Chris Danek

PHD, MBA, CEO of Bessel

Chris Danek, PHD, MBA, CEO of Bessel, is an entrepreneur and life sciences industry veteran. Chris believes in empowering medical device startups to deliver breakthroughs that scale. Trained in business and engineering, with over two decades of experience developing breakthrough technologies, Chris developed Powered by Bessel^TM, an intensive program with specialized workshops and consulting for medtech startups to boost their strategy, execution, and fundraising. Before starting Bessel, Chris led or contributed to the development of an array of clinically and commercially successful medical technologies as an independent consultant, as CEO and later CTO of AtheroMed (now Philips AtheroMed), and as VP, R&D of Asthmatx (Boston Scientific). He is an inventor of over 90 U.S. patents.

Andres Gutierrez

MSME, Bessel R&D Lead

Andres Gutierrez, MSME, Bessel R&D Lead, combines his experience in digital engineering (CAD and simulation tools) with fabrication knowledge for prototyping and design for manufacturing. Before joining Bessel, Andres designed cables and wire performance products for OEM customers at BizLink Group, supporting development from design to sourcing to production. Andres has a BS and MS in mechanical engineering from the University of Texas at El Paso and a graduate certificate in 3D Engineering and Additive Manufacturing from the UTEP Keck Center. While at UTEP, he was a graduate fellow at the Mike Loya Center for Innovation and Commerce. Andres has multiple patents pending for the innovative designs he has created for Bessel clients.

John Barrett

Advisor

John Barrett is the founder and principal at PhysisPD Consulting LLC, a Bessel partner. He is a senior executive experienced in strategic planning, organizational development, project management, innovation, product development, engineering, manufacturing, M&A, tech transfer, and portfolio lifecycle management.
As an executive leader, John contributed to the growth of Integra Lifesciences and Terumo Medical Corporation’s businesses. John has a track record of introducing innovation through internal R&D and strategic acquisitions and successfully scaling manufacturing while improving margins. He has been a key participant, from due diligence and contract negotiation to integration, in a broad range of M&A deals exceeding $1B. Today, John uses his background and experience to support the growth of early-stage businesses, tech transfer from the clinic to early-stage business, and the strategic growth needs of medical device and life science companies. He is a Board Member of the Chester County Economic Development Council Ideas X Innovation organization supporting the growth of entrepreneurial opportunities in the southeast Pennsylvania region. John holds a BS in Chemical Engineering from the Catholic University of America, an MBA from Loyola University, and an MS in Engineering from Johns Hopkins.

Nandini Venkatesh

Advisor

Nandini Venkatesh is a former Director of Product Management with 20+ years of strategic marketing and product management experience in the medical device industry at companies such as Medtronic, Boston Scientific, and J&J. For the past 15 years, Nandini has served as a strategic and commercial marketing consultant to a range of medtech clients, from early-stage start-ups to Fortune 500 companies. Her voice of customer insights and go-to-market planning are valued by Bessel clients. She is a strong global commercial leader with a track record of identifying new markets, partnering with R&D on product innovation, and launching novel medical technologies to healthcare professionals and patients. Nandini holds a BS in Civil & Environmental Engineering from UC Berkeley and an MBA from Stanford University.

Christopher St. Pierre

MBA, Advisor

Chris St. Pierre has twenty-plus years of venture-backed, growth-stage company experience, from research & development to commercialization, sales, and marketing leadership to venture funding to clinical study oversight in the U.S. and Germany, with a focus on biomedical and technology sectors.​​
Early in his career, he worked in Cardiology at the Medical Center of Louisiana – New Orleans and later followed a clinical-to-commercial personal career arc, putting patient and provider at the center of med-tech innovation and commercialization efforts with companies spun out of research associated with Emory, U.C. Berkley, and Stanford. He is the Co-Founder of Resolve Molecular Diagnostics. He currently serves on the Mentor Board for early-stage companies in the Real Advice Mentoring Program (RAMP) in the University of South Alabama’s Office of Research and Innovation. Mr. St. Pierre studied Microbiology at Louisiana State University and earned a Bachelor of Science in Cardiopulmonary Sciences from Louisiana State University Medical Center, Health Sciences Center – New Orleans, followed by earning a Master of Business Administration from Tulane University’s A. B. Freeman School of Business in New Orleans. He later completed the Emory University School of Medicine / Georgia Institute of Technology Mini-Med School Continuing Education program for Bio-Medical Science and Engineering.

