Workshop

**POSTPONED, new date being set**

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2020 Pharmaceutical Technologies in Drug Discovery & Drug Development Workshop

Date and Place
March 16-17, 2020
Truhlsen Events Center
619 South 42nd Street, Omaha, NE

Organizers: Aaron Mohs, PhD, Department of Pharmaceutical Sciences, University of Nebraska Medical Center, Omaha, NE 68198; Yazen Alnouti, PhD, Department of Pharmaceutical Sciences, University of Nebraska Medical Center, Omaha, NE 68198; Gangadhar Sunkara, PhD, Senior Global Program Clinical Head, Novartis Pharmaceuticals, One Health Plaza, East Hanover, NJ 07936

Host: Ram Mahato, PhD, Chairman, Department of Pharmaceutical Sciences, University of Nebraska Medical Center, Omaha, NE 68198

Background
The decades long basic research in chemistry, molecular biology, biophysics, drug delivery, polymer chemistry, etc, are now producing fruits in the form of novel drug therapies to treat various acute, chronic, genetic and rare diseases.  Today, the pharmaceutical and biotechnology industry is rapidly evolving to adopt various forms of interventional drug therapies such as small molecules, proteins/peptide drugs, biologics, cell/gene therapies and drug-device combinations. In this phase of rapid evolution of the industry, a workshop like this would provide a platform to share the experiences between the leaders in the industry who are part of this evolution process and curious minds of academia (graduate students, post-docs, physicians, faculty, etc).

Objectives
This workshop will provide an overview of the role of various functions in the evolving pharmaceutical/biotechnology industry associated with research and development (R&D) of novel drug, biologic and cell/gene therapies. In addition, the workshop covers the role of basic disciplines like chemistry, pharmacology, drug delivery and biophysics in the industry oriented R&D to bring novel therapies to patients. There will be specific focus on the tools/technologies used at each stage of drug discovery and development. Breakout group/panel discussion sessions will be organized to simulate cross-functional strategy and decision-making process in the drug discovery and development.

 

Speakers

Sunkara

Gangadhar Sunkara, PhD is a Senior Global Program Clinical head at Novartis, supporting drug development programs in the Global Health Development Unit.  Dr. Sunkara joined Novartis 18 years ago in the Clinical PK/PD group and has assumed positions of increasing important during this time. He obtained his Pharmacist license (B.Pharm) followed by a Master's degree in Pharmaceutics from Kakatiya University, India.  He then obtained his PhD in Pharmaceutical sciences from the University of Nebraska Medical Center in Omaha, Nebraska, with a major research focus on treating ocular diabetic complications. Dr. Sunkara also earned his MBA degree (major incorporate finance) from Fairleigh-Dickinson University. He has authored more than 60 research publications and edited a text book.

 

Roy photo

Sandip Roy, PhD, is an Associate Vice President and Therapeutic Area head of General Medicine, within the Global Regulatory Affairs and Clinical Safety (GRACS) organization and member of the GRACS Leadership Team at Merck. He leads the General Medicine Therapeutic Area, supporting multiple disease areas in this umbrella category including cardiometabolics, respiratory, neuroscience and women's health products. In addition, he leads the US Subsidiary group, which handles US-specific activities such as financial disclosure, user fees and drug shortage notifications. Dr. Roy has more than 20 years of experience in the pharmaceutical industry and at the FDA. He has authored or co-authored more than 20 articles in peer review journals in the areas of clinical pharmacology and pharmaceutical sciences. Prior to joinging Merck, he held positions of incrasing responsibilities at Novartis for almost 12 years. Dr. Roy began his career working for the FDA, first in the CDER Division of Oncology Drug Products and then later in the CDER office of Clinical Pharmacology and Biopharmaceutics. He holds a PhD in Public Health from the College of Public Health at the University of of South Florida and a Bachelor's in Pharmacy from the Department of Pharmaceutical Technology at Jadavpur University in Kolkata, India. He also completed a Clinical Pharmacology Fellowship at University of Chicago Medical Center in the Section of Hematology/Oncology.

 

Lisa-Crandall_Velesco.jpgLisa Crandall, MS, PMP, is the Vice President of Pharmaceutical Development for Velesco Pharmaceutical Services. Ms. Crandall has almost 20 years experience in the pharmaceutical industry across the CMC phase of drug development. She has an extensive background in analytical method development and validation, early stage formulation development, complex project management, and consultative CMC support. She currently leads the Project Management and Quality Control teams at Velesco Pharma as well as serving as a member of the Executive Team, determining company strategy and policy. Ms. Crandall has her BS in Biochemistry from the University of Michigan, an MS from the University of Nebraska Medical Center in Omaha, Nebraska, a graduate certificate in Pharmaceutical Project Management from the University of Washington, and her Project Management Professional certification. Her pharmaceutical journey began at Parke-Davis Pharmaceuticals, then Parke-Davis/Warner Lambert, Pfizer, and finally she took a risk to be the first employee of a start-up company rising out of the closure of Pfizer's Michigan R&D sites, Velesco Pharma.

