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CPHI ONLINE

AWARDS

April, 25-27, 2023

Pennsylvania Convention Center, Philadelphia

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    • Speaker Line Up (2023)
Our Speakers Line-Up

A WORLD-CLASS LINE-UP

Learn From Industry experts



  • A - E
  • F - J
  • K - O
  • P - T
  • U - Z

Alain Bindels

Roche
Technology and Innovation Leader

Angela Osborn

AMC
Member

Bikash Chatterjee

Pharmatech Associates- A USP Company
CEO

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Alain Bindels is an experienced Design Thinking facilitator, who leads an Innovation task force at Roche, supporting different business units to adopt innovation. He is interested in patient centric design of the healthcare industry, using new available technologies. He is applying the Design Thinking methodology to conduct workshops to test new ways of working and new technologies. Alain Bindels is part of the Precision Medicine Group Basel Area, a local Swiss based network. He is working for more than 7 years at Roche in different roles. As Project Manager he was part of the Roche-Genentech Merger Integration team to harmonize and streamline processes across the company. Thereafter he moved into a project leadership role to build up 2 medical writing groups in China and India. He is responsible for strategic outsourcing activities in the clinical development area, for Safety, Regulatory and the Medical compliance office.

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Angela has over 30 years’ experience in biopharmaceutical and cell and gene therapy businesses, processes and facilities. Angela works closely with clients to guide and support them through new product expansion projects, starting from the strategic business review, ensuring the early definition of technical requirements is focused on the business benefits and that the final solution delivers these benefits.

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Bikash Chatterjee has worked in the bio-pharmaceutical, pharmaceutical, medical device and diagnostics industry for over 30 years, guiding the successful approval of a dozen new products within the U.S. and Europe. Chatterjee has developed and transferred products and processes to satellite operations and CMOs throughout his career, designing and implementing systems to satisfy the requirements for ICH Q8, Q9, and Q10, e-pedigree, risk-based validation, and developing a six sigma-based methodology to support the PAT initiative.

Bob Girton

Partner
Edgewater Capital
 

Cimi Sivaneri

LEO Pharma Inc
Head of Business Technology & Innovation

Cavan Farley

DoubleRainbow Biosciences
Senior Vice President, Global Business Groups
 

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Bob spends his time at Edgewater driving deal origination, transaction execution, and portfolio management. Prior to joining Edgewater in 2011 as an associate, he was an investment banker at Harris Williams & Co. and Candlewood Partners. While in investment banking, Bob completed a variety of corporate finance transactions, including M&A, leveraged financings, and other advisory services. Bob has served on the Boards of Edgewater portfolio companies Fiber Materials, FAR Chemical, TRITEC Performance Solutions, Callery, Pure Wafer, DanChem, and Haematologic Technologies. Bob has a BS in Corporate Finance from the University of Akron and an MBA from the Weatherhead School of Management at Case Western Reserve University.

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Cavan Farley is Vice-President, Global Business Groups at Double Rainbow. A nationally
recognized, award-winning senior executive, Cavan has 20 years of leadership
experience at global, research-based pharmaceutical companies. She has held critical
roles across varied business channels, including market access, sales and marketing, and planning and execution.

Considered an inspired leader and team motivator, Cavan employs a multi-dimensional
approach to competitive market opportunities to drive differential performance and
ensure successful launch. Experienced in solving complex business challenges, she is
skilled at people development and cross-functional collaboration; attributes honed in
commercial leadership positions at Gilead Sciences and GlaxoSmithKline.

Prior to joining Double Rainbow, Cavan held the position of Executive Director
Corporate Accounts, Market Access for Allergan (now AbbVie). In this role, she led a
team responsible for a broad set of market access customers including national and
regional payers, the Specialty Pharmacy and Federal Channels, as well as Kaiser, totaling
more than $1B in U.S. sales.

She successfully designed and implemented an innovative account strategy and
structure in 2019 for, optimizing access and portfolio performance of approximately
$250M, and leading her team to double-digit net sales growth year-over-year,
subsequently out-pacing the nation for the previous three years. In addition, she
successfully executed launch access strategies for UBREVLY, VRAYLAR, XEN, and
DURYSTA, including pre-approval engagement and post-approval reviews, negotiation,
and coverage.

