Extra bio 6 : Alfonso

Alfonso has over 21 years experience working for the regulated industry. He has worked as Director, Quality Control/Quality Assurance, Executive Director of Operations and Director of Technical Operations for pharmaceutical top-notch companies. As a consultant, he has worked developing and implementing quality systems, implementing Interim Controls, and performing internal and supplier audits for domestic and international clients in the pharmaceutical, biopharmaceutical and medical device industries. Alfonso has a BS Chemistry from the University of Puerto Rico and has an MBA Management from the University of Phoenix. He is also ASQ Certified Quality Auditor.

Extra bio 5 : Joseph

Joseph has held various positions in the biopharma sector including Manager, Financial Analysis & IT at Therapure Biopharma Inc, a biologics manufacturing company, and Manager of Accounting at GlycoDesign Inc.. He has also worked at Goodmans LLP, a corporate law firm where he was the finance lead on ERP system conversion. Joseph has a BA from the University of Toronto and is a graduate of the CMA Professional Program and has an EMBA from Ivey Business School.

Extra bio 4 : Linda

Linda has worked as counsel for many institutions and life sciences companies. She was formerly a partner at an intellectual property law firm in Toronto where her clients included research laboratories, corporations, commercial investors, and researchers. Linda has a MSc in Medical Microbiology from the University of Manitoba and an LL.B from Osgoode Hall Law School. She is admitted to practice before the Canadian and United States Patent and Trademark Offices.

Extra bio 3 : Wendy

Wendy started her career as an epidemiologist in cancer research with the design of early phase clinical trials. She has successfully achieved approval for a number of CTA/IND filings and NDS/NDA filings in Canada, the US and Europe. Previous positions include Director of Research at Knoll Canada where she was instrumental in the clinical development of several human monoclonal antibodies (Humira®), Senior Director, Clinical Research at GlycoDesign and R&D Director, Inflammation and Neurology at Amgen Canada. As a private consultant, she has assisted biotechnology companies in preparing and executing strategic clinical and regulatory development plans for products and devices and in performing due diligence on products for potential investors. In the past, Wendy has served as an advisor to start-up companies in the health sector through the MaRS network. She is currently the Director of Clinical Development for the International Consortium on Anti-Virals (ICAV), a not-for-profit drug development initiative focused on finding treatments for neglected and emerging viral diseases.

Extra bio 2 : Patricia

Patricia was previously Managing Director and CEO and co-founder of PDC Biotech GmbH, an Austrian biotech company which successfully raised funding in Europe and advanced an early preclinical-stage drug candidate through cGMP manufacturing to clinical proof-of-concept. Other positions include Vice President, Business Development at GlycoDesign Inc., a Canadian biotechnology company, where she led commercialization efforts for the company’s cancer, vascular and inflammation programs and established and managed international strategic partnerships. As Director of International Product Development at Ferring based in Paris, Patricia led multi-disciplinary teams to successfully complete the development program (including scale-up of the peptide to support commercial needs) for two novel obstetrics products and managed the company’s strategic alliance with a major US pharmaceutical company. As an independent consultant, she conducted detailed assessments of potential in-licensing opportunities for pharmaceutical companies and created business plans and product development plans for various biotech companies.

Extra bio 1: Diana

Diane’s experience includes 17 years with GSK in positions such as Head of Marketing and Director of New Products and Licensing. She has developed an extensive international network and assisted over 30 pharmaceutical and biotech companies with over 60 Canadian and International agreements. She was Managing Director and co-founder of PDC Biotech. which raised approximately $10 million in non-dilutive and VC money. She also spent 3 years as President and Board of Director member of the successful start-up biotech company YM BioSciences Inc. Diane has served on the boards of four publicly traded Canadian biotech companies and has completed the Chartered Director Program at McMaster University/DeGroote School of Business.

Company Document Management

B4D can set up a virtual data room for your company, providing the ability to keep your information confidential but readily available to potential licensing partners and investors, as well as the appropriate company team members and consultants.

Supplier Section & Management

One of the challenges a start-up biotech company faces is to select the right contract research or manufacturing organizations (CROs/CMOs) for their specific project. There are so many to choose from and cost is not the only factor to consider. B4D has worked with many CROs/CMOs and can help you identify the most appropriate supplier for your project, obtain competitive bids, negotiate contracts and oversee work conducted at the company to ensure the project stays on track and on budget.

Board Management & Financing Controls

We have experience both as Board members and as management reporting to Boards and know what type of information they need to carry out their oversight function. We can prepare presentations for quarterly meetings along with written progress reports and develop Excel-based financial plans and budgets.

Management Support Areas

We provide management support for preclinical to clinical, chemistry and manufacturing, analytical, clinical, business development and licensing teams, whether in-house or external.