NDA Group Releases Data Comparing FDA and EMA Ahead of Annual DIA EuroMeeting in Glasgow

Drop in US drug approvals but no similar trend is seen in EU

GLASGOW, Scotland, March 28, 2017 /PRNewswire/ — NDA Group announced findings from their fourth annual comparison of drug approvals in Europe and the United States, ahead of this year’s DIA EuroMeeting in Glasgow. This year’s Status of New Drug Approvals report emphasises the need for a streamlined global development and commercialisation process across the world’s two biggest markets.

The report – based on preliminary research figures from the EMA and FDA websites in January 2017 – found that there has been a drop in US approvals but not in EU. For 2016 there were 74 new drug approvals granted in the US and EU. Of these new products, 19 were approved only in the EU, 19 only in the US, and 36 were granted in both regions. However 17 drugs that were approved in the EU in 2016 had received prior approval in 2015 or earlier in the US, while only six products registered in the US in 2016 were previously approved in the EU.

Johan Strömquist, CEO, NDA Group “Understanding the evolving regulatory landscape and requirements is a key concern for the drug developing industry, as is it for us at NDA. It is intriguing to see how expedited pathways shape this year’s statistics just like it did last year, but with a very different outcome. It’s also interesting to see the continued rise of smaller companies in the percentage of products taken to market.”

“Our analysis for 2016 shows that NDA maintains an exceptional position in supporting new drug product approvals in Europe. During the last four years NDA supported over 40% of the new drugs approved with a broad range of services. I’m also excited to see the increase of products going through the FDA that received NDA’s support. NDA supported over 20% of new drugs that achieved approval by the FDA during 2016.”

Terese Johansson, PhD, NDA’s consultant behind the research commented: “The findings show that FDA has had a significant drop in drug approvals but continues to grant more expedited and nonstandard review approval status than the EMA. The drop is not as pronounced in the EU but is likely to be more prominent in 2017. Expedited drug development and nonstandard review approval pathways are the new norm in the US, but in the EU special approval procedures are not as common. The US situation could be explained by the increased use of the shorter nonstandard approval pathways since there has also been a significant increase in complete response letter (CRL). During 2016 FDA issued 14 CRLs, compared to just two in 2015.”

“The report also highlights the continued trend that many companies first seek approval in the US. Both the EU and US show increases in drug approvals from small and medium sized pharma but big pharma still dominates the drug approval statistics. The busiest therapeutic area was oncology.”

NDA-Infographic-2016

The pooled statistics showed that of the new drug approvals, 35 were classified as novel drugs (e.g. NAS, NME or BLA), nine were approved only in the EU, nine only in the US and 17 in both regions. For the EMA, the number represents the fewest NASs approved since 2011, while the FDA has not approved this few NMEs/BLAs since 2010. Big pharma represented 53% of the new drug approvals in 2016 vs 47% from small and medium sized pharma. For big pharma this is a decrease compared to previous years. Of all new products that received marketing approval in 2016, 30 products underwent special approval procedures like Conditional, Fast Track, Breakthrough, Accelerated Approval and Priority Review, 18 in the US, seven in EU and five in. In many cases more than one of these pathways was granted per product.

NDA Strategic Advisor and former Chief Exec of the EMA, Dr. Thomas Lönngren, as well as the company’s Scientific Director, Dr. Markku Toivonen and the Director of NDA’s Regulatory Advisory Board, Prof. Steffen Thirstrup will be present at DIA EuroMeeting together with a line-up of experts, and available to discuss these findings.