Jeremiah J. Kelly

Partner
jkelly@Venable.com

Washington, DC | +1 202.344.4638

Jeremiah Kelly’s practice centers on helping companies navigate the complexities of the U.S. Food and Drug Administration’s (FDA) regulation of drugs, biologics, medical devices, and combination products. Jeremiah helps companies from “bench to bedside.” He supports companies along the development and commercialization pathway, from pre-clinical, clinical, and pre-market applications for FDA approval, licensure, clearance, or authorization to post-market compliance. Prior to joining Venable, Jeremiah served as the chief of the FDA Regulatory Law Division in the Office of the Staff Judge Advocate (JAG), U.S. Army Medical Research and Development Command (USAMRDC), and in the FDA Office of the Commissioner.

Justin A. Coen

Partner

jcoen@Venable.com
Washington, DC | +1 202.344.4639

Justin Coen specializes in guiding companies through the complexities of drug, biologic, and device development regulated by the U.S. Food and Drug Administration (FDA). He advises clients on every stage of product development, pre-and post-approval regulatory compliance, and commercialization strategies. Justin also has extensive experience negotiating research and development agreements, licenses, and purchase contracts, including contracts with the federal government. Prior to joining Venable, Justin served as a senior regulatory attorney at the Office of the Staff Judge Advocate (JAG), U.S. Army Medical Research and Development Command (USAMRDC), and he has advised the U.S. Senate Committee on Finance.

Christopher P. Borello

Partner

cborello@venable.com
New York, NY | +1 212.218.2574

Chris Borello is an intellectual property attorney who focuses on patent litigation and counseling clients on offensive and defensive patent strategies and patent portfolio development. Chris works on a broad range of technologies, including pharmaceuticals, biologics, biotechnology, computer technology, and mechanical devices. Chris has litigated patent disputes from inception through trial, including as lead trial counsel.

Alicia A. Russo

Partner

arusso@Venable.com

New York, NY | +1 212.218.2568

Alicia Russo is co-chair of Venable’s Intellectual Property Transactions Group. Alicia has significant experience in IP due diligence and licensing associated with high-profile acquisitions. She has represented clients in complex patent litigation and contested proceedings before the United States Patent and Trademark Office (USPTO), and has secured patents for clients in numerous technical fields. She focuses on biologics and small-molecule pharmaceuticals, informed by her prior work in medical research. Alicia also advises clients on matters related to energy, fiber technology, building materials, biotechnology, and bioinformatics.

Prajakta A. Sonalker, Ph.D.

Partner

psonalker@Venable.com
New York, NY | +1 212.503.0871

Prajakta Sonalker focuses her practice on complex intellectual property litigation, including patent and trade secret disputes, with an emphasis on biotechnology and pharmaceuticals. Prajakta has experience in all stages of litigation, from pre-suit investigations through trial and appeals, and proceedings before the Patent Trial and Appeal Board (PTAB). She counsels clients on a variety of technologies, including cell and gene therapies, vaccines, antisense oligonucleotides, RNA interference, biologics, small molecules, pharmaceuticals, and medical devices. Prajakta also advises clients on patent licensing and due diligence, and assists clients in multijurisdictional and parallel proceedings outside the U.S.

William N. Haddad

Partner

wnhaddad@Venable.com
New York, NY | +1 212.503.9812

Bill Haddad is a corporate attorney who handles the full range of securities offerings and corporate transactions. Bill focuses on securities, public and private financings, mergers and acquisitions, and general corporate matters, including joint ventures, partnerships, and corporate formations. His clients include privately held and publicly traded companies, family offices, venture capital firms, investment banks, financial institutions, and private equity sponsors – especially in the United States, Asia, Europe, and Australia.

James E. Nelson

Partner

jnelson@Venable.com
San Francisco, CA | +1 415.653.3730

Jim Nelson is a co-chair of the Technology, Media, and Commercial Group, member of the firm’s Management Committee, and partner-in-charge of Venable’s San Francisco office. Jim focuses on intellectual property-centered businesses that emphasize the development, production, and commercialization of IP assets. He manages a range of commercial contract and outsourcing engagements, in addition to general corporate work forming and financing companies and supporting them in mergers, sales, acquisitions, and joint ventures. His clients range from emerging growth to Fortune 50 companies—often located or acting globally—in technology, media and entertainment, music, life sciences, financial services, and hospitality, among others.

Patrick McCarthy, Esq.

Chief Executive Officer

Patrick McCarthy is an entrepreneur at heart. He brings over 30 years of positive disruption and transformational leadership in multiple segments of healthcare — from “start-up” to Fortune 50 companies and numerous clinical product franchises. As co-founder of Validcare in 2014, he led the re-engineering of the CRO model — providing simplified, compliant solutions that actually deliver an exceptional CRO experience for sponsors, investigators, and participants.

