Ralph Vitaro
Publisher/President

In 1984, Ralph began his career in publishing as a member of the start-up team for a new magazine titled Spectroscopy which was a publication serving the analytical instrumentation market. Following its success in the United States, Ralph expanded the operation abroad and introduced Spectroscopy Europe the following year. Ralph is also credited with the introduction of BioPharm magazine and later became its Publisher. In 1990, Ralph became the Publisher of Pharmaceutical Technology and then Group Publisher of Applied Clinical Trials, Pharmaceutical Executive, BioPharm, and Pharmaceutical Technology Europe. Ralph was also the General Manager for Advanstar Communication's Pharmaceutical Group of global publications, conferences, and trade shows. In 2001, after a successful 16 years with Aster Publishing and Advanstar Communications, Ralph founded Drug Development & Delivery LLC.

Dan Marino, MSc
Executive Director

Prior to launching Specialty Pharma and Drug Development & Delivery, Dan served as Managing Editor of Dentistry Today, the nation's leading clinical magazine for dentists, and more recently as Director of Continuing Medical Education for a healthcare education company in northern New Jersey. He offers Specialty Pharma and Drug Development & Delivery a fresh, approachable perspective, taking great pride in building trusting professional relationships with scientific and business authors as well as pharmaceutical companies. Dan's responsibilities include management of all day-to-day operations of Editorial and Creative content and production as well as building and managing the Editorial Advisory Board and Specialty Pharma Council. Dan earned his BS in Health Sciences and Journalism and his MSc in Medicine (Physiology) from West Virginia University in Morgantown. 

John Kiesewetter
Global Sales & Marketing Director

John Kiesewetter has spent his entire career in the B2B publishing arena as an accomplished professional working in both global and domestic markets with extensive experience in life science and related industries. In 1988, John started his career as a member of the advertising sales team for Pharmaceutical Technology and BioPharm Manufacturing. Throughout the next several years, John gained experience working on Circulation Management magazine and then expanded his role with Spectroscopy International, a start-up publication serving the European analytical instrumentation market, and Medical Device Technology, another start-up in Europe. He then returned to the US as Publisher of CADalyst, a unique opportunity to work in the computer aided design field for 3 years. From 1995 to 2007, he was the US Sales Manager for Pharmaceutical Technology Europe (playing a key role in introducing US companies to the pan-European pharmaceutical market) as well as launching Pharmaceutical Technology Asia. From 2002 to 2012 worked on Applied Clinical Trials, a niche publication serving the global clinical trials market just before the evolution of the Contract Research Organization (CRO) era. For 10 years, John acquired extensive expertise in helping his clients market their innovative services and technologies to the CRO industry, playing a key leadership role as the market grew and integrated electronic marketing campaigns changed the way business was conducted. In 2013, after a successful 25 years with Aster Publishing and Advanstar Communications, John joined Drug Development & Delivery as its Global Sales & Marketing Director.

Cindy H. Dubin

Contributor
                                   

Ms. Cindy H. Dubin has been a professional journalist since 1988. She is currently a Contributing Editor to Drug Development & Delivery as well as Editor-In-Chief of its Specialty Pharma section. Prior to these positions, she spent several years focusing her writing on pharmaceutical formulation and development. She has been recognized by the American Society of Business Press Editors for an article she wrote on nanotechnology, and her writing has been awarded by the prestigious Neal Award Committee for Journalistic Excellence. Ms. Dubin earned her BA in Journalism from Temple University in Philadelphia and her certificate in Business Logistics from Pennsylvania State University.  

