Our Executive Team

A world class management team backed up with a dedicated medical team uniquely positions BioPharma to progress your drug development programme

Renzo DiCarlo, CEO of BioPharma Services
RENZO DICARLO
Chief Executive Officer
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.
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Anna Taylor BioPharma Services
ANNA TAYLOR
Executive VP of Commercial Operations
Anna Taylor is the Executive Vice President of Commercial Operations 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 BioPharma’s Global Commercial Operations 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.
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RENEE JOHN of BioPharma Services CRO Toronto and St.Louis
RENEE JOHN
Executive VP of Clinical Operations
Renee John joined BioPharma Services as Executive Vice President Clinical Operations in 2021. With 20+ years of experience in clinical operations, strategic planning and execution, Renee has a track record at propelling and aligning diverse portfolios in ever-evolving healthcare environments. A critical-thinking operational leader, Renee has proven abilities in the oversight of diverse services from pain management to medical cannabis and home health care products, with a focus on maximizing profitability and growth.
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Dr. John Oldenhof BioPharma Services
DR. JOHN OLDENHOF
Executive VP Scientific Affairs
Dr. John Oldenhof is the Executive VP Scientific Affairs 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 300 clinical pharmacology studies including FIM, SAD/MAD, DDI and TQT studies to support pre-IND, NDA, ANDA and product launches. Dr. Oldenhof holds an Adjunct Lecturer position in the Department of Pharmacology & Toxicology at the University of Toronto and is a parent member of the Genetic Epilepsy STXBP1 Disorder Scientific Advisory Board.
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Dr. Nicki Hughes BioPharma Services
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.
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Louis Co BioPharma Services
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 20 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 St. Louis, USA. Louis attended McMaster University and George Brown College and is a Registered Nurse with the College of Nurses of Ontario.
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Jo Ann Di Sensi BioPharma Services
JO ANN DI SENSI
VP of Global Quality and Privacy Officer
Jo Ann Di Sensi is the Vice President of Global Quality Assurance and Privacy Officer at BioPharma Services. Jo Ann is an accomplished QA professional with over 24 years of Quality Assurance/Quality Systems and Compliance experience in the Clinical Research, Analytical and Cannabis Industries.   As Privacy Officer, Jo Ann ensures compliance related to privacy, security and confidentiality with application legislation for the protection of personal information. Within the Clinical Research field, she provided leadership and management of over 1000 Phase I and bioequivalence/bioavailability clinical trials. Jo Ann has been a member of the BioPharma team since March 2020 and is largely responsible for implementing the quality standards and systems that govern BioPharma’s global operations. In addition to having extensive knowledge of the International Standards of GCP and GLP, Jo Ann has successfully led numerous regulatory inspections including the US FDA, UK MHRA, ANVISA, SCC, CAEAL, CFIA, EMA, Menviq and Health Canada, as well as numerous audits by pharmaceutical and biotech companies.
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Brian Lukian BioPharma Services
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.
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Our Medical Team

DR. FATHI ABUZGAYA BioPharma Services
DR. FATHI ABUZGAYA, MD
Chief Medical Officer & Principal Investigator
Dr. Abuzgaya gained his medical degree in Libya (1981) and went on to complete his residency at the University of Toronto specializing in orthopedic surgery. He was Chief of Surgery and Chief of Staff at Rouge Valley Health System (previously Ajax and Pickering General Hospital) and continues to practice as an Orthopedic Surgeon with Rouge Valley. Beginning in 2006, Dr. Abuzgaya has served as Sub-Investigator or Principal Investigator for over 100 clinical trials for a wide range of therapeutic areas.
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Dr. Isabella Szeto BioPharma Services
DR. ISABELLA SZETO, MD
CCFP & Principal Investigator

With over 15 years of experience in Phase I and Human Abuse Potential studies, Dr. Szeto has been Principal or Sub-investigator for 150+ studies. Dr. Szeto gained her medical degree from the University of Western Ontario (2001) and has been an Emergency physician in the Toronto Area since 2003. Dr. Szeto has also practised family medicine in a remote First Nation community in Northern Ontario.
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DR. ARTAN MARKOLLARI BioPharma Services
DR. ARTAN MARKOLLARI, MD
Principal Investigator
With over 21 years of experience in Family Medicine, Dr. Markollari joined the clinical research community more than five years ago serving as an Investigator for Phase I clinical trials and Bioequivalence studies in the St. Louis area. He joined BioPharma Services in 2020 and serves as the Principal Investigator for our US centre.
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What are early phase clinical trials?

