Meet the 2018 August Land O’ Lakes Speakers

I am the Director of the Division of Post-Marketing Activities I in CDER’s Office of Pharmaceutical Quality (OPQ). My talk will focus on the approval process for New Drug Applications (NDAs) leading to post-approval changes. The talk will cover pharmaceutical analysis information in NDAs and use of process analytical technology (PAT) used for pharmaceuticals manufacturing. I look forward to discussing these issues with you in August.

I am the Director of the Division of Post-Marketing Activities II in CDER’s new Office of Pharmaceutical Quality (OPQ). My talk will focus on post approval change issues for generic drug applications (ANDAs). The types of changes, the reporting requirements, the data requirements, the approval process and goal dates as they are defined in the Generic Drug User Fee Acts (GDUFA)  will be discussed. I’m looking forward to discussing these issues with you in August.

I am a Principal Scientist in the Analytical Sciences Division at Merck and Co. in West Point. I will be talking about opportunities, approaches and challenges of developing clinically relevant dissolution specifications at the Land O Lakes Conference on 07 August 2018. Over the past several years, my work has focused on developing and evaluating in-vivo predictive technologies to link in-vitro tests with clinical performance for solid oral dosage forms. Clinically relevant specifications are an important approach to ensure product quality forms for our patients. I look forward to seeing you there!

Andre Hermans, Ph.D.
Principal Scientist, Analytical Sciences
Merck & Co., Inc.

I will be talking about “Biosimilars – Regulatory Requirements and Control Strategies” at the “August 2018 Land O Lakes Conference on Monday, August 6, 2018”. I am excited to be presenting on this topic because 1) biotherapeutic treatments are rapidly catching up with small molecule drug products, in terms of pharmaceutical market share; and 2) many of the blockbuster innovator biological products will lose their patent protection by 2020. In my presentation, I will be reviewing the implications of the Biologics Price Competition and Innovation Act (BPCIA) legislation passed in 2010, which enabled developers to rely on previously disclosed pre-clinical and clinical trial data for assessment of their product’s safety and efficacy. This puts emphasis on establishing that the new product has adequate similarity to the innovator product (in terms of molecular structure and clinical activity/safety), and I will provide examples detailing the complexity of these products and the potential impact of even minor differences on their potential for approval. I look forward to seeing you there.

I lead global analytical development activities for several drug development candidates, ranging from early development through commercialization. Much of my work is virtual and involves working with both internal and external partners, so I understand the opportunities and challenges associated with such relationships. Together with two industry colleagues, I will be facilitating the CMO/CRO Interactions Workshop at the Land O’Lakes Pharmaceutical Analysis Conference on Wed., Aug. 7, 2018.

I have worked on late-stage projects at Bristol-Myers Squibb for a decade. I will be talking about analytical challenges with fixed-dose combination drug products at the August 2018 Land O’Lakes Conference on August 8th. I’m excited to share some of the analytical challenges I’ve encountered and I’m looking forward to the opportunity to collaborate with a wider audience on this topic.

Dan Tang
Senior Research Scientist
Drug Product Science and Technology
Bristol-Myers Squibb

I will be talking about Validation of Headspace Oxygen for Container Closure Integrity Testing at the “August 2018 Land O Lakes Conference on August 8th”. I am excited to be a part of the current evolution in technology to evaluate container closure integrity. The release of USP guidance chapter <1207> has brought a number of new technologies to forefront and with new technologies come challenges in validation of test methods. I am looking forward to sharing my experience with you.

Lauren Levac
Senior Scientist
Container Closure SME
PPD, Inc

My colleges and I will be presenting some case studies on transferring difficult methods involving less common technologies between laboratories. Our presentation is on Wednesday August 8th at the Land o Lakes conference. If you want some ideas on transferring those problem methods be sure and stop by! We look forward to seeing you there.

John Bak
Principal Scientist
Physical and Chemical Characterization Group
PPD, Inc

My colleagues and I will be presenting a few case studies regarding successfully overcoming significant analytical issues with the help of our pharma partners on the 8th of Aug. My specific topic will be a project wherein PPD and its partner had to develop a wet chemistry assay for an insoluble drug substance in a complicated matrix. I think this topic illustrates the importance of cooperation between CRO’s and pharma in working together to provide a product that is most beneficial to patients. I look forward to discussing this with conference participants.

Pam Sheaff
Principal Scientist
Physical and Chemical Characterization Group
PPD, Inc

One of my primary functions is to provide analytical support to the new generic products development. Over the years, I have worked on the analytical method development, method validation, specification development and supported numerous OOS/OOT investigations. I will be talking about Discriminatory and Predictive In Vitro disintegration and dissolution tools for modified release solid oral drug products at the “August 2018 Land O Lakes Conference” in the afternoon of Aug 7th. I am excited to present and discuss the topic as this topic is important, especially to the generic drug companies as it provides an insight into the drug product’s dissolution behavior in the GI tract and thereby enhances the sponsor’s confidence going into the clinical/bioequivalence studies. I look forward to seeing you there.

Ashok Patel
Manager, Analytical R&D
Perrigo Company

My main focus at Pfizer has been on PAT for drug product process understanding, testing and real time release.  I am one of the key contributors for Pfizer’s PCMM (portable, continuous, modular and miniature) oral solid dosage platform throughout the initial design and commercial manufacturing implementation. I will be talking about “PAT for Real Time Quality Assurance in Drug Product Continuous Processes” at the “August 2018 Land O Lakes Conference on Aug 7th”.  In this presentation, I’ll share the design and implementation experience and future thinking of PAT as a critical component in the integrated control strategy for PCMM continuous manufacturing platform.

Yang Angela Liu
Associate Research Fellow
Worldwide Research and Development
Pfizer, Inc