Bill Hatfield is a biotechnology executive with over 20 years of experience in oncology leadership, commercial development, and marketing. He has led the commercial development and US launches of 10 oncology products, including Velcade at Millennium Pharmaceuticals where he achieved $100 million in sales in the first year. Currently he is Senior Vice President of Commercial Development at Karyopharm Therapeutics, leading the commercialization of Selinexor as a potential therapy for hematological malignancies and solid tumors.
Emerging economies are gaining increasing importance in the growth strategies of global life science companies, who are shifting their focus away from developed markets that have experienced a steady drop in growth opportunities. **Disclaimer: This article was previously published. Sciformix is now a Covance company.
Emerging economies are gaining increasing importance in the growth strategies of global life science companies, who are shifting their focus away from developed markets that have experienced a steady drop in growth opportunities. **Disclaimer: This article was previously published. Sciformix is now a Covance company.
This presentation provides a comprehensive overview of the current pharmaceutical industry. It begins with a look at some of the changes facing the industry and then moves into a discussion on digital technology and its impact on pharmaceutical companies. From there, the deck explores two digital trends, mobile and eDetailing. The presentation wraps up with some examples of pharmaceutical companies their digital presence.
Presentation by Ralph Foster II, AHMC's Vice President of Business Development, was given at the Med 2020 Forum in Muscat, Oman on October 27th. Mr. Foster's presentation gives an overview of Opportunities in Private Healthcare in the GCC Region.
Nutriband is a transdermal focused pharmaceutical company based in the United States with a goal to improve the safety, comfort and efficacy of existing drugs using transdermal technologies. The Company is developing a pharmaceutical pipeline to improve drug delivery technologies and capabilities for patients, physicians, and payers through transdermal delivery technologies. Nutriband’s lead product is its AVERSA® technology. AVERSA® abuse deterrent transdermal technology incorporates aversive agents to prevent the Abuse, DiVERsion, MiSuse and Accidental exposure of drugs with abuse potential, such as opioids. The Company’s first application for AVERSA® is an abuse deterrent fentanyl transdermal patch which it is developing to provide clinicians and patients a safe extended-release patch for chronic pain. The goal is to make opioid based pain treatments safe for all who need them. AVERSA technology has received patent protection in the European Union, Australia, Japan, Mexico, Russia with patent prosecution in the US and Canada. Nutriband has made sure to target all large applicable markets and its global patent protection has opened up many opportunities for the Company to make a big impact on the safety profile of drugs globally.
Trailblazing scientists who are the backbone of our industry. These are the people that discover the molecules and develop the medicines to tackle the toughest diseases we face in society.
While development of promising new products is an obvious area of focus for big pharma, there is also great pressure to grow or sustain revenue from established/mature products whilst keeping maintenance costs low. This whitepaper discusses how regulatory compliance and reducing product risk can be achieved whilst still working within these cost constraints. It also lays out why marketing authorization holders (MAH) should analyze their existing operating models for maintaining mature products and how they can benefit from an integrated safety, regulatory and benefit-risk model.
Presentation by NEPAD Agency on the African Medicines Regulatory Harmonisation made at the Euro-Africa Health Investment Conference, March 26 - 27, 2013, London, United Kingdom.
Healthcare and Business Advantage: the Case of SanofiJoseph Pategou
Leading Competitive Intelligence: Turn Strategic & Technologic watches into business advantage
The What : Using CI investments and initiatives to in order to collect, process and store information to be made available to all people at all levels of the firm to help shape its future.
The How : successful competitive intelligence execution depends as much on how firms manage competitive intelligence than solely implementing CI processes, if not more.
This presentation provides a comprehensive overview of the current pharmaceutical industry. It begins with a look at some of the changes facing the industry and then moves into a discussion on digital technology and its impact on pharmaceutical companies. From there, the deck explores two digital trends, mobile and eDetailing. The presentation wraps up with some examples of pharmaceutical companies their digital presence.
Presentation by Ralph Foster II, AHMC's Vice President of Business Development, was given at the Med 2020 Forum in Muscat, Oman on October 27th. Mr. Foster's presentation gives an overview of Opportunities in Private Healthcare in the GCC Region.
