2024 Speakers

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.

Ingrid Markovic, Ph.D. serves as Senior Science Advisor and CMC Policy Lead at the Center for Biologics, US FDA where she is responsible for providing leadership, strategic direction, and oversight for development, implementation, and integration of CMC policies for complex biologics.

In the international arena, Ingrid serves as CBER ICH Quality Lead, and is/was FDA Topic Lead for M4Q, (co)Lead for QDG and Q12. She also had an opportunity to serve as Q3E Rapporteur briefly.

Ingrid previously worked in the industry sector leading US & EU CMC Regulatory Policy efforts with focus on Technological Innovation and Cell & Gene Therapies collaborating with Trades Associations to support continual improvement and innovation in the Biopharmaceutical sector.

Ingrid completed her Ph.D. at University of Wisconsin, Madison and Post-Doctoral Training at the Laboratory of Cellular and Molecular Biophysics at the National Institutes of Health, Bethesda, MD.

Craig Beasley joined BlueRock Therapeutics in August 2021. As Chief Technology Officer he is responsible for Technical Operations including cell line derivation, process development, manufacturing, facilities and engineering, lab operations, and analytical sciences.

Prior to BlueRock, Craig served as VP, Cell Therapy Supply Chain and Patient Operations at BMS overseeing cell therapy assets (clinical and commercial stage), demand and supply planning, patient operations, external manufacturing oversight (including oversight for lentiviral vector manufacturing), materials management, cell logistics and Cell Therapy’s Business Process owners.

Craig joined Juno Therapeutics in 2016 as head of manufacturing & supply chain.

Prior to that Craig was VP, Next Generation Manufacturing at Biogen, holding leadership positions throughout the technical operations group. Craig started Biogen leading the Process & Automation engineering group and then transferred to the Director of Manufacturing for Biogen’s RTP large scale manufacturing facility. Further to that, Craig served as head of Supply Chain Quality and in addition, worked as Vice President of Financial Planning and Analysis for 2 years reporting to the CFO.

Craig holds a B.S. in Chemical Engineering from Purdue University.

Dr. Richard D. Braatz is the Edwin R. Gilliland Professor of Chemical Engineering at MIT, where he conducts research into advanced biopharmaceutical manufacturing systems. In this role, he leads process data analytics, mechanistic modeling, and control systems for several projects on campus, including those focused on monoclonal antibody, viral vaccine, and gene therapy manufacturing. Dr. Braatz received an M.S. and Ph.D. from the California Institute of Technology and was the Millennium Chair and Professor at the University of Illinois at Urbana-Champaign and a Visiting Scholar at Harvard University before moving to MIT.

Dr. Braatz has collaborated with more than 20 companies including Novartis, Pfizer, Merck, Bristol-Myers Squibb, Biogen, Amgen, Takeda, and Abbott Labs. Honors include the AIChE PD2M Award for Outstanding Contribution to QbD for Drug Substance, the AIChE Excellence in Process Development Research Award, the Technical Innovation Award from the International Society of Automation, and the IEEE Control Systems Society Transition to Practice Award. He has published over 200 papers and three books, including Fault Detection and Diagnosis in Industrial Systems. Dr. Braatz is a Fellow of IEEE, IFAC, AIChE, and AAAS and a member of the U.S. National Academy of Engineering.

Søren Thuesen Pedersen is Senior Director, External Affairs, Regulatory Policy and Intelligence at Novo Nordisk. He is a Chemical Engineer by education and has been working 30 years in Novo Nordisk. During that that time he has been engaged and lead different areas within Manufacturing, QC-Laboratory and CMC Manufacturing Development. He has been one of the founding fathers of the Novo Nordisk External Requirements’ Process; How does Novo Nordisk ensure compliance of new external requirements? Mr. Pedersen is currently responsible for the External Representation and Advocacy strategy out of Novo Nordisk’s GMP&Q area and represents Novo Nordisk in various associations ISPE, EFPIA, IFPMA and BIO. Specifically, Mr. Pedersen is a member of the EFPIA Manufacturing Quality Expert Group (MQEG) since 2019 and member of the Board of Directors in IQ Consortium.

He has furthermore been member of the Novo Nordisk Board of Directors for 12 years as an elected employee representative.

His spare time interests include Danish and EU Politics.

