PREMIER CONSULTING - Key Persons
Job Titles:
- Senior Manager
- Senior Manager Pharmacokinetics
Agnieszka Marcinowicz, Senior Manager Pharmacokinetics, has a Ph.D. in Physical Chemistry with experience in drug development, bioanalysis, preclinical studies, clinical development, data analysis, pharmacokinetics and pharmacodynamics and clinical pharmacology.
Agnieszka leverages her expertise in PK analysis and modeling, statistical analysis, bioanalysis, and nonclinical and clinical drug development to determine and implement unique MIDD approaches for a range of drugs, indications, and routes of administration.
Agnieszka also works closely with Premier's regulatory experts to write and submit PK reports and clinical study protocols and reports.
Job Titles:
- Senior Director, Research
Alain obtained his PhD in Molecular Biology from the medical faculty of Laval University (Quebec City) in 1992. Following a postdoctoral fellowship, he started to transition to biopharma by joining first the National Research council lab and then a small start-up company developing pain drugs. He then joined a respiratory-oriented biotech, where he first worked as a team leader, rising to Project Manager on the drug development team. Reporting to the VP of Drug Development, he gained significant hands-on drug development experience by managing all outsourced drug development activities including CMC, method development, toxicology studies, Phase 1 clinical trials, and supporting activities.
He then joined Premier Partners in his initial role, which involved the management of several nonclinical programs for a variety of clients. Alain gained experience with various types of drugs including small molecules, oligonucleotides, RNA, proteins, and biologics, and with multiple routes of administration and formulation such as inhalation (dry powder, liquid aerosols), intravenous, intravitreal, subcutaneous, and oral.
In 2011, he founded one of the Premier Partners R&D companies, which is responsible for managing multiple IND-enabling toxicology programs and Phase 1 clinical studies in different therapeutic indications. He focuses on helping sponsors plan, execute, monitor, and/or manage their development programs to facilitate successful regulatory submissions and initiate clinical activities.
Job Titles:
- Regulatory Strategist
- Vice President, Regulatory Affairs
Angela Drew has been a regulatory strategist since 2011. During this time, she has prepared regulatory submissions, conducted FDA meetings to obtain feedback on development programs, and advised clients on developing products for submission via the 505(b)(2) regulatory pathway. Prior to joining the pharmaceutical industry as part of the Premier team, Angela held academic appointments at the University of Cincinnati and Melbourne University investigating the interactions between inflammation, coagulation, and cancer metastasis.
Job Titles:
- Vice President, Pharmaceutical Technology
- VP, Pharmaceutical
Chris Hendry is a veteran in the development and manufacture of protein biologics with an emphasis on selection and oversight of drug substance and drug product contract manufacturing organizations, development of commercial manufacturing processes, and quality risk management. He is also experienced in the transfer and validation of drug substance and drug product manufacturing processes; preparation of CMC sections of INDs, BLAs, and CTDs; project management of cross-functional development teams; and GMP facility and equipment design, validation, and development master planning. Mr. Hendry has a bachelor's degree in biochemistry from the University of Maine.
Dean Wenham is an entrepreneur in the biotechnology and environmental sciences space. After obtaining a PhD in Pharmacology from University College London and a postdoc at the Weis Center For Research, PA, he spent several years in the UK as a senior research scientist at Pfizer AstraZeneca. Feeling more at home driving big ideas with small teams, Dean founded the group that would eventually become Premier Partners in Montreal, Canada, in 2005. As founding CEO, he built a unique drug development company specializing in helping small- to medium-sized biopharma companies navigate preclinical and early clinical development.
Dean has since co-founded and led Ocean Diagnostics in Victoria, BC, an environmental technology company specializing in addressing plastic pollution and biodiversity loss. Dean is actively involved in both the biopharma and environmental sciences industries and focuses on strategic consulting, providing scientific and business strategy for early-stage companies, entrepreneurs, and academics.
Job Titles:
- Strategic Advisor
- Strategic Advisor to
Donna Kato is strategic advisor to Premier Consulting and has spent her career in the pharmaceutical industry, specializing in regulatory affairs for the past 30 years. She started her career at Syntex in discovery research and later joined its worldwide regulatory affairs department. After Syntex, she led regulatory affairs at Acologix and Celtrix before founding Regulatory Professionals, Inc., in 1995, which she grew to a full-service regulatory affairs consultancy assisting hundreds of clients with product development worldwide. As part of her support for the regulatory affairs community, Ms. Kato has been an instructor in the Extension Certificate Program in Regulatory Affairs at the University of California, Berkeley. She holds a bachelor's degree in biochemistry from the University of California, Davis, and an MBA from Santa Clara University.
