ANDREW SANDFORD
Vice President,
Global Business Development
Drug Substance &
Biologics Analytical Services
Advisory Board
Redwood Scientific Advisory Board
Vice President,
Global Business Development
Drug Substance &
Biologics Analytical Services
Advisory Board
Redwood Scientific Advisory Board
BARRY LITTLEJOHNS
PRESIDENT
Barry Littlejohns was named President, Biologics & Specialty Drug Delivery in October 2017. Previously, Mr. Littlejohns was named President of Catalent’s Drug Delivery Systems Solutions in July 2013. Prior to that, he led Catalent’s Medication Delivery Solutions business from July 2011 to July 2013.
Mr. Littlejohns has an extensive background in leading international life science businesses in both US and European organizations. He rejoined Catalent after two years as Senior Vice President of Operations and Business Development at Danish biotechnology company, Genmab, where his responsibilities included strategic licensing and manufacturing oversight. Prior to Genmab, he served in a broad range of leadership roles at Catalent. These include Vice President of Global Business Operations, Vice President of Commercial Affairs for Medication Delivery Solutions, Vice President and General Manager of Injectables, and various financial, operational and leadership roles.
He first joined Catalent in 1989 when it was formerly the RP Scherer Corporation.
Mr. Littlejohns has two degrees in business and finance from Swindon, UK.
CORY LEWIS
VICE PRESIDENT, GENERAL MANAGER DRUG PRODUCT
Cory Lewis is the Vice President and General Manager of Catalent Biologics’ Drug Product business, supporting locations in Bloomington, Indiana; Brussels, Belgium; and Limoges, France. Cory was previously the Vice President of Business Operations for Cook Pharmica, an acquired company of Catalent Biologics, with overall responsibility for finance, contract administration, business development, and marketing. Prior to joining Cook Pharmica in 2009, Cory served as Vice President of Sales and Marketing at Althea Technologies, Inc., supporting the contract manufacturing division. He also worked at Baxter Healthcare Corporation, accruing more than a decade of biopharmaceutical experience in finance, marketing and business development. Cory graduated from Indiana University with a degree in finance and holds a MBA from Northwestern University.
MICHAEL A. RILEY
VICE PRESIDENT / GENERAL MANAGER, DRUG SUBSTANCE & BIOANALYTICAL
Mike Riley has served as Vice President/General Manager of Catalent Biologics since 2014 and has overall responsibility for strategy and management of the biologics business. Mike has 13 years of experience at Catalent where he has a demonstrated track record of strategic growth leadership across multiple businesses, previously serving as Vice President of Strategy, Advanced Delivery Technologies and Vice President, Global Business Development for Catalent Sterile Technologies. Prior to joining Catalent, Mike worked as a management consultant for Marakon Associates, providing strategic advisory to companies across multiple industries. Mike holds a B.A. from Duke University, and a MBA from The Wharton School, University of Pennsylvania.
KATHLEEN MUNSTER
VICE PRESIDENT, QUALITY
Kathleen Munster joined Catalent in February 2018 as Vice President, Quality. Kathleen is responsible for ensuring the successful delivery of quality and regulatory strategies, operational performance and driving “One Catalent” quality standards across the Biologics network. This includes six manufacturing sites responsible for more than 600M in revenue, covering analytical services, ophthalmic & respiratory products, sterile blow-fill-seal, drug substance manufacturing and parenteral drug product for distribution covering FDA, EMA and global regulatory markets. Prior to joining Catalent, Kathleen held roles at Bristol-Myers Squibb, where she worked for nearly 13 years and held roles of increasing responsibility within Quality, Supply Chain and IT. She played a key role in multiple pre-approval inspections, audits and launches during her tenure in BMS, including drug substance, API and drug product approvals. Her final role at BMS was at the Devens, Massachusetts facility, where Kathleen was responsible for a multi-faceted Quality Unit overseeing commercial manufacturing, clinical manufacturing and global stability testing. Prior to BMS, Kathleen worked for Merck & Co., Inc. Kathleen holds bachelor’s degrees from Lafayette College in Chemistry and German, as well as a MBA from Rutgers University.