Charles L. Cooney is the Robert T. Haslam (1911) Professor of Chemical and Biochemical Engineering, Emeritus in the Department of Chemical Engineering at MIT and founding Faculty Director, Emeritus of the Deshpande Center for Technological Innovation. He has been involved as founder, advisor or board member of over 25 companies and currently sits on the Boards of Directors of Codiak Bioscience, Innovent Biologics (1801.HK), Levitronix Technologies, and is chairman of GreenLight Bioscience and Mitra RxDx. In addition, he is Trustee Emeritus of Boston Ballet, Advisor Emeritus of the Boston Symphony Orchestra and Trustee of the Leventhal Map Center. Other interests include: high altitude mountaineering (assents of Denali, Ama Dablam, Mont Blanc, Kilimanjaro, Huascaran). and antique map collecting.

Dr. Joanne Beck is currently Chief Technology Officer at Aerium Therapeutics, a startup dedicated to the discovery & development of antibodies and small molecule antivirals against SARS-CoV-2 and other epidemic & pandemic threats. Prior to this, she served as COO at Boston Pharmaceuticals, a private company developing candidates across multiple indications in cardiometabolic, oncology, and immune/inflammatory diseases. Prior to joining Boston Pharmaceuticals, she was Executive Vice President of Global Pharmaceutical Development and Operations at Celgene where she oversaw the company’s Product Development, Global Manufacturing Operations, Supply Chain, Engineering and Quality. Prior to Celgene, she was SVP of Pharmaceutical Development at Shire. Prior to Shire she held roles of increasing responsibility in Process Development at Genentech and Amgen and in Operations at Abbott’s Pharmaceutical and Vascular Divisions. Beck holds a BA in Chemistry from Lewis and Clark College, a Ph.D. in Biochemistry and Molecular Biology from University of Oregon Medical School and completed a postdoctoral fellowship in the department of Pharmaceutical Chemistry at the University of California, San Francisco. Dr. Beck serves on the board of directors for Orchard Therapeutics and Astria Therapeutics.

Dr. Pat Yang is one of the most accomplished biotech manufacturing executives and technical operations leaders in the industry.

From 2017 to 2019, Pat was executive vice president at Juno Therapeutics, a leading CAR-T biotech company (now part of BMS) based in Seattle.

Previously, from 2009 to 2013, Pat was Executive Vice President and Global Head of Technical Operations at F. Hoffman-La Roche based in Basel, Switzerland. In this role, he was responsible for Roche’s biopharma process research and development, analytical sciences, engineering, quality, technical regulatory, supply chain and all manufacturing plants with approximately 15,000 employees around the world. From 2003 to 2009, Pat was Executive Vice President of Product Operations at Genentech. He assumed his role as Global Head of the combined technical operations of Roche and Genentech upon the acquisition of Genentech by Roche in 2009.

Before Genentech, Pat worked for 11 years at Merck & Company from 1992 to 2003, based in New Jersey, in various leadership positions including vice president of Asia Pacific Operations and vice president of Global Supply Chain Management. Prior to joining Merck in 1992, Pat spent 12 years at General Electric, serving in research, engineering, technology, and manufacturing leadership roles with increasing scope of responsibilities.

Pat holds a Bachelor of Science from the National Chiaotung University in Taiwan, a Master of Science from the University of Cincinnati, and a Ph.D. in engineering from Ohio State University.

Pat is a member of the Board of Directors of three public companies, Amyris, Codexis and PharmaEssentia. In addition, he is on the board of several private companies, including Acepodia, AltruBio, Antheia and Sana Biotechnology.

An international operations executive with global technical, operational, and P&L experience, Carlo has deep expertise in designing and operating global supply chains in complex regulatory environments, leading accretive M&A activity and devising and executing value-creating strategies in global markets.

Since May 2020, Carlo has been the lead advisor for Manufacturing and Supply Chain to Operation Warp Speed/Federal Covid Response, the US government initiative to support the acceleration of development and supply of Covid-19 vaccines and therapeutics. He has collaborated with the sponsors, suppliers and CDMOs to ensure the fast scale-up of manufacturing and distribution for the entire US.

In Carlo’s most recent corporate position, he was Executive Vice President of Operations at Teva Pharmaceuticals Inc.  In this role he was responsible for all Manufacturing, Technology and Capital Investments, Supply Chain, Quality and Compliance and Procurement operations, as well as the global API and CMO business. Carlo retired from this position in October 2019

Before joining Teva Pharmaceuticals in 2012, Carlo was the President, Technical Operations and Global Support Functions for Bristol Myers Squibb from 2004 to 2011. At BMS he significantly contributed to their successful transformation to a focused biopharma company.

Carlo received his Doctorate in Chemical Engineering and graduated Summa Cum Laude from the University of Naples in Naples, Italy.

