Consultants and Expertise in Biologics and Specialty Drugs: Our Biologics Consulting is a full-service regulatory and product development consulting firm for biologics, pharmaceuticals and medical devices and specialty groups. Our subject-matter expertise is consolidated to provide a comprehensive offering to meet the needs of clients.
Kathryn Bibeau, B.Sc, DABT, ERT, RAC
Kathryn is a board-certified toxicologist and certified regulatory affairs professional with over 12 years of experience in the biotechnology, pharmaceutical & healthcare industry. She has been involved in a broad range of development and regulatory activities leading to clinical trials and product registration. Kathryn’s focus is on nonclinical program development and she has been involved in the design, implementation, and monitoring of hundreds of nonclinical studies (toxicology, safety pharmacology, genotoxicity, reproductive and developmental toxicity, carcinogenicity) in support of regulatory applications.
Kathryn has also been responsible for literature-based human health safety assessments of excipients, contaminants, degradants, and impurities, often eliminating the need to conduct toxicology studies. With her Regulatory Affairs Certification and experience in the current regulatory field in the U.S. and Canada, Kathryn manages the regulatory and scientific aspects of product development programs including authorship, review, and submission of numerous successful INDs, CTAs, and NDAs.
Kathryn has participated in meetings with regulatory authorities as a regulatory and/or nonclinical representative. She also monitors nonclinical studies at international CROs for quality and compliance with GLPs, and has been an invited speaker on GLP regulations and implementation. Kathryn is a full member of the Society of Toxicology, the Safety Pharmacology Society, and the Regulatory Affairs Professionals Society.
- Prepares nonclinical testing strategies and data gap analyses for pharmaceuticals and biologics covering a broad range of therapeutic areas.
- Specializes in impurity qualification assessments for pharmaceuticals (including genotoxic impurities).
- Manages clients, CROs, and subcontractors to oversee quality, science, timelines, and budgets for nonclinical studies.
- Monitors nonclinical studies for scientific integrity and compliance with Good Laboratory Practices.
- Analyzes and interprets toxicological data in order to integrate complex scientific concepts into client-ready documents.
- Research interest in safety pharmacology and active member of the Safety Pharmacology Society.
- Toxicology expert for regulatory submissions and meetings..
Education and Professional Qualifications
- Sc. (Hons), Biomedical Toxicology, University of Guelph
- DABT, Diplomate of the American Board of Toxicology
- ERT, European Registered Toxicologist
- RAC, Regulatory Affairs Certification (U.S.)
- General Services
- Nonclinical Services
- Regulatory Affairs Services
- Product & Therapeutic Services
David McCarthy, Senior Consultant
David McCarthy has dedicated his career to the many regulatory aspects of the health care industry. Graduating from Carleton University in Ottawa (1966), he spent over 12 years with the Health Protection Branch both as a Food and Drug Inspector and as a regional manager in the application and enforcement of the Food and Drugs Act and Regulations. Between 1978 and 1981 he was the Vice-President and General Manager of one of Canada’s leading contract analytical and toxicology laboratories working with the pharmaceutical, medical device, food and cosmetic industries. He established McCarthy Consultant Services Inc. in 1981 to provide Quality Assurance (Q.A.) and Good Manufacturing Practice (G.M.P.) consulting to the pharmaceutical industry, and has since grown the company to become an internationally recognized Regulatory Management Organization serving the pharmaceutical, medical device, food, Natural Health Product, cosmetic and biotechnology industries.
David has served as Chairman of the board for CAPRA (Canadian Association of Professional Regulatory Affairs) and as Chairman for the Regulatory Committees for the Non-Prescription Drug Manufacturers Association of Canada (NDMAC) (now CHP Canada), Canadian Cosmetics, Toiletries and Fragrances Association (CCTFA), and Medical Devices Canada (MEDEC).
Paul Larocque, Senior Consultant
Since 1995 Paul Larocque has been the President of Acerna Inc. He has experience in both industry and government having held senior GMP and regulatory positions with Pfizer, SmithKline/Allergan, Eldan, and Health Canada. He has served on or chaired a number of trade association boards or committees including being the head of the Rx&D committee that negotiated the Canadian GMP Guideline, 3rd edition, which added the Sterile Products chapter and edited most other chapters. He has twice been elected Chair of the Canadian Association of Professionals in Regulatory Affairs – Association canadienne des professionnels en réglementation. After graduation from university he earned his Chartered Chemist designation from the Association of the Chemical Profession of Ontario.
Rob Ross-Fichtner has led the Regulatory and Scientific practice. His experience covers Cosmetics, OTC Drugs, Medical Devices and Natural Health Products (Dietary Supplements). Rob has completed hundreds of regulatory submissions for product registration and approval. He has served as a consultant to government agencies and as an expert witness in legal proceedings. He also has extensive experience with registering warehouse and production facilities, and is involved with QA and new product start-ups. He also has many years of experience in R&D, including formulation, stability testing, analytical chemistry and product scale-up and manufacturing. Rob has served as the science columnist for Canada’s Cosmetics Magazine and is a contributor to U.S. publication Cosmetics & Toiletries.