NDA staff can be found at booth C 10, 11 of the Congress Center and in the following presentations:

  • Shelley Gandhi & Bill Richardson – Ex MHRA Regulators
    (Pre-Conference Short Course) Short Course 4 | Wed, 29th March – 09:00-12:30
    Moving from Risk Management to Benefit / Risk Management –  Embedding Pharmacovigilance Principles into the product life cycle
  • Dr Mira Pavlovic –  HTA Expert, Session Chair
    Session 0101 | Wed, 29th March – 16:30-18:00
    Global dossier for clinical development
  • Prof. Steffen Thirstrup – Director NDA Regulatory Advisory Board – Session Chair
    Session 0302 | Thurs, 30th March – 11:00-12:30
    EU clinical trial regulation and its implications
  • Prof. Beatriz Silva Lima – Non clinical Expert
    Session 1002 | Thurs, 30th March – 11:00-12:30
    Optimising the development of paediatric medicines
  • Dr Markku Toivonen – Scientific Director & Medical Advisor – Session Chair
    Paul Chamberlain – Biopharmaceutical Development & Immunology Specialist – Session Speaker
    Session 0303 | Thurs, 30th March – 14:00-15:30
    Immunogenicity assessment-risked-based approaches

For more about NDA’s involvement with the 2017 DIA EuroMeeting, visit http://www.ndareg.com/meet-nda-at-the-dia-euromeeting-2017/.

To explore the full Status of New Drug Approvals for 2016 report, visit http://www.ndareg.com/wp-content/uploads/2017/03/NDA-Infographic-2016.pdf.

About NDA
NDA Group is a leading global drug development consultancy providing small as well as large, multi-national pharmaceutical companies with strategic advice and operational support to get good medicines to market and keep them there. Based in Boston, London, Munich, New Jersey, Stockholm and Zurich, NDA offers a range of professional drug development consulting services that spans from early development phase to lifecycle management of a medicinal product. These services span Development Strategy, Translational Science, Procedure & Submission Management, High-Stakes Meetings and Process Design & Optimisation. Clients are supported by a team of over 150 regulatory affairs, health technology assessment, pharmacovigilance, quality assurance and strategic communications professionals. Backing all major NDA projects is the unique NDA Advisory Board comprising industry experts, many of whom are ex- European Agency and FDA staff. Learn more at www.ndareg.com and follow them at www.linkedin.com/company/nda-group-ab.

About PharmApprove
The NDA PharmApprove team comprises leading strategic, regulatory, and scientific communications professionals. PharmApprove focuses on strategic and tactical support to companies facing high-profile, high-stakes events and engagements anywhere along the road to approval and commercialization – including FDA Advisory Committee meetings. PharmApprove helps clients win health authority approvals, deliver compelling regulatory communications, and make persuasive pharmacoeconomic arguments to payers and HTAs. Learn more at http://www.pharmapprove.com/ and follow them socially at twitter.com/pharmapprove.

Sarepta Receives Historic, Accelerated Approval from FDA

PharmApprove congratulates Sarepta Therapeutics on receiving accelerated approval for the first drug to treat Duchenne Muscular Dystrophy (DMD) in the US.  EXONDYS 51 has been approved for patients who have a confirmed mutation in the DMD gene that is amenable to exon 51 skipping.

This is an historic moment for Duchenne boys, their families and the larger rare disease community.

PharmApprove Hosts Tutorial at 2016 DIA Annual Meeting

How to Prepare for an FDA Advisory Committee Meeting?
PharmApprove Hosts Tutorial at 2016 DIA Annual Meeting

The leading consultancy will share best practices and “must avoids” in advisory committee preparation

Lawrenceville, NJ (June 21, 2016) – PharmApprove – a member of the NDA Group and the leading strategic, regulatory, and scientific communications consultancy in the U.S. – will lead a tutorial on FDA advisory committee preparation at the 2016 DIA Annual Meeting. The session will take place on Sunday, June 26th at 1:00 p.m. at the Philadelphia Convention Center, during DIA’s 52nd Annual Meeting. PharmApprove has more than 15 years of experience preparing companies for advisory committee meetings, and boasts an over 85 percent success rate.