An accomplished, strategic senior leader who drives global business transformation and continuous improvement in the pharmaceutical and technology spaces. Kari has excelled in areas that require a strong, broad view, visualizing connections/gaps and helping organizations to improve their operations and execution in a regulatory and compliance industry. She is recognized as a trusted partner to commercial, technical and scientific colleagues alike. 20+ years Learning & Development, Performance Management, Talent Development, Organizational Development and Learning Technology.

Paul Kopesky is the VP of Cell Therapy Process Development at Beam Therapeutics. Paul is a biological and chemical engineer by training and has over 20 years of academic and biotechnology industry experience. In his current role, he develops manufacturing processes for Beam’s ex vivo CRISPR base-editing pipeline including hematopoietic stem cell , T cell, and NK cell based therapies. Prior to Beam, he worked at Magenta Therapeutics where he was responsible for CMC program strategy and execution for Magenta’s umbilical cord blood derived, hematopoietic stem cell therapy. In addition, Paul has worked at Acusphere Pharmaceuticals, Merrimack Pharmaceuticals, and XTuit pharmaceuticals focusing on specialty pharmaceutical process development, regenerative medicine, and novel particle-based drug delivery modalities. Paul holds a BS and MS in Chemical Engineering and a PhD in Biological Engineering from the Massachusetts Institute of Technology.

John Glavas has over 25 years of operational experience in both Pharmaceutical and Biotechnology industries. He has built a reputation as a strong leader with a proven track record in successfully delivering large scale, transformative projects for the businesses.

John joined Merck as AVP Site Lead for Merck’s Oss Biologics, Netherlands manufacturing site in 2017 and as a member of the Global Biologics and Sterile Leadership Team.

In 2020, John moved to External Manufacturing for Large Molecules, where he oversaw and managed Merck’s Global COVID response Program, working with government agencies and industry partners. John is currently working in establishing global strategic partnerships for Vaccines and Biologics manufacturing.

Prior to joining Merck, John has held several leadership roles within GSK vaccines, including the Site Lead for the Flu end-to-end manufacturing, as well as the Global EHS Lead.

John has a Bachelor’s degree in Chemical Engineering and a Master’s degree in Manufacturing Management from McGill University.

Yana’s current role includes defining the Quality transformation roadmap that enables Quality standardization, simplification, and digitalization in order to support our patients and ensure uninterrupted supply of the medicines. Transformation includes all aspects of our Quality Culture program ensuring Leadership commitment to Quality, employees’ ownership and engagement, continuous improvement, upskilling and performance.

Yana’s background includes wide range of roles spanning from Digital, CSV, Quality management, and Operational Excellence. Skilled in behavioral and technical transformations, Change Management and project management, Yana is positioned to be the coach and an influencer of transformation.

Yana brings more than 25 years of experience in the industry in the organizations like Sanofi, Johnson & Johnson, and Vertex Pharmaceuticals.

Yana holds 2 degrees from NYU, Stern School of Business, in Finance and Marketing.

Senior Director of Global Manufacturing at AskBio. Responsible for managing manufacturing activities at AskBio’s primary CDMOs, Viralgen and TAAV. Has built a manufacturing team to support AskBio’s cross functional CMC development and operations activities. Over thirty years of experience in pharmaceutical and biopharmaceutical drug product development, operations and CDMO oversight. Prior to AskBio, was with Spark Therapeutics, Inc. where he spent six years helping to commercialize the first approved gene therapy in the US and progressing their clinical programs. Currently based in New Jersey. Received a bachelor of arts degree from Rutgers University and an MBA, specializing in Pharmaceutical Management, from Aspen University.

A biotechnology leader with 25 years’ experience in developmental, clinical and commercial biologics manufacturing, Christine Sheaffer joined Spark in 2018 and now serves as the Head of Manufacturing & Supply. In this role she leads both internal and external manufacturing, supply chain and operational excellence; she also has functional responsibility for operational readiness of Spark’s Gene Therapy Innovation Center, which is currently under construction in University City, Philadelphia.

While at Spark Christine has built a strong manufacturing team and played a pivotal role in the manufacturing and supply of LUXTURNA™, the first gene therapy for a genetic disease approved in the U.S. She and her team are also responsible for clinical supply of the assets in Spark’s pipeline for Fabry disease, Hemophilia A and others.

A proven leader with deep technical skills, Christine is highly experienced in technical transfer, commercialization, CMC submissions, and successfully preparing facilities and teams for regulatory inspections. At the same time, she has extensive experience working with cell culture and purification operations, stainless steel and single use bioreactors, and in general GMP manufacturing operations.

