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Contract Pharma Team



Contract Pharma Team

President, Rodman J. Zilenziger, Jr.
Rodman J. Zilenziger Jr. — President of Rodman Media since 1993. Zilenziger, son of the Company’s founder, joined Rodman Media as an Advertising Representative in 1984. In 1987 he was named International Sales Manager. Zilenziger was named President in 1993. As President of the Company, he has launched eight titles, created more than a dozen websites, and added several conferences and tradeshows to the Rodman roster of products. Under his leadership, Rodman Publishing Corporation has expanded its reach to all corners of the globe through a variety of mediums. He holds a BA in English and Economics from Denison University.
Executive Vice President / Publisher, Matthew J. Montgomery
Matthew Montgomery – Executive Vice President of Rodman Media since 2000. In addition to his role as EVP, he is also Publisher of Nutraceuticals World magazine. Montgomery joined Rodman Publishing in 1978 as an Advertising Representative, was promoted to Vice President of Sales in 1986, Publisher of Happi magazine in 1992 and then Group Publisher in 1996. He has been involved in all the new magazine launches and website launches at Rodman Media since 1995. He holds a BA Economics from Washington & Lee University.
Publisher, Gary Durr
Gary Durr has been serving the Pharma/Biopharma publishing industry for the past 23 years. He started his career as a national sales manager for Pharmaceutical Technology Magazine in 1988. He moved through the ranks to become the Publisher. In 1999, Gary left Pharmaceutical Technology and along with Damaris Kope launched Contract Pharma. Since its inception, Contract Pharma has grown to become the market leader for information and marketing opportunities for outsourcing and contract services providers.

Phone: 201-880-2229
Email: gdurr@rodmanmedia.com
Associate Publisher and Director of Sales, Damaris Kope
Damaris Kope is Associate Publisher and Director of Sales of Contract Pharma magazine. She joined Rodman Media in 1999 to launch the title which is now the largest global magazine and website devoted to pharmaceutical and biopharmaceutical outsourcing. Prior to her position at Contract Pharma, she was Associate Publisher of Pharmaceutical Executive magazine at Advanstar. Damaris hold a B.S. in Mass Communications and a minor in journalism from Kutztown University.

Phone: 732-452-0330
Email: dkope@rodmanmedia.com
Vice President / Editorial Director, Tom Branna
Tom Branna is VP/Editorial Director for Rodman Media. He has been with Rodman for more than 20 years, serving in a variety of capacities including editor of Happi. He holds a Bachelor of Arts degree from Montclair State University.

Email: tbranna@rodmanmedia.com
Editor, Tim Wright
Tim Wright is the editor of Contract Pharma magazine, which is a trade publication serving thousands of pharma and biopharma outsourcing professionals. He has been editor at Rodman Media since 2006. Prior to his position at Contract Pharma, he was an editor at Coatings Worls and Nonwovens Industry publications. Tim has a B.A. from Montclair State University in New Jersey where he studied English literature and journalism.

Phone: 201-880-2240
Email: twright@rodmanmedia.com
Associate Editor, Kristin Brooks
Kristin Brooks joined Contract Pharma as Associate Editor in November 2004. She has written extensively about market trends concerning the CRO industry and has covered regulatory as well as pharmaceutical IT topics for the magazine. Kristin is the administrator for Contract Pharma's annual Contracting & Outsourcing Conference, a leading industry event now in its 10th year. Kristin holds a Bachelor of Arts degree from Montclair State University.

