University of Rochester

West Chester University of Pennsylvania

University of Vermont

Fryeburg Academy

R&D Professional  -  Immuno-Oncology  -  Inflammation

Responsible for seeking, initiating, and managing ANTHIM® (obiltoxaximab; Anthrax anti-toxin) sales to both domestic and international partners. Tasked with attracting business interest and establishing partnerships for endeavors related to Chemical, Biological, Radiological, and Nuclear (CBRN) preparedness. Actively engaged in generating interest from various US government agencies, including DTRA, BARDA, SNS/ASPR, and JPEO, to secure support for medical countermeasure biomanufacturing through our Contract Development and Manufacturing Organization (CDMO), Scorpius. Collaborating closely with our Marketing Authorization Holder (MAH), Worldwide Distributors & Agents (WDA), and Sales & Marketing (S&M) partners across the EU, US, Canada, and APAC regions to meet procurement requirements for military and civilian stockpile requests. Role includes international business affairs and sales.

Role is also responsible for scientific oversight, leadership, and strategy as it relates to new product development, research (R&D), technology acquisition, and evaluation.  Development of preclinical and clinical assets for regulatory and market authorization.  

Role also serves as Managing Director for Life Sciences under Elusys Consulting Services (ECS).

Elusys Therapeutics, Inc.

Vice President Research and Business Development

In addition to providing leadership in research and development, this position plays a critical role in advising the CEO and executive team on potential opportunities and proposing strategic alignments. The role encompasses oversight of drug discovery, translational and preclinical development, facilitating the integration of emerging technologies, managing alliances, and ensuring alignment with corporate strategy. Key responsibilities include fostering business partnerships, engaging in external research and development, spearheading licensing campaigns, conducting searches and evaluations for new opportunities, identifying synergistic initiatives, and taking the lead in business development for new partnerships or technology integration. The primary focus areas encompass infectious diseases, host-directed therapeutics, immunology, immune modulation, auto/inflammation, oncology, immuno-oncology, and biodefense.

Regulatory submissions authored, submitted, and/or approved
> HS-130 IND for cancer vaccine (cell therapy) immunotherapy
> PTX-35 (TNFRSF25-agonist mAb) IND for cancer immunotherapy

NightHawk Biosciences, Inc

Vice President of Research & Technology Acquisition

Formerly known as Heat Biologics, Inc., this position reported directly to the CEO. Its core responsibilities included establishing the scientific strategy, vision, and preclinical development plans for both internal and external assets. The position involved overseeing a diverse team of over ten full-time employees, including senior scientists, PhD-level directors, and technical staff, with a focus on wet lab operations. Integration of drug discovery and preclinical development with BD, commercial, and clinical functions was a key aspect of the role. Asset management spanned a wide range, encompassing novel biologics such as Antibody-Drug Conjugates (ADCs), Bispecific T-cell Engagers (BiTEs), bispecific monoclonal antibodies (mAbs), vaccines, and cell therapies, targeting applications in oncology, infectious diseases, and autoimmune, and inflammatory conditions.

In addition to these responsibilities, the role involved scientific affairs, fundraising through grant synthesis, engagement with Key Opinion Leaders (KOLs), and collaboration with Principal Investigators (PIs) for existing and new partnerships. Vendor management also fell within this position's purview. Close collaboration with the Business Development team was essential for asset search and evaluation, due diligence, business intelligence, and in-licensing activities, particularly in early-stage innovation partnering.

Furthermore, this role served a dual function as the Executive Director of Scientific Operations for the Biologics Drug Discovery subsidiary, SkunkWorx Bio, Inc., situated in New Jersey.

Vice President of Research 

Served as operations lead, liaison between RTP and NJ preclinical teams.  Helped set strategic direction, served as preclinical project manager, perform business operations (MTAs, SRAs) and executed pharmacology and toxicology studies to support NBEs for IND-enabling studies.  https://skwxbio.com/

Skunkworx Bio

Executive Director of Scientific Operations

Role also doubled as Executive Director of Operations for Biologics Drug Discovery subsidiary, SkunkWorx Bio, Inc., located in New Jersey.  Therapeutic areas: immuno-oncology (I/O), inflammation, infectious disease (vaccines).

