SACRA Executive Committee (EXCO)

2019 - 2020

Nicolette Stott

SACRA CHAIR

Mobile: +27 (0)83 644 6080

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2019 - 2020

Contract Research Organisations

SACRA Chairperson

 

After completing a BSc (Honours) Clinical and Experimental Pharmacology at the University of the Witwatersrand, Johannesburg, Nicholette started her career as a medical sales representative. From there she moved into clinical research, first as a Clinical Research Associate and then transitioning into the Technology, Innovation and Performance as a Learning Specialist. During this time, her projects focussed on management of the company’s therapeutic area training, reworking and delivering the CRA on-board training programme, developing and delivering Good Clinical Practice training, developing and delivering content for global clinical training events for a multitude of sponsors and also being responsible for the development, management and delivery of sponsor-specific orientation and ongoing trainings on a regular basis.

After a couple of years, Nicolette moved back into a clinical role, as a Clinical Team Manager (CTM), and later Senior CTM, for the Global Government and Public Health Services Group. In this role, she is accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the Customer. She manages all clinical aspects of allocated studies. She is also responsible for the co-ordination and management of all Clinical Management project team members on an international basis.

 

Nicolette is responsible for the implementation and management of the necessary training, tracking and quality systems within the clinical portion of the project as well as being involved in regular and proactive liaison with the Project Manager, Clinical Managers and other functional groups as appropriate. Nicolette co-ordinates start up and clinical monitoring guidelines in addition to ensuring essential document quality and reviewing monitoring visit reports. Nicolette also identifies and performs troubleshooting activities and manages the query resolution process. She is also responsible for process improvements within the project. Nicolette is also jointly responsible for the project-specific training, both on-boarding and ongoing. As a CTM within the Global Government and Public Health Services Group, Nicolette works on a variety of therapeutic areas including HIV, Tuberculosis, Malaria and Hepatitis with a current focus on vaccine studies.

In addition, Nicolette started PPD South Africa’s Good Clinical Practice and Human Subjects Protection capacity-building training programme, developing and delivering training to site staff and colleagues. 

Nicolette stood as SACRA Chairperson for 2017 / 2018.

Gerben van den Hoogen

Mobile: +27 (0)72 804 6570

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2019 - 2020

Contract Research Organisations

Cape Town, Western Cape

After completing his master’s degree in clinical epidemiology at the Radboud University of Nijmegen, the Netherlands, Gerben started his career in 1999 in the public health sector where he implemented policies for all stakeholders in large-scale accident and disaster management.

 

In a combined role as policy maker and epidemiologist, he also performed research in the region to be able to establish new regional healthcare policies aligned to the population’s needs. For the past 2 years as the deputy site manager of Synexus Helderberg Clinical Research Centre, he has been responsible for the profitable management and oversight of the Helderberg site operations, oversight of the day-to-day effective running of the Helderberg site, management of study recruitment and retention, and accountable for study budgets.

 

During his 19-year career, he stood at the cradle (feasibilities) and the grave (archiving) of many clinical trials. With this, he has gained insight into the many aspects that make or break a study. Gerben is now passionate to apply his knowledge and skills in the drive to tip the balance in favour of ‘make’.

Teresa Scanes

SACRA VICE-CHAIR

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2019 - 2020

Contract Research Organisations

SACRA Vice-Chairperson

Teresa’s career began in the bio-analytical laboratory, developing assay methods for drugs in biological samples.

 

A transition to the clinical monitoring sphere in 2001 opened another world of constant learning. Since then, Teresa has gained experience in site monitoring, GCP training, project management and medical writing. As current Clinical Operations Manager for Novotech Clinical Research, Teresa is involved in training staff and assisting sites with GCP compliance.

 

The enjoyment of seeing the transition of an inexperienced individual into a confident researcher is what continues to motivate Teresa.

Elandré Kok

Mobile: +27 (0)82 363 9211

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2019 - 2020

Contract Research Organisations

Johannesburg, Gauteng

Elandré Kok is a driven, young career professional who is passionate about clinical research. Shortly after, quite literally, stumbling upon clinical research and regulatory affairs in 2013, he pursued postgraduate studies in those fields and currently holds a Bachelor of Science Honours degree in Pharmacology (with special focus on regulatory affairs). At present he is wrapping up his Master's Degree in Pharmacology with a focus on both clinical and regulatory aspects.

 

As of October 2015, Elandré joined Triclinium Clinical Development (TCD) and started delving into all matters related to Regulatory Affairs for clinical research. In his role, Regulatory Affairs Associate, he supported the Head of Regulatory Affairs in the execution and coordination of all tasks associated with the regulatory aspects of clinical projects undertaken by TCD.

