Margaret Vernon, Ph.D., serves as Chief Executive Officer of Biologics Consulting Group.  In this role, she has global strategic leadership and P&L responsibilities for Biologics’ clinical and non-clinical, CMC, devices, project management and publishing consulting practices and services.  She also oversees all operations and personnel in the organization.

Dr. Vernon is a subject matter expert regarding patient-reported outcome (PRO) instrument development and validation programs with a special interest in measurement in rare diseases. She has expertise in regulatory strategy and PRO clinical trial implementation and analysis, as well as significant experience and formal training in both qualitative and quantitative methods.

Margaret was previously Senior Vice President and General Manager for the Evidera Advisory Business Unit within the PPD clinical research business of Thermo Fisher Scientific. In this role, she had global executive leadership and P&L responsibilities for Evidera’s combined consulting practices (data and analytics, evidence synthesis, modeling and communication, development and value/access consulting, as well as patient-centered research, medical writing and health care communications).

Prior to joining Evidera, she began her career as a research psychologist with the U.S. Bureau of Labor Statistics.

Margaret earned a Bachelor of Science in psychology from the University of Illinois at Urbana-Champaign and a Ph.D. in psychology with a concentration in research methods and statistics from Pennsylvania State University.

Andrew Zurlo is the Chief Financial Officer of Biologics Consulting. Andrew has around 12 years of experience as finance executive, specializing in financial management, operational delivery, and data-driven analytics. Focused in overseeing large-scale teams, day-to-day financial operations, implementing investment strategies, and facilitating both organic and inorganic growth plans.

Andrew received his Master of Business Administration from the Villanova University. He received his B.S. in finance from Siena College.

Dr. Baylor joined Biologics Consulting after 20 years with the Food and Drug Administration (FDA), most recently as the director of the Office of Vaccines Research and Review (OVRR).

In his prior position at the FDA’s Center for Biologics Evaluation and Research, Dr. Baylor was responsible for planning, developing, and administering CBER’s broad national and international programs and operational activities involving vaccines and related products. He has also served as the FDA’s liaison to CDC’s Advisory Committee on Immunization Practices, and the DHHS National Vaccine Advisory Committee. Dr. Baylor continues to serve as an expert advisor to the World Health Organization in addition to providing strategic consulting to Biologics Consulting clients in the areas of vaccines and vaccine-related products.

PhD, Molecular Microbiology, University of Kentucky (1985)

MS, Microbial Genetics, University of Kentucky (1981)

BS, Medical Microbiology, University of Wisconsin-Madison (1978)

Dr. Michael Grace joined Biologics Consulting in June 2020 as Head of the CMC Business Unit. Dr. Grace has over 30 years CMC experience as a Senior Executive encompassing CMC from analytical development and drug substance/product development, to drug substance and product manufacturing, fill-finish, QC testing and release, packaging and labelling, and supply management and distribution. As a Senior Executive in the BioPharma industry, he has had responsibility for both Development Operations and Technical Operations/Manufacturing and experience in working capacity and capability from all-internal to pure-play external as well as hybrid internal/external models. His CMC experience ranges from pre-clinical/Phase 1-entry programs through Phase 3 registration and licensing programs. He has both supervisory and hands-on experience with Module 3 dossier writing, compilation and review, and has had numerous successful interactions with FDA, EMA, and other ROW RHAs, that have resulted in helping to place nine commercial products (interferon, fusion-proteins, IO mAbs, and therapeutic peptides) on the market.

As Vice President of Technical Operations & Manufacturing at Advaxis Inc., Dr. Grace led a rapid Phase 3 analytical and process development program, followed by validation and technical transfer to an EU CDMO for the MAA registration submission for an IO vaccine product. He also led the de novo establishment of an internal cGMP facility for Phase 1 manufacture of patient-specific IO vaccines. He lead and supervised the Module 3 activities for the MAA as well as several initial and updated INDs and IMPDs.

Prior to Advaxis, Dr. Grace lead Analytical Development/Technical Operations at NPS Pharmaceuticals. His leadership and subject matter expertise helped resolve drug product process and manufacturing issues that resulted in the successful FDA approval of Natpara (rhPTH (1-84)). He lead and supervised Module 3 activities for the Natpara BLA and MAA, Natpara INDs and IMPDs, and worked with FDA and EMA to address review questions and RFIs. He also lead the analytical and process review for the commercial transfer of Gattex (teduglitide) from Takeda to NPS Pharmaceuticals.

As an Executive Director in Biologics Process & Product Development at Bristol-Myers Squibb, Dr. Grace lead Phase 3 CMC bioanalytical development and validations for Orencia (abatacept) and Orencia SC, Nulojix (belatacept), and Yervoy (ipilimumab), as well as Phase 2 bioanalytical development for Opdivo (nivolumab). Dr. Grace lead the BLA, sBLA, and MAA Module 3 analytical sections authoring, compilation and review activities, and was responsible for pre- and post-approval world-wide RHA interactions for Orencia, Nulojix and Yervoy.

Dr. Grace began his career at Schering-Plough Corporation where he started as a bench-scientist leading a bioassay development laboratory. At Schering-Plough, he had increasing responsibilities in technical and managerial scope within bioanalytical and biophysical development in Biotechnology Development at the Schering Plough Research Institute.

Dr. Grace received his Ph.D. in Biochemistry from the University of Nebraska, in the laboratory of Dr. Naba Gupta while working on mammalian protein synthesis. He received his B.S. in Chemistry cum laude, from the University of Nebraska.

Dr. Melissa Badding, PhD, DABT is the Director of Biologics Consulting’s clinical, toxicology and nonclinical team.  Dr. Badding is a board-certified toxicologist with expertise in human health risk assessment, nonclinical regulatory testing, and product safety evaluations. Prior to joining Biologics, Dr. Badding was a toxicology consultant at Exponent, Inc. where she specialized in nonclinical testing and biocompatibility/safety evaluations for medical devices and drug/device combination products. In that role, she assisted clients with regulatory strategies for product testing, nonclinical study monitoring, data gap analyses, and toxicological risk assessments of extractables and leachables. She has extensive experience interfacing with both testing laboratories and FDA reviewers to support clients in their regulatory meetings and ensure reviewer feedback is incorporated into the safety testing for successful regulatory submission outcomes.

Prior to her consulting career, Dr. Badding performed laboratory research for over a decade with a focus in the areas of particulate toxicity during her postdoctoral fellowship at CDC/NIOSH and in non-viral gene therapy during her doctoral thesis work.

Education:

Ph.D., Toxicology, University of Rochester School of Medicine and Dentistry, Rochester, NY (2012)

M.S., Toxicology, University of Rochester School of Medicine and Dentistry, Rochester, NY (2009)

B.S., Biotechnology, Rochester Institute of Technology, Rochester, NY (2007)

DABT, American Board of Toxicology, Diplomate (2016-present)

Benjamin Wimmer joined Biologics Consulting in November 2009 and leads the Regulatory Operations: Publishing/Electronic Submissions team.

Prior to joining Biologics Consulting, Mr. Wimmer worked for the Electronic Publishing team at Pharmaceutical Product Development (PPD), a global contract research organization, and as an Editor’s Assistant for the Journal of Geophysical Research at the American Geophysical Union.

His expertise lies in US-Regional eCTD publishing, validation, and submission of electronic applications (Pre-INDs, INDs, BLAs, NDAs, DMFs, ANDAs) and lifecycle maintenance to the FDA via the Electronic Submissions Gateway. He also has experience in eCTD and NeeS regulatory submissions to Health Canada and the EU.

Mark O. Thornton, MD, MPH, PhD brings over 20 years of experience in the biologics development arena, including six years at FDA CBER, 14 years in the biotechnology and pharmaceutical industries, and more than two years at Biologics Consulting. As an industry physician, Dr. Thornton’s most recent positions were Chief Medical Officer and Chief Development Officer at biotechnology companies developing cutting edge products, primarily in the oncology setting. In these roles, he developed a wide breadth of experience leading Phase 1-3 clinical trials in numerous oncology settings and in many classes of drugs and biologics, including small molecules, monoclonal antibodies, gene and cell therapy and cancer vaccines. Outside the cancer arena, Dr. Thornton has also led or helped lead the development teams responsible for the FDA approval of two Biologics License Applications, one each for an immunologic agent and a preventive vaccine.

As a Medical Officer in the FDA CBER Division of Clinical Trial Design and Analysis, Dr. Thornton’s focus was on biologics therapeutics, mostly in oncology, infectious disease and inflammatory disease settings. While serving at the FDA, Dr. Thornton led or helped lead the FDA review teams responsible for the successful licensure of two Biologics License Applications, one each in an oncology and infectious disease indication.

Dr. Thornton has also provided guidance to investment and venture capital firms, as well other stakeholders interested in due diligence of clinical, safety and/or regulatory programs of biotechnology and pharmaceutical companies. Dr. Thornton also has developed expertise in FDA regulatory policy, and has published five Op-Eds in the Wall Street Journal since 2007 on issues covering the span of drug development policy. Dr. Thornton is a member of the American Society of Clinical Oncology and the Johns Hopkins Medical and Surgical Society.

Areas of Expertise

Drug Development and Licensing Strategy: Optimizing and streamlining clinical development programs through use of tools such as adaptive clinical trial designs; Shortening the critical path to market by optimizing regulatory development strategies through the use of tools such as surrogate endpoints.

Clinical Trials: Assist in protocol design; Medical / Safety monitoring of ongoing clinical studies; Assist in clinical and safety data analysis Assist in writing of Clinical Study Reports.

Regulatory Affairs: Assist in preparation for FDA meetings: pre-IND, end-of-phase 2, pre-NDA/BLA, etc.; Assist in writing of regulatory submissions: briefing documents, clinical sections of INDs, BLA/NDAs, Orphan Product, Breakthrough Therapy Designation, etc.

Due Diligence and Drug Policy: Determining the status of the clinical and regulatory programs of pharmaceutical and biotechnology companies of interest, e.g. [1] likelihood of clinical trial success, [2] probable time to data, [3] critique and evaluate regulatory communications; Advise on the possible impact of the ongoing regulatory policy changes (PDUFA, etc.) on product development plans.