Established and continued to maintain third-party academic collaborations from previous roles at the company - local and international collaborations across SRAs/CRADAs/MTAs for preclinical assets in transplantation, GVHD, oncology, autoimmunity, and virology. Formerly known as Heat Biologics, Inc., this position reported to the CEO. Its primary role was to provide essential support to core R&D endeavors while maintaining flexibility to adapt to evolving product and business development needs. The key focus of this position included the identification and synthesis of grants for fundraising activities, proactive efforts to establish valuable collaborations, and the exploration of external partnerships for existing research assets. Within Special Projects, responsibilities encompassed investor relations, the coordination of press releases, collaboration on manuscript synthesis with external laboratories, the establishment and maintenance of research partnerships, and the evaluation of emerging technologies for potential in-licensing opportunities. A portion of our responsibilities also extended to scientific affairs and program oversight.

This role actively contributed to preclinical and drug discovery work, spanning target selection, leadership in nonclinical studies, and the development of scientific strategy. Asset management included oversight of Pelican Therapeutics assets (PTX-35; oncology & non-oncology) and Zolovax (ZVX-60) subsidiaries. Additionally, this position served as the project development lead for Heat Biologics' SARS-CoV-2 COVID-19 vaccine efforts, involving NHP BSL3 studies and preIND synthesis."

Executive Director of Special Projects

Formerly known as Heat Biologics, Inc., I oversaw various key responsibilities during my tenure, which included regulatory submissions, grant funding strategies (STTRs & SBIRs), and expanding our company's research potential through collaborations with national and international universities via SRAs, MTAs, and CRADAs. Additionally, I successfully orchestrated the establishment of new laboratory facilities and executed the physical relocation of our company. This involved working closely with architects, engineers, and a range of contractors to oversee the design, construction, and procurement of equipment and real estate worth over $5 million. This expansion effectively doubled our laboratory space, including the creation of a new vivarium, and the recruitment of new full-time employees to support our growing operations. Notably, some of the regulatory submissions I managed included the HS-130 IND for a cancer vaccine (cell therapy) immunotherapy and the PTX-35 (TNFRSF25-agonist mAb) IND for cancer immunotherapy.

Executive Director of Preclinical Research

Formerly known as Heat Biologics, Inc., I held a position reporting directly to the Chief Scientific Officer (CSO). In this capacity, I led a team comprising seven laboratory personnel, overseeing in vitro and in vivo pharmacology studies. My responsibilities encompassed spearheading nonclinical pharmacology, driving drug discovery initiatives, formulating scientific strategies, and offering support for emerging and ongoing cancer immunotherapy, inflammation, and autoimmunity programs.

Furthermore, I played a pivotal role in providing scientific evaluation, support, and comprehensive review of regulatory documents, as well as conducting due diligence assessments for new assets. My role extended to include preclinical development oversight for Heat Biologics' subsidiary, Pelican Therapeutics. I was instrumental in synthesizing and submitting Pre-Investigational New Drug (PreIND) and Investigational New Drug (IND) documents, contributing to clinical protocols, and establishing new composition of matter patents.

Additionally, I fostered numerous external collaborations, resulting in groundbreaking achievements such as new clinical indications, patents, academic papers, and collaborations with Key Opinion Leaders (KOLs) in the fields of transplantation, oncology, and inflammation.

Senior Director of Preclinical Research

In a contract role, I oversaw nonclinical pharmacology and scientific strategy for various pipeline programs, supporting the Chief Scientific Officer (CSO). This included crafting investor presentations, assisting with intellectual property submissions, and drafting sections for Investigational New Drug (IND) applications. I also aided the Business Development (BD) team with due diligence, working with data from small and large molecule programs across multiple therapeutic areas, with a focus on inflammation, oncology, immuno-oncology, and gastrointestinal (GI) disorders.

My role required expertise in regulatory guidelines, Good Manufacturing Practices (GxP), Chemistry, Manufacturing, and Controls (CMC), Absorption, Distribution, Metabolism, and Excretion (ADME) studies, safety pharmacology, and toxicology. I conducted site visits and engaged in industry conferences, communicating with upper management, including the CEO, partners, and fellow consultants.

