Biologic CMC Development Consulting
Contracts are with senior-level, industry-experienced Biologics Chemical Manufacturing and Controls (CMC) Development Consultants with expertise in biotechnology products and biologics. The consultants provide technical guidance and advice on advancing early discovery and development projects through early nonclinical development and submission of an Investigational New Drug (IND) package, and in some cases, design of early clinical protocol and launch of a first in human clinical trial. Once an investigator has been selected for funding or has an award, NIH staff will interact directly with the PI and request assistance for them from consultants to review and provide expert advice on specific topics. Consultants will provide guidance on all CMC related requirements of early non clinical and early clinical development of biologics (such as peptides, antibodies, recombinant proteins, oligonucleotides, and cell and gene therapies) in accordance with the US regulatory and the ICH guidelines.
Biologic Regulatory Affairs Consulting
Contracts are with experienced regulatory affairs consultants with expertise in biotechnology products and biologics. Consultants will advise about FDA, Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) regulatory guidelines, regulations, and requirements pertaining to the early nonclinical and early clinical development of biologics. Once an investigator has been selected for funding or has an award NIH staff will interact directly with the PI and request assistance for them from consultants. Consultants will review and assess data and project related proposals, and advise on study requirements to file an IND package for a range of potential biologics therapeutic modalities in nonclinical IND-enabling development – such as peptides, antibodies, recombinant proteins, oligonucleotides, cell and gene therapies - based on regulatory precedence and compliance to Common Technical Document (CTD) format requirements.
Contracts are with consultants with statistical experience in non-clinical and clinical development efforts. NIH staff seeks statistical advice given the institute’s high priority in increasing the predictive value of non-clinical research, in order to ensure therapy projects are moving ahead to the clinic for the right reasons. The consultant will evaluate the design of Government studies and milestones for sound statistical analysis plans to ensure they are sufficiently powered and controlled with experimental and statistical rigor to lend a high degree of confidence in the studies and results.
Note: NIH staff will determine if a project should be assigned a consultant at the time of award. Investigators should not mention NIH consultants in their applications. These consultants advise NIH staff and offer investigators assistance in addition to the consultants that may be on an investigator team as stated in their funding applications. Investigators should not contact NIH consultants directly.
Deborah Barngrover, Ph.D.
Debra Barngrover has been a senior consultant with Biologics Consulting for over 5 years, with over 25 years of experience in the biopharmaceutical industry prior to that. As a Senior Consultant in Regulatory / Manufacturing, Debra utilizes her broad technical and project management expertise to assist clients in the following areas:
- Preparing and reviewing CMC sections of regulatory filings;
- 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;
- Preparing for facility inspections.
Prior to Biologics Consulting, she was Vice President, Technology Development, 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, as well as managing the Technology Development group responsible for development of more than 15 small molecule, protein and viral vector products, including seven commercial. She provided managerial leadership to process development, analytical, formulation development, project management, manufacturing, package and label engineering and risk management functions. She has authored/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 taught courses in regulatory strategy, mammalian cell culture, supply chain and recombinant protein development for RAPS, ISPE, ASME and other organizations. She holds a BS from Colorado State University and a PhD degree in Biochemical Nutrition from Cornell University.
Scott Burger, M.D.
Scott Burger is the principal of Advanced Cell & Gene Therapy, a consulting firm specializing in development and commercialization of cell therapy, gene therapy, and tissue-engineered products, providing expert guidance on product development and commercialization, regulatory affairs, GMP manufacturing and testing, and strategic issues. Dr. Burger has over 25 years of experience developing advanced biologics and related technology and has consulted for over 80 industry and academic clients in North America, Europe, Asia, and Australia. Prior to founding Advanced Cell & Gene Therapy in 2002, Dr. Burger was Vice-President for R&D at Merix Bioscience, a cellular immunotherapy company, and served as medical director of the University of Minnesota Cell Therapy Clinical Laboratory and MMCT Facility, where he was responsible for process development and GMP manufacturing of cell therapy and gene therapy products for over 70 clinical trials. Dr. Burger has chaired the Global Regulatory Affairs steering committee of the International Society for Cellular Therapy and the scientific advisory board of HemaCare Corporation, and serves on scientific advisory boards of multiple organizations and companies, including BioLife Solutions, BioCision, Longevity Therapeutics, and the Regenerative Medicine Foundation. He has served on the USP Cell, Gene and Tissue Therapies Expert Committee, the ISCT advisory board and ISCT committees on gene therapy, regulatory affairs, commercialization, and product/process development. A graduate of the University of Pennsylvania School of Medicine, Dr. Burger completed training in clinical pathology and transfusion medicine at Washington University in St. Louis, and is author of over 200 scientific publications and presentations, and recipient of numerous honors and awards.