Nutriband is a transdermal focused pharmaceutical company based in the United States with a goal to improve the safety, comfort and efficacy of existing drugs using transdermal technologies. The Company is developing a pharmaceutical pipeline to improve drug delivery technologies and capabilities for patients, physicians, and payers through transdermal delivery technologies. Nutriband’s lead product is its AVERSA® technology. AVERSA® abuse deterrent transdermal technology incorporates aversive agents to prevent the Abuse, DiVERsion, MiSuse and Accidental exposure of drugs with abuse potential, such as opioids. The Company’s first application for AVERSA® is an abuse deterrent fentanyl transdermal patch which it is developing to provide clinicians and patients a safe extended-release patch for chronic pain. The goal is to make opioid based pain treatments safe for all who need them. AVERSA technology has received patent protection in the European Union, Australia, Japan, Mexico, Russia with patent prosecution in the US and Canada. Nutriband has made sure to target all large applicable markets and its global patent protection has opened up many opportunities for the Company to make a big impact on the safety profile of drugs globally.
Trailblazing scientists who are the backbone of our industry. These are the people that discover the molecules and develop the medicines to tackle the toughest diseases we face in society.
While development of promising new products is an obvious area of focus for big pharma, there is also great pressure to grow or sustain revenue from established/mature products whilst keeping maintenance costs low. This whitepaper discusses how regulatory compliance and reducing product risk can be achieved whilst still working within these cost constraints. It also lays out why marketing authorization holders (MAH) should analyze their existing operating models for maintaining mature products and how they can benefit from an integrated safety, regulatory and benefit-risk model.
Presentation by NEPAD Agency on the African Medicines Regulatory Harmonisation made at the Euro-Africa Health Investment Conference, March 26 - 27, 2013, London, United Kingdom.
Healthcare and Business Advantage: the Case of SanofiJoseph Pategou
Leading Competitive Intelligence: Turn Strategic & Technologic watches into business advantage
The What : Using CI investments and initiatives to in order to collect, process and store information to be made available to all people at all levels of the firm to help shape its future.
The How : successful competitive intelligence execution depends as much on how firms manage competitive intelligence than solely implementing CI processes, if not more.
Viral Clearance Testing Market Will Hit Big Revenues in Futuretonnystark14
The Global Viral Clearance Testing market is projected to grow at a CAGR of around 20.10% during the forecast period, i.e., 2023-28. With expanding consumer appetite for biopharmaceutical products, strict regulatory control, and a surge in viral infection rates globally, the market has grown significantly in the past decade, and this trend is expected to continue in the coming year. The prevalence of several viral infections, such as Coronavirus, H1N1, and others, is growing globally, causing companies to manufacture & develop drugs. Due to the government's stringent regulations, this testing is an essential step to ensure the safety & efficacy of biopharmaceutical products, which may be contaminated with viruses, driving demand for this testing & propelling its market expansion.
CAREER OVERVIEW
I am a pharmaceutical management professional with experience of 8 years in the pharmaceutical sales and marketing, 1.5 years in administrative corporate management, 5 years in the research and development innovation project management, 1.5 years as a Medical Director, and one year as a CRO Managing Director. I have worked in multinational and Egyptian pharmaceutical companies with a proven track record of developing new business and motivating cross-functional teams to consistently achieve action plans. I've completed a Doctorate of Business Administration with distinction and looking for interesting opportunities in the pharmaceutical research field in which my skills set can add value to an organization with the goal of benefiting humanity. I am willing to relocate.
1. Bill Hatfield
96 North Street, Topsfield, MA 01983
Residence: (978) 887-0037 • Cell: (617) 943-9419 • fields3@comcast.net
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Biotechnology Executive
General Management • Oncology Marketing • Commercial Strategy • Product Development
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• Healthcare executive with commercial experience in biotech, pharmaceutical and medical equipment industries.
Twenty years of oncology leadership, program management, commercial development and marketing.
• Led the commercial development of 10 oncology products for the treatment of hematologic malignancies or solid
tumors including the US launch of Velcade.
• Developed and expanded the initial U.S. oncology marketing groups at Genzyme, Millennium and Sanofi.
• Experienced in building marketing and commercial organizations, planning and executing product launches,
leading global and US commercial organizations, managing partnerships, business development via product and
company acquisitions, providing commercial input on development stage products.
PROFESSIONAL EXPERIENCE
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KARYOPHARM THERAPEUTICS NEWTON, MA 2015 – Present
Senior Vice President, Commercial Development
Lead commercialization of Selinexor as a potential therapy for treatment for hematological malignancies and solid tumors
and the commercial development of SINE pipeline for additional potential indications for inflammation, autoimmune
disease certain viruses and wound-healing.
SANOFI ONCOLOGY CAMBRIDGE, MA 2011-2015
Vice President, New Products Strategy 2014–2015
Established global commercial team to provide strategic input to oncology management team, business development
organization and early stage project teams to rebuild Sanofi’s oncology pipeline.
