Eric Vanderploeg

Dark Horse Consulting Group, a leader in strategic and operational biotherapeutics consulting, is pleased to announce the acquisition of Bruder Consulting & Venture Group, a strategic advisory and consulting firm with a global footprint in biotech and biopharma, known for their expertise in the discovery, development, clinical design, and regulatory approval process of biologics, devices and combination products in the orthopedic, wound care, and plastic & reconstructive surgery markets. BCVG is now a department within Dark Horse Consulting (DHC) known as DHC Regenerative Medicine.

Bruder Consulting and Venture Group (BCVG) is a full-service consulting firm that provides strategic guidance to early start-up through large, multi-national companies spanning multiple disciplines, including product development, market assessment, regulatory affairs, commercialization and reimbursement. BCVG engages with a broad array of medical and biotechnology clients, primarily focused on partnering with companies operating within the musculoskeletal, tissue repair, wound healing and regenerative medicine sectors. BCVG's dedicated team of executive Engagement Partners has direct experience with numerous biomaterial and biologic technologies including Class III drug/device combination products, BLA pathway biologics, human cell and tissue products (HCT/Ps) and traditional 510(k) devices. For more information, please visit our website at www.bruderconsulting.com.

Technical and strategic biotechnology consulting for drug/device preclinical development. Expertise in cell therapy, regenerative medicine, combination products, biomaterials, drug delivery, biologics, and medical devices with specific focus on preclinical and regulatory strategy.

• Responsible for leading Preclinical Department for allogeneic cell and tissue therapy asset, including small and large animal in vivo programs and model development activities • Developed nonclinical strategy and authored submission materials for FDA and ex-US regulatory interactions, including pIND and Scientific Advice meetings • Directed internal and external preclinical biomarker assay development activities

• Led preclinical development activities, including pharmacology and in vivo efficacy evaluation of novel encapsulated stem cell derived islet technology for the Diabetes Research cell therapy program • Oversaw internal process development efforts through direct and matrix management for bioreactor-based iPSC differentiation protocol • Maintained and managed key CDMO relationships • Responsible for ensuring alignment with strategic partner on R&D strategy

• Led a interdisciplinary R&D team in developing a novel engineered protein therapeutic combination product for bone repair in orthopedic applications through late-stage preclinical development • Provided scientific and strategic leadership for all preclinical program activities (pharmacology, toxicology, assay development, design controls, CMC, regulatory) • Participated in preparation and execution of multiple regulatory filings and interactions with FDA, including 3 RFDs (request for designation), orphan drug application, and 2 in-person Type C meetings • Oversaw process development activities leading to successful pre-GMP/GMP campaigns for drug substance, drug product, and surgical device implants • Responsible for all scientific and technical aspects of extensive asset out-licensing effort • Led technical due diligence for multiple acquisition/partnering opportunities for pipeline development

• Directed R&D efforts to discover and develop enhanced biomaterial carriers for delivery of osteogenic proteins, both internally and with multiple external partners • Directed preclinical pharmacology development program, including identification and implementation of key CRO partners and managing numerous small and large animal studies • Led start-up activities for new laboratory and office space for satellite R&D location in Boston, MA

• Directed internal research efforts for novel delivery systems for osteogenic proteins • Held leadership roles on preclinical and clinical stage therapeutic antibody and antisense oligonucleotide programs in multiple disease areas • Provided scientific and strategic due diligence for external acquisition opportunities in advanced wound care

• Led an internal team to evaluate novel biomaterial carriers for localized delivery of protein biotherapeutics for bone, tendon, and cartilage regeneration • Identified, implemented, and managed external academic and industry collaborations

• Explored using natural ECM proteins as signaling molecules to promote mesenchymal stem differentiation in 3-D scaffolds • Designed self-assembling peptide hydrogels functionalized with motifs enabling TGF-b binding, retention, and delivery to mesenchymal stem cells • Investigated the effects of acute mechanical injury leading to fissure formation on cell and tissue morphology and gene expression as a model for osteoarthritis in articular cartilage

Dissertation Title: Mechanotransduction in Engineered Cartilaginous Tissues: in vitro Oscillatory Tensile Loading