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WHO WE ARE?

We invite you now to come and experience the true BioPharma service.  It’s our people, our culture and our community. 

BioPharma Services was founded by two surgeons dedicated to advancing medical science to improve the life and spirit of their patients. With this same dedication and vision in mind, these physicians brought life to BioPharma.

Through each success, and even some failures, the perpetual drive to make BioPharma great has been determined by the will and dedication of our people.  The will to empower their colleagues, friends and teammates to excel in all facets of clinical research and inspire performance to achieve greatness.

It is with this same culture and brand of excellence that we welcome our clients.  To experience the team community that has propelled us into a global leader in medical research, to be a client-focused partner, where people and patients matter.

Again, we invite you to come and meet our people.  Our people who have learned that success is better achieved and celebrated as a team than as an individual.

“I have been humbled by the spirit and dedication of our people.  It empowers me to see them execute high quality medical research in order to bring much needed pharmaceutical products to the market. BioPharma Services is an exciting place to work — full of passion, integrity and commitment. I look forward to the next 10 years of innovation and drive.”

Renzo DiCarlo, CEO.

WORLDWIDE 

CERTIFICATION

In this highly regulated industry that is governed by the international quality standards of GCP and GLP, it is paramount that our process, quality and governance never falters. Adhering to the principles set forth by the ICH, BioPharma’s unwavering commitment to quality and safety standards is supported by our history of regulatory inspections which spans across markets. They include routine regulatory inspections by the World Health Organization, US FDA, UK MHRA, ANSM, DKMA, ANVISA and Health Canada and a GLP certification by the SCC.

WORLDWIDE CERTIFICATION

In this highly regulated industry that is governed by the international quality standards of GCP and GLP, it is paramount that our process, quality and governance never falters. Adhering to the principles set forth by the ICH, BioPharma’s unwavering commitment to quality and safety standards is supported by our history of regulatory inspections which spans across markets. They include routine regulatory inspections by the World Health Organization, US FDA, UK MHRA, ANSM, DKMA, ANVISA and Health Canada and a GLP certification by the SCC.

World Health Organization

FDA – U.S. Food and Drug Administration

Health Canada

ANSM – French National Agency for Medicines and Health Products Safety

DKMA – Danish Medicines Agency

UK MHRA – Medicines and Healthcare products Regulatory Agency

ANVISA – Brazilian Sanitary Surveillance Agency

OECD GLP – Standards Council of Canada

THE RIGHT PARTNER FOR YOU!

We check all the right boxes that make us the Right Partner for you.

  • Full-service CRO from study design inception to clinical trial execution.  Data reporting and tabulation to the final Clinical Study Report.  See Our Services for full details.
  • Client-focused, client-centric service, transparent communication, pro-active approach, innovative thinking and solutions.
  • Two clinical centers in Toronto, Canada and Columbia, Missouri with a total capacity of 300 beds.
  • In-house bioanalytical laboratory to support LC/MS/MS analysis in different matrices.
  • Proven commitment to quality supported by successful inspections from the US FDA, UK MHRA, French and Danish authorities, ANVISA and Health Canada.
  • GLP certified by the Standards Council of Canada (SCC).
  • Expedited timelines including proven First-to-File services for US FDA drug submissions.
  • A seasoned team of Physicians, Scientists and Clinicians dedicated to our clients’ needs and objectives.
  • Key areas of focus include Phase I clinical studies, PK/PD, Human Abuse Potential and Abuse Deterrent Assessments, Bioequivalence/Bioavailability, and GLP R&D and sample analysis.
  • Robust database of healthy subject volunteers and special populations including recreational drug users, post-menopausal/surgically sterile females and hypogonadol males.

OUR MANAGEMENT TEAM

RENZO DICARLO
Chief Executive Officer

Renzo DiCarlo is Chief Financial Officer (CFO) and Member of the Board of Directors at BioPharma Services. Since 2011, Renzo has been integral in expanding BioPharma’s clinical footprint into the USA and fortifying their Bioanalytical Lab operations to meet the growing volume demand. Prior to his joining BioPharma, Renzo held senior executive management posts in the Life Sciences sector with extensive international experience working in North America, Europe, Asia and Africa. He has inspired teams to innovate and deliver first-in-world NDA approved therapeutic drugs and medical devices in a variety of cultures and languages.