Introducing The Drug Development & Delivery
Editorial Advisory Board

Shaukat Ali

Shaukat Ali, PhD, MSc
Technical Support Manager
BASF Pharma Solutions

Dr. Shaukat Ali has over 13 years of experience in drug design and formulations development. He has been with BASF Pharma Solution for over 3 years working in the areas of formulations, solubilization, drug delivery, film coating and film development technologies. Dr. Ali started his career in the pharmaceutical industry at Liposome Co. (Elan), where he worked on drug discovery and preformulation development of lipid-based anti-cancer and anti-inflammatory drugs. That effort led to pre-IND development of a number of NCEs and pro-drugs for application in cancer treatment. He joined Penwest Pharmaceutical, where he worked on sustained-release TimeRx matrix, and later joined Lavipharm, where he worked on transdermal drug delivery. Dr. Ali holds 25 publications in peer-reviewed scientific journals and 12 US patents. He has published and presented over 30 abstracts and posters to scientific meetings. He has organized innumerable technical presentations and roundtable discussions with scientists to promote and support BASF's excipients and actives in the NAFTA region. Before joining the pharmaceutical industry, Dr. Ali joined the faculty of University of Bridgeport, Connecticut, where he taught chemistry and biochemistry. He earned his BS and MS from the Universities in India; an MSc from Laurentian University, Sudbury, Ontario; and his PhD from the City University of New York; all in Chemistry. Following his graduate degree, Dr. Ali also obtained 4 years of post-doctoral training at the University of Minnesota and Cornell University and worked on surface chemistry and membrane biochemistry of lipids. He is a member of AAPS, ACS, and CRS.

Jack Aurora, PhD
Chief Scientific Officer, Generic Drugs
Hisun Pharma Co. Ltd.

Dr. Jack Aurora is currently Chief Scientific Officer, Generic Drugs at Hisun Pharma Co. Ltd. Previously, he wasVP, Formulations Operations for Azopharma Product Development Group and Senior Director, R&D for the Perrigo Company. In this role, Dr. Aurora was responsible for leading formulation research and development in Perrigo's consumer healthcare business. Most recently he was Director of Pharmaceutical Research and Development with Pharmascience Inc. based in Montreal. He also worked as Director of Formulation Development at Labopharm, Inc, a specialty pharmaceutical company focused on controlled-release drug delivery design and development. Prior to joining Labopharm, Dr. Aurora worked at Patheon, Inc, as Manager of Formulation Development, where he was responsible for formulation development and business support activities for various clients involving solids, semi-solids, and nasal (NDA) product development. Dr. Aurora is also a consultant with Council of Healthcare Advisors, an association of leading physicians, scientists, and other healthcare professionals. He is also part time facility member with Seneca College in Toronto and member of visiting scientist program sponsored by AAPS. His research focuses include development of Controlled-Release Systems, Pelletization Technology, and Nasal Formulation Development. In the field of controlled-release development, he has one US patent to his credit and another four are in process. 

Anand R. Baichwal, PhD
Managing Partner
LacertaBio BD&L

Anand R. Baichwal, PhD, is Managing Partner of LacertaBio BD&L. He was previously the Chief Scientific Officer and Senior VP of Research and Pharmaceutical Development for Penwest. His professional career started with a Bachelor of Pharmacy and Masters in Pharmacy from Bombay University, India, in 1977 and 1979, respectively. He continued his education in the United States of America with a Masters in Industrial Pharmacy from St. John's University in New York in 1981. He completed his PhD in Industrial Pharmacy from the University of Maryland in 1985. Dr. Baichwal started his business career in 1986 with the Mendell Co., which was acquired by Penwest in 1991. Penwest Pharmaceuticals is a publicly traded Specialty Pharma company. He has been with this organization since 1986 in various technical positions. Dr. Baichwal is the co-inventor of its flagship oral drug delivery technology, TIMERx? and other extensions to this technology. He has a number of patents on these systems and has presented and published extensively on drug delivery. His research interests include excipients, formulation technology, and drug delivery. He is a member of professional associations, such as AAPS and CRS.

John A. Bermingham
Executive VP & COO
1st Light Energy & Conservation Lighting, Inc.

           
John A. Bermingham is currently the Executive Vice President & COO of 1st Light Energy & Conservation Lighting, Inc. He was previously Co-President and COO of AgraTech, a biotech enterprise. Previous to that, he was President & CEO of Cord Crafts, LLC, a leading manufacturer and marketer of permanent botanicals. More previously, he was President & CEO of Alco Consumer Products, Inc., Lang Holdings, Inc., and President, Chairman, and CEO of Ampad, all of which he turned around and successfully sold. With more than 20 years of turnaround experience, he also held the positions of Chairman, President, and CEO of Centis, Inc., Smith Corona, Corporation, and Rolodex Corporation as well as turning around several business units of AT&T Consumer Products Group and served as the EVP of the Electronics Group, and President of the Magnetic Products Group, Sony Corporation of America. Mr. Bermingham served 3 years in the US Army Signal Corps with responsibility for Top Secret Cryptographic Codes and Top Secret Nuclear Release Codes, earned his BA in Business Administration from Saint Leo University, and graduated from the Harvard University Graduate School of Business Advanced Management Program.

