Expert Details
Pharmaceuticals & Clinical Development: Drug Development Issues, Vaccines, Infectious Diseases, Pediatrics/Rare Diseases, Immunology, and Neurology
ID: 740293
Pennsylvania, USA
Over the past decade, Expert transitioned to consulting through his own practice, where he provides clinical and strategic guidance to both large and emerging biotech firms. His recent positions include Senior Medical Director at Grifols, where he led the AMBAR program for Alzheimer’s, and Vice President of Clinical Development at Immunovant, where he oversaw Phase III trials for treatments targeting neurological disorders. In these roles, Expert’s responsibilities have encompassed everything from study design and regulatory meetings to mentoring junior physicians and guiding multi-disciplinary teams.
In addition to his extensive clinical trial and consulting experience, Expert has held academic appointments as Professor of Pediatrics at prestigious institutions and is widely published in areas relevant to pediatric and emergency medicine. He has contributed to numerous scientific and advisory boards and has been invited to speak at international conferences on topics ranging from vaccine safety to emergency pediatric care. His dedication to advancing medical science and his ability to translate complex clinical insights into actionable therapeutic strategies make him a respected leader in the field of clinical development.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1984 | Degree: MD | Subject: Medicine | Institution: University of Pennsylvania, School of Medicine |
| Year: 1980 | Degree: BS | Subject: Biologic Basis of Behavior & Natural Sciences | Institution: University of Pennsylvania |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2013 to Present | Employer: Undisclosed | Title: President and Clinical Development Consultant | Department: |
Responsibilities:Independent consulting practice offering clinical development expertise to large and small pharma companies. Therapeutic areas of expertise include Infectious Diseases/Vaccines, Pediatric/Rare Diseases, Neurology and Immunology. Services offered include:• Assisting with clinical development plans and planning • Helping prep for regulatory interactions including briefing book prep and question prep • Attending and summarizing scientific meetings with emerging information relevant to the sponsor • Authoring Pediatric Investigational plans or Pediatric Study Plans • Writing/revising/editing protocols • Monitoring clinical trials • Assisting with study start up activities including site ID, site visits, investigator meetings • Assisting in planning and orchestration of advisory boards and scientific symposia |
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| Years | Employer | Title | Department |
| Years: 2022 to 2023 | Employer: Grifols Scientific Innovation Office | Title: Senior Medical Director – Head of Neurology Division | Department: |
Responsibilities:Responsible for coordinating the clinical development plan for all assets within the neurology space, including work on AKT1220 (LTA4 inhibitor), AMBAR trial and IGI405. AMBAR trial was targeting an intervention to slow the progression of Alzheimer’s Disease in subjects with Mild to Moderate Disease.• Developed and studied budgets and timelines and executed within the targets set. • Represented the company on all regulatory interactions • Oversaw the work of medical directors within the division • Mentored junior physicians within the group on clinical development strategy and execution • AMBAR program: Authored phase 3 protocol, prep and execution of Type C FDA meeting and EMA Scientific Advice meeting, due diligence for new assets • AKT1220: Worked with translational medicine incorporating learnings from animal findings with AKT1220 into human trials |
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| Years | Employer | Title | Department |
| Years: 2021 to 2022 | Employer: Immunovant, Inc. | Title: Vice President, Clinical Development | Department: |
Responsibilities:Therapeutic Area Head for Neurology Division reporting directly to the CMO. Responsible for the clinical development program of Batoclimab for the treatment of neurological disorders including Myasthenia Gravis and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).Clinical Lead for the Myasthenia Gravis program (currently in Phase III) • Authored the Phase III protocol and shepherded its review via FDA, EMA and PMDA • Responsible for all elements of study design, regulatory interactions, study start up, clinical monitoring and operations • Medical lead representative on multi-disciplinary teams tasked with successful development of Immunovant’s lead clinical indication • KOL interactions at Advisory Boards, Scientific Meeting and in Recruiting member for Scientific Advisory Committee and Data Monitoring Board |
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| Years | Employer | Title | Department |
| Years: 2019 to 2021 | Employer: Janssen Pharmaceuticals | Title: Senior Medical Advisor/Director | Department: |