Education

MPH, (Masters in Public Health) Johns Hopkins School of Public Health, Baltimore, MD (2000)

Clinical Pharmacology Research Fellowship, Johns Hopkins School of Medicine, Baltimore, MD (1994-1995)

Internal Medicine Internship, Bethesda Naval Hospital, Bethesda, MD (1987-1988)

MD, West Virginia University, Morgantown, WV (1987)

PhD, Pharmacology and Toxicology, West Virginia University, Morgantown, WV (1983)

Ms. Ablashi has been working in the biotech industry since 1990 and joined Biologics Consulting in 2005. As a CMC Technical Writer at Biologics Consulting, Ms. Ablashi utilizes her GMP manufacturing, quality, and project management experience to assist clients with the preparation of CMC portions of their regulatory submissions to the FDA, EMA, and other regulatory bodies. Specifically, Ms. Ablashi writes and reviews the Quality Overall Summary (QOS, CTD Section 2.3) and CTD Module 3 sections of pre-IND, IND, BLA, NDA, PAS, and Master Files in accordance with ICH M4Q. To do this, she interacts directly with each client’s SMEs and regulatory experts. Ms. Ablashi also prepares and reviews worksheets, white papers, and SOPs. Since joining Biologics Consulting, Ms. Ablashi has also reviewed completed batch records and laboratory notebooks, assisted with the preparation of an Investigator’s Brochure for an early-phase clinical project, performed review of the Tables, Listings, and Figures of clinical data for an MAA / BLA submission, mapped the contents of a traditional “Section 7” CMC Section to a CTD Module 3 section. She has also served as a regulatory project manager for Biologics Consulting clients, which involves coordinating the preparation of regulatory submissions and serving as the point of contact with FDA Regulatory Project Managers. Her clients range from academia to industry, with projects in all phases of clinical development, from Pre-IND to post-marketing.

Ms. Ablashi received a BS in General Biological Sciences at the University of Maryland, College Park, in 1989 and earned a MS in Environmental Biology from Hood College in 2000. After completing her undergraduate education, she went on to work with HIV and other infectious viruses at Universal Biotechnologies (1990 – 1991) and then at Microbiological Associates (now BioReliance) (1991 – 2001). At BioReliance, she worked first in a GLP testing environment and then in the cGMP manufacturing facility, producing and supervising the production of gene therapy and cell-associated products for clinical use. She also supervised the cGMP Cell Banking suite before moving into technology transfer / process development group. In 2000, Ms. Ablashi became a Project Manager specializing in GMP Manufacturing. From there, she moved to become a Project Manager handling the CROs and CTOs for manufacturing and preclinical testing at Biosynexus Incorporated, a biopharmaceutical company specializing in anti-staphylococcal agents.

Education

MS, Environmental Biology, Hood College, Frederick, MD (2000)

BS, General Biological Science, Emphasis in Zoology, The University of Maryland, College Park, MD (1989)

Debra came to Biologics Consulting with over 25 years of experience in the biopharmaceutical industry. Prior to joining Biologics Consulting, she was Vice President, Technology, at Genzyme Corporation. During her tenure at Genzyme, she led the process development team for a recombinant protein from initial product concept through approval to market launch in over 40 countries, and managed the Technology Development group responsible for development of more than 15 small molecule, protein and viral vector products, including seven commercial products. She provided managerial leadership to process development, analytical, formulation development, project management, manufacturing package and label engineering and risk management functions. She has authored and reviewed several CMC BLA submissions and participated in agency meetings and plant inspections. She was responsible for developing a Supply Chain Risk Management program, which monitored the risks and mitigation strategies for the commercial supply chains, many involving Contract Manufacturing Organizations around the world. Additionally, she has experience in designing packaging and logistics solutions for cold chain products to multiple markets. She has taught courses in regulatory strategy, mammalian cell culture, supply chain and recombinant protein development for RAPS, ISPE, ASME and other organizations. She holds a B.S. from Colorado State University and a Ph.D. degree in Biochemical Nutrition from Cornell University.

As a Senior Consultant in Regulatory / Manufacturing at Biologics Consulting with 4 years of experience, Debra utilizes her broad technical and project management expertise to assist clients in the following areas:

• Gap analysis for regulatory filings
• Preparing and reviewing CMC sections of regulatory filings (pre-INDs, INDs, BLAs, sBLAs)
• Protein, cell therapy and viral vector process development, technology transfer and scale-up
• Product development planning, program and alliance management
• Strategic capacity planning, make/buy decisions, CMO selection and management
• Temperature sensitive distribution strategy development and packaging design
• Biosimilar development
• Risk analysis, FMEA workshops and determination of process control strategies
• Preparing for facility inspections

Education

PhD, Nutritional Biochemistry, Cornell University, Ithaca, NY

BS, Colorado State University, Fort Collins, CO

Chris joined BC as a Senior Consultant in 2015 after two years as an independent CMC consultant and more than 25 years of experience in the development, manufacturing, and quality control of clinical and commercial biopharmaceutical products, as well as IVDs. 14 of those years were in plant management with primary responsibility for operational success and maintaining regulatory licenses. Since 1994 Chris has been leading teams in process improvement, technology transfer, quality improvement, facility design, and validation. He has supported no less than 40 large-molecules (antibodies, vaccines, and peptides), 6 gene therapy products, 5 live biotherapeutic products, and 10 small molecule APIs bridging Pre-clinical development to Post-approval lifecycle management. His authoring at BC alone includes 22 IND/IMPDs, 8 BLAs, 2 Type V Master Files, a 510(k), and 12 formal FDA meeting background packages.

Prior roles include VP of Operations at One Lambda, Inc., VP of Pharmaceutical Operations at BioVascular, Inc., Vice President and General Manager of Cambrex BioScience Baltimore, Inc., and Senior Director of Technical Operations at Chiron Corporation. He holds a PhD in Chemical Engineering from William Marsh Rice University and a BA in Chemistry from the University of California at San Diego. Active with the Parenteral Drug Association since 2001, he contributed to Technical Reports #42, #14, and #15, and was on the Biotechnology Advisory Board.

His expertise and interests include technology transfer; facility and process engineering design; process development; technical troubleshooting; cell substrate, drug substance, and drug product characterization; annual production reviews; due diligence; supply chain analysis; microbiology support; manufacturing oversight (man-in-plant); quality systems support; risk management; FMEA; training; operations strategy; operational excellence; validation of cleaning, equipment, process, and software; vendor qualification and audits; regulatory submissions support for your Annual Report, IND, NDA, ANDA, BLA, IMPD, MAA, and 510K; formal FDA meeting requests and briefing documents; supplier and GMP audits; mock pre-approval inspection auditing; CAPA and deviation investigation and resolution; vaccines; blood products; cell and gene therapy; recombinant proteins; monoclonal antibodies; live biotherapeutic products; oligonucleotide products, small molecule APIs; and human microbiome products.

Education

PhD, Chemical Engineering, Rice University, Houston, TX (1986)

BA, Chemistry (Biochemistry emphasis), University of California, San Diego, CA (1977)

20 years of domestic and global experience in analytical methods, quality control, CMC regulatory affairs, and strategic planning in both start-up and growth organizations focused on biotechnology products, including cell and gene therapy products. Key technical experience includes potency assays, release and characterization assays, stability, specifications, raw materials, and all associated quality documentation. Direct experience authoring IND/IMPD and BLA/MAA sections and briefing documents.

Vijay Jethwa, PhD joined Biologics Consulting as a Senior Consultant (Analytical/CMC) in 2013. Vijay comes to Biologics Consulting with over 25 years of industry experience in the development, validation, and routine performance of potency assays, cell-based bioassays, and immunoassays for diagnostics, PK/PD studies, drug substance & drug product characterization, lot release, and stability, as well as immunogenicity assessments.

Most recently, he started up the new GMP Bioanalytical Laboratories at the Merck Vaccines Facility in Durham, NC. His group developed and transferred analytical methods for the characterization and release of live virus vaccines. Prior to joining Merck, Vijay was at Biogen Idec for over 12 years in various capacities including leading all CMC activities related to biosimilar development and serving as the site-head of the cGMP Bioassay, Microbiology, and Virology QC Laboratories. He established GLP testing laboratories at Biogen, including laboratory design, equipment sourcing and validation, supporting antibody and PK/PD testing for various GLP/GCP studies.

Vijay prepared and presented Quality sections for Regulatory advice meetings and has authored, reviewed, and approved sections of several regulatory submissions (IND, IMPD, BLA, etc.) Vijay has presented on bioanalytical topics at several national and international scientific symposia.

As a Senior Consultant with Biologics Consulting, Vijay will utilize his broad technical expertise to assist clients in the following areas:

• Development and Validation of Bioassays and Immunoassays for potency and immunogenicity
• CMC Analytical support
• QA/QC support
• GLP and GMP auditing, including focused data integrity audits
• Regulatory submission gap analyses, writing and review (IND, IMPD, BLA, etc.)

Areas of Expertise

• 25+ years of experience in the development, validation, and routine performance of bioassays and immunoassays for potency, host cell protein assays, host cell DNA assays, PCR-based mycoplasma testing, rapid microbiology assays, and immunogenicity assessments.
• Biologics pre-IND through post-marketing CMC Analytical support including strategy and execution (Technical and Regulatory)
• Laboratory Quality Systems development and implementation
• Global GLP/GMP auditing, including PAI-preparedness and Data Integrity Auditing
• Development of Biosimilars
• PhD Molecular & Cellular Pathology; MBA Leadership & Strategy

Education

MBA, Kenan-Flagler Business School, University of North Carolina, Chapel Hill, NC (2012)

PhD, Molecular and Cellular Pathology, University of North Carolina, Chapel Hill, NC (1998)

BS, Medical Technology, University of North Carolina, Chapel Hill, NC (1992)

BS, Biology, University of North Carolina, Chapel Hill, NC (1987)

Mr. Kutner joined Biologics Consulting in May 2022 and has over 22 years of cell and gene therapy expertise, including 12 years of industry experience at platform-based biotech companies. He has direct experience in discovery, process and analytical development, vendor development, process characterization/validation, and authoring regulatory submissions. Mr. Kutner also has experience in nonclinical and clinical assay development. He supports process and analytical development for cell or vector products (Pre-IND through Phase III), developing functionality and genetic transfer assays for potency or mobilization of inserted vector, comparability study design and CMC regulatory filings as needed.

Robert previously worked for Avrobio as Head of Process and Analytical Development where he reverse tech-transferred external manufacturing for multiple ex-vivo gene therapy products. In addition, he established the comparability strategy for translating Investigator Sponsored Trials into the Avrobio Plato™ platform.
Prior to Avrobio, he worked for Rocket Pharmaceuticals as Head of Human Gene Therapy. In this role, he managed the establishment of CDMOs to support drug substance and drug product for multiple gene therapeutics.

Before Rocket, Robert worked for bluebird bio where he first gained his industry experience. As Head of Process Development, he was responsible for developing and scaling-up the rLV platform process to support multiple ex-vivo gene therapeuitics. His efforts followed through characterization and validation of these drug substances and included development of clinical and non-clinical assays. His procedures are currently in use for commercial production or testing of lentiviral vectors in multiple regions.

Prior to bluebird, he worked for LSU Medical School where he spent a decade researching scaleable processes and testing methods for viral vectors and vaccines. As Director of the Vector Core for the Gene Therapy Program, Robert gained his experiences on pDNA, rAd, rAAV, rLV, alphavirus, fowl-pox, and modified vaccinia platforms. Including the various typing and expression cassettes, he worked on well over 250 constructs and designed several production platforms.