DR. JANICE FAULKNOR
Medical Director

Dr. Janice Faulknor is Medical Director and Principal Investigator at BioPharma Services. With a Doctorate in Medicine in 1996 from the University of Ottawa, Janice has held senior medical roles within the contract research industry, responsible for Phase I, Abuse Liability and BE/BA studies. With 15 years of clinical research experience behind her, Janice’s more prominent accomplishment is in the conduct of Abuse Liability programs to support the FDA’s mandate to address drug prescription abuse. Mentored by Dr. Ed Sellers at the start of her research career, Janice went on to serve as Medical Director and PI at Ventana, Kendle and INC Research.

DR. JOHN OLDENHOF
VP of Clinical Pharmacology

Dr. John Oldenhof is the Vice President of Clinical Pharmacology at BioPharma Services. John joined the BioPharma team in 2018 and brings with him 18 years of senior management experience in Phase I clinical pharmacology, product development, biostatistics, data management and regulatory and scientific affairs. His published work and experience includes the development of novel methodologies, innovative study designs and direct collaboration with the US Food and Drug Administration (FDA) to advance human abuse potential studies and pharmacometrics analyses.

Over his tenure in Clinical Pharmacology, Dr. Oldenhof has provided scientific and regulatory guidance to biotech and pharmaceutical sponsors on over 200 clinical pharmacology studies including FIM, SAD/MAD, DDI and TQT studies to support pre-IND, NDA, ANDA and product launches.

Renzo DiCarlo is Chief Executive Officer (CEO) and Member of the Board of Directors at BioPharma Services. Since 2011, Renzo has been integral in expanding BioPharma’s clinical footprint into the USA and fortifying their Bioanalytical Lab operations to meet the growing volume demand. Prior to his joining BioPharma, Renzo held senior executive management posts in the Life Sciences sector with extensive international experience working in North America, Europe, Asia and Africa. He has inspired teams to innovate and deliver first-in-world NDA approved therapeutic drugs and medical devices in a variety of cultures and languages.

Dr. Janice Faulknor is Medical Director and Principal Investigator at BioPharma Services. With a Doctorate in Medicine in 1996 from the University of Ottawa, Janice has held senior medical roles within the contract research industry, responsible for Phase I, Abuse Liability and BE/BA studies. With 15 years of clinical research experience behind her, Janice’s more prominent accomplishments is in the conduct of Abuse Liability programs to support the FDA’s mandate to address drug prescription abuse. Mentored by Dr. Ed Sellers at the start of her research career, Janice went on to serve as Medical Director and PI at Ventana, Kendle and INC Research.

Dr. John Oldenhof is the Vice President of Clinical Pharmacology at BioPharma Services. John joined the BioPharma team in 2018 and brings with him 18 years of senior management experience in Phase I clinical pharmacology, product development, biostatistics, data management and regulatory and scientific affairs. His published work and experience includes the development of novel methodologies, innovative study designs and direct collaboration with the US Food and Drug Administration (FDA) to advance human abuse potential studies and pharmacometrics analyses.

Over his tenure in Clinical Pharmacology, Dr. Oldenhof has provided scientific and regulatory guidance to biotech and pharmaceutical sponsors on over 250 clinical pharmacology studies including FIM, SAD/MAD, DDI and TQT studies to support pre-IND, NDA, ANDA and product launches.

LOUIS CO
VP of Global Clinical Operations

Louis Co is the Vice President of Global Clinical Operations at BioPharma Services. Louis first joined BioPharma in 2009 to oversee day-to-day clinical operations. During his tenure, Louis has focused on optimizing operational effectiveness, executed effective change management and positioned BioPharma for growth and expansion. With 17 years of clinical research experience and 500+ clinical trials executed, Louis is now responsible for global operations of both BioPharma’s clinical units in Toronto, Canada and Columbia, USA. Louis attended McMaster University and George Brown College and is a Registered Nurse with the College of Nurses of Ontario.

DR. NICKI HUGHES
VP of Lab Operations

Dr. Nicki Hughes is the Vice President of Bioanalytical Operations at BioPharma Services. Nicki joined the BioPharma team in 2016 after facilitating an acquisition that would have her former team at Bioanalytical Laboratory Services (BLS), a division of LifeLabs, and founded by Nicki in 2013, merge with BioPharma’s existing bioanalytical operations. This acquisition reinforced BioPharma’s footprint in delivering best in class bioanalytical services, making it a global leader in clinical research. Nicki has over 20 years of research experience and proven leadership skills. Her mandate starts with R&D, to develop robust and reliable methods to drive efficiency, expedite analysis and deliver accurate and time-critical results.