 

At the start of 2019, Elandré has changed gears in his career and is currently is Clinical Research Associate (CRA) for PPD, leveraging his prior Regulatory experience whilst monitoring for the Global Government and Public Health Services team.

Dr Mohammed Tayob

M.B., Ch.B (1988) & Dip. Occupational Health & Medicine (2012)

 

Mobile: + 27 (0)82 553 3158

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2019 - 2020

Investigators/SMOs Sector

Johannesburg, Gauteng

Dr Tayob co-founded Mzansi Ethical Research Centre (MERC), with Dr Ayesha Bassa in 2000. In 2015 MERC-Middelburg was awarded the SCRS (Society for Clinical Research) “SPRIA” award, a global award in recognition of their TEAM’s achievements. MERC has established two other Clinical Trial sites in South Africa: MERC-Cape Town as well as MERC-Oncology (Pretoria).

MERC has patnered with MeDiNova in the UK to form a Global SMO – “MeDiNova MERC UK” with sites directly owned in South Africa, United Kingdom, Spain & the USA. “MeDiNova MERC SA” has 15 affilaited sites in South Africa and still growing.

Dr Tayob has established a capacity building course – currently piloted in Mpumalanga – training public-sector healthcare professionals in clinical trials; in the process, expanding and transforming the industry. He is also part of the programme which is training healthcare professionals from Swaziland to establish a credible clinical trial industry in their country.

Social projects have been the bedrock of his life, participating in many humanitarian aid missions around the world as well as a number of projects in his home town; earning him the “Paul Harris Fellowship Award” for humanitarian work – awarded by Rotary International.

He has served on many boards ranging from businesses to NGO’s including, inter alia:

  • Chairman of Amnesty International SA,

  • Board member of Agrément SA – appointed by Minister of Public Works,

  • Private Hospitals,

  • Founder & Chairman: Bambanani Economic Development (BED) – Incubator for Black Healthcare Professionals.

 

 His motto: “if your dreams don’t scare you; they are not big enough”

Dr Essack Mitha

Principal Investigator - Newtown Clinical Research Centre

Mobile: + 27 (0)82 322 3402

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2019 - 2020

Investigators/SMOs Sector

Johannesburg, Gauteng

Dr Mitha qualified as a medical doctor at University of Kwa-Zulu Natal in 1998 and currently works as a full time principal investigator in Newtown, Johannesburg.

 

Dr Mitha has published 2 scientific letters in the South African Medical Journal. Currently working towards a Master’s degree in medical science.

 

Dr Mitha assisted with the setup and training of new investigators and staff in Synapta Clinical Research, in Durban.

 

He served as a SACRA Exco member in 2008 and 2009 and assisted with increasing exposure of SACRA to investigators and sites, and drew up SOP guidelines for SACRA. Worked on Site SOPs that were work-shopped SACRA meetings. His plan is to draw up policy documents, which would assist to standardise the clinical trial industry in SA.

Dr Vathiswa Papu-Zamxaka

Mobile: + 27 (0)71 643 6294

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2019 - 2020

Investigators/SMOs Sector

Johannesburg, Gauteng

Dr Vathiswa Papu-Zamxala has a unique skill set and has proven to be an energetic, loyal and hard-working team player who maintains a consistently high-standard of work. Vathiswa is currently the Departmental Head of Project Management, Patient Recruitment and Feasibility at Synexus, where she leads growth expansion in Africa and develops relationships with academic hospitals and Contract Research Organisations.

Vathi holds a PhD degree from London South Bank University, in the UK and a Masters degree in Public Health from Umea University in Sweden. In 2014, she was appointed by the Minister of Science & Technology to serve in the Board of the National Research Foundation. She is also currently serving in the Board of Sci-Bono Discovery Centre. As a woman in Science, she has been on a number of magazines, radio & tv stations, pushing science agenda in the country.

 

Outside work, she hosts a TV show on DSTV, channel 265, every Wednesdays at 20:00.

In 2017, she organized and spearheaded the National  Symposium on Clinical Research, bringing together Government, Pharma, CRO’s, Healthcare and Academia.

Dr Michelle Middle

Mobile: +27 (0)82 493 4621

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2019 - 2020

Investigators/SMOs Sector

Bloemfontein, Free State

Dr Michelle Middle is currently the Chief Medical Officer for FARMOVS, the dedicated Clinical Research Organization now wholly owned by the University of the Free State.  She is spearheading the expansion of clinical research at the UFS' Medical School and is responsible for planning and implementation of the FARMOVS-UFS' Strategy on "Clinical Research Capacity Building and Research Transformation". 

 

Dr Middle, who holds a Medical degree and a Master’s degree in Pharmaceutical Medicine, has 26 years medical and research experience, spanning the full range of Phase I to IV studies and has worked in South Africa, the US and the UK.  She has worked for four years as Medical Advisor and Strategic Business Executive for Synexus, the world’s largest Clinical Research Site Management Organization, and for six years for PAREXEL International, one of the top 6 CROs, where she held various international Executive Leadership positions.

