Pharma Manufacturing World Summit

Holger has more than 20 years of industry experience in operations and supply chain. He started his career in the areas of process development, manufacturing, and general management. Afterwards, he held various positions with increasing responsibility in Supply Chain Management, both in Germany and the US. After having led global operations for API manufacturing, he assumed his current role as Head of Product Supply for the Bayer Pharmaceuticals division being responsible for global technical operations and supply chain.

Holger Weintritt holds a PhD in organic chemistry from the Max Planck Institute in Muelheim an der Ruhr, Germany.

Flemming Dahl is Senior Vice President at Novo Nordisk heading up the area Fill & Finish Expansions which is responsible for all major fill & finish expansion projects across Novo Nordisk globally. A key focus area in Mr. Dahl’s role is a focused drive to professionalize and standardize fill & finish facilities via a modular approach to aseptic production, finished production, intralogistics and quality control while designing the facilities for flexibility, automation and compliance. Mr. Dahl runs a double-digit billion DKK portfolio of expansion projects spanning multiple time zones. He has been with Novo Nordisk since 1994 and held several senior leadership positions, including Senior Vice President for the global Quality organisation covering all units in Novo Nordisk and has headed up the company’s biopharmaceutical production also as Senior Vice President. Mr. Dahl holds a Master Degree in Chemical Engineering from the Technical University of Denmark.

A relentless visionary, Robin Kumoluyi consistently moves people and organizations forward. Throughout her career, she has expertly crafted complex quality management strategies for multi-billion-dollar matrixed organizations. Committed to the belief that patients and customers must have access to effective medicine, Robin intentionally chose the quality function within the pharmaceutical indutry.

Robin Kumoluyi is the Vice President and Chief Quality Officer, Pharmaceuticals at Johnson & Johnson Corporation. Robin has responsibility for Quality & Compliance for the Global Pharmaceuticals Segment in Pre-Market R&D, Supply Chain and Post Market Commercial. Prior to her current role, Robin was VP, Global Quality Services at Johnson & Johnson, where she drove the organization’s Enterprise Quality transformation by defining, leading, and executing the strategic direction and oversight of the Quality Policies, Standards, Digital Healthcare, Innovation and Analytics, Value Chain Quality, and the overall Q&C Strategy and associated processes.

Her proven track record spans thirty years of robust experience leading change while holding senior leadership roles within Quality, R&D, and Manufacturing Compliance in the pharmaceutical and food industries. Her broad expertise encompasses a wide portfolio of product types including OTC, Biological, Pharmaceutical, Devices, Veterinarian, Nutraceuticals, and Food and Beverage products.

Robin is a transformative leader who can steadily garner followership. Her keen ability to co-create for best outcomes led to the successful results in complex start-up and turn-around situations such as new operations, consent decrees, and warning letter remediations.

As a leader, Robin knows it is her responsibility to enable people to achieve their fullest potential. She is committed to the well-being of her colleagues, peers, and community, actively collaborating with people and teams in the name of career growth and progress. She is a champion for diversity and inclusion, which she knows fosters innovation and drives business success. Steadfast in the belief that what is good for the person is good for the organization, she fully embraces her role as a guide and coach and considers it the most rewarding part of her work. She actively engages with industry and leadership organizations such as ISPE (Women in Pharma), PDA, and Rx360, where she was co-leader of the audit operations group. She is an active member of Advancing Women Executives (AWE), an organization creating equity and economic development in the workplace, and Achieving Women’s Excellence in Supply chain Operations, Management and Education (AWESOME) and United Way.

Robin holds a bachelor’s degree in Biological Sciences (specializing in microbiology) from Rutgers University and a master’s degree in Quality Assurance and Regulatory Affairs from Temple University School of Pharmacy. A native of New Jersey Robin currently lives in North Carolina with her husband and son.

Family, Faith, Service, Curiosity and Growth are words that best describe Robin’s passion and purpose. When she is not driving transformation, Robin can be found spending time with her family enjoying a movie or a new park; emerging in “beautiful environments” whether it is art, music, a spa, or silence; learning something new; cooking; and asking with an open heart-what can I do to help someone today.

