. Cassisi has more than 30 years of experience, including at Pharmathec (now Aptalis)  as Director, Business Development; Recordati as Leader of the Generic Portfolio; and  Ciba-Geigy as Product Manager, Strategic Manager and Sales Manager. Mr. Cassisi holds an MBA in Economics and Business Management.

Dr. Marr is an expert in computer-aided analytical method development, optimization and validation for APIs and drug products. He is also an expert in the development of stability programs and troubleshooting of analytical methods. +

Dr. Marr is an expert in computer-aided analytical method development, optimization and validation for APIs and drug products. He is also an expert in the development of stability programs and troubleshooting of analytical methods.

Currently, Dr. Marr leads the PDS Analytical Development Group at our Cincinnati, OH facility. In his 24 years in the industry, Dr. Marr has served as Director, Analytical Development at both Meridian Medical Technologies and MDS Pharma Services. He has also worked as a Research Scientist and Control Development Scientist at Pharmacia, Pharmacia & Upjohn, and The Upjohn Company.

Dr. Marr earned his Ph.D. in Pharmaceutical Analysis from Bradford University, England; his M.Sc. in Clinical Pharmacology from Aberdeen University, Scotland; and his B.Sc. in Pharmacy from Herriot Watt University, Scotland. He has been a Registered Pharmacist in the U.K. since 1981.

Mr. Gill has amassed a broad range of expertise in his 25 years of global pharmaceutical operations and product development. He has direct experience in plant operations management, QA and QC laboratory management, aseptic manufacturing, large volume parenterals, delivery devices, and the majority of solid dose forms. Mr. Gill has also lead operational excellence transformations in multiple companies. +

Mr. Gill has amassed a broad range of expertise in his 25 years of global pharmaceutical operations and product development. He has direct experience in plant operations management, QA and QC laboratory management, aseptic manufacturing, large volume parenterals, delivery devices, and the majority of solid dose forms. Mr. Gill has also lead operational excellence transformations in multiple companies.

In his Executive role at Patheon, Mr. Gill leads our quality, operational excellence, and training functions. Previously he was Site Leader with Pfizer, where he directed the operations of a 7.5 billion dose per year OTC oral solid pharmaceutical manufacturing and packaging operation. Before that he was PPU Director for Wyeth where he directed operations of 75 million unit per year OTC pharmaceutical operation. Mr. Gill also held several positions with Baxter, culminating with Director of Engineering. His responsibilities included directing the top-priority R&D program in the Renal Division, establishment of the Asia Product Development Group, and directing the operations of a large volume parenteral manufacturing facility supplying Asian markets.

Mr. Gill earned his M.S. in Microbiology from East Tennessee State University.

Dr. Vaughn has expertise in early and preclinical development of liquid, semi-solid and solid dosage formulations, including hot melt extrusion and enhancement of solubility and bioavailability. +

Dr. Vaughn has expertise in early and preclinical development of liquid, semi-solid and solid dosage formulations, including hot melt extrusion and enhancement of solubility and bioavailability.

In his 12 years in the pharmaceutical industry, Dr. Vaughn has quickly risen to scientific leadership positions. Previous to Patheon he was Director of Research at Enavail; Director of Formulation Development at DPT Laboratories; and VP, Operations at PharmaForm.

Dr. Vaughn earned his Ph.D. in Pharmaceutics from the University of Texas at Austin, College of Pharmacy.

Mr. Hermier has more than 20 years experience in the pharmaceutical industry in companies like Patheon Pharmaceuticals Inc., Hoechst Marion Roussel, Marion Merrell Dow where he played roles including Business Management, Head of the Packaging department, and Capital project management. +

Mr. Hermier has more than 20 years in the pharmaceutical industry in companies like Patheon Pharmaceuticals Inc., Hoechst Marion Roussel, Marion Merrell Dow where he played roles including Business Management, Head of the Packaging department, and Capital project management.

Mr. Hermier expertise is in solid dosage form processes, solid dose Packaging (blistering), non sterile, liquid, and packaging.

