Speaker Biographies

Janet Woodcock | Kripa Ram | Patricia Hurter | Margaret Ruesch | John Polowczyk | Sarah O’Keeffe | Jon-Paul Sherlock | Rahul Singhvi | Julien Meissonnier | Douglas Hausner | Behnam Ahmadian Baghbaderani | Moheb Nasr | Sau (Larry) Lee | Manuel Osorio | Dolores Hernan Perez de la Ossa | Yoshihiro Matsuda | Frank Montgomery

Janet Woodcock

Janet Woodcock is the FDA’s Principal Deputy Commissioner. In this role, she works closely with the Commissioner of Food and Drugs to develop and implement key public health initiatives and helps oversee the agency’s day-to-day functions. She served as the Acting Commissioner of Food and Drugs from Jan. 20, 2021, until Feb. 17, 2022. Dr. Woodcock began her FDA career in 1986 at the Center for Biologics Evaluation and Research (CBER) where she served as the Director of the Division of Biological Investigational New Drugs and as Acting Deputy Director and Director of CBER’s Office of Therapeutics Research and Review, which oversaw the approval of the first biotechnology-based treatments for multiple sclerosis and cystic fibrosis during her tenure.
In 1994, she was named Director of the FDA’s Center for Drug Evaluation and Research (CDER), leading the Center’s work that is the world’s gold standard for drug approval and safety. In 2004, she became the FDA’s Deputy Commissioner and Chief Medical Officer. Later she took on other executive leadership positions in the Commissioner’s Office, including Deputy Commissioner for Operations and Chief Operating Officer.
In 2007, she returned as Director of CDER until asked to be the therapeutics lead for “Operation Warp Speed” in early 2020. This entailed supporting the development, evaluation, and availability of treatments such as monoclonal antibodies and antiviral drugs for patients with COVID-19. Dr. Woodcock holds a Bachelor of Science in chemistry from Bucknell University (Lewisburg, PA), and a Doctor of Medicine from the Feinberg School of Medicine at Northwestern University Medical School (Chicago). She is board certified in internal medicine.

Kripa Ram

Kripa Ram is the Senior Vice President of Global CMC Development at Sanofi and is responsible for process, formulation, analytical development, and clinical manufacturing for biologics, small molecules, gene, and cell therapy projects in Sanofi’s R&D pipeline. With a PhD in Chemical Engineering, Kripa has more than 30 years’ experience in CMC spanning Merck, GSK, Biogen, MedImmune/AstraZeneca, and Sanofi. He considered himself lucky to have contributed to bringing several products to patients.

Patricia Hurter

Patricia Hurter, Ph.D., is the CEO of Lyndra Therapeutics and a member of the Lyndra Board of Directors. She also serves on the board of biotech company Synologic Inc. Named one of FiercePharma’s “Fiercest Women in Life Sciences” and a PharmaVoice 100 honoree, Dr. Hurter is a leader who executes aggressively, creating momentum for organizational change and growth. Under Dr. Hurter’s leadership, Lyndra Therapeutics opened a GMP manufacturing facility and is ramping up a custom-designed fully continuous manufacturing line to support the clinical research and potential commercialization of its lead asset oral weekly risperidone (LYN-005) for the treatment of schizophrenia and bipolar 1 disorder.
Before joining Lyndra, Dr. Hurter was senior vice president of pharmaceutical and preclinical sciences at Vertex Pharmaceuticals, where she led the development and commercialization of five transformative therapies; established an internal continuous GMP manufacturing facility; and pioneered the first-of-its-kind fully continuous drug product manufacturing line. She also previously served as director of formulation design and characterization at Merck.
Dr. Hurter holds a Doctorate in chemical engineering from MIT, a Master of Science in mechanical engineering from West Virginia University and a Bachelor of Science in chemical engineering from the University of KwaZulu-Natal in South Africa. An avid equestrian, she is a competitive show jumper and also dedicates time to professional mentorship with organizations such as the Posse Foundation and WEST (Women in the Enterprise of Science and Technology). 