Rodney K. Nuss

Chief Operating Officer<

Rod Nuss is an entrepreneur whose passion is delivering innovative solutions that transform healthcare. He has owned a medical device manufacturing/distribution company, built products from concept to commercialization, and led the strategic development of a key IDN. His experience spans the medical device and specialty pharmaceutical sectors. In 2014, Rod co-founded Validcare.

Tigran Arzumanov

Chief Business Officer

Tigran Arzumanov is the Chief Business Officer at Validcare, leading partnerships and business development in clinical trials and patient-focused healthcare. He specializes in bringing stakeholders together to drive innovation and progress in life sciences.

Eduard Malayan

Business Development Specialist

Eduard Malayan is a Business Development Specialist with a focus on drug development, clinical trials, and eClinical solutions. He excels at building strategic partnerships and driving growth in the life sciences sector.

Stefan Czyniewski
Stefan Czyniewski is a seasoned clinical research professional with over two decades of experience in the medical device industry. He co-founded Mobius Medical in 2008, where he serves as Clinical Director and CEO of Mobius Medical USA Inc. In these roles, Stefan oversees clinical trial design and management, site feasibility, monitoring, data management, and quality assurance.
Prior to establishing Mobius Medical, Stefan was the Clinical and Scientific Research Manager at Ventracor Limited, focusing on clinical trials for the VentrAssist Left Ventricular Assist Device (LVAD). He also held positions at the NHMRC Clinical Trials Centre.
Stefan holds a Bachelor of Medical Science from the University of Sydney and an MBA from the University of Sydney Business School. Under his leadership, Mobius Medical expanded into the U.S. market in 2023, opening an office in Minneapolis to better serve its American clients. This strategic move underscores Stefan’s commitment to advancing clinical research and supporting the development of innovative medical technologies globally.

David Pomfret
David Pomfret, RPh, brings over three decades of leadership experience in clinical operations, regulatory affairs, and medical device development to his role at Mobius Medical. As Vice President of Clinical Operations – US, David oversees the execution of first-in-human and early-stage clinical trials, ensuring seamless support throughout the lifecycle of client programs.
Prior to joining Mobius, David held key leadership positions at Conformal Medical and VDyne, driving global clinical development initiatives. His extensive career includes expertise in regulatory submissions, site management, and trial oversight across therapeutic areas, with a focus on innovative cardiovascular technologies. With a proven track record in both operational strategy and hands-on execution, David is a trusted partner for medtech innovators navigating complex clinical and regulatory landscapes.

John L. Ajello, Rplu

Medmarc | Vice President, Business Development and Marketing

John Ajello has over 30 years of experience in underwriting, underwriting management, and program leadership with specialty insurance companies. He joined Medmarc in 2010 as the Underwriting Manager, where he was responsible for program management and leading the life sciences underwriting team. In January 2017, John transitioned to the Sales & Marketing Department, where he now leads the business development, distribution, company alliances, and marketing efforts while continuing to serve as the primary contact for Medmarc’s reinsurance treaty. John earned his Bachelor of Arts degree in Government from the College of William and Mary in Williamsburg, Virginia.

Lynn Carney

Medmarc | Director of Agency and Alliances

Lynn Carney has extensive experience in the insurance industry. She joined Medmarc in 2007, starting as the Manager of the Marketing and Business Development Department and later advancing to the Director of Agency and Alliances. Prior to her time at Medmarc, Lynn worked as a Producer at Kerxton Insurance Agency from 2000 to 2007. She began her career in 1996 at Preferred Insurance Associates, where she served as President until 2000. Lynn holds a Bachelor of Science degree in Animal Science from Virginia Tech.

Edwin Coker

Higginbotham | Managing Director

Edwin (Ed) Coker is one of 42 managing directors at Higginbotham, selected to lead the firm since 2004. He managed the Denton sales operations until the 2012 consolidation and maintains a significant commercial insurance portfolio. With extensive experience in brokerage and risk management in high tech, manufacturing, and real estate, he co-founded Higginbotham’s Life Sciences Risk & Insurance Practice for pharmaceutical companies. Before joining Higginbotham in 1994, Ed worked in underwriting and marketing with several insurance firms. Ed is involved with Child Protective Services and local philanthropic organizations and holds a BBA in Insurance and Risk Management from the University of North Texas. He is a Certified Insurance Counselor (CIC).