Mr. Kutner has extensive experience in industrial scale production for cell and gene therapy. He is trained in GMP and can advise on best practices to implement during development of drug substances or drug products.

Education

Mr Kutner received his B.S. in Chemistry from the University of Oklahoma in 1999.

Vidhya joined Biologics Consulting in July 2022 and has over ten years of experience in analytical development and quality control, including five years of experience authoring regulatory submissions for FDA, EMA, and MHRA.

Vidhya previously worked for bluebird bio as a Senior Analytical Product Lead where she served as the single point of contact for authoring and coordinating analytical updates for clinical and commercial regulatory filings. She authored Module 3 submissions for two BLAs and developed responses to FDA Information Requests.

Prior to bluebird bio, she worked at Corbus Pharmaceuticals as a Manager in Analytical Development. Here Vidhya managed method development, validation, and transfer for small molecule drug substance and drug product at CMOs in a fully virtual company. She also authored analytical sections of IND and IMPD submissions and prepared CMC sections of FDA briefing documents. .

Vidhya received her B.A. in Chemistry from Boston University and her M.S. in Pharmaceutical Sciences from University of Florida.

Aaron joined Biologics Consulting in November 2024 and has 10 years of industry experience with a focus on analytical development and quality control for biologics. He has direct experience supporting biologics programs from pre-IND through BLA. His expertise includes analytical development, quality control, protein characterization, stability programs, process development and authoring regulatory submissions. Aaron was most recently Associate Director of Analytical Development at Aurinia Pharma where he led the biologics analytical development team, developed CMC strategy, and authored Module 3 sections and responses to FDA requests. Prior to Aurinia Therapeutics, he worked at Aimmune Therapeutics and Nektar Therapeutics. He was a Principal Scientist at Aimmune and responsible for addressing post-approval analytical and formulation commitments for the company’s peanut allergy drug Palforzia. At Nektar, he was a Senior Scientist with responsibility for: team lead for external analytical testing; method development, transfer and validation; oversight and management of the internal biologics GMP lab; quality records for OOS/OOT investigations, manufacturing and testing deviations; and audit support. Aaron received his B.S. in Cell and Molecular Biology from Oklahoma State University and his Ph.D. in Biochemistry from the University of Oklahoma Health Sciences Center.

Vincent Narbut, MBA joined Biologics Consulting as a Senior Consultant (Biopharmaceutical Products) in February 2011. Vince has over 30 years of experience in the biopharmaceutical industry including technical expertise and management experience in process development, manufacturing, engineering, IT and quality assurance. Since joining Biologics Consulting, his work has included:  Establish quality systems and develop simulation models for raw material distributor. Develop cleaning and process validation master plans and perform process risk assessments. cGMP manufacturing facility (DS/DP/Cell Therapy; Client and CMO), quality system, drug depot, raw material/component and computerized system vendor audits. CMC regulatory submission gap analysis, drafting and reviews (32S, 32P, 32A manufacturing and development sections). QbD assessments and review of process validation documents. Cell culture and purification process troubleshooting. Facility design reviews (drug substance, drug product, cell therapy facilities). Quality Engineering oversight for new biopharmaceutical manufacturing facility design, construction, commissioning and validation. Due diligence assessments for products and corporate capabilities. Drug substance and drug product process validation support (including development of procedures for Process Design using QbD, Process Performance Qualification, Continued Process Verification).

Vince worked for over 25 years at Biogen in Cambridge, MA and Research Triangle Park, NC. As Director of Quality Technical Systems at Biogen, Vince was responsible for cGMP oversight of corporate IT systems and automation as well as the strategic direction of the IT platforms used to support the Global Quality organization (LIMS, Training management, Deviation/CAPA/Change control management, Product Complaints and Document management. Prior to this role, Vince served as Director of QA Validation with responsibility for developing and consolidating all facility/equipment, cleaning, automation, computerized system, analytical method, process, and shipping validation approaches used in the company into a comprehensive global program. Prior to joining the Quality organization at Biogen, Vince spent several years in the Global Engineering organization as Manufacturing Technology Principal. He was instrumental in the design and startup of the company’s 15,000 L scale manufacturing facilities in RTP, NC and Hillerod, Denmark. He also worked on the engineering design of two Aseptic Fill/Finish facilities in Europe. Vince spent the first 15 years of his career at Biogen in clinical and commercial product manufacturing, managing the operation of the company’s 2,000 L scale facilities in Cambridge, MA and RTP. These efforts culminated with the successful global regulatory agency inspections of both facilities for commercial licensure of Avonex, the company’s first commercial product.

Vince has made numerous presentations at technical forums including PDA, Interphex, ISPE, CASSS, Waterside Biotechnology Conference and NC Biotechnology Center Investor forum. He holds a BA in Biochemistry from Cornell University and a Master of Business Administration from Babson College.

Education

MBA, Babson College, Babson Park, MA

BA, Biochemistry, Cornell University, Ithaca, NY

Languages

Fluent in French

Vineeta Sharma has joined Biologics Consulting in January 2025 and has over fourteen years of experience in analytical development and quality control operations and five years of management and leadership experience. Vineeta has worked on several modalities such as cell and gene therapy, vaccines, monoclonal antibodies and radiopharmaceutical. She brings with her combination of large pharmaceutical, CDMO and clinical stage biopharma experience. Vineeta has strong expertise in QC core functions of DS, DP release and stability programs and has sound background in analytical method development, method validation, QMS systems and regulatory and technical writing. She has also written several federal, small business and non-profit grant applications and raised funding to support research and pre-clinical studies. Vineeta has authored several review articles; research papers and serves as an Editorial board member for few Scientific Journals. Vineeta has a Ph.D. in Hematology from the All India Institute of Medical Sciences, India and a post-doctoral Fellowship from the Children’s Hospital Oakland Research Institute, CA.

Christina Vessely, PhD comes to Biologics Consulting with over 18 years of experience in analytical and formulation development within the biotechnology industry. Her experience ranges from early stage research and development for small and start-up firms through late stage development and commercialization for mid-sized and large pharmaceutical companies. She has been involved in priority review and/ fast track programs, she has participated in Pre-approval inspections (PAI) and PAI enabling activities such as design and execution of validation studies and evaluation of GMP systems, as well as authoring and editing of analytical sections for multiple filings in both the U.S. and in the EU (IND/IMPD, BLA/MAA).

In the analytical arena, Christina’s areas of expertise have included analytical method development and validation, development of reference standards and other critical reagents, stability strategy and evaluation, and establishment of comparability and/or similarity. Her product experience includes vaccines, insulin analogs, cytokines, monoclonal antibodies, and other therapeutic proteins. She has been involved in the development and execution of CMC/Regulatory strategy for both novel and biosimilar products.

Christina earned her PhD at the University of Colorado Health Sciences Center (now CU Denver). She studied in the laboratory of Dr. John Carpenter, where she utilized various biophysical and biochemical techniques for the characterization of proteins. Through various projects within the biotechnology industry she has expanded her formulation development experience to include therapeutic proteins (including monoclonal antibodies), both liquid and lyophilized, for both traditional and non-traditional delivery systems. She additionally has worked with vaccines and with peptide based therapies. In addition to her PhD, she holds a MS in Chemistry from CU Denver and a BS in Chemical Engineering from the Colorado School of Mines in Golden, CO.

As a Senior Consultant in Analytical and Formulation, Christina will utilize her expertise to assist clients in the following areas:

• Development, Qualification and validation of analytical methods for raw materials, In-process testing, Lot release, Stability, and assessment of comparability and similarity
• Application of Biophysical and Biochemical techniques for extended characterization of products and to further demonstrate comparability and biosimilarity. Techniques include various spectroscopic techniques, evaluation of thermal properties, and evaluation of sub-visible particles
• The development and characterization of critical reagents including product specific reference standards, assay specific reagents, and strategy to demonstrate continuity of standards across the life span of the program
• Formulation strategy and development including the design of preliminary and later stage screening studies, application of biophysical techniques to evaluate formulation stability for short term studies, evaluation of stability profiles for lead candidate formulations in longer term studies, and evaluation of container/closure systems for drug substance and drug product

Education

PhD, Pharmaceutical Sciences University of Colorado Health Sciences Center, Denver, CO (2006)

MS, Chemistry, University of Colorado, Denver, CO (2002)

BS, Chemical Engineering, Colorado School of Mines, Golden, CO (1996)

Radhika is a consultant for pharmaceutical drug substances, and products, and assists in preparation of dossiers for regulatory submissions to the FDA- CDER during various stages of application process.
Radhika has retired from the FDA, Center for Drug Evaluation and Research after almost 24 years of service in various capacities. She had served as an Expert Reviewer, held both Team Leader position and interdisciplinary position within Office of Pharmaceutical Quality (OPQ) - policy office from Life Cycle Products, during the development and implementation of ANDA stability Guidance. She has delivered 5 FDA guidances during her tenure; hired and mentored scores of reviewers with in CDER OPQ. During her FDA tenure, she also served as a Special Assistant to the Chemistry Director. Prior to FDA, she spent 7 years with the Pharma R & D having worked for both Warner Lambert - Parke Davis division, as well as Bristol Myers Squibb. She has contributed to writing portions of IND, Supplements, and NDAs and worked under GMP. Her experience over the years covers Rx, and Rx to OTC switches.
Radhika has a Ph.D. in Organic Chemistry from Oklahoma State University and has completed postdoctoral research from the University of Kansas, Lawrence in Bioanalytical Chemistry.
She has about 6 yrs. experience with 505 (b, b2) and 505 i) applications for new and generic drug development strategies with companies; assists in FDA deficiencies response preparation, and review device related packages and labeling; trained to conduct mock inspections for drug manufacturing/testing sites on QMS, Laboratory Controls, Reference standard and Equipment Qualification. Experienced in small molecules formulation development and Pre-submission meeting package preparations. Assisted in filing several supplemental applications for NDAs, & ANDAs. She has served as an expert witness in Court cases involving few drugs and product related issues.

Oliver is a highly motivated pharmaceutical professional with a proven track record in the cMP manufacturing of antibody drug conjugates (ADCs) and radiopharmaceuticals. With expertise in technical project management, stakeholder engagement, and cost-of-goods management strategies, Oliver has successfully managed projects across early to late-phase clinical manufacturing. His experience spans CDMO, CTO, and CRO management, as well as the development and optimization of manufacturing processes for antibody drug conjugates.
Oliver's career highlights include his strategic oversight of CMC activities at BioNTech, where he is currently Associate Director for ADC drug substance development. He has led the development and scale-up of ADC manufacturing processes, guided critical partnerships with CDMOs, and played an integral role in regulatory submissions, including IND, BLA, and MAA preparations. Notably, he designed and patented low-cost aggregate removal devices and process improvements that have increased process robustness while reducing costs.
With a PhD in Protein Biochemistry & Molecular Biology from the University of Canterbury, Oliver's scientific expertise is complemented by his extensive industry experience in process development, analytical method validation, and regulatory dossier preparation. He is passionate about advancing bio pharmaceutical manufacturing and optimizing processes to meet stringent regulatory standards.
Oliver's diverse professional journey has taken him across several countries, and he has been recognized for his contributions with numerous awards, including the Telix Pharmaceuticals "Global Manufacturing* award and the University of Canterbury Dean's Publication Award.