Clinical Trials are divided into 4 phases.  Phase 1 and 2 trials constitute early phase trials, Phase 3 and 4 research studies are late-phase trials.

The primary objective of Phase 1 studies is to determine the correct drug dosage by evaluating drug safety and determining if there are any side effects.  Phase 1 trials are conducted in healthy volunteers.

Phase 2 studies also study the safety of a drug but focus on evaluating its effectiveness. These studies can be conducted in healthy volunteers or in individuals who have a certain disease or condition.

What is a clinical trial?

A Clinical trial is a process which is performed to determine whether an investigational drug, device or therapy is safe and effective.   In early phase research (i.e. Phases 1 and 2), the safety and effectiveness of the drug will be evaluated in healthy volunteers.

What is an investigational drug?

An investigational drug can also be called an experimental drug and is being studied to see if your disease or medical condition improves while taking it. Scientists are trying to prove in clinical trials:

  • If the drug is safe and effective.
  • How the drug might be used in that disease.
  • How much of the drug is needed.
  • Information about the potential benefits and risks of taking the drug.
Why do you need to take blood draws and how many blood draws will be required?

In order to evaluate the drug profile, we need to understand its pharmacokinetics. This is essentially how the body reacts to a drug after its administration through the mechanisms of absorption, distribution, as well as the metabolic changes. Therefore, blood draws are collected at various time points to better understand this mechanism. Each study requires a specific number of blood draws and total blood volume. These values will be provided to you and clearly stipulated in the informed consent form (ICF). The amount of blood that will be taken is outlined in the ICF.

Should I expect to experience any side-effects while doing studies?

As every study is testing an investigational product, there may be side effects. You will be provided with a list of side effects that have been reported in previous trials (if any), so you can make an informed decision whether or not to participate in the trial. During the trial you will be required to immediately inform clinic study staff of any adverse effects that you are experiencing. These side effects usually resolve upon discontinuation of the study drug.

Will I be compensated for doing a clinical study?

Volunteers are compensated and the amount varies depending on the length of the clinical trial, length of stay and number of follow-up visits. The compensation is not specifically related to the risks or type of drug involved in the trials or studies. Every study is different and therefore, the compensation will vary. Study volunteers may receive between $1000 to $4000 for a trial (based on the factors listed above).

Are food and accommodation provided over the course of the trial?

Food – Clinical trials are conducted in a controlled setting which means that all food is provided and  trial volunteers receive standardised meals.  Individual meal plans or meal preferences cannot be provided.  If you have any food allergies or hypersensitivity to food product(s) that are clinically significant or life-threatening you may not be able to participate in a trial.    Please contact us to discuss any food issues.

Accommodation – During your in-clinic stay you will share sleeping areas with other volunteers who are of the same gender.  Similar to a hospital setting, supervision will be provided to ensure that your health and safety are being monitored.

What is the length of a study and do I have to complete all the visits?

Details of the duration of a study can be found on the Volunteer Hub.

What is informed consent and how is it carried out?

Before you decide whether or not to take part in a clinical research study, you will be required to read and understand the information provided in an Informed Consent Form (ICF).  The ICF describes the clinical research study and the nature of the investigational product to be used, including:

  • Your rights and responsibilities as a study participant.
  • What you will be asked to do during study participation.
  • The potential risks that you should be aware of.

During this process, you will have the opportunity to discuss and ask questions related to the conduct of the clinical research study with the study doctor/ study staff.  You are under no obligation to participate and your decision to take part in a clinical trial is voluntary.

Can I bring my own food?

All aspects of clinical trials are closely monitored including the food and drink consumed by participants. While you are in the clinic, you will be provided with all meals as per the study guidelines. You will need to eat all the food provided to ensure the guidelines are met. Watch video

What do I need to pack?

Wondering what to pack before your site visit? Visit our Packing List page to learn more.

When do I receive compensation for taking part in a study?

You will receive compensation as outlined during the Informed Consent process. Typically, you will receive compensation once all study visits have been completed. If, for any reason, you do not complete all study visits, your compensation will be on a pro-rated basis (i.e. for the time that you have participated in the trial)

Where will I sleep during the clinical study?

We provide a clean, safe socially distance sleeping environment, in a dormitory of hotel room style. Watch video

What COVID-19 precautions are you taking?

The safety of our volunteers is a top priority. Learn more about the measures we are taking to create a safe environment for you.

Can I bring my own device?

Yes, we encourage you to bring items that will help to pass the time while you are in the clinic. You can use the time to study or work or catch up on the movies you’ve been meaning to watch.

Privacy

We respect and value the privacy of our volunteers. View our Privacy and Cookie Policy here.