Bryant Rutledge

Higginbotham | Vice President- Business Insurance

Bryant Rutledge is a commercial insurance broker specializing in the Life Science and Healthcare industries, working with both start-up R&D firms and publicly traded companies. He joined Higginbotham in March 2020 and previously spent six years in the medical device industry with Stryker Orthopaedics. A board member of BioMedSA, he actively serves on various committees. Bryant earned his Bachelor’s in Kinesiology from Angelo State University in 2013, where he played collegiate baseball and was team captain, and completed his Master’s in Sport Administration in 2015, being recognized as academic student of the year.

S. Wade Johnson

Shareholder

Denver, CO | 720.931.8134

wadejohnson@polsinelli.com

Wade Johnson is a shareholder in the Science and Technology practice at Polsinelli. He practices in the areas of patent preparation and prosecution, patent post-grant proceedings and litigation, patent opinions, and intellectual property licensing and acquisition. Wade’s clients are located across the country and internationally and cover the spectrum from universities and startups to Fortune 500 companies.
Capabilities

• Digital Health
• Electrical Engineering & Computer Science Patent Prosecution

Wade is a licensed professional engineer with over eight years of real world engineering experience prior to graduating from law school.
As a patent attorney, Wade has patent prosecution and opinion experience in the areas of mechanical devices and systems, electromechanical devices, microprocessor controlled systems, electrical devices and systems, wireless communication systems, and software.

Intellectual Property

• Counseling & Opinions
• Licensing & Transactions
• Life Sciences
• Mechanical Engineering & Medical Devices Patent Prosecution
• Medical Devices
• Patent Preparation & Prosecution
• Technology

For over two decades, Wade has primarily focused his patent practice on medicaltechnology. As a result, he understands the complex interplay between the realms of patent, FDA, reimbursement and engineering. This understanding is absolutely critical in developing successful patent strategies for medical technologies that typically exist in crowded prior art areas.
Wade guest lectures on medical technology patent strategies for graduate programs of a number of universities, medical technology entrepreneur organizations and international medical associations.

Wade’s medical technology patent experience includes, but is not limited to, the following:

• Cardiac ablation
• Cardiac stents and associated delivery tools
• Implantable pulse generators, leads and associated delivery tools for cardiac and pain management applications
• Programmers for programming implanted pulse generators
• Cardiac patient management
• Heart valves
• Robotic systems for heart valve implantation
• Aneurysm treatment
• Blood clot removal
• Joint replacement implants
• Spine implants
• Surgical planning and simulation
• Robotic systems for spine, orthopedic and colon surgeries
• Medical imaging including MRI, CT and echocardiography
• Ophthalmological examination, surgery and implants
• Endoscopic and laparoscopic surgeries
• Biopsies
• Carpal and cubital tunnel surgeries
• Oral health products
• Dental tools and implants
• Intubation
• Surgical filters
• Wound healing
• Medicament administration including via injection, infusion and transdermal delivery
• Prosthetics
• Laboratory processing
• Surgical tables
• Patient transporting
• Medical fluid pathway connectors and valves
• Bone substitute materials
• Stem cell harvesting
• Breast health monitoring and tumor detection
• Liposuction
• Physical therapy
• Diabetic neuropathy treatment
• Systems for managing epilepsy
• Medical data mining
• Medical facility communication systems
• Health monitoring, diagnostic and treatment systems employing photoplethysmography
• Electrostatic filtration systems for breathing apparatus, HVAC and other uses in medical, laboratory, CBRN and other environments

Education

• University of Montana (J.D., high honors, 2001)
• CALI Awards for Excellence in Legal Analysis and Legal Writing
• James H. Kilbourne Award for Excellence in Legal Writing
• Brigham Young University (B.S., 1991)
• Mechanical Engineering Bar Admissions
• Admitted to practice before the United States Patent and Trademark Office
• Colorado
• Montana

Memberships

• Colorado Bar Association
• Intellectual Property Section
• American Intellectual Property Law Association
• Montana State Bar Association Recognition
• Selected for inclusion in Best Lawyers in America for Patent Law, 2024-2025
• Selected for inclusion in the IAM Patent 1000 list of the World’s Leading Patent Practitioners, 2022-2024, Colorado – Recommended Prosecution
• Professional Engineer, Montana State Board of Professional Engineers, 1996
• Professional Engineer, Colorado State Board of Professional Engineers, 1997
• Selected for inclusion in IAM Patent 1000, 2013-2021

Shareholder

Boston, MA | 617.406.0354
jarak@polsinelli.com

Jeremy Arak provides timely, pragmatic advice to emerging growth companies and investors across a wide array of industries. Jeremy acts as an advisor and outside general counsel, advising entrepreneurs, startups and high-growth companies throughout their life cycles. Focusing on gaining a deep understanding of client business, Jeremy helps with day-to-day business needs, venture capital financings, commercial relationships, and corporate governance matters. Jeremy focuses on simple, solutions-oriented approaches to challenges in order to provide efficient, comprehensive counsel, bringing clarity to complex issues to help clients achieve their business objectives.

