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Welcome
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We are pleased to welcome Himanshu Kashyap, MD to the company as Chief Financial Officer. Dr. Kashyap joins Becker Consulting, along with the firm's sister companies, Becker Venture Services Group and Samson Venture Partners, after serving in the corporate finance team of B.C. Ziegler & Co., a leading healthcare-focused investment bank.
“Himanshu comes to us with a strong entrepreneurial spirit and a depth of knowledge and skill in healthcare, finance, and mergers & acquisitions essential to the continued successful growth of our companies,” said Karen M. Becker, PhD, CEO of Becker Consulting. In his role as CFO, Dr. Kashyap will expand the quality and depth of services offered by the company to the financial community, provide strategic financial leadership for the firm, and manage and build new business initiatives.
Dr. Kashyap has spent his entire career in the healthcare sector, including several years on Wall Street in mergers & acquisitions as an investment banker. During this time, Dr. Kashyap led multiple M&A, leveraged buyout, private equity placement, debt financing and financial restructuring transactions across industries and within healthcare, for a sum of over $2.0 billion in completed transactions. Within the healthcare sector, Dr. Kashyap’s experience spans the biopharmaceutical, biotechnology, medical devices, specialty pharmaceutical, healthcare services and healthcare information technology markets.
Dr. Kashyap earned his Doctor of Medicine from Bangalore University, India and his Master in Business Administration in Corporate Finance from the University of Southern California, Marshall School of Business, where he was a Dean's fellow.
Contact: himanshu.kashyap@becker-consult.com |
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News
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Campbell T. Hutton, Vice President, Strategic Consulting Group, and Alice S. Bailey, Senior Consultant, interviewed Dr. Jonathan Sackner-Bernstein, Associate Director for Postmarket Operations at US FDA. The interview was published in the May/June edition of the Regulatory Affairs Journal (RAJ), Devices. [Reprint]
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Phil Phillips, Director, Medical Device Practice and Robert A. Rhoades, Director, Pharmaceutical Quality & Compliance Practice, will participate in the 52nd Annual FDLI & FDA Conference held April 22-23, 2009 in Washington, DC. The conference will focus on the opportunities and challenges facing FDA and the new administration.
More information on the FDLI & FDA Conference can be found at www.fdli.org/conf/annual-09/letter.html.
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Phil Phillips, Director, Medical Device Practice, will speak at the Medical Device Manufacturer Association's (MDMA) Premarket Approval (PMA) and 510(k) Premarket Notification Seminar on March 26, 2009 in Boston. The seminar brings perspective from leading FDA attorneys, industry representatives, and FDA officials to companies seeking insight on how to best prepare for a 510(k) or PMA submission.
More information on the MDMA Seminar can be found at www.medicaldevices.org/public/programs/510kPMAMassachusetts.asp.
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Ron Ginor, MD, Managing Director of Samson Venture Partners, in an inverview with BioIsrael after the recent $2 million investment round in Tel Aviv's SteadyMed, stated: "We expect to invest about $20 million in ten different companies in the next five years." Article.
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Samson Venture Partners LLC, the investment management arm of Becker & Associates Consulting, closed an initial $2 million strategic funding round for SteadyMed, Ltd. on January 26, 2009.
SteadyMed, an Israeli company, has developed a miniature disposable infusion pump technology, called PatchPump®, with unique drug delivery characteristics to enable enhanced portability and optimized drug infusion. Press Release.
Samson Venture Partners identifies opportunities and manages investments in companies providing unique clinical, regulatory, strategic or clinical opportunities in the life science sector. Press Release.
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Elaine C. Messa, Director, Medical Device Quality Systems and Compliance, will speak at the Medical Design & Manufacturing West conference held from February 9-12, 2009. The MD&M West conference features many thought-provoking presentations from industry and regulatory experts within the medical manufacturing community, providing expert advice for implementing the best practices and processes. Elaine Messa will chair sessions on Wednesday, February 11, focusing primarily on international medical device quality compliance.