Dr. Edward (Teddy) R. Zartler has over two decades of experience in large molecule drug development. He received his B.A in Chemistry from Goucher College and M.S. and Ph.D in Chemistry from the University of Pennsylvania. His post-doctoral work examined protein hyperthermostability using NMR.  He started his career at Eli Lilly & Co., followed by positions at Merck, Pfizer, Catalent, SGS, Molecular Templates, Kiniksa, Hillevax, and as a consultant. In his twenty five years in the industry, he has worked across a wide range of modalities, primarily vaccines and therapeutic proteins, leading diverse groups in CMC Operations.  He has deep expertise in analytical and formulation from early development to commercial.  He has edited two books: one on Fragment-based Drug Discovery and one Biophysics in Drug Development.  He has been an invited speak at conferences on three continents. 

Founder and CEO of Ronald Marchesani Consulting, LLC. With over 48 years' experience in the Pharmaceutical, Biologics, Vaccines and Medical Device industries. Have held senior Quality executive positions in at Alvotech (Iceland), Samsung Biologics (South Korea), Onyx Pharmaceuticals/Amgen (CA, USA) and Shire Biologics/ID Biomedical (Canada). Have direct experience in working government contracts (DOD, CDC, Canadian DND and British MOD) on biodefense vaccines (example, 2n generation Smallpox vaccine) and strategic pharmaceutical stockpiles.
Since consulting from 2019, have held Executive Advisor positions with various Virtual and small to midsized Biotechnology companies and acted as interim head of Quality for various client companies. Have direct experience in hosting and interfacing with the following international regulatory organizations:
FDA, Health Canada, EMA, MHRA, MFDS, PMDA and TFDA.

Have conducted audits (100+) and mock Pre-Approval Inspections for various companies and clients.

Dr. Nanda Subbarao, PhD is a Pharmaceutical CMC expert with over 30 years of experience in the pharmaceutical industry. She specializes in analytical method development, validation and implementation in QC and in Data Integrity.   

Mr. Krueger joined Biologics Consulting in April 2020, after more than 15 years with the U.S. Food and Drug Administration (FDA) in the Center for Devices and Radiological Health (CDRH). His experience includes over 6 years in pre-market submissions including PMAs, HDEs, 510(k)s, IDEs, 513(g)s, and de novo submissions and over 11 years reviewing and supervising the review of manufacturing information and compliance actions, including Quality Systems, PMA and HDE manufacturing information, recalls, allegations, injunctions, seizures, civil money penalties, and warning letters. His experience involves a variety of devices areas including cardiovascular, orthopedic, neurology, physical medicine, and dental devices. He has also worked on combination products with CDRH, CDER, and CBER as the lead reviewing centers.
Before joining Biologics Consulting, Mr. Krueger worked as an Assistant Director overseeing the Neurosurgical Team in the Office of Product Evaluation and Quality’s Office of Neurology and Physical Medicine Devices. As the Assistant Director, he was involved in all aspects of pre-market and post-market review of neurosurgical devices. Mr. Krueger joined the Office of Product Evaluation and Quality and the Office of Neurology and Physical Medicine Devices as part of 2018 reorganization of CDRH.

Prior to joining the Office of Product Evaluation and Quality, Mr. Krueger worked in the CDRH Office of Compliance where he started as a Biomedical Engineer and reviewer in the Vascular and Circulatory Support Branch. He went on to be the Branch Chief of the Orthopedic and Physical Medicine Devices Branch in the Division of Enforcement B and then following a reorganization, the Physical Medicine, Orthopedics, Neurology, and Dental Devices Branch in the Division of Manufacturing and Quality. As the branch chief, he was responsible for overseeing the review work of staff who reviewed regulatory actions such as injunctions, seizures, civil money penalties, and warning letters, as well as establishment inspection reports, recalls, allegations, promotion and advertising, and PMA and HDE manufacturing information for original and site change supplements. In 2017, Mr. Krueger completed a detail serving as the Acting Division Director for the Division of International Compliance Operations (DICO) where he managed branches responsible for foreign enforcement, imports, exports, and the Medical Device Single Audit Program (MDSAP) giving him experience and insight into each of these regulatory programs.

In his first position with the FDA and prior to working in the Office of Compliance, Mr. Krueger was a Mechanical Engineer and reviewer in the Office of Device Evaluation’s Division of Cardiovascular Devices, working in the Peripheral Vascular Devices Branch. As a Mechanical Engineer, he served as both a lead reviewer and a consulting reviewer for Mechanical Engineering testing on a variety of vascular devices including peripheral and coronary stents, IVC filters, endovascular stent grafts, endovascular catheters and delivery systems.

Education

Mr. Krueger received his BS in Mechanical Engineering from Southern Methodist University, and MS in Bioengineering from the University of Pennsylvania.

Jennifer Moyer joined Biologics Consulting in January 2021 and has 24 years of experience in standards development across multiple regulated industries.

Jennifer most recently worked at the Association for the Advancement of Medical Instrumentation (AAMI) as a Senior Director in the Standards Department. During her 12 years there, Jennifer worked with a large and diverse portfolio of standards committees to publish essential performance and basic safety standards for medical devices. Jennifer has worked closely with many of the stakeholders in the medical device arena: clinicians, FDA, academic, and industry. She also was team lead for all the device standards under AAMI’s purview, currently over 500 projects and publications

Education

MS Regulatory Affairs for Drugs, Biologics, and Medical Devices, Northeastern University (2020)
MA Management and Leadership, Webster University (2014)
BA English Literature (major), History (minor), Drew University (1986)

Dr. Tillman came to Biologics Consulting in 2012 with over 17 years of medical device experience with the Food and Drug Administration (FDA), Center for Devices and Radiological Health.

Donna-Bea began her career at the FDA in 1994 as a reviewer in the Ob/Gyn devices branch, and entered management as the Branch Chief for Pacing and Electrophysiology Devices. She went on to become the Deputy Division Director for Cardiovascular Devices, and then served as director of the Office of Device Evaluation from 2004-2010. Although Donna-Bea has experience with many different types of medical devices, her area of special expertise is regulation of medical device software. During her early years at FDA, she performed numerous software reviews, and was a key member of the teams that wrote most of the FDA guidance document on software review. In 2000, she took over leadership of the FDA Software Policy Working Group, and over the next ten years, emerged as the FDA expert in the regulation of medical device software.

In 2010 Dr. Tillman joined Microsoft’s Health Solutions Group as the Director of Regulations and Policy, where she was responsible for obtaining the appropriate global premarket registrations and managing Microsoft’s post-market safety programs. Over the nearly two years that she was at Microsoft, her team established a medical device quality system and obtained ISO 13485 certification.

Donna-Bea received her BSE in Engineering from Tulane University, her PhD in Biomedical Engineering from the Johns Hopkins University, and her Master’s in Public Administration from the American University.

As a Senior Consultant for Medical Devices at Biologics Consulting, Donna-Bea utilizes her broad technical and regulatory expertise to assist clients in the following areas:

• Advising clients on the regulatory requirements that may apply to software used in a medical environment
• Short and long term regulatory strategy for medical device technologies and combination products
• Assisting clients with strategy and development of preclinical testing and other product development issues
• Assisting clients in preparing for FDA meetings and FDA Advisory Panel meetings
• Preparing and assisting in the preparation of RFDs, Pre-IDEs, IDEs, 510(k)s and PMAs
• Providing clients with a comprehensive “FDA style” review of submissions

Education

MPA, American University, Washington, DC (2005)

PhD, Biomedical Engineering, Johns Hopkins University, Baltimore, MD (1991)

BSE, Engineering and Biology, Tulane University, New Orleans, LA (1985)

Julie Schoell joined Biologics Consulting in February 2025 with over 20 years in industry, 15 years specifically in regulatory affairs across medical device, pharmaceutical, and in-vitro diagnostic products. Julie joined Biologics Consulting from her previous role as Associate Director of the human health and animal health diagnostic regulatory team at Zoetis. In this role, she managed local and international compliance for diagnostic devices in both human and animal health. Her notable achievements outside of 510(k) submission support include creating a Quality Plan for In Vitro Diagnostic Devices Regulation 2017/746 (IVDR) implementation, Regulatory Manager of the internal IVD testing laboratory, and leading cross-functional teams to comply with European regulations.

Previously, Julie held various positions at Stryker where she received multiple 510(k) clearances with both patient specific and craniomaxillofacial (CMF) implant devices, was acting U.S. Agent for the CMF division, assessed and determined reporting requirements for customer complaints, and responsible for advertising and promotion compliance. Prior to this, Julie supported FIH and preclinical studies at Pfizer, and managed annual reports and post-market PAS/CBE submissions on radiopharmaceutical and generic APIs at Covidien. In addition to her professional experience, Julie has worked in academia as a Laboratory Manager at Washington University and University of Michigan, as well as an Instructor and IACUC administrator at the Vet Tech Institute at Hickey College.

Julie holds a Master of Science in Orthopedic Regulatory and Clinical Affairs from Grace Seminary College and a Bachelor of Science in Veterinary Technology from Michigan State University. She is a registered veterinary technician in Missouri and holds a Regulatory Affairs Certification (RAC). Julie is an active member of the Regulatory Affairs Professionals Society (RAPS).

Ms. Choudhuri joined Biologics Consulting in May 2024 with 17 years of regulatory experience in medical devices and combination products. Her experience includes 13 years at FDA, where she served as a lead reviewer of cardiovascular, respiratory/sleep, and general hospital devices, and as a manager of the voluntary MedSun post-market surveillance program.

Prior to joining Biologics, she was at ProPharma Group, where she led medical device and combination product work for the US Regulatory Sciences team. While there, she developed and supported regulatory strategies and submissions for clients with both pipeline and marketed medical products across a broad range of therapeutic areas. Ms. Choudhuri has successfully supported medical device Q-submissions, IDEs, 510(k)s, DeNovos, PMAs, and HDEs. She has also written the device modules for several combination product INDs and NDAs, and assisted clients with Master Files for platform devices, pre-RFDs, and Threshold Analyses. As part of these activities, Ms. Choudhuri has experience developing preclinical testing strategies, assessing human factors study needs, representing clients at both CDRH- and CDER-led FDA meetings, addressing FDA deficiencies, and assisting clients with meeting warning letter commitments to ensure US regulatory approval and compliance. Further, Ms. Choudhuri has worked with global counterparts on the alignment of US and OUS strategies to ensure successful product registration in the EU and Canadian markets. She also has experience conducting due diligence activities to guide client decision making related to product acquisitions.