Prior to joining Spark, Christine served as Senior Director of Manufacturing at Endo Pharmaceuticals where she led the tech transfer and commercialization of Xiaflex™.

Christine earned a BS in Biology from Bloomsburg University.

Peter Shearstone is Vice President of Global Quality and Regulatory Affairs for Thermo Fisher Scientific, a position he’s held since 2018. He leads a team of over 8,000 quality and regulatory affairs (Q&RA) professionals at the enterprise level and in Thermo Fisher Scientific’s many businesses and operations spanning more than 140 countries. Peter leads a comprehensive Q&RA ecosystem that includes Clinical Affairs, Design Quality, Product Legislative Compliance, Quality Assurance, Quality Control, Quality Engineering, Quality Management, Quality Systems, Regulatory Affairs and Supplier Quality.

Under Peter’s leadership, the Q&RA organization introduced the company’s first enterprise-wide quality policy, launched a companywide initiative challenging every employee to make quality personal, built a talented global team, supported the approval and launch of hundreds of new products, and improved performance across key Q&RA metrics.

Prior to joining Thermo Fisher, Peter held executive quality and regulatory roles with companies in the health care and life sciences industries during the course of nearly 35 years.

Peter is passionate about inspiring and developing the quality and regulatory leaders of tomorrow, and participates in programs promoting science, technology, engineering and mathematics (STEM) education. He speaks at universities, has hosted visits for STEM classes at Thermo Fisher facilities and encourages and mentors students to pursue careers in the life sciences industry. Peter also encourages his teams to mentor STEM students and participate in efforts to increase awareness of opportunities in the Q&RA profession.

Peter holds a bachelor’s degree in biology from Salem State University in Salem, Massachusetts.

Dottie Barr serves as Senior Vice President, Manufacturing and Technical Operations. She joined Lantheus in 2015. Ms. Barr has served in positions of increasing responsibility at Lantheus, including most recently as Vice President of Manufacturing and Supply Chain, and brings more than 35 years of industry experience.

Prior to joining Lantheus, she served as Vice President, Supply Chain, Materials, and Logistics at T2 Biosystems. She has also held positions of increasing responsibility at Haemonetics, where she ultimately rose to the position of Vice President, Global Supply Chain. Ms. Barr earned a Bachelor of Arts in economics from Framingham State University and a Master of Business Administration from Babson College.

Dottie’s Philosophy “Find your passion and do what you love!”

Elena Kichula is the Sr. Director of Manufacturing Science and Technology and Process Engineering at Spark.  Her team provides technical process and equipment expertise across Spark’s internal and external manufacturing sites.

She has more than 15 years of experience in the biopharmaceutical field holding roles across both the innovator and CDMO space.

Prior to her current role at Spark, Elena held a role as a CMC Lead managing CMC strategy for a portfolio of Spark’s clinical assets, including their hemophilia A program.  Before joining Spark, Elena was with Thermo Fisher where she held several roles, both domestically and internationally, of increasing responsibility spanning process development, site operations, and program management.  In her last role there she served as Site Head & Director of Program Management of one of their Biologics Process Development Sites.

Elena earned her doctorate degree in Bioengineering from the University of Pennsylvania and bachelor’s degree in Biological Resources Engineering from the University of Maryland.

Vaishal currently has responsibility of providing end to end Quality support and CMO oversight for multiple gene therapy programs at Spark Therapeutics. Vaishal has spent 18 years in pharmaceutical industry holding roles and responsibilities in analytical development, formulation development and Quality Assurance areas for products spanning from small molecule to AAV gene therapy. His core expertise lies in operational support to biopharmaceutical manufacturing, product quality management, process qualification, sterile manufacturing, and continuous process improvements. His personal passion is to follow good science to deliver a quality product to people at the end of the supply chain.

Prior to joining Spark, Vaishal was a Sr. Quality Advisor at GSK where he led QA team supporting manufacturing, site readiness and successful health authority inspections for GSK’s first Antibody Drug Conjugate (ADC) product. He championed fit for purpose quality systems to ensure successful commercial supply chain for the product. Previous to GSK, Vaishal was with Auxilium Pharmaceuticals (now Endo) where he was responsible of manufacturing and testing oversight of a biopharmaceutical products at multiple CMOs and CTLs in the supply chain.

Vaishal received her BS in Pharmacy at Pune University (India) and MS at Temple University. He is based in Philadelphia area.