Mr. Hermier has an MsC in Advanced manufacturing technologies from the Portsmouth University UK and an MsC in Mechanical Engineering, France.

An expert in scale-up and technology transfers, Mr. Gabriele’s 10 years of pharmaceutical industry experience includes API bulk production, quality control, and research and development. His experience includes the evaluation of new projects and client relationship management. +

An expert in scale-up and technology transfers, Mr. Gabriele’s 10 years of pharmaceutical industry experience includes API bulk production, quality control, and research and development. His experience includes the evaluation of new projects and client relationship management.

Mr. Gabriele earned an Executive MBA from the Luiss Business School in Rome, Italy. He is also a graduate of University of Rome La Sapienza with a degree in pharmaceutical chemistry.

Dr. Hlodan is an expert in the development of biopharmaceuticals, including analytical method development and validation, stability program management, and formulation development. +

Dr. Hlodan is an expert in the development of biopharmaceuticals, including analytical method development and validation, stability program management, and formulation development.

More than half of Dr. Hlodan’s 16 years in the pharmaceutical industry have been with Patheon. Prior to his current position as Technical Affairs Specialist, he was Section Manager, PDS Analytical Development. Previously, he held Senior Scientist positions at Cambridge Antibody Technology and Therexsys/Cobra Therapeutics.

Dr. Hlodan earned his Ph.D. in Biochemistry at University of Newcastle upon Tyne, and his B.Sc. in Biochemistry at University of Leeds.

With 17 years of experience in pharmaceutical development and operations leadership in Europe, and as a certified Qualified Person (QP), Dr. Chiaramonti is an expert in quality and EU regulatory requirements. +

With 17 years of experience in pharmaceutical development and operations leadership in Europe, and as a certified Qualified Person (QP), Dr. Chiaramonti is an expert in quality and EU regulatory requirements.

Dr. Chiaramonti has been with Patheon for more that ten years, and is a member of the Global PDS Management Team. His responsibilities include directing operations at our facility in Ferentino, Italy and establishment of PDS operations in France. His experience includes all aspects of sterile product development, including formulation, analytical and process development, clinical and small-scale commercial manufacturing, project management, and quality assurance. Previously he worked with two other companies in a variety of quality control management positions.

Dr. Chiaramonti received his training as a Pharmaceutical Chemist at University of Rome La Sapienza and Liceo Scientifico in Italy, where he is certified as a Pharmacist and as a QP.

Mr. Closs possess more than 23 years of experience in formulation development, tech transfer, scale-up and commercialization of solid dosage pharmaceuticals. He is an expert in process analytical technologies (PAT), Quality by Design (QbD), and process optimization and development. +

Mr. Closs possess more than 23 years of experience in formulation development, tech transfer, scale-up and commercialization of solid dosage pharmaceuticals. He is an expert in process analytical technologies (PAT), Quality by Design (QbD), and process optimization and development.

Highly active in AAPS/ISPE/ASTM, Mr. Closs has taken on leadership roles such as AAPS Chair, Process Development Focus Group; AAPS Annual Meeting Program Moderator; and participated in developing programs for supply chain, disposable technologies, and green process engineering. He was also a member of the ASTM E55 sub-committee for PAT standards development. 

A sought-after thought leader, Mr. Closs has been invited to speak at numerous AAPS, Interphex and Global Outsourcing events. He has had articles appear in multiple peer reviewed article publications, including Pharm Tech Magazine, ISPE Newsletter, Tablets and Capsule Magazine, and AAPS Journal.

Mr. Closs has been a valued member of the Patheon team for 12 years. Before his current position of Director, Global Technical Affairs, his roles with the company include Associate Director, Pharmaceutics and Process Technology, PDS; Senior Process Engineer; Senior Technologist, PDS; and Leader of Centre of Excellence Teams for PAT and Design of Experiments. Prior to joining Patheon, he worked in the operations group at Novartis Pharma. Mr. Closs earned his B.Sc. at the University of Toronto.