Marshall Crew, PhD
VP, Global PDS Scientific Excellence
Patheon

Dr. Marshall Crew became the VP, Global PDS Scientific Excellence at Patheon after Agere Pharmaceuticals (where he was the President, CEO & Founder) was acquired by Patheon in 2015. The company supports clients from formulation design and development through cGMP manufacturing for Phase I through Phase IIb clinical trials. Dr. Crew has devoted his career to improving oral bioavailability, developing innovative technologies and approaches for the delivery of poorly soluble drugs and then managing their application to achieve client success. Prior to Agere, he was VP of Chemical and Biological Sciences at Bend Research. Dr. Marshall’s scientific expertise includes formulation design and development, solid state characterization of drug substance and product, and computational modeling (predicting shelf-life and pharmacokinetic and bioavailability for oral, devices and parenteral delivery). He is a world expert in the design of API physical properties to optimize efficacy and overcome PK and delivery constraints. Over 27 patents and patent applications have been issued or filed under his name on various drug delivery platforms, including controlled release, nanotechnology and solid dispersions. Dr. Marshall earned his PhD in Physical Chemistry from Oregon State University, and is a member of Agere’s Board of Directors.

Debra Bingham

Ms. Debra Bingham
Partner
Valeo Partners

Ms. Debra Bingham is a Partner of Valeo Partners. She brings clients over a decade of specialized expertise in the pharmaceutical and biotech industries. At Valeo, her primary focus is in helping clients in the areas of business strategy, business development, growth opportunity assessment, and strategic partnering. Ms. Bingham leads Valeo's strategic partnering offering in affiliation with Stonecroft Capital, a DC-based investment bank, which provides full-service transactional capabilities from licensing to M&A. She spent the majority of the past 10 years working in the pharmaceutical industry assisting companies with strategic business assessment and business development. Ms. Bingham has authored many drug delivery business articles and technology reviews and is a featured speaker at industry trade conferences.

Josef Bossart, PhD
Managing Director
Bionumbers LLC

Dr. Josef Bossart is the Managing Director of Bionumbers LLC (www.bionumbers.com). Bionumbers is a boutique research group based in Austin, TX, offering critical numbers and actionable insight into the parameters that impact the success and performance of products and companies in the biopharmaceutical sector. Dr. Bossart has more than 25 years of global biopharmaceutical experience in the areas of business development, strategy, operations, as well as sales and marketing. His biopharmaceutical company experience includes, most recently, executive positions at Enzon Pharmaceuticals and GeneMedicine, Inc. Prior to that, he spent 15 years within the RHne-Poulenc Rorer group, lastly as Vice President of Business and Marketing Development for the RPR Gencell division. Dr. Bossart earned his PhD in Medicinal Chemistry from The Ohio State University, College of Pharmacy, and his BSc (Hon.) in Chemistry from Carleton University. 

Matthew Burke

Matthew D. Burke, PhD
Principal Scientist, Exploratory Pharmaceutics
GlaxoSmithKline

Dr. Matthew D. Burke currently serves as a Principal Scientist at GlaxoSmithKline in the Exploratory Pharmaceutics division of Pharmaceutical Development in the Research Triangle Park, NC, site. His responsibilities include development of novel drug delivery systems focusing on gastroretention and advanced polymer applications. In addition, he is responsible for the evaluation of external drug delivery technologies and specialized analytical technologies to be applied primarily in the area of oral drug delivery development. Within GSK, Dr. Burke serves as Co-chair of an international drug delivery group that assesses oral, inhalation, transdermal, and buccal delivery systems. Dr. Burke has published approximately 18 articles and symposium abstracts and is an active member of the American Association of Pharmaceutical Scientists. Dr. Burke earned his BS in Biochemistry and BS in Chemical Engineering from Virginia Tech and his MS and PhD in Chemical Engineering from North Carolina State University.  

Mahesh V. Chaubal, PhD, MS
Senior Director, R&D
Baxter Healthcare

Mahesh Chaubal is the Senior Director of R&D for Baxter Healthcare and the Founder and Principal of Drugdel.com, an online information website and consulting firm specializing in the field of drug delivery and alternative formulations. Dr. Chaubal earned his BS in Chemical Engineering from the University of Bombay (UDCT) and his MS and PhD in Chemical and Biochemical Engineering from the University of Maryland. His PhD research involved developing novel formulations for protein C, a zymogen precursor of the active ingredient of Xigris, which is the first FDA-approved protein therapeutic for severe sepsis. Dr. Chaubal has worked in the field of drug delivery and pharmaceutical polymers for more than 9 years and has published approximately 30 peer-reviewed articles, symposium abstracts, and industry reports in this field. He was a member of the team that brought Gliadel, the first sustained-release chemotherapeutic formulation, to market. His experience in drug delivery systems includes novel polymer research, development of innovative formulations for small molecules, proteins, and gene-based drugs as well as scale-up and validation of processes for drug delivery formulations.  

