Biologics Consultants support the translational development of novel biologics through technical recommendations and advice to PI and her/his team. Consultants provide feedback and guidance on project milestones, development strategy, study design, and data interpretation. Each Lead Development Team (LDT) receives support from BPN-Biologics consultants. Consultants are assigned to a project with consideration of the project team's individual needs and consultants' expertise.
Current NIH-contracted Biologics Consultants:
Voisin Consulting Life Sciences (VCLS) is a regulatory science and market access advisory consulting firm assisting Biotechnology, Pharmaceutical, and MedTech companies and manufacturers throughout product development, market access, and life cycle management. Voisin Consulting assists innovative Healthtech developers in designing regulatory strategies, supporting and implementing clinical trials and vigilance plans, obtaining regulatory authorizations, as well as in elaborating market access strategies. With close to 24 years of experience, long-standing relationships with regulators and payers, a presence in seven locations across Europe, USA, and India, and with over 200 employees including in house ex-agency experts and excellent preferred partnerships, Voisin Consulting assembles one of the world's largest multidisciplinary groups of scientific and medical experts devoted to Regulatory Science.
Dr. Alexandra Beumer Sassi, Ph.D., RAC. (CMC)
Dr. Alexandra Beumer Sassi has over 20 years of experience in the biopharmaceutical industry and consulting services, with her expertise spanning both the US and European markets. She brings significant expertise in analytical method development, quality control, formulation development, product manufacturing scale-up, stability, and CMC matrix team leadership. Prior to joining VCLS, Dr. Beumer Sassi was a Regulatory Affairs CMC Consultant at Cardinal Health Regulatory Sciences where she provided regulatory strategy and assisted clients on regulatory submissions. Earlier, she was a CMC Regulatory Executive at GlaxoSmithKline, where she developed CMC strategy and coordinated regulatory submissions for Marketing Authorization in US, EU, Japan, and emerging markets. Alexandra held several positions at a generic pharmaceutical company in Brazil in quality control, formulation, and manufacturing. Dr. Beumer Sassi is US RAC certified, a member of the Regulatory Affairs Professional Society (RAPS), the Association of Women in Bio, the Alliance for Regenerative Medicine, an Associate Director for the Advisory Committee of CASSS, and an active member of the Scientific Organizing Committee for the Cell and Gene Therapy Products Symposium. Dr. Beumer Sassi received her PhD in Pharmaceutical Sciences from the University of Pittsburgh, School of Pharmacy. She received her Pharmacy degree from the University of Sao Paulo, Brazil. She completed her post-doctoral studies at Magee-Womens Research Institute.
Dr. Thérèse Croughs, M.D. (Regulatory Affairs)
Dr. Thérèse Croughs brings a high-level of medical expertise in translational/clinical development in biotechnology and regulatory science (EU/US/Asia), having taken several early-stage compounds from preclinical to the clinic. This expertise has been honed over 32 years working in the Pharma and Biotech Industry, where Dr. Croughs specialized in the provision of clinical development and strategic regulatory services to manufacturers and developers of biologics and biotech products.
Dr. Croughs began her career working in R&D for Bayer, NovoNordisk, and Onxeo (formerly BioAlliance Pharma), before joining Cytheris and then, Neovacs as CMO. She was also responsible for the registration of Kogenate® in EU, Loramyc® (miconazole Lauriad) in FR-EU and US/Japan, together with other applications using the same drug delivery technology. Thérèse has enriched her networking while providing consulting in different fields. Dr. Croughs has authored several scientific publications in peer-reviewed journals. She holds an M.D. with specialty in Internal Medicine awarded from Université Catholique de Louvain, Brussels, Belgium, together with certificates in Molecular Biology and Statistics from Université Paris VI, France.
Dr. Jennifer Woods, Ph.D. (CMC)
Dr. Jennifer Woods has over 10 years of experience in the pharmaceutical/biopharmaceutical industry. She brings significant expertise in quality control, formulation development, product manufacturing development and validation, stability, and CMC matrix team leadership. Prior to joining VCLS, Dr. Woods was a Principal Scientist and then an Investigator at GlaxoSmithKline, Biopharmaceutical CMC. Prior to her role as Principal Scientist, Jennifer completed her post-doctorate work at GlaxoSmithKline investigating opalescent monoclonal antibody formulations. Dr. Woods received her Ph.D. in Chemical Engineering from the University of Delaware with her thesis on mechanisms of protein aggregation. She received her bachelor’s degree in Chemical Engineering from Florida State University.