I independently designed and executed studies for lead molecule identification, candidate selection, and IND submissions. I managed international collaborations, academic partnerships, and interactions with vendors for outsourced activities. Additionally, I played a crucial role in determining Pharmacokinetics/Pharmacodynamics (PK/PD) relationships and designed experiments to support IND-enabling studies.

I also successfully obtained regulatory approval for the CIN-102 deuterated domperidone Investigational New Drug (IND) application for gastroparesis treatment.

CinRx Pharma

Director of Preclinical Pharmacology

In my role overseeing global pediatric and adult clinical oncology programs and serving as a product director for Unituxin/dinutuximab in the medical affairs department, I conducted due diligence for business development initiatives related to technologies supporting the franchise, like Armed-Abs and CAR-T therapies. I also built relationships with external companies to advance cancer immunotherapy agents.

In a supervisory capacity, I oversaw project management and Medical Science Liaison (MSL) functions in oncology. This included KOL recruitment, collaboration with internal stakeholders (medical and scientific affairs, pharmacovigilance, regulatory affairs, health economics), and coordination with sales and marketing for label extensions and commercial support. I also delivered medical and scientific presentations for training purposes.

Key accomplishments include:

1. Initiating the company's first adult oncology program, a phase 2/3 trial for small cell lung cancer (SCLC).

2. Leading internal antibody development efforts in neuro-oncology and immuno-oncology (I-O).

3. Managing program teams, coaching staff, budgeting ($100 million), clinical strategy, operations, and lifecycle management (LCM).

4. Active participation in conventions, symposiums, advisory boards, and congresses to provide medical and scientific support.

Additionally, I authored, submitted, and obtained regulatory approvals for Unituxin/dinutuximab Investigational New Drug (IND) applications and Phase 3 SCLC trials.

United Therapeutics

Oncology Program Director

I provided comprehensive scientific evaluation and conducted business case analyses for potential assets across various therapeutic areas, including metabolic diseases, biodefense/CBRN, cardiovascular conditions, gastrointestinal disorders, respiratory ailments, oncology, inflammation, and immuno-oncology (I-O). My role extended to assisting clients in establishing contractual collaborations with Contract Research Organizations (CROs) and academic institutions specialized in drug development.

I played a pivotal role in designing experimental studies, defining Target Product Profiles (TPPs), and reviewing project proposals. Additionally, I offered guidance on target selection, animal models, preclinical testing, and regulatory strategies. My responsibilities also encompassed providing strategic scientific insights, management consulting, market research, R&D financial modeling (including Net Present Value (NPV) and Internal Rate of Return (IRR) analysis), clinical candidate proof-of-concept planning, and the creation of pitch decks, including presentations as necessary.

My work required a deep familiarity with International Council for Harmonisation (ICH) guidance and Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) regulations.

www.BlueSkyBioAdvisors.com

BlueSky BioAdvisors, LLC

Principal Consultant

The position involved overseeing nonclinical operations and pharmacology leadership across multiple projects in various therapeutic areas, including respiratory (COPD, IPF, Asthma), cardiovascular (CHF), inflammation/autoimmunity, immuno-oncology/I-O, gastrointestinal (IBD, IBS), and CNS/pain. Support was also provided for specialty and bio-generic product lines. Team leadership responsibilities included guiding discovery candidates into early development, constructing IB/IND documents, monitoring IND-enabling studies, and facilitating knowledge transfer to commercial, legal, clinical, and regulatory affairs functions.

The role required active participation in global cross-functional teams to set strategic directions and articulate value propositions for potential products, involving PK/PD strategies and executing preclinical studies. Additionally, responsibilities included designing, coordinating, and executing in vitro and in vivo immune monitoring assays, adhering to ICH guidances and GLP regulations.

Key achievements during the tenure included:
> Leading nonclinical development efforts for various clinical programs, including the successful FDA approval of CINQAIR®/Reslizumab.
> Spearheading the pharmacology aspects of anti-IL-12/23p40 mAb and anti-TNFalpha mAb IND submissions.
> Developing innovative therapeutics for cardiometabolic indications and orphan diseases.
> Gaining experience in interventional cardiology medical devices with REVASCOR® for congestive heart failure.