Wei-Guo Dai, PhD
Janssen Fellow & Scientific Director
Johnson & Johnson

Dr. Weiguo Dai is currently an inaugural Janssen Fellow and Scientific Director in Drug Product Development at Janssen, the Pharmaceutical Companies of Johnson and Johnson. Dr. Dai's research and innovation have focused on improving both biological and small molecule drug products through design and development of novel formulations, proprietary delivery technologies, device, and processes. His technology innovations have directly led to the launch of a current commercial product by Johnson and Johnson, and established the development projects for clinical trials. Dr. Dai is the recipient of several prestigious awards including 2011 Johnson and Johnson Corporate Philip B. Hofmann Research Scientist Award. He has authored/co-authored over 40 peer-reviewed journal articles, and currently serves on the Editorial Advisory Board for 4 peer-reviewed pharmaceutical journals. He also serves as an Adjunct Professor at University of the Pacific in California, USA. In addition, Dr. Dai is currently President-Elect of Sino-American Pharmaceutical Professionals Association (SAPA)-Greater Philadelphia, a nonprofit professional organization with over 4,000 members. Dr. Dai earned his PhD from The Johns Hopkins University, and his prior experience included R&D positions in Guilford Pharmaceuticals (now Eisai), Amgen, and ALZA/Johnson and Johnson.      

Clifford M. Davidson, Esq.
Founding Partner
Davidson, Davidson & Kappel, LLC

Clifford M. Davidson, Esq. is a Founding Partner at Davidson, Davidson & Kappel, LLC, an Intellectual Property law firm with offices in New York City and Frankfurt, Germany. He counsels pharmaceutical clients in pharmaceutical patent-related matters, including patent prosecution, freedom to operate and infringement opinions, due diligence and tech-transfer, and litigation (including ex parte and inter partes proceedings worldwide). He has assisted specialty pharma and drug development companies to create significant patent portfolios, and the patents he has written and the patent portfolios he has created have been recognized as creating significant value for his clients. He has written patents covering virtually all areas of drug development, and has pioneered strategic patent focus on the pharmacokinetic profiles and the pharmacologic activity of drug/drug formulations. Mr. Davidson earned his BS in Pharmacy and his JD from Rutgers University and is a member of the New York and New Jersey Intellectual Property Law Associations, the American Pharmaceutical Association, and The Controlled Release Society. His area of expertise includes new chemical entities; new pharmaceutical formulations (including controlled release oral dosage forms, injectables, transdermals,ophthalmics, inhalation, intranasal, sublingual, suppository, and implantation administration); new combinations of previously known drugs; new modes of administration of previously known drugs; method of treatment; pharmaceutical excipients; and methods of preparation.

  John Fraher

Chief Executive Officer

Adare Pharmaceuticals


Mr. John Fraher is the Chief Executive Officer of Adare Pharmaceuticals, which provides enhanced medicines, creating new possibilities for improved patient health. He was previously President at Aptalis Pharmaceutical Technologies. Prior to Aptalis, he held a number of executive positions at Eurand, including CEO, President, and Chief Commercial Officer. He also held positions with a number of multinational pharmaceutical companies in Ireland. Mr. Fraher earned his degree in Biochemistry from University College Dublin, Ireland.




 

Jane Fraser, PhD

Research & Development Director

Capsugel (Encap)

 

Jane Fraser, PhD, is Research and Development Director at Capsugel’s Edinburgh facility. She has more than 16 years of experience within the pharmaceutical industry, in both CRO and biopharmaceutical environments. In her current role, she leads the site management of all activities relating to drug product development. This includes responsibility for the formulation development, analytical development, quality control, and project management teams. In addition, she oversees the related manufacturing requirements for clinical products. She earned an honors degree in Applied Biochemistry in 1994 and her PhD in 1999, both from the University of Paisley. After leaving university, Dr. Fraser worked with Vitrolife for 3 years as a Research Scientist, before moving to Aptuit (formerly Quintiles) in 2000. During her time there, she held positions as Senior Formulation Scientist, Formulation Supervisor, Formulation Development Manager, and Director of Pharmaceutics. Dr. Fraser is also the author on two patents. 