                   

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Nagesh Bandi, PhD, is an Executive Director at Merck & Co., Inc., in the GRACS-CMC (New Products - early phase to post approval) organization. Prior to Merck, Dr. Bandi was a Director at Pfizer, wherein he was responsible for driving CMC regulatory strategy (cradle to grave) and external advocacy-related issues. Dr. Bandi is a transformational leader and has unique skills to establish regulatory standards for complex and controversial issues. He strongly advocates application of science and risk-based approaches and closely collaborates with industry partners within PhRMA, ICH, PQRI, AAPS and DIA technical committees. He has authored peer-reviewed publications and contributed to several scientific conferences, invited talks and presentations on a variety of quality topics. More recently, he supported IFPMA towwards finalization of the ICH M9 guideline. Dr. Bandi is the past Chair of AAPS Regulatory Sciences (RS) section and is the recipient of several AAPS recognitions including Associate Editor - AAPS Open, Regulatory Sciences Recognition Award, Regulatory Sciences Service Award, and Outstanding Graduate Research Award. Prior to his regulatory role, he specialized in R&D areas of new product development and novel drug delivery spproaches with GSK and Sanofi. Dr. Bandi has a PhD from the University of Nebraska Medical Center in Omaha, Nebraska (Department of Pharmaceutical Sciences) and Undergraduate degree in Pharmacy from Andhra University in India.            

 

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Haiying Sun, PhD is currently a Director in the clinical pharmacology department at Novartis. She graduated from the University of Nebraska Medical Center in the College of Pharmacy in 2001. She joined the industry in Vertex Pharmaceuticals in pre-clinical DMPK for 2 years prior to joining Novartis in 2003. Dr. Sun has over 18 years of extensive industry experiences in different stages of drug development from candidate selection to clinical phase I-IV, with both small molecules and biologics. Her deep expertise in PK/PD has led to a track record of successful regulatory submissions while leading the clinical pharmacology strategy and its implementation in drug development teams and during her 4 years tenure as a therapeutic area group head. Dr. Sun is an active member in PK/PD community and was an invited speaker at a FDA workshop.

 

 

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Renee Bergeron, PhD, DABT, is an Executive Director at Novartis Pharmaceuticals. She received a PhD in Pharmacology and Experimental Therapeutics from LSU Medical Center in New Orleans, LA, and completed a postdoctoral fellowship in the Endocrine Toxicology field at the Chemical Industry Institute of Toxicology in RTP, NC, and is certified by the American Board of Toxicology. Following her postdoctoral fellowship, Dr. Bergeron took a position as Toxicologist with Exxon Biomedical Sciences, Inc. (EBSI) in New Jersey before moving to Schering-Plough Research Institute as a Study Director. Following four years as a Study Director, she joined the Preclinical Safety department of Novartis in 2003 as a Regularoy Toxicologist on cross-functional drug development teams most recently focused on respiratory diseases. In her current role, Dr. Bergeron manages a team responsible for the design and interpretation of preclinical safety studies and the overall preclinical strategy supporting development of pharmaceutical candidates.

 

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Manoj Jadhav, PhD, FCP, is a Vice President at CRC Pharma in the Clinical Development and Business Strategy function. He is an expert and contributes to the clinical development plans, target product profile for the clinical and scientific develop projects e.g. NCE, 505(b)(2) across different therapeutic areas e.g., infectious diseases, oncology, autism, Huntington disease. He has supported several pre-IND meetings, IND compilations for US-FDA communications for small molecules, synthetic peptides and biologics. Dr. Jadhav has over 10+ years of experience in industry and academia. He is a trained clinical pharmacologist wtih extensive experience in planning, designing, execution and interpretation of clinical studies (prospective, retrospective, interventional and observational) in the area of cancer, cardiovascular and infectious diseases. Dr. Jadhav was part of a successful team which developed first Indian liposomal amphotericin B (FungisomeTM) and launched in Indian market. He has over 25 peer-reviewed publications, co-edited a book, have made numerous posters and oral presentations internationally. Dr. Jadhav received his PhD in Pharmaceutics from Bombay College of Pharmacy and KEM Hospital, University of Mumbai, India, and did his postdoctoral fellowship at the Colleges of Pharmacy and Medicine at the University of Florida in Gainesville, Florida.

 

Hanumantha-Rao-Marepalli---Sannova-Analytical-Inc.jpg

Hanumantha Rao Marepalli, PhD, is the CEO and CSO of Sannova Analytical, Inc. After receiving his PhD at Osmania University, he completed postdoctoral studies at the City University of New York, where he worked on methods to constrain and control the conformations of peptides via cyclization techniques. In 1995, he joined Sandoz Pharmaceuticals, which merged with Ciba Geigy to form Novartis. As Senior Fellow at Novartis, Dr. Marepalli focused on developing high throughput techniques that expanded access to cutting edge analytical tools for both discovery and development teams. Among the techniques developed were novel LC-MS-SPE-cryoNMR methods that streamlined the isolation of metabolites and impurities while greatly reducing cost and the environmental impact of isolation and analysis. Following his tenure at Novartis, in 2006 Dr. Marepalli founded Sannova Analytical, Inc., where he leads a team of dedicated scientists who have developed and validated highly accurate and precise bioanalytical methods that have been utilized in more than 1000 clinical trials. In addition, the team he leads has developed complex analytical methods for scores of formulations. Under his direction, the company has enjoyed continued growth in an atmosphere of regulatory and scientific excellence. Dr. Marepalli has made presentations at scientific pharmaceutical conferences around the world, published scientific papers in prestigious journals, and has trained and developed scientists meeting the highest standards in the pharmaceutical industry.