“We ensure that our clients are 100 percent prepared for all scenarios when they appear before the FDA,” explained Lisa Peluso, director of coaching and client engagement for PharmApprove. “We understand what it takes to make a winning case before an advisory committee, and how to avoid potential pitfalls. Our expert support and coaching allows drug and device developers to clearly articulate the case for approval, and then focus on what’s really important – bringing new cures and treatments to patients.”

Peluso will lead the tutorial, which was developed with support from PharmApprove Founder and Executive Communications Strategist, Pete Taft. The tutorial helps corporate executives and other professionals across all R&D disciplines to effectively prepare for successful advisory committee meetings. PharmApprove has led thousands of training workshops and coaching sessions for regulatory, Medical Science Liaison, business development and payer negotiation teams at pharmaceutical companies around the world.

“When PharmApprove merged with NDA Group a few months ago, it heralded a truly exciting time for the company, with expanded global reach, expertise and talent. But that’s only one part of the equation,” said Laurie Smaldone MD, COO/CSO of NDA Group. “Our experienced coaching team and unsurpassed advisory committee preparation practices remain our strongest assets, allowing us to continue offering the best FDA approval consulting in the business.”

Visit http://dia201652ndannualmeeting.sched.org/event/61Nm for registration and scheduling information about the upcoming tutorial. Follow the social conversation online with the hashtag #DIA2016.

 

About PharmApprove

PharmApprove is the leading strategic, regulatory, and scientific communications consultancy to the pharmaceutical and biotech industries. The firm offers both strategic and tactical support to companies facing high-profile, high stakes events and engagements anywhere along the road to approval and commercialization – including FDA Advisory Committee meetings. PharmApprove helps clients win health authority approvals, deliver compelling regulatory communications, and make persuasive pharmacoeconomic arguments to payers and HTAs. PharmApprove merged with NDA in March of 2016. Learn more at pharmapprove.com or ndareg.com/pharmapprove and follow them socially at twitter.com/pharmapprove and facebook.com/pharmapprove.

About NDA

NDA Group is a leading global drug development consultancy providing small as well as large, multi-national pharmaceutical companies with strategic advice and operational support to get good medicines to market and keep them there. Based in Boston, London, Munich, New Jersey, Stockholm and Zurich, NDA offers a range of professional drug development consulting services that spans from early development phase to lifecycle management of a medicinal product. These services incorporate regulatory affairs, health technology assessment, pharmacovigilance and quality assurance. Clients are supported by a team of over 100 consultants and a unique Advisory Board comprising industry experts, many of whom are ex- European Agency and FDA staff. For more information, visit ndareg.com.

Tutorial at DIA Annual Meeting

We’re at DIA2016!  PharmApprove, as the leader in FDA Advisory Committee Preparation, will once again be teaching an informative, engaging and interactive class on “Preparing for a FDA Advisory Committee Meeting.” Can you identify the critical factors in preparing for a successful advisory committee meeting?  We’ll help you recognize and evaluate those factors that are most applicable to your team, and successfully design the most effective preparation for your team. Join us on Sunday, 26 June at 1:00.  Register here:   Click here

NDA Group Releases Data Comparing FDA and EMA Ahead of Annual DIA EuroMeeting in Hamburg

In spite of similar approval numbers, the US continue to outpace Europe Oncology is most active therapeutic area

Hamburg, Germany (April 5, 2016) – NDA Group announced today their findings from its third annual comparison of drug approvals in the United States and Europe, in preparation for this year’s DIA EuroMeeting in Hamburg. This year’s Status of New Drug Approvals report serves to emphasize the need for a streamlined global development and commercialization process across the world’s two biggest markets.

This year’s report – based on preliminary research figures distilled from the FDA and EMA websites on January 26, 2016 – found that FDA and EMA were equally productive in 2015, with a total of 89 new approvals granted. However, while 34 of those approvals came from the US and 32 in the EU, 24 drugs approved in the EU in 2015 had received prior approval in the US, while only 10 products out of 34 registered in the US in 2015 were previously approved in the EU.