  Thomas B. “Brad” Gold, PhD

Vice President of Pharmaceutical Development

Metrics Contract Services

 

Dr. Thomas B. “Brad” Gold serves as Vice President of Pharmaceutical Development at Metrics Contract Services, where he is responsible for fast-track development, clinical batch manufacture, scale up, and commercial validation of solid oral dosage forms. A contract pharmaceutical industry veteran of 20 years, Dr. Gold recently was awarded a US patent for a zero-order release kinetics coated tablet, which provides osmotic-like delivery benefits without the accompanying manufacturing challenges. Prior to joining Metrics, he held scientific roles at DSM as a group leader and Banner Life Sciences as scientist and pilot plant manager. At the latter organization, he led the start up of a business unit focused on early-phase development and clinical supplies manufacture of soft elastic gelatin capsules. Dr. Gold earned his PhD in Pharmaceutics from the University of Kentucky, from which he earned his MSc in Chemistry. One area of his expertise is the prediction of crosslinking and drug dissolution rates using near-infrared spectrophotometry.


Derek G. Hennecke, MBA

President

Capsugel (Xcelience)

 

Mr. Derek Hennecke is President of Xcelience, which was acquired by Capsugel in January 2016. From 2004 to 2006, he served as Vice President and General Manager, Pharmaceutics and Biopharmaceuticals of MDS Pharma Sciences, Inc. In this capacity, he was responsible for the business and operations of MDS' CRO formulation development, including capsule development, tablet formulation, modified-release tablets, suspensions, solutions, suppositories, creams, ointments, and gels. Prior to joining MDS, Mr. Hennecke held various drug development management positions for DSM in Canada, Egypt, The Netherlands, and Mexico. In these roles, he built the operations or businesses to introduce various drug products for Europe and the US. Mr. Hennecke has also worked for Roche's research activities in Germany and Canada. He earned his BSc from the University of Alberta (Canada) and his MBA at the Erasmus University in Rotterdam, (The Netherlands). 


Keith Horspool, PhD
Vice President, Material & Analytical Sciences
Boehringer Ingelheim

Dr. Keith Horspool is Vice President of Material and Analytical Sciences at Boehringer-Ingelheim, Ridgefield, CT.  His department develops and applies scientific methods and tools to generate improved product and process understanding and robustness. This is a new organization, and the goal is to apply physical/material sciences-based approaches (eg, crystal engineering, structural analyses, physical characterization, predictive modeling) throughout the duration of the drug development and commercial lifespan of a product supporting the implementation of effective, cost-efficient processes for the manufacture of drug product and drug substance. Prior to joining BI, he worked at Pfizer and Astra Zeneca. He has ~27 years of experience during which he has managed preformulation, product development, drug delivery, and materials science.  He earned his BSc in Pharmacy and his PhD in Pharmaceutical Chemistry.

 

Syed T. Husain, MBA

Chief Commercial Officer

Alcami Corporation

Syed Husain is Chief Commercial Officer at Alcami, a world-class supplier of comprehensive pharmaceutical development and manufacturing services across Drug Substance and Drug Product. He is responsible for all commercial & business activities within the organization. Syed brings valuable commercial leadership with over 11 years of in-depth experience in sales, business development, marketing, and operations for the custom development and manufacturing of Chemical (Small Molecules, Antibody Drug Conjugates, Peptides) and Biologic (Mammalian and Microbial) drug substance and drug product within the Pharmaceutical and Biotech industry. Prior to joining Alcami, Syed served as Head of Business Team at Lonza, responsible for the Chemical API manufacturing business. From 2005 to 2013, while also at Lonza, he served as Director, Sales & Business Development responsible for Biologic and Chemical APIs and Head of Sales & Business Development for the Chemical API Manufacturing Business Unit. Syed earned his BS in Chemical Engineering from New Jersey Institute of Technology and his MBA from Cornell University.



  Paul Josephs
Senior VP, Sales, Marketing & Corporate Development
DPT

Paul Josephs earned his BS in Political Science from The University of Western Ontario in 1988. He joined DPT in 1997 after a very impressive and successful term as Senior Business Manager with Patheon, Inc., where he held responsibility for leadership of the business development team. Prior to Patheon, he enjoyed an equally successful career as a Medical Sales Representative and Trade Marketing Manager with Marion Merrell Dow. He joined DPT as an Account Manager and rapidly progressed with increasing responsibilities, to Director, Strategic Business Unit. Mr. Josephs was promoted to Vice President in 2001. In his role as Vice President, he has held responsibility for Sales, Project Management, Commercial Services, and Marketing. In his current capacity, he is responsible for Sales, Marketing, and Corporate Development.