KAY SCHMIDT
VICE PRESIDENT, PRODUCT DEVELOPMENT
Kay has worked for Catalent for nine years, all in Product Development, with dosage experience in blow fill seal (BFS) and pre-filled syringe sterile filling, including Biologics and Oral Solids. Prior to joining Catalent, Kay held numerous roles at GE Healthcare, working on medical devices and differentiating medical device components. Kay is a certified Six Sigma Green Belt with a broad background in New Product Development, Engineering, Operations and medical device service. She holds a Bachelor of Science degree in Computer Science from Carroll University and a Master of Science degree from the University of Wisconsin-Whitewater.
GREG BLECK, PH.D.
GLOBAL HEAD OF R&D, BIOLOGICS
Greg Bleck is Global Head of Research and Development at Catalent Biologics with overall responsibility for development and acquisition of new products and technologies. Dr. Bleck has over 20 years in biopharma R&D. He received his BS and PhD from the University of Wisconsin-Madison and performed postdoctoral work at the University of Illinois-Urbana-Champaign working in the areas of gene regulation and expression. At Catalent, Dr. Bleck has transferred his knowledge of gene expression and transgenic systems to the development and continued optimization of retrovector expression systems and development of the proprietary GPEx® process. Dr. Bleck has published over 60 research papers and authored three book chapters. He has 14 issued patents and eight patents currently under review. His work at the University of Illinois was recently highlighted in a book about the greatest advances in the first 150 years of innovation at the University.
DAVID RABUKA, PH.D.
GLOBAL HEAD OF R&D, CHEMICAL BIOLOGY
David Rabuka is Global Head of Research and Development, Chemical Biology at Catalent Biologics with overall R&D responsibility for the SMARTag™ protein conjugate platform. He joined Catalent Biologics following Catalent’s acquisition of Redwood Bioscience Inc., where he was founder, President and Chief Scientific Officer. David received a Ph.D. in Chemistry at the University of California, Berkeley as a Chevron Fellow in the lab of Professor Carolyn Bertozzi where his research included developing and applying Redwood’s platform technology to cell surface modification. Prior to pursuing his Ph.D., David worked at the Burnham Institute synthesizing complex glycans and later at Optimer Pharmaceuticals, which he joined as an early employee, focused on the development of glycan and macrolide based antibiotics. David graduated with double honors B.S. in Chemistry and Biochemistry from the University of Saskatchewan where he received the Dean’s Science Award and holds a M.S. in Chemistry from the University of Alberta. He is an author on over 50 major publications as well as numerous books chapters and patents.
BRIAN C. RILEY
VICE PRESIDENT, OPERATIONS
Brian Riley is VP, Operations at Catalent Biologics with overall responsibility for five facilities in the US and EU, including North Carolina, Wisconsin, Illinois, France and Belgium. Brian has over 20 years of management experience in commercial development, quality operations and plant management within the biotech and medical device fields. He joined Catalent Biologics as the General Manager of Madison, Wisconsin in 2014 from BioMerieux where he was Site Director of Operations and Site Management in Durham, North Carolina. Previously, he held senior positions in Quality and Operations at Biogen Idec, Amgen, Diosynth Biotechnology, and Covance Laboratories. Brian holds a B.S. in Pre Medical from North Carolina State University and an MBA from Campbell University.
KAREN RHYNER
VICE PRESIDENT, FINANCE
Karen Rhyner is Vice President, Finance for the Catalent Biologics & Specialty Drug Delivery business unit. She is responsible for financial accuracy and support of eight locations covering drug substance, drug product, and respiratory & ophthalmic operations. She also plays a key role in the integration of Catalent’s recent acquisitions. Previously, Karen was the Vice President, Finance for Catalent’s Clinical Supplies Services business unit, as well as the Senior Finance Director for the Kansas City, MO site. Karen came to Catalent in February 2012 through the Aptuit acquisition where she held roles of increasing responsibility in finance and operations for over seven years. Prior to Aptuit, she worked at Colgate-Palmolive for 16 years and held roles in corporate and operational finance. She is a certified public accountant and lean six sigma black belt.
BERNIE CLARK
VICE PRESIDENT, MARKETING & STRATEGY
Bernie Clark is the Vice President of Marketing and Strategy for Catalent Biologics. His responsibilities include leading the strategic business planning and market assessment process, managing strategic initiatives and product launches, as well as driving the execution of global marketing campaigns that ensure optimal targeting, messaging and lead generation among customer segments. Prior to Catalent, Bernie was the global head of marketing for LabCorp's clinical trials division that included central lab, bioanalytical and specialty testing services such as companion diagnostics (CDx), advanced flow cytometry and next-generation sequencing (NGS). There, he had the opportunity to lead the global integration teams for marketing and communications after closing LabCorp's $6.2 billion acquisition of Covance. Bernie holds a B.A. in Cognitive Psychology from Allegheny College, as well as MBA and MS in Marketing Management from the University of Maryland University College. He also serves on the executive committees of the American Marketing Association (AMA Philadelphia) and Global Clinical Supplies Group (GCSG).