More information on the MD&M West conference can be found at www.devicelink.com/expo/west09/index.html.
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Risky Business: Managing the Quality of America's Medicines has been released in its second edition by FDAnews. Authored by Robert A. Rhoades, Director, Pharmaceutical Quality & Compliance at Becker & Associates Consulting, the book offers insights from 30 years in the industry. The update for the second edition is timely in light of significant events in the industry throughout 2008. With a new administration, an embattled FDA under scrutiny from Congress, and an industry under fire for insufficient controls in the supply chain from foreign manufacturing sites, Bob provides clear and actionable guidance for executives responsible for risk management, both here and abroad.
"We are at the start of a hyper-vigilant period when it comes to the inspection and enforcement of quality systems, both nationally and internationally," said Ron Ginor, MD, President of Becker & Associates Consulting. "Given recent events, consumers and regulators have little tolerance for system failures, and corporations have to proactively redouble their efforts in order to protect their consumers and their reputation in this context." Press Release.
The book is available through FDAnews at www.fdanews.com. |
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News Archive |
September 21, 2008 - The Gray Sheet Announcement:
Becker & Associates taps Elaine C. Messa as Director, Medical Device Quality Systems and Compliance. As former director of FDA’s Los Angeles field district office, Messa oversaw the largest import operations and medical device workload in the agency, the health care consulting firm says. Messa, who has also chaired CDRH’s field committee, left FDA in 1999 to join Quintiles Transnational. At Becker, Messa is charged with expanding the firm’s compliance practice, where she will focus on enforcement action responses and international supply-chain risk management.
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Our branch office opens November 1, 2007
BECKER VSG - ISREAL
1 Azrieli Center
30th Floor (Round Tower)
Tel Aviv 67021
Israel
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BECKER CONSULTING is pleased to sponsor:
ILSI BIOMED ISRAEL 2007
June 5-7
Tel Aviv, Israel
Bringing together the international life science and
venture capital community.
See http://www.kenes.com/biomed/conference/home.asp. |
We are moving to accomodate growth.
Effective January 8, 2007, please note our new suite number:
2001 Pennsylvania Avenue NW
Suite 950
Washington, DC 20006 |
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Welcome |
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We are pleased to welcome Elaine C. Messa in August as Director, Medical Device Quality Systems and Compliance Practice. Ms. Messa has more than 30 years of experience in the field at both FDA and as a consultant to industry leaders. At FDA, Ms. Messa was Director of the Los Angeles District which is the district responsible for the largest import operations and medical device workload in the US. Contact: elaine.messa@becker-consult.com.
Ms. Messa brings the same degree of prominent depth and experience as our existing Pharmaceutical Quality and Compliance Practice directed by Robert A. Rhoades. Contact: bob.rhoades@becker-consult.com.
Ms. Messa’s Biography
We are pleased to welcome M. Blythe Karow, MBA as General Manager, Business Strategies. Ms. Karow is a recent graduate of the Darden School of Business Administration at the University of Virginia, and has an undergraduate degree in biomedical engineering. Ms. Karow's industry experience includes employment at BlueSky, Ethicon, and Medtronic.
We are pleased to announce that Robert A. Rhoades joins the firm as Practice Director, Quality Systems and Compliance. Mr. Rhoades and his team have 30 years of experience and leading technical competence in both the pharmaceutical and medical device industry. (January 2008)
We are pleased to welcome Ronda A. Balham, OD as Deputy Director, Medical Device Practice. Dr. Balham served 20 years in the U.S. Public Health Service, with senior executive positions at the FDA, including in the Office of Device Evaluation (CDRH) and the Office of the Commissioner. (September 2007)
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We are pleased to welcome Laura Straub, Priyanka Vakkalanka, and Danielle Altares to our staff as Research Associates. (June - July 2007) |
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Invited Presentations |
Phil
Phillips presented at the RAPS Horizons 2007 Conference & Exhibition in San Francisco, March 28, 2007: "Device Classification Mechanisms and Regulatory Strategy." See www.raps.org. |
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Phil
Phillips presented at the Scientific Affairs Committee Meeting of
the Consumer Healthcare Products Association in Washington, DC
on
May 1,
2006
: "Medical Devices for Over-the-Counter Use."