Cavan’s career has informed her knowledge and expertise across varied disease states
and therapeutic areas, including infectious and rare diseases, neurology, and
immunology amongst others.

She has a B.A. in Journalism and Business from the University of Richmond.

Dave Schoneker

IPEC Americas
Independent Consultant
 

David McCarthy

Pfizer
Senior Director/TL - Supply Assurance and Risk Management

Dave Malenfant

Biotech Supply Management Alliance
Executive Vice President
 

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David R. Schoneker is currently the President/Owner of Black Diamond Regulatory Consulting, LLC, a consulting firm specializing in providing regulatory and quality consulting for the pharmaceutical, dietary supplement, food and related industries. The firm provides expert advice for difficult problems and training on excipient and food additive regulatory, quality and supply chain concerns.
With over 45 years of experience working in these areas, Dave has developed strong networks with trade associations, regulatory agencies and pharmacopeias around the world. He is also an Adjunct Professor at Temple University's School of Pharmacy in their RA/QA Master's Program teaching courses in Global Excipient Regulations and the Regulation of Dietary Supplements.

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David McCarty is Senior Director, Sourcing Operations & Enablement at Pfizer where he leads overall TPRM (third party risk management) for the enterprise, with particular focus on supply assurance and risk mitigation for direct materials. He joined Pfizer in 1998. David also has extensive experience in sourcing of direct materials, manufacturing supplies and services, logistics, and capital equipment. He has a proven track record of building and leading high performing teams and delivering innovative solutions as well as significant financial results. He has managed teams across four continents and builds strong relationships with senior company leaders, business partners, and suppliers. Prior to joining Pfizer, he worked at Colgate-Palmolive as well as Nabisco (Mondelēz) in technical roles. David holds a B.S. Chemical Engineering, B.A Business and MBA Finance from Rutgers University.

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M. Dave Malenfant currently serves as Director of Outreach and Partnerships and oversees the Advisory Board for the Center for Supply Chain Innovation at Texas Christian University. Prior to this appointment, Dave served on the Advisory Board for the center from its inception in 2002. With a passion for talent development and career planning, Dave has helped develop the Executive Apprenticeship Program, judged the LINKS simulation game, and assisted students with internships and case competitions. Dave is also Executive Vice President of Industry Liaison and Talent Development for the BSMA (Biotech Supply Management Alliance) responsible for bringing best practices across the Biotech Industry

Feng Peng

Merck
Principal Scientist

Howard Federoff

Ryne Technology
Co-founder and Chief Medical Officer

James Manser

Endo Pharmaceuticals
Executive Director, Government & External Affairs

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Howard J Federoff, MD, PhD is co-founder, director and Chief Medical Officer of Ryne Bio, an allogeneic stem cell start-up company focused on neurologic disorders. He also co-founded in 2022 Kaleibe a gene therapy focused on rare neurodegenerative diseases. He is the former CEO, President and director of Brooklyn ImmunoTherapeutics. He was receently a distinguished professor of neurology at the University of California, Irvine. He is the former CEO of UCI Health, vice chancellor for Health Affairs and dean of the UCI School of Medicine.

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Jennifer L. Northcott

Merck
Director, West Point Clinical Supplies Operations,

Jessica R. Riggleman

Mydecine Innovations Group
Senior Director Clinical and Regulatory Affairs

Jim Fries
 

Rx-360
CEO
 

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An agile CPM certified project manager currently working within the clinical supply chain managing a team of project managers eager to optimize and strength the the supply chain and get medicine to patients more efficiently. Prior 13 years of pharmaceutical experience, 5 years' managing clinical trials and 8 years’ experience executing high level scientific engagement meetings for various therapeutic areas, orchestrating cross-functional presence at international and national congresses, and managing clinical and pre-clinical investigator initiated trials.

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Jessica is the Senior Director of Clinical and Regulatory Affairs for Mydecine Innovations Group. She has spent the last ten years in the clinical research industry and has worked closely with cross-functional teams to develop clinical evidence generation strategies for global indication submissions. Jessica has supported and published research in robotics, orthopaedics, trauma, biologics, transcranial magnetic stimulation, and now psychedelic-assisted psychotherapy. She is enthusiastic about the future of integrative healing models in the United States healthcare system. Jessica received her graduate degree in Clinical Research Administration from the George Washington University and resides in the Greater Philadelphia area in the United States.