      
     
 

Cindy R. Kent, MBA
Vice President & General Manager
3M Drug Delivery Systems Division

Cindy Kent is the Vice President and General Manager of 3M Drug Delivery Systems Division. Ms. Kent most recently served as the Vice President of Strategy, Business Development and US Medical Key Accounts for 3M Healthcare. Prior to joining 3M, she was Vice President and General Manager of the Gastro/Urology Therapies Business Unit of Medtronic, Inc. and has held a number of roles at Eli Lilly in manufacturing, human resources, sales, and marketing, giving her broad expertise in the pharmaceutical and medical device industries.
Ms. Kent holds a BS in Industrial Engineering and Management Science from Northwestern University as well as both an MBA in Marketing and Masters in Divinity from Vanderbilt University.


Uday B. Kompella, PhD
Professor of Pharmaceutics
Department of Pharmaceutical Sciences
University of Colorado, Denver

Dr. Uday B. Kompella is a Professor of Pharmaceutics in the Department of Pharmaceutical Sciences at the University of Colorado, Denver. He held the same position at the University of Nebraska Medical Center in Omaha, Nebraska. He is Chair-Elect (2001-2002) of the AAPS Regulatory Sciences (RS) section, and is a member of the AAPS Annual Meeting Programming and Program Coordination Committees. A 1997 recipient of the AAPS New Investigator Award in Pharmaceutics and the Pharmaceutical Technologies, Dr. Kompella is also one of the founders and current Chair for the AAPS Ocular Drug Delivery & Disposition focus group of AAPS. His research interests include drug delivery via ocular, nasal, and pulmonary routes, and ongoing research in his laboratory includes developing drug delivery approaches for diabetic complications. He has been published extensively, held various academic appointments, received numerous grants, and participates in several professional and government organizations/ institutions. Dr. Kompella earned his BS and Masters in Pharmacy in India and his PhD in Pharmaceutical Sciences from the University of Southern California.

Rakesh Patel, PhD, MPharm
Assistant Professor & Head
Pharmaceutics & Pharmaceutical Department
S.K. Patel College of Pharmaceutical Education & Research

Dr. Rakesh Patel is currently working as Assistant Professor and Head of Pharmaceutics and Pharmaceutical Technology Department at the S.K. Patel College of Pharmaceutical Education and Research (SKPCPER), Ganpat University, Ganpat Vidyanagar, India. He earned his PhD in Pharmaceutical Sciences from Hemchandrachrya North Gujarat University, Patan and his MPharm in Pharmaceutical Technology from M.S. University, Baroda. His current research interests include formulation and development of novel and conventional pharmaceutical products, dissolution enhancement techniques, drug delivery, regulatory affairs, industrial pharmaceutical manufacturing, and antimicrobial plant screening. He has completed several industrial research and consultancy projects related to formulation development and regulatory affairs. He has prepared more than 100 dossiers for product registration in various countries for a pharmaceutical company. He has more than 50 research publications and 40 presentations in international and national journals and conferences, respectively. He is working as an Advisory Editorial Committee Member of Dissolution Technologies and Pharmaceutical Manufacturing, USA.

  Graham Reynolds
Vice President, Marketing & Innovation
West Pharmaceutical Services

Mr. Reynolds joined West in 1980 as a Polymer Technologist, and throughout his 33-year career with the company, has held a range of positions with increasing responsibility. In his current role as Vice President, Marketing & Innovation, Mr. Reynolds works as part of the leadership team within the Delivery Systems business segment, where he leads initiatives and develops strategies for growth of West business, including the acquisition and development of new technologies that enhance the West portfolio. His activities include working to understand market and customer needs, with a focus on Integrated Drug Delivery Systems for injectable products, including prefillable syringes, self-injection systems, and various safety and administration systems. Mr. Reynolds earned his degree in Polymer Technology at Trowbridge college in the UK.



