Chat with us, powered by LiveChat
3rd New Product Planning Summit -

3rd New Product Planning Summit
December 12 - 13, 2018
Boston, MA

Understand how to navigate the changing regulatory landscape and effectively manage resources and timelines

Faculty – 3rd New Product Planning Summit


Dr. Raymond Donninger
Vice President, Head of Insights and Analytics, PRESCIENT HEALTHCARE GROUP

view speaker profile

Bart J. Lombardi, a founder and managing director of Clarion, brings over 20 years of experience in commercialization strategy, corporate and portfolio strategy, new product launches, indication prioritization, managed care strategy, and BD&L strategy. For over 10 years Bart has been partnering with emerging biotech companies to develop commercialization and organizational scale-up strategies for the launch of their first commercial asset.

Bart co-founded and has built Clarion into a boutique consultancy providing expert-based insight, guidance, and operational support to innovator companies in the industry. Working across the spectrum from emerging biotech to Fortune 100 companies, Bart and the Clarion team understand the challenges and opportunities afforded by the continuously evolving health system landscape and the value of working closely with leadership teams to deliver on the promise of innovation.


Vincent Fisher
Director, Commercial Planning - HIV, GILEAD SCIENCES

view speaker profile

Vincent Fisher is a Director, Commercial Planning for Gilead Sciences. Commercial Planning at Gilead is responsible for Global Marketing, New Product Planning and Commercial Strategy. Vincent recently led the global commercial launches of three new products in six months. GENVOYA(r), the lead product is the most successful antiretroviral launch to date. Vincent works with research on pre-clinical product profiles, with clinical and project teams for those in development (Phase1-3) for registration and with medical affairs and the affiliates on approved products.

Prior to Gilead, Vincent had roles in multinational pharmaceutical companies (Pfizer, SP/Merck and Boehringer Ingelheim) as well as smaller biotechs (Agouron and ABH). He has therapeutic experience in antivirals, epilepsy, Parkinson’s disease, multiple sclerosis, regenerative medicine and oncology.


John Garcia
Global Commercial Excellence Lead, ALNYLAM PHARMACEUTICALS

view speaker profile

John Garcia is the Global Commercial Operations Lead at Alnylam, a rare disease company focused on the development and commercialization of RNAi based therapeutics. In addition, to building launch capabilities John spends much of his time at Alnylam supporting commercial and medical teams in the development of novel patient discovery methods and running day to day commercial operations. Before Alnylam, John spent his time leading many different commercial teams in biopharma, starting a med device company, and consulting with a host of early stage ventures in life sciences. Prior to John’s life sciences career he was an active duty Marine Officer and retired as a Marine Infantry Major.

John holds degrees from Berkeley and the United States Naval Academy and has done coursework at Brown, Stanford, and University of North Carolina.


Abizer Harianawala, Ph.D.
Senior Director, Product Development and Technical Operations, TARIS BIOMEDICAL

view speaker profile

Abizer Harianawala is currently a Senior Director of Product Development and Technical Operations at Taris Biomedical in Lexington, MA. His expertise is in developing oral and controlled release parenteral products, formulation and process optimization using quality by design, scale-up, validation, achieving organizational excellence, and building high performance CMC teams. Abizer has played a key role in development of eight commercial products that are sold in global markets. He is a recipient of several patents for solving complex formulation and manufacturing challenges. He received his BS and MS degrees in Pharmacy from Gujarat University, India and his Ph.D. in Pharmaceutics from University of Connecticut. He has 20 plus years of experience in the pharmaceutical industry. Prior to joining Taris, Abizer worked with Ariad, Zalicus, Genzyme and Bristol-Myers Squibb.


Paul Harney
President, North America, PRESCIENT HEALTHCARE GROUP

view speaker profile

Paul oversees our business activities in North America. Since completing his PhD in chemistry at Stony Brook University, he has spent more than 20 years providing guidance and support to the healthcare industry. He has held leadership roles at various consulting firms that engage with biopharmaceutical and medical technology companies in nearly all functional areas, including sales, marketing, medical affairs, business development and supply chain. Paul’s focus at Prescient is helping our clients achieve and sustain peak commercialization targets across a wide range of therapy areas.