Mr. Pidgeon has nearly three decades of experience in the formulation and process development of sterile and solid products, both small molecule and biopharmaceuticals. He is an expert in the exploitation of the advantages of disposable (single-use) manufacturing technologies. +

Mr. Pidgeon has nearly three decades of experience in the formulation and process development of sterile and solid products, both small molecule and biopharmaceuticals. He is an expert in the exploitation of the advantages of disposable (single-use) manufacturing technologies.

In his 28 years in the pharmaceutical industry, Mr. Pidgeon has worked at both large pharma and small biotech companies, almost exclusively in formulation and process development. His roles in Patheon’s PDS operations include Head of Technical Affairs, Head of Sterile Operations, and Head of Process Technology.

Mr. Pidgeon holds a B.Sc. (Hons) in Chemistry from The University of Manchester, U.K.

Dr. Weiser is an expert in analytical method development and validation for APIs and drug products. His expertise includes stability program development, analytical method troubleshooting, preparation of the CMC Section of IND/NDA/CTD submissions, and U.S. agency for European API manufacturers. +

Dr. Weiser is an expert in analytical method development and validation for APIs and drug products. His expertise includes stability program development, analytical method troubleshooting, preparation of the CMC Section of IND/NDA/CTD submissions, and U.S. agency for European API manufacturers.

Active in the leadership of AAPS, Dr. Weiser has served as the organization’s Annual Meeting Program Chair, Publications Vice Chair, Small Company Task Force Chair, and Drug Substance Short Course Leader.

Over 26 years, Dr. Weiser has held key scientific leadership positions. Before joining Patheon, he was General Manager, Pharmaceutical Development at Liquidia Technologies; President of Techlytic Consulting; VP, Analytical Chemistry at Magellan Laboratories; and International Technical Development Coordinator and Development Scientist at Burroughs Wellcome.

Dr. Weiser earned his Ph.D. in Analytical Chemistry from Purdue University, and his B.S. in Chemistry from the College of William & Mary. He is RAC Certified, U.S. FDA.

Dr. Newman’s expertise is in solid-state chemistry: physical forms, polymorphism, salts, cocrystals, and amorphous solid dispersions, including screening, characterization, form selection, and process induced transformations. In her more than 25 years in the industry, she has played a key role in the development of more than eight successfully launched commercial products. +

Dr. Newman’s expertise is in solid-state chemistry: physical forms, polymorphism, salts, cocrystals, and amorphous solid dispersions, including screening, characterization, form selection, and process induced transformations. In her more than 25 years in the industry, she has played a key role in the development of more than eight successfully launched commercial products.

Working primarily at large pharmaceutical companies and contract research organizations, Dr. Newman started at ER Squibb (later Bristol-Myers Squibb) in the Pharmaceutical Research Institute where she was responsible for the physical characterization function for both drug substances and drug products from late drug discovery through commercialization. At SSCI Inc. she supported both small and large phama companies by solving solid-state form issues in APIs and formulations. As VP, Research at Aptuit she implemented a new global research initiative covering API, solids, formulation, preclinical (PK and toxicology), clinical packaging, and regulatory. Dr. Newman has authored and collaborated on more than 100 articles, book chapters and presentations, and is currently an adjunct professor at Purdue University.

Dr. Newman earned her Ph.D. in Inorganic Chemistry from the University of Connecticut.

Having ushered multiple products to market though the entire development process, Dr. Lipper is an expert in the efficient transition from discovery to proof of concept and beyond. This includes evaluation of the "developability" of new chemical entities, diagnosing and recommending solutions to bioavailability challenges, development strategies, and CMC regulatory strategies. +

Having ushered multiple products to market though the entire development process, Dr. Lipper is an expert in the efficient transition from discovery to proof of concept and beyond. This includes evaluation of the "developability" of new chemical entities, diagnosing and recommending solutions to bioavailability challenges, development strategies, and CMC regulatory strategies.