 

Dana Settell, PhD
Vice President
Capsugel (Bend Research)

Dr. Dana Settell oversees large, late-stage manufacturing and engineering programs at Capsugel’s Bend, Oregon, facility. Formerly, she was Director of Business Development. In addition, in a previous position as Director of Operations at the company’s current Good Manufacturing Practice (cGMP) facility, she assisted with the installation, commissioning, start-up, maintenance, validation, and operation of a PSD-2/FSD-4 spray dryer. Ms. Settell has extensive experience with scaling-up drug production from development through commercial production. She was instrumental in the start-up of a $90-million commercial plant in Ireland to manufacture spray-dried dispersion (SDD) technology at the metric ton scale. Ms. Settell earned her Bachelors of Science in Chemical Engineering from the University of Colorado. She holds two US patents and has two publications to her credit. She has been with the company since 1999.


 

Frank Sorce, MBA

Vice President, Business Development

UPM Pharmaceuticals

 

Frank Sorce serves as UPM’s Vice President of Business Development. Mr. Sorce has over 25 years of experience in sales, marketing, and business development in the pharmaceutical and medical device industry and has a passion for meeting and exceeding client expectations. Mr. Sorce joined UPM in 2007 as Director, Marketing and Northeast Sales, and was appointed Senior Director, Business Development and Marketing in 2015. Mr. Sorce began his career with Merck Sharp & Dohme as a professional representative in Brooklyn, NY, and was an initial member of the Astra Merck Group. Thereafter, Mr. Sorce has held senior sales leadership positions of Regional Business Director with Reliant Pharmaceuticals, National Sales Director with InVentiv Health, and Director, National Sales for Songbird Hearing with responsibility for all sales and marketing efforts in North America. Mr. Sorce earned his BS in Management Science from Kean University, and his MBA in Marketing from Seton Hall University.


 

James Smith, PhD
President
NanoSmart Pharmaceuticals

Dr. James Smith has over 15-years of experience in regulatory affairs and the development of novel technologies from concept through commercialization. Dr. Smith earned his PhD in Pharmacology and Toxicology from the University of California, Irvine. He is experienced in all aspects of regulatory affairs, quality and data management systems, supervision of R&D, development of new product specifications, and with evaluating and registering medical drug and device product lines.

  Hugh Smyth, PhD
Bergen-Brunswig Fellow
Associate Professor, Pharmaceutics
Pharmaceutics Graduate Student Advisor 
The University of Texas at Austin College of Pharmacy


Dr. Hugh Smyth, Associate Professor of Pharmaceutics and Bergen-Brunswig Fellow at the University of Texas at Austin, College of Pharmacy, has numerous US patents both issued and applications. His research interests include pharmaceutical technologies and drug delivery systems. His current research focuses on novel drug delivery systems, including inhalation, nasal, ophthalmic, transdermal, and solid dosage forms. He has experience in microencapsulation, powder technology, polymeric-based drug delivery, and nanotechnology. He has been published extensively in many journals and is editor and author of three books. Dr. Smyth has participated in several national and international scientific symposia and conferences, served as a consultant to the NIH, NSF, and several pharmaceutical companies. He currently is the consulting Chief Scientist for Respira Therapeutics. He serves on the editorial advisory board for several academic and B2B publications. He earned his BPharm and PhD in Pharmaceutics from the University of Otago, New Zealand.

Jay S. Trivedi, MS, MBA
Head of Development Programs
Patrin Pharma

Mr. Jay S. Trivedi is Head of Development Programs for Patrin Pharma, a specialty drug development company based in the Chicago area. The development programs are focused on oral drug delivery technologies. Prior to joining Patrin Pharma, Mr. Trivedi was Director in the New Products Department at Schwarz Pharma and Senior Scientist in Product Development at Searle/Pfizer. His other assignments included 8 years at Abbott's Product Development department. Mr. Trivedi's experience spans from Drug Discovery to product launches. He has developed dosage forms from oral (tablet, capsule, chewable pediatric), suspensions, and parenteral dosage forms. He has authored more than 30 articles, a chapter in the book Water Insoluble Drug Formulations, and holds more than 9 patent applications. He is an international speaker at various drug delivery and specialty pharma conferences, a Council Board Member for Specialty Pharma magazine, and an active member of AAPS-PDD section (Chair, Preformulation Podium Session 1995, 1996, 1997) and Mid-Western Meeting's sponsor chair (1996). Mr. Trivedi also serves on the Editorial Board of two leading drug delivery journals and is Associate Editor (North America) for Current Drug Delivery journal.  