Scott Burian, PhD, RAC
Scott Burian, Senior Research Scientist, is a broadly-experienced regulatory affairs professional specializing in pharmaceutical development, regulatory strategy, and chemistry, manufacturing, and controls (CMC). Prior to joining Rho in early 2016, Dr. Burian served most recently as the Director, Regulatory Affairs CMC at Mallinckrodt Pharmaceuticals. In this role he provided input into drug substance and drug product development plans, authored CMC related documentation for regulatory submissions, provided input on regulatory strategies related to CMC, participated in FDA interactions, and performed man-in-the-plant activities at contract manufacturing organizations. Prior to Mallinckrodt Pharmaceuticals, Dr. Burian held Director of CMC Regulatory Affairs positions at Kowa Research Institute and Cato Research from 2002 through 2015.
In summary, Dr. Burian has more than 15 years of experience in the pharmaceutical industry and has contributed to the development of a diverse range of small molecule, biologic, and nanoparticle-based products. He has supported the development of lingual spray, solid oral, topical, parenteral, and nasal spray dosage forms. In this role Dr. Burian has managed numerous CMC vendors to ensure that the pharmaceutical development activities are proceeding at the proper pace to coincide with both non-clinical and regulatory timelines. His responsibilities included review of analytical methods, manufacturing batch records, conducting vendor audits, and coordinating clinical packaging operations. Dr. Burian has also served as project manager and pharmaceutical development scientist on multidisciplinary matrix-based project teams. Further, he has participated in numerous FDA interactions, including pre-IND meetings, Type A meetings, and Advisory Committee meetings. Dr. Burian has also acted as the U.S. Agent for several European-based companies. He is fully-versed in eCTD format and has authored a variety of CMC submissions, including numerous pre-IND meeting packages, INDs, NDAs, and IMPDs.
Dr. Burian earned a doctorate in pharmacology from Wake Forest University School of Medicine in 2002 and has maintained the Regulatory Affairs Certification from RAPS since 2012. Prior to pursuing his doctoral degree, from 1995 through 1997, he worked as a Drug Manufacturing Technician and Production Manager at Cambridge Biotech Corporation and Cornell University Duck Research Laboratory.
Ken Cheung, Ph.D.
Ken Cheung, PhD, Professor of Biostatistics in the Mailman School of Public Health at Columbia University. He has general interests in the development and evaluation of evidence-based treatments, interventions and policies at all phases of translational research. He is an expert in adaptive designs in clinical trials in cancer, stroke, and other neurological disorders, SMART designs for adaptive intervention and behavioral intervention technologies, N-of-1 study designs, implementation study designs, and the analysis of high dimensional physical activity data. He is a recipient of IBM Faculty Award. He is a member of the American Heart Association, American Statistical Association, the International Biometric Society, and the Society for Clinical Trials. He is an elected Fellow of the American Statistical Association. He serves as an associate editor for Biometrics and Clinical Trials.
Bill Macklin, Ph.D., RAC
Bill Mackin is the President and Founder of WMackin & Associates Inc., a professional services company that provides technical and regulatory support to companies and academic institutions developing novel bio-therapeutics. Bill is a seasoned CMC drug development and Regulatory Affairs expert with 35+ years in the biopharmaceutical industry. He has a strong technical background in the CMC and GMP manufacturing of Biologics including proteins, nucleic acids, carbohydrates and cell-based therapies. Dr. Mackin has expertise in bioanalytical assay development and validation and has designed and managed Quality Control Systems. Dr. Mackin’s scientific and drug development experience is very broad and encompasses the therapeutic areas of oncology, CNS disease, pain, inflammation, infectious and dermatology. Dr. Mackin is an experienced Regulatory Affairs professional. He works closely with Investigators in developing successful regulatory strategies and managing their execution. He and is company, WMA, have successfully submitted 65+ INDs to FDA in all therapeutic areas. Bill holds a PhD in immunology and microbiology from the University of Illinois Medical Center in Chicago, Illinois, USA. He did his postdoctoral studies at the University of Connecticut Health Center in the areas of inflammatory cell biology and biochemistry. He spent 13 years at the DuPont Pharmaceutical Company engaged in the discovery and development of small molecule drugs for the treatment of cancer and inflammatory diseases and then moved to smaller companies in the Boston area working in the development of carbohydrate, protein and cell-based therapies. Dr. Mackin was US Regulatory Affairs Certified in 2006 and served as Head, Global Regulatory Affairs for Aptuit Consulting from 2006 to 2010. He now serves as the US Regulatory Agent to FDA for several US and non-US based companies. Dr. Mackin speaks frequently at numerous professional conferences on drug development and the regulatory aspects of Biologics development and regulatory approval.