Capabilities

• Venture Capital & Emerging Growth Companies
• Corporate & Transactional

Education

• Boston University School of Law (J.D., magna cum laude, 2014)
• Tufts University (B.S., cum laude, 2008) Bar Admissions
• Corporate Governance
• Mergers, Acquisitions & Divestitures
• Private Equity
• Private Equity – Mergers & Acquisitions
• Corporate Transparency Act
• Life Sciences
• Massachusetts, 2014 Memberships
• Boston Bar Association Recognition
• Named one of Best Lawyers: Ones to Watch in America in:

Technology Law, 2022-2025
Corporate Law, 2022-2025
Venture Capital Law, 2022-2025 ®

Matters

• Represented Sandbox Banking, a fintech company building a low-code integration platform for banking, on its $4.3 Million Series Seed financing.
• Represented CareAcademy, the leading care enablement platform for home care and home health organizations, on its strategic acquisition of assets from NextStep, an innovative digital healthcare training and job placement company for certified nursing assistants (CNAs).
• Represented Caraway Home Inc., known for making quality cookware without the chemicals, in its recent $35 million Series A Financing.
• Represented Edisn.ai Inc., an AI-powered fan engagement and monetization platform with patent pending player recognition technologies in acquisition by fuboTV Inc.
• Represented Motif FoodWorks, Inc. a food technology company providing ingredients for plant-based manufacturers on its $226 million Series B funding round which is the largest food technology financing to date.
• Represented Hull, Inc. a client data management company in the acquisition of MessageBird, the Amsterdam-based leader in omni-channel communications.
• Represented Indico Data Solutions Inc., the leading provider of Intelligent Process Automation (IPA) solutions in its $22 Million Series B Financing.
• Represented Stream.io, Inc. a software company located in Boulder, Colorado in its $38 Million Series B Financing.
• Represented CareAcademy.co, Inc., the leading home care & home health workforce empowerment platform, upskilling and preparing workers for the growing eldercare market and home care model, in its $9.5 Million Series A Financing.
• Represented ETF Action, Inc., an independent technology and research firm focused on helping investment professionals, in its $2 Million Series Seed Financing.
• Represented Rammer.ai (Symbl) in its $4.7 Million Series Seed-Plus Financing.
• Represented Trust Ventures in leading a $10 Million Series A Financing of Avvir, Inc., a startup using laser scans and AI to catch construction mistakes.

Andre LaFreniere

Vice President, Commercial Business Development and Sales, Medical Devices, Pharma/Drug Delivery, Data Science, Health

Andre LaFreniere leverages his 20 years experience in healthcare technology to advance opportunities and solve challenges in healthcare. Andre’s product development and commercialization knowledge spans collaborations with commercial clients across pharmaceuticals, biotechnology, medical devices, diagnostics, and healthcare.

Breck Petrillo

Director, Commercial Business Development and Sales, Medical Devices, Pharma/Drug Delivery, Data Science, Health

Breck Petrillo’s approach is centered on understanding and meeting client needs. With over 30 years of experience in healthcare technologies, he shares his expertise in product realization, from hands-on development and engineering to project planning and management, operational leadership, and strategizing for commercialization. He values his clients and ensures their needs are met through collaborative, efficient delivery of solutions.

Stephen E. Chelberg

Partner, Tokyo, Japan

​T +81 3 5774 1800​
stephen.chelberg@squirepb.com

Stephen Chelberg is the Asia Pacific chair of the global Corporate Practice and the leader of both the Life Sciences Group as a whole and in Asia Pacific. His practice focuses on cross-border corporate transactions, including public and private company mergers and acquisitions, divestitures, corporate restructurings, joint ventures, strategic alliances, venture capital, IPOs and financing projects for clients involved in a wide variety of sectors.
Stephen’s experience includes advising clients involved in the pharmaceutical, medical device, biotechnology, telecommunications, aerospace, software, computer hardware, semiconductor manufacturing and test equipment, iron and steel, machinery, transportation and chemical industries. Stephen also has extensive experience advising clients on a wide variety of commercial and intellectual property transactions, including collaborative research and development agreements, acquisition of IP rights, licensing and distribution arrangements and international dispute resolution and corporate compliance and regulatory issues, including anti-bribery laws. Stephen has also been involved in major infrastructure development, project finance and joint venture projects on behalf of clients in China, Thailand, India, Indonesia and Vietnam.
Twice in his career, Stephen took time out from the practice of law to establish and run, as president, two companies in Japan: a semiconductor equipment manufacturer and a supply chain software company.