Dr. Lipper has more than 30 years of international product development experience at Pfizer and Bristol-Myers Squibb, and has been an independent consultant for five years. He is a member of the American Association of Pharmaceutical Scientists (AAPS) and the Parenteral Drug Association (PDA). He currently serves on the Dean's Industrial Advisory Council for the Purdue University College of Pharmacy and the Dean's Advisory Committee for the University of Michigan College of Pharmacy. Dr. Lipper is also on the editorial advisory board of the Journal of Pharmaceutical Innovation, is co-editor of the "AAPS Advances in the Pharmaceutical Sciences" book series, and served on the board of directors of the Product Quality Research Institute.

Dr. Lipper earned his Ph.D. in Pharmaceutical Chemistry from the University of Michigan, and his B.S. in Pharmacy from Purdue University.

With 30 years of experience converting discoveries into businesses, Dr. Fix holds 24 patents, including 4 NECs, 13 LCMs, 4 OTCs, and 3 generics. His expertise is the business of the business: Strategic planning and implementation, business and technology integration, in/out licensing due diligence, and all aspects of product development. Dr. Fix is an expert in laying the foundation for lasting pharmaceutical companies. +

With 30 years of experience converting discoveries into businesses, Dr. Fix holds 24 patents, including 4 NECs, 13 LCMs, 4 OTCs, and 3 generics. His expertise is the business of the business: Strategic planning and implementation, business and technology integration, in/out licensing due diligence, and all aspects of product development. Dr. Fix is an expert in laying the foundation for lasting pharmaceutical companies.

Dr. Fix has held a number of executive positions, including President and COO of CyDex, EVP and COO of NanoSystems/Elan, President and CTO of Yamanouchi Pharma Technologies, Associate Director of Biological Sciences for both ALZA and Merck. A recognized expert in drug delivery, he has served on the Board of CRS. He has also held adjunct faculty positions at the University of Southern California, Purdue University and the University of Kansas.

Dr. Fix holds a Ph.D. in neurophysiology from the University of Kansas, and an MBA from Pepperdine University.

With over 35 years of experience, Dr. Kent offers expertise in overcoming development challenges for orals, topicals and ophthalmics, plus specialized expertise in sterile products. He has proven experience resolving organizational, productivity and global regulatory issues. His contributions have resulted in more than 20 commercial products and multiple CMC IND and NDA filings. +

With over 35 years of experience, Dr. Kent offers expertise in overcoming development challenges for orals, topicals and ophthalmics, plus specialized expertise in sterile products. He has proven experience resolving organizational, productivity and global regulatory issues. His contributions have resulted in more than 20 commercial products and multiple CMC IND and NDA filings. 

Dr. Kent’s corporate experience includes serving as VP, Pharmaceutical Science at both Theravance and Allergan. He was also Director, Pharmaceutical Development at Syntex, and on the Scientific Advisory Board at BioScreen Testing Services.

Dr. Kent earned is Ph.D. in Pharmaceutics and B.S. in Pharmacy at the?University of Wisconsin, Madison.

Dr. Mooney has 35 years’ experience in pharmaceutical sciences and exploratory drug development. He combines in-depth pharmaceutical knowledge with experience in multiple scientific applications to provide clients an optimal path to the achievement of drug candidate goals. Dr. Mooney has contributed to more than 30 NDA product filings and over 100 IND filings and has led large multidisciplinary groups in the Pharmaceutical Industry. +

Dr. Mooney has 35 years’ experience in pharmaceutical sciences and exploratory drug development. He combines in-depth pharmaceutical knowledge with experience in multiple scientific applications to provide clients an optimal path to the achievement of drug candidate goals. Dr. Mooney has contributed to more than 30 NDA product filings and over 100 IND filings and has led large multidisciplinary groups in the Pharmaceutical Industry.