After receiving his PhD from the University of Pittsburgh and completing post-doctoral studies at Scripps Research, Jonathan (Jon) Tripp embarked on an industrial career at both Bristol Myers Squibb and Gilead Sciences in process chemistry where his experiences span the entire drug development spectrum from pre-IND deliveries to the commercialization of two small molecule therapies. Throughout these experiences Jon has gained a significant appreciation for how impactful small changes early on in process development can have a huge impact on the overall sustainability of a product over its development and commercial lifetime. This appreciation has led Jon to champion the integration of sustainable manufacturing practices into the small molecule process development framework with the goal of ensuring that the ultimate commercial manufacturing process is as sustainable as possible.

Mike received his B.S. in Chemistry from the University of Wisconsin – Madison and his Ph.D. in Organic Chemistry from the University of Texas at Austin under the supervision of Prof. Stephen Martin. He was also an American Cancer Society postdoctoral fellow in the labs of Prof. Barry Trost at Stanford, prior to beginning his industrial career with Gilead Sciences just under 11 years ago. Mike is currently the drug substance lead for obeldesivir, which was until recently under investigation for the treatment of SARS-CoV-2 infection. He has, however, had the opportunity to work on numerous other development projects during his time at Gilead, including lenacapavir, the API in Sunlenca®. Mike is also a champion for Quality by Design and leads Gilead’s Design of Experiments working group.

Mr. Paul Testa joined Kyowa Kirin in 2019 as EVP for supply chain and operations. Previously, he held senior executive positions in global supply chain and operations at Shire (acquired by Takeda) and Johnson & Johnson — most recently leading 500+ professionals in 25+ countries, leading a supply chain strategic transformation, and helping Shire to grow its revenue from $3 billion to ~$15 billion. He earned a bachelor of science degree from Rensselaer Polytechnic Institute, a master of science degree from Washington University, and a master of business administration degree from Boston University.

Sandra joined Mythic Therapeutics in July 2020 as Chief Operating Officer, bringing more than 25 years of biopharma industry experience in strategic and operational areas including advanced therapy and biological drug development, manufacturing, business operations, and company building.  Prior to Mythic, she served as Chief Operating Officer of LogicBio Therapeutics, and Executive Vice President of Technical Operations and Commercial Development at ImmunoGen, Inc.

Before Immunogen, she spent over 15 years in leadership roles at Genzyme Corporation (acquired by Sanofi) including Vice President and General Manager of Genzyme Flanders in Belgium, and Senior Vice President of Biologics Manufacturing, overseeing global commercial manufacturing of six biologics across five manufacturing sites in the US and EU.

Sandra currently serves on the board of directors of Travere Therapeutics, was formerly on the board of directors of Viacyte, Inc. (until its acquisition by Vertex) and she served on the supervisory board for Valneva, SE.  Sandra holds both a B.A.Sc and M.A.Sc in chemical engineering from the University of Waterloo (Canada).

Marian is a pharmaceutical industry executive, experienced in leading drug discovery, development, and commercial Chemistry, Manufacturing, and Controls (CMC) organizations. With over 20 years of experience at Merck, she has held various leadership positions, spanning early-stage clinical development and translational research to late-stage development, commercial technology transfers, new product launches, and post-market product supply. Marian’s expertise includes small molecules, oligonucleotides, biologics, and vaccines, where she has demonstrated a track record of driving product innovation.

Marian currently serves as Vice President Small Molecule Science & Technology at Merck, leading a worldwide organization responsible for late-stage development of Merck’s small molecule pipeline across drug substance, drug product and packaging as well as all technical support for in-line small molecule products and lifecycle management activities. The group also manages development of new manufacturing technologies and provides site-based technical support to all of Merck’s small molecule sites.

Marian is a proven leader with a passion for scientific rigor, innovation, and strategic thinking. Her commitment patients is central to the impact that she has made throughout her career.  Marian holds a B.S. degree in Chemical Engineering from Rutgers University and PhD from Princeton University’s Department of Chemical and Biochemical Engineering.

Teresa Gorecki comes to Compliance Architects^® from Johnson & Johnson, Janssen Pharmaceuticals, where she was most recently Vice President, Market Quality.   At Johnson & Johnson, Teresa was one of J&J’s top Quality professionals, known for her ability to manage inspections and remediate and improve deficient operations.  Teresa had senior level roles across all three sectors within Johnson & Johnson:  Pharmaceuticals, Consumer Products and Medical Devices.

Teresa is one of Compliance Architects’^® lead subject matter experts, and has primary responsibility for strategic client engagements.

