Brian Ziegelaar (PhD)

Program leader ophthalmology and cardiology indications, project leader neurotrauma. Inventor on use patents for the lead drug candidate at Implicit Bioscience in all three of these therapeutic areas. Currently focused on the establishment of Line 6 Biotechnology Inc., a wholly owned US subsidiary of Implicit Bioscience Ltd. Australia, for the development of a therapeutic for retinal diseases and developing/positioning Implicit's lead asset for a phase 2 clinical study in ST-elevated myocardial Infarction (STEMI). This role spans every aspect of drug development e.g., pre-clinical, CMC, Intellectual property, IND enabling studies, clinical studies and corporate strategy in which I have the pleasure of working with the talented team at Implicit Bioscience and associated expert consultants.

Helping to re-purpose an existing biologic and small molecule drugs to new indications (dengue, myocardial infarction, stroke, neuro-inflammatory diseases, dermatology). Working with the team to develop business partnerships for licencing/co-development partnerships for the newly identified indications. Project managed a successful phase 1 clinical study in MND. Currently running a proof of concept study in stroke. Have carriage of acute the neuroinflammation and injury portfolio. Grant submissions to support university/industry collaborative developments including US DoD grants.

Assessing and directing the re-purposing of an existing drug from Implicit Biosciences to a new indications. This Involves assessing the unmet need, commercial analysis, competitive analysis, indication development, scientific review and generating possible mechanism of actions for the drug. Helping to re-purpose a biologic from Implicit Biosciences to a new indication in infectious diseases.

Marketing and Strategy: Conducted market and competition analysis to redefine the patient population for the healing promoter VitroGro® ECM in order to re-position the product to broader use within the chronic wound market. Analysis and identification of potential partners for the VitroGro® ECM program.

Product Launch, Marketing & Market Access: Coordinated and developed a pre and post-launch market access program for VitroGro® ECM. Coordinated and developed the positioning for the European launch of a synthetic protein for the treatment of chronic wounds (VitroGro® ECM). Helped create and budget a European launch program. Background: VitroGro® ECM is the first synthetic protein to consist of a portion of the vitronectin protein and the growth factor IGF-I. The vitronectin segment is a sticky peptide specifically active in adhering to other proteins found in the wound bed. This segment provides sites for the attachment of skin cells. The IGF-I segment promotes the migration and proliferation (growth) of skin cells. In this way VitroGro® ECM is specifically designed to restore healing in chronic wounds (e.g. venous leg ulcers and diabetic foot ulcers), in which the anchorage dependent proliferation and migration of skin cells is compromised delaying or halting the normal healing process.

Sales and Marketing: Helped manage, train and support a sales network consisting of European, South East Asian, Middle Eastern and Australian distributors. Direct sales of Lymphedema assessment and obesity management devices into hospital and clinic environments in Australia. Innovation: Drove product innovation through a customer and patient centric approach to product support. Developed IP for fluid analysis in renal applications and created software requirement specifications for the next generation of L-Dex (lymphedema Index) devices for ImpediMed Limited. Background: L-Dex devices are used for the early detection of lymphoedema (swelling) in cancer survivors. Early detection has treatment and quality of life benefits for patients at risk of lymphoedema.

Sales, Technical Support & Product Development: Technical and product specialist support of customers using ImpediMed's product world-wide. Helped drive policy change by working with KOL’s and peak bodies to embrace the early assessment and intervention of lymphoedema in breast cancer survivors. Supported the 510k regulatory filing of the L-Dex device for US market approval. Innovation: Co-inventor of the L-Dex scale which was a product improvement to an existing bioimpedance spectroscopy (BIS) device that was driven by customer feedback and customer support activities. The L-Dex device is now the leading product and brand for ImpediMed Limited and has allowed the company to become a leader in the early detection of Lymphedema. Developed IP for fluid analysis in renal applications and created software requirement specifications for the next generation of L-Dex (lymphedema Index) devices for ImpediMed Limited. Supported customers using ImpediMed's product world-wide.

Tissue Engineering of cartilage and epithelium for the replacement of damaged tracheal tissue.

Biocompatibility of Poly HEMA for the production of an artificial cornea.