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Jim Fries is a success-based executive with more than 25 years of experience building medical device and diagnostic companies across all pathways, including growth-oriented commercial initiatives, regulatory, and market access. Jim has been involved in driving thought-leader panels and committees within the areas of vascular intervention, cardiometabolics, diabetes, orthopedics, and pharmaceutical quality, which has resulted in numerous guidelines and consensus papers. Jim became CEO of Rx-360 in February of 2018, as a way of fulfilling his personal lifelong commitment to patient safety.

Marisa Sharkey

Harmony Biosciences
Director, Corporate Communications
 

Michael Frank

Memorial Sloan Kettering Cancer Center
Business Development and Digital Ventures Lead

Mikaella Gorelik

Bristol Myers Squibb
Executive Director, Global Procurement, Global Product Supply Operations

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Marisa is an Award-winning communications and public relations executive with proven experience leading organization-wide, integrated internal and external communications strategy development and execution, and managing direct reports. Corporate and consultancy background, with leadership team experience. Keen intuition and ability to cultivate relationships and influence colleagues and stakeholders in highly matrixed environments. Lean Six Sigma Yellow Belt, Certified Executive/Professional Coach and Accredited in Public Relations.

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Michael Frank is the Digital Ventures Lead in Memorial Sloan Kettering’s Office of Technology Development. He is a member of the Digital Health team in OTD’s Technology Management and Commercialization group.
Before joining MSK in 2021, Michael spent more than 15 years in life sciences and digital venture roles in the biopharmaceutical and management consulting industries. Most recently, he worked at Pfizer, Inc. as Senior Director, Breakthrough Change in the CEO’s Transformation/Innovation function. Earlier, Michael worked as a strategy consultant at Booz & Co (a PWC Company) and PA Consulting. He was also VP of technology at Phosplatin Therapeutics, a NYC biotech startup, and Director of BD and Commercial Operations at CombinatoRx.

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Mikaella Gorelik has 20+ years’ experience in the pharmaceutical industry, spanning across procurement, supply chain, operations, and business development. She is the Executive Director, Strategic Sourcing & Procurement at BMS, a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. Mikaella is responsible for strategic procurement of global direct materials for Biologics, Small Molecule and Cell Therapy, as well as Site Procurement Operations. She has extensive experience in developing supplier partnerships for mutual success of organizations.Mikaella lives in Bucks County, PA with her family. When Mikaella isn’t working hard at BMS, you’ll find her enjoying the outdoors with her family and friends.

Parviz Shamlou

Thomas Jefferson University
Executive Director, Jefferson Institute for Bioprocessing, Jefferson Institute for Bioprocessing

Rick Peevey

Elucida Oncology, Inc
Executive Director, Manufacturing's Operations & External Supply
 

Sheila Iyer

GlaxoSmithKline
Senior Director Supply Chain Planning and Strategy
 

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Marisa is an Award-winning communications and public relations executive with proven experience leading organization-wide, integrated internal and external communications strategy development and execution, and managing direct reports. Corporate and consultancy background, with leadership team experience. Keen intuition and ability to cultivate relationships and influence colleagues and stakeholders in highly matrixed environments. Lean Six Sigma Yellow Belt, Certified Executive/Professional Coach and Accredited in Public Relations.

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Rick is a technical operation professional, driven to develop and lead high-performing organizations and committed to the success of my teams and my colleagues. Rick is strongly committed to collaborating acrossfunctional lines and drive a vision for success. His diverse background and experience has enabled him to play a leading role in all aspects of the External Supply site and its development to its current state, as well as creating the vision for the future.

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Shelia is a GLOBAL SUPPLY CHAIN, PROCUREMENT, SOURCING leader with extensive experience across many life science, medical, and pharmaceutical related products, treatments and therapeutic areas. Proven at maximizing margins, improving forecasting accuracy, reducing costs, leveraging technology, and driving excellence. Earned a reputation for being a highly trusted, visionary, proactive business partner with excellent negotiating, presentation, organizational, communications, and analytical skills. Works with a “whatever-it-takes”, results oriented mindset. Comfortable with large-value negotiations and thrives in cross-functional, matrix environments.

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