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Margaret Ruesch

Meg holds a BS in biology from The University of Notre Dame and a PhD in cancer biology from Northwestern University. Prior to joining Pfizer, Meg held various roles in development, manufacturing and quality at Abbott Laboratories and Pharmacia & Upjohn in Chicago, St. Louis and Kalamazoo, MI. Meg is currently a Vice President in Biotherapeutics Pharmaceutical Sciences, an organization responsible for the development of robust manufacturing and quality strategies for Pfizer’s portfolio of biotherapeutics, gene therapies, and vaccines. Meg is also the R&D site leader for Pfizer Andover (Massachusetts)—a critical Pfizer site involved in the development and manufacturing of the Pfizer-BioNTech COVID-19 vaccine (Comirnaty®).

John Polowczyk

John Polowczyk is a Managing Director in the Government and Public Sector of Ernst & Young LLP. John is the Supply Chain and Operations Field of Play leader. He is a supply chain and logistics professional with 34 years of experience across strategy development, information technology, financial, government contracting & acquisition management. John recently served as the White House Supply Chain lead on the Coronavirus Task Force to ensure health care workers got what they needed when they needed it. John was brought in from the Joint Staff to stabilize the supply chain in response to the pandemic and worked across federal, state, local governments as well as commercial industry to increase the availability of material and expand the US industrial base. John was the lead official responsible for the use of the Defense Production Act (DPA) to first procure and distribute supplies and then expand the US industrial base. He was responsible for more than 80 uses of the DPA to increase US manufacturing capabilities as well distribution processes.
Previously, John served as the Vice Director for Logistics to the Chairman of the Joint Chiefs of Staff. In this role he managed all global logistics for the Joint force to include transportation, supply chains for munitions and petroleum for DOD’s global responses. John also ran the Joint Requirements Oversight Council (JROC) process for all logistics and sustainment capabilities. As the Director for Navy Logistics Programs and Business Operations he was responsible for all Navy supply chain policy and operations to include all Navy business systems. During this tour he modernized Navy ERP to meet Navy audit goals. John completed a career in the Navy as a Rear Admiral which included operational assignments across multiple platforms to included submarines, surface combatants and aircraft carriers. In these roles he was the officer responsible for managing global supply chains. John is also DAWIA level III in acquisition and contracting.

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Sarah O’Keeffe

Sarah is the Sr. Vice President for the Synthetic Molecule Design and Development (SMDD) team at Lilly. She is accountable for the technical development of small molecule, synthetic peptide and oligonucleotide APIs and solid oral drug product. In this role, she also has accountability for technology development and deployment including continuous manufacturing for both drug substance and drug product.
Since joining Lilly in 2007, she has held roles across discovery, development and manufacturing. She has also been involved in the design and start-up of Lilly’s Small Volume Continuous facility at Kinsale, Ireland. She has leveraged these experiences and network to promote, develop and sustain integrated innovation partnerships that can speed medicine to patients.
Sarah earned her BSc (Chemistry) and PhD (Organic Chemistry) from University College Cork, Ireland,

Jon-Paul Sherlock

Jon-Paul Sherlock is Executive Director, Innovative Manufacturing Technology. He is responsible for the development and introduction of new manufacturing technologies that improve quality and process robustness, supply chain agility, reduce costs and ensure the AstraZeneca Global Operations supply network is fit for the future. He has a PhD in Chemical Engineering, is a chartered chemical engineer, Fellow of the IChemE and has over 20 years’ experience of pharmaceutical Research and Development. Jon-Paul has created links between industry and academia founding significant collaborations in formulation, physical processing and advanced manufacturing technologies. He is a Visiting Professor at the University of Manchester and University of Strathclyde, is a member of the MMIC Leadership Team and has chaired the of the CMAC Industry Board until the end of 2022.

Rahul Singhvi

Rahul is a global leader in the Life Sciences industry. Most recently, he was an Operating Partner at Flagship Pioneering, where he was responsible for founding and operating companies launched from Flagship’s innovation foundry, Flagship labs. Before joining Flagship, Rahul was the Chief Operating Officer of Takeda’s Vaccine Business Unit where he was responsible for worldwide vaccine CMC and manufacturing operations. Before Takeda, Rahul was President and CEO of Novavax, Inc. where he transformed the company from a specialty pharmaceutical business to a vaccine development company. Rahul’s career began at Merck & Co in 1994, where he held several positions in R&D and manufacturing.
Rahul serves on the Executive Advisory Board of the Leonard Davis Institute of Health Economics at the University of Pennsylvania and on the Scientific Advisory Board of the anti-microbial resistance research group at the Singapore MIT Advance Research and Technology program. He also serves on the Board of Trustees of the Keck Graduate Institute and Board of Directors for Codexis.