Phone: 201-880-2237
Email: kbrooks@rodmanmedia.com

Columnists

S. Harachand: “India Reports”
S. Harachand is a pharmaceutical journalist based in Mumbai. He can be reached at harachand@gmail.com and twitter.com/pillscribe
Dave Jensen: “Managing Your Career”
David J. Jensen, Managing Director, Kincannon & Reed Global Executive Search. Mr. Jensen has nearly 30 years experience in executive search for biotechnology, pharmaceuticals, research products, medical devices, nutraceuticals, and academic research. He is the founder and former CEO of two executive search firms focused on life sciences -- Search Masters International (now a part of a $4.4 billion human resources organization) and CareerTrax Inc. His monthly column "Managing Your Career" has been a visible part of the biotech industry for nearly twenty years and is in each issue of Contract Pharma where Jensen is Contributing Editor. A popular speaker at biotechnology events, Jensen has delivered keynote presentations or workshops for NIH, the EPA, Karolinska Institute, Princeton, Harvard, and regional affiliates of BIO, such as MassBio, SoCalBio and BayBio. For more than two decades, Mr. Jensen has been an active participant in workforce development boards in various regions of the world, all of them biotechnology economic development zones. (928) 274-2266, djensen@krsearch.net
Mak Jawadekar: “I, Mak”
Dr. Mak Jawadekar was formerly a Director, Portfolio Management & Analytics, as well as a Vice president of CRG Asia Pacific Group at Pfizer, Inc. in CT. In the recent past, he was responsible for Benchmarking R & D Portfolio for Pfizer, working with Benchmarking Forums, Drug Delivery Technology Assessment function involving external ‘Drug Delivery' technologies. He has extensive experience in creating and cultivating external partnerships for Outsourcing CMC as well as DDS alliances for Pfizer Global R & D. He began his professional career at Pfizer Central Research in early 1982, after having completed his Ph.D. in Pharmaceutics at the University of Minnesota. He spent twenty-eight plus years with Pfizer Inc. . This includes R & D areas, heading Solids R&D, Drug Product formulation/ Dosage Form/ Drug Delivery research & development, Clinical Trials Supply Manufacturing and Packaging, Scale-up and Technology Transfer as well as Pharmacy (CMC) areas. He managed several functions/groups within Pharmaceutical R&D for many years. In the recent past, he had been also been engaged in coordinating outsourcing R & D activities with external partners/service providers. He was presented with the "M.L. Khorana Memorial Lecture of the Year Award" at the Indian Pharmaceutical Congress held in New Delhi, India, in December 2001 for his Presentation on 'Advances in Drug Development and Delivery Systems with a Focus on Protection of Intellectual Property Rights'. He has presented at many professional meetings and has participated in various Panel Discussions/Round Tables. He was one of the invited guests for a ‘Leadership Summit' held by the President of India, Dr. Abdul Kalam during 2003. He was also one of the invitees to join President George W. Bush's trade delegation to India in March 2006. During December 2007, Mak accompanied Dr. John LaMattina (former PGRD President) to India on his official trip to India, where President of India, Mrs. Pratibha Patil invited both of them to the President's Palace in New Delhi. He also recently accompanied Pfizer R & D President Dr. Martin Mackay during Feb 2009 to India for participating in Bio Asia 2009. He received an honorary doctorate (D.Sc.) Degree in February 2011 from DYP Mumbai University.
Derek Lowe: “The Lowe Down”
Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his Ph.D. in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. His blog, In the Pipeline, is located at www.corante.com/pipeline and is an awfully good read. He can be reached at derekb.lowe@gmail.com and is on twitter at twitter.com/Dereklowe.
Michael A. Martorelli: "Financial Analysis"
Michael A. Martorelli is a Director at the investment banking firm Fairmount Partners. In addition to participating in Fairmount's healthcare investment activities, Mr. Martorelli contributes to the firm's marketing and business development efforts with periodic industry reports and conference presentations. For most of the past decade, he has focused those writing and speaking efforts on pharmaceutical services companies, including those providing tools and technologies used in pre-clinical and clinical research functions. He has participated in conferences and similar programs covering varied outsourcing topics and sponsored by the Drug Information Association (DIA), the Association for Clinical Research Professionals (ACRP), the Tufts Center for the Study of Drug Development (CSDD), and other organizations. He can be reached at michael.martorelli@fairmountpartners.com, or at Tel: (610) 260-6232; Fax (610) 260-6285.
Kevin O'Donnell: "Advanced Degrees"
Kevin O'Donnell retired in 2005 as a Principle Packaging Engineer after a 26-year career at Abbott Laboratories and until 2011 was employed as Technical Director at ThermoSafe Brands, a company specializing in insulated packaging solutions for temperature-sensitive drug products. Kevin's contributions to industry are widely recognized and go back more than 25 years. He is well respected as an advocate, author, blogger educator, training developer, and champion of good distribution practices for temperature-sensitive drugs. His involvement with industry spans such organizations as the International Air Transport Association, the World Health Organization, the United States Pharmacopeia, Transport Canada, and the Parenteral Drug Association. His blog, Where Cooler Heads Prevail, can be found at www.coolerheadsblog.com/blog/
Ed Silverman: “The Pharma Beat”
Ed Silverman is a prize-winning journalist who has covered the pharmaceutical industry for The Star-Ledger of New Jersey, one of the nation's largest daily newspapers, for more than 12 years. Prior to joining The Star-Ledger, Ed spent six years at New York Newsday and previously worked at Investor's Business Daily. Ed blogs about the drug industry at Pharmalot, at www.pharmalot.com. He can be reached at ed.silverman@comcast.net.
Steve Snyder: “Preclinical Outsourcing”
Steven Snyder is the President of Outsourcing Support Services, Inc. (www.outsource-support.com), a consulting company that provides preclinical study monitoring and CRO assessments for pharmaceutical and biotechnology companies. Much of his career consists of job experiences in the toxicology divisions at Wyeth, Johnson & Johnson, and at Eli Lilly where he managed the in-life general toxicology department. He later learned the inner workings of the preclinical CRO industry at Charles River Laboratories through roles in marketing and project management. With 30 years of industry experience, Mr. Snyder is regarded as an industry expert in toxicology operations, study management, and preclinical outsourcing. He is familiar with the management, facilities, and capabilities at most of the leading preclinical CROs. Steve has a B.S. in biology from Bloomsburg University and a M.S. in biology from Villanova University. He is a regular contributor to the trade publication, Contract Pharma, where his articles on preclinical outsourcing appear each month and he is a highly regarded advisor to the investment community on the preclinical outsourcing industry. He can be reached at info@outsource-support.comor 317-408-0286.