Dr. Marie-Agnès Cassar, Ph.D. (Toxicology)
Dr. Marie-Agnès Cassar has more than 20 years of experience as a toxicologist and nonclinical manager in both the pharmaceutical industry and in a contract research organization. This includes running safety studies (toxicology, reprotoxicology, genotoxicology, safety pharmacology, in vitro studies), having responsibility for the management of a team of Study Directors/Monitors, and preparing all the nonclinical regulatory documentation (briefing packages, IBs, INDs, IMPDs, DSURs, etc.). Prior to joining VCLS, Marie-Agnès worked at Debiopharm, where she developed an expertise in the fields of oncology and anti-infective therapeutics (small molecules and biologics). She also worked for 11 years at Galderma R&D as a nonclinical manager. Dr. Cassar completed a Ph.D. in Pharmacology (« Sciences du Medicament ») at the University Henri-Poincaré Nancy in 1999, followed by two years conducting post-doctoral research and teaching. She was awarded European Registered Toxicologist status in 2008.
Petra Pfaeffle, M.Sc. (Quality Assurance)
Ms. Petra Pfaeffle brings more than 20 years of experience in the pharmaceutical and medical device industry including eight years as registered Qualified Person in Switzerland. Her long-term industry experience and strong understanding of operational processes, especially in small and medium size pharmaceutical companies, allow her to provide hands-on experience and expertise in all aspects of quality assurance. Her expertise includes the set up and revision of Quality Management Systems, establishment of compliance processes, employee training, set up of supplier qualification programs, and audit conduction. Prior to joining VCLS, Ms. Pfaeffle worked for several pharmaceutical manufacturing companies as Head of Quality Management and Qualified Person. Petra earned a M.Sc. degree in Applied Chemistry from the University of Applied Sciences in Mannheim, Germany.
Dr. Michael Day, Ph.D. (Regulatory Affairs)
Dr. Michael Day has over 24 years of experience in the pharmaceutical/biopharmaceutical industry and consulting services, having worked on the review, preparation, and maintenance of numerous regulatory documents and submissions, including INDs, ANDAs, BLAs, and NDAs. Prior to joining VCLS, Dr. Day was the Managing Director of CMC/Global Regulatory Affairs at Cardinal Health Regulatory Sciences where he was responsible for providing comprehensive regulatory and CMC global strategy to clients at various stages of their product development. Michael has led and attended multiple Agency meetings and interactions with numerous divisions of the FDA, including information requests, pre-IND, end-of-phase 2, pre-NDA, and Type C/Scientific advice.
Dr. Day received his PhD in Pharmaceutical Sciences and Chemistry from the University of Missouri-Kansas City. He also currently serves as adjunct faculty for University of Missouri-Kansas City, School of Pharmacy and is the Vice-President of the Pharmaceutical Technical Exchange Association.
Shabas Solutions, LLC is a Virginia-based, minority and women-owned, Small Disadvantaged Business providing management consulting services.
Shabas offers scientific and technical services, management advisory services, medical logistics and supply chain management support, financial management support, technology integration, training, and communication and outreach to Federal Government Agencies. The company’s experts convey deep knowledge in full lifecycle of drug development including pre-clinical, clinical, scale-up and tech-transfer, licensure and pharmacovigilance covering small molecules, biologics, combination products and medical devices. Shabas’ consultants also have in-depth industry experience in CBRN medical countermeasures and biological therapeutics development.
Dr. Clyde Schultz, Ph.D. (CMC and Quality Assurance)
Dr. Schultz has 40+ years of experience in the field of microbiology with expertise in manufacturing of multiple biological therapeutics platforms, including modalities such as purified proteins and antibody-based therapies. His experience includes research in infectious diseases (Meningitis, Dengue, and Leishmaniasis), international regulatory expertise (bringing 10 products to the market), has seven patents and 100+ publications/posters/invitations to his credit. He is experienced with IP matters as a founder of two biotech ophthalmologic products (CNS agents).
Dr. Schultz has expertise in a range of best practices and processes: from large scale experiment design, FDA’s GLP and relevant animal testing rules, to conducting bio-assays, toxicology studies, in-vitro and in-vivo testing, and manufacturing process design including validation practices. Dr. Schultz earned his Ph.D. focused on Microbiology and Immunology, from University of Maryland. He completed his Master’s degree in Biology and received two undergraduate degrees – in Biology and in Chemistry.
Pharmalex specializes in providing advisory services to scientific and biomedical product developers.