Senior Partner, Washington DC

​T +1 202 626 6676​
john.wyand@squirepb.com

John Wyand, the US lead of our Life Sciences Group, is based in the Washington DC office. He is an experienced healthcare and life sciences lawyer who represents pharmaceutical companies, biotech companies and device manufacturers in a variety of FDA matters. He also represents hospitals and other direct-care providers in a wide range of strategic, regulatory and transactional matters. John is an M.B.A. with more than 20 years’ prior experience as a senior executive with a number of healthcare systems.
John has deep expertise in the full range of health IT-related issues. His experience includes advising a broad spectrum of clients on data privacy and security, cloud computing, social media, certified electronic health record technology, telehealth and mobile health applications.
John advises clients engaged in cross-border medical services, patient mobility and medical travel programs, as well as financing healthcare infrastructure. John has experience advising clients in implementing Healthcare Reform initiatives such as accountable care organizations (ACOs), clinical co-management arrangements, clinically integrated networks, patient-centered medical homes, and joint ventures between hospitals and physicians.
John contributes to publications on healthcare compliance issues including fraud and abuse, and the Health Insurance Portability and Accountability Act (HIPAA) privacy and security regulations, as well as on the deployment and meaningful use of certified electronic health records.
He is a Fellow of the American College of Healthcare Executives, a member of the American Bar Association and its Ehealth, Privacy & Security Committee, the American Health Lawyers Association and the District of Columbia Bar Association and its Health Law Section.

Delia A. Deschain

Partner, Washington DC

​T +1 202 457 6000​
delia.deschaine@squirepb.com

Delia Deschaine is a partner in the firm’s Global Corporate Practice, where she advises clients on the US Food and Drug Administration (FDA)’s laws, the US Drug Enforcement Administration (DEA)’s laws, and US state-controlled substance and pharmacy laws. Her practice focuses on providing comprehensive counsel to pharmaceutical and biotechnology manufacturers on a diverse array of issues, such as:

• ​New product development and approval, regulatory submissions, regulatory exclusivity, formal dispute resolution, controlled substances scheduling, advisory committee review, and citizen petition drafting and commentary.
• ​Compliance with the FDA’s Current Good Manufacturing Practices (CGMPs), Risk Evaluation and Mitigation Strategies (REMS), the Drug Supply Chain Security Act, and the requirements surrounding registration and listing; field alert reporting; import and export; recalls; and labeling, advertising and promotional activities.

Delia possesses a deep understanding of the FDA’s requirements concerning CGMPs and the FDA’s Quality System Regulations (QSR). She routinely advises clients on their obligations in this regard, encompassing quality systems, data integrity, supply chain management, aseptic processing, validation and sterilization protocols. Delia utilizes her expertise to assist manufacturers and suppliers in responding effectively to FDA Form 483s, warning letters and import alerts.
Additionally, Delia concentrates her practice on the intricate federal and state regulation of controlled substances. She defends pharmaceutical and biotechnology companies, distributors, pharmacies, hospitals, physician groups, academic medical centers, and researchers in controlled substances’ related government investigations and litigation. Her advisory services in this realm include:

• Assisting clients in navigating controlled substances scheduling matters
• Ensuring compliance with stringent DEA and state law regulatory frameworks
• Conducting thorough internal investigations to address potential compliance issues

Delia further utilizes her subject matter expertise to deftly advise clients in corporate transactions, conduct regulatory diligence, and draft and negotiate commercial agreements, including manufacturing services agreements, research agreements and quality agreements.

Delia has been named in ​DC Super Lawyers​ Rising Stars (2018-2020) and ​The Best Lawyers in America​ (2023-2024).