While at the FDA, Ms. Choudhuri served as a member of CDRH’s early feasibility study (EFS) program for clinical trials, led the review of breakthrough device submissions, and contributed to policy development in the areas of clinical trials, real-world evidence, and patient science. She also led the review of one of the first marketing submissions to leverage registry data as the control arm in its pivotal clinical trial. These experiences, along with a detail position within CDRH’s Office of Clinical Evidence and Analysis, make Ms. Choudhuri adept in assisting device clients with clinical trial strategies. Ms. Choudhuri started her career at FDA as a biocompatibility reviewer and trained others in this area. She has experience with resorbable polymers, animal tissue products, gas pathway devices, and the hemocompatibility of blood contacting devices.

Education:

M.S. Biomedical Engineering, Northwestern University (2006)

B.S. Biological Resources Engineering, University of Maryland (2004)

Certificate in Pharmaceutical Outcomes & Policy, University of Florida (2020)

Bryan Pinder joined Biologics Consulting in May 2024 with over 17 years of experience between the U.S. Food and Drug Administration (FDA) and industry.  Bryan began his career in 2006 as biomedical engineer and lead reviewer of orthopedic devices at FDA within the Office of Device Evaluation (ODE).  Bryan organized and led multi-disciplinary teams in the review and assessment of 510(k)s, PMAs, HDEs, IDEs, and pre-submissions for various orthopedic device types, including those for trauma/fracture fixation, soft tissue fixation, and joint arthroplasty. During these reviews, Bryan worked with industry counterparts to clarify non-clinical and clinical requirements to help ensure least-burdensome approaches to the market. He also helped develop guidance documents for FDA staff and industry on regulatory SOPs and review practices.

Bryan left FDA in 2015 and started working for Hillrom (now Baxter International) as a senior risk manager.  In this role, Bryan was able to apply the principles of proving device safety and efficacy that he learned at FDA to a broad device portfolio at Hillrom that included software as medical devices (SaMDs), ophthalmic cameras, picture archiving and communication systems, and monitoring systems.  Bryan developed risk management files for these devices and presented risk profiles to executive management prior to gate and market releases.  Bryan transitioned to a regulatory position at Hillrom where he was responsible for establishing regulatory pathways and requirements for new product development, in addition to providing regulatory change control assessments for sustaining projects.  Many of Bryan’s projects involved either SaMDs or software in medical devices (SiMDs) where the proper use of user interfaces (UIs) was required for safe device use.  Bryan gained experience in the evaluation of these UIs using human factors analyses.

In 2019, Bryan returned to the world of orthopedics, supporting US and EU registrations as a contractor in the trauma division of a large orthopedics company.  Bryan worked on and received clearance/approval for 510(k)s, PMA supplements for manufacturing and labeling changes, and HDE supplements and amendments.  He provided regulatory change assessments for sustaining projects and authored internal documentation (i.e. letters-to-file) for changes not requiring submissions.  Bryan worked with both local and national IRBs to support HDE compliance.  On the EU side, Bryan performed updates to Technical Documentation to support EU MDR compliance.

Education:

BS and MS in bioengineering from Syracuse University

Regulatory Affairs Certification – Medical Devices (RAC-Devices) credential from the Regulatory Affairs Professional Society (RAPS).

Mr. Crist joined Biologics Consulting in 2018 with 7 years of experience as a biomedical engineer and lead reviewer at the FDA in the Office of Device Evaluation (ODE), Division of Surgical Devices (DSD), where he evaluated a wide variety of device and submission types. His experience includes review of IDEs, 510k(s), De Novos, PMAs, HDEs, Q-Submissions (Pre-Submissions), and Expedited Access Pathway (EAP) submissions. Examples of his device expertise include biosurgery products, surgical hemostats, surgical sealants, adhesion barriers, wound dressings, aesthetic and reconstructive implants, dermal fillers, surgical mesh, surgical staplers, as well as software based devices such as lipoplasty systems, negative pressure wound therapy devices, and robotically-assisted surgery devices.

While at the FDA, Mr. Crist served as a member of the Additive Manufacturing Working Group and has experience evaluating 3D-printed medical devices. He also led the Hemostatic Trauma Devices Working Group, and has experience in CFR 50.24 clinical studies with exception from informed consent for emergency research. In his review of biosurgery and polymer-based devices, he has dealt with complex biocompatibility testing to support in-situ polymerizing devices and chemical characterization to support polymer equivalency.

Prior to joining the FDA, Mr. Crist conducted 4 years of cell and tissue engineering laboratory research under Dr. Elisseeff at Johns Hopkins University’s Translation Tissue Engineering Center (TTEC). His research focused on mesenchymal stem cells and biopolymer tissue adhesives for cartilage repair, in-vitro models of osteoarthritis and osteoporosis, and the interactions of glycoengineering with stem cell behavior.

Mr. Crist received both his B.S. and M.S.E. in Biomedical Engineering from Johns Hopkins University with highest honors, in 2010 and 2011, respectively.

As a Consultant for Medical Devices with Biologics Consulting, Mr. Crist utilizes his scientific and regulatory expertise to assist clients in the following areas:

• Preparation of device submissions (Q-Sub, 510k, PMA, IDE, etc.)
• Short and long term regulatory strategy for medical devices and combination products
• Product development and preclinical testing strategies
• Animal study and clinical trial development to achieve regulatory success
• Crafting responses to FDA deficiencies and communicating with FDA on behalf of clients

Education

M.S.E. Biomedical Engineering, Johns Hopkins University, Baltimore, MD (2011)

B.S. Biomedical Engineering, Highest Honors, Johns Hopkins University, Baltimore, MD (2010)

I graduated from the USAF Academy in 1973 and flew with the Air Force until 1979 when I went to work for the Air Force as a civilian engineer. I worked for the Air Force for seven years and private industry for four years. In private industry I designed instrumentation systems including a patient worn activity monitor. I went back to school full-time in 1990 and obtained a PhD in Biomedical Engineering from Vanderbilt University. After graduating from Vanderbilt I went to work for FDA/CDRH until my retirement at the end of 2021. I now consult part-time.

Senior technical leader with extensive experience in the innovative product development and manufacturing of parenteral drug delivery combination products and medical devices. Versatile leader with unique balance of strategic and technical skills. Recognized for delivering high impact solutions in a collaborative manner. Adept in leading cross-functional teams in matrix organizations.

CORE COMPETENCIES:

- Technical Leadership
- Strategic Planning
- Execution
- Product Development
- Manufacturing
- Problem Solving
- CMO Management
- Project Management
- Quality System

Melissa is a seasoned medical device regulatory expert with over 11 years of experience specializing in Food and Drug Adminstration (FDA) regulations for medical devices. As a former-FDA reviewer, manager, industry educator, and policy analyst, she has a deep understanding of the Agency’s position and regulatory pathways. In her current role as a regulatory consultant and advisor, she assists companies in preparing effective regulatory submissions and offers strategic communication with the FDA. Continuing her passion for industry education, Melissa is an active RAPS member who has spoken at various RAPS conferences, including most recently, RAPS Convergence 2024 about effectively utilizing eSTAR. She also serves as a regulatory advisor to various MedTech start-up companies in the Larta accelerator program. She has experience assisting clients in the cardiovascular, orthopedic, spine, ENT, ophthalmology, dental, and imaging medical device spaces. 

With over fifteen years of leadership in digital health strategy, product innovation, and FDA policy, Aubrey Shick is a
passionate digital health strategist and regulatory expert whose career sits at the intersection of FDA policy, product
design, and user experience. As a former Sr. Digital Health Advisor at the FDA’s Digital Health Center of Excellence, she
led landmark policy initiatives in AI/ML-enabled device transparency, created the Digital Health Policy Navigator, and
launched the cross-functional Digital Health Advisory Committee, including its inaugural 2024 meeting on generative
AI-enabled devices. Aubrey has particular expertise in digital mental health devices and on integrating consumer products
such as smartwatches and AR/VR headsets into digital therapeutics, diagnostics and clinical decision support tools.

Dr. Tongde Wu joined Biologics Consulting Group in January 2025, bringing a strong foundation in Pharmacology and Toxicology. Prior to this, she was a key member of Eliquent Life Sciences from 2021 to 2024 and served as a Research Assistant Professor at North Carolina Central University. Dr. Wu earned her Ph.D. in Pharmacology and Toxicology from the University of Arizona, where she worked as a mechanistic toxicologist. She led research that uncovered a novel mechanism of CCl4-induced hepatotoxicity. Afterward, she completed postdoctoral training in Pulmonary Physiology at the University of North Carolina at Chapel Hill, focusing on the interaction between environmental toxicants and respiratory systems. She continued her research in pulmonary toxicology at North Carolina Central University, leading a team that demonstrated how house dust mites (HDM) exacerbate Th2 inflammation in the asthmatic airway through proteolytic activity. Before joining Biologics Consulting Group, Dr. Wu worked as a senior nonclinical consultant, demonstrating comprehensive regulatory proficiency in the development of monoclonal antibodies, small molecule drugs, and gene and cell therapies, across therapeutic areas such as solid tumors, infectious diseases, and metabolic diseases. As a subject matter expert in pharm and tox, she consistently applied her deep scientific understanding of nonclinical drug development, working with colleagues and clients to address deficiencies in nonclinical study designs and enhance programs for regulatory success. Dr. Wu played a key role in conducting nonclinical gap assessments, reviewing study protocols, study reports, and refining regulatory submissions. At Eliquent Life Sciences, she contributed to the preparation of over a dozen IND applications and PIND meetings, advancing numerous development programs. She also supported clients in obtaining Orphan Drug Designation (ODD), Fast Track (FT), and Regenerative Advanced Medicine Therapy (RAMT) designations. Dr. Wu became an invaluable asset to both Eliquent Life Sciences and its clients, recognized for her attention to detail, strong communication, and regulatory expertise. She has been a DABT since 2022 and earned her RAC in 2023. Dr. Wu earned a B.S. in Biotechnology from Anhui Medical University in Hefei, Anhui, China, and an M.S. in Biochemistry and Molecular Biology from Fudan University in Shanghai, China. She is proficient in Microsoft Office Suite, Adobe Photoshop, GraphPad Prism, and Vector NTI, and is bilingual in English and Chinese Mandarin. Dr. Wu also holds a US patent for peptide inhibitors of calcium channels (US10894811B2).