At Johnson & Johnson, Teresa’s key accomplishments included:

• Chair of Johnson & Johnson Cross Sector Business Quality Governance Team responsible for developing a Governance Model and Organizational Structure to develop and oversee an aligned Quality Management System, Processes and Procedures across the J&J Enterprise Business/Marketing Company Quality Units.
• Member of J&J Company Leadership Teams/Boards including Regional Management  Board for North America; J&J Consumer Healthcare Company (CHC) Board; and Neutrogena Management Board.
• Management of all aspects of Quality Systems, Quality Assurance, and Regulatory Compliance with Worldwide Regulatory Authorities including FDA (CBER, CDER and CDRH), MHRA,EMA, ANVISA, CFDA, Health Canada, etc.  Extensive experience in combination products, pharmaceutical dosage forms for both OTC and Rx products; biological (r­ DNA and monoclonal antibody) products and a wide range of consumer products (class I and II medical devices, OTC drugs, cosmetics and consumer products) in the US and Puerto Rico.
• Over 20 years’ experience and lead J&J subject matter expert in handling FDA inspections (routine, special cause, and PAI) for Cosmetic and Consumer, Combination Drug/Device, Pharmaceutical, and Biological products.
• Extensive experience with new product introduction; product and technology transfer, and commissioning of new/re-constructed facilities.
• Leadership of ERP System (SAP) implementation for Pharmaceutical Sourcing Group of the Americas Sites in New Jersey and Puerto Rico. Management of large-scale Supply Chain projects for “Demand Pull,” or LEAN Manufacturing.  Sponsorship of Six Sigma initiatives in Manufacturing and QA, which increased quality and compliance and yielded business benefits.

Teresa received her B.S. in Microbiology, with a minor in Chemistry from South Dakota State University.

Jacob Greenwood has spent his 15+ year professional career working in the Life Sciences industry. At Project Farma, Jacob is a strategic leader, creating and fostering client relationships and building brand awareness within the pharmaceutical and biotech industries.

In addition to his experience with Project Farma, Jacob spent 5 years as a business development professional within the Architecture, Engineering, and Construction industry, delivering projects totaling nearly $500M. Prior to developing his sales career, he was an active member of the preclinical research community, managing vivariums in both Maryland and North Carolina. Jacob remains committed to helping medicines and therapies move through the research and development stage into manufacturing and ultimately into a position to positively impact the lives of patients.

Robert Honer is a seasoned professional with a solid background in finance, supply chain management, and software solutions. He currently holds the position of Senior Director, Supply Chain Practice at Anaplan where he leverages his vast experience to develop effective supply chain strategies and support new software launches. Robert’s education background includes a Masters degree in Finance and Supply Chain Management from Syracuse University. Prior to joining Anaplan, Robert spent over a decade at Blue Yonder, serving in various supply chain-focused leadership roles

Alex Cooke is the founder & CEO of Phase 3 Search- a boutique executive search firm driven by their mission to accelerate drug development through building and supporting the world’s life sciences leadership teams.

Alex’s expertise lies in building out executive teams in early stage companies, working with PE & VC backed biotechs to accelerate their growth and development. He provides much more than placement, acting as a trusted advisor to his clients.

With 11 years industry expertise placing biotech executives at home and abroad in Europe, Alex is a visionary and active member of the FORBES Business Council.

Vaishali Shukla is a proven leader with expertise in quality compliance and in developing the teams required to deliver it.

In her current role as VP, of Quality at Kite, Vaishali leads 700+ professionals globally across multiple manufacturing sites. In this role, Vaishali oversees functional and site strategies at each of the Kite manufacturing locations, setting overarching goals and objectives as well as developing and executing short- and long-term strategic direction.

With ~ 20 years of experience in the biopharmaceutical industry, she is an expert in a broad variety of subjects ranging from early clinical development to commercialization of Cell and Gene therapy, biologics & small molecules.

Vaishali’s career includes work at BioVest International, Takeda Pharmaceuticals, Shire Pharmaceuticals, and UniQure, where she implemented novel processes for continuous development.

With a BS in Biology, master’s degrees in Botany, Regulatory Affairs, Pharmaceutical Economics and Policy, and a Ph.D. in Pharmaceutical Science.

Vaishali lives in the Boston area and is the proud mother of her daughter Smita, who is following her footsteps as a female trailblazer in the biosciences.

Karin Ann Payne is the Vice President of Corporate Quality in BMS.

In this role, Karin provides strategic quality and compliance leadership in the GxP development and implementation of an integrated QMS across the Enterprise including Research and Early development, Global Drug Development, Global Product and Supply and Medical Affairs and in support of the product lifecycle.