Noteworthy regulatory submissions included:
> CEP-37248 IND for inflammatory conditions.
> CEP-41570 IND for heart failure.
> Reslizumab BLA for eosinophilic asthma.
> Several 505(b)(2) NDA applications for New Therapeutic Entities.
> Various 505(j) ANDA applications for generic pharmaceuticals.

Teva Pharmaceuticals, R&D, Global Branded Products (GBP)

Senior Manager Pharmacology Project Leader, Product Development

Manager Pharmacology Project Leader, Product Development

This was a supervisory role which recruited, managed and directed a team of associate-level research scientists with expertise in both oncology and autoimmunity to start the first ever immunology lab at Cephalon R&D.  Worked across multidisciplinary teams and tested small molecules (targets: kinase, proteasome, chaperone), biologics and peptide immunotherapies in SLE, RA, IBD, and various mouse and human tumor models (xenograft, syngeneic, spontaneous, PDX) to support pipeline and discovery programs.  Role established a core functional immunology lab and resource group that included the purchasing and managing of large capital equipment expenditures (Flow cytometers, Luminex, Confocal, Elispot, IVIS).  Developed multiple in vivo animal models, cell lines and immunoassays to support inflammatory disease and oncology drug discovery efforts.  Prepared discovery target proposals, nomination documents, manuscripts, book chapters and patents for various projects.  Role required communication to internal stakeholders of complex scientific findings and technical expertise in cellular immunology methods (FACS, RT-PCR, rodent handling, histology, cell culture, immunoassays – ELISA, Elispot, MSD).  Training of FTEs in both the field of immunology and a technical application was required for job function

Major accomplishments included championing drug discovery efforts for JAK kinase and proteasome inhibitor programs for inflammatory and I-O indications.  Worked with several small molecule inhibitors of enzymes and kinases such as ALK, cMET, FAK, PARP, Syk and early discovery leads.  Identified IRAK4 as a target for autoimmunty and chaperone proteins GRP78, HSP90 and pathway components of the UPR to turn “cold tumors hot” by TME modulation to boost anti-tumor immune responses

Regulatory submissions authored, submitted or approved:
> CEP-18770 proteasome inhibitor for lupus nephritis
> CEP-33779 JAK2 inhibitor for inflammatory disorders
> Lupuzor peptide therapeutic for lupus

Cephalon, Inc., Small Molecule Drug Discovery

Lab Head, Discovery Team Leader - Inflammation and Oncology

Oncoceutics Pharmaceuticals, Inc., Philadelphia, PA
In collaboration with its founder, Dr. Wafik El-Deiry, this role was responsible for recruiting company interest, building business plans, and attracting early investors.  This role helped the founder and key scientific members secure seed-capital funding, recruit and manage external consultants, organize multi-party meetings, and maintain stakeholder relationships.  This was early in the company’s birth from the founder’s lab at University of Pennsylvania.
•	Real-world understanding of Bayh-Dole Act with University invention ownership and strategy of SRAs
•	Helped bring a company from an idea to reality by building business plans and initiating licensing options

Oncoceutics Pharmaceuticals, Inc.

Biotech Consultant

Built and characterized several Listeria-based anti-cancer vaccine vectors (therapeutic live-attenuated) for various preclinical mouse models of cancer.  Position focused on this novel biologic to help vaccinate against, and treat, metastatic melanoma and breast cancer.  Experience gained handling and working with infectious BSL2/3 agents.  Mapped Her-2/neu cytotoxic T-lymphocyte epitopes for vaccine targets and determined the efficacy of live vaccine vectors and DNA vaccines to impact the growth, mutation rate, and angiogenesis of implantable and spontaneous breast tumors in vivo.  Used novel immunotherapy in combination with current treatments such as metronomic chemotherapy, antibody therapy and whole-cell vaccines
•	Discovered and characterized a new role for several tumor-vasculature targeting, Listeria-based, bacterial vaccines to treat established breast tumors (HMW-MAA, VEGFR2) that lead to patents that supported clinical programs at Advaxis

Matthew M. Seavey