“Understanding the needs and requirements of regional or even local stakeholders has become critical for biopharmaceutical companies looking to achieve a product’s full market potential,” said Johan Strömquist, CEO, NDA Group. “Integrating these requirements and developing strategies and plans to successfully meet them is at the heart of what we do at NDA. The differences between the two regions are natural given history, procedures and available regulatory pathways. The gap is however unnecessary and by bridging it companies would get the benefits of market presence in the world’s two largest markets. Critically, addressing this would provide patients on both continents access to important medical therapies faster.”

Last month, NDA Group, a leading strategic regulatory and HTA consultancy in Europe announced its merger with PharmApprove, a leading strategic regulatory and scientific communications consultancy in the US.

Olga Björklund, PhD, NDA’s Senior Consultant behind the research commented: “The findings released today indicate that drug development companies generally prefer to apply for approval in the US before pursuing the EU. Additionally, the FDA has a higher rate of granting special approval status through priority review designation, accelerated approval, fast track designation, and expedited approval. It is expected that with the EMA’s initiatives, such as early interactions between regulatory and health technology assessment bodies, interactions with committee for advanced therapies and the recent launch of the scheme for priority medicines (PRIME) there will be a noticeable impact on the approval statistics in Europe.”

Of all new products that received marketing approval in 2015, 41.6% (37/89) underwent special approval procedures, with FDA granting 27 and EU 13, which is a small increase compared to 2014, but almost double the number from 2013 in both regions.

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As for therapeutic areas, the busiest was oncology, with 23.6% (23/89) of the marketing authorizations granted during 2015. Approvals in infections dropped to second place, from 23.3% in 2014 to 14.6% for 2015. Those were followed by the products for endocrine system (12/89), cardiovascular (9/89) and respiratory system (9/89). Filgrastrim Sandoz was the only biosimilar to be approved in the US in 2015 (approved in the EU in 2009). In the EU no new approvals for biosimilars were granted in 2015, though 3 gained approval in 2014.

NDA’s CEO, Johan Strömquist as well as the company’s Scientific Director, Dr. Markku Toivonenand and the Director of NDA’s Advisory Board, Prof. Steffen Thirstrup together with a line-up of experts, will be present at DIA EuroMeeting and available to discuss these findings, as well as the global implications of NDA’s merger with PharmApprove. NDA staff can be found in stand A 2, 3 of Congress Center, and in the following presentations:

  • Shelley Gandhi & Bill Richardson

pre-conference tutorials Tutorial 2 | Wednesday, 06 April, 09:00-12:30

Moving from Risk Management to Benefit/ Risk Management – Embedding Pharmacovigilance Principles into the product life cycle

  • Shelley Gandhi

Session 1402 | Thursday 7th April – 11:00 -12:30
Communicating Benefit risk information in risk management plans to medical professionals and the general public – Benefit Risk communication in the life cycle & how it is reflected in PSURs and RMPs

  • Dr. Gopalan Narayanan

Session 0201 | Thursday 7th April 09:00-10.30
Translation of Cell & Gene Therapies

Session 0903 | Thursday 7th April, 14:00-15:30
Advanced Therapies: Planning the Long Term Follow up?

  • Professor Steffen Thirstrup

Session 1302 | Thursday, 07 April, 11:00-12:30

How will Payers React to the Future of Drug Development?

  • Dr. Simon Day Session 0106 | Friday, 08 April, 11:00 – 12:30

Standards of Evidence – From Block busters to Orphans

  • Professor Beatriz Silva Lima Session 0406 | Friday, 8th April – 11:00 -12:30

Evolving Areas of Regulatory Science

 

To learn more about NDA’s recent merger with US-based PharmApprove, visit ndareg.com/pharmapprove or contact info@ndareg.com (EU) or info@pharmapprove.com (US). To learn more about NDA’s involvement with the 2016 DIA EuroMeeting, visit ndareg.com/meet-nda-at-the-dia-euromeeting-2016/.