Editorial Advisory Board

Dr. Ali Afnan, Step Change‚ Pharma, Inc.
Dr. Ali M. Afnan is the president of Step Change Pharma, Inc., a consultancy targeting the development and delivery of Pharmaceutical Manufacturing Excellence. Dr. Afnan was recruited in May 2003 by CDER at FDA to join the Agency's PAT and Drug Product Quality initiatives. He was a member of the PAT steering team and a co-author of the PAT Guidance. He had also been a member of the core team responsible for drafting and finalizing the most recent Guidance from FDA on Process Validation. Dr. Afnan has received several FDA and CDER level awards. He left the FDA in March 2010.

Dr. Afnan has a degree in industrial chemistry and a Ph.D. in Instrumentation for Analytical Science. He began his career in ICI engineering as a control-electrical engineer, and then joined the engineering group at AstraZeneca. He was responsible for the development and implementation of PAT that led to the design, construction and implementation of a solid dosage facility total control over manufacturing during the production operations.
Shaukat Ali, Ph.D., Technical Sales Manager Solubilizers, BASF
Dr. Ali has more than 18 years of industrial experience, including 11 years' experience in drug delivery and formulations development in pharma and biotech industries, and 9 years with BASF supporting its solubilization platform. He has expertise in lipid-based liposomes and liposome drug delivery, spray drying and melt extrusion, and emulsification systems involving FDA-approved lipids/solubilizers such as phospholipids, Cremophors, Solutol and Poloxamers and PEGs.

Dr. Ali is a member of the American Chemical Society, the America Association of Pharmaceutical Scientists, and the Controlled Release Society.
Dr. Jack Aurora, Chief Scientific Officer, Generic Drugs, Hisun Pharma (Hang Zhou) Co. Ltd.
Jack Aurora has a Ph.D. in pharmaceutical sciences with over 19 years of quality- and compliance-driven research and management experience to his credit. At present, Dr. Aurora is working in the capacity of chief scientific officer, Generic Drugs for Hisun Pharma Co., Ltd. based in China. In this role Dr. Aurora is responsible for the setup and implementation of the newly constructed facility for U.S. FDA and EU submission, approval and commercialization aspects of generic drug development. His key areas of focus include introducing a Quality by Design (QbD) approach and culture of the development capabilities for ANDA products, leading to the highest standard for global R&D and corporate quality compliance for satisfactory approval from the regulatory agencies in the U.S. and Europe.