Aakanksha Khandelwal, Ph.D., MBA
Head of Innovation & Scientific Leadership, EMD SERONO

view speaker profile

Aakanksha is currently the Head of Innovation & Scientific Leadership at EMD Serono. Just prior to this she led the launch of Bavencio while also helping to build out a US Oncology Franchise from the ground up. Her prior experience includes working at the FDA in oncology and roles at J&J and Roche in commercial functions. Aakanksha has a Ph.D. in pharmacology from the University of Maryland and an MBA from the London Business School.


Sarah Kurz
Chief Commercial Officer, PARTNER THERAPEUTICS

view speaker profile

Sarah Kurz, Chief Commercial Officer of start-up Partner Therapeutics, has more than 15 years of experience in biotech start-ups and has been instrumental in building three commercial organizations. Sarah is known for thoughtful and rigorous pre-launch planning and challenging the norm when it comes to customer engagement and field force design.


Bart Lombardi
Founder and Managing Director, CLARION | A LIFE SCIENCES CONSULTANCY

view speaker profile

Bart J. Lombardi, a founder and managing director of Clarion, brings over 20 years of experience in commercialization strategy, corporate and portfolio strategy, new product launches, indication prioritization, managed care strategy, and BD&L strategy. For over 10 years Bart has been partnering with emerging biotech companies to develop commercialization and organizational scale-up strategies for the launch of their first commercial asset.

Bart co-founded and has built Clarion into a boutique consultancy providing expert-based insight, guidance, and operational support to innovator companies in the industry. Working across the spectrum from emerging biotech to Fortune 100 companies, Bart and the Clarion team understand the challenges and opportunities afforded by the continuously evolving health system landscape and the value of working closely with leadership teams to deliver on the promise of innovation.


Karen McCulloch
Global Marketing Director, Respiratory Early Pipeline, GLAXOSMITHKLINE

view speaker profile

Karen McCulloch is a Global Marketing Director in the Respiratory Franchise at GlaxoSmithKline. Karen is responsible for leading all aspects of commercial input for two phase 2 stage assets. This includes working closely with the research & development project teams as well as the key markets to define the commercial vision, branding, positioning and evidence needs for each asset. Prior to joining the global team, Karen held multiple roles in the US Pharma business at GSK with a focus on Respiratory. Karen was the Regional Commercial lead for BREO ELLIPTA and for TRELEGY ELLIPTA during the development phase. Karen also led the US Portfolio Strategy & Planning team which had responsibility for all new assets as well as the development of the respiratory strategic and tactical plans for the US business in addition to multiple cross portfolio initiatives. Karen has over 25 years of experience in the pharmaceutical industry and her passion is linking the customer insights to evidence generation and strong customer value propositions to build successful brands in market.


Scott Megaffin
Chief Executive Officer, TRAGARA PHARMACEUTICALS INC.

view speaker profile

Scott Megaffin is the Chief Executive Officer of Tragara, he joined the company as a founder in 2018. Mr. Megaffin has more than 30 years of related experience in the pharmaceutical industry. Scott plans and directs all aspects of Tragara operational objectives, policies and initiatives. He is responsible for the development of the functional business strategy of Tragara, including the communication of the corporate vision and supporting values.

Prior to joining Tragara, Mr. Megaffin served as President of Churchill Pharmaceuticals LLC. Scott has held numerous global strategic and operational positions of increasing responsibility including Senior Vice President of Commercial Development for Onconova Therapeutics, Inc and also Cephalon, Adolor, Yamounchi and Bristol-Myers Squibb He has led five global launches, within a variety of therapeutic categories including oncology, hematology, virology, critical care, anti-infectives, pain and inflammation. Scott received a B.S. in Biology from Pittsburg State University.


Charles Pak
Vice President, New Product Planning, SYROS PHARMACEUTICALS

view speaker profile

Charlie Pak has over 18 years of product marketing and new product planning experience with various pharmaceutical and biotech companies, including Bristol-Myers Squibb, Vertex Pharmaceuticals, and Eisai Pharmaceuticals. He has covered multiple therapeutic areas including oncology, autoimmune / inflammatory, and viral diseases. Prior to his commercial experiences, Charlie was a scientist with post-doctoral training at the NIH and worked at The Liposome Company. He received a BA from Rice University, PhD from University of Texas Health Science Center, and a MBA from The Wharton School.

He is currently at Syros Pharmaceuticals, where he serves as the VP of New Product Planning.


Brad Payne, MBA
Partner, ARTISAN HEALTHCARE CONSULTING

view speaker profile

Brad Payne is a Partner for Artisan Healthcare Consulting, and advises clients on how to optimize commercial outcomes for their own pipeline and newly launched products. He has lead and delivered >100 consulting engagements with established and emerging pharmaceutical, biotech, and medical device companies, and across therapeutic areas such as oncology, rare diseases, cardiovascular, and vaccines.