Neha joined Biologics Consulting in January 2025, leveraging nearly four years of experience as a nonclinical Study Director at leading Contract Research Organizations (CROs), Charles River Laboratories and Altasciences. In these roles, she served as the primary liaison for clients, overseeing GLP and non-GLP nonclinical studies, including IND-enabling programs for both small and large molecules across various therapeutic areas and species. She collaborated with clients to design customized protocols, monitor study progress, and draft nonclinical study reports while working closely with internal and external teams to achieve key deliverables and milestones. In addition to her technical expertise, Neha has contributed to the training and mentoring of new Study Directors and students, fostering a collaborative and supportive learning environment. She also served on the Institutional Animal Care and Use Committee (IACUC), where she participated in protocol development and compliance initiatives. Neha holds a Ph.D. in Pharmaceutical Sciences, where her research focused on neuropharmacology and neurotoxicology. Her dissertation assessed the therapeutic potential of compounds for central nervous system (CNS) disorders and investigated the neurotoxic effects of stimulants, including synthetic cathinones. At Biologics Consulting, Neha applies her background in nonclinical study management and regulatory compliance to support clients. As an Associate Consultant, she collaborates with senior and principal-level consultants on multidisciplinary teams, ensuring clients achieve regulatory success and advance their development programs. Education: Ph.D., Pharmaceutical Sciences, Mercer University, College of Pharmacy, Atlanta, GA (2021) Bachelor of Pharmacy (B. Pharm.), Institute of Chemical Technology, Mumbai, India (2017)

Bruce Pearce, PhD, is a classically trained pharmacologist and toxicologist with broad expertise in early and late-stage development of small molecules and biologics. Prior to Dr. Pearce’s decade plus tenure at Biologics Consulting, he held a number of positions in both the biotech industry and academia including as an independent consultant and within biotech as Director of Clinical Research and Pharmacology and Manager of Trauma Program Manager for a Hemoglobin-based Blood Substitute and a principle in the development of a Botulinum Toxin based therapeutic. The scope and depth of Dr. Pearce’s research and drug development interests is reflected, in part, in his more than 85 publications including peer-reviewed journals.

Dr. Pearce’s expertise comprises design, oversight, reporting of in vitro and in vivo pharmacology studies, safety pharmacology, mode of action, receptor interaction studies, pharmacokinetics tissue distribution, and translational pharmacology supporting clinical testing. Toxicological testing of small molecules, biologics and combination products, including juvenile and adult animal acute and chronic toxicology, genotoxicity, drug metabolism and transporter studies supporting drug-drug interaction. Developmental and reproductive toxicology (DART) testing. Toxicological risk assessments of drug candidates and excipients genotoxicity, carcinogenicity testing and submissions to the Executive Carcinogenicity Assessment Committee (Exec CAC). Biocompatibility and toxicology (ISO 10993) testing for medical devices.

Dr. Pearce routinely provides gap analyses, program development plans, study monitoring and complete program oversight including acting as a virtual head of nonclinical development.  Due diligence review at all stages of development, program analysis for pitfall avoidance, troubleshooting and strategy development for problem resolution. Authoring regulatory submissions and participation in 505(b)(1) and 505(b)(2) INTERACT, preIND, IND, End of Phase 2, preBLA, preNDA, Advisory Committee Meetings and preparation of BLAs and NDAs.  Biowaivers under 21 CFR 320.22(b)(3) and 510(k) submissions for medical devices.

Consultation for drugs and biologics including small molecules, peptides and proteins, particularly engineered recombinant proteins. The latter including monoclonal antibody (mAb) receptor and signaling pathway agonists and antagonists including engineered cytokine super agonists and antagonists, bispecific antibody (BsAbs) conjugates, bispecific fusion proteins, including BsAb coupled to T cell receptor (TCR) ligands, albumin (HSA), toxins, and BsAb fragments such as single-chain variable fragments (scFv), FcRN ligands and immunomodulators. Recombinant Toxins, and Enzymes. Therapeutic blood products including Human IgGs and Hemoglobin-based oxygen Carriers (HBOCs). Bacteriophages, and Botulinum toxin-based therapeutics, small inhibitory RNAs, siRNAs, nanoparticle-based therapeutics including nanoparticle encapsulated signaling and immune modulators, exosomes/extracellular vesicle (EV)-based therapeutics both tissue-derived and engineered.  Therapeutic enzyme inhibitors including Monoamine Oxidase Inhibitors (MAOIs).

Received his BA in both Chemistry & Biology at the University of Massachusetts at Boston and his Ph.D. in Pharmacology and Experimental Therapeutics at SUNY at Buffalo and was an NIH postdoctoral fellow at Yale University School of Medicine and Harvard Medical School and recipient of a Glaxo Cardiovascular Discovery Award and Alfred P Sloan Foundation Fellowship. Dr. Pearce joined Biologics Consulting as a Senior Consultant in April of 2010. He currently resides with his family in Hudson, New Hampshire.

Education

Postdoctoral Pharmacology, Harvard University, Cambridge, MA (1985-1987)

Postdoctoral Pharmacology, Yale University, New Haven, CT (1983-1985)

PhD, Pharmacology, State University of New York, NY (1984)

BA, Chemistry/Biology, University of Massachusetts, MA (1978)

David Pepperl, PhD, is a pharmacologist and toxicologist with experience in the early-stage development of biologic products. Prior to joining Biologics Consulting, David served as toxicologist and preclinical development scientist at TherImmune Research Corporation, where he drafted nonclinical development plans, authored nonclinical sections of regulatory submissions, and managed preclinical development programs for clients.

Dr. Pepperl’s graduate and post-doctoral work focused on in vitro and cell biological models of drug action, safety and signaling. During his tenure at Biologics Consulting, he has designed and overseen numerous nonclinical development programs for a variety of biologic products, including cell and gene therapies, mRNA therapies, vaccines, blood products, monoclonal antibodies, live biotherapeutics and protein therapeutics as well as small molecules. In addition to protocol and study report reviews, Dr. Pepperl routinely performs nonclinical safety assessments, and both authors and reviews development plans for a diverse array of drugs and biologic products. He has written numerous nonclinical sections of pre-INDs, INDs and CTDs on behalf of clients, and routinely assists sponsors with FDA meetings and other interactions with regulatory agencies. Dr. Pepperl has also worked closely with sponsors to source and manage nonclinical and GLP safety studies at contract research organizations (CROs) and routinely performs GLP compliance inspections on behalf of clients.

David received his BS in Biochemistry from Michigan State University in 1988, and his PhD in Pharmacology & Toxicology from the University of Arizona in 1994 with an emphasis on the pharmacology and signaling of G-protein coupled adrenergic receptors. He subsequently completed post-doctoral work at Pharmacia and Parke-Davis Pharmaceuticals. Dr. Pepperl joined Biologics Consulting as a Senior Consultant in January of 2004 and has served as Nonclinical group lead since 2015. He currently resides with his family in Montgomery Village, Maryland.

Education

PhD, Pharmacology and Toxicology, University of Arizona, Tucson, AZ (1994)

BS, Biochemistry, Michigan State University, East Lansing, MI (1988)

Mark O. Thornton, MD, MPH, PhD brings over 20 years of experience in the biologics development arena, including six years at FDA CBER, 14 years in the biotechnology and pharmaceutical industries, and more than two years at Biologics Consulting. As an industry physician, Dr. Thornton’s most recent positions were Chief Medical Officer and Chief Development Officer at biotechnology companies developing cutting edge products, primarily in the oncology setting. In these roles, he developed a wide breadth of experience leading Phase 1-3 clinical trials in numerous oncology settings and in many classes of drugs and biologics, including small molecules, monoclonal antibodies, gene and cell therapy and cancer vaccines. Outside the cancer arena, Dr. Thornton has also led or helped lead the development teams responsible for the FDA approval of two Biologics License Applications, one each for an immunologic agent and a preventive vaccine.

As a Medical Officer in the FDA CBER Division of Clinical Trial Design and Analysis, Dr. Thornton’s focus was on biologics therapeutics, mostly in oncology, infectious disease and inflammatory disease settings. While serving at the FDA, Dr. Thornton led or helped lead the FDA review teams responsible for the successful licensure of two Biologics License Applications, one each in an oncology and infectious disease indication.

Dr. Thornton has also provided guidance to investment and venture capital firms, as well other stakeholders interested in due diligence of clinical, safety and/or regulatory programs of biotechnology and pharmaceutical companies. Dr. Thornton also has developed expertise in FDA regulatory policy, and has published five Op-Eds in the Wall Street Journal since 2007 on issues covering the span of drug development policy. Dr. Thornton is a member of the American Society of Clinical Oncology and the Johns Hopkins Medical and Surgical Society.

Areas of Expertise

Drug Development and Licensing Strategy: Optimizing and streamlining clinical development programs through use of tools such as adaptive clinical trial designs; Shortening the critical path to market by optimizing regulatory development strategies through the use of tools such as surrogate endpoints.

Clinical Trials: Assist in protocol design; Medical / Safety monitoring of ongoing clinical studies; Assist in clinical and safety data analysis Assist in writing of Clinical Study Reports.

Regulatory Affairs: Assist in preparation for FDA meetings: pre-IND, end-of-phase 2, pre-NDA/BLA, etc.; Assist in writing of regulatory submissions: briefing documents, clinical sections of INDs, BLA/NDAs, Orphan Product, Breakthrough Therapy Designation, etc.

Due Diligence and Drug Policy: Determining the status of the clinical and regulatory programs of pharmaceutical and biotechnology companies of interest, e.g. [1] likelihood of clinical trial success, [2] probable time to data, [3] critique and evaluate regulatory communications; Advise on the possible impact of the ongoing regulatory policy changes (PDUFA, etc.) on product development plans.

Education

MPH, (Masters in Public Health) Johns Hopkins School of Public Health, Baltimore, MD (2000)

Clinical Pharmacology Research Fellowship, Johns Hopkins School of Medicine, Baltimore, MD (1994-1995)

Internal Medicine Internship, Bethesda Naval Hospital, Bethesda, MD (1987-1988)

MD, West Virginia University, Morgantown, WV (1987)

PhD, Pharmacology and Toxicology, West Virginia University, Morgantown, WV (1983)

Dr. Aron Yustein is a physician and regulatory expert with over two decades of leadership at the U.S. Food and Drug Administration (FDA). He has served in pivotal roles including Medical Officer in the Office of Orphan Products Development and Associate Director for Postmarket Programs at the Center for Devices and Radiological Health. Dr. Yustein is recognized for pioneering the FDA’s Signal Management Program and leading national initiatives to enhance medical device safety, postmarket surveillance, and rare disease product development.

His technical expertise spans clinical data analysis, clinical writing, regulatory strategy, real-world evidence integration, and business process improvement. He has overseen complex safety signal evaluations, developed cross-functional task forces, and led the implementation of innovative surveillance systems. Dr. Yustein is also skilled in stakeholder engagement, scientific communication, and the design and oversight of FDA-funded research grants. His contributions have earned him multiple FDA honors, including the Commissioner’s Special Citation and the Award of Merit.