Prior to this he has worked as vice president, Formulations Operations with Azopharma Product Development Group, and with Perrigo Co., Pharmascience, Labopharm, Patheon and Ranbaxy — where he started his professional career — in various management and technical capacities. Dr. Aurora is also a consultant with GLG Healthcare and Biomedical Council and Guidepoint Global, associations of leading physicians, scientists, and other healthcare professionals. He is acting as adjacent faculty member and Prestige Appointment with School of Pharmacy; University of Toledo, Seneca College and Toronto Institute of Pharmaceutical Technology (TIPT) based in Toronto. Dr. Aurora is also member of the visiting scientist program sponsored by AAPS.
Jim Botkin, Senior Vice President, Contract Pharma Services, Alkermes plc
Jim Botkin oversees Alkermes' contract pharmaceutical services business and manufacturing operations, with plant oversight in Athlone, Ireland, Wilmington, OH and Gainesville, GA. Mr. Botkin joined Alkermes with the closing of the merger between Elan Drug Technologies (EDT) and Alkermes, Inc. in September 2011. From 2007 until that time, he served as senior vice president, Head of Operations at EDT. He was formerly vice president and general manager of Elan's operations in Gainesville from October 2001 to June 2007. He previously served as president of Sharp Corporation, and was vice president, U.S. Production Operations of Sandoz Pharmaceutical. Mr. Botkin has more than 40 years of experience in pharmaceutical industry operations.
Elise Brownell, Ph.D., Founding partner, ZephyrBiotech
Dr. Elise Brownell has extensive experience in senior project management and leadership positions in the global pharmaceutical and biotechnology industries. Most recently she was a founding member, head of project management and senior director of Aerovance, Inc., a venture-backed biotechnology company spun out from Bayer Healthcare. At Aerovance she created and managed effective team processes to bring four product candidates into full-scale clinical Phase I and II development. Prior to Aerovance, Dr. Brownell acted as head of project management for Bayer's Biotechnology Unit, where she integrated project strategies to meet therapeutic and market needs. Other roles were directed toward building and negotiating partnerships with third parties to support the development programs, and leading research teams through early bench-to-clinic development phases.

Dr. Brownell received her MS, M.Phil. and Ph.D. (Biology) from Yale University, and her BS (Biology) from Allegheny College. Dr. Brownell has been named as a member of the Life Science Committee for ASTIA (www.astia.org) the nation's premier entrepreneurial organization focused on women-led businesses. She also serves as a chairperson for the Leaders Network subgroup of Women in Consulting (www.womeninconsulting.org).
Dr. Suggy S. Chrai, President, Chrai Associates
Suggy Chrai has more than 30 years of experience in the pharmaceutical, device and biotech industry. He has served in a variety of high-level roles at Delsys Pharmaceutical, The Liposome Company, Mova Pharmaceutical, Bristol-Myers Squibb and Schering Plough. He is a past president of the American Association of Indian Pharmaceutical Scientists. Suggy received his B.S. from Jadavpur University, his M.S. and Ph.D. from University of Wisconsin and his MBA from Fairleigh Dickinson University.
Joseph Colleluori, Vice President of Corporate Development, Lonza Group Ltd.
 
Paul D'Angio, RPh, Senior Vice President -‚ÄàGlobal Technical Operations, Celgene Corp.
Paul D'Angio is senior vice president, Technical Operations at Celgene Corporation. Paul is a Registered Pharmacist, with his BSc in Pharmacy from Duquesne University. He also has an MSJ in Healthcare Law from Seton Hall University Law School. Paul has been in the pharmaceutical industry for more than 25 years, with experience in commercial manufacturing, drug product development, risk management operations and investigational materials supply.
Dr. Tony DeStefano, Vice President of General Chapters, U.S. Pharmacopeia
Tony DeStefano received his B.S. in Chemistry from Villanova University and his M.S. and Ph.D. in Physical Chemistry from Cornell University. He began his career at Procter & Gamble's Miami Valley Laboratories in mass spectrometry in Cincinnati, OH. After P&G purchased Norwich Eaton Pharmaceuticals, he moved to Norwich, NY and managed Physical Measurement and Method Development Sections for several years. In 1991 he established Norwich's first Bioanalytical Section. In 2002 he returned to Cincinnati to manage the bioanalysis programs for several large clinical studies.