About NDA

NDA Group is a leading global drug development consultancy providing small as well as large, multi-national pharmaceutical companies with strategic advice and operational support to get good medicines to market and keep them there. Based in Boston, London, Munich, New Jersey, Stockholm and Zurich, NDA offers a range of professional drug development consulting services that spans from early development phase to lifecycle management of a medicinal product. These services incorporate regulatory affairs, health technology assessment, pharmacovigilance and quality assurance. Clients are supported by a team of over 100 consultants and a unique Advisory Board comprising industry experts, many of whom are ex- European Agency and FDA staff. For more information, visit ndareg.com.

About PharmApprove

PharmApprove is the leading strategic, regulatory, and scientific communications consultancy to the pharmaceutical and biotech industries. The firm offers both strategic and tactical support to companies facing high-profile, high stakes events and engagements anywhere along the road to approval and commercialization – including FDA Advisory Committee meetings. PharmApprove helps clients win health authority approvals, deliver compelling regulatory communications, and make persuasive pharmacoeconomic arguments to payers and HTAs. Learn more at pharmapprove.com and follow them socially at twitter.com/pharmapprove and facebook.com/pharmapprove.

 

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NDA Group and PharmApprove Announce Merger

European and US-based companies combine to create the world’s leading drug development consultancy

Princeton, NJ and Stockholm, Sweden (March 22, 2016) – NDA Group, a leading strategic regulatory and HTA consultancy in Europe, and PharmApprove, a leading strategic regulatory and scientific communications consultancy in the US, announced their merger today. The newly combined company will allow clients to streamline the global development and commercialization process, accelerating patient access to important medical therapies. Through the merger, NDA and PharmApprove will offer clients an unparalleled breadth of global experience and expertise to drive efficient product development across the US and Europe.

“NDA has supported over 45% of new medicinal products that were approved in Europe over the past three years, and more than half from the last year,” said Johan Strömquist, CEO of NDA Group. “By working together, NDA and PharmApprove offer clients a single partner that can provide a clear development path – considering both regulatory and market access requirements – to offer streamlined, strategic drug development advice across the world’s two largest markets.”

“With a high success rate of supporting clients preparing for FDA Advisory Committees and other regulatory milestones, PharmApprove has a long track record of great results,” said Laurie Smaldone Alsup MD, President of PharmApprove. “We will continue to provide comprehensive advisory committee services and expand our global support. Our culture is a perfect complement to NDA Group; we both believe in engaging highly experienced and high-quality people who provide expert guidance to our clients.”

The combined companies offer more than 35 years of experience in the drug development space, and boast a network of over 1,000 experts across a range of technologies, disciplines and therapeutic areas. NDA and PharmApprove will each retain their current staff and leadership, including more than 150 consultants, while adding to their capabilities and transatlantic reach.

“The deep knowledge of regulatory agencies and their requirements that I and my fellow NDA and PharmApprove consultants can provide is essential for any company looking to bring important new treatments to patients in need,” said NDA Group’s Strategic Advisor, and former head of the European Medicines Agency, Dr. Thomas Lönngren. “With our involvement in every step of the drug development process, we can prevent costly missteps – and ultimately ensure that clients have the best chance to prove the safety and efficacy of their drugs worldwide.”

The merger comes after nearly a year of strategic alliance between the two top firms.

“My experience working with NDA and PharmApprove clearly demonstrated that this is a case where the whole is greater than the sum of its parts,” explained Dr. Ron Robison, Vice President, Global Regulatory Affairs, Pharmacovigilance and R&D QA for AbbVie. “Having seamless, simultaneous access to regulatory experts in multiple markets helped us to develop the strategies we need to support optimal labeling and market access opportunities.”

PharmApprove was created in 1999 by New Jersey-based Taft and Partners. Pete Taft, founder and CEO of PharmApprove, will no longer have an executive role, but will continue to serve as a consultant to the combined company.