Dr. Daina Vanags, Ph.D. (PK/PD/ADME)
With over 20 years’ experience in scientific research, biopharmaceutical product development and pharmaceutical consulting services in Australian, EU and US regulatory affairs, Dr. Daina Vanags has experience, spanning the areas of drugs biotech/biologics/biosimilars and cell/gene therapies in the US, Europe, Australia NZ and India, including the first successful marketing authorisation for a stem cell product in the EU. Daina has a range of skills including executive management in the biotechnology industry (listed and unlisted companies), management of preclinical and clinical studies, intellectual property, and bioanalytical assay development, validation and data analysis (PK, PD and immunogenicity). Dr. Vanags has operational, strategic product development and regulatory knowledge including product characterization and bioanalytical assay development (GMP), preclinical (GLP) and clinical study management (GCP) in Australia, New Zealand, Europe, Asia and the USA, including gap analyses, authoring of IB, IMPD, pre-IND, IND, nonclinical dossier sections, Scientific Advice and registration dossiers. Interactions with and presentations to regulatory agencies including US FDA, EMA, TGA, CDSCO and presenting training workshops in Regulatory Affairs.
Daina trained in Pharmacology with a first-class honour’s degree and Ph.D. from the University of Adelaide, postdoctoral positions at Oxford University (Clinical Pharmacology), and the Karolinska Institute (Toxicology and Environmental Medicine), in platelet pharmacology and apoptotic tumour cell death mechanisms. She has published scientific and clinical research studies in several key peer-reviewed publications, including The Lancet and The British Journal of Haematology.
Fabrice Nollevaux, M.S. (Toxicology)
Holder of a Master in Biological Sciences and a Master of Advanced Studies in Molecular Biology from the University of Namur, Belgium, Mr. Nollevaux has more than 25 years of experience in pharmacokinetic/pharmacodynamic (PK/PD) and the statistical analyses, and modelling of clinical and pre-clinical data. Mr. Fabrice Nollevaux has worked for 14 years in the Biometrics department of SGS Life Sciences Services, first as pharmacokineticist and statistician and, for the last five years, as Head of the Pharmacokinetic and Toxicokinetic group.
In 2011, Mr. Nollevaux joined Arlenda as Senior Principal Pharmacometrician and Statistician. Within involvement in the overall coordination of the statistical and pharmacometric clinical activities, one of his key responsibilities was the continuous development and implementation of applied pharmacometrics, modelling and simulation, and model-based drug development approaches as improvement tools in the design, the optimization, and the analysis of clinical trials.
Dr. Sean O’Shea, Ph.D. (Medical Writing)
Dr. Sean O’Shea is a former US academic researcher with 20+ years laboratory experience in biochemistry, molecular pharmacology, and neuroscience. Prior to joining the PharmaLex team in Mannheim, he authored peer-reviewed academic publications, presented at international scientific congresses, and lectured. Sean has now been a stable core member of the Nonclinical and Clinical Regulatory Writing team for over 7 years, and remotely leads multiple international writing teams. Dr. O’Shea draws from his diverse international scientific and regulatory experience to author EU and US regulatory submissions including new chemical entities, biologics, and herbal medicines. These projects range from development stage (including IMPDs, INDs, CTAs, IBs, preparation of scientific advice (SA), and orphan drug designation (ODD, OMPDs documents)) to marketing authorizations in eCTD format (MAA / BLA Module 2), as well as pediatric investigation plans (PIPs / PSPs).
Bio-Val Consulting (BVC), a woman-owned small business established in 2013 committed to helping clients meet today's demands for regulatory compliance with their bioanalytical needs. BVC's mission is to assist clients to condense drug development timelines and get products to market efficiently without compromising quality or budget.
Dr. Kristin Clement (Bioassay Development)
Dr. Kristin Clement has more than 20 years of experience leading analytical development and validation projects in both pharmaceutical industries and contract research organizations. While serving for over a decade as a GLP study director at Battelle Memorial Institute she led analytical development/validation efforts and established a new critical reagent repository to support vaccines and therapeutics treating various CDC Category A infectious diseases including, but not limited to Anthrax, Plague, and Ebola. While serving as Product Development Specialist at Countervail Corporation she developed and co-patented a novel lateral flow point of care device for the detection of organophosphate (OP) poisoning by OP-nerve agents (Sarin, Soman, Tabun, VX) and OP-pesticides. As CEO of Bio-Val Consulting she served as the analytical SME for Respiratory Syncytial Virus (RSV) vaccine assays, therapeutic monoclonal antibody potency release assays (for cancer and migraine indications), and technology transfer of assays of SARS-CoV2 (etiologic agent for Covid-19) for Operation Warp Speed (OWS). For Aruvant Sciences she coordinated the validation of assays for GMP release of plasmids and therapeutic viral vectors (Lentiviral and AAV vectors) at various CTLs, and has developed novel MOA-reflective potency release functional assays. Dr. Clement also has experience with regulatory writing contributing analytical sections to INDs and NDAs. For the past three years she has also served on the scientific board for BEBPA (BioPharmaceutical Emerging Best Practices Association), a consortium of best-in-class analytical and biostatistical consultants that provide a forum to discuss scientific issues and problems encountered in the biopharmaceutical community through biannual domestic and international scientific conferences.