Dr. Ruth Stevens has more than 20 years of experience in the development of new drugs and therapeutic agents. She has led more than 100 FDA regulatory meetings in her career and continues to lead numerous meetings. She has authored more than 70 abstracts/publications and is frequently requested as a speaker both nationally and internationally. In addition, Stevens served as an Advisory Committee Member (non-voting) to the FDA's Blood Products Advisory Committee Meeting in 2013.
Before joining Premier Consulting, Stevens was senior director of clinical affairs at Duramed Pharmaceuticals overseeing Phase I-IV scientific and clinical activities, with an emphasis on women's health and HRT products. She also served as director of pharmacokinetics and pharmacodynamics at Phoenix International Life Sciences where she was responsible for scientific management of clinical pharmacology Phase I and II studies.
Stevens began her career at the FDA as a pharmacokinetic reviewer and a team leader in the Office of Clinical Pharmacology and Biopharmaceutics in the Center for Drug Evaluation and Research (CDER).
Job Titles:
- Regulatory Operations Professionals
- Vice President, Regulatory and Business Operations
- VP, Regulatory / Operations
Elizabeth Narciso leads a team of regulatory operations professionals in preparing and submitting regulatory documentation on behalf of clients to the Food and Drug Administration and other health authorities. She has spent her career in regulatory operations and has integrated regulatory affairs in a variety of roles, including research associate, regulatory associate, documentation specialist, and publisher. Additionally, she has experience developing and maintaining systems and procedures. Prior to becoming part of Premier Consulting, Ms. Narciso held roles at Genitope, PDL Biopharma, CV Therapeutics, Matrix Pharmaceutical, and Theravance. She holds a bachelor's degree in biology with an emphasis in microbiology from San Francisco State University.
Job Titles:
- Director, Regulatory / Affairs
- Senior Director of Regulatory Affairs
Fedra Molaie-Holagh is a Senior Director of Regulatory Affairs at Premier Consulting. She has 21 years of experience in the pharmaceutical and biotech industry, with 19 years focused on regulatory affairs.
In her previous role, she led the regulatory, quality, and pharmacovigilance teams at Acerus. She has also worked at Amgen, Novartis Animal Health, YM Bioscience, and BGP Pharma on teams managing innovative products at different stages of development, as well as post registration product stewardship, in a wide spectrum of therapeutic areas, including oncology, nephrology, pain, and men's health.
Ms. Molaie-Holagh has dealt with health authorities in Canada, the US, the EU, Australia, and Japan through health authority interactions including scientific advice and EOPII meetings and and through submissions including INDs, CTAs, NDSs, NDAs, MAAs, and BLAs. She holds an HBSc in molecular genetics from University of Toronto.
To learn more about Premier Consulting's regulatory services & support, click here.
Job Titles:
- Vice President, Regulatory Affairs
Greg has been in the pharma, biopharma and medical device industry for over 30 years and has gained regulatory approvals in more than 20 countries. He has represented companies during numerous interactions with the FDA, European national and EU regulators, and the Australian TGA and has worked on the development, submission, and commercialization of NMEs and 505(b)(2) products in oncology, neurology, and dermatology. His specialty areas include biologics and drug-device combination products.
Job Titles:
- Director, Nonclinical Development
Heli Parenteau obtained a master's degree at the University of Eastern Finland (Kuopio) in the Environmental Sciences program, which was rooted in laboratory animal science, toxicology, biology, and health sciences. In the early stages of her career, she engaged in an outsource service program for toxicity testing for the pharmaceutical industry and was involved in establishing a GLP-compliant laboratory at the National Animal Laboratory Center in Kuopio, Finland.
After relocating to Canada, she gained further experience in pharmacokinetics, toxicology, and CNS/pain as well as pre-formulations as a research scientist, study director, study monitor, sponsor representative, and outsourcing coordinator. With over 25 years working in academic service provider laboratories, CROs, and the pharma industry (15 of them at AstraZeneca R&D Montréal), Heli has gained valuable insight in nonclinical methodology and study design as well as experience in problem-solving spanning from discovery to toxicity and safety testing.
For the past six years, Heli has managed multiple IND-enabling toxicology programs of different therapeutic indications (e.g., pain, cancer, pulmonary diseases, infection, and anti-virals) for a variety of administration routes (e.g., oral, intravenous, and inhalation) with a proactive and collaborative approach. In her role at Premier Partners, she is intent on helping sponsors with their development programs to enable them to meet their strategic objectives towards regulatory submissions and early clinical activities.