ANDREW SANDFORD
VICE PRESIDENT, GLOBAL BUSINESS DEVELOPMENT, DRUG SUBSTANCE & BIOLOGICS ANALYTICAL SERVICES
Andrew Sandford is Vice President of Business Development at Catalent Biologics with responsibility for leading an international team of highly skilled business developers chartered to meet and exceed revenue objectives. Andrew has 24 years of experience in business development and marketing. He joined Catalent Biologics from Selexis where he was VP of Business Development. Previously, he held positions at Lonza/Cambrex, DOW Chemical and GE. Andrew holds a B.Sc. in Microbiology from State University of New York at Plattsburgh.
KARIM ABDELKADER
VICE PRESIDENT, BUSINESS DEVELOPMENT & DRUG PRODUCT
Karim Abdelkader is Vice President of Business Development, Drug Product at Catalent Biologics with responsibility for leading and growing the drug product business in the US. Karim has over 20 years of experience in the CDMO space with a proven history of generating business growth while improving both profitability and customer satisfaction. Karim has an extensive and diverse background in global marketing, sales, business development and quality control and assurance. Prior to joining Catalent, Karim held roles of exceeding responsibility at Cook Pharmica, DSM, Baxter, Pfizer and Cook Pharmaceutical Solutions. Karim holds a B.S. in Biology from Marian University in Indianapolis, IN.
VIC VINCI, PH.D.
VICE PRESIDENT, PRODUCT AND PROCESS DEVELOPMENT
Dr. Victor Vinci is the Vice President of Product & Process Development with overall responsibility for biologics process and product development, manufacturing sciences, and project management at Catalent Bloomington. Victor has more than 25 years of technical and leadership experience in the pharmaceutical industry. He joined Catalent Biologics following Catalent's acquisition of Cook Pharmica where he also served as the Vice President of Product and Process Development. Prior to his time at Cook Pharmica, Vic spent six years as an Manufacturing Science & Technology section head at Merck & Co., Inc. before moving to Eli Lilly and Company in Indianapolis. At Lilly, he was responsible for leading a range of bioprocess development efforts including: process development, tech transfer from development to large-scale clinical trial and commercial production, and process optimization and characterization to assure manufacturability. He was the company lead for the A-Mab Quality-by-Design case study which was a groundbreaking industry-FDA collaboration. Victor holds a Bachelor degree in both chemistry and microbiology from Bowling Green State University, and a Masters and Ph.D. in microbiology from The Ohio State University.
RYAN HAWKINS
GENERAL MANAGER, BLOOMINGTON
Ryan Hawkins serves as the General Manager at Catalent Biologics in Bloomington, Indiana. He has over 10 years of experience at the Bloomington site, originally a Cook Pharmica facility, where he began as project director responsible for the design and delivery of the fill-finish expansion before becoming Vice President of Drug Product Manufacturing in 2011 and Vice President of Operations and Supply Chain in 2016. Prior to his time at Cook Pharmica, Ryan held various roles of increasing responsibility in fill-finish manufacturing operations with Baxter BioPharma Solutions and Cook Pharmaceutical Solutions. Ryan holds a Bachelors in biology from the University of Wisconsin-Milwaukee, and a MBA from Indiana Wesleyan University.
GRAHAM BREARLEY, PH.D.
GENERAL MANAGER, MADISON
Dr. Brearley has over 30 years in the biopharma industry, primarily in the area of biologics. His experience includes process development, clinical and commercial manufacturing, facility management and business development. Prior to joining Catalent in June 2018, Dr. Brearley worked at Baxter, Baxalta and Shire for a combined 22 years, including roles as Plant Manager at multiple sites. He has a B.Sc. in Applied Biology and a Ph.D. in Protein Biochemistry.
ERIC KUMMER
GENERAL MANAGER,
BRUSSELS
With over 25 years of experience in the pharmaceutical industry, Eric has served as the General Manager for Catalent Biologics’ drug product manufacturing site in Brussels, Belgium since 2015. Previously, he was the general manager for the Limoges, France drug product manufacturing site, having joined in 2012. Prior to joining Catalent, Eric worked for Novo Nordisk as Aseptic Manufacturing Director, ran his own business in the Manufacturing and Supply Chain consultancy, served as Operations Director Europe for CUNO/3M and as Distribution Manager and Industrial Projects Manager for Warner.