Dana Minnick, PhD, DABT, RAC
Dana Minnick, Senior Research Scientist, is a toxicologist and regulatory affairs professional with more than 18 years’ experience supporting drug and biologics programs throughout the development lifecycle in both the pharmaceutical and CRO industry. Dr. Minnick has demonstrated capability in identifying gaps and defining drug development strategies with specific expertise in nonclinical safety assessment and regulatory affairs to support proposed clinical trials and enable successful regulatory filings. Her experience in early phase drug development has resulted in many successful FDA pre-IND meetings and IND filings. Dr. Minnick is also experienced in safety assessment of impurities and excipients and preparation of position papers for FDA submissions. Prior to joining Rho, Dr. Minnick was a drug development program manager at RTI International. At RTI, Dr. Minnick led the regulatory affairs team for the NHLBI Science Moving towArds Translation and Therapy (SMARTT) program. In this role, Dr. Minnick provided extensive drug development consulting and advice to over 30 investigators, leading to 8 pre-IND meetings, 4 successful IND filings and 3 Orphan Drug Designations. Dr. Minnick was also an integral regulatory and nonclinical team member for the Global Alliance for Tuberculosis. As part of the TB Alliance RTI team, Dr. Minnick managed two nonclinical programs, participated in several FDA meetings, IND submissions, IND annual reports and Investigator Brochure updates. Dr. Minnick also participated as a toxicologist, regulatory affairs member and Steering Committee member for a Clinical Translational Science Award (CTSA) program in partnership with University of North Carolina and NC A&T, and led the regulatory affairs and nonclinical development of a USAID program evaluating the use of a long acting injectable therapeutic for HIV-1 prevention. Prior to RTI International, Dr. Minnick provided nonclinical and regulatory expertise as a consultant at Aclairo Pharmaceutical Development Group, a toxicologist and product development scientist at Viamet Pharmaceuticals, a project manager at Calvert Research, and a program leader, senior research investigator and toxicologist at GlaxoSmithKline.
Dr. Minnick’s has worked in several therapeutic areas including neurology, psychiatry, gastroenterology and inborn errors, metabolic diseases, cardiovascular, hematology, respiratory, oncology and antimicrobials. She earned a doctorate in environmental health sciences/toxicology from Case Western Reserve University in 1992 and continued her genetic toxicology studies as an IRTA Fellow at NIEHS. She is a Diplomate of the American College of Toxicology and has maintained certification in Regulatory Affairs (RAPS) since 2008.
Jack Modell, M.D.
Jack Modell, Vice President and Senior Medical Officer, is a board-certified psychiatrist with 35 years of experience in clinical research, including 20 years in academia teaching, providing patient care, and conducting clinical trials, as well as 15 additional years of experience in clinical drug development (proof of concept through market support), medical affairs, successful NDA filings, medical governance, drug safety, compliance, and management within the pharmaceutical and CRO industries. Dr. Modell’s specialties and expertise include neuroscience, pharmacology, drug development, clinical research, medical governance, and clinical diagnosis and treatment.
Prior to joining Rho, Dr. Modell had a distinguished academic career, ultimately attaining the rank of a tenured professor, in which he authored over 50 peer-reviewed publications spanning numerous therapeutic and scientific areas, including addiction medicine, anesthesiology, psychiatry, neurology, and nuclear medicine. He subsequently joined GlaxoSmithKline where he helped lead several successful development programs in the neurosciences, was responsible for both drugs in development and marketed products as a global vice president of neurosciences, and as a vice president in medical governance helped to harmonize research policies and standards across the organization. Jack has been a key opinion leader in the neurosciences, has served on numerous advisory and editorial boards, and is nationally known for leading the first successful development of preventative pharmacotherapy for the depressive episodes of seasonal affective disorder.
David Shoemaker, Ph.D.
David Shoemaker, Senior Vice President, Research and Development, has over 25 years of CRO-industry experience in the development of drugs, biologics, medical devices, and combination products, with over 20 years as a Regulatory Affairs professional. Prior to joining Rho, he served as the Senior Vice President of Global Regulatory Affairs and Strategic Product Development at PPD and as Managing Director of Cato Research Ltd. He also served as a postdoctoral fellow at Yale University School of Medicine’s Department of Physiology and as a Research Assistant Professor at Emory University School of Medicine’s Department of Physiology.
At Rho, Dr. Shoemaker is responsible for oversight of company compliance with applicable FDA regulations and guidance documents and all regulatory operations, including controlled document, regulatory document, and procedural documentation management; product safety; regulatory submissions; sponsor or agency audit preparation; and quality assurance. He has moderated dozens of regulatory agency meetings and been responsible for over a hundred CTAs and IND submissions and over 25 marketing approval applications for small molecules and biologics in the US and EU. He has participated in both commercial projects and projects from government agencies, including several CRADA and SBIR efforts for anti-bioterrorism products.