Most recently Dr. Mooney was VP, Exploratory Development Portfolio at Pfizer, and VP, Pharmaceutical Sciences at Pfizer Europe. Previously he was at GD Searle, Boehringer Ingelheim (USA) and American Cyanamid. He is qualified as a Pharmacist in the U.K.

Dr. Mooney earned his Ph.D. in Pharmaceutical Sciences at University of Kansas, and B.S. and M.S. in Pharmacy at University of London. He is a William Pitt Fellow at Pembroke College Cambridge, U.K., and a member of the American Association of Pharmaceutical Scientists and of the Royal Pharmaceutical Society of Great Britain.

Dr. Gatlin is an industry veteran with more than 36 years of scientific and leadership experience. He is an expert in the formulation and process development of sterile and biopharmaceutical products. He has expertise in small and large molecules, as well as lyophilization. He is also a recognized expert in process optimization and personnel development. +

Dr. Gatlin is an industry veteran with more than 36 years of scientific and leadership experience. He is an expert in the formulation and process development of sterile and biopharmaceutical products. He has expertise in small and large molecules, as well as lyophilization. He is also a recognized expert in process optimization and personnel development. 

Dr. Gatlin has three formulation and process patents, and has contributed to multiple IND and NDA filings. His diverse experience includes work with the U.S. Public Health Service - NIH Clinical Center, The Upjohn Company, Genentech, Glaxo (Glaxo-Wellcome), Biogen, and Pfizer. In senior-level management roles, he has lead teams in formulation, analysis, and packaging development. He has successfully resolved manufacturing issues, including increasing manufacturing throughput by ten fold, rapid scale-ups with minimal resources, and reduction of freeze-drying cycle times by as much as fifty percent. 

A recognized expert in sterile process optimization and personnel development, Dr. Gatlin is an experienced public speaker and has authored numerous papers and book chapters. Dr. Gatlin earned his Ph.D. in Pharmaceutical Sciences at the University of Kentucky, and his B.S. in Pharmacy at Oregon State University.

With more than 30 years of drug development experience, Dr. Van Campen is an expert in the establishment of best practices in large, mid-size and start-up organizations. She is a proven scientist, manager and executive who has played key roles in the development and launch of 18 products representing 8 dosage forms, and 3 devices. She has special expertise with dry powder and metered dose inhalation product development. +

With more than 30 years of drug development experience, Dr. Van Campen is an expert in the establishment of best practices in large, mid-size and start-up organizations. She is a proven scientist, manager and executive who has played key roles in the development and launch of 18 products representing 8 dosage forms, and 3 devices. She has special expertise with dry powder and metered dose inhalation product development.

Dr. Van Campen’s career is highlighted by her ability to guide effective development science into successful products. As the first Director of the Zeeh Pharmaceutical Experiment Station at the University of Wisconsin School of Pharmacy, she defined the mission, hired the staff and established the client relationships to ensure the lab’s long-term success. Previously she served as VP, Pharmaceutical Development at Inhale/Nektar, and Director, Pharmaceutics at both Boehringer Ingelheim and Synergen.

Dr. Van Campen further solidifies herself as a premier industrial pharmaceutical scientist through her many research and technical publications, book chapters, and numerous presentations. In 2007, Dr. Van Campen received the AAPS Presidential Citation for her leadership in the strategic visioning and implementation of sections representing nearly half of the Association’s members.

Dr. Van Campen earned both her Ph.D. and M.S. in Pharmaceutics from the University of Wisconsin, Madison.

Having worked 32 years with all early to mid-stage companies, Dr. Staples is an expert at the early development of small organic molecules, peptides, proteins, biologics, and combination products. He offers specialized expertise in the management of outsourced lab and manufacturing resources, as well as the collection and compilation of data for the Chemistry, Manufacturing and Controls (CMC) section of Regulatory submissions. +

Having worked 32 years with all early to mid-stage companies, Dr. Staples is an expert at the early development of small organic molecules, peptides, proteins, biologics, and combination products. He offers specialized expertise in the management of outsourced lab and manufacturing resources, as well as the collection and compilation of data for the Chemistry, Manufacturing and Controls (CMC) section of Regulatory submissions.