Prior to joining Focal Point, Rob spent almost 20 years in Management positions at Procter & Gamble in both Canada and the US. He was involved with all aspects of P&G’s new product program, including Formulation, Process Engineering, Packaging, and Regulatory and Government Affairs. Rob is a member of the Technical/Regulatory Committee of the Independent Cosmetics Manufactures and Distributors (ICMAD), the Personal Care Products Council (PCPC), the Society of Cosmetic Chemists (SCC) and a member of the Board of Directors of the Canadian Cosmetic and Toiletries and Fragrance Association (CCTFA). Rob completed B.Sc. and M.Sc. degrees in organic chemistry from McMaster University in Hamilton Ontario. Rob is an avid sailor and guitar player.
Ian Hilley, Senior Consultant
Ian Hilley is a pharmacist. He has been a trusted business partner providing strategic leadership and advice to clients to achieve their commercial goals in areas such as business development, engagingprivate payors, product development, market access and pricing. Ian has more than 20 years’ executive leadership experience in global generic pharmaceutical companies operating in Canada and internationally (EU, Canada, USA, Brazil and Mexico).
Most recently Ian was the VP Government Affairs and Market Access at Mylan Pharmaceuticals Canada (formerly, Genpharm). Ian has a strong reputation for collaboration, integrity and professionalism amongst a broad, nationwide and international community of colleagues and peers in associations, governments, the pharmaceutical industry (CGPA & Innovative Medicines of Canada), pharmacy (NPAC, OPA, BCPhA) and other stakeholders (CAPDM, CHLIA members).
He has been a leader in advocacy and lobbying campaigns with governments and other stakeholders in Canada. Ian is committed to making a positive difference through volunteering and providing leadership in community focused, not for profit organizations. He is the President of the Canadian Hemochromatosis Society and sits on the Board and chairs the Quality Committee of CHATS which provides health and wellness services to seniors in York Region. He is dedicated to continuing education and that of others.
Rita Cassola, Senior Consultant
Rita Cassola is recognized as an expert and a leader in the area of pharmacovigilance. Rita is a registered pharmacist with over 15 years of experience in global and Canadian pharmacovigilance and medical information. Prior to Advising Arcus, Rita spent 5 years providing expert pharmacovigilance guidance to pharmaceutical companies in Canada. She acted as the lead auditor in several audits and assisted companies in preparing for GVP inspections. Rita was also instrumental in setting up pharmacovigilance systems for Canadian companies. Rita’s earlier work experience includes 10 years at Novartis Consumer Health in Canada and in Switzerland, including a global senior management role in aggregate reporting and case processing. In addition, Rita is engaged in teaching pharmacovigilance courses to the industry. Rita is a member of the Drug Information Association (DIA) and the Canadian Pharmacovigilance Network and has presented at several conferences/webinars organized by these professional associations.
Agnes Jankowicz, M.Sc, Senior Consultant
Agnes is an industry leader with over fifteen years of experience in various areas of the pharmaceutical industry, including over a decade of PV and MI experience. Prior to joining Arcus, Agnes was a Director, PV at OptumInsight. In this leadership function, she headed the PV & MI Department of one of the ten biggest pharmaceutical companies in Canada. She provided strategic PV & MI advice for over 15 other clients. Having led numerous PV audits of contractual partners and vendors on behalf of Marketing Authorisation Holders, Agnes is an expert PV auditor. She is also a recognized PV trainer. Her extensive industry experience includes 9 years in PV & MI roles at Bayer Inc. Agnes is a member of the Drug Information Association (DIA) as well as a member of the Canadian Pharmacovigilance Network. She holds a graduate degree in Pharmacology & Toxicology.
Dr. Nora Cutcliffe
Dr. Nora Cutcliffe provides consulting expertise in strategic stakeholder communications, primarily targeting medical, investor and government audiences in the health care & biopharma sectors.
With over 20 years experience as a Communications, Business Development and Marketing professional, Dr. Cutcliffe knows and understands the biopharmaceutical industry. She consults with several public and private companies, as well as industry and medical associations, providing expertise in communicating key messages. Dr. Cutcliffe offers a unique combination of skills in both science and business. As a result, clients consider her ability to communicate with medical, scientific, investor, government and lay audiences to make the critical difference in targeting/influencing these stakeholder groups. Her forte lies in ensuring message clarity, accuracy and consistency across multiple audiences in Canada and the US, including careful alignment with external Communications strategy. Dr. Cutcliffe also provides expertise in designing and conducting primary Market Research studies (involving interviews with physicians, clinicians, and patients), as well in developing market & competitive analyses from secondary/published sources.
Specialties: Medical Communications; KOL & CME Development; Investor Relations; Government Relations/Policy; Market Research; Market Access & Reimbursement Strategy; Business Development. Significant experience with biologics, particularly blood products and vaccines.