He retired from P&G in January of 2008 and joined the U.S. Pharmacopeia as its vice president of General Chapters. In that role he is leading initiatives to maintain, update and redesign the General Chapters. He is an active member of the American Association of Pharmaceutical Scientists (AAPS), holding or having held leadership positions in the Bioanalytical Focus Group, the APQ Section and AAPS programming committees.
William Downey, President, HighTech Business Decisions
William Downey, MBA is president of HighTech Business Decisions, a market research firm serving the biotechnology and pharmaceutical industries. HighTech Business Decisions closely follows and reports on the biopharmaceutical contract manufacturing industry with both private and public market reports. Before joining the company, Mr. Downey held various positions in marketing, strategic planning and finance. Over his career, Mr. Downey has worked on financing and investment transactions totaling more than $1.0 billion. Mr. Downey has an MBA from Washington University in St. Louis and Bachelors from the University of Michigan in Ann Arbor.
Thomas Handel, Senior Vice President - Commercial Pharmaceuticals, Meridian Medical Technologies
Tom Handel serves as senior vice president – commercial pharmaceuticals for Meridian Medical Technologies, a Pfizer company. His responsibilities include marketing, sales, and commercial operations for Meridian's commercial acute care pharmaceutical products.

Beginning in 2006 Tom simultaneously managed King Pharmaceuticals Canada, a subsidiary of Meridian Medical Technologies, until this organization was integrated into Pfizer Canada following the acquisition of Meridian's parent company in 2011.

During his career in the pharmaceutical industry, he has acquired a unique blend of business, technical and managerial experience, and a broad range of knowledge in chemistry, microbiology, physical quality control, auditing, aseptic manufacturing, project management, business development and sales/marketing. Tom has served in a variety of positions with Meridian. In his current role, he is responsible for developing and implementing strategies to enhance and grow Meridian's auto-injected acute care products.

Previously, Tom served as Executive Director of Business Development for Akorn, Inc. He also worked in a variety of quality assurance positions at Syntex Laboratories, Invitron Corp. and Chevron Chemical. Tom earned his bachelor's degree in biology from St. Louis University, and his MBA from Maryville College, St. Louis.
Mico Holguin, Jr., Pharma Partner Executive, Baxter BioPharma Solutions / Baxter Healthcare Corp.
Mico Holguin graduated from the University of Notre Dame before entering the U.S. Army as an Infantry Officer. After completing several assignments at Fort Bragg, NC, Fort Lewis, WA and Fort Knox, KY, Mico resigned from the Army and held sales positions in Colgate-Palmolive and Abbott Laboratories.

In 1993, Mico transitioned to business development for Abbott Laboratories while representing API and eventually Fill/Finish contract management services. Mico also spent seven years with Cardinal/Catalent in BD also representing Fill/Finish services before recently taking a Pharma Partner Executive position with Baxter Biopharma Solutions.

Mico completed his MBA in 1999 and retired from the U.S. Army after 27 years of Active/Reservist service which includes four years as a member of Special Forces. He resides in Illinois and is a current member of PDA.
Dr. Makarand S. Jawadekar, Consultant, Pfizer Global R&D (ret'd.)
Dr. Mak Jawadekar was formerly a director, Portfolio Management & Analytics, as well as a vice president of CRG Asia Pacific Group at Pfizer, Inc. in CT. In the recent past, he was responsible for Benchmarking R&D Portfolio for Pfizer, working with Benchmarking Forums, and Drug Delivery Technology Assessment functions. He has extensive experience in creating and cultivating external partnerships for Outsourcing CMC as well as DDS alliances for Pfizer Global R&D.

He began his professional career at Pfizer Central Research in early 1982, after having completed his Ph.D. in Pharmaceutics at the University of Minnesota. He spent more than 28 years with Pfizer, including R&D areas, heading solids R&D, drug product formulation/dosage form/drug delivery R&D, clinical trials supply manufacturing and packaging, and scale-up and technology transfer, as well as pharmacy (CMC) areas. He managed several functions/groups within pharmaceutical R&D for many years.

In the recent past, he had been also been engaged in coordinating outsourcing R&D activities with external partners/service providers. He was presented with the "M.L. Khorana Memorial Lecture of the Year Award" at the Indian Pharmaceutical Congress held in New Delhi, India, in December 2001 for his Presentation on 'Advances in Drug Development and Delivery Systems with a Focus on Protection of Intellectual Property Rights.' He has presented at many professional meetings and has participated in various panel discussions and roundtables.
Paul Josephs, Vice President, Sales and Marketing, DPT Laboratories
Paul Josephs earned a BS in Political Science from The University of Western Ontario. He joined DPT in 1997 after a successful term as senior business manager with Patheon, Inc. Prior to Patheon, Paul enjoyed an equally successful two years as a Medical Sales Representative with Marion Merrell Dow. He joined DPT as an account manager and rapidly progressed with increasing responsibilities to director, Strategic Business Unit. Paul was promoted to vice president, Sales and Marketing for DPT in 2001.
Balaji V. Kadri, QS Pharma
Balaji V. Kadri has more than 18 years of formulation and process development experience within the contract research and generic industry. He was previously senior director of Pharmaceutical Operations at PharmaForm, where he was responsible for analytical, formulation development, and cGMP manufacturing. Prior to that, he headed the Preformulation and Formulation Development group at Xcelience for 10 years. He previously worked in formulation development and scale-up manufacturing at Apotex for six years.