Prior to joining BMS she was the VP of NA Quality for Bayer where she was responsible for ensuring that Bayer remained committed to the highest standards of quality, which is paramount to the patients and customers it serves every day. She joins Bayer from Reckitt Benckiser, where she most recently held the role of Head of Global Corporate Quality Compliance. In this role, she was responsible for managing the company’s Global Quality Management System, Corporate Quality audits, and its Global metrics and Computer System Validations teams. She also managed the Europe and North America Commercial Quality teams, responsible for managing market quality. Prior to that, she held a variety of roles in Quality Assurance and Compliance including positions at Actavis and Pfizer, managing the unique challenges and opportunities of both the consumer health and pharmaceutical industries.

She holds an MLS in Pharmaceutical law (High Honors) from Seton Hall, MBA in Financial Management (High Honors) with a Certificate in International Finance from Iona University and a Bachelor’s in Biological Sciences from Rutgers University

Peter is a biopharmaceutical manufacturing expert with more than 20 years of experience in the industry. He comes to SmartLabs from Catalent Biologics where he managed business development efforts in the northeast region. Prior to that, he held various roles in Product Development and Product Management for GE Healthcare’s Biomanufacturing Solutions business incorporating both automated unit operations and single-use connectivity.

His many accomplishments include:

• Developed an automated, turnkey manufacturing solution for mAb production with a single use platform that now has over 100 global installations
• Developed automated mixing and filtration unit operations to fill gaps in GE Healthcare’s portfolio
• Created first end-to-end single use connectivity solutions for mAb manufacturing platform
• Led process engineering design and commissioning for world’s largest cellulosic ethanol plant for British Petroleum

Zillery A. Fortner is an esteemed thought leader in the life sciences industry. She has over 30 years of experience in the medical device field, with her roles expanding to surgical assistant, quality assurance specialist, regulatory affairs expert, and accreditation professional. Currently, she serves as Industry and Business Development Director at Honeywell, where she acts as the voice of customers within the organization, using her extensive expertise to drive innovation and progress in the industry.   

Zillery is actively involved in multiple professional organizations, and her advice is highly valued in shaping the future of quality in the industry. She has been granted two patents and has several more in the process. Her vast experience in the industry has provided her with valuable insights into several aspects of quality, enabling her to drive digital innovation and help meet regulatory compliance requirements. 

April is an MES Technical Solutions Consultant at Honeywell, bringing over 5 years of expertise in the life sciences industry. Her focus lies in digital transformation projects ensuring MES design is aimed at streamlining production floor activities and developing tailored solutions and trainings for clients. Before venturing into the pharma industry, April leveraged her skills by leading operations in numerous research laboratories at the University of Notre Dame.

Amy leads the Pharma Automation Product Group Business Operations team (Business Development, Sales, Pre-Sales, Marketing, Operations and Client Success) that’s providing SmartFactory Rx® automation solutions.  SmartFactory Rx® is developed for process manufacturing to harness the power of data, reduce development time, and improve productivity to optimize high value manufacturing, while increasing throughput, decreasing risk, and accelerating time to market for new products.  Amy earned a Master’s Degree in Biotechnology Engineering from Northeastern University.

Scott is currently Head of Business Development and Licensing, USA at Boehringer Ingelheim, based out of both Ridgefield, CT and Cambridge, MA.He received his BS in Cellular Biology from the University of Connecticut and began his research career with Pfizer in Groton, CT.He later earned a PhD in Molecular Biology from the University of North Carolina and did his postdoc at the lab of Nobel Laureate Robert Lefkowitz at Duke University, studying G protein coupled receptor signaling.In late 2007, Scott co-founded a start-up company called Trevena Inc ($TRVN on Nasdaq), helping discover and develop Olinvyk®.After his startup adventure, Scott left Trevena to join BI, initially working in the research group. Scott later moved to lead Cancer Immunology BD&L and assumed his current role as head of the US BD&L team in early 2020.

Dr. Michael Kraich is Vice President of Global Project & Product Management within Boehringer Ingelheim’s Biopharma Contract Development and Manufacturing Business called BioXcellence.

Michael has more than 15 years of experience in Biopharmaceutical Development, Manufacturing, Project Management and Contracting. In his previous role he was heading the Global External Manufacturing Network of Boehringer Ingelheim’s Animal Health Business accountable for the strategic development and management of a global CMO and API supplier network. Before this, he was a member of the site leadership team of the Biopharma Site in Biberach, Germany, leading the local CMC Project Management organization dedicated to CMB customers.