• Led 9- person team consisting of commercial leads, market research, value and access, and medical affairs to
support senior management review of portfolio of 10 clinical stage oncology assets, resulting in advancement of
C-Met inhibitor to registration trial for NSCLC, clinical study of kinase inhibitors in CRC and HCC and 3ADCs
in breast cancer, NSCLC, CRC, ovarian and gastric cancers, closure of 4 programs, while establishing clear
go/no go criteria with Merck Serono on 2 clinical collaborations.
• Represented Sanofi as a member of the joint steering committee and joint project teams with partner companies
including Merck Serono, and Abbott Diagnostics responsible for managing the development of shared programs.
• Provided commercial and strategic input to business development assessment of multiple opportunities to enter
the field of immune-oncology via acquisitions of assets or collaborations with leading pharmaceutical and
biotechnology companies and academic institutions.
Vice President, Project Lead Fedratinib 2013–2014
Assumed responsibility for overall management of phase III program and project team during a time of crisis.
• Oversaw project team investigation of safety signal arising out of clinical trials and closure of program.
o Consulted with DSMB, neurology experts, steering committee, investigators and FDA on the
interpretation of Wernicke’s like symptoms and supported presentation of data to Sanofi senior
management resulting in decision to terminate development.
o Executed discontinuation of clinical development including communications to investigators, KOL and
patient advocacy.
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2. o Communicated clinical data to Incyte and Novartis to ensure the safety and facilitated access of 300
patients to alternative MF therapies.
o Provided direction to project team in preparation and submission of final clinical reports to FDA.
Bill Hatfield
Vice President, Global Commercial Lead Fedratinib 2011–2013
Developed and executed the global brand strategy for Fedratinib, JAK2 inhibitor for the treatment of myelofibrosis.
• Established global brand team and developed presentation to Sanofi senior management to define commercial
strategy, positioning, messaging, pre-launch market development and launch plan for Fedratinib to gain approval
of US and European launch strategy and resources.
• Coordinated with clinical operations and medical affairs to raise awareness of company sponsored trials resulting
in enrollment of over 300 patients and on appropriate communications of emerging phase I, II and III data at
major conferences.
• Led project team through refinement of global KOL prioritization and engagement plans, the development of
MPN Centers of Excellence, Expanded Access Program, and Patient Support Program.
• Collaborated with Sanofi EVD and access teams to develop core dossier and presented value proposition to NICE.
• Led team through CFMD process, recommended clinical development strategy and obtained Sanofi Oncology
endorsement and budget to support 20 investigator sponsored trials and for scientific collaborations with 10
leading academic centers focused on advancing an understanding of the biology and clinical implications of
myelofibrosis.
GENZYME CAMBRIDGE, MA 2006-2011
Vice President, General Manager Clolar/Evoltra 2010–2011
Led project team responsible for the development and execution of the global brand strategy for Clolar/Evoltra including
clinical and regulatory strategy, commercialization, and life-cycle management.
• Provided global marketing plan to guide local execution in 43 countries and maintained adherence to global
pricing to achieve 2011 WW revenue of $130 million, while managing a $56 million budget and delivering an
operating margin of >$50 million.
• Refined clinical development and commercial strategy to pursue indication for treatment of adult acute leukemias
through the support of multiple US and European cooperative group phase III trials.
• Coordinated with medical affairs team on appropriate communications of emerging clinical data from company
sponsored phase III trial and over 70 investigator initiated trials including presentations of data at major medical
conferences, publications and scientific exchange via field based Medical Science Liaison teams in US, European
and International markets.
• Developed lifecycle plan including an investigational trial program to evaluate clofarabine in the setting of bone
marrow transplant via 15 ISTs and a clinical development and regulatory strategy for oral formulation focused on
MDS and NHL opportunities.
Vice President U.S. Marketing, Transplant & Oncology 2009–2010
Responsible for the development and execution of the US commercial and marketing strategies for the Genzyme
Transplant and Oncology product portfolio.
• Directed 22 person team responsible for marketing, market research and commercial services for 6 products in
hematology/oncology, bone marrow transplantation and solid organ transplantation and delivered $380 million in
2010 revenue while managing a $23 million budget.
• Oversaw commercial teams responsible for planning the U.S. launch of an adult AML indication for Clolar.
• Developed the commercial plan for expansion of Thymoglobulin into the U.S. GVHD/BMT market.
• Stabilized the declining performance of products acquired from Bayer by revised positioning of Campath to focus
on high risk CLL patients, improved Leukine account contracting strategies and process to compete with Amgen
on selected accounts.