His broad dosage form experience includes immediate release tablets and capsules, sustained release capsules/tablets/beads, liquid/semi-solid in capsule, gels, pediatric solutions, suspensions, and parenterals. His expertise includes formulation development from preclinical to commercialization, overcoming solubilization challenges, enhancing bioavailability, taste masking, and development of controlled release dosage forms. He has authored numerous articles, presented many abstracts, is co-inventor of several patents and is a contributor of several excipient monographs in “Handbook of Pharmaceutical Excipients” 7th edition (2012). He is an active member of the American Association of Pharmaceutical Scientists (AAPS) and a registered life member in the Karnataka State Pharmacy Council in India.
Bobby A. Kanuga, Executive Director of External Manufacturing Operations, Merck & Co., Inc.
Bob Kanuga has over 20 years' of experience in manufacturing and business development within the pharmaceutical industry He is currently Executive Director of External Manufacturing at Merck & Co., Inc. responsible for the global supply of outsourced chemical intermediates, active pharmaceutical ingredients, sterile and non-sterile drug products, drug delivery systems and packaging services. Prior to this role, he held many commercial and operations related positions within the company's Manufacturing Division, including Vaccine & Sterile Manufacturing, Global Procurement, and Business Affairs. He received his BS and MBA from Lehigh University.
Dr. Faiz Kermani, Associate Scientific Advisor, Health Interaction
Faiz Kermani has several years' experience in the European and US. pharmaceutical sectors. He has worked in pharmaceutical R&D, pricing and reimbursement, marketing and medical communications. He holds a Ph.D. in Immunopharmacology from St. Thomas' Hospital, London. He serves as president of the Global Health Education Foundation (GHEF), a not-for-profit healthcare charity that seeks to improve educational resources and training for healthcare professionals in developing countries.
Richard Korsmeyer, Head of Licensing, Worldwide Pharmaceutical Sciences, Pfizer Global R&D
Richard Korsmeyer has been with Pfizer since 1986 in various roles as a scientist and manager. He is currently a Senior Research Fellow and the Head of Business Development for Pharmaceutical Sciences, where leads a cross-divisional team comprising representatives from Pharmaceutical Sciences (R&D) and Pfizer Global Supply (Commercial Manufacturing), responsible for supporting all Business Development activities including in-licensing, out-licensing, mergers, acquisitions, divestitures, and income-generating initiatives. This team manages all project aspects related to CMC for opportunities from Due Diligence through negotiations and project on-boarding.

As a member of the Technology and Strategic Sourcing organization, he also supports research and technology collaborations and sourcing strategy for R&D stage programs. He maintains a special interest in drug delivery technology.

Richard obtained his Bachelor's degree in Chemistry from Vanderbilt University and subsequently graduated from Purdue University with a Master's and a PhD in Chemical Engineering. Before coming to Pfizer, he worked as a chemist and engineer. He has published in the areas of organic chemistry, polymer science, diffusion, and drug delivery and holds a number of patents. He is a member of American Institute of Chemical Engineers, American Association of Pharmaceutical Scientists, The Controlled Release Society, and the College of Fellows of the American Institute of Medical and Biological Engineering.
Michael J. Kosko, President, Pfizer CentreSource
Michael J. Kosko is president of the Pfizer CentreSource (PCS) organization, which is comprised of the Fine Chemical and Contract Manufacturing business units. The organization markets active pharmaceutical ingredients, intermediates and drug product to the pharmaceutical industry. PCS is an operating unit within Pfizer Global Supply, one of the world's preeminent supply organizations, and is based in Kalamazoo, MI.