Job Titles:
- Associate
- Principal
- Principal Associate, Pharmacokinetics
Isaac Asante, Principal Associate, Pharmacokinetics, is a pharmacist with a doctorate in Clinical Therapeutics and a Masters in Drug Development and Regulation. He has experience in the various stages of drug development including biomarker discovery and development, bioanalytical assay development and bioanalysis, preclinical studies, clinical development, data analysis, and clinical pharmacology (PK and PD).
Job Titles:
- Principal Scientist, Pharmacokinetics
Jayesh Patel, Principal Scientist, Pharmacokinetics, uses his expertise in pharmacometrics, clinical development, and clinical pharmacology to identify and develop a multitude of PK modeling approaches that are fit-for-purpose and drive client's projects forwards. Jayesh provides hands-on functional inputs in clinical pharmacology strategies, study requirements and designs, and regulatory submissions. In addition, Jayesh conducts PK analysis, modeling, and simulation for ongoing clinical trials being conducted by Premier Research.
In 2003, Ken Phelps applied more than three decades of industry experience to found Camargo Pharmaceutical Services in Cincinnati with Dr. Ruth Stevens (chief scientific officer and executive vice president). It is no coincidence that 2003 was also the year the US FDA introduced guidelines governing the 505(b)(2) approval pathway. In the beginning, Camargo focused solely on being the industry's 505(b)(2) development partner of choice.
Job Titles:
- Vice President, Regulatory Affairs
Laura Kilgore leads regulatory affairs for chemistry, manufacturing, and controls. Additionally, she specializes in providing strategic input, project management, and technical writing support for the development of agency meeting requests, original investigational new drug applications and new drug applications, and briefing documents. Ms. Kilgore has extensive experience in providing regulatory chemistry, manufacturing, and controls and quality leadership for development products supporting marketing approvals, as well as in lifecycle management for a broad range of marketed products across pharmaceutical, biologic, and medical device products, including solid oral dosage forms, topicals, transdermals, combination products, biosimilars, and devices. She spent six years at Actavis Laboratories and more than 10 years at Nektar Therapeutics in regulatory affairs and quality assurance. Ms. Kilgore holds a bachelor's degree in chemistry, magna cum laude, from Auburn University and has Regulatory Affairs Certification for the United States.
Job Titles:
- Vice President, Regulatory Affairs
Matthew is a GxP regulatory, clinical, and quality assurance professional with 30 years of experience providing regulatory and quality assurance services for healthcare companies, including medical device, IVD, and pharmaceutical companies. He is knowledgeable in both medical device and drug development regulations, including Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Manufacturing Practice (GMP) regulations.
Matthew has direct experience with Class III IVDs as well the successful implementation of an LDT from initial design validation to successful processing of samples for multiple solid tumor cancer types in the US and India. Matthew has developed and advanced innovative technologies from surgical robotics to molecular diagnostics, biologics, blood products, and all classes of medical devices, both therapeutics and IVDs.
He has developed, executed, and managed global quality assurance programs at various healthcare organizations and has experience in assessing conduct compliance of clinical research/development activities to applicable regulations and guidelines, scientific protocols, and SOPs. He has also prepared and managed several successful global product registrations including PMA, 510(k), NDA, and BLA submissions and their international equivalents.
Michael King Jolly joined Premier Research in 2016 to oversee strategic drug development partnerships and to implement innovative technologies and alliances. He has more than 35 years of clinical research and drug development experience, having held senior positions in strategic partnering, medical and regulatory affairs, clinical operations, and R&D at some of the industry's leading companies.
Dr. Jolly holds a Doctor of Pharmacy degree from the University of Texas-Austin and a bachelor's degree in zoology from the University of North Carolina-Chapel Hill and is a graduate of the Burroughs Wellcome Management Institute. He teaches at the School of Pharmacy at the University of North Carolina-Chapel Hill.
Job Titles:
- Vice President, CMC Services
Dr. Aloba has more than 25 years of leadership experience in pharmaceutical research and development, pharmaceutical technology, and regulatory strategy. He is a subject matter expert in drug product development, with special expertise in the application of quality-by-design (QbD) to formulation and process development, analytical development, and development strategy. He is a registered pharmacist and holds a US Regulatory Affairs Certification (RAC) through the Regulatory Affairs Professional Society.