Catalina Vargas is the Senior Vice President of Global Supply Chain and as such plays a strategic role in driving enterprise initiatives.

Catalina has more than 20 years of experience in the biopharma industry and has held positions of increasing responsibility in a range of local, regional and global roles in global strategic sourcing and procurement as well as manufacturing; she has also served as the Chief of Staff to the CEO prior to current role and also as a product portfolio leader.

She joined Bristol Myers Squibb in 2018 as vice president, Strategic Sourcing and Procurement, Global Product Development and Supply, managing a complex supply chain need to ensure the uninterrupted supply of medicines to our patients. Prior to joining Bristol Myers Squibb, she was with Pfizer for 18 years in a number of leadership positions.

“I was drawn to the biopharma industry to help bring much-needed treatments to patients with serious diseases,” she says. “In my roles in procurement, a strategic area that helps advance a company’s competitive capabilities, I was proud to play a part in delivering innovative medicines to patients.”

Born and educated in Colombia, Catalina earned her bachelor’s degree in industrial engineering from Universidad Javeriana and a graduate degree in finance and capital markets from Universidad de La Sabana.

As Chief Technical Operations and Quality Officer, Dr. Collins is responsible for the technical development, quality, and supply of preclinical, clinical and commercial programs within Moderna’s portfolio.

Dr. Collins joined Moderna from Novartis, where he held roles of increasing responsibility over the last nearly 30 years, focused on pharmaceutical production and manufacturing, including roles serving as Head of Global Chemical Operations and Anti-Infectives and as Head of Global Chemical Operations.

Dr. Collins received his Bachelor of Science in Chemistry and his Ph.D. in Organic Chemistry from University College Cork, Ireland. He also conducted post-doctoral cancer research at Arizona State University.

As the Senior Vice President for Specialty Care Manufacturing & Supply at Sanofi in Paris, Daniela Ottini oversees the global Manufacturing Network for Specialty Care products. With extensive experience spanning over a decade at AbbVie,  she has held leadership positions such as Vice President of External and Contract Manufacturing in Rome, Italy, and Vice President of Biologics Manufacturing in Dublin, Ireland. Her career highlights include managing diverse portfolios and leading strategic initiatives like the integration of AbbVie-Allergan for Operations. Previously, at Abbott, Daniela held various roles over 16 years, including Manufacturing Director in Italy and Regional Purchasing Manager in the UK.  She holds a degree in Chemical Engineering from Sapienza Università di Roma and a Master’s in Business Engineering from the University of Rome Tor Vergata.

Anil Sawant is Senior Vice President, Global Quality Compliance at Merck. He is a healthcare Executive with over 35 years of operations experience in Quality Operations, Ethics & Compliance, Research Integrity and Auditing functions. A strategic thinker experienced in development and deployment of management controls, governance processes, and quality and compliance systems in diverse business environments and cultures. Anil leads groups managing branded and generic products, small molecules, vaccines, bio-pharmaceutical, medical devices and consumer products. He was part of the teams that commercialized the first antibody-drug conjugate product and first photoactive drug. Expertise in interpretation of GMPs, GLPs, and GCPs. Good understanding of SOX, Anti-Kickback, Anti-Trust, Privacy and FCPA. Skilled crisis manager and pragmatic thinker with excellent understanding of regulatory requirements, global pharmaceutical supply chain and R&D operations. Extensive experience in resolving compliance matters with US FDA and international regulatory agencies. Subject matter expert in pharmaceutical microbiology and aseptic processing.

Nicolas is an executive leader and change Agent with 34 years of global, well-rounded experience in the Immunodiagnostics, Biopharmaceutical & Medical Device businesses.  He holds an outstanding record for driving successful compliance, operational excellence, and personnel development, and has led multiple large-scale projects to grow businesses and organizational capacity.

Before joining Gilead, Nicolás completed 27 years in Abbott Laboratories where he held positions of expanded leadership in Technical Support, Analytical Laboratory Operations, Regulatory Compliance, Quality Assurance Operations and Quality Systems in Puerto Rico, the continental US and in Europe, Northwest Africa and Russia.  At Gilead Sciences, Nicolas has been spearheading the Quality digital strategy, including advancing the implementations of Veeva Vault Quality Docs, QMS and RIM.  He is complementing these with a global strategy for Advanced Analytics, Data Visualization, Technology Adoption Tools and modernizing the employee learning experience.