Prior to joining the company, Mike was senior vice president of the pharmaceutical business at Banner Pharmacaps, a contract manufacturer of dosage form products. He has 27 years of sales, marketing, sales management and business management experience in the chemical and pharmaceutical industries. Mike holds a B.S. in Chemistry from the University of Connecticut and an M.B.A. from the University of New Haven. In addition to being a board member for Hackett Catholic Central High School, he is also a board member of Junior Achievement of Southwest Michigan.
Steve Massah, Strategic Drug Product Outsourcing, Gilead Sciences
Steve Massah has more than 25 years’ of GMP experience including manufacturing operations, drug and device product development, business development, and global outsourcing within the pharmaceutical industry. He is currently senior manager of Strategic Drug Product Outsourcing, managing solid dosage and biologic manufacturing at Gilead Sciences Inc. He is responsible for the global supply of outsourced clinical trial materials, and supply chain for solid dosage and sterile drug products.

Prior to this role, he held many commercial and operations related positions with Avanir Pharmaceuticals, Neurocrine Biosciences, Dura Pharmaceuticals, acquired by Elan, ISTA Pharmaceuticals, acquired by Bausch and Lomb. He received his BS in Chemical Engineering, MS in Organic Chemistry, MS in Materials Sciences Engineering from University of Texas and MBA from University of Phoenix. He currently has California State Board of Pharmacy License for Manufacture of Dangerous Drugs.
Dr. Jeffrey Millard, Director of Pharmaceutical Development, Oncothyreon, Inc.
Jeffrey Millard, Ph.D. is director of Pharmaceutical Development at Oncothyreon Inc., an innovator biopharmaceutical corporation focused in oncology with both targeted small molecule and peptide APIs in the clinic. His background is in organic and pharmaceutical chemistry. He has authored several funded SBIR grants, is inventor on two composition of matter patents, and has been responsible for the CMC R&D efforts of four INDs. He manages the in-house and contract CMC activities for APIs and drug products and has developed numerous dosage forms from solid oral to lyophilized liposomal parenteral.
Richard V. Myer, Vice President, Business Development, Argenta Limited
Richard V. Myer has more than 15 years' experience in business development within the pharmaceutical services and device industries. In his role as director, Business Development for Xcelience, he manages a business development team focused on formulation development, analytical services and clinical supply manufacturing. Prior to the launch of Xcelience, Mr. Myer held business development positions with contract service providers, enabling him to develop expertise across the drug development continuum. Mr. Myer began his career conducting molecular biology research at Rush-Presbyterian-St. Luke's Medical Center in Chicago. He received his BA and MBA from Purdue University.
Sudha Nair, Ph.D., Director, Global Business Development, Apotex Fermentation, Inc.
 
Terence S. Novak, President, Commercial Operations, Norwich Pharmaceuticals
Terry Novak has more than 30 years of experience in the pharmaceutical and biotech industries, including 10 years in executive leadership in the contract development and manufacturing industry. Currently Terry is president of Norwich Pharmaceuticals, a comprehensive global provider of contract development and manufacturing services. Previously he served as president of North America and chief commercial officer at Patheon, Inc. as well as president of DSM Pharmaceuticals.

Terry has also held various senior healthcare management positions, including vice president at Cytogen, executive vice president at Algos Pharmaceuticals, and vice president at Innovex, a division of Quintiles Transnational, as well as various sales and marketing positions at Bristol-Myers Squibb. Terry is a highly regarded speaker at industry conferences and serves on the board of directors at Frontline Pharmaceuticals. Terry holds a BS in Biology from Muhlenberg College.
Dilip M. Parikh, President, DPharma Group, Inc.
Dilip M. Parikh is president of DPharma Group Inc., a pharmaceutical technology development and consulting group located in Ellicott City, MD. Trained as an industrial pharmacist, he has more than 35 years of experience in product development, manufacturing, plant operations and process engineering at various major pharma companies in Canada and the U.S.. Prior to staring DPharma Group, he held the positions of vice president Operations and Technology at Synthon Pharmaceuticals in NC, and vice president and General Manger at Atlantic Pharmaceuticals Services in MD.