Henry Y. Wu, PhD
Director of Biopharmaceutics & Parenteral Delivery
Merck Research Laboratories

Dr. Henry Y. Wu is the Director of Biopharmaceutics and Parenteral Delivery in Pharmaceutical R&D of Merck Research Laboratories at West Point, PA. He leads a group of biopharmaceutical and parenteral formulation development scientists. The primary responsibilities of his group include a) development and implementation of in vivo, in vitro, and in silico models to guide oral or parenteral drug delivery in all development stages and b) development of parenteral formulations for small molecules and peptides to enable toxicology and clinical studies. Dr. Wu has published over 40 research papers. He earned his BS in Polymer Chemistry from University of Science & Technology of China, his MS in Medicinal Chemistry from Shanghai Institute of Pharmaceutical Industry, and his PhD in Organic Analytical Chemistry from New York University.

Cornell Stamoran, PhD
Vice President of Strategy & Corporate Development
Catalent Pharma Solutions
Executive Board Member
Catalent Applied Drug Delivery Institute


Dr. Cornell Stamoran was named Vice President of Corporate Development and Strategy of Catalent in November 2007. Mr. Stamoran has more than 20 years of experience in the pharmaceutical industry. Since joining Catalent in 1992, he has held many roles across a variety of disciplines, including financial and tax accounting; SEC reporting and financial planning; strategic business and technology planning; sales/business development; market intelligence; corporate development; marketing and branding; innovation; and public and investor relations. Prior to Catalent, he worked at Arthur Andersen & Co. In his current role, he leads Catalent’s market intelligence and strategic planning efforts as well as supporting its global M&A activities. Additionally, he serves as investor relations officer for the company’s debt holders. Mr. Stamoran earned a BS in Accounting and Management from the University of Michigan. He is also a Certified Public Accountant (CPA), a Certified Management Accountant (CMA), a Certified Information Systems Auditor (CISA), and a Certified Licensing Professional (CLP). In addition to being a member of the Association for Corporate Growth, the National Investor Relations Institute, the Society of Competitive Intelligence Professionals, and the World Futures Society, Mr. Stamoran has published articles in a variety of pharmaceutical trade publications. He has also served as conference chair and board member for several drug delivery and outsourcing industry conferences.
           
 

Vijaykumar Sutariya, BPharm, MPharm, PhD
Assistant Professor, Department of Pharmaceutical Sciences
USF College of Pharmacy

Dr. Sutariya is currently working as an Assistant Professor in the Department of Pharmaceutical Sciences at the USF College of Pharmacy and has a joint appointment with the Department of Internal Medicine, Division of Translational Medicine at University of South Florida. Prior to joining USF, he served as an Assistant Professor in the Department of Pharmaceutical Sciences at the Northeast Ohio Medical University (NEOMED). Dr. Sutariya has published more than 20 manuscripts in peer-reviewed journals and has presented at several national and international meetings. He is serving as a reviewer of many national and international journals and as a member of editorial advisory board of two journals. Dr. Sutariya’s research is focused on development of novel drug delivery systems, such as nanoparticles, liposomes, and thermo-reversible gels. His main research is focused on brain-targeted drug delivery and ocular drug delivery. Dr. Sutariya is currently serving as a Co-Investigator on two NIH grants (R01 and R15). In addition to research, Dr. Sutariya is instrumental in teaching various courses related to pharmaceutics in the PharmD curriculum. Dr. Sutariya is a member of American Association of Pharmaceutical Scientists (AAPS) and American Association of Colleges of Pharmacy (AACP). Dr. Sutariya earned his Bachelor of Pharmacy and Master in Pharmacy from L.M. College of Pharmacy, Gujarat University, Ahmedabad, India, and his PhD in Pharmacy from The M.S. University of Baroda, Vadodara, India. He conducted his post-doctoral training in the field of pharmaceutics and drug delivery from Butler University, Indianapolis, IN.

  Lilli Zakarija, MSME, MBA

Co-Founder & President

EdgeOne Medical Inc.

 

Lilli Zakarija is Co-Founder and President of EdgeOne Medical Inc, an ISO 13485- certified medical device testing firm and consultancy focused on supporting combination products through the device development (design control) process. Prior to founding EdgeOne Medical, she developed and led the global device engineering function for Baxter’s BioScience division (now Baxalta) in support of all its combination (biologic and device) products and single-use, disposable medical devices. Ms. Zakarija earned her BS in Biomedical Engineering, her Masters in Engineering Management from Northwestern University, and her Executive MBA from Kellogg School of Management.







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