 

Dr Middle was the founder and CEO of 3 Clinical Research companies in South Africa.  She has been author and co-author of numerous articles and abstracts.

Nyeleti Mthombeni

Mobile: +27 (0)82 312 6158

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2019 - 2020

Pharma Sector - Sites

Johannesburg, Gauteng

Ms Nyeleti Bicky Mthombeni, Msc Project Management, UP; Msc Pharmacology, Medunsa. Current Reginal Trial Manager at Sanofi with over 10 Years industry experience, started at the National Department of Health, MCC in 2006, five years as CRA, start-up specialist and clinical project lead. 

 

She possesses the expertise, leadership, training, and motivation necessary to support the vision of SACRA. Passionate about capacity building and transformation. Contributed to the transformational idea which led to an establishment of an SMO.

 

Strive on implementation and outcome of successful projects and learn from the ones that do not reach their success factors to improve in future.  Passionate about building a professional careers with continuous learning to become one of the industry key leaders.

Nicky Kramer

Mobile: +27 (0)81 046 2785

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2019 - 2020

Pharma Sector - Sites

Cape Town, Western Cape

Nicky Kramer is a senior pharmacist at the Clinical Research Centre (CRC) at the University of Cape Town.  She has a Bachelor of Pharmacy degree from Rhodes University and a Masters of Public Health from the University of Cape Town, specialising in epidemiology and biostatistics.

 

Nicky previously worked in the Division of Clinical Pharmacology conducting research in pharmacovigilance, and joined the CRC team in 2014. She has a passion for clinical trial pharmacy practice and chaired a Pharmacy Forum for several years aimed at teaching and collaborating with  research pharmacists from sites within Cape Town.

 

She has received training in the UK regarding IMP management, with the intention of aligning local practices to MHRA/EMA guidelines. She has a keen interest in oncology research having worked at Pfizer UK in the Oncology Business Unit as part of the scientific/medical team and in various private oncology centres in SA.

Leonard Lazarus

SACRA TREASURER

Mobile: + 27 (0)83 294 1430

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2019 - 2020

Service Provider Sector

Johannesburg, South Africa

Leonard has been involved in clinical trial logistics for the past 21 years.  He is currently serving as the Service Provider representative on the SACRA 2014 Executive Committee.

 

Over the past 20 years I have attended investigator meetings. He has managed and controlled large clinical trials and assisted CRO’S  in setting up complex clinical studies with TAT from 6 hours to 24 hours temperature controlled in SA and Africa. 

 

Leonard has done presentations to companies on handling, shipping and storage of clinical trial medication and blood samples.  He has assisted with documentation required for shipping medication and samples.

 

He has assisted with the required packaging and temperature monitoring devices and ensured that all regulations are met for shipping of samples / medication. He visits investigators / CRA’s and advises them on shipping requirements / packing / handling.  He facilitated 5 day training for Pathogenic Avian flu testing for WHO /CDC and, Webinars on Logistic and Regulatory challenges in Africa for Clinical Trials.

 

He assists client with permit for the various state departments (VET/DOH/MCC) Source and with Thermal Container systems / Validations. He has been Trainer / Facilitator for IATA 6.2 shipping Approved trainer by CAA SA. Clinical storage Drug facility set up (Writing Site Master file /Sops) which is approved by Pharmacy Council / DOH.

 

He Liaises with MCC on regulatory for Depot. As a speaker he has presented a talk on Shipper logistics and IATA Regulations at SACRA. His other duties include Setting up complex trials in Africa. Leonard is involved in business development on the African continent in the industry. He currently sits on the National Department of Health Task Force on transportation of biological samples.

Natasha Samsunder

Mobile: + 27 (0)84 402 4842

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2019 - 2020

Service Provider Sector - Labs

Durban, KwaZulu- Natal

Natasha Samsunder is the Laboratory Director at CAPRISA. She has been at CAPRISA for the past 13 years. Prior to that she worked at a leading private diagnostic laboratory.

 

She is a clinical pathology qualified Medical Technologist with a BTECH in quality. She oversees the functioning of the CAPRISA Laboratory and provides guidance and assistance to laboratories associated with CAPRISA or provides a service to CAPRISA. She has an extremely strong quality assurance focus and this ensures that all aspects of functioning are to the highest quality levels.

 

She is a voting member of the ACTG/IMPAACT Laboratory technologist committee and serves currently as the Medical Technologist on 2 IMPAACT protocols. She also has served as a SACRA EXCO member. She has functioned as an external auditor for numerous institutions and bodies and facilitates the Good Clinical Laboratory Practices training for local and international organisations. 

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