Anshul Mangal is President of Project FARMA and Precision ADVANCE. Anshul founded and grew PF into a leading global biologics and advanced therapy engineering consulting firm. Under Anshul’s leadership, PF has partnered with over 100+ therapeutic innovators, developed state-of-art manufacturing facilities for complex biologics and pioneered the industrialization of advanced therapies including many commercially approved cell and gene therapies. PF was acquired by Precision Medicine Group in 2020 to be the cornerstone of Precision ADVANCE. ADVANCE is a collection of Precision’s services uniquely focused on the complexities of research and clinical development, regulatory, manufacturing, and commercial needs to successfully bring an advanced therapy to market.  In addition, Anshul is an investor, board member and advisor at several biotech organizations.  Prior to PF, Anshul was a patent litigator at Jones Day and a consultant at Morgan Stanley & Discover Financial Services.

Jason Politi is the chief technical operations officer at Verve Therapeutics. Jason brings over 25 years of industry experience in development, manufacturing, and project management. Jason previously served as senior vice president of technical operations at Verve since 2021. Prior to joining Verve, he served as senior vice president, technical operations at Prevail Therapeutics, where he helped to build and lead the chemistry, manufacturing and controls (CMC) team and managed the company’s AAV gene therapy programs. He was instrumental in the approval of Prevail’s first three investigational new drug applications with the FDA and the supply for Prevail’s clinical trials prior to the company’s acquisition by Eli Lilly in 2021. Before Prevail, Jason served as senior director, clinical manufacturing at Alexion. Earlier in his career, he held leadership roles at various biotechnology and pharmaceutical companies, including Dyax, Biogen and AbbVie.

Jason holds a B.S. in Chemical Engineering from the Massachusetts’s Institute of Technology and an MBA from Boston College.

As the senior vice president of go-to-market strategy, Marty Smyth is responsible for market intelligence, product strategy, and bringing MasterControl quality and manufacturing products to market globally. He brings 20 years of technology strategy, marketing, sales, and support experience across high-growth private SaaS companies as well as Fortune 500 companies.

In previous roles, Marty has driven strategic planning, customer experience, and go-to-market for technology leaders like Cisco, Panasonic, Verizon, and AT&T. He is a University of Notre Dame alumnus.

Edward Garibian, CEO of LLumin, is an accomplished entrepreneur and visionary of CMMS (computerized maintenance management systems) technology, having more than 28 years of expertise. He has a successful track record in solving challenges customers face, such as bringing products to market faster, optimizing manufacturing processes to improve product quality, helping organizations to more effectively track, manage, and maintain their assets and critical infrastructure. Under his leadership, LLumin was named by the Silicon Valley Review as one of the top 50 Leading Companies of 2024. He holds a Bachelor of Science in Electrical Engineering from the University of Massachusetts, Amherst.

Dennis Ladd has spent 40 years in enterprise software. More than 30 years ago, he joined the R&D group at SAP in Walldorf, Germany and made significant contributions to SAP’s flagship ERP product. This product became the de facto standard for business applications in the Fortune 500. As chief technology officer, and later as president and CEO at Sweden-based StreamServe, Dennis was a driving force behind the company’s products for automated business communications, used in 10,000+ enterprises worldwide. Presently he serves as a senior sales executive with eschbach North America, where he advises manufacturing operations teams on using technology to support shift team communication and collaboration to increase efficiencies and production.

Jin Seok Hur received his Ph.D. degree in Chemical Engineering at Purdue University in 2006. After, he joined Novasep in US as a process development scientist and became the R&D manager in 2008. Between Sep 2011 and Dec 2013, he led the R&D and cGMP Kilo Lab teams at Novasep in Pompey, France. Upon returning to Novasep US in Jan 2014, he was responsible for the R&D and Technology. He currently serves as the General Manager of Axplora US as well as the Director of Technical Sales for ADC and purification.

Based in Raubling (Germany), Arul oversees the Global Marketing Strategy and Business Intelligence and has a global role bringing together the BU Marketing organizations to foster our business impact in close relations with the BU Presidents and the sales teams.

A Chartered Chemical Engineer from the UK with an MBA from INSEAD, Arul has a 25-year business career as a General Manager, Executive Coach and Commercial Negotiator. He led Commercial (Marketing & Sales) and Operational (Technical Operations & Supply Chain) organizations at Novartis, Baxalta & Shire in several countries and has also served as CEO of a Swiss Biologics CDMO. Most recently, he has been supporting a major German pharma company set up a global rare dermatology business.

Arul likes to practice his six languages at our sites, while indulging in a conversation or two about the local region and sports, many of which he follows. Outside of work, he is an avid skier and hiker with his family.