Dr. Staples has held senior leadership positions with several early stage companies, including MicroCHIPS, GlycoGenesys, and Praecis. He rose to the position of Section Head, Development at Biogen, where he founded and lead the Formulation and Analytical Development Group. Dr. Staples’ experience encompasses all analytical, formulation and process development functions, work that has resulted in the launch of 3 biologic and small molecule products.

Active in the advancement of the industry, Dr. Staples chaired the Biotechnology Section and numerous committees for the AAPS. He has also served on the Board, and as President and Treasurer, of the Parenteral Drug Association (PDA) New England Chapter.

An expert in the development of scientific and business strategies for start-ups, Dr. Pearlman brings a unique balance of experience from the lab as well as the corner office. He has lead numerous emerging companies through the development of formulations, processes and delivery systems, while at the same time hiring management teams, raising capital and establishing operations plans. +

An expert in the development of scientific and business strategies for start-ups, Dr. Pearlman brings a unique balance of experience from the lab as well as the corner office. He has lead numerous emerging companies through the development of formulations, processes and delivery systems, while at the same time hiring management teams, raising capital and establishing operations plans.

Dr. Pearlman has more than 30 years of industry experience. In addition to his consulting work, Dr. Pearlman serves as President of The Bluefield Project working to develop a cure for frontotemporal dementia. Previously, Dr. Pearlman served as the President and/or CEO of several start-ups, including Saegis Pharmaceuticals, Nuon Therapeutics, and InCarda Therapeutics. Saegis, was acquired by Danish neuropharmaceutical firm H. Lundbeck while under his management. Dr. Pearlman has also held leadership positions at Valentis and Genentech, was a Senior Scientist at Eli Lilly, and was on the faculty at the University of Texas, Austin.

Dr. Pearlman earned his Ph.D. in Pharmaceutical Chemistry from the University of Kansas, and his B.S. and M.S. in Pharmacy from the Victorian College of Pharmacy in Melbourne, Australia.

Dr. Appel has over 20 years’ experience in the pharmaceutical industry developing drug delivery technologies and products. She is an expert in oral solid dosage forms including controlled release and delivery of poorly soluble compounds. She is an inventor on 35 drug delivery patents and patent applications. +

Dr. Appel has over 20 years’ experience in the pharmaceutical industry developing drug delivery technologies and products. She is an expert in oral solid dosage forms including controlled release and delivery of poorly soluble compounds. She is an inventor on 35 drug delivery patents and patent applications. 

Prior to founding Green Ridge Consulting, Dr. Appel was Director, Controlled Release at Bend Research; Sr. Pharmaceutical Scientist at Sarcos; and Sr. Research Chemist at INTERx (a division of Merck).

Dr. Appel earned her Ph.D. in Pharmaceutics from the University of Utah, and her B.S. in Chemical Engineering from UCLA.

Dr. Berner holds more than 40 patents in various areas of drug delivery, but is an internationally recognized expert in controlled release, oral and transdermal technologies. In accomplishing these breakthroughs, he has led formulation, clinical and regulatory development and patent activities, and has expertise in analytical chemistry. +

Dr. Berner holds more than 40 patents in various areas of drug delivery, but is an internationally recognized expert in controlled release, oral and transdermal technologies. In accomplishing these breakthroughs, he has led formulation, clinical and regulatory development and patent activities, and has expertise in analytical chemistry. 

Over his 35 years in pharmaceutical development, Dr. Berner has played a key role in the commercialization of more than a dozen products. He was Chief Scientific Officer and VP, Product Development at Depomed; VP, Development and Drug Delivery at Cygnus Systems; Director, Basic Pharmaceutics Research, at Ciba Geigy; and started his career as Staff Scientist at Procter & Gamble. A prolific author, Dr. Berner has published over 90 articles and books.

Dr. Berner received his Ph.D. from UCLA, and B.A. from the University of Rochester.