 

Day 1 (8:00 am - 5:30 pm, Dinner Following) -- March 16, 2020
Time Topic Title Theme Speaker
8:00-8:30 Breakfast    
8:30-8:45 Welcome Workshop Overview Aaron Mohs (UNMC)
8:45-9:00 Opening Remarks Senior Vice Chancellor for Academic Affair’s Address H. Dele Davies (UNMC)
9:00-9:45 Current State of Drug Discovery and Drug Development in the Pharmaceutical Industry Overview of how the pharmaceutical/biotechnology R&D has evolved over the last two decades and are the critical or emerging areas of focus now. This presentation will set the stage for faculty/students about the overall expected skill set suitable for the industry. Gangadhar Sunkara (Novartis)
9:45-10:30 Drug Development and the Role of Regulatory Affairs Key milestones and critical data required in the journey of discovering/developing a drug product and various phases of drug development. Provides an overview about various modules and FDA interactions. Sandip Roy (Merck)
10:30 -10:45 Break    
10:45-11:30 Practical CMC Tips: Considerations in Research and Development and Perspectives from Big Pharma to Small Specialized CRO Building upon a background of the scope and regulatory aspects of CMC, practical CMC tips will provide a broad look into the different factors that should be considered both as a job seeker in the pharmaceutical industry and as an innovator with a compound. Lisa Crandall (Velesco Pharma)
11:30-12:15 Reduced Bioanalytical Variability, the Z-Factor - A Path to Product Success! Role of analytical chemistry in drug discovery and development from the perspective of drug substance, drug product and biomedical characterization will be discussed. Hanumantha Rao Marepalli (Sannova)
12-15-12:30 Group Photo Lobby Stairwell  
12:30-1:30 Lunch    
1:30-2:30

Global Regulatory Strategics for CMC Development: Accelerated Pathways and Novel Technologies

A brief overview of the regulatory framework underlying CMC development activities will be discussed. In addition, regulatory considerations for accelerated submissions and novel manufacturing technologies will be discussed.

Nagesh Bandi (Merck)

2:30-3:15 Panel Discussion (Q&A)  

Five teams (max 8-10)

  • Mixture of participants from various functions -- simulation like project teams in the industry
  • 15 min case introduction
  • 60 min case discussion
  • 30 min case report preparation
  • 15 min for presentation

Topics will cover few scenarious of product development issues, etc.

 All
3:15-3:30 Break    
3:30-4:15

Preclinical to Clinical PK/PD

PK/PD from candidate selection to clinical phase I to IV.

Haiying Sun (Novartis)

4:15-5:00

Preclinical Safety in Drug Development:  From Toxicology Study to Product Label

This presentation is an overview of the role of toxicology in the drug development process from molecular discovery to marketed product, including regulatory requirements of toxicology to support both clinical trials and product registration.The objective is for students to have a general introduction on how toxicology fits within the pharmaceutical process.

Renee Bergeron (Novartis)

5:00-5:30 Drug Repurposing: Key Strategic Considerations (Case Study: Diclofenac Sodium for Cancer Treatment) In this presentation, Dr. Jadhav will elaborate on the importance of having the right drug development strategy (clinical, formulation, TPP) for drug repurposing and specific formal interactions with the different divisions of the US FDA. Setting the right path can fulfill the aim of getting maximum benefits/waivers from the agency. Dr. Jadhav will also cover specific case studies to illustrate this point.  Manoj Jadhav (CRC Pharma)
5:30-6:00 Tour Tour of UNMC Campus (Labs)  Students
6:30-8:00 Dinner for All Attendees with UNeMed Learning about UNeMed assets and opportunities to collaborate with industry Michael Dixon (UNeMed)
Day 2 (8:00 am - 1:00 pm) -- March 17, 2020
8:00-8:45 Breakfast    
8:45-9:00 Remarks from Dean Dean, College of Pharmacy Dean Olsen (UNMC)
9:00-11:00 Breakout Sessions

Five teams (max 8-10)

  • Mixture of participants from various functions -- simulation like project teams in the industry
  • 15 min case introduction
  • 60 min case discussion
  • 30 min case report preparation
  • 15 min for presentation

Topics will cover few scenarious of product development issues, etc.

 All
11:00-11:45 Panel Discussion (Q&A) Opportunities for industry-academia collaboration and career opportunities for graduate students and postdocs.  All
11:45-12:00 Closing Remarks Chair's Closing Message Ram Mahato (UNMC)
12:00-1:00 Lunch