Mr. Cligrow joined Biologics Consulting in June 2021 and has experience working in the drug/medical device industry, including a year working as an electronic publishing specialist. He worked with publishing tools to submit electronic submissions to the FDA via cloud software. Mr. Cligrow also has experience working in a laboratory setting including working in a parasitology lab to examine mammalian samples to determine the existence of parasites or other harmful bacteria.

Nolan previously worked for Hikma Pharmaceuticals as a regulatory affairs publishing specialist to submit original ANDA and NDA applications for approval to the FDA. In addition to original applications, submissions such as annual reports, PADERS, labeling, CBE-0 and CBE-30, as well as amendments were processed and compiled before sending to the FDA.

Prior to Hikma, he worked for IDEXX laboratories as an assistant lab technician in order to analyze and process samples from veterinarian clinics for the existence of parasites and harmful bacteria.

Mr. Cligrow has experience in reviewing eCTD-formatted applications as well as electronic publishing requirements and can compile various types of applications to be sent to the FDA for approval.

Education

Mr. Cligrow received his B.S. in Biochemistry from The Ohio State university in 2017 and obtained his M.S. degree in Bioinformatics from Jonhs Hopkins in 2019 where he studied genomic databases and how to process and parse them using various software and command-line tools such as Python, Java, and SQL.

Tamara DuBois, BS joined Biologics Consulting as an Electronic Publishing Specialist in September 2019.

Tamara comes to Biologics Consulting with over 4 years of submission experience. Recently, she was an Electronic Publishing Specialist at PPD. She is experienced in publishing CRFs and submission documents.

Education

Tamara holds a BS in Anthropology with a minor in Forensics from University of North Carolina at Wilmington.

David Ijeh, BS joined Biologics Consulting as an Electronic Publishing Specialist in February 2021.

David comes to Biologics Consulting with over 3 years of regulatory submission experience. Recently, he was a Regulatory Specialist at Technical Resources International. He is experienced in the process of publishing, validation, submission and life-cycling of regulatory documents in eCTD format

Education

He holds his BS in Biology from Salisbury University.

James C. Taylor joined Biologics Consulting in April 2015, as an Electronic Publishing Specialist.

James comes to Biologics Consulting with over 14 years of experience in the medical research industry at Pharmaceutical Product Development. Most recently, James was Senior Publishing Specialist responsible for leading a number of eCTD publishing projects, including large-scale case report form projects.

Prior to that, James was the lead specialist for publishing standard operating procedures and working practice documents for PPD’s Clinical Quality Assurance.

James holds a Bachelor of Arts degree from the University of Akron.

Education

BA, English, University of Akron, Akron, OH (1985)

Ellen has experience in providing nonclinical and clinical research management support to Sponsors regulated by CBER and CDER. She supports the organization of product development source information into clear, comprehensible applications, including Investigational New Drug (IND) applications (Phase I through Phase III), marketing applications (BLA/NDA), abbreviated and biosimilar marketing applications (505b2, ANDA, 351k), Master Files, and amendments and supplements. Ellen has managed numerous marketed products and development programs and has served as the FDA primary contact person for commercial and development products. She has direct experience in regulatory consulting, authoring of regulatory submissions, study coordination, and quality control. Prior to her role with Biologics, Ellen served as Senior Global Regulatory Affairs Consultant at AustinBio Consulting where she gained experience in regulatory project management and project coordination and execution, in addition to the management of several eCTD NDAs, INDs, BLAs, briefing package submissions. Ellen has experience in many different indications including oncology, haematology, cell and gene therapy, vaccines and immunology in clinical trials and has coordinated submissions globally. Ellen has a B.Sc in Chemistry, M.Sc in Regulatory Science from John Hopkins University.

Guangyuan (Claire) Li joined Biologics Consulting in August 2025 and has over five years of regulatory affairs experience spanning early- to late-phase clinical trial applications across a broad range of therapeutic areas. Her expertise includes regulatory consulting, regulatory project management, and eCTD submissions. Claire has broad experience with small molecules, biologics, and cell and gene therapy products, and is familiar with FDA regulations, guidance documents, and regulatory procedures at CBER and CDER.

She has led and supported a variety of regulatory submissions, including INTERACT, pre-IND, and end-of-phase meeting briefing packages; INDs and amendments; orphan drug designation (ODD) applications; initial pediatric study plans (iPSPs); expedited program requests; and marketing applications. Claire provides regulatory guidance to ensure the preparation of high-quality, compliant submissions in eCTD format and is proficient in electronic publishing tools and FDA submission requirements.

Prior to joining Biologics Consulting, Claire served as a Senior Regulatory Specialist at ELIQUENT Life Sciences, where she managed multiple regulatory projects, acted as U.S. Agent for Sponsors, and supported the preparation and submission of applications in eCTD format. She maintained regular communication with FDA staff at CBER and CDER and participated in FDA – Sponsor meetings. Earlier in her career, she was a Project Manager at WuXi Biologics and an ORISE Research Fellow at the U.S. FDA, where she conducted regulatory science research in
the Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), building on her molecular biology research background in academic institutions.

Claire holds a Ph.D. in Zoology and Physiology and a B.Sc. in Physiology from the University of Wyoming. She is RAC-certified and fluent in English and Mandarin Chinese.

Amanda joined Biologics Consulting in September of 2025.and has over a decade of project management experience at the FDA in CBER’s Office of Compliance and Office of Regulatory Operations. She has experience leading cross-functional review teams through all phases of product development and lifecycle management and has a proven track record managing complex regulatory submissions and ensuring compliance with federal regulations.

Amanda gained valuable federal policy experience during her tenor at the Office of Operations in CBER. Amanda served as CBER’s subject matter expert for formal meetings with sponsors and developed several SOPs and procedures for use both by CBER staff and external stakeholders. She participated in several modernization projects and cross-center committees with CDER and CDRH to help streamline CBER’s processes.

Prior to this, Amanda worked at CBER’s Office of Compliance and Product Quality. She gained vital experience with all submission types, from pre-IND through to BLA and post market supplements and reports. She served as the point of contact for applicants and sponsors and managed multidiscipline teams in the review of regulatory submissions from receipt through approval, including PAI and PLI inspections.
Amand worked at NIH before moving to FDA where she managed grants and contracts for both NIAID and NCAAM. She has also worked in research and development for a vaccine company. Amanda has a Bachelors of Science degree in Biological Sciences from University of Maryland Baltimore County.

Ana Muresan is an accomplished commercial leader with over 15 years’ experience driving strategic growth in the biotech, pharmaceutical, and medical device industries. As Vice President, Commercial at Biologics Consulting, she leads company-wide business development efforts, strengthens client partnerships, and shapes market positioning in regulatory consulting services across biologics, drugs, combination products and medical devices.

Ana brings deep expertise in regulatory affairs, real-world evidence (RWE), health economics and outcomes research (HEOR), and consultative sales strategy. Her proven ability to align scientific and regulatory expertise with commercial objectives has contributed to sustainable revenue growth and expanded service offerings. Prior to joining Biologics Consulting, she held a management role at Merative where she led a high-performing sales team and played a key role in go-to-market strategies. Ana also held senior sales roles at Evidera (Thermo Fisher Scientific), SmartAnalyst, and Mapi Group, where she secured multimillion-dollar deals, driving and achieving revenue targets. Ana started her career in medical and commercial roles within pharmaceutical and medical device companies. She is passionate about fostering a culture of client service, innovation, and cross-functional collaboration.

Ana holds a Master of Biotechnology and an Honors Bachelor of Science in Cell & Molecular Biology from the University of Toronto. She is also actively engaged in her community, having volunteered with refugee support programs and various charitable organizations.

DANS-K Consulting LLC is a boutique pharmacovigilance sevice provider based in the USA. Faunded by Myaya Kuppa, PharD. DANS-K Consultants are experts in the field. Working independenty or as a team to provide the pharmacovigilance services, our consultants are ready to support ary project need. Mhat sets up apart from other service providers is that we are all professionals in the field and each consultant has actual hands on experience in the PV space. Our senior consultants have a minimum of 10 years + of direct PV experience working for large and small pharma. Our founder, Vijaya has 16+ years of experience in the field
Our value proposition is based on our personal and professional reputation in the industry. Our consultants come with excellent references. We are flexible and can work independently ortogether as a team to provide vendor styled services to our clients.

Genedrift is a leading consultancy and solutions provider specializing in compliance and risk management services for the Life Sciences industry, with a focus on Regulatory Affairs and Pharmacovigilance. We enable faster, smarter pathways to market for pharmaceuticals, medical devices, cosmetics, and food supplements across global markets. 

With a presence in over 18 countries across APAC, Africa, CIS, and other key regions, Genedrift is committed to simplifying and accelerating the "To The Market" process—delivering efficient, compliant, and tailored solutions to meet the evolving needs of our clients.

Lighthouse BioSolutions provides scientific, technical, and strategic 
solutions to its life science clients:
* Biologics drug developers: Lighthouse BioSolutions supports early and 
 late-stage companies and academic investigators developing vaccines,  cell and gene therapies, monoclonal antibodies, and other biologics.

Leveraging decades of experience in academia, biotech and contract research organizations, Lighthouse BioSolutions helps life science innovators expedite their candidates through preclinical and clinical 
 development.
* Contract Research Organizations : Lighthouse BioSolutions supports CROs in expanding their service offering through the implementation of new platforms and assays.
* Investors: advises Private Equity Firms and VCs by providing expert scientific due diligence, de-risking key investment decisions.

Royalmount Laboratories specializes in small and large molecule bioanalysis in support of discovery, preclinical and clinical programs. Our regulated (GLP/GCP/GMP) and non-regulated services also include immunogenicity, biomarkers, molecular biology and PK/TK reporting.

Regulatory Compliance Coverage in over 90+ Countries:
U.S. / International

CLIENT SERVICES with offices / affiliates in Columbus, Ohio; Brussels, Belgium; Dubai, UAE, Sao Paulo, Brazil, Mexico City, Mexico; Buenos Aires, Argentina; Canada, Japan, S. Korea, Singapore, India, Taiwan, China, Philippines, Malaysia, MENA Nations, South Africa + additional in-country affiliates globally. [95 Countries in total]
Industry & Product Coverage: Pharmaceuticals / Biologics / Medical Devices / IVDs / Combination Products /
Dietary Supplements / Personal Care / Cosmetics

Trag is a CMC Compliance and Regulatory professional with over 30 years of experience in biotechnology CMC and GMP compliance. Experienced in all phases and types of CMC-related regulatory submissions, strategy and meetings, from IND/IMPD to BLA. Trag has particular expertise in CTD Modules 3 and 2.3, comparability strategies and reports, meeting and pre-meeting packages, CMC amendments, CMC regulatory strategy, responding to FDA questions/observations, and due diligence. Product-type experience includes monoclonal antibodies, vaccines, LVP biologics, recombinant proteins, ADCs and some cell therapy. Indication experience includes oncology, HIV, communicable diseases requiring vaccine development. Meeting experience with FDA includes face-to-face and teleconferences for dozens of INDs, BLA submissions, Breakthrough Designation, and CMC amendments. Trag also provides training on CTD requirements and writing technical documents.
Trag provides all aspects of CMC QA and has performed more than 275 compliance audits including due diligence, vendor qualification, and for-cause. Trag offers GMP training at all levels, from annual refreshers to Executive Management GMP training. Trag provides development or remediation of Quality Management Systems, including SOPs, deviation reports, root cause analysis and CAPA. Trag has been Regulatory Affairs Certified since 1994.

