Archives: Speakers

Laszlo Farkas

A seasoned supply chain professional specialized on clinical trial service outsourcing, supply and logistics. My current main focus is on defining Merck KGaA´s clinical innovation and digitalization strategy together with my counterparts in clinical Research & Development

Tony Carita

Tony is an Outsourcing professional with almost 40 years of progressive and diversified experience in negotiation and management of research and development contracts in both BioPharma and high tech industries. Tony is currently applying those skills with Deciphera Pharmaceuticals in Waltham MA.   This includes leadership roles in development of outsourcing process/procedures, developing corporate strategies, selecting strategic partners, governance and alliance management.  In addition to strategic goals Tony supports tactical day-to-day sourcing activities such as development of RFPs, evaluation and selection of best in class providers, negotiation of new and amended MSAs and SOWs, coordinating of activities with functional operations and legal, and on-going management of vendor performance/issue resolution across the organization.

Kristine Bernard

Kristine has over 20 years of experience in clinical operations overseeing and managing multiple phase clinical studies with both device and pharmaceutical companies.

Kate Hoffman

Kate has a PhD in Neurological Sciences, and extensive industry experience, including roles in Medical/Scientific Affairs, Clinical Operations/Clinical Development, and Project/Program Management.

Lynn Newbould

Lynn Newbould is a clinical development, strategic sourcing professional with
more than 25 years of experience supporting prominent sponsors in the
pharmaceutical and biotech industry with their CRO strategy development,
supplier selections, vendor and alliance management as well as contract and
budget negotiations. In her current role at Alnylam Pharmaceuticals, a leader
in the translation of RNA interference into a new class of medicines, she is a
member of the CRO governance team, chairs the Clinical Development
Sounding Board and manages her team in supporting the sourcing needs for
the clinical development plan.

Lynn earned her BA from Lehigh University and MBA from Penn State University.

Randall Messer

Randy Messer is a Sr. Category Manager at Alnylam Pharmaceuticals has spent 15 years in the Pharmaceutical industry, with 12+ years of Strategic Sourcing experience across a wide range of categories. His prior role at Takeda Pharmaceuticals included time supporting categories such as Facilities, R&D, and Phase IV programs, as well as leading a team of Procurement Project Managers. In his role at Alnylam, he manages Clinical category spend (Phase I – III) and works closely with Clinical Operations stakeholders, along with CROs outside the organization. He received his MBA and BS from Boston College.

Amy Neubauer

Amy Neubauer serves as Director, Data Quality Oversight at Alkermes, a company developing innovative medicines that address the unmet needs and challenges of people living with debilitating diseases, such as schizophrenia, depression, addiction, multiple sclerosis, and cancer.  She has 15 years of experience in clinical research with expertise in data management, project management, and vendor management, and is an experienced auditor of clinical trial systems, technologies, services and software.  In her current role, Amy is responsible for the development of a clinical data sciences team to lead risk-based approaches and strategic data quality efforts for the organization through development and interpretation of algorithms, code, reports and visualizations in support of clinical trial operations activities with a focus on impactful data insights and clinical data review.

Melissa Suprin

Melissa’s career spans manufacturing, research, quality, EH&S, strategy, and operations.  She started with Air Products and Chemicals as a production engineer, moved to R.R. Donnelley and Sons as a manufacturing supervisor and then transitioned to Pfizer in 2001.  Roles at Pfizer have given Melissa a breadth of experience across Pfizer’s divisions and functions.  Melissa completed her undergraduate studies in Chemical Engineering at Villanova University, has an MBA and is a Lean Six Sigma Black Belt.  Her leadership in operations and expertise in risk management led to her current role at Pfizer as the Head of Quality Risk Management for Clinical Development.  She is the lead author of the recently published TransCelerate manuscript on risk management. Melissa enjoys sailing, reading, and gardening in her free time.