To learn more about the integrated global expertise this merger represents, visit www.ndareg.com/pharmapprove or contact info@ndareg.com (EU) or info@pharmapprove.com (US).

About NDA

NDA Group is a leading global drug development consultancy providing small as well as large, multi-national pharmaceutical companies with strategic advice and operational support to get good medicines to market and keep them there. Based in Boston, London, Munich, New Jersey, Stockholm and Zurich, NDA offers a range of professional drug development consulting services that spans from early development phase to lifecycle management of a medicinal product. These services incorporate regulatory affairs, health technology assessment, pharmacovigilance and quality assurance. Clients are supported by a team of over 100 consultants and a unique Advisory Board comprising industry experts, many of whom are ex- European Agency and FDA staff. For more information, visit ndareg.com.

About PharmApprove

PharmApprove is the leading strategic, regulatory, and scientific communications consultancy to the pharmaceutical and biotech industries. The firm offers both strategic and tactical support to companies facing high-profile, high stakes events and engagements anywhere along the road to approval and commercialization – including FDA Advisory Committee meetings. PharmApprove helps clients win health authority approvals, deliver compelling regulatory communications, and make persuasive pharmacoeconomic arguments to payers and HTAs. Learn more at pharmapprove.com and follow them socially at twitter.com/pharmapprove and facebook.com/pharmapprove.

PharmApprove Adds Patient Advocacy Expert

Leading strategic, regulatory and scientific communication consultancy welcomes former National Organization for Rare Disorders executive Diane Dorman

Lawrenceville, NJ (February 9, 2016) – PharmApprove announced today the hiring of Diane Dorman, former Vice President for Public Policy for the National Organization for Rare Disorders (NORD). Dorman will lead PharmApprove efforts to work with patients, caregivers, and patient advocacy groups to ensure their voices are heard throughout the drug regulatory review process.

“Adding Diane Dorman is just the latest in a series of moves to further strengthen our already-impressive roster of pharmaceutical industry experts,” said President and Chief Scientific Officer Dr. Laurie Smaldone. “Anyone who has worked in the regulatory space over the years is aware of Diane’s significant contributions to the patient advocacy landscape. Over the course of many years working to gain approvals for drugs treating rare diseases, she has developed an unparalleled network of federal regulators, Members of Congress and patient advocacy group representatives. Most importantly, she knows how to get things done.”

As VP for NORD, Dorman was the primary representative for more than 30 million Americans suffering from 7,000 known rare diseases. Her advocacy on their behalf was instrumental in passing several laws (including the Rare Diseases Act, the Rare Diseases Orphan Product Development Act, and House Concurrent Resolution 147), and in adopting numerous programs, regulations and guidances, leading to increased incentives for the development of orphan drugs, devices, and diagnostics. She served as a primary liaison with the Food and Drug Administration, the National Institutes of Health, the Social Security Administration, and the Center for Medicare and Medicard Services.

Dorman was co-founder and former president of the Alliance for a Stronger FDA, where she continues to serve on the Board of Directors. She has also been a member of the Council of the Convention of the U.S. Pharmacopeia and the Strategic Team for the Entrepreneurs in Residence Program at the Center for Devices Radiological Health at the FDA.

“I have always been dedicated to helping make life better for patients,” said Dorman. “The courage they and their caretakers show under extreme conditions has inspired me to work tirelessly on their behalf. I am thrilled to work with my new colleagues at PharmApprove to help get safe, effective treatments to the people who need them.”

Last year, PharmApprove announced that it entered a strategic alliance with European-based NDA Group. More information about their combined efforts to provide seamless global regulatory, scientific, and market access communications services to the life sciences industry can be found at ndareg.com/pharmapprove.