ANNA TAYLOR
Executive VP of Business Development

Anna Taylor is the Executive Vice President of Business Development at BioPharma Services. Having been a member of the BioPharma team since 2007, Anna brings together her extensive knowledge of clinical trial research and strong acumen for client service and relationship management to successfully lead and foster BioPharma’s Global Business Development unit. With over 15 years of experience in the Contract Research Organization industry, Anna has held management positions in both Business Development and Project management, assisting pharmaceutical clients with their Phase I, Bioequivalence and Bioanalytical needs.

Louis Co is the Vice President of Global Clinical Operations at BioPharma Services. Louis first joined BioPharma in 2009 to oversee day-to-day clinical operations. During his tenure, Louis has focused on optimizing operational effectiveness, executed effective change management and positioned BioPharma for growth and expansion. With 17 years of clinical research experience and 500+ clinical trials executed, Louis is now responsible for global operations of both BioPharma’s clinical units in Toronto, Canada and Columbia, USA. Louis attended McMaster University and George Brown College and is a Registered Nurse with the College of Nurses of Ontario.

Dr. Nicki Hughes is the Vice President of Bioanalytical Operations at BioPharma Services. Nicki joined the BioPharma team in 2016 after facilitating an acquisition that would have her former team at Bioanalytical Laboratory Services (BLS), a division of LifeLabs, and founded by Nicki in 2013, merge with BioPharma’s existing bioanalytical operations. This acquisition reinforced BioPharma’s footprint in delivering best in class bioanalytical services, making it a global leader in clinical research. Nicki has over 20 years of research experience and proven leadership skills. Her mandate starts with R&D, to develop robust and reliable methods to drive efficiency, expedite analysis and deliver accurate and time-critical results.

Anna Taylor is the Executive Vice President of Business Development at BioPharma Services. Having been a member of the BioPharma team since 2007, Anna brings together her extensive knowledge of clinical trial research and strong acumen for client service and relationship management to successfully lead and foster BioPharma’s Global Business Development unit. With over 15 years of experience in the Contract Research Organization industry, Anna has held management positions in both Business Development and Project management, assisting pharmaceutical clients with their Phase I, Bioequivalence and Bioanalytical needs.

ANDJICA TASIC
VP of Global Quality Assurance

Andjica Tasic is the Vice President of Global Quality Assurance at BioPharma Services. A member of the BioPharma team since 2008, Andjica has been largely responsible for implementing the quality standards and systems that govern BioPharma’s global operations. With an intimate knowledge of the international standards of GCP and GLP, Andjica has successfully led numerous regulatory inspections including the US FDA, UK MHRA, ANSM, DKMA, ANVISA and Health Canada, and countless audits by pharmaceutical and biotech companies. With over 25 years of clinical research experience, Andjica is also a Certified Clinical Research Professional (SOCRA) and earned her certificate and accreditations from the American Society of Quality (CQA).

BRIAN LUKIAN
Chief Financial Officer

Brian Lukian is the Chief Financial Officer at BioPharma Services. With over 25 years of experience in financial, strategic and business leadership, Brian joined BioPharma in 2016 with a proven track record of increasing company productivity including several start-up organizations. Previous to his joining, Brian held senior executive financial roles managing revenues of $35M to $200M, annually. Brian’s primary strength and expertise is centered around financial strategy, acquisitions and equity negotiations. Brian was educated at Concordia University and earned his accreditations from McGill University and Ernst & Young.

Andjica Tasic is the Vice President of Global Quality Assurance at BioPharma Services. A member of the BioPharma team since 2008, Andjica has been largely responsible for implementing the quality standards and systems that govern BioPharma’s global operations. With an intimate knowledge of the international standards of GCP and GLP, Andjica has successfully led numerous regulatory inspections including the US FDA, UK MHRA, ANSM, DKMA, ANVISA and Health Canada, and countless audits by pharmaceutical and biotech companies. With over 25 years of clinical research experience, Andjica is also a Certified Clinical Research Professional (SOCRA) and earned her certificate and accreditations from the American Society of Quality (CQA).

Brian Lukian is the Chief Financial Officer at BioPharma Services. With over 25 years of experience in financial, strategic and business leadership, Brian joined BioPharma in 2016 with a proven track record of increasing company productivity including several start-up organizations. Previous to his joining, Brian held senior executive financial roles managing revenues of $35M to $200M, annually. Brian’s primary strength and expertise is centered around financial strategy, acquisitions and equity negotiations. Brian was educated at Concordia University and earned his accreditations from McGill University and Ernst & Young.