ASPHALION is an international Regulatory, Scientific & Safety consultancy with offices in Barcelona, Madrid, Pamplona, Munich, and London. Founded in 2000, it has grown steadily, now employing over 200 professionals from more than 16 nationalities. ASPHALION is a key player in the global healthcare sector and a reference in implementing new regulatory standards. Its experts have provided solutions to over 1,000 Pharmaceutical, Biotech, and MedTech companies from 50+ countries in 5,000+ projects, covering non-clinical and clinical development, CMC, dossier writing, regulatory procedures, vigilance, eSubmissions, and data management. It offers strategic advice, expert consulting, operational support, and full outsourcing for all therapeutic areas. ASPHALION is actively pursuing its digitalization pathway, embracing innovative technologies and data-driven processes to reinforce its position as a leader in regulatory science. To ensure the best solutions, ASPHALION collaborates with international authorities, notified bodies, scientific associations, and key opinion leaders, maintaining a strong network of geographic and functional partners. 

Dr. Lei is a seasoned expert in drug development and molecular diagnostics, with over 25 years of experience in regulatory affairs, biomarker strategy, and clinical trial support. Dr. Lei brings unique expertise in biomarker development and validation, drug–diagnostic co-development, companion diagnostics, and IVD/LDT product development.

A proven leader, Dr. Lei has successfully established CLIA/CAP-certified laboratories in both large institutions and startup environments and has served as a CAP inspection team leader for multiple domestic and international inspections. Board-certified by the American Board of Medical Genetics and Genomics (ABMGG), Dr. Lei is highly experienced in molecular genetics, oncology, infectious diseases, and biomarker-driven diagnostics.

Throughout a distinguished career, Dr. Lei has led and supported numerous clinical trials through biomarker strategy development and assay validation, managed CRO services, and built strategic partnerships for companion diagnostics. As a clinical laboratory director, Dr. Lei has held leadership roles across hospitals, industry, and independent reference laboratories, driving innovation and excellence in molecular diagnostics and personalized medicine.

Timothy is a experienced professional with more than 30 years in Microbiology and Quality in cGMP / cGTP industry for cell 
and gene therapies, regenerative medicines, biopharmaceuticals, and medical devices. Specific emphasis on 
implementation of a variety of contamination control measures including setting up EM and personnel monitoring 
programs with risk-based approaches (e.g. FMEA, HACCP), rapid sterility methods, validation of microbiological 
and rapid methods, PCR Mycoplasma, microbial identification, aseptic processing and training, media fills, 
disinfection and sanitization, water and utility monitoring programs, radiation sterilization validation, bacterial 
endotoxin testing, among other control measures.

Joe Quinn is an independent consultant working in the biopharmaceutical industry. Joe has forty years of experience, with emphasis in CMC and Regulatory Affairs. Joe was previously employed by Sanofi Pasteur for twenty-eight years, where he served in the position of Senior Director, Head of North American Regulatory Affairs until 2014. Joe’s prior experience includes assignments in Quality Control, Research, Product Development & Scale-Up, Bioanalytical Development & Validation, and Project Management.  Joe teaches biologics chemistry, manufacturing, and control (CMC) and bioprocessing graduate regulatory courses as an adjunct faculty member in the Temple University School of Pharmacy Regulatory Affairs and Quality Assurance program.  Joe holds a Master of Science degree in Quality Assurance and Regulatory Affairs (Temple University School of Pharmacy), Master of Science degree in Chemistry (University of Scranton), Bachelor of Science degree in Biochemistry (The Pennsylvania State University), and Regulatory Affairs Certification (RAC) through the Regulatory Affairs Professional Society. 

Dessi is a board-certified toxicologist providing strategic nonclinical safety consulting to biotech and pharma companies developing cutting-edge therapeutics. She is a Diplomate of the American Board of Toxicology and holds an MS in Pharmacology and Toxicology from Michigan State University. 

Dessi brings 15 years of experience spanning nonclinical safety strategy, in vivo toxicology, and regulatory submission leadership. Her expertise covers a wide range of modalities—including small molecules, biologics, ADCs, oligonucleotides, radiopharmaceuticals, gene and cell therapies—and therapeutic areas such as oncology, immunology, CNS, and rare diseases. 

Prior to launching her consultancy, she held roles at Pfizer, Epizyme, and Q32 Bio, leading toxicology programs from early discovery through IND/CTA submission. She is also an invited speaker, published author, and active contributor to professional societies including ACT, SOT, and CDISC. 

Senior regulatory affairs and diagnostic development expert with PhD and 20+ years of experience in IVD/CDx
development and regulatory strategy. Proven track record in drug-diagnostic co-development and strategy 
development for Cell & Gene Therapy (CGT) and precision medicine programs, managing multiple IVD 
partnerships, and ensuring successful regulatory outcomes in the US FDA and knowledgeable in global IVD/CDx 
regulations (EU, Japan, China). Deep expertise in biomarker testing technologies (NGS, PCR, flow cytometry, 
immuno-assays) and strong leadership in cross-functional teams. Extensive experience in regulatory submissions 
(510(k), PMA, DeNovo, IDE, Breakthrough designation, pre-submission) and regulatory authority interactions. 
Skilled in developing integrated diagnostic strategies for IVD/CDx in different therapeutic areas including oncology 
and CGT

Crown Point Biotech Consulting is runned by Steven M. Erb, Ph.D.

Steve has over 13 years of industry experience in CMC product development specializing in analytical. development and strategy, quality control, and CMC regulatory affairs at small biotech and big pharma companies with focus on cell therapy and virus vaccines. He has expertise in in-process, release and characterization method development, method qualification, control strategies, quality control. product comparability, tech transfer, stability authoring IND/IMPD/DMF/briefing documents, and external vendor management. Steve is the owner and principal consultant for Crown Point Biotech Consulting LLC where he supports client CMC needs.
Prior to starting Crown Point Biotech Consulting, as Associate Director AD &QC Steve led NK cell therapy product analytical development and QC activities for Sanofi and Kiadis Pharma (acquired by Sanoft) at multiple CDMOs. He implemented the outsourcing strategy for development and qualification of analytical methads, performed due diligence for CDMO selection, and tech transferred the entire NK cell analytical paradigm to external partners. He led the Quality Control program at CDMOs for disposition of product for clinical trials and was the internal Analytical Team Leader for a gene edited NK cell therapy program bringing the product analytics from pre-clinical to IND phase. Steve also strategized and designed complex drug product
authored multiple Module 3 IND and briefing book sections supporting the program.
As part of CBR International, a regulatory consuhancy. Steve was the pamar, author and reviewer of CMC Module 3 sections for multiple IND and IMPD submissions and provided guidance on regulatory strategy for diverse biologies products.
Steve began his industry career as a scientist working for Takeda Vaccine Inc, and yagen Ire. (acquired by Takeda) on a live attenuated tetravalent dengue virus vaccine that has since been commercially released. He was project lead fior multiple areas of vaccine developmert in the CMC organization including analytical method development for cel-based potency assays and formulation development where he is co-inventor on patents in both areas. He managed and executed the drug product stabilty program and was the program lead and process owner for yophilization development of the tetravalent vaccine. Steve abtained his Ph.D. in virology at Colorado State Unversity.

Rich is a Nonclinical Development strategist and board-certified toxicologist with >25 years’ experience in industry, including expertise in planning, conduct, and/or management of GLP-compliant safety testing of small-molecule and anti-sense-based therapeutics, biopharmaceuticals, enzyme and mRNA replacement therapies, vaccines, genetic therapies, and medical devices. He has broad industry experience with general, repro-, neurotoxicology, and genetic toxicology, safety pharmacology, PK/ADME, carcinogenicity, combined PoC/BD/tumorigenicity studies, and niche expertise in investigative, immuno-, and molecular toxicology. He has implemented IND/CTA- and NDA/BLA/MAA-enabling nonclinical development programs and regulatory submissions across a broad range of therapeutic categories: e.g., a significant contributor to >90 projects, >35 development-track decisions, >30 IND/CTA/CTNs, >5 NDA/BLA/MAAs, >25 diligences, and hundreds of supporting and integrated final reports. Rich had been with AVROBIO ~7 years, most recently as Vice President, Toxicology, Research and Preclinical Development, and provided timely and resource-efficient execution of all pre/nonclinical activities needed to advance unique ex vivo LV-based gene therapies into Phase I/II/III testing (LSD/rare disease indications). Eighth (8th) employee hired, he led pre/nonclinical efforts through Series B and IPO financing, including CTA and IND approvals for the lead programs, and sale of the cystinosis GT asset to Novartis Cell & Gene Therapy. Before AVROBIO, Rich spent 7 years at Shire (now Takeda) as Head of Toxicology and, more recently, as Nonclinical Research Fellow, Global Nonclinical Development. In this capacity, he provided technical and strategic leadership in toxicology and drug safety assessment across R&D, initiated and partnered in alliances with other companies, ensured support of business development/due diligence efforts, and provided leadership and oversight of a nonclinical toxicology group. Prior to joining Shire, Rich functioned as Drug Safety expert on exploratory, discovery, and Global Development/Learn Teams across a broad range of therapeutic areas for Wyeth Research (now Pfizer). At Wyeth, he also headed an exploratory toxicology group, chaired the Immunotoxicology-Expert Working group, and served as a member of the ILSI HESI Immunotoxicology Technical Committee. Rich has directed and managed nonclinical safety assessment for new chemical/molecular entities in the contract services industry and served as Senior Toxicologist in Ciba-Geigy Corp.’s Plant Protection Division (now Syngenta). He was Assistant Professor of Toxicology in the Purdue University School of Pharmacy & Pharmacal Sciences and is peer-recognized in immunotoxicology, molecular carcinogenesis (tumor promotion), intrathecal enzyme replacement, and ex vivo gene therapy with more than 60 authored or co-authored papers, abstracts, and book chapters. Rich pursued postdoctoral fellowships in Immunotoxicology at the Chemical Industry Institute of Toxicology and the National Institute of Environmental Health Sciences. He received a BS in Biology from Bucknell University and a PhD in Pharmacology from the University of Rochester School of Medicine & Dentistry.