Responsibilities:Study-responsible physician for nine Phase I trials involving new anti-viral being developed for the treatment of Respiratory Syncytial Virus Infections in Hospitalized Adults; charged with reviewing all study-related data and providing medical input as needed into all documents prepared related to said trials. Responsible for trial testing the safety and efficacy of an immunomodulator for the treatment of patients with SARS-Cov2 infection.Clinical lead of the maternal fetal medicine program tasked with designing a clinical development plan for numerous (MFM) indications surrounding NIPOCALIMAB, an FcRn inhibitor recently acquired from Momenta pharmaceuticals. Designed and executed the clinical development plan and associated protocols surrounding this asset; leading a multi-disciplinary development team consisting of representatives from regulatory, translational medicine, biostatistics, clinical development, clinical operations, feasibility, data science, and commercial. Conceptualization of potential basket trial for multiple linked auto-immune indication while evaluating pros and cons of this trial versus individual trials for each indication. Medical monitor of 7 phase 1 trials for RSV asset. Work on multidisciplinary team conceptualizing a new protocol for use of IL 1 and 6 inhibitor to prevent Severe COVID in high risk patients. |
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| Years | Employer | Title | Department |
| Years: 2019 to 2020 | Employer: Worldwide Clinical Trials (through Clinical Pharma Solutions) | Title: Senior Medical Advisor/Director | Department: |
Responsibilities:Contract position serving as Global Medical Lead for two Rare Disease Trials: one involving 20 sites distributed over 20 countries on three different continents and the second involving eight sites distributed in the US and the EU. Responsible for overseeing all aspects of study start-up, study operations, document preparation, site interactions, and sponsor communication |
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| Years | Employer | Title | Department |
| Years: 2018 to 2019 | Employer: IQVIA International (through Clinical Pharma Solutions) | Title: Senior Medical Advisor | Department: Center of Excellence for Pediatrics and Rare Disease |
Responsibilities:• Provided scientific and strategic guidance to clients and internal project groups with emphasis on medical issues• Consulted in clinical drug development from pre-clinical through post-marketing • Supported protocol development, regulatory submissions, and manuscript development • Therapeutic area training, evaluation of new technologies, and safety monitoring • Attendance at multiple bid defense meetings to discuss medical considerations of each protocol • Focused on rare disease protocols and those in general pediatric conditions |
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| Years | Employer | Title | Department |
| Years: 2017 to 2017 | Employer: PTC Therapeutics (contract position via Greenfield Source, Inc.) | Title: Clinical Development Consultant | Department: |
Responsibilities:• Provided drug development expertise for Ataluren, a new investigational agent (licensed in EMEA) for the treatment of non-sense mutation Duchenne’s Muscular Dystrophy• Coordinated drug development strategy for this compound US and ex US • Coordinated drug development efforts for EMLAZA, a novel corticosteroid for the long-term treatment of inflammatory disorders; specific efforts included authoring protocols, clinical development plans, regulatory correspondence, and interactions and lifecycle management • Prepared and conducted an FDA Advisory Committee Meeting • Development of Phase 1 Thorough QT protocol to assess potential effects of Deflazicort on cardiac conduction |
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| Years | Employer | Title | Department |
| Years: 2015 to 2017 | Employer: Parexel International Corporation (through Clinical Pharma Solutions) | Title: Senior Medical Director | Department: |
Responsibilities:• Provided scientific and strategic guidance to clients and internal project groups with emphasis on medical issues• Consulted on clinical drug development from pre-clinical through post-marketing • Supported protocol development, regulatory submissions, and manuscript development • Therapeutic area training, evaluation of new technologies, and safety monitoring • Focus was on Vaccines and Infectious Disease protocols |
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| Years | Employer | Title | Department |
| Years: 2015 to 2015 | Employer: Kinderpharm (through Clinical Pharma Solutions) | Title: Senior Director, Head of Clinical Development | Department: |
Responsibilities:• Responsible for design and conduct of clinical studies conducted by this Contract Research Organization which specialized in pediatric drug development• Responsible for building an infrastructure for conducting pediatric clinical trials network, for monitoring ongoing trials, and for assisting companies in evaluating whether new medicines would require pediatric development plans or could qualify for waivers related to pediatric drug development |
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| Years | Employer | Title | Department |
| Years: 2013 to 2014 | Employer: InfaCare Corporation (through Clinical Pharma Solutions) | Title: Vice President, Clinical Development | Department: |