See www.chpa-info.org. |
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Dr. Ryung
Suh presented in the “Ethics Forum Poster Session” at the
American Public Health Association conference in Boston, MA, November 6-7, 2006. See www.apha.org. |
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Phillips presented at the Premarket Approval (PMA) and 510(k) Premarket Notification
Workshop, San Diego, CA, September 28, 2006. Co-sponsored by MDMA, California
Healthcare Institute, and Latham & Watkins. See www.medicaldevices.org. |
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Phil
Phillips moderated the FDLI Audioconference on "An Update on CDRH’s Draft Guidance for Industry and FDA Staff – The Review and Inspection of Premarket Approval Application Manufacturing Information and Operations."
September 11, 2006.
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Phil
Phillips participated in an audio conference entitled
"Doing Double Duty: Collecting Data for FDA and CMS in the Same
Study" for Compliance-Alliance LLC.
June 1, 2006.
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Dr. Ryung
Suh and Dr. Brent R. Gibson presented in Washington, DC on
May 24, 2006:
"Avoiding the Pitfalls: Calculating ROI and Making the Business
Case for Health Promotion and Education Programs" at the 24th
National DHPE/CDC Conference on Health Promotion and Education. See
www.dhpe.org. |
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Kristin
Zielinski directed a workshop in London, England on May 22-25,
2006: "Introduction to US FDA Regulation of Medical Devices"
at IBC's 12th Course on Medical Device Regulations. |
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Phil
Phillips moderated "FDA Center Happenings: Priorities and Possibilities"
with Dr. Daniel Schultz, Director of the Center for Devices and
Radiological Health, at FDLI’s
49th Annual Conference on April 5-7, 2006. See www.fdli.org. |
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Dr. Ryung
Suh presented at a pharmacoeconomics
conference in Shanghai, China on March 5-7, 2006: "Economic
Evaluation of Disease Management" at the International Society
for Pharmacoeconomics and Outcomes Research
(ISPOR) 2nd Asia-Pacific Conference. See www.ispor.org. |
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Brent
R. Gibson and Ryung Suh presented at a prevention conference
in Reno, Nevada on February 22-26, 2006: "Assessing and Improving
Public Health Data" and "Toward Consensus in the Economic
Evaluation of Disease Management" at the American College of
Preventive Medicine annual meeting. See www.acpm.org. |
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Kristin Zielinski directed a workshop in Berlin, Germany
on November 21-24, 2005: "Introduction to US FDA Regulation of Medical Devices" at IBC's 11th Course on Medical Device Regulations.
See www.ibc-lifesci.com.
Brochure. |
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Ryung
Suh moderated the 3rd Annual Healthcare Day
Marketing Panel for the Healthcare Business Alliance at the
McDonough School of Business, Georgetown University. Washington, DC.
November 18, 2005.
See www.msb.edu.
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Ryung
Suh discussed "Humanity as a Weapon of War" at
the Council on Foreign Relations 10th Annual Term Member
Conference. New York, NY.
November 11, 2005. See www.cfr.org. Summary. |
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Phil Phillips discussed "510(k)s: Has the Bar Been Raised?"
at the RAPS 2005 Annual Conference and Exhibition. Baltimore, MD. October 16-19, 2005.
See www.raps.org. |
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Phil
Phillips moderated an FDLI audioconference
with FDA's Deputy Commissioner, Dr. Scott Gottlieb on
October 3, 2005.
See www.fdli.org.
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Medical Device Manufacturers Association Workshop:
What Every Medical Technology Company Should Know About the 510(k) Process. Burlington, MA. September 30, 2005.
Presentation by Dr. Karen Becker: "Designing Your Study To Support a 'Substantial Equivalence' Determination".