Danielle Asaad

Partner, New York, New York

​T +1 212 872 9800​
danielle.asaad@squirepb.com

A partner in the Global Corporate Practice, Danielle Asaad focuses her practice on private equity, as well as mergers and acquisitions. Danielle has completed numerous complex transactions on behalf of many sophisticated private equity firms, including leveraged buyouts, co-investments, recapitalization and cross-border transactions. She also represents private equity sponsors and their portfolio companies in follow-on acquisitions, dispositions, financings, corporate governance and management equity and incentive plans. In addition, Danielle advises private equity sponsors and senior deal professionals with respect to compensation and governance arrangements.
Danielle is an adjunct professor at the School of Law at Case Western Reserve University, where she teaches international business transactions. Danielle previously served on ​Law360​’s Editorial Advisory Board for Private Equity and has been quoted several times in ​The Wall Street Journal​.

Michael E. Helmer

Partner, New Jersey

​T +1 973 848 5610​

michael.helmer@squirepb.com

Mike Helmer is the Americas deputy practice group leader for the Corporate Practice in our New York and New Jersey offices. His practice is focused primarily on M&A, corporate finance and other commercial transactions. He has closed scores of transactions in his 30 years of practice, and is perpetually recognized as a ​Chambers​-rated lawyer. Mike has particular expertise in cross-border matters and regularly acts as outside general counsel to privately held companies.
In the past few years, Mike has been the lead US Corporate partner in more than US$1 billion of M&A transactions in the life sciences, technology, telecom, energy and power, and transportation/infrastructure sectors. He has been named a Super Lawyer and Top Deal Maker by NJ Biz and previously served as Adjunct Professor in Corporate Finance at Seton Hall Law School.
With respect to charitable and ​pro bono​ endeavors, Mike has served on a number of boards and committees with 501(c)(3) and other non-profit organizations, including the Summit Public Foundation, the United States Golf Foundation, Baltusrol Golf Club and Summit Elks Lodge No. 1246. He has lectured at the Entrepreneurial Bootcamp for Veterans on multiple occasions and was named by the Boy Scouts of America in 2018 as one of their Distinguished Citizens of the Year. He was previously honored by the Arc of New Jersey, an organization that protects the human rights of individuals with intellectual and developmental differences.

Janice Rice

Partner, San Francisco, California

​T +1 415 954 0353​
janice.rice@squirepb.com

Janice Rice has 20 years of experience assisting clients with their intellectual property needs in chemistry, pharmaceuticals, life sciences and cannabis industries. For more than 12 years of that time, she served as in-house patent counsel at small to mid-sized pharmaceutical companies. Her work includes representing companies in collaborations with institutes, universities and large pharmaceutical companies.
She has developed and managed portfolios covering small molecules, small molecule-antibody conjugates, polymorphs, formulations, consumer products, process chemistry, peptides and oligosaccharides. Her practice includes developing US and international patent strategies, patent drafting and prosecution, evaluation and protection of trade secrets, patentability and freedom to operate analyses, patent due diligence and advising on intellectual property licensing issues. Janice has contributed to patent protection for IMBRUVICA®, COTELLIC® and TALZENNA®, among other approved products.
Janice works as a strategic partner with companies on compounds at all stages of development, ranging from preclinical to approved drugs. She has a deep understanding of the pharmaceutical industry and the intersection of business objectives and patent strategy. In her work, she has advised clients on IP-related regulatory issues, product life cycle management and the handling of inventions made overseas.
Prior to her legal career, Janice worked for nine years as a synthetic organic chemist. She is the author of numerous scientific publications and has presented some of her research.

Todd A. Ostomel

Partner, Palo Alto, California

​T +1 650 843 3251​

todd.ostomel@squirepb.com

Todd Ostomel helps entrepreneurs and inventors develop patent and trade secret portfolios for protecting and monetizing inventions and ideas in the fields of organic chemistry, inorganic chemistry, materials science and biotechnology.
Todd focuses on patent prosecution and portfolio management, patent opinions, due diligence, utility and design patent applications, and trade secret counseling. Todd has extensive experience preparing and prosecuting US and international patent applications for small and large molecules, polymorphs, antibody-drug conjugates, ceramics, rechargeable batteries, biofuels, bioinformatics, diagnostic methods, methods of medical treatment, chemical processes, cryptocurrency, LEDs, photovoltaics, food products, energy storage, and machine learning technology. Todd also has extensive experience with trade secret enforcement.
His clients appreciate his ability to understand the technical details of their inventions as well as the legal issues relevant to their business goals.