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3. • Leveraged emerging health economic data and realigned field force to broaden the adoption of Mozobil in support
of multiple myeloma and Non Hodgkins lymphoma patients undergoing transplantation.
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4. Bill Hatfield
Vice President Global Marketing Transplant & Oncology 2008–2009
Managed 27 person team responsible for global strategy, marketing, market research, reimbursement and commercial
services for the Genzyme Transplant and Oncology product portfolio.
• Supported Genzyme’s acquisition of Campath, Fludara and Leukine from Bayer Schering Pharmaceuticals.
• Member of senior management team that developed a new commercial organization including building up the
U.S. field sales organization from 25 to 90 and establishing the pan European and in-country organization
structure and staffing.
• Managed global team responsible for developing and executing marketing plans for the in-line and acquired
products, including the European launch of Mozobil for mobilization of patients undergoing autologous HSCT,
the launch of Clolar in Canada, Australia, and Israel, and the integration of Campath, Fludara and Leukine
• Provided commercial input to Genzyme team responsible for filing a U.S. SNDA for an adult AML indication for
Clolar and presenting to the FDA and ODAC.
• Primary interface with Genzyme Genetics business unit to develop personalized medicine strategies for acute and
chronic leukemias.
Senior Director U.S. Marketing, Oncology 2006–2008
Established Genzyme’s US oncology commercial team, developed US business plan, brand plans and supported field
execution through Genzyme’s oncology sales force, medical science liaisons, and Berlex’s commercial and field teams.
• Directed 8 person team responsible for marketing, market research, reimbursement and commercial services.
• Developed commercial plan to expand Clolar beyond pediatric indication to the adult acute leukemia market
• Managed Genzyme’s relationship with commercial partner, Bayer Schering Pharmaceuticals, on the U.S.
marketing and sales of Campath including the expansion of Campath’s indication from 3rd
line to 1st
line treatment
of CLL the U.S. launch of front line indication
• Supported Genzyme’s acquisition of Bioenvision to obtain ex-U.S. rights to Clolar and collaborated with regional
management on the development of the European and Latin American teams to market Clolar
MILLENNIUM PHARMACEUTICALS CAMBRIDGE, MA 1999-2005
Senior Director U.S. Marketing Velcade 2004–2005
Directed all aspects of the U.S. marketing to establish Velcade (bortezomib) as standard of care for relapsed multiple
myeloma.
• Achieved US sales of $200 million from niche indication while directing 8 person marketing group and managing
a $22 million budget including on-label promotion and continuing medical education.
• Executed tactical programs key to commercial success including; training and direction to 70 person sales force,
developing relationships with U.S. Oncology, ION, NOA, Oncology Associates and the VA, funding CME
symposia at ASH and ASCO, regional CME meetings, internet based educational programs for MDs and nurses,
patient advocacy activities through MMRF and IMF, supporting development of > 50 clinical trials, presentation
of data at major medical meetings and execution of publication plan, organizing key opinion leader advisory
boards and regional advisory consulting meetings, and obtaining the optimal positioning of VELCADE in NCCN
guidelines and compendia to facilitate reimbursement.
• Authored new product labeling with clinical and regulatory affairs and launched expanded indication for the
treatment of 2nd
line multiple myeloma.
• Chaired multiple myeloma strategy team, cross functional committee accountable for development of clinical,
regulatory and commercialization plan to optimize therapy for front line and relapsed disease.
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5. Bill Hatfield
Director of Marketing – Oncology 2002–2004
Led the U.S. launch of Velcade for the treatment of multiple myeloma and achieved $100 million in U.S. sales during first
12 months on market in niche relapsed, refractory indication. Velcade was recognized as one of the top 10 product
launches during 2003-2004.
• Led cross functional launch team including marketing, sales, market research, medical affairs, patient advocacy,
public relations, commercial manufacturing, reimbursement, regulatory affairs, and legal and managed $13
million commercial launch budget.
• Played key role in defining the Millennium commercial organization, recruiting and training of 70 person
oncology sales force, 13 person medical scientific liaison field team, medical affairs, reimbursement and patient
advocacy functions.
• Authored product labeling with clinical and regulatory affairs, developed core brand elements including trade
name, generic name, commercial packaging, product positioning, promotional messages and creative platform,
negotiated pre-clearance of launch promotional materials with FDA and delivered them to the sales force within
45 days of approval.
Director of Commercial Development 1999–2002
Informed the commercial development of clinical stage oncology products. Recognized with Millennium’s Outstanding
Contributor Award in 2000 for role in the approval and launch of Campath.
• Founding member of Oncology Business Team responsible for development and implementation of annual
business plans for the Millennium oncology franchise.