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Julien Meissonnier

Julien Meissonnier is Catalent’s Vice President & Chief Scientific Officer, and also serves on the company’s executive leadership team. In this role, Julien leads new product development, providing customers with scientific advice when initiating a relationship and later, in developing their programs. He also heads Catalent’s technology innovation strategies and efforts across existing and emerging therapeutic modalities, helping Catalent achieve its mission to develop, manufacture and supply products that help people live better, healthier lives. He also oversees Catalent’s scientific community, which has more than 3,000 scientists, engineers, and technicians, united in their aim to accelerate life science innovation. Joining Catalent in 2001, Julien led Catalent’s R&D teams in Europe until 2015. Under his leadership, the company helped innovators launch over 120 new products. Before joining Catalent, he held product development positions of increasing responsibilities in the CDMO industry.

Douglas Hausner

Doug is currently leading the solid dose Continuous Manufacturing program at Thermo Fisher Scientific. He has been working in the field for over a decade advocating for continuous manufacturing, publishing articles, book chapters and participating in industry forums as well as expert groups on continuous manufacturing. Doug joined Thermo Fisher Scientific in July of 2020 after spending nearly a decade helping to lead the development of continuous manufacturing technology at Rutgers University as associate director of the NSF Engineering Research Center, C-SOPS, and a member of the Chemical Engineering department. Doug holds a PhD in Physical Chemistry.

Behnam Ahmadian Baghbaderani

Dr. Baghbaderani is the global head of Process Development, Cell and Gene Technologies at Lonza, focusing on the development of cell and gene therapies for clinical and commercial applications. He has over 24 years of experience in the area of Biotechnology and bioprocess engineering.
Dr. Baghbaderani holds a PhD degree in Biomedical Engineering from the University of Calgary (Canada), where he developed bioreactor protocols for large-scale expansion of human neural stem cells for clinical applications. He then completed three years of postdoctoral program, in the area of stem cell engineering.
Since joining Lonza in 2011, he led a group of scientists in process development, establishing pluripotent stem cell platform technologies and a cGMP compliant manufacturing process for iPSCs. Dr. Baghbaderani then led the cell therapy development department, offering process and analytical development services for cell therapies. In his current role, Dr. Baghbaderani has been leading a global organization offering development services for a wide range of early and late stage viral vector- gene therapies, autologous and allogeneic cell therapies, and exosome-based applications at Lonza, Cell and Gene Technologies.

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Moheb Nasr

Moheb Nasr is the principal of his own consulting company, Nasr Pharma Regulatory Consulting (NPRC). NPRC was established in February 2018 and provides regulatory consulting with a focus on pharmaceutical manufacturing, pharmaceutical quality, and CMC regulatory strategy. Dr Nasr serves as a senior regulatory advisor for several chemical and biopharmaceutical companies in the US, Europe, and Asia. In addition, Dr Nasr continues to play a leading role in global regulatory harmonization and introduction of modern pharmaceutical manufacturing platforms, including Continuous Manufacturing.
Dr. Nasr retired from GSK in August 2017. AT GSK, Dr Nasr was responsible for the development and the execution of GSK global CMC regulatory strategy. In recognition of his scientific and regulatory contributions, Dr Nasr is an elected GSK Senior Research Fellow. Prior to joining GSK, Dr. Nasr spent over 22 years at the US FDA. At the FDA, Dr. Nasr was the head of FDA/CDER CMC regulatory office. Dr. Nasr represented FDA and PhRMA at ICH and was instrumental in the development of the Quality by Design (QbD) concept and several regulatory ICH guidelines. Dr. Nasr obtained his Pharmacy and MS degrees at the University of Cairo, Egypt, and his Ph.D. degree in Chemistry from the University of Minnesota in Minneapolis, Minnesota, USA.
Dr. Nasr is an elected Fellow of the American Association of Pharmaceutical Scientists (AAPS), a recipient of AAPS Regulatory Science Achievement Award, a recipient of the International Council of Harmonisation (ICH) Award for outstanding Contribution to ICH Harmonisation for better health, and numerous academic and US Government awards.