Nicolás holds a BS degree in Biochemistry and a Masters in Microbiology Immunology from Stony Brook University and the Temple University Medical School, respectively where he completed research work in hormone biochemistry and in the immunoregulation of autoimmune diseases.

Ciaran joined Vertex in 2021 and is the Vice President of MSAT, which provides technical leadership within the commercial manufacturing organization. This includes partnering with the R&D teams to develop and implement robust and scalable processes that are capable of reliably supplying patients with high quality medicines. The team also directly support the manufacturing sites to resolve complex technical issues and implement new technologies and technical agendas to drive continuous improvement.

Ciaran previously worked at Human Genome Sciences, Eli Lilly and Co. and Bristol-Myers Squibb in roles of increasing responsibility and has over 20 years of industry experience in manufacturing and process development, primarily for biologic medicines. During his career, he has directly contributed to the successful approvals, launches and supply of medicines such as Benlysta, Trulicity, Taltz, Opdivo and Orencia.

Ciaran is a native of Ireland and earned bachelor’s and Ph.D. degrees in Biotechnology from Dublin City University in Ireland. He subsequently moved to the U.S. to undertake a post-doctoral program in vaccine process development at the National Institutes of Health in Bethesda, MD.

Dr Mire-Sluis is currently Head of Global Quality at AstraZeneca.  He was previously Vice President, North America, Contract, Singapore and Product Quality at Amgen Inc.  Prior to working at Amgen, he was Principal Advisor, Regulatory Science and Review, Office of Biotechnology Products, CDER and Head of Analytical Sciences and Standards, Office of the Director, CBER, FDA, in Bethesda, Maryland. He trained in Genetics and Biometry and has a PhD in Cell biology and Biochemistry. Dr Mire-Sluis was the Head of the Cytokine Group in the Division of Immunobiology at the National Institute for Biological Standards and Control, Potters Bar, UK.  Dr Mire-Sluis specialized in the development of assays for the characterization and quantitation of biological products. He then became Director of BioAnalytical Sciences at Genentech and prior to joining FDA, was Executive Director of Analytical Sciences at CancerVax Corporation, San Diego.

Ryan Bartock is Vice President and Head of Engineering, Technical & Digital at Spark Therapeutics, a fully integrated gene therapy company and member of the Roche group.

Ryan joined Spark Therapeutics as Head of Supply Chain and Network Strategy in 2017 where he established Spark’s Supply Chain function and launched the first ever FDA approved Gene Therapy, LUXTURNA^TM. Additionally, Ryan has held interim roles as the Head of Technical Development, overseeing Process and Analytical development, Automation and Pre-Clinical Manufacturing as well as the Head of Quality Assurance.

He is currently responsible for all things process and data related at Spark including MSAT, CMC Program Management, Engineering, Automation, Instrumentation & Digital Transformation.

Ryan holds B.Sc. in Engineering and Business from Drexel University. His 20 years of experience spans process & analytical development, manufacturing operations, supply chain, QA, CMC, product strategy and new product launches in vaccines, consumer health, biologics and gene therapies.

Olav Lyngberg, PhD leads the MSAT Innovation and Technology Deployment team within, J&J Innovative Medicine Supply Chain. Olav is responsible for orchestrating a talented and innovation-focused group of scientists and engineers to accelerate technology scouting and deployment in the internal and external network of mfg. sites, while leveraging new emerging innovation ideas across platforms, and products.

Prior to his current role Olav was Sr. Scientific Fellow, MSAT where he led teams responsible for developing and deploying technological solutions in manufacturing, to address issues in the areas of process robustness, process efficiency, release timelines and advanced process control.

Before joining J&J, Olav worked for Bristol-Myers Squibb Company as part of Chemical Development. At BMS Olav held roles spanning Process Engineer, Innovation and Technology lead and CMC leader. Olav holds a PhD in Chemical Engineering from University of Minnesota and a Master of Science in Biotechnology from the Technical University of Denmark.