• Project Manager for Campath (alemtuzumab) on Millennium team that gained FDA and EMEA approvals and
launched product through Schering AG/Berlex in U.S. and Europe. Responsible for managing relationships with
development partner ILEX and marketing partner Schering AG/Berlex. Product achieved launch year sales goal
of $28 million during 6 months ending December 2001.
• Developed valuation of Campath to support restructuring of business arrangement with ILEX.
SANOFI (Formerly STERLING WINTHROP PHARMACEUTICALS) NY, NY 1988-1999
Director of Business Development 1998-1999
Supported U.S. licensing activity for oncology business including in-license and acquisition of products, co-promotion
of products, strategic partnering and acquisition of companies.
Director of Marketing, Oncology 1996-1998
Built Sanofi’s oncology marketing team and directed the commercialization of Sanofi oncology products in the U.S.
including the launch Photofrin (Porfimer sodium), a novel treatment for esophageal cancer, launch plans for Zyrkamine
(MGBG) for the treatment of AIDS related non-Hodgkin’s Lymphoma and the commercial planning for Eloxatin
(oxaliplatin) for colorectal cancer, urate oxidase for chemotherapy induced hyperuricemia, and Tirazone (tirapazamine)
for non-small cell lung cancer.
PRIOR EXPERIENCE; Business development, product management, market research, national accounts and sales at
Sanofi, Sterling Drug, Honeywell Medical Electronics and Bristol Myers.
EDUCATION
BOSTON UNIVERSITY, SCHOOL OF MANAGEMENT BOSTON, MA
Degree: BS in Business Administration, Major in Marketing
Graduated Magna Cum Laude
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6. Bill Hatfield
Director of Marketing – Oncology 2002–2004
Led the U.S. launch of Velcade for the treatment of multiple myeloma and achieved $100 million in U.S. sales during first
12 months on market in niche relapsed, refractory indication. Velcade was recognized as one of the top 10 product
launches during 2003-2004.
• Led cross functional launch team including marketing, sales, market research, medical affairs, patient advocacy,
public relations, commercial manufacturing, reimbursement, regulatory affairs, and legal and managed $13
million commercial launch budget.
• Played key role in defining the Millennium commercial organization, recruiting and training of 70 person
oncology sales force, 13 person medical scientific liaison field team, medical affairs, reimbursement and patient
advocacy functions.
• Authored product labeling with clinical and regulatory affairs, developed core brand elements including trade
name, generic name, commercial packaging, product positioning, promotional messages and creative platform,
negotiated pre-clearance of launch promotional materials with FDA and delivered them to the sales force within
45 days of approval.
Director of Commercial Development 1999–2002
Informed the commercial development of clinical stage oncology products. Recognized with Millennium’s Outstanding
Contributor Award in 2000 for role in the approval and launch of Campath.
• Founding member of Oncology Business Team responsible for development and implementation of annual
business plans for the Millennium oncology franchise.
• Project Manager for Campath (alemtuzumab) on Millennium team that gained FDA and EMEA approvals and
launched product through Schering AG/Berlex in U.S. and Europe. Responsible for managing relationships with
development partner ILEX and marketing partner Schering AG/Berlex. Product achieved launch year sales goal
of $28 million during 6 months ending December 2001.
• Developed valuation of Campath to support restructuring of business arrangement with ILEX.
SANOFI (Formerly STERLING WINTHROP PHARMACEUTICALS) NY, NY 1988-1999
Director of Business Development 1998-1999
Supported U.S. licensing activity for oncology business including in-license and acquisition of products, co-promotion
of products, strategic partnering and acquisition of companies.
Director of Marketing, Oncology 1996-1998
Built Sanofi’s oncology marketing team and directed the commercialization of Sanofi oncology products in the U.S.
including the launch Photofrin (Porfimer sodium), a novel treatment for esophageal cancer, launch plans for Zyrkamine
(MGBG) for the treatment of AIDS related non-Hodgkin’s Lymphoma and the commercial planning for Eloxatin
(oxaliplatin) for colorectal cancer, urate oxidase for chemotherapy induced hyperuricemia, and Tirazone (tirapazamine)
for non-small cell lung cancer.
PRIOR EXPERIENCE; Business development, product management, market research, national accounts and sales at
Sanofi, Sterling Drug, Honeywell Medical Electronics and Bristol Myers.
EDUCATION
BOSTON UNIVERSITY, SCHOOL OF MANAGEMENT BOSTON, MA
Degree: BS in Business Administration, Major in Marketing
Graduated Magna Cum Laude
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