Rahul Pathak

Partner, Palo Alto, California

​T +1 650 843 3304​

rahul.pathak@squirepb.com

Rahul Pathak assists clients with intellectual property rights in the fields of chemistry and biochemistry. His practice includes patent prosecution and portfolio management, patent opinions, patent reexaminations and patent due diligence. Representative clients include startup companies, established companies, leading life science companies, academic institutions, and investment firms in the pharmaceutical, biotechnology, renewable chemical, food and energy storage industries.During his legal career of more than 20 years, he has advised clients on developing and managing global patent portfolios for marketed pharmaceuticals and biopharmaceuticals, conducting intellectual property due diligence for private and public investments in pharmaceutical and biotechnology companies, and developing a patent portfolio of biofuels. Rahul holds a Ph.D. in chemistry and has extensive experience with small molecule therapeutics, therapeutic antibodies, antibody-drug conjugates, therapeutic peptides, therapeutic polypeptides, nucleic acid diagnostics, polypeptide biochemistry, structural biology and molecular biology. Dr. Pathak has contributed to patent protection for PEGASYS®, TYZEKA®, FOCALIN®, ZULRESSO™ and QBREXZA™, among other approved products.
Rahul was named to the ​Daily Journal​’s 2015, 2014 and 2013 lists of Top 25 intellectual property portfolio managers in California – an annual list of the most highly regarded lawyers in the state who advise clients in the management of their IP portfolios or patent prosecutions.
Rahul is a co-author of “Biofuels: A (Carbon) Balanced Act,” published in the ​San Diego Daily Transcript​ in 2008.

Jessie Mao

VP, General Manager of Tigermed America LLC of International Business Unit of Innovative Drug

Jessie Mao, VP, General Manager:

• 2022 President’s Award Winner
• More than 20 years of industry experience in leading Phase I-IV clinical trial studies and programs/portfolios both globally and regionally in various roles
• Participated in over 300 clinical trials and over 600 drug and medical device registration related experience
• Mainly involved in Oncology (Solid tumors, Lung cancer, Nasopharyngeal carcinoma, Breast cancer, liver cancer, Metastatic bone cancer, Esophageal cancer, Endometrial cancer, Cervical cancer, Prostate cancer, Colorectal cancer, GBM etc.), Cardiovascular diseases, ophthalmology, respiratory, dermatology, orthopedics, endocrinology, surgery, infectious diseases, in vitro fertilization ,OB/GYN, radiology, nephrology, urology, neurology, pediatrics, gastroenterology, In Vitro Diagnosis, Rehabilitation etc., and a variety of medical devices
• Graduated from Beijing Medical University and received Master and PhD degrees from Iowa State University

Shaun McAlpine

Director, Americas

Shaun McAlpine is the Trade and Investment Director for Investment NSW, based in California. Shaun is responsible for supporting US companies looking to set up, grow and do business in New South Wales, Australia as well as supporting Australian companies to expand their business in North America.
Shaun was previously an Investment Director for the Government of Victoria, based in San Francisco. He was responsible for driving investment outcomes and job creation across key investment sectors including tech, energy and decarbonization.
Prior to joining the Government of Victoria, Shaun was a Senior Executive for Scottish Development International (SDI) for 8 years across Boston, NY and Silicon Valley, responsible for working with both Fortune 500 and high-tech startups expanding in Scotland. Shaun also spent time working with Scottish exporters across key sectors to access the North American market.

Katie Edwards

Director of Biological & Medical Sciences

Katie Edwards is the Director of Biological and Medical Sciences at CUBRC. She has Ph.D. in Microbiology and Immunology and is a Program Management Certified Professional. She has over 17 years of experience leading drug, vaccine and diagnostics development programs with funding totaling over $220M from numerous government agencies including DTRA, NIAID, FDA, and BARDA.

David Mangino

Vice President

David Mangino is the Vice President of CUBRC’s Chemical, Biological and Medical Sciences Sector and is responsible for developing and leading CUBRC’s portfolio of medical countermeasure development programs for government and commercial clients. Mr. Mangino works with partner companies to develop strategies to pursue, propose and win non-dilutive investment from the US Government to advance partner technologies while providing the Government with critical capabilities to address our nation’s most pressing public health and security challenges. Mr. Mangino has been with CUBRC since 2001 and has 35 years of experience working in the Defense, Intelligence, Homeland Security and Medical communities. David received an undergraduate degree in Chemistry and a Master’s degree in Physical Chemistry from the SUNY College at Buffalo.

Kim Wiltshire

Strategic Engagement and Partnerships | Life Sciences | Social Impact | Community Development

Kim Wiltshire is based in the United States and focuses on growing trade and investment opportunities to benefit the Western Australian health and medical life sciences sector. Building from her foundations as a trained medical professional and ensuing 12 years working on strategy development, complex stakeholder engagement and corporate social investment projects, Kim is passionate about making a tangible difference in healthcare outcomes that will benefit populations across the globe. Connect on LinkedIn.