Brad’s expertise includes:

  • Early development strategy expert for biopharma and medical devices:
    • Competitive differentiation
    • Early market access strategy development
    • Product development strategy
    • Life cycle management and indication prioritization
  • BD/L&A support, ranging from short-term due diligence assessments to developing an overarching BD strategy
  • Lead advisor for 15+ device and pharmaceutical product launches

Prior to joining Artisan, Brad worked as a consultant at Trinity Partners. He holds a BA (cum laude) in Economics from Harvard University and an MBA from Arizona State University.


Tony Russell
Senior Director, Product Strategy and Commercial Planning, THERAVANCE BIOPHARMA

view speaker profile

Tony Russell is currently the Senior Director, Product Strategy and Commercial Planning on Theravance Biopharma with a primary focus on new product planning for respiratory and dermatology. Tony’s prior therapeutic area experiences include pain, oncology, rare diseases, anemia, and nephrology.

Over the course of Tony’s nearly 20-year career, he has established a unique blend of skills and therapeutic area knowledge providing valuable perspectives and insights for the development and commercialization of biologic and small molecule therapeutics. Tony has successfully utilized these experiences in developing commercialization strategies and evaluations for new drug candidates as well as in the market conditioning and launching of new therapeutics.


Joel Sangerman
Chief Commercial Officer, CLICK THERAPEUTICS

view speaker profile

Joel serves as Chief Commercial Officer for Click Therapeutics. Click develops software as prescription medical treatments to improve the lives of patients throughout the world. For over 25 years Joel has advanced new health technologies in the pharmaceutical industry. He is a graduate of DePaul University and a fellow of the Advisory Board Company.


Jake Schutz
Vice President, Southwest Lead, PROMIDIAN CONSULTING

view speaker profile

A Vice President with Promidian, Jake has more than a decade of experience helping life sciences and other healthcare organizations make better, more strategic decisions in the areas of product commercialization, R&D, portfolio planning, corporate development, asset valuation, analytics, digital health, and more across a broad range of therapeutic areas.

Prior to joining Promidian, Jake was one of the first leaders of the newly created IBM Watson Health business unit, leading a team responsible for creating and prototyping innovative solutions fueled by artificial intelligence and predictive analytics across the healthcare and life science domains. During his time at IBM Watson Health, Jake executed multiple strategic partnerships. He brings deep expertise in leveraging innovative methodologies and large clinical and commercial data sets to support analysis and strategic decision-making. Prior to IBM Watson Health, Jake was a Director and Los Angeles office lead for ICON plc’s Commercialization Strategy and Science division, focusing on Corporate Development and Launch Strategy in the Life Sciences sector.

Jake earned a bachelor’s degree in finance with a minor in healthcare management from the University of Wisconsin–Madison and an MBA in global strategy from the University of Southern California Marshall School of Business.


John Sears, Ph.D., MBA
Health Care Quality and Commercial Strategy Director, JOHNSON & JOHNSON

view speaker profile

John Sears is currently a Director of Health Care Quality Strategy with Johnson & Johnson Health Care Systems. In his current role, John develops internal commercial strategies that support pipeline, inline and above-brand workstreams by bridging any gaps between Janssen’s capabilities and the evolving US healthcare system. John has previous experience with global marketing, sales operations, medical affairs and business consulting working across the majority of therapeutic areas within Janssen.


Jennifer Sherak
Global Head, Oncology New Product Planning, TAKEDA PHARMACEUTICALS

view speaker profile

Jennifer is currently the Global Head of Oncology New Product Planning at Takeda Pharmaceuticals. In her current role, she is responsible for ensuring that the value of the oncology pipeline is maximized globally by integrating commercial insights early in development.

Prior to joining Takeda, Jennifer was the Global Commercial Strategy Lead for Hematology at Shire Pharmaceuticals and oversaw the successful integration and commercialization of hematology/oncology products acquired from Baxalta.

During Jennifer’s comprehensive career in the pharmaceutical industry, she has held strategic commercial positions with Shire Pharmaceuticals, Biodesix, Celgene, Bristol Myers Squibb and Novartis leading global strategy teams and managing lifecycle planning. She is a transformative leader with a passion for ensuring patients globally have access to the medicines they need.


live chat software