About PharmApprove: PharmApprove is the leading strategic, regulatory, and scientific communications consultancy to the pharmaceutical and biotech industries. The firm offers both strategic and tactical support to companies facing high-profile, high stakes events and engagements anywhere along the road to approval and commercialization – including FDA Advisory Committee meetings. PharmApprove helps clients win health authority approvals, deliver compelling regulatory communications, and make persuasive pharmacoeconomic arguments to payers and HTAs. Learn more at http://www.pharmapprove.com and follow them socially at www.twitter.com/pharmapprove and www.facebook.com/pharmapprove.

PharmApprove Expands Consultancy Team with Addition of New Clinical Regulatory Advisor

Leading strategic, regulatory and scientific communication consultancy welcomes
Renu Gupta, MD

Lawrenceville, NJ (October 15, 2015) – PharmApprove announced today the addition of Renu Gupta, MD to its consulting team. As a Clinical Regulatory Advisor, she joins a senior team of advisors with drug development and regulatory expertise. These advisors complement the more than 25 consultants, who provide pharmaceutical and biotech companies with regulatory strategy, scientific communications, and market access support.

“Dr. Renu Gupta is a wonderful addition to PharmApprove,” said President and Chief Scientific Officer Dr. Laurie Smaldone. “She has spent over 25 years working in the pharmaceutical industry and has extensive experience leading global research and development programs in infectious diseases, pulmonology, immunology, and oncology among other areas. Her vast expertise certainly makes her an asset to our team.”

Before becoming a consultant for PharmApprove, Dr. Gupta was a Special Advisor to the CEO of Insmed Incorporated, where she advised the CEO on new business strategy, portfolio assessment, acquisition targets, and due diligence. Prior to that, she was Executive Vice President of Development and the Chief Medical Officer at Insmed, and also served as Director of the UK subsidiary of Insmed Limited. Dr. Gupta’s past experience also includes Antigenics, Inc; Novartis; Covance; and Bristol-Myers Squibb

Dr. Gupta has been credited with leading a fully funded RSV research laboratory to examine host immune responses to viral infections and partnering with the National Institutes of Health to test RSV proteins in vaccinia expression vector. She has also advised Merck on vaccine portfolio and development strategies and led a study evaluating long-term immunity. Additionally, Dr. Gupta advised Bristol-Myers Squibb on drug discovery targets for in-house programs and for in-licensing in Infectious Diseases and Immunology therapeutic areas. She has also been an invited speaker and panelist at FDA and EMA workshops, and at the IOM.

Dr. Gupta is also a longtime member of many industry related organizations, including the American Association for Advancement of Science, the American Thoracic Society, American Society of Microbiology, American Society of Clinical Oncology, and the Infectious Disease Society of America.

“I am impressed with PharmApprove’s growing worldwide reputation for strategic, regulatory, and scientific communication expertise,” said Dr. Gupta. “I am excited to have the opportunity to use my experience with top life sciences companies, to help others succeed in bringing new treatments and cures to the patients who need them.”

About PharmApprove: PharmApprove is the leading strategic, regulatory, and scientific communications consultancy to the pharmaceutical and biotech industries. The firm offers both strategic and tactical support to companies facing high-profile, high stakes events and engagements anywhere along the road to approval and commercialization – including FDA Advisory Committee meetings. PharmApprove helps clients win health authority approvals, deliver compelling regulatory communications, and make persuasive pharmacoeconomic arguments to payers and HTAs. Learn more at http://www.pharmapprove.com and follow them socially at www.twitter.com/pharmapprove and www.facebook.com/pharmapprove.

 

Read more

PharmApprove Welcomes Two New Principals

Leonard Baum, RPh, and Neelu Agrawal, MBA, Join PharmApprove

PharmApprove Announces Strategic Alliance With NDA Group

“By working together, we are able to help companies get their products to market more efficiently with an optimized global label and market access position,” explained Dr. Laurie Smaldone, President and CSO, PharmApprove. “Too often companies hire one firm for US and another for EU regulatory advice and furthermore delink the planning for regulatory and market access success. This alliance offers a single partner who can provide global solutions instead of reinventing the wheel for every new market, thus saving time and money.”

Read more here.