REKHA PATEL
DIRECTOR, BIOLOGICS ANALYTICAL SERVICES
Rekha Patel is Director, Biologics Analytical Services with responsibility for overseeing comprehensive CMC analytical solutions for biologics and large molecules at Catalent Kansas City for development and GMP needs. Rekha has more than 20 years of experience in biopharmaceutical analytics with the last 20 focused on Large Molecules and Biologics analytical. She joined Catalent Biologics from Aptuit where she was Director, Large Molecule Analytical Chemistry for nine years. Rekha holds a B.S. in chemistry from Missouri Southern State University, a Master’s of Science in analytical chemistry and a MBA in finance, both from University of Missouri, Kansas City.
FRANK LI, PH.D.
DIRECTOR, PROCESS DEVELOPMENT
Dr. Li joined Catalent Biologics following the acquisition of Cook Pharmica. He is the Director of Process Development at Catalent Bloomington and leads the process, analytical and formulation development to meet client drug substance and drug product development needs. He also serves as Adjunct Associate Professor in The Department of Industrial & Physical Pharmacy at Purdue University teaching various classes to graduate students and pharmacy students the biopharmaceutical development. Prior to his current role, Frank worked at Merck & Co. in various roles including, group leader for analytical method development and high throughput testing, group leader for biophysical characterization and later served as the Associate Principal Scientist in formulation development at Merck in Kenilworth, New Jersey. He was responsible for formulation development and fill finish process development for Merck biologics including monoclonal antibodies, therapeutic proteins and antibody-drug conjugates. At Merck, he was also the technical lead on the drug product process compatibility studies and responsible for process transfer to internal manufacture sites and CMOs. In a previous role at Merck, he led the analytical team supporting formulation development, cGMP testing for release and stability studies. He also led efforts on the biophysical characterization for sub-visible particle analysis and protein higher order structure characterization. Prior to joining Merck, Frank worked for Amgen as a scientist responsible for late stage drug product development including formulation, fill finish process development and lyophilization scale-up. Frank has a Ph.D. in Pharmaceutical Chemistry from The University of Kansas, a M.Sc. in Chemistry from the University of British Columbia and a B.Sc. in Chemistry from Peking University in Beijing. He has published over 10 peer-reviewed publications.
MARIA VIRGINIA POLI
ASSOCIATE GENERAL COUNSEL
Maria Virginia Poli joined Catalent in July 2012 as Senior Legal Counsel to give support to the Softgel business unit in Latin America. In March, 2014 she was promoted to Assistant General Counsel and she remained as the legal lead for the Softgel business unit in the Latin America region. Lastly, in October 2016 Virginia was promoted to Associate General Counsel and relocated with her family from Buenos Aires to New Jersey in order to assume a broader role as Associate General Counsel for the BSDD Business Unit. Virginia is a member of the Legal & Compliance Department, providing direct support to the General Counsel and to the Company’s BSDD business unit, as well as providing support as needed to other attorneys on a wide variety of matters. Virginia is the senior legal resource for the BSDD business unit and a member of its Leadership Team, providing advice on, and assistance in negotiating and documenting, all commercial relationships, as well as mergers and acquisition matters and all other matters relating to the success of the business unit. Her responsibilities include legal advice and support, as needed, on such topics as business disputes, personnel matters, and real estate issues, as well as legal training for the business unit’s business development team. Prior to joining Catalent, Virginia held legal roles at Bayer in Argentina, where she worked for nearly 6 years. Prior to Bayer, Virginia worked for two top law firms located in Buenos Aires, Argentina. Virginia holds a degree in Law (with Honors) from Buenos Aires University. She speaks fluently Spanish, English & Portuguese.
BRENT BURKS
GLOBAL DIRECTOR, PROCUREMENT
Brent Burks serves as Global Director of Procurement for Catalent’s Biologics business. Brent was previously Director of Supply Chain, supporting the Catalent Bloomington site. Prior to joining Catalent, Brent spent over 20 years in various roles of increasing responsibility, including Director of Operations, Director of Sales, and Director Global of Procurement in Pharma, Food Manufacturing and Consumer Goods companies. Brent graduated from Indiana University with a degree in Accounting.