Dr. Shoemaker earned a doctorate in Physiology and Pharmacology from Duke University and earned the Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society (RAPS) and the Regulatory Affairs Certification Board, Rockville, Maryland. He has experience in a wide array of therapeutic areas, including central nervous system (analgesia, attention deficit hyperactivity disorder, Parkinson’s Disease, Huntington’s Chorea) oncology (leukemia, lymphoma, pancreatic, gastric, colon, prostate, head and neck, melanoma), hematology (hemophilia, thrombocytopenia, sickle cell disease), transplantation (renal, hepatic), infection/parasitic disease, endocrine/metabolic, mental disorders, circulatory, respiratory, genitourinary, dermatology, and musculoskeletal.
Karl Whitney, Ph.D., RAC
Karl Whitney, Assistant Vice President of Operations, has 15 years of experience in the pharmaceutical industry in both the CRO and sponsor settings. In this management position, Dr. Whitney oversees a group of product development specialists engaging in regulatory strategy; biostatistics, statistical programming, and data management work; and full-service clinical research. He specializes in clinical and regulatory strategy and compliance aspects of pharmaceutical development as a certified regulatory affairs professional. At Rho, he leads multiple project teams providing integrated development services spanning the development spectrum. Core project activities include planning, managing, and overseeing concurrent manufacturing, nonclinical, clinical, and regulatory activities to achieve cost-effective and time-efficient project goals. He also offers technical and regulatory consultation for a broad array of drug and biologics projects company-wide. Dr. Whitney has also contributed to preparation of many regulatory submissions, including large IND applications, clinical and nonclinical final study reports, pre-IND, EOP2, and pre-NDA meeting packages, IBs, fast-track and orphan-drug applications, IND and orphan annual reports/updates, and NDAs for electronic submission in eCTD format, clinical protocols and amendments, and numerous other documents. Additionally, Dr. Whitney has provided regulatory strategy consultation, regulatory document authorship and review, regulatory submission reviews, site essential document review/approval support to Rho’s federal coordinating centers, and mentoring to younger colleagues in the organization.
Prior to joining Rho, he served as Director of Regulatory Programs in the Global Health Technologies unit of RTI International, a large international contract research and program implementation organization. In this role, Dr. Whitney served as the lead development scientist for multiple integrated tuberculosis drug development programs sponsored by 2 nonprofit organizations; as a company-wide regulatory affairs resource for a wide array of projects at all development stages for government-funded and commercial clients; and as the regulatory advisor on a Phase II study of a contraceptive device/drug combination that was being handled under the drug’s previously established IND. Dr. Whitney was also previously a regulatory scientist at Cato Research Ltd.
Dr. Whitney’s therapeutic areas of expertise include tuberculosis and CNS disorders such as pain, Huntington’s disease, and schizophrenia. He earned a doctorate in pharmacology from Duke University in 1999 and went on to a postdoctoral research fellowship at GlaxoSmithKline to study nuclear hormone receptor pharmacology and molecular biology, developing expertise in these areas as well as in neuropharmacology, neuroimmunology, and genomics research techniques. He has maintained the Regulatory Affairs Certification from RAPS since 2003.
William Wilkison, Ph.D.
William Wilkison, Ph.D. has over 25 years of experience in clinical trial conduct, regulatory submissions, and drug discovery and development. He is currently a Senior Research Scientist at Rho, Inc, specializing in medical writing and regulatory affairs. Previously Dr. Wilkison was the Chief Scientific Officer and founder of Avolynt, Inc., a clinical stage pharmaceutical company focused on developing novel therapeutics for metabolic diseases, where his main role was leadership and oversight of the clinical and regulatory development aspects of late stage clinical assets. Prior to founding Avolynt, Dr. Wilkison spent several years at GSK in business development managing key relationships between GSK and partner companies and participating in project team meetings. Prior to GSK, Dr. Wilkison was a founder and Chief Operating Officer at Artecel Sciences, Inc. a stem cell development company, which was spun off from Zen-Bio, Inc. another biotech company founded by Dr. Wilkison, focused on the development and commercialization of human adipose cells. Dr. Wilkison spent six years at Glaxo/GlaxoWellcome studying metabolic disease and was responsible for target/lead identification and development. During this time, he was responsible for a number of development programs, preclinical and clinical. Dr. Wilkison’s work has involved a variety of therapeutic areas including neurology, gastroenterology and inborn errors, metabolic diseases, cardiovascular, respiratory, and antimicrobials. Dr. Wilkison has published numerous peer-reviewed manuscripts and is an inventor on several issued patents. Dr. Wilkison holds a Ph.D. from Duke University Medical Center and did his postdoctoral work at Harvard Medical School. Text to be collapsed.