Responsibilities:• Responsible for the clinical development of all pre-marketed products for the company• Charged with planning and orchestrating the clinical development plan for all products in development as well as providing the medical expertise to articulate the health care proposition offered by products in development |
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| Years | Employer | Title | Department |
| Years: 2010 to 2013 | Employer: Merck Research Laboratories | Title: Director, Vaccine Clinical Research | Department: |
Responsibilities:Clinical Lead – Pneumococcal Conjugate Vaccine Candidate: Responsible for authoring the clinical development plan according to protocol development for all Phase III studies, basis for licensure, and planned indications at licensure. Assumed role while program was beginning Phase II and served as medical monitor for Phase II trial while authoring the development plan.Clinical Lead – C. Difficile Vaccine Candidate: Responsible for orchestrating all early phase clinical development of this vaccine, including constructing the early development plan, the target product profile, and the basis for licensure of this vaccine candidate. Developed Phase I, II, and III protocol outlines for the candidate vaccine. Program Lead – Pneumovax Program: Responsible for coordinating all Phase IV activity and label optimization activity for this marketed product. |
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| Years | Employer | Title | Department |
| Years: 2004 to 2010 | Employer: Wyeth Vaccines/Pfizer | Title: Senior Director of Vaccines, Global Medical Affairs | Department: |
Responsibilities:Core member of Prevnar and Prevnar 13 Global Brand teams. Responsible for the development of the lifecycle strategy for Prevnar 13.• Served as medical monitor for numerous Phase IV studies worldwide • Inaugurated the “rapid response” team charged with timely review and critique of all key literature related to Wyeth Vaccines; reviews/critiques distributed to Wyeth/Pfizer Vaccine medical personnel worldwide • Interim medical lead of the adult PCV13 program • Planned and orchestrated two advisory boards each year • Evaluated Investigator-originated Proposals for potential funding • Completed regulatory requests including clinical overviews/expert report • Provided marketing support including key opinion leader and advocate interaction • Conducted promotion review of advertising materials |
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Career Accomplishments
| Associations / Societies |
|---|
| • Member, American Academy of Pediatrics, Section on Emergency Medicine • Fellow, American Academy of Pediatrics • Member, American Academy of Pediatrics, Section on Emergency Medicine • Member, Program Committee. American Academy of Pediatrics Annual Meeting, Section on Emergency Medicine • Member, Society for Pediatric Research • Member, Strategic Planning Committee, Ambulatory Pediatric Association • Member, Emergency Medical Services for Children (EMSC) Coordinating Committee • Member, Virginia College of Emergency Physicians Health Finance/Reimbursement Committee • Member, Advanced Pediatric Life Support, Joint Task Force of the American Academy of Pediatrics, and the American College of Emergency Physicians |
| Licenses / Certifications |
|---|
| • MD, State of Pennsylvania • Board Certified in Pediatric Emergency Medicine |
| Professional Appointments |
|---|
| • Co-Chairman, Subcommittee for Emergency Medicine Resident Trainees Curriculum. American Academy • Pediatrics, Section on Emergency Medicine. • Executive Committee. American Academy of Pediatrics, Section on Emergency Medicine • Chair, Executive Committee. American Academy of Pediatrics Section on Emergency Medicine • Numerous editorial positions (list available upon request) |
| Medical / Professional |
|---|
| • Internship in Pediatrics, Children's Hospital of Northern California, Oakland, CA • Residency in Pediatrics, Children's Hospital of Philadelphia, PA • Fellowship, Pediatric Emergency Medicine, Children’s Hospital of Pittsburgh, PA • Assistant Professor of Pediatrics, Department of Pediatrics, Medical College of Wisconsin • Assistant/Associate Professor of Pediatrics, Department of Pediatrics, University of Pittsburgh School of Medicine • Professor of Pediatrics, Department of Pediatrics, Eastern Virginia Medical School • Professor of Pediatrics, University of Pennsylvania School of Medicine • Professor of Clinical Pediatrics, Drexel University School of Medicine |
| Publications and Patents Summary |
|---|
| • Publications: 54 • Biography Abstracts: 28 • Bibliography/Reviews and Chapters: 22 • Lectures by Invitation: 51 |
Additional Experience
| Expert Witness Experience |
|---|
| Expert has served as an expert witness on three cases to date in the pharma space. |
Fields of Expertise
Pharmaceuticals, clinical research, Clinical & Pharmacovigilance informatics, Clinical Bioethics, Healthcare,, clinical data management, clinical development, infectious diseases, vaccines, pediatric medicine, regulatory interactions, therapeutic development, neuromuscular disorders, respiratory infections, rare pediatric diseases, clinical operations, neurological disorders, vaccine safety, emergency pediatric care, neurology, immunology, clinical trial design, Alzheimer's disease