Sau (Larry) Lee

Dr. Sau (Larry) Lee is the Deputy Super Office Director of Science in the Office of Pharmaceutical Quality. He directs the activities of staff members in OPQ sub-offices responsible for the quality assessment of regulatory submissions. He represents OPQ in programs and activities that impact quality assessments by coordinating with OPQ, CDER, and ORA. He also serves as the point person for the pharmaceutical industry and scientific/academic groups in developing programs to support science- and risk-based application assessment and approval. He developed and established the Emerging Technology Program in CDER. He has been serving as a rapporteur for ICH Q13 on Continuous Manufacturing of Drug Substances and Drug Products. Dr. Lee received a B.S. degree in Chemical Engineering from the University of Virginia with a minor in Materials Science and a Ph.D. in Chemical Engineering from Princeton University.

Manuel Osorio

Manuel Osorio is the lead for the Advanced Technologies Program in the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA). Prior to this role, Dr. Osorio was a researcher/reviewer for 16 years in the Office of Vaccines Research and Review in CBER. He received a BS degree from UCLA in Biochemistry and PhD degree in Cellular Immunology from the University of California at Santa Cruz. He was a postdoctoral fellow at the National Institutes of Health before joining the FDA.

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Dolores Hernan Perez de la Ossa

Dolores Hernan Perez de la Ossa is a Senior Quality Specialist at the European Medicines Agency (EMA) in Amsterdam, Netherlands, where she has been working for over 13 years. In her role, she provides scientific peer-review of all quality aspects throughout the lifecycle of medicinal products, supporting European Committees, Working Parties as well as the preparation of guidelines. Within the Quality Office Dolores is responsible of the scientific secretariat of the Quality Working Party (QWP) and the newly established Quality Innovation Group (QIG) and is the topic lead for QbD/continuous manufacturing, nanomedicines, and CMC aspects of PRIority MEdicines/early access schemes, among others. She represents EMA at the ICH Q13 EWG and the IPRP nanomedicines working group. During the ongoing pandemic she has been involved in the authorisation and lifecycle management of mRNA vaccines and several rapid scientific advices for COVID-19 products. Prior to joining EMA, Dolores worked as a researcher obtaining a European PhD in Pharmaceutical Technology from the Complutense University, Madrid, Spain conducting research stays at USA Virginia Commonwealth University and the Institute of Biomolecular Chemistry of the Italian National Research Council.

Yoshihiro Matsuda

Dr. Matsuda is a pharmacist and a senior scientist for Quality, Pharmaceuticals and Medical Devices Agency (PMDA). He received Ph.D. degree in Medicine from Tokyo Medical and Dental University in 2003. He joined the Pharmaceuticals and Medical devices Evaluation Center, the predecessor of PMDA, in 2003 and he is currently responsible for quality assessment of medicines. He was a member of ICH Q9 Expert Working Group, ICH Quality Implementation Working Group (Q-IWG) and ICH Informal Quality Discussion Group (IQDG). He leads Innovative Manufacturing Technology Working Group (IMT-WG) at PMDA and he is a regulatory chair person of ICH Q13.

Frank Montgomery

Frank Montgomery was awarded his PhD in Synthetic Organic Chemistry at Imperial College London and completed Post Doctoral studies at Ohio State University. He is now Vice President CMC Regulatory Affairs at AstraZeneca.
Frank is a member of the Implementation Working Group (IWG) as EFPIA Expert for ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management working alongside ICH regulatory agency members drafting the guideline and training materials. He has been a member of the EWG since its initiation in 2014 and has been responsible for leading teams drafting several sections of the guideline.
He has presented and organised several international conferences on implementation of QbD & ICH Q12 for DIA, ISPE, PDA, CASSS, facilitated training and workshops with regulatory agencies on learning from implementation of ICH Q8-11 and opportunities for ICH Q12. Frank’s group is working with FDA ETT towards commercialisation of a product made by CDC.

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