Dr. Aloba joined Premier Consulting in 2014 and, in his current role, leads Premier Consulting's Chemistry Manufacturing and Controls (CMC) service offerings focusing on pharmaceutical development strategising, planning, execution, and documentation in support of drug development programs for Premier Consulting's clients. He also serves as senior technical advisor on Premier Consulting's drug, device, and biologics initiatives and is responsible for continuing development of the pharmaceutical quality expertise, knowledgebase, and policy at Premier Consulting.
Before joining Premier Consulting, Dr. Aloba was the Director of Pharmaceutical Development at Warner Chilcott, where he was responsible for utilizing external and internal resources to oversee the development of specialty pharmaceuticals in various therapeutic categories, including women's health, dermatology, and urology. In this role, he directed the pharmaceutical development of several brand name products from concept through regulatory approval. He has also held scientific management positions at Warner Lambert, where he was involved in the pharmaceutical development of a number of brand name and generic products. He was also an analytical and pharmaceutical development scientist at Forest Laboratories.
Dr. Aloba earned a Bachelor of Pharmacy degree from University of Benin, Nigeria, and MS and PhD degrees in Pharmaceutical Science from St. John's University. Dr. Aloba is a co-inventor on several pharmaceutical patents and has authored scientific articles and presented his work at numerous conferences.
Shari Medendorp leverages her more than 20 years of industry knowledge and experience to lead Premier Consulting, a highly integrated business unit of Premier Research that specializes in strategic product development and global regulatory consulting for emerging biotech and specialty pharma companies.
Ms. Medendorp's experience includes leading Premier Research's biometrics operations, holding positions as Senior Vice President of Biometrics at CliniRx, Reliance Clinical Research Services, and SCIREX Corporation, among other executive roles. She started her career as a Biostatistician working with medical staff at the Cleveland Clinic Foundation on the design and analysis of clinical studies. Ms. Medendorp holds a master's degree in public health in biostatistics from the University of Michigan and a bachelor's degree in mathematics from Calvin University.
Willette Jones Whitmore is a Certified Clinical Research Professional with over 20 years of diverse biotech industry experience in various phases of global clinical trials management and quality assurance (QA) for regulated medical devices, pharmaceuticals, and biologics. She has spent more than 12 years with CROs, focusing on compliance with global health authority regulations and ICH GCP guidelines. She is a transformational and innovative Leader with proven successes in developing global quality and clinical/operational teams, strategies, and other specialized services within QA. She has also authored various controlled documents, user manuals, course platforms, and training curricula.
You can read Willette's Employee Story here and learn more about Premier Consulting's quality assurance capabilities here.
Job Titles:
- Director, Commercial / Strategy
- Director, Commercial Strategy Solutions
Will Bainbridge, Sr. Director, Commercial Strategy Solutions, leads commercial strategy at Premier Consulting. He has over 20 years of leadership experience in the Pharmaceutical, Biotech, MedTech, and Consulting industry across multiple therapeutic areas, business models and companies, including Novo Nordisk and GSK. He has held US and global strategic leadership positions with full P&L responsibility. Will has extensive experience in business development, strategic planning, portfolio strategy, and new product planning for small to mid-size Biotech companies and Big Pharma. It spans the entire clinical development journey. His combined operating and advisory experience enable him to provide firsthand client focus, define risk, create opportunity, and develop practical solutions to address complex business needs.
"I recently commented to our Premier Consulting lead that all virtual biopharma companies should engage Premier as a strategic partner. It is not only the depth of regulatory experience-meeting with the FDA five to six times a month-and the breadth of functional expertise, but also their responsiveness. Premier Consulting is a key strategic partner that will help us succeed and bring our life-saving products to market."
Job Titles:
- Vice President, Regulatory Toxicology and Clinical Pharmacology
William Salminen, PhD, DABT, PMP is board certified in Toxicology and Project Management and has over 20 years of drug development experience for an array of drug products and indications. He leads the Nonclinical/Toxicology and Clinical Pharmacology/Pharmacokinetic groups within Premier Consulting, which provide clients with nonclinical and clinical pharmacology strategies, study requirements and designs, pharmacokinetic modeling, input on regulatory submissions, and addressing nonclinical and clinical issues (e.g., Clinical Holds) with regulatory authorities (e.g., US FDA). William's key experience includes but is not limited to regulatory strategy and advice, nonclinical safety and toxicology strategy and advice, US FDA pre-IND meetings, IND applications and maintenance and NDA and BLA submissions. He has significant experience with 505(b)(2) NDAs and the unique regulatory, nonclinical, and clinical strategies involved with developing drugs under the 505(b)(2) pathway.