Meet us at the DIA and BIO International conventions

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This June, NDA will be attending the DIA USA and BIO convention with a strong line-up of world-leading speakers and experts.

The 53rd DIA Annual Meeting 2017 is being held on June 18-22, at McCormick Place, Chicago. Whilst, the BIO International Convention is on June 19-22, at San Diego Convention Center, San Diego.

If you are planning to attend this year’s DIA or BIO, we would really like to meet up with you. If you’d like to arrange a meeting with us, please email anna.perrin@ndareg.com.

Hear the experts

NDA’s experts will present on a number of critical drug development related topics at both the DIA and the BIO meeting.

NDA at DIA USA

Neelu AgarwalPete_TaftNeelu Agrawal, Principal, PharmApprove

Pete Taft, Founder and Chief Executive Officer, Taft and Partners/PharmApprove

 

Tutorial:  Preparing for a US FDA Advisory Committee Meeting
Track: 5 Regulatory Affairs #30
Day: Sunday June 18
Time: 13:00 – 16:30

Shelley_GandhiShelley Gandhi, Pharmacovigilance and Drug safety Expert expert, NDA Group
Title: The Good Pharmacovigilance Practices in the EU: Global Applications
Track: 6 Safety & PV #43
Day: Sunday June 18
Time: 09:00 – 17:00

Title:  Future Regulatory Goals of the Periodic Benefit-Risk Evaluation Reports (PBRER ): Are They Being Achieved?
Track: 6 Safety & PV #280 Developing Pharmacovigilance Policy based on Impact
Day: Tuesday June 20
Time: 16:00 – 17:15

Lesley_WiseLesley Wise, Principal Consultant, Pharmacoepidemiology, NDA Group
Title: Incorporating Patient Preferences in Benefit-Risk Assessments: Interpreting ICH M4E (R2)
Track: 4 Patient Engagement, Forum #251 Defining the Science of Patient Input to Enhance Drug Development & Approval: Regulatory
Day: Tuesday June 20
Time: 14:00 – 15:15

 


NDA at BIO USA

Lisa-PelusoMarkku ToivonenLisa Peluso, Director Coaching and Client Engagement, PharmApprove

Markku Toivonen, Scientific Director, NDA Group

 

Title: Bridging the Atlantic: How to Involve Patients in Orphan Drug Development and Approval Processes Given Differences between FDA and EMA
Day: Wednesday June 21
Time: 15:00 – 16:00 Room 3

 


To find out more or schedule an appointment with members of the NDA team, please email anna.perrin@ndareg.com

We look forward to hearing back from you about a meeting and to seeing you at the events!

 

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.

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.

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.

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 Panel at BIO Addresses Success in Drug Development Beyond Regulatory Approval

Lawrenceville, NJ (May 20, 2015) – PharmApprove – the leading strategic, regulatory and scientific communication consultancy to the pharmaceutical and biotechnology industries – will be presenting an interactive discussion on market access during the 2015 BIO International Convention in Philadelphia, PA. PharmApprove’s session, titled “Approval ≠ Commercial Success: Start Thinking Like a Payer,” will take place on June 16th at 10:15 am.

Dr. Laurie Smaldone, PharmApprove President and CSO, will moderate the group, which includes Steffen Thirstrup, PhD, Director of NDA Group’s Regulatory Advisory Board and former Head of Division at the Danish Health and Medicines Authority (former Danish Medicines Agency) and Coos de Graaf, PharmApprove Vice President, European Operations and former EVP and Head of Global Development at Solvay Pharmaceuticals.

According to Dr. Smaldone: “With this panel, we want to ensure that companies don’t waste their development dollars on products that will ultimately have no standing in the marketplace. Regulatory approval is a huge success benchmark, but it’s just as important to make sure that approved medications are positioned for optimal reimbursement. That’s why we want to help biotech companies anticipate what payers are going to want to know, and make sure those considerations are included in the development plan from day one.”

Prior to joining PharmApprove, Dr. Smaldone was Senior Vice President of Global Regulatory Science at Bristol-Myers Squibb, and also served as CEO of an early-stage inflammation company. She received her MD at Yale University, where she completed her residency in Internal Medicine and fellowship in Medical Oncology. Panelists Thirstrup, who is also an adjunct professor in pharmacotherapy, and de Graaf also have extensive experience with both clinical development and payer negotiations.

“The question of how to anticipate payer concerns is applicable to large and small biotech companies, all over the world” said de Graaf. “Any company’s survival is contingent on being commercially successful. And if you’re not inviting all of the necessary voices to the table early, you might wind up overlooking considerations that not only support approval but valuation until it’s too late.”

PharmApprove’s panel will begin with an overview, before moving into an interactive discussion involving several real-life case studies that showcase some of the pitfalls that can occur when payer concerns aren’t addressed early enough. Audience participation is encouraged throughout. Participants will leave with a clear understanding of the differences between designing programs for regulatory approval and for commercial success – and how to achieve both.

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, helping them win health authority approvals, deliver compelling regulatory communications, and make persuasive pharmacoeconomic arguments to payers and HTAs. Learn more at http://www.pharmapprove.com.

Join Us June 14th – Preparing for a US FDA Advisory Committee Meeting

PharmApprove Communications Coach Lisa Peluso to present at DIA’s Annual Meeting

“Preparing for a US FDA Advisory Committee Meeting”

June 14, 2015 1:00PM – 4:30PM

DIA Annual Meeting
Washington, DC
Walter E. Washington Convention Center

Learn more