See www.medicaldevices.org. |
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Phil Phillips discussed "Raw Materials Specifications"
at Japan's Pharmaceutical Affairs Law: What You Need to Know, sponsored by AdvaMed. Gaithersburg, MD. September 17, 2005.
See www.advamed.com. |
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Compliance-Alliance. August 11, 2005.
Teleconference with Phil Phillips: "Integrating a CMS Reimbursement Strategy into Your FDA Planning Process". See
www.compliance-alliance.com. |
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Expert Briefings. July 27, 2005.
Audioconference with Phil Phillips: "How to Meet Premarket Clearance Requirements with Evolving Device Design and Labeling." See
www.expertbriefings.com. |
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CBI's
Executive Summit on Medical Device Reimbursement and Medicare Coverage co-sponsored
by The Wall Street Journal. Washington, DC. June 16-17, 2005.
Presentation by Dr. Karen Becker: "Conduct a Competitive
Landscaping and Analysis". See www.cbinet.com. |
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Fonds de Solidarite FTQ. Montreal, Canada. May 25, 2005.
Presentation by Dr. Ryung Suh and Phil Phillips: "Strategic Reimbursement in the United States". See
www.fondsftq.com. |
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A Conversation with Phil Phillips:
Insights into CDRH's Office of Device Evaluation hosted by FOI Services. An interactive teleconference with Phil Phillips. May 5, 2005.
See www.foiservices.com. |
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FDLI's Introduction
to Medical Device Law and Regulation Workshop. Washington, DC. May 4-5, 2005. Presentation by Dr. Karen Becker. See
www.fdli.org. |
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CBI's Inaugural Medical Device
and Diagnostics Marketing Compliance Congress co-sponsored by The Wall Street Journal.
Washington, DC. April 18-19, 2005.
Presentation by Dr. Karen Becker: "Develop a Risk Management Strategy for Your
DTC Advertising Campaign". See
www.cbinet.com.
Conference Brochure.
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Women's Health: Legal, Regulatory, and Policy Issues.
FDLI & National Association of Women Lawyers. Washington, DC. December 3,
2004. Dr. Karen Becker, Planning Committee. See
www.fdli.org.
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Medical Device Manufacturers Association Workshop: What Every Medical Technology
Company Should Know About the 510(k) Process. Washington, DC. September 2004.
Dr. Karen Becker on Study Designs. See
www.medicaldevices.org.
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FDLI's Advanced Medical Device Issues Program.
San Francisco, CA. June 24-25, 2004. Dr. Karen Becker discussed "Premarketing
Clinical Programs" and "Postmarketing Clinical Programs". See
www.fdli.org. |
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Food and Drug Law Institute. Introduction to Medical Device Law and Regulation. Dr. Karen Becker. Washington, DC. October 28-29, 2002. See
www.fdli.org.
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Drug Information Association. Medical Devices. Successful Approaches to Approval of Class III
(PMA) Products. Dr. Karen Becker. Philadelphia, PA. February 2002. See
www.diahome.org.
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Publications |
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Zielinski KM, Gardner LD, Speed RL. 2005. Postmarketing Surveillance in the US: A System under Scrutiny.
Regulatory Affairs Journal (Devices) 13:67-72.
Reprint (with correction).
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New FDA bioresearch monitoring initiatives are summarized in
Zielinski KM, Tuskey CL. 2004. FDA Bioresearch Monitoring: New Initiatives for Medical Device Clinical Trials.
Regulatory Affairs Journal (Devices) 12:259-263.
Reprint.
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Of Interest |
BECKER CONSULTING retained to provide independent quality and compliance services to heparin manufacturer in China. Reprint.
BECKER CONSULTING was a Gold Sponsor for the ILSI BIOMED ISRAEL 2007 in Tel Aviv, Israel, June 5-7, 2007. See http://www.kenes.com/biomed/conference/home.asp.
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BECKER CONSULTING submitted comments to the FDA Docket on
Guidance for Saline, Silicone Gel, and Alternative Breast Implants. (April 12, 2004).
See www.fda.gov.
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