He is the editor of "Handbook of Pharmaceutical Granulation" 3rd edition (2009, Informa Health, NY). He has published several book chapters and articles on various pharmaceutical technologies, quality by design, and contract manufacturing. He has been invited as speaker at scientific conferences held worldwide on solid dosage technologies development and manufacturing.
Dr. Enrico T. Polastro, Vice President, Arthur D.Little Benelux SA/NV
Enrico Polastro is a vice president of the Arthur D.Little Chemical and Health care practice. He has over 30 years' experience in pharmaceutical fine chemicals and related industries. He holds a Ph.D. in bio-organic chemistry and a Master in Management Sciences.
Jack Regan, Vice President, Contract Manufacturing, BioMarin Pharmaceutical
Jack Regan previously served as co-founder and chief operating officer of cGMP Associates Inc., a consulting firm with clients in the U.S. and Asia, as well as director of Regulatory Affairs for Powder Pharmaceuticals Inc., a pharma company based in Hong Kong. Prior to that, he was senior vice president of Operations with Anesiva and led CMC efforts in the development of multiple products in clinical development and the FDA approval/commercialization of the drug/device combination product, Zingo. Prior to Anesiva, Mr. Regan served in a variety of manufacturing management positions at Genentech Inc., where he was involved in multiple plant inspections, selection and management of CMOs, and the FDA approval of eight products. He has more than 30 years of GMP experience including manufacturing operations, drug and device product development, business development and global outsourcing.
Sam Ricchezza, Senior Vice President, Business Development, Diteba Research Laboratories Inc.
Sam Ricchezza brings more than 24 years of pharmaceutical and medical device industry experience to his role as senior vice president, Business Development at Diteba Research Laboratories. Sam has extensive business development, sales management and marketing experience with some of the leading organizations in contract services. He has developed and executed strategic business, marketing and sales plans and successfully developed and negotiated long-term supply and services agreements with multi-national pharmaceutical, biotechnology and clinical research companies. Sam also has a background in consumer product marketing and finance in the medical device industry. He is a frequent guest speaker at strategic account management training programs.
Fred Schulze Vice President, Sales & Marketing, Coating Place, Inc.
 
James R. Scull, General Manager, NSF Pharmalytica
James Scull, Ph.D. has more than 24 years of pharmaceutical development experience, spanning all areas from discovery support to Phase III trials. His current responsibilities include providing strategic scientific and technical leadership with a global perspective to the NSF Pharmalytica, part of NSF's Health Sciences Division. Dr. Scull is focused on providing clients with technical expertise and project management designed to accelerate the drug development process.

Dr. Scull's primary expertise is in the areas of GLP analytical chemistry, formulation, compliance and separation science. He is also an expert in conducting extractable & leachable studies and oliognulceotide analysis. Prior to joining NSF Pharmalytica, Dr. Scull served as executive director of Pharmalytica Services, LLC, principal research scientist for the DuPont Pharmaceutical Co. and GLP outsourcing manager for Purdue Pharma. Dr. Scull holds a Ph.D. in Analytical Chemistry from Villanova University and a BS in Chemistry from Widener University.
Daniel Stehn, Director of Biotechnology Packaging, Sharp Corporation
Dan Stehn has spent the past 21 years in business development roles for contract service providers supporting life science organizations. Late in 2008, Dan joined Sharp Corporation (United Drug plc) as director of Biotechnology Packaging where he is responsible for managing Sharp's biotechnology platform, which provides custom packaging solutions for injectable vials, pre-filled syringes and pens. Previously, Mr. Stehn spent more than 11 years with Catalent Pharma Solutions (fka Cardinal Health) as a senior account executive. Though some of his responsibilities during his career have been with large pharmaceutical accounts, the majority of his focus was with drug development & virtual organizations whose business models are based on the outsourcing of their commercial packaging presentations. Mr. Stehn has directed more than a dozen FDA product launches; for many clients these were their first commercial product introduction and for most in time-sensitive situations. Mr. Stehn has a BS in Packaging Science from Rochester Institute of Technology.
Dr. Martin Steinman, Consultant, Kuraray America
Dr. Martin Steinman retired from Schering-Plough where he held positions in Discovery Chemistry, Chemical Process R&D, and Outsourcing. He holds some 35 patents and 20 publications. Since retiring, he has been a consultant to Kuraray America Inc., and numerous other companies, and has been an expert witness in a legal case.
Paul Titley, MD, Director, Formulation Development, Aesica Pharmaceuticals Ltd.
 
Phillip G. Trager, Director, Analytical Services, Consumer Product Testing Co.
 
Michael J. Valazza, Vice President, Global Business Development - Oral Solids and Controlled Release Technologies, Catalent Pharma Solutions
 
Falguni Vaidya, Director of External Manufacturing Procurement, Bristol Myers Squibb

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